NEBRASKA MPJE REVIEW

Transcription

1 NEBRASKA MPJE REVIEW Updated 2015

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3 DISCLAIMER The MPJE Review for Nebraska is a review of state and federal statutes/regulations that govern pharmacy practice in Nebraska. This review is organized by our interpretation of the laws as they relate to the NABP Competency Statements (included throughout the review) for the MPJE. You are responsible for knowing all of the laws as they are written. All study materials, including this document are to supplement studying the statutes and regulations. You are encouraged to use this review as a supplement, but also study the actual statutes and regulations for a better understanding and more comprehensive review as anything can be fair game for questions. Please note that Nebraska regulations have not been recently updated to keep pace with changes in statutes. It is important to remember that the statute will prevail over obsolete language in regulations.

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5 NPA CONTACT INFORMATION If you have questions, please contact us at or by phone at We wish you the best of luck on the exam and hope that you value membership in the Nebraska Pharmacists Association (NPA). Visit our website at

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7 TABLE OF CONTENTS Multistate Pharmacy Jurisprudence Examination (MPJE) MPJE: What is it?...1 About The Test...2 Important Reminders...3 Common Errors...4 Study Tips...5 Types of Questions...6 Testing Tips...7 Study Materials...8 MJPE Competency Statements...9 Area 1 Pharmacy Practice...10 Area 2 Licensure, Registration, Certification and Operational Requirements...11 Area 3 Regulatory Structure and Terms...12 Know Relevant Statutes and Regulations...13 Area 1: Pharmacy Practice, Section 1.01 Duties of Pharmacy Personnel...17 Pharmacist-In-Charge...18 Pharmacist-In-Charge Duties...19 Pharmacist-In-Charge Duties, Parkinson s Disease Registry...20 Change of Pharmacist-In-Charge...21 Pharmacist-In-Charge Duties, Pharmacy Closing...22 Pharmacy Closing...23 Transfer of Controlled Substances...24 Practice of Pharmacy, Defined...25 Pharmacy, Scope of Practice...26 Unprofessional Conduct, Defined...27 Coercion to Dispense a Drug...31 Consultant Pharmacist, Defined (Delegated Dispensing Permit)...32 Consultant Pharmacist Duties (Delegated Dispensing Permit)...33 Pharmacy Technician Duties...38 Pharmacy Technicians, Unauthorized Tasks...39 Definition of Supervision...40 Definition of Verification...41 Board of Pharmacy Permission for Use of Pharmacy Technicians...42 Written Control Procedures and Guidelines for the Use of Pharmacy Technicians...44 Pharmacy Technician Registration...45 Pharmacist Intern, Qualifications, Registration...46 Pharmacist Intern Requirements...47 Pharmacist Intern Duties...50 Supervision Ratio...51 Nebraska Pharmacists Association i

8 TABLE OF CONTENTS Area 1: Pharmacy Practice, Section 1.02 Federal Laws, Acquisition and Distribution...57 Restrictions on Sales/Purchase/Trade of Prescription Drug Samples...58 Drug Sample or Sample Medication...59 Drug Storage Requirements...60 Distribution...61 Wholesale Drug Distributor...62 Wholesale Drug Distribution Does Not Include...63 Emergency Medical Reasons...64 Area 1: Pharmacy Practice, Section 1.03 What is a Valid Prescription?...69 Corresponding Responsibility...70 Practitioner, Defined...71 Pain Management with Drugs...72 Administration of a Narcotic to a Narcotic Dependent Person...73 The Drug Addiction Treatment Act of 2000 (DATA 2000)...75 Optometrist Prescribing Authority...76 Advanced Practice Registered Nurse (APRN)...77 Nurse Practitioner (APRN-NP) Prescribing Authority...78 Certified Registered Nurse Anesthetist (APRN-CRNA) Performance of Duties...79 Certified Registered Nurse Anesthetist (APRN-CRNA) Prescribing Authority...80 Certified Nurse Midwife (APRN-CNM) Prescribing Authority...81 Practice of Certified Nurse Midwife (APRN-CNM) Regulations...82 Physician Assistant (PA) Prescribing Authority for Drugs and Devices, Restrictions...83 Dentist Prescribing Authority...84 Veterinarian Prescribing Authority...85 Podiatrist Prescribing Authority...86 Doctor of Medicine and Doctor of Osteopathic Medicine Prescribing Authority...87 Nebraska Pharmacists Association Area 1: Pharmacy Practice, Section 1.04 Drugs, Medicines, and Medicinal Substances, Defined...93 Controlled Substance, Defined...94 Schedule II Controlled Substance Prescriptions...95 Schedule III, IV & V Controlled Substance Prescriptions...97 What Changes Can a Pharmacist Make on a CII Prescription?...98 Dispensing Emergency CII Prescriptions From an Oral Order...99 Drug Paraphernalia Schedule I Controlled Substances Schedule II Controlled Substances Schedule III Controlled Substances Schedule IV Controlled Substances Schedule V Controlled Substances ii

9 TABLE OF CONTENTS Dispensing A Controlled Substance Without A Prescription Construction of A Valid DEA Registration Number for Practitioners Verifying A Prescriber s DEA Registration Number Persons Entitled to Issue Prescriptions Transmission of Prescriptions by Facsimile Prescription, Defined How Long Is A Prescription Valid? Manner of Issuance of Prescriptions Dispensing Requirements Automated Medication Systems Act Risk Evaluation and Mitigation Strategy (REMS) Electronic Transmission, Defined Authority to Administer Authority to Administer, Practice Agreements Authority to Administer, Pharmaceutical Care Defined Federal Law, Dispensing Federal Law, Poison Prevention Packaging Act Most Common Exemptions From Poison Prevention Packaging Act Labeling of Poisons Poison Register Restricted Distribution Programs Prescription Requirements Medical Order, Duration, Dispensing, Transmission Persons Excepted From the Practice of Pharmacy Legend Drug Label Prescription Container Label Labeling of Substances and Filling of Prescriptions (Schedule II) Labeling of Substances and Filling of Prescriptions (Schedule III, IV or V) Availability of Records to Department and Law Enforcement Unlawful Acts Regarding Controlled Substances Prescription Drug or Device or Legend Drug or Device, Defined Nebraska Drug Product Selection Act Drug Product Selection Terms, Defined Drug Product Selection, Exceptions Drug Product Selection and Formularies Drug Product Selection, Patient Advising Drug Product Selection, Protection of Pharmacist Transferring Prescriptions Transferring Pharmacy Receiving Pharmacist/Pharmacist Intern Transferring Prescriptions Summary Return of Dispensed Prescriptions Return of Dispensed Prescriptions From Long-Term Care Facilities Nebraska Pharmacists Association iii

10 TABLE OF CONTENTS Return of Drugs by Community Health Center Patients Return of Dispensed Drugs From Correctional Facilities Cancer Drug Repository Immunosuppressant Drug Repository Disposal of Controlled Substances Reverse Distributors Authorized to Dispose Controlled Substances Controlled Substance Theft or Significant Loss Breakage and Spillage of Controlled Substances Emergency Box Drugs, Types of Drugs Included Emergency Box Drug Inspection Emergency Box Drug, Requirements of Facility Destruction of Drugs in Long-Term Care Facilities Long-Term Care Facilities, Pharmacist Responsibilities An Accident, Natural Disaster, or Interruption in Utility Services Disaster Preparedness and Management Compounding, Defined Compounding, FDA Compliance Policy Compounding vs. Manufacturing Delegated Dispensing Permit Delegated Dispensing Permit, Formularies Delegated Dispensing Permit, Worker, Qualifications Delegated Dispensing Permit, Workers, Training, Requirements, Documentation Pharmacy Inspections Area 1: Pharmacy Practice, Section 1.05 Federal Laws Pharmacist Duties, Prospective Drug Utilization Review Patient Records Patient Counseling Pharmacist Patient Counseling Duties, Not Required Patient Package Inserts (PPIs) Medguides Voluntary Reporting to FDA Nebraska Pharmacists Association Area 1: Pharmacy Practice, Section 1.06 NonPrescription Drugs, Defined Federal Law, Over-the-Counter Drug Facts Label (1999) Over-the-Counter Labeling Requirements Commercial Drug Label Combat Methamphetamine Epidemic Act (CMEA) of Methamphetamine Precursor, Seller, Duties, Waiver Authorized iv

11 TABLE OF CONTENTS Area 1: Pharmacy Practice, Section 1.07 Patient Records Medical Records (includes Prescriptions) Pharmacist, Patient Information, Privileged HIPAA: Health Information Portability & Accountability Act Patients Records Are Confidential From Pharmacy Perspective Confidential Communication Records for Dispensing, Prescription Files Prescription Files Readily Retrievable Defined By Controlled Substances Act (CSA) Procedure for Ordering Controlled Substances Lost or Stolen DEA Form Controlled Substance Inventory Security of Drugs in a Pharmacy Records of Acquisition and Disposition of Drugs Records of Controlled Substances Records of Controlled Substance Refills Refilling Prescriptions, Issuance of Multiple Prescriptions Area 2: Licensure, Registration, Certification, & Operational Requirements, Section 2.01 License, Duration, Issuance Credential, Availability, Identity of Profession or Business Issuance of Credential Recredentialing Eligibility for Recredentialing Licensee Assistance Program Membership of the Nebraska Board of Pharmacy Qualifications for a Pharmacy Inspector Department Inspector or Investigator Requirements for a Pharmacist License Application for a Pharmacist License Licensure as a Pharmacist on the Basis of Reciprocity from Another State/Jurisdiction Temporary Educational Permit Pharmacist License Renewal Procedures Requirements for Continuing Competency Pharmacy Technician Registration, Renewal Fee Pharmacist Intern, Qualifications, Registration Persons with a Suspended Credential Persons with a Revoked Credential Nebraska Pharmacists Association v

12 TABLE OF CONTENTS Area 2: Licensure, Registration, Certification, & Operational Requirements, Section 2.02 Pharmacy License General Requirements Licensing Requirements and Procedures Department Process for Initial Licensure, Pharmacy Department Process for Initial Licensure, Provisional Pharmacy License Area 2: Licensure, Registration, Certification, & Operational Requirements, Section 2.03 Physical Standards for a Pharmacy Required References for a Pharmacy Pharmacy Quality Assurance Report (PQAR) Mandatory Reporting Mandatory Reporting, Same Profession Mandatory Reporting, Different Profession Mandatory Reporting, Self Mandatory Reporting, Exceptions Report, Confidential, Immunity, Use of Documents Ophthalmic Provider, Contact Lens Prescription Mail Order Ophthalmic Provider Registration Mail Service Pharmacy License, Requirements, Fee CLIA Waivers Wholesale Drug Distributor License Wholesale Drug Distribution Area 3: Regulatory Structure and Terms, Sections 3.01 and 3.02 Food, Drug and Cosmetic Act Types of NDAs New Drug Entities Federal Laws, Manufacturing Adulterated Drug Food, Drug and Cosmetic Act Misbranded Drug Food, Drug and Cosmetic Act Adulteration, What Constitutes Misbranding, What Constitutes Examples of Misbranded Drugs FDA, New Drug Approval 17 Year Process Investigational New Drug Application FDA, Package Inserts Drug Recall Classes Nebraska Pharmacists Association Quiz Answer Key Abbreviations Acts vi

13 1 MPJE: WHAT IS IT? Multistate Pharmacy Jurisprudence Examination Tests on mastery of pharmacy law as outlined by MPJE Competency Statements Assesses ability to apply knowledge, skills, and abilities to evaluate situations involving the applicable federal and state statutes and regulations that govern the practice of pharmacy in Nebraska. State specific, so results are not transferable to other states. Computer-adaptive examination Assesses answers for each question Estimate of ability level based on difficulty of questions answered correctly Review the Registration Bulletin with regard to the Computer-Adaptive MPJE, MPJE Competency Statements, and MPJE Sample Items at The Registration Bulletin takes you through all expectations for physically taking the test and suggestions for preparation.

14 2 ABOUT THE TEST 2 hour seating time no breaks 90 multiple-choice questions 75 questions used to calculate test score 15 questions used as pretest questions (do not impact your MPJE score but you won t know which ones, as they are dispersed throughout the exam) There is a penalty if you do not answer all 90 questions it is advised to answer ALL questions Passing score is 75 (not a %) Determines ability level If at first you don t succeed Retake after a minimum of 30 days per each state. NABP forwards scores to the Board Of Pharmacy (BOP). Your score results will not be given to you if you call the BOP or released at the test center. Scores will be posted online.

15 3 IMPORTANT REMINDERS You cannot change your answers once your choice is confirmed! You cannot go back and review questions! You cannot skip questions! No distinction is made between federal and state laws Answer each question in terms of prevailing laws in the state you are seeking licensure (Nebraska) More strict rule always applies between state vs. federal laws

16 4 COMMON ERRORS Not reading the question carefully in order to understand the question. e.g.: Which one of the following is NOT required to be placed by the pharmacist onto a prescription? e.g.: Which one of the following is NOT required to be placed by the pharmacist onto a prescription label? Basing answers on what you do in the pharmacy in which you are employed instead of your knowledge of the law as it is written.

17 5 STUDY TIPS Concentrate on major topics DO NOT memorize exact citations Know date of origin for major laws Spend time on the Controlled Substances Act Carefully review Nebraska Revised Statute Section Federal Pharmacy law suggests spending most of the review on the Federal Controlled Substances Act Pay attention to shall or may Shall is an absolute requirement, may is less stringent indicating permission to do something.

18 6 TYPES OF QUESTIONS Types of MPJE questions that you may encounter include: Multiple-choice Multiple-response Ordered-response Refer to the NABP Registration Bulletin, MPJE Sample Questions section at:

19 7 TESTING TIPS Read each question carefully Spend a majority of your time reading the question before looking at the answer choices Determine what concept, general principle, or specific law is being tested More strict law applies (federal or state) Classify drugs specifically mentioned Controlled substances (CS), non-cs, or OTC Assume each question is straightforward Don t overanalyze Your first choice is probably the best choice

20 8 STUDY MATERIALS Federal Law Pharmacist s Manual Code of Federal Regulations/Controlled Substances Act Poison Prevention Packaging: A Guide for Healthcare Professionals ( Nebraska Pharmacy Statutes Uniform Credentialing Act Statutes Relating to Pharmacy Practice Act Nebraska Pharmacy Regulations Practice of Pharmacy NAC 128 Wholesale Drug Distributors NAC 131 Pharmacies NAC 8 Mandatory Reporting NAC 5 Public Health Clinics with Delegated Dispensing Permits NAC 134 Skilled Nursing Facilities, Nursing Facilities and Intermediate Care Facilities -175 NAC 12 Cancer Drug Repository Program NAC 6 Immunosuppressant Drug Repository Program NAC 7 Nebraska Pharmacy Statutes and Regulations may also be found in the current copy of the NPA Pharmacy Law Manual, order on line at or by calling the NPA office at

21 9 MPJE COMPETENCY STATEMENTS Area 1: Pharmacy Practice Approximately 84% of test Area 2: Licensure, Registration, Certification, and Operational Requirements Approximately 13% of test Area 3: Regulatory Structure and Terms Approximately 3% of test

22 10 AREA 1: PHARMACY PRACTICE 1.01 Identify the legal responsibilities of the pharmacist and other pharmacy personnel Identify the requirements for the acquisition and distribution of pharmaceutical products, including samples Identify the legal requirements that must be observed in the issuance of a prescription/drug order Identify the procedures necessary to properly dispense a pharmaceutical product, including controlled substances, pursuant to a prescription/drug order Identify the conditions for making an offer to counsel or counseling appropriate patients, including the requirements for documentation Identify the requirements for the distribution and/or dispensing of nonprescription pharmaceutical products, including controlled substances Identify the proper procedures for keeping records of information related to pharmacy practice, pharmaceutical products and patients, including requirements for protecting patient confidentiality.

23 11 AREA 2: LICENSURE, REGISTRATION, CERTIFICATION AND OPERATIONAL REQUIREMENTS 2.01 Identify the qualifications, application procedure, necessary examinations, and internship requirements for licensure, registration, or certification of individuals engaged in the storage, distribution, and/or dispensing of pharmaceutical products (prescription and nonprescription) Identify the requirements and application procedure for the registration, licensure, certification, or permitting of a practice setting or business entity Identify the operational requirements for a registered, licensed, certified, or permitted practice setting.

24 12 AREA 3: REGULATORY STRUCTURE AND TERMS 3.01 Identify the purpose of, and the terms and conditions found in, the laws and rules that regulate or affect the manufacture, storage, distribution, and dispensing of pharmaceutical products (prescription and nonprescription), including controlled substances Identify the authority, responsibilities, and operation of the agencies or entities that enforce the laws and rules that regulate or affect the manufacture, storage, distribution, and dispensing of pharmaceutical products (prescription and nonprescription), including controlled substances.

25 13 KNOW RELEVANT STATUTES AND REGULATIONS Obtaining and maintaining a pharmacist license, including continuing pharmacy education (CPE) credits Structure/duties of Board of Pharmacy and authorized inspection bodies Standards of practice for filling/refilling Rx Drug substitution Purchasing, storing, and record keeping of drugs Including dispensing Controlled Substances Counseling patients, confidentiality of prescriptions and medical records Registration/maintenance of pharmacy Community and institutional Pathways/requirements for bringing new drugs to market Individual statutes/regulations that impact the practice of pharmacy Federal or State

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27 AREA 1: PHARMACY PRACTICE 1.01 Identify the legal responsibilities of the pharmacist and other pharmacy personnel.

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29 17 DUTIES OF PHARMACY PERSONNEL Listing the duties of pharmacy personnel can tremendously help improve work flow. Pharmacist-in-Charge (PIC) Pharmacists Consultant Pharmacists Pharmacy Technicians Pharmacist Interns

30 18 PHARMACIST-IN-CHARGE A pharmacy must have a pharmacist-in-charge, even in a mail service pharmacy. Pharmacist in charge means a pharmacist who is designated on a pharmacy permit or designated by a hospital as being responsible for the practice of pharmacy in the pharmacy for which a pharmacy license is issued and who works within the physical confines of such pharmacy for a majority of the hours per week that the pharmacy is open for business averaged over a twelve-month period or thirty hours per week, whichever is less. Nebraska Revised Statute

31 19 PHARMACIST-IN-CHARGE DUTIES Pharmacist-in-charge (PIC) accepts responsibility for pharmacy operations in conformance with all laws pertinent to the practice of pharmacy and the distribution of drugs. The pharmacist-in-charge must be present for the initial on-site inspection. File required reports, including but not limited to: Annually submits a completed Pharmacy Quality Assurance Report Semiannually reports to the Department as required by the Parkinson s Disease Registry Act Notify the Department of Health & Human Services of changes: Pharmacy ownership Pharmacy address Pharmacy closing Prepare and sign Written Control Procedures and Guidelines for use of Pharmacy Technicians Notify patients of pharmacy closing The pharmacist-in-charge shall be responsible for the practice of pharmacy and the establishment of written control procedures and guidelines governing the qualifications, onsite training, functions, supervision, and verification of the performance of pharmacy technicians. Makes sure that pharmacists, pharmacy technicians, and pharmacist interns are properly credentialed. PIC can be disciplined if pharmacists, pharmacist interns or pharmacy technicians are not licensed/registered Nebraska Revised Statute

32 20 PHARMACIST-IN-CHARGE DUTIES, PARKINSON S DISEASE REGISTRY The pharmacist-in-charge of each pharmacy located within the state or doing business in the state shall file a semi-annual report with the department listing persons to whom the pharmacist has dispensed drugs on the list of drugs required to be reported under this section for Parkinson s disease. The report shall include the name, address, and social security number of the person for whom the drugs were prescribed and the name and address of the prescribing physician. Nebraska Revised Statute 81-6,103

33 21 CHANGE OF PHARMACIST-IN-CHARGE The licensee must notify the Nebraska Department of Health & Human Services immediately when there is a change in the pharmacist-in-charge. 175 NAC Each pharmacy registered with the D.E.A. to handle controlled substances must complete a controlled substances inventory whenever there is a change in the pharmacist-in-charge. Such inventory must contain all information required in the biennial inventory and the original copy of this inventory must be maintained in the pharmacy for five years.* 175 NAC C2 A copy of the initial controlled substances inventory, biennial controlled substances inventory, or a controlled substances inventory taken pursuant to a change in the pharmacist-in-charge must be forwarded to the Department, within 30 days after completion.* 175 NAC C4 *Note: Nebraska Revised Statute Section requires an annual inventory of controlled substances. This statute supersedes the regulations listed above.

34 22 PHARMACIST-IN-CHARGE DUTIES, PHARMACY CLOSING When the closing of a pharmacy is anticipated, the pharmacist-incharge or practitioner is responsible for notifying patients of the pharmacy that they will need to seek service elsewhere. The notification can be accomplished through: Advertisement in a newspaper appropriate to the location of the pharmacy, Written notice to patients of the pharmacy, or Other such notice as is appropriate. 175 NAC D

35 23 PHARMACY CLOSING The pharmacist-in-charge or practitioner must return the following to the Department: 1. The pharmacy license, 2. The pharmacy s DEA Registration, if any, 3. All unused DEA Forms 222, if any, and 4. All unused DEA Forms 222a or 222d. 175 NAC C

36 24 TRANSFER OF CONTROLLED SUBSTANCES A pharmacy may hire an outside firm to inventory, package, and arrange for the transfer of its controlled substances to another pharmacy, the original supplier, or the original manufacturer. The pharmacy is responsible for the actual transfer of the controlled substances and for the accuracy of the inventory and records. The records involving the transfer of controlled substances must be kept readily available by the pharmacy for two years for inspection by the DEA. To transfer schedule II controlled substances, the receiving registrant must issue an official order form (DEA Form 222) or an electronic equivalent to the registrant transferring the drugs. The transfer of schedules III-V controlled substances must be documented in writing to show the drug name, dosage form, strength, quantity, and date transferred. The document must include the names, addresses, and DEA registration numbers of the parties involved in the transfer of the controlled substances. Reverse Distributors Authorized to Dispose Controlled Substances A pharmacy may forward controlled substances to a DEA registered reverse distributor who handles the disposal of controlled substances. When a pharmacy transfers schedule II controlled substances to a reverse distributor for destruction, the reverse distributor must issue an official order form (DEA Form 222) or the electronic equivalent to the pharmacy. When schedules III-V controlled substances are transferred to a reverse distributor for destruction, the pharmacy must maintain a record of distribution that lists the drug name, dosage form, strength, quantity, and date transferred. The DEA registered reverse distributor who will destroy the controlled substances is responsible for submitting a DEA Form 41 (Registrants Inventory of Drugs Surrendered) to the DEA when the controlled substances have been destroyed. A DEA Form 41 should not be used to record the transfer of controlled substances between the pharmacy and the reverse distributor disposing of the drugs. DEA Pharmacist s Manual

37 25 PRACTICE OF PHARMACY, DEFINED Practice of pharmacy, defined: (1) Practice of pharmacy means (a) the interpretation, evaluation, and implementation of a medical order, (b) the dispensing of drugs and devices, (c) drug product selection, (d) the administration of drugs or devices, (e) drug utilization review, (f) patient counseling, (g) the provision of pharmaceutical care, and (h) the responsibility for compounding and labeling of dispensed or repackaged drugs and devices, proper and safe storage of drugs and devices, and maintenance of proper records. (2) The active practice of pharmacy means the performance of the functions set out in this section by a pharmacist as his or her principal or ordinary occupation. Nebraska Revised Statute

38 26 PHARMACY, SCOPE OF PRACTICE (1) Except as provided for pharmacy technicians in sections to , for persons described in subdivision (12) or (13) of section , and for individuals authorized to dispense under a delegated dispensing permit, no person other than a licensed pharmacist, a pharmacist intern, or a practitioner with a pharmacy license shall provide pharmaceutical care, compound and dispense drugs or devices, or dispense pursuant to a medical order. Notwithstanding any other provision of law to the contrary, a pharmacist or pharmacist intern may dispense drugs or devices pursuant to a medical order of a practitioner authorized to prescribe in another state if such practitioner could be authorized to prescribe such drugs or devices in this state. (2) Except as provided for pharmacy technicians in sections to , for persons described in subdivision (12) or (13) of section , and for individuals authorized to dispense under a delegated dispensing permit, it shall be unlawful for any person to permit or direct a person who is not a pharmacist intern, a licensed pharmacist, or a practitioner with a pharmacy license to provide pharmaceutical care, compound and dispense drugs or devices, or dispense pursuant to a medical order. (3) (3) It shall be unlawful for any person to coerce or attempt to coerce a pharmacist to enter into a delegated dispensing agreement or to supervise any pharmacy technician for any purpose or in any manner contrary to the professional judgment of the pharmacist. Violation of this subsection by a health care professional regulated pursuant to the Uniform Credentialing Act shall be considered an act of unprofessional conduct. A violation of this subsection by a facility shall be prima facie evidence in an action against the license of the facility pursuant to the Health Care Facility Licensure Act. Any pharmacist subjected to coercion or attempted coercion pursuant to this subsection has a cause of action against the person and may recover his or her damages and reasonable attorney s fees. Nebraska Revised Statute

39 27 UNPROFESSIONAL CONDUCT, DEFINED Unprofessional Conduct means any departure from or failure to conform to the standards of acceptable and prevailing practice of a profession or the ethics of the profession, regardless of whether a person, consumer, or entity is injured, or conduct that is likely to deceive or defraud the public or is detrimental to the public interest, including, but not limited to: (1) Receipt of fees on the assurance that an incurable disease can be permanently cured; (2) Division of fees, or agreeing to split or divide the fees, received for professional services with any person for bringing or referring a consumer other than (a) with a partner or employee of the applicant or credential holder or his or her office or clinic, (b) with a landlord of the applicant or credential holder pursuant to a written agreement that provides for payment of rent based on gross receipts, (c) with a former partner or employee of the applicant or credential holder based on a retirement plan or separation agreement, or (d) by a person credentialed pursuant to the Water Well Standards and Contractors Practice Act; (3) Obtaining any fee for professional services by fraud, deceit, or misrepresentation, including, but not limited to, falsification of third-party claim documents; (4) Cheating on or attempting to subvert the credentialing examination; (5) Assisting in the care or treatment of a consumer without the consent of such consumer or his or her legal representative; (6) Use of any letters, words, or terms, either as a prefix, affix, or suffix, on stationery, in advertisements, or otherwise, indicating that such person is entitled to practice a profession for which he or she is not credentialed; (7) Performing, procuring, or aiding and abetting in the performance or procurement of a criminal abortion; Nebraska Revised Statute

40 28 UNPROFESSIONAL CONDUCT, DEFINED CONTINUED... (8) Knowingly disclosing confidential information except as otherwise permitted by law; (9) Commission of any act of sexual abuse, misconduct, or exploitation related to the practice of the profession of the applicant or credential holder; (10) Failure to keep and maintain adequate records of treatment or service; (11) Prescribing, administering, distributing, dispensing, giving, or selling any controlled substance or other drug recognized as addictive or dangerous for other than a medically accepted therapeutic purpose; (12) Prescribing any controlled substance to (a) oneself or (b) except in the case of a medical emergency (i) one s spouse, (ii) one s child, (iii) one s parent, (iv) one s sibling, or (v) any other person living in the same household as the prescriber; (13) Failure to comply with any federal, state, or municipal law, ordinance, rule, or regulation that pertains to the applicable profession; (14) Disruptive behavior, whether verbal or physical, which interferes with consumer care or could reasonably be expected to interfere with such care; and (15) Such other acts as may be defined in rules and regulations. Nothing in this section shall be construed to exclude determination of additional conduct that is unprofessional by adjudication in individual contested cases. Nebraska Revised Statute

41 29 UNPROFESSIONAL CONDUCT, DEFINED CONTINUED... In addition to the unlawful or unprofessional acts listed in Neb. Rev. Stat through , the following conduct will be considered unprofessional acts as defined by the Board per Neb. Rev. Stat (10): 1. Return of dispensed drugs or devices to saleable stock, unless specifically allowed by law; 2. Failure to conduct patient/client counseling, unless specifically exempt as provided in Neb. Rev. Stat. 71-1,147.35; 3. Claiming credit for any continuing education activities not actually participated in and earned; 4. Willfully or negligently violating the confidentiality between a pharmacist and a patient, except as allowed by law; 5. Any false or misleading statement on a pharmacy self inspection form; 6. Practicing pharmacy under a false or assumed name; 7. Except as otherwise permitted by law, dispensing, selling, administering, distributing, ordering, or giving to a person, known by the pharmacist to be an addict or any person previously drug dependent, any drug legally classified as a controlled substance; 8. Refusal to allow access to the records required to be kept pursuant to 175 NAC ; 9. Refusal to cooperate or furnish evidentiary information, legally requested in writing, in an investigation by the Department or law enforcement of any alleged violation; 10. Violation of any provision(s) of the Pharmacy Practice Act, or the Uniform Controlled Substances Act, or the rules and regulations of the Department or of an action, stipulation, or agreement of the Board or Department; 11. Any violation of the federal Controlled Substances Act; 12. Exercising influence on the patient in such a manner as to exploit the patient for the financial gain of the pharmacist or of a third party, which includes, but is not limited to, the promotion or sale of services, goods, drugs, devices, or biologicals;

42 30 UNPROFESSIONAL CONDUCT, DEFINED CONTINUED Refusal to provide professional service to a person because of such person s race, creed, color, or national origin; 14. Dispensing, selling, or administering anabolic steroids to a person for other than therapeutic purposes; 15. Lack of or inappropriate direction, collaboration or direct supervision of any person employed by, supervised by or assigned to the pharmacist; 16. Any violation of the Medicare / Medicaid anti-kickback statute, 42 United States Code Chapter 7 Section 1320a-7b(b), which prohibits illegal remuneration, including but not limited to any kick-back or bribe; 17. Any violation of the federal Resource Conservation and Recovery Act; 18. Any violation of the federal Prescription Drug Marketing Act of 1987; 19. Any violation of the federal Poison Prevention Packaging Act of 1970; 20. Any violation of the Cancer Drug Repository Program Act; 21. Any departure from or failure to conform to the ethics of the pharmacy profession, which ethics were adopted by the membership of the American Pharmacists Association on October 27, 1994, and are attached to these regulations and incorporated by this reference; 22. Misrepresentation of material facts in applying for or procuring a renewal of a license/certification/registration/permit; 23. Misrepresenting one s credentials in an application submitted to a healthcare facility, insurance company, or prospective employer; or 24. The use of false or deceptive statements in any advertisement. 172 NAC

43 31 COERCION TO DISPENSE A DRUG It is unlawful for any employer or such employer s agent to coerce a pharmacist to dispense a drug product against the professional judgment of the pharmacist or as ordered by a prescribing practitioner. Nebraska Revised Statute

44 32 CONSULTANT PHARMACIST, DEFINED (DELEGATED DISPENSING PERMIT) Delegated dispensing, defined Delegated dispensing means the practice of pharmacy by which one or more pharmacists have jointly agreed, on a voluntary basis, to work in conjunction with one or more persons pursuant to sections to under a protocol which provides that such person may perform certain dispensing functions authorized by the pharmacist or pharmacists under certain specified conditions and limitations. Nebraska Revised Statute Delegated dispensing agreements A pharmacist may delegate certain specified dispensing tasks and functions under specified conditions and limitations to another person by entering into a delegated dispensing agreement which serves as the basis for a delegated dispensing permit. A delegated dispensing agreement shall include the address of the site where the dispensing will occur, the name and license number of each pharmacist who will assume the responsibilities of the delegating pharmacist, the name and signature of any individual who will be dispensing pursuant to such agreement, the manner in which inspections must be conducted and documented by the delegating pharmacist, and any other information required by the board. A delegated dispensing agreement shall not become effective until a delegated dispensing permit based upon such agreement is issued by the department, with the recommendation of the board, pursuant to section Nebraska Revised Statute Consultant Pharmacist, defined Consultant Pharmacist as used in these regulations shall mean an actively practicing Nebraska pharmacist who holds an unrestricted license designated on the drug dispensing permit as the pharmacist who is responsible for all duties set forth in Part A of these regulations. 175 NAC Chapter A consultant pharmacist to a public health clinic must be an actively practicing pharmacist who holds an unrestricted license to practice pharmacy issued by the state of Nebraska. 175 NAC Chapter Note: While some pharmacists may provide consulting services to a variety of facilities, such as nursing homes, in Nebraska statutes, the term consultant pharmacist refers specifically to those working with a public health clinic.

45 33 CONSULTANT PHARMACIST DUTIES (DELEGATED DISPENSING PERMIT) Consultant Pharmacist Requirement and Duties All public health clinics which dispense legend drugs and devices pursuant to a drug dispensing permit shall have an actively practicing pharmacist with an unrestricted Nebraska license listed as the consultant pharmacist on the permit A The consultant pharmacist shall perform and document the following: A1 That he or she is physically in the public health clinic at least once every thirty (30) days; A2 That he or she conducts monthly inspections of the environment, inventory, record keeping of all drugs and devices received, stored or dispensed by the public health clinic, storage, security, dispensing and labeling procedures of all drugs and devices; A3 That he or she approves and maintains a policy and procedure manual governing the storage, control, distribution and dispensing of drugs and devices within the public health clinic as set out in Subpart A13 of these regulations; A4 That he or she approves supplemental information and instructions regarding approved formulary drugs and devices dispensed to patients; A5 That he or she approves the proficiency of public health clinic workers at the public health clinic for the dispensing of authorized refills of oral contraceptives at least annually; A5a Documentation of proficiency shall be maintained in the employee s personnel file and the policy and procedure manual A6 That he or she approves training of public health clinic workers; and A7 That he or she will report any discrepancies in the inventory of the public health clinic with a drug dispensing permit to the Board of Pharmacy and the administrator of the public health clinic.

46 34 CONSULTANT PHARMACIST, DUTIES (DELEGATED DISPENSING PERMIT) CONTINUED Availability of Consultant Pharmacists at any time that dispensing is occurring from the public health clinic with a drug dispensing permit, the consultant pharmacist or any other actively practicing pharmacist licensed to practice pharmacy in Nebraska must be available, either in person or by telephone, to answer questions from clients, staff, public health clinic workers, or volunteers A The consultant pharmacist or on-call pharmacist shall inform the public health clinic if he or she will not be available during the time that his or her availability is required and such notification shall be documented by the public health clinic and the pharmacist On-call pharmacist shall mean an actively practicing pharmacist who holds an unrestricted license to practice pharmacy in Nebraska and who is available in the event the consultant pharmacist is not available as defined in Subsection of the these regulations. 172 NAC Chapter 134 Note: If there is no consultant pharmacist or on-call pharmacist, dispensing is prohibited.

47 35 CONSULTANT PHARMACIST, DUTIES (DELEGATED DISPENSING PERMIT) CONTINUED... Adequate refrigeration when required which ensures the preservation and maintenance of the integrity of approved formulary drugs and devices. The consultant pharmacist is responsible for periodically reviewing and evaluating the refrigeration storage conditions to ensure sanitary conditions exist. 172 NAC A12

48 36 Q1: According to Nebraska Pharmacy Law, a copy of the initial controlled substances inventory, annual controlled substances inventory, or a controlled substances inventory taken pursuant to a change in the pharmacist-in-charge must be forwarded to the Department within: A) 72 hours of completion B) 24 hours of completion C) 15 days of completion D) 30 days of completion E) 60 days of completion Q2: When a pharmacy goes out of business, the unused DEA 222 forms must be: A) Destroyed in the presence of a licensed medical person B) Destroyed by a paper shredder C) Sent back to the DEA D) Marked void and properly disposed of E) Returned to the Department of Health and Human Services

49 37 Q3: A delegated dispensing agreement shall include which of the following? (Select ALL that apply.) A) The address of the site where the dispensing will occur B) The name and license number of each delegating pharmacist C) The name and signature of any individual who will be dispensing under the agreement D) The manner in which inspections will be conducted and documented by the delegating pharmacist E) A listing of any controlled substances on formulary Q4: Which of the following activities is (are) the responsibility of a pharmacist-in-charge? (Select ALL that apply.) A) Must be present for the initial on-site inspection B) Develop written control procedures and guidelines for use of pharmacy technicians C) Maintain records in the pharmacy describing the training and education regarding work functions performed by all pharmacy personnel D) Annually submit a report to DEA of all CII sales E) Annually submit a completed Pharmacy Quality Assurance Report

50 38 PHARMACY TECHNICIAN DUTIES A pharmacy technician may only perform tasks which do not require professional judgment and which are subject to verification to assist a pharmacist in the practice of pharmacy. Nebraska Revised Statute

51 39 PHARMACY TECHNICIANS, UNAUTHORIZED TASKS The functions and tasks which shall not be performed by pharmacy technicians include, but are not limited to: Receiving oral medication orders from a practitioner or his or her agent; Providing patient counseling; Performing any evaluation or necessary clarification of a medical order or performing any functions other than strictly clerical functions involving a medical order; Supervising or verifying the tasks and functions of pharmacy technicians; Interpreting or evaluating the data contained in a patient s record maintained pursuant to section ; Releasing any confidential information maintained by the pharmacy; Performing any professional consultations; Drug product selection, with regard to an individual medical order, in accordance with the Nebraska Drug Product Selection Act Nebraska Revised Statute Notes: Specific pharmacy technician duties are not listed in the Pharmacy Practice Act. The focus is more on what they are not allowed to do. It is the responsibility of the pharmacist to review then override DUR alerts as appropriate.

52 40 DEFINITION OF SUPERVISION Supervision means the personal guidance and direction by a pharmacist of the performance by a pharmacy technician of authorized activities or functions subject to verification by such pharmacist. Supervision of a pharmacy technician may occur by means of a real-time audiovisual communication system. Nebraska Revised Statute

53 41 DEFINITION OF VERIFICATION Verification means the confirmation by a supervising pharmacist of the accuracy and completeness of the acts, tasks, or functions undertaken by a pharmacy technician to assist the pharmacist in the practice of pharmacy. Verification shall occur by a pharmacist on duty in the facility, except that if a pharmacy technician performs authorized activities or functions to assist a pharmacist and the prescribed drugs or devices will be administered to persons who are patients or residents of a facility by a credentialed individual authorized to administer medications, verification may occur by means of a real-time audiovisual communication system. Nebraska Revised Statute

54 42 BOARD OF PHARMACY PERMISSION FOR USE OF PHARMACY TECHNICIANS The pharmacy may employ pharmacy technicians. Prior to the use of pharmacy technicians in a pharmacy, a copy of the pharmacy s written control procedures and guidelines must be submitted to the Department and these guidelines must be approved by the Board. The original, approved, written control procedures and guidelines and any approved amendments must be retained at the pharmacy. The written control procedures and guidelines, for the use of pharmacy technicians must contain the following information: 1. Name, street address, and telephone number of the pharmacy; 2. Name and Nebraska license number of the pharmacist-in-charge; 3. Means used by the pharmacy to determine that pharmacy technicians are at least 18 years of age; 4. Means used by the pharmacy to determine that pharmacy technicians have met the educational requirements of a high school diploma or G.E.D.; 5. Means used by the pharmacy to determine that pharmacy technicians have never been convicted of any drug-related misdemeanor or felony;* 6. Means used by the pharmacy to provide training, on-site in the pharmacy, by a pharmacist, within the first month of employment of a pharmacy technician, on all components required by law; 7. Means used to document training of pharmacy technicians; 175 NAC D *Note: Nebraska Revised Statute changes the requirement to include that a pharmacy technician has never been convicted of any nonalcohol, drug-related misdemeanor or felony.

55 43 BOARD OF PHARMACY PERMISSION FOR USE OF PHARMACY TECHNICIANS CONTINUED Means used by the pharmacy to confirm that pharmacy technicians have achieved a basic level of competency following training; 9. Maximum ratio of pharmacy technicians to one pharmacist working in the pharmacy at any time; 10. Method used by the pharmacy to supervise pharmacy technicians; 11. Tasks and functions which pharmacy technicians are allowed to perform in the pharmacy; 12. Method used by the pharmacy to assure that pharmacy technicians do NOT perform any task or function, which requires professional judgment; 13. Method of documentation used by the pharmacy to show that all drugs, devices, or biologicals dispensed with the assistance of a pharmacy technician conform to the order that authorized the drug, device, or biological to be dispensed; 14. Method of documentation used by the pharmacy to show that all acts, tasks and functions performed by pharmacy technicians are verified by a pharmacist as being accurate and complete; 15. Method used to identify pharmacy technicians while on duty; and 16. A notarized, signed statement from the pharmacist-in-charge verifying that all information in the application is correct. 175 NAC D

56 44 WRITTEN CONTROL PROCEDURES AND GUIDELINES FOR THE USE OF PHARMACY TECHNICIANS Written control procedures and guidelines means the document prepared and signed by the pharmacist-in-charge and approved by the board which specifies the manner in which basic levels of competency of pharmacy technicians employed by the pharmacy are determined, the manner in which supervision is provided, the manner in which the functions of pharmacy technicians are verified, the maximum ratio of pharmacy technicians to one pharmacist used in the pharmacy, and guidelines governing the use of pharmacy technicians and the functions which they may perform. Nebraska Revised Statute

57 45 PHARMACY TECHNICIAN REGISTRATION (1) All pharmacy technicians employed by a facility licensed under the Health Care Facility Licensure Act shall be registered with the Pharmacy Technician Registry created in section (2) To register as a pharmacy technician, an individual shall (a) be at least eighteen years of age, (b) be a high school graduate or be officially recognized by the State Department of Education as possessing the equivalent degree of education, (c) have never been convicted of any nonalcohol, drugrelated misdemeanor or felony, (d) file an application with the department, and (e) pay the applicable fee. (3) A pharmacy technician shall apply for registration as provided in this section within thirty days after being hired by a pharmacy or facility. Nebraska Revised Statute Each pharmacy technician must be identified as a pharmacy technician while performing the duties of a technician. 172 NAC

58 46 PHARMACIST INTERN, QUALIFICATIONS, REGISTRATION A pharmacist intern shall be A student currently enrolled in an accredited pharmacy program, or A graduate of an accredited pharmacy program serving his or her internship, or A graduate of a pharmacy program located outside the United States which is not accredited and who has successfully passed equivalency examinations approved by the board. Intern registration based on enrollment in or graduation from an accredited pharmacy program shall expire not later than fifteen months after the date of graduation or at the time of professional licensure, whichever comes first. Intern registration based on graduation from a pharmacy program located outside of the United States which is not accredited shall expire not later than fifteen months after the date of issuance of the registration or at the time of professional licensure, whichever comes first. Nebraska Revised Statute

59 47 PHARMACIST INTERN REQUIREMENTS A person may apply for registration as a pharmacist intern under the following conditions: After enrollment in an accredited program, After graduating from a foreign pharmacy program, After graduating and not currently licensed in Nebraska, prior to licensure as a pharmacist 172 NAC

60 48 PHARMACIST INTERN REQUIREMENTS CONTINUED... An applicant for registration as a pharmacist intern on basis of current enrollment in an accredited pharmacy program must: Be currently enrolled in an accredited pharmacy program; and Submit an application to the Department including: (1) Legal name; (2) Place and date of birth; (3) Social Security Number; (4) Mailing address; (5) Telephone number (optional) (6) address/fax number (optional) (7) Permanent address; (8) Name and location of accredited pharmacy program attended by the applicant; official documentation of the month and year the applicant enrolled in the pharmacy program and the expected month and year of graduation; A statement that the applicant is aware that s/he must not practice as a pharmacist intern without the immediate personal supervision of a licensed pharmacist; and A signed statement from the applicant verifying that all information in the application is true and correct; The required licensure fee; A copy of a birth certificate, marriage license, driver s license, or other valid verification of age. 172 NAC

61 49 PHARMACIST INTERN REQUIREMENTS CONTINUED... No person may function as a pharmacist intern until s/he receives a registration card from the Department. A pharmacist intern must have his/her registration card available at all times when functioning as an intern. 172 NAC Each pharmacist intern must be identified as a pharmacist intern while performing the duties of an intern. 172 NAC

62 50 PHARMACIST INTERN DUTIES A pharmacist intern must be supervised at all times while performing the functions of a pharmacist intern, which may include all aspects of the practice of pharmacy unless otherwise restricted. This supervision must be provided by a pharmacist who possesses a Nebraska pharmacist s license which is free from disciplinary measures at the time of supervision. This requirement for pharmacist supervision does not apply to pharmacist interns who are receiving experiential training directed by the accredited pharmacy program in which he/she is enrolled. 172 NAC A pharmacist intern must not supervise another pharmacist intern nor a pharmacy technician. 172 NAC

63 51 SUPERVISION RATIO A pharmacist may supervise up to two pharmacy technicians at any time, unless prohibited by a disciplinary action. A pharmacist may supervise up to three pharmacist interns at any time, unless prohibited by a disciplinary action. A pharmacist may supervise any combination of pharmacy technicians and pharmacist interns at any time up to a total of three people, as long as no more than two are pharmacy technicians. The supervision ratios of these regulations do not apply to pharmacist interns who are receiving experiential training directed by the accredited pharmacy program in which he or she is enrolled. 172 NAC

64 52 Q1: Who may counsel a patient, according to Nebraska Pharmacy Law? (Select ALL that apply.) A) Pharmacists B) Certified pharmacy technicians C) Pharmacist interns D) Registered pharmacy technicians E) Cashiers employed by a pharmacy Q2: A pharmacy technician may perform all of the following duties EXCEPT: A) Entering prescription data into a data processing system B) Taking a new oral medical order from a prescriber C) Receiving refill authorization requests D) Reconstituting medications E) Compounding sterile preparations of medications

65 53 Q3: A registered pharmacy technician shall: (Select ALL that apply.) A) Be at least eighteen years of age B) Be a high school graduate or be officially recognized by the State Department of Education as possessing the equivalent degree of education C) Have never been convicted of any nonalcohol, drug-related misdemeanor or felony D) Become certified within a period of six months E) Submit to a mandatory preliminary urine drug screen Q4: Which of the following statements are TRUE according to Nebraska Pharmacy Law? (Select ALL that apply.) A) A pharmacist may supervise up to two pharmacy technicians at any time B) A pharmacist may supervise up to three pharmacist interns at any time C) A pharmacist may supervise any combination of pharmacy technicians and pharmacist interns at any time up to a total of three people, as long as no more than two are pharmacy technicians D) Supervision ratios do not apply to pharmacist interns receiving experiential training E) Ratios for pharmacist supervision of technicians and pharmacist interns are not explicitly defined

66

67 AREA 1: PHARMACY PRACTICE 1.02 Identify the requirements for the acquisition and distribution of pharmaceutical products, including samples.

68

69 57 FEDERAL LAWS, ACQUISITION AND DISTRIBUTION Food and Drug Act 1906 Prohibited Interstate Commerce of adulterated food, drinks, drugs Did not regulate cosmetic products or medical devices Fell short of protecting the public since it did not require manufacturers to list ingredients or directions for use of product on label Fair Packaging and Labeling Act 1967 Requires consumer products in interstate commerce to be properly labeled (including OTC) Prescription Drug Marketing Act 1987 Enacted to correct the problem of diversion from normal distribution channels Products manufactured domestically and exported, can be reimported only by the original manufacturer States are required to establish controls on the wholesale distribution of legend or prescription drugs The sale, purchase, or trade of any drug which was purchased by a public or private hospital or other health care entity is prohibited The sale, purchase or trade of any drug sample or drug coupon redeemable for a drug product is prohibited

70 58 RESTRICTIONS ON SALES/PURCHASE/TRADE OF PRESCRIPTION DRUG SAMPLES Bars retail pharmacies from receiving prescription drug samples. Starter packs are allowed Distributed free to pharmacies Not considered samples; intended for initiation of drug therapy for a patient Not labeled as a sample Vouchers or coupons Prescription drug samples obtained by a practitioner cannot be delivered to a retail pharmacy for distribution to that practitioner s patients. Possession of prescription drug samples by retail pharmacies would be considered drug diversion by the FDA. Institutional pharmacies may receive prescription drug samples. Licensed prescriber requested Disposition precisely recorded Stored separately from normal drug stock Licensed practitioners provide written requests for prescription drug samples. Drug manufacturers/distributors keep requests for 3 years Sales representatives are responsible for prescription drug samples/annual inventory

71 59 DRUG SAMPLE OR SAMPLE MEDICATION Drug sample or sample medication means a unit of prescription drug that is not intended to be sold and is intended to promote the sale of the drug. Each sample unit shall bear a label that clearly denotes its status as a drug sample, which may include, but need not be limited to, the words sample, not for sale, or professional courtesy package. Nebraska Revised Statute

72 60 DRUG STORAGE REQUIREMENTS The pharmacy must provide equipment for the storage of drugs, devices, and biologicals at the proper temperature: 1. Drugs, devices, or biologicals requiring refrigeration must be stored between 36 and 46 degrees Fahrenheit. 2. Drugs, devices, or biologicals requiring a freezer must be stored between -4 and 14 degrees Fahrenheit. 3. Drugs, devices, or biologicals requiring storage in a cool place must be stored between 46 and 59 degrees Fahrenheit, or under refrigeration, between 36 and 46 degrees Fahrenheit, unless otherwise specified. 4. Drugs, devices, or biologicals requiring storage at controlled room temperature must be stored between 59 and 86 degrees Fahrenheit. 5. Other labeled storage instruction for drugs, devices, or biologicals must be followed. Drugs, devices, and biologicals stored in a refrigerator must be kept in a separate compartment from food. The prescription inventory and prescription records of the pharmacy must be maintained in a secure location when there is no pharmacist on the premises. Loss of prescription inventory or prescription records due to theft or any other cause resulting from failure to secure the inventory or records are grounds for disciplinary action. The pharmacy must not have in its dispensable inventory any drug, device, or biological which is misbranded or adulterated. 175 NAC

73 61 DISTRIBUTION Distribute means to deliver a drug or device, other than by administering or dispensing. Nebraska Revised Statute

74 62 WHOLESALE DRUG DISTRIBUTOR Wholesale drug distributor means any person or entity engaged in wholesale drug distribution in this state, including: Manufacturers Repackagers Own-label distributors Jobbers Brokers Private-label distributors Wholesale medical gas distributors Independent wholesale drug traders Retail pharmacies that engage in wholesale distribution in this state Warehouses: manufacturer and distributor, chain pharmacy, and wholesale drug Nebraska Revised Statute

75 63 WHOLESALE DRUG DISTRIBUTION DOES NOT INCLUDE (a) Intracompany sales of prescription drugs, including any transaction or transfer between any division, subsidiary, or parent company and an affiliated or related company under common ownership or common control; (b) The sale, purchase, or trade of or an offer to sell, purchase, or trade a prescription drug by a charitable organization described in section 501(c)(3) of the Internal Revenue Code, a state, a political subdivision, or any other governmental agency to a nonprofit affiliate of the organization, to the extent otherwise permitted by law; (c) The sale, purchase, or trade of or an offer to sell, purchase, or trade a prescription drug among hospitals or other health care entities operating under common ownership or common control; (d) The sale, purchase, or trade of or an offer to sell, purchase, or trade a prescription drug for emergency medical reasons; (e) The sale, purchase, or trade of, an offer to sell, purchase, or trade, or the dispensing of a prescription drug pursuant to a prescription; (f) The distribution of drug samples by representatives of a manufacturer or of a wholesale drug distributor; (g) The sale, purchase, or trade of blood and blood components intended for transfusion; or (h) The delivery of or the offer to deliver a prescription drug by a common carrier solely in the usual course of business of transporting such drugs as a common carrier if the common carrier does not store, warehouse, or take legal ownership of such drugs. Nebraska Revised Statute No wholesale drug distributor, manufacturer, or pharmacy shall knowingly purchase or receive any prescription drug from any source other than a person or entity licensed under the Wholesale Drug Distributor Licensing Act except transfers for emergency medical reasons and except as provided in subsection (3) of section , the gross dollar value of which shall not exceed five percent of the total prescription drug sales revenue of the transferor or transferee holder of a pharmacy license or practitioner as defined in section during the immediately preceding calendar year, and except as otherwise provided in the act. Nebraska Revised Statute

76 64 EMERGENCY MEDICAL REASONS Emergency medical reasons, defined Nebraska Revised Statute For the purposes of this section, emergency medical reasons means the alleviation of a temporary shortage by transfers of prescription drugs between any of the following: (1) Holders of pharmacy licenses, (2) Health care practitioner facilities (3) Hospitals (4) Practitioners Emergency medical reasons also means a natural disaster or other situations of local, state or national emergency No wholesale drug distributor, manufacturer, or pharmacy shall knowingly purchase or receive any prescription drug from any source other than a person or entity licensed under the Wholesale Drug Distributor Licensing Act except transfers for emergency reasons and except as provided in subsection (3) of section , the gross dollar value of which shall not exceed five percent of the total prescription drug sales revenue of the transferor or transferee holder of a pharmacy license or practitioner during the immediately preceding calendar year. Nebraska Revised Statute (1)

77 65 Q1: Samples of prescription drugs received by a physician from medical representatives can be: (Select ALL that apply.) A) Given to patients B) Sold to a chain pharmacy store C) Sold to another physician D) Sold to a hospital pharmacy E) Sold at a discount to public health clinics Q2: A pharmacy must register as a wholesale drug distributor if it distributes more than: A) 2% of gross dollar value of the total prescription drug sales revenue in a 12-month period B) 5 % of gross dollar value of the total prescription drug sales revenue in a 12-month period C) 3% of gross dollar value of the total prescription drug sales revenue in a 24-month period D) 4% of gross dollar value of the total prescription drug sales revenue in a 6-month period E) 5% of gross dollar value of the total prescription drug sales revenue in a 6-month period

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79 AREA 1: PHARMACY PRACTICE 1.03 Identify the legal requirements that must be observed in the issuance of a prescription/drug order

80

81 69 WHAT IS A VALID PRESCRIPTION? To be valid, a prescription for a controlled substance must be issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. The practitioner is responsible for the proper prescribing and dispensing of controlled substances. A prescription may not be issued in order for an individual practitioner to obtain controlled substances for supplying the individual practitioner for the purpose of general dispensing to patients. DEA Pharmacist s Manual

82 70 CORRESPONDING RESPONSIBILITY A pharmacist also needs to know there is a corresponding responsibility for the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is an invalid prescription within the meaning and intent of the CSA (21 U.S.C. 829). The person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances. A pharmacist is required to exercise sound professional judgment when making a determination about the legitimacy of a controlled substance prescription. Such a determination is made before the prescription is dispensed. The law does not require a pharmacist to dispense a prescription of doubtful, questionable, or suspicious origin. To the contrary, the pharmacist who deliberately ignores a questionable prescription when there is reason to believe it was not issued for a legitimate medical purpose may be prosecuted along with the issuing practitioner, for knowingly and intentionally distributing controlled substances. Such action is a felony offense, which may result in the loss of one s business or professional license. DEA Pharmacist s Manual

83 71 PRACTITIONER, DEFINED Practitioner means a certified registered nurse anesthetist, a certified nurse midwife, a dentist, an optometrist, a nurse practitioner, a physician assistant, a physician, a podiatrist, or a veterinarian. Nebraska Revised Statute

84 72 PAIN MANAGEMENT WITH DRUGS (1) The Legislature finds that many controlled substances have useful and legitimate medical and scientific purposes and are necessary to maintain the health and general welfare of the people of Nebraska. Principles of quality medical practice dictate that the people of Nebraska have access to appropriate and effective pain relief. (2) The Legislature finds that the appropriate application of up-todate knowledge and treatment modalities can serve to improve the quality of life for those patients who suffer from pain. The Legislature therefor encourages physicians to view effective pain management as a part of quality medical practice for all patients with pain, acute or chronic, including those patients who experience pain as a result of terminal illness. (3) The Legislature finds that a physician should be able to prescribe, dispense, or administer a controlled substance in excess of the recommended dosage for the treatment of pain so long as such dosage is not administered for the purpose of causing, or the purpose of assisting in causing, death for any reason and so long as it conforms to policies and guidelines for the treatment of pain adopted by the Board of Medicine and Surgery. (4) The Legislature finds that a health care facility, hospice, or third-party payor should not forbid or restrict the use of controlled substances appropriately administered for the treatment of pain. Nebraska Revised Statute

85 73 ADMINISTRATION OF A NARCOTIC TO A NARCOTIC DEPENDENT PERSON (1) It is unlawful to prescribe any narcotic drug listed in section , except buprenorphine, for the purpose of detoxification treatment or maintenance treatment except as provided in this section. (2) A narcotic drug may be administered or dispensed to a narcotic-dependent person for detoxification treatment or maintenance treatment by a practitioner who is registered to provide detoxification treatment or maintenance treatment pursuant to section (3) A narcotic drug may be administered or dispensed to a narcotic-dependent person when necessary to relieve acute withdrawal symptoms pending the referral of such person for detoxification treatment or maintenance treatment by a physician who is not registered to provide detoxification treatment or maintenance treatment under section Not more than one day s supply of narcotic drugs shall be administered or dispensed for such person s use at one time. Such treatment shall not be continued for more than three successive calendar days and may not be renewed or extended. Nebraska Revised Statute

86 74 ADMINISTRATION OF A NARCOTIC TO A NARCOTIC DEPENDENT PERSON CONTINUED... (4) A narcotic drug may be administered or dispensed in a hospital to maintain or detoxify a person as an incidental adjunct to medical or surgical treatment conditions other than dependence. (5) Any person who violates this section is guilty of a Class IV felony. (6) For purposes of this section: (a) Detoxification treatment means the administering or dispensing of a narcotic drug in decreasing doses to a person for a specified period of time to alleviate adverse physiological or psychological effects incident to withdrawal from the continuous or sustained use of a narcotic drug and to bring such person to a narcotic drug-free state within such period of time. Detoxification treatment includes short-term detoxification treatment and long-term detoxification treatment; (b) Long-term detoxification treatment means detoxification treatment for a period of more than thirty days but not more than one hundred eighty days; (c) Maintenance treatment means the administering or dispensing of a narcotic drug in the treatment of a narcotic-dependent person for a period of more than twenty-one days; and (d) Short-term detoxification treatment means detoxification treatment for a period of not more than thirty days. Nebraska Revised Statute

87 75 THE DRUG ADDICTION TREATMENT ACT OF 2000 (DATA 2000) This act enables qualifying physicians to receive a waiver from the special registration requirements in the Controlled Substances Act for the provision of medication-assisted opioid therapy. This waiver allows qualifying physicians to practice medicationassisted opioid addiction therapy with Schedule III, IV, or V narcotic medications specifically approved by the Food and Drug Administration (FDA). On October 8, 2002 Subutex (buprenorphine hydrochloride) and Suboxone tablets (buprenorphine hydrochloride and naloxone hydrochloride) received FDA approval for the treatment of opioid addiction. The Drug Enforcement Administration (DEA) assigns the physician a special identification number. This number will begin with the letter X. DEA regulations require this ID number to be included on all buprenorphine prescriptions for opioid addiction therapy, along with the physician s regular DEA registration number.

88 76 OPTOMETRIST PRESCRIBING AUTHORITY Optometrist (OD) can prescribe and apply Lenses Devices with lenses Prisms Contact lenses Ophthalmic devices Orthoptics Vision training Pharmaceuticals Prosthetics Can dispense contact lenses Includes those containing authorized pharmaceutical agents Optometrists are limited to prescribing for the eyes Legend drugs, for eyes only CII, but only topical ophthalmics CIII-CV, but only for eyes Controlled substances to spouse, child, parent, sibling, or person living in same household only in an ophthalmic emergency Cannot prescribe controlled substances to self Can prescribe epinephrine auto injector for treatment of anaphylaxis and an oral steroid, oral glaucoma agent, or oral immunosuppressive agent.. Nebraska Revised Statute

89 77 ADVANCED PRACTICE REGISTERED NURSE (APRN) Nurse Practitioner (APRN-NP), Certified Registered Nurse Anesthetist (APRN-CRNA), and Certified Nurse Midwife (APRN-CNM) Can dispense sample medications (incident to practice only) Prescribing authority limited to scope of practice Clinical Nurse Specialist (APRN-CNS) Does not have prescribing authority in their scope practice Cannot dispense sample medications

90 78 NURSE PRACTITIONER (APRN-NP) PRESCRIBING AUTHORITY Legend drugs CII-CV Contraception Smoking cessation Anti-Anxiety Weight loss Controlled substances to spouse, child, parent, sibling, or any other person living in the same household as prescriber in an emergency only Cannot prescribe controlled substances to self Limited to scope of practice Nebraska Revised Statute

91 79 CERTIFIED REGISTERED NURSE ANESTHETIST (APRN-CRNA) PERFORMANCE OF DUTIES (1) The determination and administration of total anesthesia care shall be performed by the certified registered nurse anesthetist or a nurse anesthetist temporarily licensed pursuant to section in consultation and collaboration with and with the consent of the licensed practitioner. (2) The following duties and functions shall be considered as specific expanded role functions of the certified registered nurse anesthetist: (a) Preanesthesia evaluation including physiological studies to determine proper anesthetic management and obtaining informed consent; (b) Selection and application of appropriate monitoring devices; (c) Selection and administration of anesthetic techniques; (d) Evaluation and direction of proper postanesthesia management and dismissal from postanesthesia care; (e) Evaluation and recording of postanesthesia course of patients; and (f) Use of fluoroscopy in conjunction with a licensed medical radiographer in connection with the performance of authorized duties and functions upon (i) the successful completion of appropriate education and training as approved jointly by the department and the board and promulgated by the department in rules and regulations pursuant to section and (ii) a determination regarding the scope and supervision of such use consistent with subsection (3) of this section. (3) The determination of other duties that are normally considered medically delegated duties to the certified registered nurse anesthetist or to a nurse anesthetist temporarily licensed pursuant to section shall be the joint responsibility of the governing board of the hospital, medical staff, and nurse anesthetist personnel of any duly licensed hospital or, if in an office or clinic, the joint responsibility of the duly licensed practitioner and nurse anesthetist. All such duties, except in cases of emergency, shall be in writing in the form prescribed by hospital or office policy. Nebraska Revised Statute

92 80 CERTIFIED REGISTERED NURSE ANESTHETIST (APRN-CRNA) PRESCRIBING AUTHORITY Can prescribe only for pre-anesthesia, anesthesia, and postanesthesia care Legend drugs CII-CV Anti-anxiety Controlled substances to spouse, child, parent, sibling, or any other person living in the same household as prescriber in an emergency only Cannot prescribe controlled substances to self Limited to scope of practice

93 81 CERTIFIED NURSE MIDWIFE (APRN-CNM) PRESCRIBING AUTHORITY The conditions under which a certified nurse midwife is required to refer cases to a collaborating licensed practitioner shall be specified in the practice agreement (Neb. Rev. Stat ). Certified Nurse Midwives can only prescribe when delegated to do so by a physician (MD or DO) whose practice includes obstetrics. CII-72 hours for pain only CIII-CV Legend drugs Contraception Nicotine cessation Antianxiety Weight loss (if not a CII) Controlled substances to spouse, child, parent, sibling, or any other person living in the same household as prescriber for obstetric/gynecologic emergency only Cannot prescribe controlled substances to self Limited to scope of practice

94 82 PRACTICE OF CERTIFIED NURSE MIDWIFE (APRN-CNM) REGULATIONS The statement that the specific medical functions delegated to the nurse midwife are based upon the educational preparation and continued experience of the nurse midwife. Validation and documentation of education/training and assessment of competency are the responsibility of the nurse midwife and the physician(s). Specific medical functions may include: a. Attending cases of normal childbirth; b. Providing prenatal, intrapartum, and postpartum care; c. Providing normal obstetrical and gynecological services for women; d. Providing care for the newborn immediately following birth; and e. Prescribing legend drugs, Schedule II controlled substances for up to 72 hours and for pain control, and Schedule III, IV and V controlled substances. 172 NAC (6)

95 83 PHYSICIAN ASSISTANT (PA) PRESCRIBING AUTHORITY FOR DRUGS AND DEVICES, RESTRICTIONS May only prescribe when delegated to do so by physician (MD or DO) Legend drugs CII-CV Contraception Smoking cessation Anti-Anxiety Weight loss Controlled substances to spouse, child, parent, sibling, or any other person living in the same household as prescriber in an emergency only Cannot prescribe controlled substances to self Any restrictions on the prescribing authority by the supervising physician must be recorded on the physician assistant s scope of practice agreement All prescriptions/prescription container labels must contain the name of the PA; name of prescriber is only required if needed for reimbursement purposes Nebraska Revised Statute

96 84 DENTIST PRESCRIBING AUTHORITY Dentist (DDS/DMD) CII-CV for mouth only Legend drugs for mouth only Antianxiety for dental visit only Controlled substances to spouse, child, parent, sibling, or any other person living in the same household as prescriber for human teeth or jaws, or adjacent structures for an emergency only Dentists cannot prescribe for Contraception Weight loss Controlled substances to self

97 85 VETERINARIAN PRESCRIBING AUTHORITY Veterinarian (DVM) can only prescribe to treat animals CII-CV Legend drugs Contraception Anti-anxiety Weight loss Cannot prescribe To treat humans Nicotine cessation

98 86 PODIATRIST PRESCRIBING AUTHORITY Podiatrist (DPM) Can prescribe only for the human foot, ankle, and related governing structures CII-CV Legend drugs Anti-anxiety Controlled substances to spouse, child, parent, sibling, or any other person living in the same household as prescriber for the human foot, ankle, and related governing structures for an emergency only Cannot prescribe Contraception, nicotine cessation, weight loss Controlled substances to self

99 87 DOCTOR OF MEDICINE AND DOCTOR OF OSTEOPATHIC MEDICINE PRESCRIBING AUTHORITY MD (doctor of medicine) and DO (doctor of osteopathic medicine) CII-CV Legend drugs Contraception Anti-Anxiety Nicotine cessation Weight loss Controlled substances to spouse, child, parent, sibling, or any other person living in the same household as prescriber for emergency only Cannot prescribe controlled substances to self

100 88 Q1: How can a pharmacist verify that a prescriber is allowed to prescribe Suboxone or Subutex for opioid addiction? (Select ALL that apply.) A) Confirm that the prescriber has been granted a waiver via SAMHSA website or by contacting SAMHSA by phone B) Check the prescriber's regular DEA registration number: It ends with X C) The pharmacist must contact the prescriber to verify prescriber eligibility D) Check the prescriber's Drug Enforcement Administration (DEA) number; physicians granted a waiver under DATA 2000 are issued a special DEA number that always begins with "X E) The pharmacist must contact the State medical board to verify prescriber eligibility Q2: According to Nebraska Pharmacy Law, which of the following practitioners may prescribe a narcotic Schedule II controlled substance in the course of their professional practices? (Select ALL that apply.) A) Physicians assistant B) Nurse Practitioner (APRN-NP) C) Veterinarian D) Optometrist E) Physical therapist

101 89 Q3: According to Nebraska Pharmacy Law, if a prescription is issued by a physician assistant, both the name of the physician assistant and the name of the supervising physician must appear on prescription when: A) Each prescription is issued B) The prescription is for a controlled substance C) The physician assistant has less than 2 years of practice experience D) It is issued for greater than a 30 day supply E) It is needed for billing purposes only Q4: A licensed veterinarian, in the course of his professional practice, may prescribe a drug for: (Select ALL that apply.) A) Lucy the dog B) Contraception for a horse C) A human in an emergency D) The owner of a pet E) A cat for weight loss

102

103 AREA 1: PHARMACY PRACTICE 1.04 Identify the procedures necessary to properly dispense a pharmaceutical product, including controlled substances, pursuant to a prescription/drug order.

104

105 93 DRUGS, MEDICINES, AND MEDICINAL SUBSTANCES, DEFINED Drugs, medicines, and medicinal substances means (1) articles recognized in the official United States Pharmacopoeia, the Homeopathic Pharmacopoeia of the United States, the official National Formulary, or any supplement to any of them, (2) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases in humans or animals, (3) articles, except food, intended to affect the structure or any function of the body of a human or an animal, (4) articles intended for use as a component of any articles specified in subdivision (1), (2), or (3) of this section, except any device or its components, parts, or accessories, and (5) prescription drugs or devices. Nebraska Revised Statute

106 94 CONTROLLED SUBSTANCE, DEFINED Controlled substance shall mean a drug, biological, substance, or immediate precursor in Schedules I to V of section Controlled substance shall not include distilled spirits, wine, malt beverages, tobacco, or any nonnarcotic substance if such substance may, under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301 et seq., as such act existed on January 1, 2009, and the law of this state, be lawfully sold over the counter without a prescription; Nebraska Revised Statute (4)

107 95 SCHEDULE II CONTROLLED SUBSTANCE PRESCRIPTIONS (1) Except as otherwise provided in this section or section or when administered directly by a practitioner to an ultimate user, a controlled substance listed in Schedule II of section shall not be dispensed without a prescription from a practitioner authorized to prescribe. No prescription for a controlled substance listed in Schedule II of section shall be filled more than six months from the date of issuance. A prescription for a controlled substance listed in Schedule II of section shall not be refilled. (2) A prescription for controlled substances listed in Schedule II of section must contain the following information prior to being filled by a pharmacist or dispensing practitioner: (a) Patient's name and address, (b) name of the drug, device, or biological, (c) strength of the drug or biological, (d) dosage form of the drug or biological, if applicable, (e) quantity of the drug, device, or biological prescribed, (f) directions for use, (g) date of issuance, (h) prescribing practitioner's name and address, and (i) Drug Enforcement Administration number of the prescribing practitioner. If the prescription is a written paper prescription, the paper prescription must contain the prescribing practitioner's manual signature. If the prescription is an electronic prescription, the electronic prescription must contain all of the elements in subdivisions (a) through (i) of this subsection, must be digitally signed, and must be transmitted to and received by the pharmacy electronically to meet all of the requirements of the Controlled Substances Act, 21 U.S.C. 801 et seq., as it existed on January 1, 2014, pertaining to electronic prescribing of controlled substances. (3) In emergency situations as defined by rule and regulation of the department, a controlled substance listed in Schedule II of section may be dispensed pursuant to an oral prescription reduced to writing in accordance with subsection (2) of this section, except for the prescribing practitioner's signature, and bearing the word "emergency". (4)(a) In nonemergency situations: (i) A controlled substance listed in Schedule II of section may be dispensed pursuant to a facsimile of a written, signed paper prescription if the original written, signed paper prescription is presented to the pharmacist for review before the controlled substance is dispensed, except as provided in subdivision (a)(ii) or (iii) of this subsection; (ii) A narcotic drug listed in Schedule II of section may be dispensed pursuant to a facsimile of a written, signed paper prescription (A) to be compounded for direct parenteral administration to a patient for the purpose of home infusion therapy or (B) for administration to a patient enrolled in a hospice care program and bearing the words "hospice patient"; and (iii) A controlled substance listed in Schedule II of section may be dispensed pursuant to a facsimile of a written, signed paper prescription for administration to a resident of a long-term care facility. Nebraska Revised Statute

108 96 SCHEDULE II CONTROLLED SUBSTANCE PRESCRIPTIONS CONTINUED (b) For purposes of subdivisions (a)(ii) and (iii) of this subsection, a facsimile of a written, signed paper prescription shall serve as the original written prescription and shall be maintained in accordance with subsection (1) of section (5)(a) A prescription for a controlled substance listed in Schedule II of section may be partially filled if the pharmacist does not supply the full quantity prescribed and he or she makes a notation of the quantity supplied on the face of the prescription or in the electronic record. The remaining portion of the prescription may be filled within seventy-two hours of the first partial filling. The pharmacist shall notify the prescribing practitioner if the remaining portion of the prescription is not or cannot be filled within such period. No further quantity may be supplied after such period without a new written, signed paper prescription. (b) A prescription for a controlled substance listed in Schedule II of section written for a patient in a long-term care facility or for a patient with a medical diagnosis documenting a terminal illness may be partially filled. Such prescription shall bear the words "terminally ill" or "long-term care facility patient" on its face or in the electronic record. If there is any question whether a patient may be classified as having a terminal illness, the pharmacist shall contact the prescribing practitioner prior to partially filling the prescription. Both the pharmacist and the prescribing practitioner have a corresponding responsibility to assure that the controlled substance is for a terminally ill patient. For each partial filling, the dispensing pharmacist shall record on the back of the prescription or on another appropriate record, uniformly maintained and readily retrievable, the date of the partial filling, quantity dispensed, remaining quantity authorized to be dispensed, and the identification of the dispensing pharmacist. The total quantity of controlled substances listed in Schedule II which is dispensed in all partial fillings shall not exceed the total quantity prescribed. A prescription for a Schedule II controlled substance for a patient in a long-term care facility or a patient with a medical diagnosis documenting a terminal illness is valid for sixty days from the date of issuance or until discontinuance of the prescription, whichever occurs first. Nebraska Revised Statute

109 97 SCHEDULE III, IV & V CONTROLLED SUBSTANCE PRESCRIPTIONS (1) Except as otherwise provided in this section or when administered directly by a practitioner to an ultimate user, a controlled substance listed in Schedule III, IV, or V of section shall not be dispensed without a written, oral, or electronic medical order. Such medical order is valid for six months after the date of issuance. Original prescription information for any controlled substance listed in Schedule III, IV, or V of section may be transferred between pharmacies for purposes of refill dispensing pursuant to section (2) A prescription for controlled substances listed in Schedule III, IV, or V of section must contain the following information prior to being filled by a pharmacist or dispensing practitioner: (a) Patient's name and address, (b) name of the drug, device, or biological, (c) strength of the drug or biological, (d) dosage form of the drug or biological, if applicable, (e) quantity of the drug, device, or biological prescribed, (f) directions for use, (g) date of issuance, (h) number of refills, not to exceed five refills within six months after the date of issuance, (i) prescribing practitioner's name and address, and (j) Drug Enforcement Administration number of the prescribing practitioner. If the prescription is a written paper prescription, the paper prescription must contain the prescribing practitioner's manual signature. If the prescription is an electronic prescription, the electronic prescription must contain all of the elements in subdivisions (a) through (j) of this subsection, must be digitally signed, and must be transmitted to and received by the pharmacy electronically to meet all of the requirements of 21 C.F.R. 1311, as the regulation existed on January 1, 2014, pertaining to electronic prescribing of controlled substances. (3) A controlled substance listed in Schedule III, IV, or V of section may be dispensed pursuant to a facsimile of a written, signed paper prescription. The facsimile of a written, signed paper prescription shall serve as the original written prescription for purposes of this subsection and shall be maintained in accordance with subsection (2) of section (4) A prescription for a controlled substance listed in Schedule III, IV, or V of section may be partially filled if (a) each partial filling is recorded in the same manner as a refilling, (b) the total quantity dispensed in all partial fillings does not exceed the total quantity prescribed, and (c) each partial filling is dispensed within six months after the prescription was issued. Nebraska Revised Statute

110 98 WHAT CHANGES CAN A PHARMACIST MAKE ON A CII PRESCRIPTION? According to Nebraska Board of Pharmacy Policies: After consultation with the prescribing practitioner, the pharmacist is permitted to add or change the dosage form, drug strength, drug quantity, directions for use and issue date. The pharmacist is never allowed to make changes to the patient s name, controlled substance prescribed (except for generic substitution) or the prescriber s signature. Nebraska Board of Pharmacy Newsletter, February 2009

111 99 DISPENSING EMERGENCY CII PRESCRIPTIONS FROM AN ORAL ORDER An emergency prescription in this context, is defined to mean that the immediate administration of the drug is necessary for proper treatment of the intended ultimate user, that no alternative treatment is available (including a drug which is not a schedule II controlled substance), and it is not possible for the prescribing practitioner to provide a written prescription for the drug at that time. In a bona fide emergency, a practitioner may telephone a schedule II prescription to the pharmacist who may then dispense the prescription. The prescribing practitioner must provide a written and signed prescription to the pharmacy within seven days and meet the below requirements: 1. The drug prescribed and dispensed must be limited to the amount needed to treat the patient during the emergency period. Prescribing or dispensing beyond the emergency period must be pursuant to a written prescription order. 2. The prescription order must be immediately reduced to writing by the pharmacist and must contain all information, except for the prescribing practitioner s signature. 3. If the prescribing individual practitioner is not known to the pharmacist, he/she must make a reasonable effort to determine that the oral authorization came from a registered individual practitioner, which may include a call back to the prescribing individual practitioner using his or her telephone number as listed in the telephone directory and/or other good faith efforts to insure his or her identity. The quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period (dispensing beyond the emergency period must be pursuant to a paper or electronic prescription signed by the prescribing individual practitioner); The prescription shall be immediately reduced to writing by the pharmacist and shall contain all information required in , except for the signature of the prescribing individual practitioner. If the prescribing individual practitioner is not known to the pharmacist, he must make a reasonable effort to determine that the oral authorization came from a registered individual practitioner, which may include a callback to the prescribing individual practitioner using his phone number as listed in the telephone directory and/or other good faith efforts to insure his identity. Within 7 days after authorizing an emergency oral prescription, the prescribing individual practitioner shall cause a written prescription for the emergency quantity prescribed to be delivered to the dispensing pharmacist. In addition to conforming to the requirements of , the prescription shall have written on its face Authorization for Emergency Dispensing, and the date of the oral order. The paper prescription may be delivered to the pharmacist in person or by mail, but if delivered by mail it must be postmarked within the 7-day period. Upon receipt, the dispensing pharmacist must attach this paper prescription to the oral emergency prescription that had earlier been reduced to writing. For electronic prescriptions, the pharmacist must annotate the record of the electronic prescription with the original authorization and date of the oral order. The pharmacist must notify the nearest office of the Administration if the prescribing individual practitioner fails to deliver a written prescription to him; failure of the pharmacist to do so shall void the authority conferred by this paragraph to dispense without a written prescription of a prescribing individual practitioner. Central fill pharmacies shall not be authorized under this paragraph to prepare prescriptions for a controlled substance listed in Schedule II upon receiving an oral authorization from a retail pharmacist or an individual practitioner. DEA Pharmacist s Manual

112 100 DRUG PARAPHERNALIA As used in sections , , and to , unless the context otherwise requires, drug paraphernalia shall mean all equipment, products, and materials of any kind which are used, intended for use, or designed for use, in manufacturing, injecting, ingesting, inhaling, or otherwise introducing into the human body a controlled substance in violation of sections , , and to or the Uniform Controlled Substances Act. Nebraska Revised Statute Drug paraphernalia; deliver or manufacture; unlawful; exception; penalty. (1) It shall be unlawful for any person to deliver, possess with intent to deliver, or manufacture with intent to deliver, drug paraphernalia, knowing, or under circumstances in which one reasonably should know, that it will be used to manufacture, inject, ingest, or inhale or otherwise be used to introduce into the human body a controlled substance in violation of sections , , and to (2) This section shall not apply to pharmacists who sell hypodermic syringes or needles for the prevention of the spread of infectious diseases. Nebraska Revised Statute

113 101 Q1: Faxing a written, signed, paper prescription for Schedule II controlled drugs may serve as the original prescription in which of the following situations: A) For a patient undergoing home infusion of a narcotic B) For a patient living in a LTCF C) For a patient in hospice care receiving a narcotic D) For a patient picking up medication at a community pharmacy E) None of the above Q2: After verbally consulting with a practitioner, according to the Nebraska Board of Pharmacy, what changes may a pharmacist make to a prescription written for a Schedule II drug? A) The patient's address B) Directions for use C) The quantity prescribed D) The name of the controlled substance E) The issue date Q3: A pharmacist receives a fax for a compounded narcotic CII prescription for direct parenteral administration to a patient for the purpose of home infusion therapy. The pharmacist should: A) Compound the prescription as ordered B) Not compound the prescription C) Ask for the original prescription prior to compounding D) Hold the prescription for a physician's authorization E) Call and verbally verify the prescription

114 102 Q4: In Nebraska, a prescription for morphine sulfate shall NOT be filled after how many months after issuance? A) 1 month B) 2 months C) 6 months D) 12 months E) 3 months Q5: Which of the following cannot be refilled under any circumstances? A) Valium (diazepam) B) Tylenol No 3 (acetaminophen with codeine) C) Actiq (fentanyl) D) Lomotil (diphenoxylate and atropine) E) Ambien (zolpidem) Q6: The partial filling of morphine sulfate for terminally ill patients must be done within how many hours from the initial filling? A) 72 hours B) 7 days C) 30 days D) 60 days E) 6 months Q7: What is the maximum number of refills that can be supplied on a prescription for Ambien (zolpidem)? A) None B) Two C) Four D) Five E) No limit Q8: A patient who is not terminally ill or a resident of a LTC facility comes to a pharmacy with a prescription for OxyContin. After processing the claim, the pharmacist finds out that he does not have enough quantity to dispense the full supply. Under this circumstance, the pharmacist must fill the remaining quantity within: A) 24 hours B) 48 hours C) 72 hours D) 7 days E) 14 days

115 103 Q9: A patient presents a new prescription for alprazolam. The prescription is written on April 1, 2011 and reads: Alprazolam 1 mg, 1 tablet by mouth three times daily as needed for anxiety, quantity #90, 5 Refills. The prescription can legally be dispensed in which of the following ways: (Select ALL that apply.) A) Filled once for a quantity of 180 tablets on 5/2/2011 B) Filled 10 times each for a quantity of 18 tablets within 6 months of issuance C) Filled on 4/1/2011 for 150 tablets and on 5/2/2011 for 40 tablets D) Filled on 4/1/2011 for 90 tablets and on 11/2/2011 for 90 tablets E) Filled 7 times each for a quantity of 30 tablets within 6 months of issuance Q10: An emergency oral prescription for Schedule II controlled drugs must be mailed to the pharmacy by an authorized prescriber within: A) 48 hours after an oral authorization B) 7 days after an oral authorization C) 10 days after an oral authorization D) 72hours after an oral authorization E) 30 days after an oral authorization Q11: After dispensing an emergency Schedule II drug, the pharmacist has to contact which of the following upon not receiving a written prescription from the prescriber within the designated number of days? (Select ALL that apply.) A) The prescriber B) The DEA C) The Department of Regulation and Licensure D) The State Board of Pharmacy E) The State Board of Medicine

116 104 SCHEDULE I CONTROLLED SUBSTANCES Substances in this schedule have a high potential for abuse, have no currently accepted medical use in treatment in the United States, and there is a lack of accepted safety for use of the drug or other substance under medical supervision. Some examples of substances listed in Schedule I are: heroin, lysergic acid diethylamide (LSD), marijuana (cannabis), peyote, methaqualone, and 3,4-methylenedioxymethamphetamine ( ecstasy ). DEA Pharmacist s Manual

117 105 SCHEDULE II CONTROLLED SUBSTANCES Substances in this Schedule have a high potential for abuse which may lead to severe psychological or physical dependence. Examples of single entity Schedule II narcotics include morphine and opium. Other Schedule II narcotic substances and their common name brand products include: hydromorphone (Dilaudid ), methadone (Dolophine ), meperidine (Demerol ), oxycodone (OxyContin ), and fentanyl (Sublimaze or Duragesic ). Examples of Schedule II stimulants include: amphetamine (Dexedrine, Adderall ), methamphetamine (Desoxyn ), and methylphenidate (Ritalin ). Other Schedule II substances include: cocaine, amobarbital, glutethimide, and pentobarbital. DEA Pharmacist s Manual

118 106 SCHEDULE III CONTROLLED SUBSTANCES Substances in this Schedule have a potential for abuse less than substances in Schedules I or II and abuse may lead to moderate or low physical dependence or high psychological dependence. Examples of Schedule III narcotics include combination products containing not more than 90 milligrams of codeine per dosage unit (Tylenol with codeine ). Also included are buprenorphine products (Suboxone and Subutex ) used to treat opioid addiction. Examples of Schedule III non-narcotics include benzphetamine (Didrex ), phendimetrazine, ketamine, and anabolic steroids such as oxandrolone (Oxandrin ) DEA Pharmacist s Manual

119 107 SCHEDULE IV CONTROLLED SUBSTANCES Substances in this Schedule have a low potential for abuse relative to substances in Schedule III. Schedule IV substances include, but not limited to: alprazolam (Xanax ), carisoprodol (Soma ), clonazepam (Klonopin ), clorazepate (Tranxene ), diazepam (Valium ), lorazepam (Ativan ), midazolam (Versed ), temazepam (Restoril ), and triazolam (Halcion ). DEA Pharmacist s Manual Note: Ephedrine is a Schedule IV controlled substance in Nebraska, with the exception of the brand-name products: Bronkaid Dual Action Caplets and Primatene Tablets. (Generics of these products are considered a Schedule IV).

120 108 SCHEDULE V CONTROLLED SUBSTANCES Substances in this Schedule have a low potential for abuse relative to substances listed in Schedule IV and consist primarily of preparations containing limited quantities of certain narcotics. These are generally used for antitussive, antidiarrheal, and analgesic purposes. Examples include cough preparations containing not more than 200 milligrams of codeine per 100 milliliters or per 100 grams (Robitussin AC and Phenergan with Codeine ). DEA Pharmacist s Manual Note: Nebraska law does not allow dispensing of a CV without a prescription.

121 109 Q1: Schedule I controlled drugs are classified as: (Select ALL that apply.) A) Having a high potential for abuse B) Having a low potential for abuse C) Having no accepted medical use in the US D) Having an accepted medical use in the US E) Having a lack of accepted safety for use even under medical supervision Q2: Which of the following is/are classified as Schedule I controlled substance(s)? (Select ALL that apply.) A) Peyote B) Morphine C) Marijuana D) Codeine E) Amphetamine Q3: Which of the following is/are classified as Schedule II controlled drug(s)? (Select ALL that apply.) A) Heroin B) Morphine C) Methylphenidate D) Cocaine E) Modafinil Q4: A DEA 222 form is required to purchase which of the following? A) MS Contin (morphine) B) Fiorinal (butalbital, aspirin and caffeine) C) Provigil (modafinil) D) Klonopin (clonazepam) E) Phenobarbital

122 110 Q5: A pharmacist is adding 1000 mg of codeine phosphate powder to 100 cc of Tylenol with codeine elixir (120 mg/12 mg/5 cc). The resultant mixture should be classified as: A) Schedule V B) Schedule IV C) Schedule III D) Schedule II E) Schedule I Q6: According to Nebraska Pharmacy Law, which of the following shall be classified as Schedule IV controlled substances: (Select ALL that apply.) A) Ephedrine B) Bronkaid C) Primatene D) Soma E) Lyrica Q7: In Nebraska, Phenergan with Codeine (promethazine with codeine) syrup is classified as: A) Schedule II B) Schedule III C) Schedule IV D) Schedule V E) Schedule VI Q8: Which of the following oral liquids is/are usually classified as a Schedule V controlled drug? I. Guaifenesin with codeine II. Hydrocodone with acetaminophen III. Acetaminophen with codeine A) I only B) I and II C) I and III D) II and III E) I, II and III

123 111 DISPENSING A CONTROLLED SUBSTANCE WITHOUT A PRESCRIPTION A controlled substance listed in Schedules II, III, IV, or V which is not a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act, may be dispensed by a pharmacist without a prescription to a purchaser at retail, provided that: (a) Such dispensing is made only by a pharmacist (as defined in part 1300 of this chapter), and not by a nonpharmacist employee even if under the supervision of a pharmacist (although after the pharmacist has fulfilled his professional and legal responsibilities set forth in this section, the actual cash, credit transaction, or delivery, may be completed by a nonpharmacist); (b) Not more than 240 cc. (8 ounces) of any such controlled substance containing opium, nor more than 120 cc. (4 ounces) of any other such controlled substance nor more than 48 dosage units of any such controlled substance containing opium, nor more than 24 dosage units of any other such controlled substance may be dispensed at retail to the same purchaser in any given 48-hour period; (c) The purchaser is at least 18 years of age; (d) The pharmacist requires every purchaser of a controlled substance under this section not known to him to furnish suitable identification (including proof of age where appropriate); 21 CFR Note: Nebraska law does NOT allow dispensing of a CV without a prescription.

124 112 DISPENSING A CONTROLLED SUBSTANCE WITHOUT A PRESCRIPTION CONTINUED... (e) A bound record book for dispensing of controlled substances under this section is maintained by the pharmacist, which book shall contain the name and address of the purchaser, the name and quantity of controlled substance purchased, the date of each purchase, and the name or initials of the pharmacist who dispensed the substance to the purchaser (the book shall be maintained in accordance with the recordkeeping requirement of Sec of this chapter); and (f) A prescription is not required for distribution or dispensing of the substance pursuant to any other Federal, State or local law. (g) Central fill pharmacies may not dispense controlled substances to a purchaser at retail pursuant to this section. 21 CFR Note: Nebraska law does NOT allow dispensing of a CV without a prescription.

125 113 CONSTRUCTION OF A VALID DEA REGISTRATION NUMBER FOR PRACTITIONERS Knowing how a DEA registration number is constructed can be a useful tool for recognizing a forged prescription. Prior to October 1, 1985, DEA registration numbers for physicians, dentists, veterinarians, and other practitioners started with the letter A. New registration numbers issued to practitioners after that date begin with the letter B, F or G. Registration numbers issued to mid-level practitioners begin with the letter M. The first letter of the registration number is almost always followed by the first letter of the registrant s last name (e.g., J for Jones or S for Smith) and then a computer generated sequence of seven numbers (such as MJ ).

126 114 VERIFYING A PRESCRIBER S DEA REGISTRATION NUMBER 1. Examine the DEA number. The first letter of a valid registration number indicates a registrant type and usually is an "A", "B, F, G or M. ( M is for mid-level practioners) 2. Note the second letter of the DEA number. It should be the first letter in the practitioner's last name. For example, "J" will be the second letter if the doctor's last name is Johnson, unless a change in name has occurred. 3. Add the first, third and fifth digits of the DEA number. 4. Add the second, fourth and sixth digits of the DEA number. 5. Multiply the result of the second set of digits by two. 6. Add the result of the first set of numbers and the result of the second set of numbers. The last digit of this result must be the same as the last digit of the DEA number.

127 115 PERSONS ENTITLED TO ISSUE PRESCRIPTIONS (a) A prescription for a controlled substance may be issued only by an individual practitioner who is: (1) authorized to prescribe controlled substances by the jurisdiction in which he is licensed to practice his profession and (2) either registered or exempted from registration pursuant to Sections (c) and of this chapter. (b) A prescription issued by an individual practitioner may be communicated to a pharmacist by an employee or agent of the individual practitioner. 21 CFR

128 116 TRANSMISSION OF PRESCRIPTIONS BY FACSIMILE A prescription for a legend drug may be transmitted by the practitioner or the practitioner s agent to a pharmacy by facsimile or electronic transmission. Except as otherwise provided in sections and for prescriptions for Schedule II, III, IV, or V controlled substances, the facsimile or electronic transmission shall serve as the original prescription. Nebraska Revised Statute

129 117 PRESCRIPTION, DEFINED Prescription means an order for a drug or device issued by a practitioner for a specific patient, for emergency use, or for use in immunizations. Prescription does not include a chart order. Nebraska Revised Statute Chart order means an order for a drug or device issued by a practitioner for a patient who is in the hospital where the chart is stored or for a patient receiving detoxification treatment or maintenance treatment pursuant to section Chart order does not include a prescription. Nebraska Revised Statute A Chart Order Must Contain the Following Information: 1. Patient s name, 2. Date of the order, 3. Name of the drug, device, or biological, 4. Strength of the drug or biological, if applicable, 5. Directions for administration to the patient, including the dose to be given, and 6. Prescriber s name. 172 NAC

130 118 HOW LONG IS A PRESCRIPTION VALID? How long is a prescription, which includes a medical order, valid in Nebraska? (1) All medical orders shall be valid for the period stated in the medical order, except that (a) if the medical order is for a controlled substance listed in section , such period shall not exceed six months from the date of issuance at which time the medical order shall expire and (b) if the medical order is for a drug or device which is not a controlled substance listed in section or is an order issued by a practitioner for pharmaceutical care, such period shall not exceed twelve months from the date of issuance at which time the medical order shall expire. Nebraska Revised Statute

131 119 MANNER OF ISSUANCE OF PRESCRIPTIONS (a) All prescriptions for controlled substances shall be dated as of, and signed on, the day when issued and shall bear the full name and address of the patient, the drug name, strength, dosage form, quantity prescribed, directions for use, and the name, address and registration number of the practitioner. (b) A prescription for a Schedule III, IV, or V narcotic drug approved by FDA specifically for "detoxification treatment" or "maintenance treatment" must include the identification number issued by the Administrator under Sec (d) of this chapter or a written notice stating that the practitioner is acting under the good faith exception of Sec (e) of this chapter. (c) Where a prescription is for gamma-hydroxybutyric acid, the practitioner shall note on the face of the prescription the medical need of the patient for the prescription. (d) A practitioner may sign a paper prescription in the same manner as he would sign a check or legal document (e.g., J.H. Smith or John H. Smith). Where an oral order is not permitted, paper prescriptions shall be written with ink or indelible pencil, typewriter, or printed on a computer printer and shall be manually signed by the practitioner. A computer-generated prescription that is printed out or faxed by the practitioner must be manually signed. (e) Electronic prescriptions shall be created and signed using an application that meets the requirements of part 1311 of this chapter. 21 CFR

132 120 MANNER OF ISSUANCE OF PRESCRIPTIONS CONTINUED... (f) A prescription may be prepared by the secretary or agent for the signature of a practitioner, but the prescribing practitioner is responsible in case the prescription does not conform in all essential respects to the law and regulations. A corresponding liability rests upon the pharmacist, including a pharmacist employed by a central fill pharmacy, who fills a prescription not prepared in the form prescribed by DEA regulations. (g) An individual practitioner exempted from registration under Sec (c) of this chapter shall include on all prescriptions issued by him the registration number of the hospital or other institution and the special internal code number assigned to him by the hospital or other institution as provided in Sec (c) of this chapter, in lieu of the registration number of the practitioner required by this section. Each paper prescription shall have the name of the practitioner stamped, typed, or handprinted on it, as well as the signature of the practitioner. (h) An official exempted from registration under Sec (a) of this chapter must include on all prescriptions issued by him his branch of service or agency (e.g., "U.S. Army" or "Public Health Service") and his service identification number, in lieu of the registration number of the practitioner required by this section. The service identification number for a Public Health Service employee is his Social Security identification number. Each paper prescription shall have the name of the officer stamped, typed, or hand printed on it, as well as the signature of the officer. 21 CFR

133 121 DISPENSING REQUIREMENTS What information must a prescription contain prior to being filled? Patient s name Name of drug/device/biological Strength Quantity Dosage form Directions for use Date of issue Prescriber name, name of supervising or collaborating physician (when applicable) Number of refills 175 NAC B and 172 NAC

134 122 DISPENSING REQUIREMENTS CONTINUED... What information must a prescription contain prior to being filled? If the prescription is written, it must contain the prescriber s signature and the name of the prescriber stamped, typed, or clearly handwritten in addition to the signature. Prescriptions for controlled substances also require Patient s address Prescriber s address Prescriber s DEA number 175 NAC B and 172 NAC Quantity for residents of long-term care facilities must be 60 days, unless otherwise limited by the prescriber. Refills CII no refills allowed CIII-CV can have up to 5 refills within 6 months of date of issuance Non-controls refill for up to 12 months from date of issuance Use professional judgment in accepting or refusing to fill a prescription.

135 123 AUTOMATED MEDICATION SYSTEMS ACT For purposes of the Automated Medication Systems Act: For purposes of the Automated Medication Systems Act: (1) Automated medication distribution machine means a type of automated medication system that stores medication to be administered to a patient by a person credentialed under the Uniform Credentialing Act; (2) Automated medication system means a mechanical system that performs operations or activities, other than compounding, administration, or other technologies, relative to storage and packaging for dispensing or distribution of medications and that collects, controls, and maintains all transaction information and includes, but is not limited to, a prescription medication distribution machine or an automated medication distribution machine. An automated medication system may only be used in conjunction with the provision of pharmacist care; (3) Chart order means an order for a drug or device issued by a practitioner for a patient who is in the hospital where the chart is stored, for a patient receiving detoxification treatment or maintenance treatment pursuant to section , or for a resident in a long-term care facility in which a long-term care automated pharmacy is located from which drugs will be dispensed. Chart order does not include a prescription; (4) Hospital has the definition found in section ; Nebraska Revised Statute (1) Hospital means a facility where diagnosis, treatment, medical care, obstetrical care, nursing care, or related services are provided on an outpatient basis or on an inpatient basis for a period of more than twenty-four consecutive hours to persons who have an illness, injury, or deformity or to aged or infirm persons requiring or receiving convalescent care. (2) Hospital includes a facility or part of a facility which provides space for a general acute hospital, a rehabilitation hospital, a long-term care hospital, a critical access hospital, or a psychiatric or mental hospital. (3) Hospital does not include a health care practitioner facility in which persons do not receive care or treatment for a period of more than twenty-four consecutive hours. Nebraska Revised Statute

136 124 AUTOMATED MEDICATION SYSTEMS ACT CONTINUED... (5) Long-term care automated pharmacy means a designated area in a long-term care facility where an automated medication system is located, that stores medications for dispensing pursuant to a medical order to residents in such long-term care facility, that is installed and operated by a pharmacy licensed under the Health Care Facility Licensure Act, and that is licensed under section ; (6) Long-term care facility means an intermediate care facility, an intermediate care facility for persons with developmental disabilities, a long-term care hospital, a mental health center, a nursing facility, or a skilled nursing facility, as such terms are defined in the Health Care Facility Licensure Act; (7) Medical order means a prescription, a chart order, or an order for pharmaceutical care issued by a practitioner; (8) Pharmacist means any person who is licensed by the State of Nebraska to practice pharmacy; (9) Pharmacist care means the provision by a pharmacist of medication therapy management, with or without the dispensing of drugs or devices, intended to achieve outcomes related to the cure or prevention of a disease, elimination or reduction of a patient's symptoms, or arresting or slowing of a disease process; (10) Pharmacist remote order entry means entering an order into a computer system or drug utilization review by a pharmacist licensed to practice pharmacy in the State of Nebraska and located within the United States, pursuant to medical orders in a hospital, long-term care facility, or pharmacy licensed under the Health Care Facility Licensure Act; Nebraska Revised Statute

137 125 AUTOMATED MEDICATION SYSTEMS ACT CONTINUED... (11) Practice of pharmacy means (a) the interpretation, evaluation, and implementation of a medical order, (b) the dispensing of drugs and devices, (c) drug product selection, (d) the administration of drugs or devices, (e) drug utilization review, (f) patient counseling, (g) the provision of pharmaceutical care, and (h) the responsibility for compounding and labeling of dispensed or repackaged drugs and devices, proper and safe storage of drugs and devices, and maintenance of proper records. The active practice of pharmacy means the performance of the functions set out in this subdivision by a pharmacist as his or her principal or ordinary occupation; (12) Practitioner means a certified registered nurse anesthetist, a certified nurse midwife, a dentist, an optometrist, a nurse practitioner, a physician assistant, a physician, a podiatrist, or a veterinarian; (13) Prescription means an order for a drug or device issued by a practitioner for a specific patient, for emergency use, or for use in immunizations. Prescription does not include a chart order; (14) Prescription medication distribution machine means a type of automated medication system that packages, labels, or counts medication in preparation for dispensing of medications by a pharmacist pursuant to a prescription; and (15) Telepharmacy means the provision of pharmacist care, by a pharmacist located within the United States, using telecommunications, remote order entry, or other automations and technologies to deliver care to patients or their agents who are located at sites other than where the pharmacist is located. Nebraska Revised Statute

138 126 AUTOMATED MEDICATION SYSTEMS ACT CONTINUED... Any automated machine that dispenses, delivers, or makes available, other than by administration, prescription medication directly to a patient or caregiver without the provision of pharmacist care is prohibited. Nebraska Revised Statute Any hospital, long-term care facility, or pharmacy that uses an automated medication system shall develop, maintain, and comply with policies and procedures developed in consultation with the pharmacist responsible for pharmacist care for that hospital, long-term care facility, or pharmacy. At a minimum, the policies and procedures shall address the following: (1) The description and location within the hospital, long-term care facility, or pharmacy of the automated medication system or equipment being used; (2) The name of the pharmacist responsible for implementation of and compliance with the policies and procedures; (3) Medication access and information access procedures; (4) Security of inventory and confidentiality of records in compliance with state and federal laws, rules, and regulations; (5) A description of the process used by a pharmacist or pharmacy technician for filling an automated medication system; (6) A description of how and by whom the automated medication system is being utilized, including processes for verifying, dispensing, and distributing medications; (7) Staff education and training; (8) Quality assurance and quality improvement programs and processes; (9) Inoperability or emergency downtime procedures; (10) Periodic system maintenance; and (11) Medication security and controls. Nebraska Revised Statute

139 127 AUTOMATED MEDICATION SYSTEMS ACT CONTINUED... A prescription medication distribution machine: (1) Is subject to the requirements of section ; and (2) May be operated only in a licensed pharmacy where a pharmacist dispenses medications to patients for self administration pursuant to a prescription. Nebraska Revised Statute An automated medication distribution machine may be operated in a hospital or long-term care facility for medication administration pursuant to a chart order or prescription by a licensed health care professional. Drugs placed in an automated medication distribution machine shall be in the manufacturer's original packaging or in containers repackaged in compliance with state and federal laws, rules, and regulations relating to repackaging, labeling, and record keeping. Nebraska Revised Statute A pharmacist providing pharmacist remote order entry shall: (1) Be located within the United States; (2) Maintain adequate security and privacy in accordance with state and federal laws, rules, and regulations; (3) Be linked to one or more hospitals, long-term care facilities, or pharmacies for which services are provided via computer link, video link, audio link, or facsimile transmission; (4) Have access to each patient s medical information necessary to perform via computer link, video link, or facsimile transmission a prospective drug utilization review as specified before December 1, 2008, in section 71-1, and on or after December 1, 2008, in section ; and (5) Be employed by or have a contractual agreement to provide such services with the hospital, long-term care facility, or pharmacy where the patient is located. Nebraska Revised Statute NOTE: The automatic or vending machine provisions found in Title 175 Nebraska Administrative Code Chapter A have been superseded by the Automated Medication Systems Act.

140 128 RISK EVALUATION AND MITIGATION STRATEGY (REMS) The Food and Drug Administration Amendments Act of 2007 gave FDA the authority to require a Risk Evaluation and Mitigation Strategy (REMS) from manufacturers to ensure that the benefits of a drug or biological product outweigh its risks Currently Approved Shared System REMS Buprenorphine Transmucosal Products for Opioid Dependence (BTOD) REMS Extended-Release and Long-Acting (ER/LA) Opioid Analgesics REMS Isotretinoin ipledge REMS Mycophenolate REMS Rosiglitazone REMS Transmucosal Immediate-Release Fentanyl (TIRF) Products REMS For more information, visit: nforpatientsandproviders/ucm htm#shared

141 129 ELECTRONIC TRANSMISSION, DEFINED Electronic transmission means transmission of information in electronic form. Electronic transmission may include computerto-computer transmission or computer-to-facsimile transmission. Nebraska Revised Statute

142 130 AUTHORITY TO ADMINISTER Administer, defined: Administer means to directly apply a drug or device by injection, inhalation, ingestion, or other means to the body of a patient or research subject. Nebraska Revised Statute Practice of pharmacy, defined: The administration of drugs or devices is part of the definition of practice of pharmacy. Nebraska Revised Statute (d) Pharmacist; powers Unless specifically limited by the board or the department, a pharmacist may: (1) engage in the practice of pharmacy and telepharmacy as defined in section , (2) use automation in the practice of pharmacy and telepharmacy, (3) use the abbreviation R.P. or the title licensed pharmacist, (4) enter into delegated dispensing agreements, and (5) possess, without dispensing, prescription drugs and devices, including controlled substances, for purposes of administration. Nebraska Revised Statute

143 131 AUTHORITY TO ADMINISTER, PRACTICE AGREEMENTS A pharmacist may enter into a practice agreement with a licensed medical practitioner to provide pharmaceutical care according to written protocols The pharmacist must assure that the Board is notified of any practice agreement. Such notice must be given to both the Board of Pharmacy and the medical practitioner s professional Board. Such notice must contain the names of the pharmacist(s) and the licensed medical practitioner(s) and a description of the therapy being monitored or initiated. 1. A copy of the practice agreement and written protocols must be available for review by any representative of the Department, and 2. A copy of the practice agreement or written protocols must be sent to the Board upon request from the Board. 3. Written notice must be given to the Board at initiation and at any time there is a change in parties or protocols Practice agreements and written protocols must be signed by the pharmacist and the medical practitioner and must be reviewed, signed, and dated every 12 months Practice agreements and written protocols will cease immediately upon: 1. The death of either the pharmacist or the licensed medical practitioner, or 2. Loss of license of either the pharmacist or the medical practitioner, or 3. Disciplinary action limiting the ability of either the pharmacist or the medical practitioner to enter into practice agreements, or 4. Individual decision or mutual agreement of the pharmacist(s) or medical practitioner(s) to end the agreement Nothing in these agreements will allow a pharmacist to practice beyond his/her scope of practice. 172 NAC

144 132 AUTHORITY TO ADMINISTER, PHARMACEUTICAL CARE DEFINED A pharmacist or properly supervised pharmacist intern may administer drugs or devices pursuant to a prescription, chart order, or practice agreement. Pharmaceutical care, defined. (1) Pharmaceutical care means the provision of drug therapy for the purpose of achieving therapeutic outcomes that improve a patient's quality of life. Such outcomes include (a) the cure of disease, (b) the elimination or reduction of a patient's symptomatology, (c) the arrest or slowing of a disease process, or (d) the prevention of a disease or symptomatology. (2) Pharmaceutical care includes the process through which the pharmacist works in concert with the patient and his or her caregiver, physician, or other professionals in designing, implementing, and monitoring a therapeutic plan that will produce specific therapeutic outcomes for the patient. Nebraska Revised Statute

145 133 Q1: A chart order in a hospital must contain all of the following: (Select ALL that apply.) A) Patients name B) Date of the order C) Prescriber s signature D) Directions for administration E) Prescriber s name Q2: In Nebraska, a pharmacist should not dispense any noncontrolled drug or device if the prescription is presented: A) More than 180 days after the date of issuance B) More than 90 days after the date of issuance C) More than 365 days after the date of issuance D) More than 30 days after the date of issuance E) More than 60 days after the date of issuance Q3: According to Nebraska Pharmacy Law, a pharmacist may enter into a practice agreement with a licensed medical practitioner to provide pharmaceutical care according to written protocols. These practice agreements and written protocols must be signed and reviewed by the pharmacist and the medical practitioner every: A) 30 days B) 6 months C) 12 months D) 24 months E) 3 years

146 134 FEDERAL LAW, DISPENSING Durham-Humphrey Amendment 1951 Established two classes of drugs Prescription Nonprescription All Rx bottles must have legend: Caution: Federal Law prohibits dispensing without prescription or Rx Only

147 135 FEDERAL LAW, POISON PREVENTION PACKAGING ACT The PPPA was signed into law in 1970 and was enforced by the FDA until 1973; jurisdiction is now with the US Consumer Product Safety Commission. The legislation was enacted due to compelling evidence that childhood ingestions were reduced by child-resistant packaging. Special packaging is designed to be significantly difficult for children under 5 years of age to open, and not difficult for normal adults to use properly. Studies are performed to make sure the majority of children are kept out and majority of adults can gain access to the child-resistant prescription containers. The patient can make either a single prescription request or a blanket waiver for all prescriptions. Pharmacists, however, cannot justify a single patient request for non-child-resistant container as justification to dispense all prescriptions this way. Poison Prevention Packaging Act 1970 Administered by US Consumer Product Safety Commission All oral medications dispensed for humans must be in childresistant containers Childhood ingestions reduced by child-resistant packaging Packaging difficult for children to open Requirements for iron products that contain a total of 250 mg or more of elemental iron per package

148 136 FEDERAL LAW, POISON PREVENTION PACKAGING ACT CONTINUED... Refills must be in containers with new plastic parts Replace cap and bottle if plastic Threaded containers can be reused, but plastic closure replaced Many plastic closures can lose their effectiveness after repeated use OTC manufacturer/packer is allowed a single package size to be non-compliant (not child-resistant) This package for households without young children Must have that substance available in compliant containers as well New/refill prescriptions must be in child-resistant closure unless: Prescriber specifies none to be used Can only specify for each individual prescription Patient indicates they do not want such closure Differentiate single request vs. blanket waiver Drugs are maintained/administered by health professionals Hospitals and nursing homes do not require child-resistant packaging unless those medications may go home with the patient, so you assess the situation with the test question do children live in the home? Customer must choose to receive non-child-resistant packaging for all prescriptions Blanket waivers acceptable Best practice: Written waiver with follow up Document on the Rx A single request on a specific prescription does not constitute a blanket waiver The dispensing pharmacist is responsible. Be sure to document that the patient chose to receive a non-child-resistant package. Assess whether or not the prescription is likely to enter a home with children.

149 137 MOST COMMON EXEMPTIONS FROM POISON PREVENTION PACKAGING ACT Nitroglycerin-SL Isosorbide dinitrate SL/Chew 10 mg ASA or APAP Effervescent or granules Potassium supplements Unit dose packaging Anhydrous cholestyramine or colestipol packets Aerosol containers Inhalation therapy Oral Contraceptives in mnemonic packs Information, including exemptions can be found at:

150 138 LABELING OF POISONS It shall be unlawful for any person to vend, sell, dispense, give away, furnish or otherwise dispose of, or cause to be vended, sold, dispensed, given away, furnished or otherwise disposed of, either directly or indirectly, any poison as defined in section , without affixing, or causing to be affixed, to the bottle, box, vessel or package containing the same, a label, printed or plainly written, containing the name of the article, the word poison, the name and place of business of the seller, manufacturer, packer or distributor, and the date of sale; nor shall it be lawful for any person to deliver any of such poisons until he has satisfied himself that the person to whom delivery is made is aware of and understands the poisonous nature of the article, and that such poison is to be used for a legitimate purpose. Nebraska Revised Statute

151 139 POISON REGISTER Every person who disposes of or sells at retail or furnishes any of the poisons in section or any other poisons which the Department of Health and Human Services may from time to time designate, as provided in section , shall, before delivery, enter in a book kept for that purpose, to be known as the Poison Register, the date of sale, the name and address of the purchaser, the name and quantity of the poison, the purpose for which it is purchased, and the name of the dispenser, and such record shall be signed by the person to whom the poison is delivered. Such record shall be kept in the form prescribed by the department, and the book containing the same must be always open for inspection by the proper authorities, and must be preserved for at least two years after the last entry. Nebraska Revised Statute

152 140 RESTRICTED DISTRIBUTION PROGRAMS Required by FDA to be established by manufacturers for drugs with special safety concerns. Review in Guide to Federal Pharmacy Law; STEPS and ipledge are two programs more frequently seen in pharmacies. STEPS: thalidomide ipledge: isotretinoin Prescribing Program for Lotronex (PPL) Tracleer Access Program (TAP) Clozaril National Registry Tikosyn in Pharmacy System (T.I.P.S) Exjade Patient Assistance & Support Program IRESSA Access Program Resources for Expert Assistance & Care Helpline (REACH)

153 141 PRESCRIPTION REQUIREMENTS MEDICAL ORDER, DURATION, DISPENSING, TRANSMISSION (2) Prescription drugs or devices may only be dispensed by a pharmacist or pharmacist intern pursuant to a medical order, by an individual dispensing pursuant to a delegated dispensing permit, or as otherwise provided in section Notwithstanding any other provision of law to the contrary, a pharmacist or a pharmacist intern may dispense drugs or devices pursuant to a medical order or an individual dispensing pursuant to a delegated dispensing permit may dispense drugs or devices pursuant to a medical order. The Pharmacy Practice Act shall not be construed to require any pharmacist or pharmacist intern to dispense any drug or device pursuant to any medical order. A pharmacist or pharmacist intern shall retain the professional right to refuse to dispense. Nebraska Revised Statute

154 142 Q1: Permission to dispense a prescription in a non-childresistant container may be requested by the: I. Patient II. Prescriber III. Pharmacist IV. Patient s family member A) I only B) I and II C) I and III D) I and IV E) I, II and IV Q2: When refilling a prescription that was initially dispensed in a threaded child-resistant container, the pharmacist must always replace a: I. Glass container II. Plastic container III. Plastic closure A) I only B) III only C) II only D) II and III E) I and II

155 143 PERSONS EXCEPTED FROM THE PRACTICE OF PHARMACY As authorized by the Uniform Credentialing Act, the practice of pharmacy may be engaged in by a pharmacist, a pharmacist intern, or a practitioner with a pharmacy license. The practice of pharmacy shall not be construed to include: (1) Persons who sell, offer, or expose for sale completely denatured alcohol or concentrated lye, insecticides, and fungicides in original packages; (2) Practitioners, other than veterinarians, certified nurse midwives, certified registered nurse anesthetists, and nurse practitioners, who dispense drugs or devices as an incident to the practice of their profession, except that if such practitioner regularly engages in dispensing such drugs or devices to his or her patients for which such patients are charged, such practitioner shall obtain a pharmacy license; (3) Persons who sell, offer, or expose for sale nonprescription drugs or proprietary medicines, the sale of which is not in itself a violation of the Nebraska Liquor Control Act; (4) Medical representatives, detail persons, or persons known by some name of like import, but only to the extent of permitting the relating of pharmaceutical information to health care professionals; (5) Licensed veterinarians practicing within the scope of their profession; (6) Certified nurse midwives, certified registered nurse anesthetists, and nurse practitioners who dispense sample medications which are provided by the manufacturer and are dispensed at no charge to the patient; (7) Hospitals engaged in the compounding and dispensing of drugs and devices pursuant to chart orders for persons registered as patients and within the confines of the hospital, except that if a hospital engages in such compounding and dispensing for persons not registered as patients and within the confines of the hospital, such hospital shall obtain a pharmacy license or delegated dispensing permit; (8) Optometrists who prescribe or dispense eyeglasses or contact lenses to their own patients, including contact lenses that contain and deliver ocular pharmaceutical agents as authorized under the Optometry Practice Act, and ophthalmologists who prescribe or dispense eyeglasses or contact lenses to their own patients, including contact lenses that contain and deliver ocular pharmaceutical agents; Nebraska Revised Statute

156 144 PERSONS EXCEPTED FROM THE PRACTICE OF PHARMACY CONTINUED (9) Registered nurses employed by a hospital who administer pursuant to a chart order, or procure for such purpose, single doses of drugs or devices from original drug or device containers or properly labeled prepackaged drug or device containers to persons registered as patients and within the confines of the hospital; (10) Persons employed by a facility where dispensed drugs and devices are delivered from a pharmacy for pickup by a patient or caregiver and no dispensing or storage of drugs or devices occurs; and (11) Persons who sell or purchase medical products, compounds, vaccines, or serums used in the prevention or cure of animal diseases and maintenance of animal health if such medical products, compounds, vaccines, or serums are not sold or purchased under a direct, specific, written medical order of a licensed veterinarian; (12) A pharmacy or a person accredited by an accrediting body which or who, pursuant to a medical order, (a) administers, dispenses, or distributes medical gas or medical gas devices to patients or ultimate users or (b) purchases or receives medical gas or medical gas devices for administration, dispensing, or distribution to patients or ultimate users; and (13) A business or a person accredited by an accrediting body which or who, pursuant to a medical order, (a) sells, delivers, or distributes devices described subsection (2) of section to patients or ultimate users or (b) purchases or receives such devices with intent to sell, deliver, or distribute to patients or ultimate users. Nebraska Revised Statute

157 145 LEGEND DRUG LABEL Labeling on or within the package from which the drug is to be dispensed bears adequate information for its use, including indications, effects, dosages, routes, methods, and frequency and duration of administration, and any relevant hazards, contraindications, side effects, and precautions under which practitioners licensed by law to administer the drug can use the drug safely and for the purposes for which it is intended, including all purposes for which it is advertised or represented. 21 CFR (c) (1)

158 146 PRESCRIPTION CONTAINER LABEL The prescription container label must contain the following information: 1. Name, address, and telephone number of the dispensing pharmacy and central filling pharmacy, if central fill is used 2. Serial number of the prescription 3. Name of the drug, device, or biological Name of drug, device or biological can be left off the prescription if instructed so by prescriber. 4. Strength of drug or biological, if applicable 5. Directions for use 6. Quantity of drug, device or biological Quantity is not required on unit-dose containers. 7. Any cautionary statements contained in the prescription 8. Name of patient or if the patient is non-human, the name of the owner and species of the animal 9. Name of the prescriber If written by a PA, the name of the physician is required only if needed for reimbursement purposes. 10. Dosage form of the drug or biological if applicable 11. Date of filling 175 NAC F and 172 NAC

159 147 LABELING OF SUBSTANCES AND FILLING OF PRESCRIPTIONS (SCHEDULE II) (a) The pharmacist filling a written or emergency oral prescription for a controlled substance listed in Schedule II shall affix to the package a label showing date of filling, the pharmacy name and address, the serial number of the prescription, the name of the patient, the name of the prescribing practitioner, and directions for use and cautionary statements, if any, contained in such prescription or required by law. (b) If the prescription is filled at a central fill pharmacy, the central fill pharmacy shall affix to the package a label showing the retail pharmacy name and address and a unique identifier, (i.e. the central fill pharmacy's DEA registration number) indicating that the prescription was filled at the central fill pharmacy, in addition to the information required under paragraph (a) of this section. 21 CFR

160 148 LABELING OF SUBSTANCES AND FILLING OF PRESCRIPTIONS (SCHEDULE II) CONTINUED... (c) The requirements of paragraph (a) of this section do not apply when a controlled substance listed in Schedule II is prescribed for administration to an ultimate user who is institutionalized: Provided, That: (1) Not more than 7-day supply of the controlled substance listed in Schedule II is dispensed at one time; (2) The controlled substance listed in Schedule II is not in the possession of the ultimate user prior to the administration; (3) The institution maintains appropriate safeguards and records regarding the proper administration, control, dispensing, and storage of the controlled substance listed in Schedule II; and (4) The system employed by the pharmacist in filling a prescription is adequate to identify the supplier, the product, and the patient, and to set forth the directions for use and cautionary statements, if any, contained in the prescription or required by law. (d) All written prescriptions and written records of emergency oral prescriptions shall be kept in accordance with requirements of Sec (h) of this chapter. (e) Where a prescription that has been prepared in accordance with section (b) contains instructions from the prescribing practitioner indicating that the prescription shall not be filled until a certain date, no pharmacist may fill the prescription before that date. 21 CFR

161 149 LABELING OF SUBSTANCES AND FILLING OF PRESCRIPTIONS (SCHEDULE III, IV OR V) (a) The pharmacist filling a prescription for a controlled substance listed in Schedule III, IV, or V shall affix to the package a label showing the pharmacy name and address, the serial number and date of initial filling, the name of the patient, the name of the practitioner issuing the prescription, and directions for use and cautionary statements, if any, contained in such prescription as required by law. (b) If the prescription is filled at a central fill pharmacy, the central fill pharmacy shall affix to the package a label showing the retail pharmacy name and address and a unique identifier, (i.e. the central fill pharmacy's DEA registration number) indicating that the prescription was filled at the central fill pharmacy, in addition to the information required under paragraph (a) of this section. 21 CFR

162 150 LABELING OF SUBSTANCES AND FILLING OF PRESCRIPTIONS (SCHEDULE III, IV OR V) CONTINUED... (c) The requirements of paragraph (a) of this section do not apply when a controlled substance listed in Schedule III, IV, or V is prescribed for administration to an ultimate user who is institutionalized: Provided, That: (1) Not more than a 34-day supply or 100 dosage units, whichever is less, of the controlled substance listed in Schedule III, IV, or V is dispensed at one time; (2) The controlled substance listed in Schedule III, IV, or V is not in the possession of the ultimate user prior to administration; (3) The institution maintains appropriate safeguards and records the proper administration, control, dispensing, and storage of the controlled substance listed in Schedule III, IV, or V; and (4) The system employed by the pharmacist in filling a prescription is adequate to identify the supplier, the product and the patient, and to set forth the directions for use and cautionary statements, if any, contained in the prescription or required by law. (d) All prescriptions for controlled substances listed in Schedules III, IV, and V shall be kept in accordance with (h) of this chapter. 21 CFR

163 151 AVAILABILITY OF RECORDS TO DEPARTMENT AND LAW ENFORCEMENT (1) Paper prescriptions for all controlled substances listed in Schedule II of section shall be kept in a separate file by the dispensing practitioner and shall be maintained for a minimum of five years. The practitioner shall make all such files readily available to the department and law enforcement for inspection without a search warrant. (2) Prescriptions for all controlled substances listed in Schedule III, IV, or V of section shall be maintained either separately from other prescriptions or in a form in which the information required is readily retrievable from ordinary business records of the dispensing practitioner and shall be maintained for a minimum of five years. The practitioner shall make all such records readily available to the department, the administration, and law enforcement for inspection without a search warrant. Nebraska Revised Statute

164 152 UNLAWFUL ACTS REGARDING CONTROLLED SUBSTANCES (1) It shall be unlawful for any person: (a) (b) (c) (d) (e) (f) (g) To omit, remove, alter, or obliterate a symbol required by the federal Controlled Substances Act, 21 U.S.C. 801 et seq., as the act existed on September 1, 2001, or required by the laws of this state; To alter, deface, or remove any label affixed to a package of narcotic drugs; To refuse or fail to make, keep, or furnish any record, notification, order form, statement, invoice, or information required under the Uniform Controlled Substances Act; To refuse any entry into any premises for inspection authorized by the act; To keep or maintain any store, shop, warehouse, dwelling house, building, vehicle, boat, aircraft, or place whatever which such person knows or should know is resorted to by persons using controlled substances in violation of the Uniform Controlled Substances Act for the purpose of using such substances or which is used for the keeping or selling of the same in violation of the act; To whom or for whose use any controlled substance has been prescribed, sold, or dispensed by a practitioner or the owner of any animal for which any such substance has been prescribed, sold, or dispensed by a veterinarian to possess it in a container other than which it was delivered to him or her by the practitioner; or To be under the influence of any controlled substance for a purpose other than the treatment of a sickness or injury as prescribed or administered by a practitioner. In a prosecution under this subdivision, it shall not be necessary for the state to prove that the accused was under the influence of any specific controlled substance, but it shall be sufficient for a conviction under this subdivision for the state to prove that the accused was under the influence of some controlled substance by proving that the accused did manifest physical and physiological symptoms or reactions caused by the use of any controlled substance. (2) Any person who violates this section shall be guilty of a Class III misdemeanor. Nebraska Revised Statute

165 153 PRESCRIPTION DRUG OR DEVICE OR LEGEND DRUG OR DEVICE, DEFINED (1) Prescription drug or device or legend drug or device means: (a) A drug or device which is required under federal law to be labeled with one of the following statements prior to being dispensed or delivered: (i) (ii) (iii) Caution: Federal law prohibits dispensing without prescription; Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian; or "Rx Only"; or (b) A drug or device which is required by any applicable federal or state law to be dispensed pursuant only to a prescription or chart order or which is restricted to use by practitioners only. (2) Prescription drug or device or legend drug or device does not include a type of device, including supplies and device components, which carries the federal Food and Drug Administration legend "Caution: Federal law restricts this device to sale by or on the order of a licensed health care practitioner" or an alternative legend approved by the federal Food and Drug Administration which it recognizes, in published guidance, as conveying essentially the same message. Nebraska Revised Statute

166 154 NEBRASKA DRUG PRODUCT SELECTION ACT The purposes of the Nebraska Drug Product Selection Act are to provide for the drug product selection of equivalent drug products and to promote the greatest possible use of such products. Nebraska Revised Statute (This is also known as generic substitution.)

167 155 DRUG PRODUCT SELECTION TERMS, DEFINED For purposes of the Nebraska Drug Product Selection Act, unless the context otherwise requires: Bioequivalent means drug products: (a) That are legally marketed under regulations promulgated by the federal Food and Drug Administration; (b) that are the same dosage form of the identical active ingredients in the identical amounts as the drug product prescribed; (c) that comply with compendial standards and are consistent from lot to lot with respect to (i) purity of ingredients, (ii) weight variation, (iii) uniformity of content, and (iv) stability; and (d) for which the federal Food and Drug Administration has established bioequivalent standards or has determined that no bioequivalence problems exist; Brand name means the proprietary or trade name selected by the manufacturer, distributor, or packager for a drug product and placed upon the labeling of such product at the time of packaging. Nebraska Revised Statute

168 156 DRUG PRODUCT SELECTION TERMS, DEFINED CONTINUED... Chemically equivalent means drug products that contain amounts of the identical therapeutically active ingredients in the identical strength, quantity, and dosage form and that meet present compendial standards. Drug Product means any drug or device as defined in section , Drug product select means to dispense, without the practitioner s express authorization, an equivalent drug product in place of the brand-name drug product contained in a medical order of such practitioner. Equivalent means drug products that are both chemically equivalent and bioequivalent. Generic name means the official title of a drug or drug combination as determined by the United States Adopted Names Council and accepted by the federal Food and Drug Administration of those drug products having the same active chemical ingredients in the same strength and quantity. Nebraska Revised Statute

169 157 DRUG PRODUCT SELECTION, EXCEPTIONS A pharmacist can drug product select except when: Practitioner designates that drug product selection is not permitted by specifying on the prescription or by phone, fax, electronic transmission, OR A patient or designated representative or caregiver of such patient instructs otherwise. When the practitioner does not permit drug product selection For written prescriptions, the practitioner shall specify in his or her own handwriting on the prescription the phrase no drug product selection, dispense as written, brand medically necessary, or no generic substitution or the notation N.D.P.S., D.A.W., or B.M.N. or words or notations of similar import to indicate that drug product selection is not permitted. The pharmacist shall make the notation on the prescription (when communicated orally by the practitioner) A pharmacist shall not drug product select a drug product unless: (a) (b) (c) (d) The drug product, if it is in solid dosage form, has been marked with an identification code or monogram directly on the dosage unit; The drug product has been labeled with an expiration date; The manufacturer, distributor, or packager of the drug product provides reasonable services, as determined by the board, to accept the return of drug products that have reached their expiration date; and The manufacturer, distributor, or packager maintains procedures for the recall of unsafe or defective drug products. Nebraska Revised Statute

170 158 DRUG PRODUCT SELECTION AND FORMULARIES (1) Whenever a drug product has been prescribed with the notation that no drug product selection is permitted for a patient who has a contract where under he or she is reimbursed for the cost of health care, directly or indirectly, the party that has contracted to reimburse the patient, directly or indirectly, shall make reimbursements on the basis of the price of the brandname drug product and not on the basis of the equivalent drug product, unless the contract specifically requires generic reimbursement under the Code of Federal Regulations. (2) A prescription drug or device when dispensed shall bear upon the label the name of the drug or device in the container unless the practitioner writes do not label or words of similar import on the prescription or so designates orally or in writing which may be transmitted by facsimile or electronic transmission. (3) Nothing in this section shall (a) require a pharmacy to charge less than its established minimum price for the filling of any prescription or (b) prohibit any hospital from developing, using, and enforcing a formulary. Nebraska Revised Statute

171 159 DRUG PRODUCT SELECTION, PATIENT ADVISING Whenever a pharmacist receives a prescription for a brand name product and chooses to dispense a bioequivalent drug, device or biological, the pharmacist must advise the patient or the patient s caregiver that drug product selection has occurred. The patient or the patient s caregiver may instruct the pharmacist that s/he does not desire drug product selection. Patient/caregiver must be advised of the generic substitution. Patient/caregiver can opt for brand. 172 NAC

172 160 DRUG PRODUCT SELECTION, PROTECTION OF PHARMACIST The employer or such employer s agent may not restrict a pharmacist from choosing to dispense, without the duly licensed prescriber s express authorization, a chemically equivalent and bioequivalent drug product in place of the drug product ordered or prescribed. 175 NAC I

173 161 TRANSFERRING PRESCRIPTION REFILLS Original prescription information for any controlled substance in Schedule III, IV, or V and non-controlled prescription drugs/devices may be transferred for purposes of refill dispensing on a one-time basis, except that pharmacies electronically accessing a real-time, on-line data base may transfer up to the available refills. Transfer is communicated between two pharmacists or pharmacist interns except when the pharmacies can use a realtime, on-line database. Nebraska Revised Statute

174 162 TRANSFERRING PHARMACY Indicate void on the record of the prescription Indicate on the record that the prescription is transferred Record Name, address, and, if a controlled substance, the Drug Enforcement Agency (DEA) number of receiving pharmacy Name of receiving pharmacist/pharmacist intern Name of transferring pharmacist/pharmacist intern Date of transfer Both the original and transferred prescriptions must be maintained by the transferring and receiving pharmacy for a period of five years from the date of transfer. Nebraska Revised Statute

175 163 RECEIVING PHARMACIST/PHARMACIST INTERN Transferred prescription includes: Date of issue of original prescription Original number of refills authorized The date of original dispensing Number of valid refills remaining The date and location of last refill Name, address, and DEA number (if controlled substance) of transferring pharmacy Name of transferring pharmacist/pharmacist intern Original prescription number Date of transfer Indicate in record that prescription is transferred Record any information that is normally required on a new prescription. Nebraska Revised Statute

176 164 TRANSFERRING PRESCRIPTION REFILLS SUMMARY Between pharmacists/pharmacist interns Real-time, on-line database Can transfer as many times as there are refills, as long as accessing a real-time, on-line database Not a real-time, on-line database One-time transfer of all remaining refills

177 165 Q1: When a pharmacist transfers any remaining authorized refills of a controlled substance prescription to another pharmacy, what things must the "transferor pharmacist" do to the original prescription? I. Write "void" on the prescription II. Write name, address, DEA number of receiving pharmacy III. Record name of transferring and receiving pharmacists A) I only B) II only C) I and II D) II and III E) I, II and III Q2: Which of the following drug(s) is/are exempt from the PPPA? I. Aspirin tablets II. A unit dose pack of acetaminophen containing 4 tablets; each containing 500 mg III. A single unit dose tablet of Ibuprofen containing 600 mg IV. Sublingual nitroglycerin tablets A) I only B) II only C) IV only D) II and IV E) III and IV Q3: Which of the following drug(s) is/are exempt from the PPPA? (Select ALL that apply.) A) Effervescent aspirin tablet B) Questran powder packet C) Sublingual isosorbide dinitrate tablets D) Oral contraceptives in manufacturers mnemonic (memory aid) packages E) Sublingual nitroglycerin tablets

178 166 Q4: When a prescriber writes "do not label" on the original written prescription, which of the following shall NOT be placed on a dispensing label? (Select ALL that apply.) A) Name and address of dispensing practitioner B) Name of drug C) Date of filling D) Name of the prescribing practitioner E) Directions for use Q5: Which of the following shall be required on the prescription if the prescription is written for an animal? I. Name of an animal II. The species of animal III. The name of the owner of the animal A) I only B) I and II C) I and III D) II and III E) I, II and III Q6: The labeling requirements do not apply when a Schedule II, III, IV, or V drug is prescribed for administration to an institutionalized patient provided that: (Select ALL that apply.) A) Not more than 7-day supply for a schedule II drug is dispensed at one time B) Not more than a 34-day supply or 100 dosage units, whichever is less, is dispensed at one time for a schedule III, IV and V C) The medication is not in the possession of the ultimate user prior to administration D) The medication is stored in a locked cabinet if in the possession of the ultimate user prior to administration E) The institution maintains appropriate safeguards and records regarding the proper administration, control, dispensing, and storage of the drug Q7: A pharmacist may select a drug product except when a prescriber indicates: (Select ALL that apply.) A) N.T.B.S. B) N.D.P.S. C) B.M.N. D) D.A.W. E) No generic substitution

179 167 RETURN OF DISPENSED PRESCRIPTIONS (1) To protect the public safety, dispensed drugs or devices: (a) (b) (c) (d) May be collected in a pharmacy for disposal; May be returned to a pharmacy in response to a recall by the manufacturer, packager, or distributor or if a device is defective or malfunctioning; Shall not be returned to saleable inventory nor made available for subsequent relabeling and redispensing, except as provided in subdivision (1)(d) of this section; or May be returned from a long-term care facility to the pharmacy from which they were dispensed for credit or for relabeling and redispensing, except that: (i) No controlled substance may be returned; (ii) The decision to accept the return of the dispensed drug or device shall rest solely with the pharmacist; (iii) The dispensed drug or device shall have been in the control of the long-term care facility at all times; (iv) The dispensed drug or device shall be in the original and unopened labeled container with a tamper-evident seal intact, as dispensed by the pharmacist. Such container shall bear the expiration date or calculated expiration date and lot number; and (v) Tablets or capsules shall have been dispensed in a unit dose container which is impermeable to moisture and approved by the Board of Pharmacy. Nebraska Revised Statute

180 168 RETURN OF DISPENSED PRESCRIPTIONS CONTINUED... (2) Pharmacies may charge a fee for collecting dispensed drugs or devices for disposal or from a long-term care facility for credit or for relabeling and redispensing. (3) Any person or entity which exercises reasonable care in collecting dispensed drugs or devices for disposal or from a long-term care facility for credit or for relabeling and redispensing pursuant to this section shall be immune from civil or criminal liability or professional disciplinary action of any kind for any injury, death, or loss to person or property relating to such activities. (4) A drug manufacturer which exercises reasonable care shall be immune from civil or criminal liability for any injury, death, or loss to persons or property relating to the relabeling and redispensing of drugs returned from a long-term care facility. (5) Notwithstanding subsection (4) of this section, the relabeling and redispensing of drugs returned from a long-term care facility does not absolve a drug manufacturer of any criminal or civil liability that would have existed but for the relabeling and redispensing and such relabeling and redispensing does not increase the liability of such drug manufacturer that would have existed but for the relabeling and redispensing. (6) For purposes of this section: (a) (b) (c) Calculated expiration date means the expiration date on the manufacturer s, packager s, or distributor s container or one year from the date the drug or device is repackaged, whichever is earlier; Dispense, drugs, and devices are defined in the Pharmacy Practice Act; and Long-term care facility does not include an assisted-living facility as defined in section Nebraska Revised Statute

181 169 RETURN OF DISPENSED PRESCRIPTIONS FROM LONG-TERM CARE FACILITIES The facility must ensure the proper disposal of all prescription medications. The facility may send prescribed medication with a resident upon discharge only with the order of a medical practitioner and all medication containers must be properly labeled by the dispensing pharmacy. Discontinued Medications When any prescription medication is discontinued permanently or the resident has expired, the facility must either: Return the medication to the dispensing pharmacy for credit in accordance with Neb. Rev. Stat ; or Properly dispose of any residue. The disposal must take place on the site of the facility; and the medication name, strength and quantity disposed of must be recorded in the resident s medical record. 175 NAC E8 Unit-Dose is a Packaging System 1. That contains individual sealed doses of a drug; 2. That may or may not attach the sealed doses to each other by placement in a card or other container; 3. Where the container may not contain doses for a period of greater than 14 days; and 4. That is non-reusable. 175 NAC C

182 170 RETURN OF DISPENSED PRESCRIPTIONS FROM LONG-TERM CARE FACILITIES CONTINUED... Unit-dose containers returned to the dispensing pharmacy, from a long-term care facility, for credit, must have a lot number and expiration date/calculated expiration date. 1. The calculated expiration date is used when the drug has been repackaged by the pharmacist into a unit-dose packaging system and is 25% of the remaining time between the date of repackaging and the manufacturer s or distributor s expiration date or six months from the date of packaging, whichever is less.* 2. Lot number is the lot number assigned by the manufacturer, distributor, or packager. 175 NAC D In order for a pharmacy to accept the return of tablets or capsules from a long-term care facility, these tablets and capsules must be packaged in a unit-dose container meeting the following requirements: 1. Unit-dose containers must meet the Class A or Class B guidelines for single-unit containers and unit-dose containers for capsules and tablets as set forth by the United States Pharmacopoeia. 2. Manufacturers, distributors or pharmacists wishing to use a unit-dose packaging system must present certified, scientific data demonstrating compliance with the Class A or Class B guidelines for moisture permeability as required by the United States Pharmacopoeia. 3. A new certificate of moisture impermeability is required when changes are made in the product. These changes may include, but are not limited to changes in: a. Adhesives; b. Plastics; or c. Cardboard formulation. 175 NAC E *Note: (a) supersedes the regulation listed above. In that statute, calculated expiration date means the expiration date on the manufacturer's, packager's, or distributor's container or one year from the date the drug or device is repackaged, whichever is earlier.

183 171 RETURN OF DISPENSED PRESCRIPTIONS FROM LONG-TERM CARE FACILITIES CONTINUED Only containers, which meet the following tamper-evident requirements and are approved by the Board, are considered to be returnable unit-dose containers: a. The package has an indicator or barrier to entry which, if breached or missing, can reasonably be expected to provide visible evidence to the health care practitioner that tampering has occurred. b. To reduce the likelihood of substitution of a tamper-evident feature after tampering, the indicator or barrier to entry is required to be distinctive by design or by the use of an identifying characteristic. Distinctive by design means that the packaging cannot be duplicated or replaced with readily available materials or through commonly available processes. c. A tamper-evident package may involve an immediate-container and closure system or a secondary-container or carton system or any combination of systems intended to provide a visual indication of package integrity. d. The tamper-evident feature must be designed to be and must remain intact when handled in a reasonable manner during dispensing to and storage at a long-term care facility. e. The tamper-evident feature is destroyed or rendered useless after the container is opened. 5. The return to the pharmacy of controlled substances, halved tablets, other broken dosage forms, and extemporaneously compounded tablets and capsules is prohibited. 175 NAC E

184 172 RETURN OF DRUGS BY COMMUNITY HEALTH CENTER PATIENTS (1) Prescription drugs or devices which have been delivered to a community health center for dispensing to a patient of such health center pursuant to a valid prescription, but which are not dispensed or administered to such patient, may be delivered to a pharmacist or pharmacy under contract with the community health center for relabeling and redispensing to another patient of such health center pursuant to a valid prescription if: (a) The decision to accept delivery of the drug or device for relabeling and redispensing rests solely with the contracting pharmacist or pharmacy; (b) The drug or device has been in the control of the community health center at all times; (c) The drug or device is in the original and unopened labeled container with a tamper-evident seal intact. Such container shall bear the expiration date or calculated expiration date and lot number; and (d) The relabeling and redispensing is not otherwise prohibited by law. Nebraska Revised Statute

185 173 RETURN OF DISPENSED DRUGS FROM CORRECTIONAL FACILITIES (1) Prescription drugs or devices which have been dispensed pursuant to a valid prescription and delivered to a Department of Correctional Services facility, a criminal detention facility, a juvenile detention facility, or a jail for administration to a prisoner or detainee held at such facility or jail, but which are not administered to such prisoner or detainee, may be returned to the pharmacy from which they were dispensed under contract with the facility or jail for credit or for relabeling and redispensing and administration to another prisoner or detainee held at such facility or jail pursuant to a valid prescription as provided in this section. (2) (a)the decision to accept return of a dispensed prescription drug or device for credit or for relabeling and redispensing rests solely with the pharmacist at the contracting pharmacy. (b) A dispensed prescription drug or device shall be properly stored and in the control of the facility or jail at all times prior to the return of the drug or device for credit or for relabeling and redispensing. The drug or device shall be returned in the original and unopened labeled container dispensed by the pharmacist with the tamper-evident seal intact, and the container shall bear the expiration date or calculated expiration date and lot number of the drug or device. (c) A prescription drug or device shall not be returned or relabeled and redispensed under this section if the drug or device is a controlled substance or if the relabeling and redispensing is otherwise prohibited by law. Nebraska Revised Statute

186 174 CANCER DRUG REPOSITORY Cancer drug means a prescription drug used to treat (a) cancer or its side effects or (b) the side effects of a prescription drug used to treat cancer or its side effects. Participant means a physician s office, pharmacy, hospital, or health clinic that has elected to voluntarily participate in the program and that accepts donated cancer drugs under the rules and regulations adopted and promulgated by the department for the program. Nebraska Revised Statute Cancer drug repository program; established The department shall establish a cancer drug repository program for accepting donated cancer drugs and dispensing such drugs to Nebraska residents. Participation in the program shall be voluntary. Nebraska Revised Statute Cancer drug donation Any person or entity, including, but not limited to, a cancer drug manufacturer or health care facility, may donate cancer drugs to the program. Cancer drugs may be donated to a participant. Nebraska Revised Statute

187 175 CANCER DRUG REPOSITORY CONTINUED... Cancer drug; accepted or dispensed; conditions (1) A cancer drug shall only be accepted or dispensed under the program if such drug is in its original, unopened, sealed, and tamperevident packaging. A cancer drug packaged in single unit doses may be accepted and dispensed if the outside packaging is opened but the single-unit-dose packaging is unopened. There shall be no limitation on the number of doses that can be donated to the program as long as the donated drugs meet the requirements of this section. An injectable cancer drug may be accepted if it does not have temperature requirements other than controlled room temperature. (2) A cancer drug shall not be accepted or dispensed under the program if (a) such drug bears an expiration date prior to the date of donation, (b) such drug is adulterated or misbranded as described in section or , or (c) such drug has expired while in the repository. (3) Subject to limitations provided in this section, unused cancer drugs dispensed under the medical assistance program established pursuant to the Medical Assistance Act may be accepted and dispensed under the program. Nebraska Revised Statute

188 176 CANCER DRUG REPOSITORY CONTINUED... Participant; duties; fee authorized (1) A participant shall comply with all applicable provisions of state and federal law relating to the storage, distribution, and dispensing of donated cancer drugs and shall inspect all such drugs prior to dispensing to determine if they are adulterated or misbranded as described in section or Such drugs shall only be dispensed pursuant to a prescription issued by a prescribing practitioner. Such drugs may be distributed to another participant for dispensing. (2) A participant may charge a handling fee for distributing or dispensing cancer drugs under the program. Such fee shall be established in rules and regulations adopted and promulgated by the department. Cancer drugs donated under the program shall not be resold. Nebraska Revised Statute

189 177 CANCER DRUG REPOSITORY CONTINUED... Any person or entity who wishes to donate cancer drugs to the program must contact a participant to obtain a form on which they must specify the cancer drug to be donated. The form must include: 1. Name of the cancer drug; 2. Quantity of the cancer drug; 3. The name of the person to whom the cancer drug was originally prescribed; 4. The relationship between the person or entity donating the cancer drugs and the person to whom the cancer drug was prescribed; 5. Signature of the person donating the cancer drug; and 6. Date the form was signed. 181 NAC The following categories of drugs are acceptable for dispensing or distribution under the program: 1. A cancer drug that is in its original, unopened, sealed, and tamper-evident packaging; 2. A cancer drug packaged in single unit doses if the outside packaging is opened but the single-unit-dose packaging is unopened; 3. A cancer drug that was dispensed under the medical assistance program established in Neb. Rev. Stat that meets the requirements of 1 or 2 above; 4. A cancer drug that does not require refrigeration, freezing, or other special temperature requirements beyond controlled room temperature; and 5. An injectable cancer drug if it does not have temperature requirements other than controlled room temperature. 181 NAC

190 178 CANCER DRUG REPOSITORY CONTINUED... The following categories of drugs are not acceptable for dispensing or distribution under the program: 1. A cancer drug that bears an expiration date prior to the date of donation because the effectiveness of the cancer drug cannot be ensured; 2. A cancer drug that is adulterated or misbranded pursuant to Neb. Rev. Stat or because the effectiveness and safety of the cancer drug cannot be ensured; 3. A cancer drug that has expired while in the repository program; 4. A cancer drug in packaging that has been opened, unsealed, or tampered with or that is no longer in its original container because the safety of the cancer drug can no longer be ensured; 5. A cancer drug packaged in single unit doses if the outside packaging is opened and the single-unit-dose packaging is also opened because the safety of the cancer drug can no longer be ensured; 6. A cancer drug that requires refrigeration, freezing, or other special temperature requirements beyond controlled room temperature because the effectiveness and safety of the cancer drug cannot be ensured; or 7. Controlled substances because Federal Law prohibits their return. 181 NAC

191 179 CANCER DRUG REPOSITORY CONTINUED... Dispensing and Distribution Requirements A participant must comply with all applicable provisions of state and federal law relating to the storage, distribution, and dispensing of donated cancer drugs. (Nebraska Pharmacy Statutes Pertaining to Practice of Pharmacy Neb. Rev. Stat. 71-1,142 to 71-1,151; 172 NAC 128 Regulations Governing the Practice of Pharmacy; and 175 NAC 8 Regulations Governing Licensure of Pharmacies.) 181 NAC A A participant must inspect all such drugs prior to dispensing or distributing to determine if they are adulterated or misbranded pursuant to Neb. Rev. Stat or NAC B The following persons are authorized pursuant to Neb. Rev. Stat. 71-1,143 to dispense drugs: 1. Licensed physicians who do not charge a handling fee for the cancer drugs; 2. Licensed physicians who charge a handling fee for the cancer drugs and who hold a valid dispensing practitioner pharmacy license; and 3. Licensed pharmacists. 181 NAC C Cancer drugs may only be dispensed pursuant to a prescription issued by a prescribing practitioner. 181 NAC D

192 180 CANCER DRUG REPOSITORY CONTINUED... Cancer drugs accepted by a participant from the donor may be: 1. Dispensed to an ultimate user of the cancer drug; or 2. Distributed to another participant for dispensing. 181 NAC E Cancer drugs donated under the program must not be resold. 181 NAC F Patients for whom cancer drugs are dispensed under the program must be notified by the prescribing practitioner that the cancer drugs they receive were originally dispensed to another patient and were returned for redispensing through the program. 181 NAC G Storage Requirements The participant that receives donated cancer drugs for dispensing or distribution must: 1. Provide equipment for the storage of cancer drugs donated to the program at controlled room temperature that must be stored between 59 and 86 degrees Fahrenheit; 2. Maintain the inventory of donated cancer drugs separate from all other drug inventory of the participant; and 3. Establish a secure location for the storage of the donated cancer drugs. 181 NAC A

193 181 CANCER DRUG REPOSITORY CONTINUED... Record Keeping Requirements A perpetual inventory log book of all cancer drugs received, dispensed and distributed by a participant under the program must be maintained. 181 NAC A The perpetual inventory log book must contain the following information regarding all cancer drugs received, dispensed and distributed by a participant under the program: 1. Name of the cancer drug; 2. Quantity of the cancer drug; 3. Expiration date of the cancer drug; 4. Lot number of the cancer drug; 5. Name of participant; 6. Name of person who donated the cancer drug; 7. Name of person to whom the cancer drug was originally prescribed; 8. Name of person to whom the cancer drug was dispensed; 9. Date the cancer drug was dispensed; 10. Name of the prescribing practitioner who wrote the prescription for the cancer drug to be dispensed under the program; 11. Name of the participant to which the cancer drug was distributed; 12. Date the cancer drug was distributed to another participant; 13. Date of destruction of the expired cancer drug; and 14. Whether a handling fee was charged and the amount of any such fee. 181 NAC B Hard copies of all prescriptions dispensed must be maintained by the participant to document the receipt of a prescription for the cancer drug to be dispensed and must be kept for five years pursuant to Neb. Rev. Stat. 71-1, NAC C

194 182 CANCER DRUG REPOSITORY CONTINUED... Handling Fee A participant that receives donated cancer drugs may charge a handling fee to the ultimate user for dispensing or distribution of cancer drugs under the program, except that a physician must hold a valid dispensing practitioner pharmacy license in order to charge the handling fee. 181 NAC A If a handling fee is charged to the ultimate user to whom the cancer drug is dispensed or to the entity to which the cancer drug was distributed, the handling fee must not exceed the Medicaid provider dispensing fee that is applicable at the time the dispensing or distribution occurs. Participant Registry The participant registry must include: 181 NAC B 1. Participant s name; 2. Participant s address; 3. Participant s telephone number; and 4. Whether the participant is a physician s office, a pharmacy, a hospital, or a health clinic. 181 NAC A It is the responsibility of the participant to: 1. Notify the department of the desire to participate in the program; and 2. Provide the required registry information to the department. 181 NAC B

195 183 CANCER DRUG REPOSITORY CONTINUED... Updates to the Participant Registry It is the responsibility of the participant to notify the department: 1. Of any change of name, address, telephone number, or participant type; and 2. When the participant no longer wishes to participate in the program. 181 NAC A Access to the Participant Registry The department will make the participant registry information available to any person or entity wishing to donate cancer drugs to the program. 181 NAC A The department will make the participant registry information available to any person or entity wishing to donate cancer drugs to the program. 181 NAC B

196 184 IMMUNOSUPPRESSANT DRUG REPOSITORY Immunosuppressant drug means anti-rejection drugs that are used to reduce the body s immune system response to foreign material and inhibit a transplant recipient s immune system from rejecting a transplanted organ. Immunosuppressant drugs are available only as prescription drugs and come in tablet, capsule, and liquid forms. The recommended dosage depends on the type and form of immunosuppressant drug and the purpose for which it is being used. Immunosuppressant drug does not include drugs prescribed for inpatient use; Participant means a transplant center that has elected to voluntarily participate in the program, that has submitted written notification to the department of its intent to participate in the program, and that accepts donated immunosuppressant drugs under the rules and regulations adopted and promulgated by the department for the program. Transplant center means a hospital that operates an organ transplant program, including qualifying patients for transplant, registering patients on the national waiting list, performing transplant surgery, and providing care before and after transplant. Transplant program means the organ-specific facility within a transplant center. A transplant center may have transplant programs for the transplantation of hearts, lungs, livers, kidneys, pancreata, or intestines. Nebraska Revised Statute

197 185 IMMUNOSUPPRESSANT DRUG REPOSITORY CONTINUED... The department shall establish an immunosuppressant drug repository program for accepting donated immunosuppressant drugs and dispensing such drugs. Participation in the program shall be voluntary. Nebraska Revised Statute Any person or entity, including, but not limited to, an immunosuppressant drug manufacturer or transplant center, may donate immunosuppressant drugs to a participant or return previously prescribed immunosuppressant drugs to the transplant center where they were originally prescribed. Nebraska Revised Statute (1) An immunosuppressant drug shall only be accepted or dispensed under the program if such drug is in its original, unopened, sealed, and tamper-evident packaging. An immunosuppressant drug packaged in single unit doses may be accepted and dispensed if the outside packaging is opened but the single-unit-dose packaging is unopened. There shall be no limitation on the number of doses that can be donated to the program as long as the donated drugs meet the requirements of this section. (2) An immunosuppressant drug shall not be accepted or dispensed under the program if (a) such drug bears an expiration date prior to the date of donation or (b) such drug is adulterated or misbranded as described in section or (3) Subject to limitations provided in this section, unused immunosuppressant drugs dispensed under the medical assistance program may be accepted and dispensed under the immunosuppressant drug repository program. Nebraska Revised Statute

198 186 IMMUNOSUPPRESSANT DRUG REPOSITORY CONTINUED... (1) A participant shall comply with all applicable provisions of state and federal law relating to the storage, distribution, and dispensing of donated immunosuppressant drugs and shall inspect all such drugs prior to dispensing to determine if the drugs are adulterated or misbranded as described in section or or if the drugs bear an expiration date prior to the date of dispensing. Such drugs shall only be dispensed pursuant to a prescription issued by a prescribing practitioner. Such drugs may be distributed to another participant for dispensing. (2) Immunosuppressant drugs donated under the program shall not be resold. Nebraska Revised Statute The department, upon the recommendation of the Board of Pharmacy, shall adopt and promulgate rules and regulations to carry out the Immunosuppressant Drug Repository Program Act. Such rules and regulations shall include, but not be limited to: (1) Eligibility criteria and other standards and procedures for participants that accept and distribute or dispense donated immunosuppressant drugs; (2) Necessary forms for administration of the program, including, but not limited to, forms for use by persons or entities that donate, accept, distribute, or dispense immunosuppressant drugs under the program. The forms shall include the name of the person to whom the drug was originally prescribed; and (3) (a) Categories of immunosuppressant drugs that may be donated or returned under the program and (b) categories of immunosuppressant drugs that cannot be donated or returned under the program and the reason that such drugs cannot be donated or returned. Nebraska Revised Statute

199 187 IMMUNOSUPPRESSANT DRUG REPOSITORY CONTINUED... (1) Any person or entity, including an immunosuppressant drug manufacturer, which exercises reasonable care in donating, accepting, distributing, or dispensing immunosuppressant drugs under the Immunosuppressant Drug Repository Program Act or rules and regulations adopted and promulgated under the act shall be immune from civil or criminal liability or professional disciplinary action of any kind for any injury, death, or loss to person or property relating to such activities. (2) Notwithstanding subsection (1) of this section, the donation of an immunosuppressant drug by a drug manufacturer does not absolve the manufacturer of any criminal or civil liability that would have existed but for the donation, nor shall such donation increase the liability of such drug manufacturer that would have existed but for the donation. Nebraska Revised Statute Donating Immunosuppressant Drugs Any person or entity, including but not limited to an immunosuppressant drug manufacturer or transplant center, may donate immunosuppressant drugs to a participant or return previously prescribed immunosuppressant drugs to the transplant center where they were originally prescribed. 181 NAC

200 188 IMMUNOSUPPRESSANT DRUG REPOSITORY CONTINUED... Any person or entity who wishes to donate immunosuppressant drugs to the program must contact a participant to obtain a form on which they must specify the immunosuppressant drug to be donated. The form must include: 1. Name of the immunosuppressant drug; 2. Quantity of the immunosuppressant drug; 3. The name of the person to whom the immunosuppressant drug was originally prescribed; 4. The relationship between the person or entity donating the immunosuppressant drug and the person to whom the immunosuppressant drug was prescribed; 5. Signature of the person donating the immunosuppressant drug; and 6. Date the form was signed. 181 NAC Participation in the program is voluntary. 181 NAC There is no limitation on the number of doses than can be donated to the program as long as the donated drugs meet the requirements of these regulations. 181 NAC

201 189 IMMUNOSUPPRESSANT DRUG REPOSITORY CONTINUED... Acceptable Immunosuppressant Drugs The following categories of drugs are acceptable for dispensing or distribution under the program: 1. An immunosuppressant drug that is in its original, unopened, sealed, and tamper-evident packaging; 2. An immunosuppressant drug packaged in single unit doses if the outside packaging is opened but the single-unitdose packaging is unopened; 3. An immunosuppressant drug that was dispensed under the medical assistance program established in Neb. Rev. Stat that meets the requirements of 1 or 2 above; and 4. An immunosuppressant drug that does not require refrigeration, freezing, or other special temperature requirements beyond controlled room temperature. 181 NAC

202 190 IMMUNOSUPPRESSANT DRUG REPOSITORY CONTINUED... Non-Acceptable Immunosuppressant Drugs The following categories of drugs are not acceptable for dispensing or distribution under the program: 1. An immunosuppressant drug that bears an expiration date prior to the date of donation because the effectiveness of the immunosuppressant drug cannot be ensured; 2. An immunosuppressant drug that is adulterated or misbranded pursuant to Neb. Rev. Stat or because the effectiveness and safety of the immunosuppressant drug cannot be ensured; 3. An immunosuppressant drug in packaging that has been opened, unsealed, or tampered with or that is no longer in its original container because the safety of the immunosuppressant drug can no longer be ensured; 4. An immunosuppressant drug packaged in single unit doses if the outside packaging is opened and the single-unitdose packaging is also opened because the safety of the immunosuppressant drug can no longer be ensured; 5. An immunosuppressant drug that requires refrigeration, freezing, or other special temperature requirements beyond controlled room temperature because the effectiveness and safety of the immunosuppressant drug cannot be ensured; or 6. Controlled substances because Federal Law prohibits their return. 181 NAC

203 191 IMMUNOSUPPRESSANT DRUG REPOSITORY CONTINUED... Dispensing and Distribution Requirements A participant must comply with all applicable provisions of state and federal law relating to the storage, distribution, and dispensing of donated immunosuppressant drugs. (Nebraska Pharmacy Statutes Pertaining to Practice of Pharmacy Neb. Rev. Stat. 71-1,142 to 71-1,151; 172 NAC 128 Regulations Governing the Practice of Pharmacy; and 175 NAC 8 Regulations Governing Licensure of Pharmacies.) 181 NAC A A participant must inspect all such drugs prior to dispensing or distributing to determine if they are adulterated or misbranded pursuant to Neb. Rev. Stat or or if the drugs bear an expiration date prior to the date of dispensing. 181 NAC B The following persons are authorized pursuant to Neb. Rev. Stat. 71-1,143 to dispense drugs: 1. Licensed physicians; 2. Licensed physician assistants; and 3. Licensed pharmacists. 181 NAC C

204 192 IMMUNOSUPPRESSANT DRUG REPOSITORY CONTINUED... Immunosuppressant drugs may only be dispensed pursuant to a prescription issued by a prescribing practitioner. 181 NAC D Immunosuppressant drugs accepted by a participant from the donor may be: 1. Dispensed to an ultimate user of the immunosuppressant drug; or 2. Distributed to another participant for dispensing. 181 NAC E Immunosuppressant drugs donated under the program must not be resold. 181 NAC F Patients for whom immunosuppressant drugs are dispensed under the program must be notified by the prescribing practitioner that the immunosuppressant drugs they receive were originally dispensed to another patient and were returned for re-dispensing through the program. 181 NAC G

205 193 IMMUNOSUPPRESSANT DRUG REPOSITORY CONTINUED... Storage Requirements The participant that receives donated immunosuppressant drugs for dispensing or distribution must: 1. Provide equipment for the storage of immunosuppressant drugs donated to the program at controlled room temperature that must be stored between 59 and 86 degrees Fahrenheit; 2. Maintain the inventory of donated immunosuppressant drugs separate from all other drug inventory of the participant; and 3. Establish a secure location for the storage of the donated immunosuppressant drugs. 181 NAC A Record Keeping Requirements A perpetual inventory log book of all immunosuppressant drugs received, dispensed and distributed by a participant under the program must be maintained. 181 NAC A The perpetual inventory log book must contain the following information regarding all immunosuppressant drugs received, dispensed and distributed by a participant under the program: 1. Name of the immunosuppressant drug; 2. Quantity of the immunosuppressant drug; 3. Expiration date of the immunosuppressant drug; 4. Lot number of the immunosuppressant drug; 5. Name of participant; 6. Name of person who donated the immunosuppressant drug; 7. Name of person to whom the immunosuppressant drug was originally prescribed;

206 194 IMMUNOSUPPRESSANT DRUG REPOSITORY CONTINUED Name of person to whom the immunosuppressant drug was dispensed; 9. Date the immunosuppressant drug was dispensed; 10. Name of the prescribing practitioner who wrote the prescription for the immunosuppressant drug to be dispensed under the program; 11. Name of the participant to which the immunosuppressant drug was distributed; 12. Date the immunosuppressant drug was distributed to another participant; and 13. Date of destruction of the expired immunosuppressant drug. 181 NAC B Hard copies of all prescriptions dispensed must be maintained by the participant to document the receipt of a prescription for the immunosuppressant drug to be dispensed and must be kept for five years pursuant to Neb. Rev. Stat. 71-1, NAC C

207 195 IMMUNOSUPPRESSANT DRUG REPOSITORY CONTINUED... Compliance Inspections Each participant has the responsibility to be in compliance, and to remain in compliance, with the regulations set out in this chapter. For the purpose of assuring initial and continued compliance, the Department will conduct inspections of participants as set out below: 181 NAC Initial Onsite Inspection - The Department will conduct an initial onsite inspection within 60 days after the Department has received written notification from a transplant center of their intent to participate in the program. The inspection must determine whether the participant is in compliance with these regulations. 181 NAC Department Determination - Such determination must be made when the pharmacy inspector verifies that the participant: 1. Requires persons or entities wishing to donate immunosuppressant drugs to the program to provide information about the donated drugs pursuant to 181 NAC ; 2. Is accepting only donations of immunosuppressant drugs that meet the requirements of 181 NAC ; 3. Is not accepting donations of non-acceptable immunosuppressant drugs as specified in 181 NAC ; 4. Is storing donated immunosuppressant drugs pursuant to 181 NAC ; and 5. Is maintaining records of all immunosuppressant drugs received, dispensed and distributed by the participant under the program pursuant to 181 NAC NAC A

208 196 IMMUNOSUPPRESSANT DRUG REPOSITORY CONTINUED... Biennial Onsite Inspection - All participants are subject to an onsite inspection at least once every two years to determine whether a participant is in compliance with these regulations. Biennial onsite inspections will be conducted by the Department in the same manner as an initial onsite inspection pursuant to 181 NAC NAC Inspection for Cause - The Department may inspect a participant to determine violations when any one or more of the following conditions or circumstances occur: 1. An accident or natural disaster resulting in damage to the physical plant; or interruption of utility services which could result in adverse effects to the potency, efficacy, safety or security of the immunosuppressant drugs; 2. A complaint alleging violation of the Immunosuppressant Drug Repository Program Act or these regulations; 3. A complaint that raises concern about the maintenance, operation, or management of the participant; and 4. Any other event that raises concerns about the maintenance, operation, or management of the participant. 181 NAC

209 197 IMMUNOSUPPRESSANT DRUG REPOSITORY CONTINUED... Results of Inspections The Department will notify the participant of the results of an inspection within 10 days after conducting the inspection. 181 NAC A When the Department finds that the participant is not in compliance with these regulations, and the nature of the violations would create an imminent danger of death or serious physical harm or immediate adverse effect to the safety or security of the immunosuppressant drugs, the participant must cease participation in the program immediately. 181 NAC B When the Department finds that the participant is not in compliance with these regulations, but the nature of the violations do not create an imminent danger of death or serious physical harm to the patients of the participant and no direct or immediate adverse effect to the safety or security of the immunosuppressant drugs, the participant must correct any deficiencies noted in the inspection within 30 days after receiving the inspection results. 181 NAC C Participants that are not fully in compliance with these regulations within 30 days after receiving the inspection results will no longer be allowed to participate in the program. 181 NAC D

210 198 Q1: Pharmacies not using a real-time, on-line database may transfer authorized refills for a prescription for Schedule III, IV and V substances: A) One time B) Two times C) Three times D) Four times E) Five times Q2: In accordance with Nebraska Pharmacy Law a pharmacist may accept return of the dispensed drug or device when: I. A device is defective or malfunctioning II. The patient changes their mind and wants a refund III. It is collected for the purpose of disposal by the pharmacy IV. In response to a recall by the manufacturer, packager, or distributor A) I only B) I and II C) I, II, and III D) I, III, and IV E) I, II, III and IV Q3: Which of the following defines a Unit Dose Packaging System? (Select ALL that apply.) A) It is a packaging system that contains individual sealed doses of a drug. B) It is a packaging system that is non-reusable. C) It is a packaging system where the container may not contain doses for a period greater than 3 days. D) It is a packaging system where the container may not contain doses for a period greater than 14 days. E) It is a packaging system designed to help patients remember when to take their medications Q4: Under the Cancer Drug Repository Program a cancer drug can be accepted if: (Select ALL that apply.) A) It is an injectable drug that does not have temperature requirements other than controlled room temperature B) The drug bears an expiration date prior to the date of donation C) The drug is adulterated or misbranded D) The drug is not in tamper-evident packaging E) The drug is in unopened single-unit-dose packaging

211 199 DISPOSAL OF CONTROLLED SUBSTANCES A pharmacy may transfer controlled substances to a DEA registered reverse distributor who handles the disposal of controlled substances. The pharmacy should contact the local DEA Diversion Field Office for an updated list of DEA registered reverse distributors. In no case should drugs be forwarded to the DEA unless the registrant has received prior approval from the DEA. The DEA procedures established for the disposal of controlled substances must not be construed as altering in any way the state laws or regulations for the disposal of controlled substances. DEA Pharmacist s Manual

212 200 REVERSE DISTRIBUTORS AUTHORIZED TO DISPOSE CONTROLLED SUBSTANCES A pharmacy may forward controlled substances to a DEA registered reverse distributor who handles the disposal of controlled substances. When a pharmacy transfers schedule II controlled substances to a reverse distributor for destruction, the reverse distributor must issue an official order form (DEA Form 222) or the electronic equivalent to the pharmacy. When schedules III-V controlled substances are transferred to a reverse distributor for destruction, the pharmacy must maintain a record of distribution that lists the drug name, dosage form, strength, quantity, and date transferred. The DEA registered reverse distributor who will destroy the controlled substances is responsible for submitting a DEA Form 41 (Registrants Inventory of Drugs Surrendered) to the DEA when the controlled substances have been destroyed. A DEA Form 41 should not be used to record the transfer of controlled substances between the pharmacy and the reverse distributor disposing of the drugs. DEA Pharmacist s Manual

213 201 CONTROLLED SUBSTANCE THEFT OR SIGNIFICANT LOSS The theft of controlled substances from a registrant is a criminal act and a source of diversion that requires notification to DEA. A pharmacy must notify in writing the local DEA Diversion Field Office within one business day of discovery of a theft or significant loss of a controlled substance. Although not specifically required by federal law or regulations, the registrant should also notify local law enforcement and state regulatory agencies. Prompt notification to enforcement agencies will allow them to investigate the incident and prosecute those responsible for the diversion. A pharmacy must also complete a DEA Form 106 (Report of Theft or Loss of Controlled Substances). The DEA Form 106 is used to document the actual circumstances of the theft or significant loss and the quantities of controlled substances involved. If completing the paper version, the pharmacy should send the original DEA Form 106 to the local DEA Diversion Field Office and keep a copy for its records. DEA Pharmacist s Manual A copy of the DEA Form 106 must also be sent to the Nebraska Department of Health & Human Services, per Neb. Rev. Stat. Section 38-1,124(3). Any credential holder who is required to file a report of loss or theft of a controlled substance to the Federal Drug Enforcement Administration shall provide a copy of such report to the department. Nebraska Revised Statute 38-1,124(3)

214 202 BREAKAGE AND SPILLAGE OF CONTROLLED SUBSTANCES The breakage or spillage of controlled substances does not constitute a "loss" of controlled substances. When there is breakage, damage, or spillage or some other form of destruction, any recoverable controlled substances must be disposed of according to DEA requirements. When this disposal occurs, it must be reported to DEA on a DEA Form 41 (Registrants Inventory of Drugs Surrendered). Damaged goods may also be disposed of through shipment to a reverse distributor or by a DEA approved process. DEA Pharmacist s Manual

215 203 EMERGENCY BOX DRUGS, TYPES OF DRUGS INCLUDED Long-term care facilities Includes drugs required to meet the immediate therapeutic needs of patients Not available from other sources in sufficient time to prevent risk of harm by delay from obtaining from other sources Must be provided and sealed by supplying pharmacy (tamperevident seal) Must be stored in medication room or other secured area Prevent unauthorized access Ensure proper environment for preservation Exterior must be labeled Clearly indicate use in emergencies only Listing of drugs: name, strength, quantity, route, expiration Name, address, telephone number of supplying pharmacy Shall not contain multiple dose vials Shall not contain more than 10 drugs that are controlled substances Shall contain no more than a total of 50 drugs All drugs must be in original manufacturer s or distributor s container, or repackaged by supplying pharmacy Shall include: manufacturer/distributor name, lot number, drug name, strength, dosage form, NDC, route and expiration on a typewritten label. Repackaged drug label shall include calculated expiration date, which means the expiration date on the manufacturer's, packager's, or distributor's container or one year from the date the drug or device is repackaged, whichever is earlier. Nebraska Revised Statute

216 204 EMERGENCY BOX DRUG INSPECTION Inspected by pharmacist designated by the supplying pharmacy Once every 30 days After reported use Inspection to determine expiration date and quantity of drugs in the box Every inspection documented and record of inspection retained by LTC facility for 5 years Nebraska Revised Statute

217 205 EMERGENCY BOX DRUG, REQUIREMENTS OF FACILITY Supplying pharmacy and LTC facility jointly determine drug contents (identity/quantity) Supplying pharmacy must keep list identical to the list on exterior of the drug box List must be made available to the department upon request When emergency box drug is delivered to LTC facility Supplying pharmacy shall obtain receipt signed by director of nursing of the facility; acknowledges initial contents are identical to initial list on exterior of the drug box. Supplying pharmacy shall keep this receipt for 5 years. Removal of drugs by prescription only Prescription and evidence (documentation) of use to be provided to pharmacy Whenever box is opened Pharmacy must be notified within 24 hours Pharmacist restocks/reseals box and updates list on exterior Expiration Pharmacist replaces any expired drug; reseals box and updates exterior list Contents are inventory of pharmacy until removed for administration Pharmacy means the supplying pharmacy; pharmacist is one designated by the supplying pharmacy Nebraska Revised Statute

218 206 DESTRUCTION OF DRUGS IN LONG-TERM CARE FACILITIES (1) The owner of any stock of controlled substances may cause such controlled substances to be destroyed pursuant to this section when the need for such substances ceases. Complete records of the destruction of controlled substances pursuant to this section shall be maintained by the registrant for five years after the date of destruction. (2) If the owner is a registrant: (a) Controlled substances listed in Schedule II, III, IV, or V of section may be destroyed by a pharmacy inspector, by a reverse distributor, or by the administration. Upon destruction, any forms required by the administration to document such destruction shall be completed; (b) Liquid controlled substances in opened containers which originally contained fifty milliliters or less or compounded liquid controlled substances within the facility where they were compounded may be destroyed if witnessed by two individuals credentialed under the Uniform Credentialing Act and designated by the facility and recorded in accordance with subsection (4) of section ; or (c) Solid controlled substances in opened unit-dose containers or which have been adulterated within a hospital where they were to be administered to patients in such hospital may be destroyed if witnessed by two individuals credentialed under the Uniform Credentialing Act and designated by the hospital and recorded in accordance with subsection (4) of section (3) If the owner is a resident of a long-term care facility or hospital, a controlled substance listed in Schedule II, III, IV, or V of section shall be destroyed by two individuals credentialed under the Uniform Credentialing Act and designated by the facility or hospital. Nebraska Revised Statute

219 207 LONG-TERM CARE FACILITIES, PHARMACIST RESPONSIBILITIES Pharmacotherapy Services Supervision: The facility must employ or obtain the services of a Nebraska-licensed pharmacist to provide for the development, coordination, and supervision of all pharmaceutical services. The pharmacist is responsible for: 1. Consultation on all aspects of the provision of pharmacotherapy services in the facility; 2. Ensuring that the pharmacotherapy service has procedures for control and accountability of all medications throughout the facility; 3. Ensuring that medication records are in order and that an account of all Schedule II and III controlled substances is maintained and reconciled; 4. Maintaining records of receipt and disposition of all controlled substances in sufficient detail to enable an accurate reconciliation; and 5. Reviewing the drug regimen of each resident at least monthly and reporting any irregularities to the primary medical practitioner and Director of Nursing Services in accordance with standards of care. The drug regimen review must include a signed and dated statement that: a. No potential problems were found; b. A problem was found but it was deemed not significant; or c. A significant problem was found. The statement must include a description of the situation and the information that was communicated to the individual with the authority to correct it, usually the medical practitioner. 175 NAC B

220 208 AN ACCIDENT, NATURAL DISASTER, OR INTERRUPTION IN UTILITY SERVICES The licensee must notify the Department in writing by electronic mail, facsimile, or postal service within 24 hours of any change in environment which will adversely affect the potency, efficacy, safety or security of the drugs, devices or biologicals in the pharmacy. The notification may be made by telephone if the event has affected the licensee s capacity to communicate. 175 NAC

221 209 DISASTER PREPAREDNESS AND MANAGEMENT The pharmacy must establish and implement disaster preparedness plans and procedures to protect the potency, efficacy, safety, and security of the drugs, devices, or biologicals in the pharmacy in instances of natural (tornado, flood, etc.) or other disasters, disease outbreaks, interruption of utility services, or other similar situations. Such plans and procedures must address and delineate: 1. How the pharmacy will provide for the storage of drugs, devices, and biologicals at the proper temperature; 2. How the pharmacy will provide for the disposal of drugs, devices, and biologicals if the pharmacy determines their potency, efficacy, or safety has been adversely affected; 3. How the pharmacy will secure the drugs, devices, and biologicals from the public; and 4. How the pharmacy will maintain patient records and inventory records. 175 NAC

222 210 COMPOUNDING, DEFINED Compounding means the preparation of components into a drug product As the result of a practitioner s medical order or initiative occurring in the course of practice based upon the relationship between the practitioner, pharmacist, and patient OR For the purpose of, or as incident to, research, teaching, or chemical analysis and not for sale or dispensing. Compounding includes the preparation of drugs or devices in anticipation of receiving medical orders based upon routine, regularly observed prescribing patterns. Nebraska Revised Statute

223 211 COMPOUNDING, FDA COMPLIANCE POLICY Ingredients must meet official standards Cannot be withdrawn/removed from market Pharmacy may advertise it specializes in prescription compounding Not actively solicit business for specific products Interstate distribution is no more than 5% of total Rxs filled by that pharmacy (may be manufacturing if greater than 5%) In 2002, the Supreme Court ruled that the FDA could not restrict pharmacies from advertising or promoting products solely because they are compounded. Compounding Quality Act Outsourcing facilities: See FDA Compliance Policy Guide of 1992 May voluntarily elect to register with the FDA Must comply with CGMP requirements, Will be inspected by FDA according to a risk-based schedule, and Must meet certain other conditions, such as reporting adverse events and providing FDA with certain information about the products they compound Are not required to be licensed as a pharmacy in a state. If compounders register with the FDA as outsourcing facilities, hospitals and other health care providers can provide their patients with drugs that were compounded in outsourcing facilities that are subject to CGMP requirements and federal oversight. See Title I of the Drug Quality and Security Act of 2013

224 212 COMPOUNDING VS. MANUFACTURING Compounding is different from manufacturing, which is guided by GMPs (see Good Manufacturing Practices for Bulk Pharmaceutical Excipients). Some of the characteristics or criteria that differentiate compounding from manufacturing include the existence of specific practitioner-patient-compounder relationships; the receiving of a prescription or a prescription order; and the prescription orders. USP 795 Pharmaceutical Compounding Nonsterile Preparations It is compounding, not manufacturing, when: Quantity is reasonable for filling existing or anticipated prescription Anticipation is based on prescribing habits of local prescribers or prescriptions already on file Compounded drug products are not commercially available FDAapproved products Dosage forms are not sold to other pharmacies or third parties such as physician offices for dispensing to patients.

225 213 DELEGATED DISPENSING PERMIT Pharmacist delegates specific dispensing tasks Per delegated dispensing agreement Must apply to the department and pay a fee and pass inspection for a delegated dispensing permit Separate permits needed for separate locations even if under same management Nebraska Revised Statutes to

226 214 DELEGATED DISPENSING PERMIT, FORMULARIES Board recommended formulary The formulary for a public health clinic shall consist of a list of drugs and devices for contraception, sexually transmitted diseases, and vaginal infections which may be dispensed and stored, patient instruction requirements which shall include directions on the use of drugs and devices, potential side effects and drug interactions, criteria for contacting the on-call pharmacist, and accompanying written patient information. Such formulary shall not include: Controlled substances; Drugs with significant dietary interactions; Drugs with significant drug-drug interactions; and Drugs or devices with complex counseling profiles Nebraska Revised Statute

227 215 DELEGATED DISPENSING PERMIT, WORKER, QUALIFICATIONS No person shall act as a public health clinic worker in a public health clinic or as a dialysis drug or device distributor worker for a dialysis drug or device distributor unless the person: (1) Is at least eighteen years of age; (2) Has earned a high school diploma or the equivalent; (3) Has completed approved training as provided in section ; and (4) Has demonstrated proficiency as provided in section Nebraska Revised Statute

228 216 DELEGATED DISPENSING PERMIT, WORKERS, TRAINING, REQUIREMENTS, DOCUMENTATION (1) A delegating pharmacist shall conduct the training of public health clinic workers. The training shall be approved in advance by the board. (2) A delegating pharmacist shall conduct training of dialysis drug or device distributor workers. The training shall be based upon the standards approved by the board. (3) The public health clinic, the dialysis drug or device distributor, and the delegating pharmacist shall be responsible to assure that approved training has occurred and is documented. Nebraska Revised Statute

229 217 PHARMACY INSPECTIONS Each pharmacy has the responsibility to be in compliance, and to remain in compliance, with the regulations set out in this chapter. The Department has the responsibility to determine that the pharmacies are in compliance at all times. For the purpose of assuring initial and continued compliance, each pharmacy must prepare Pharmacy Quality Assurance Reports and the Department will conduct inspections. 175 NAC Chapter 8-005

230 218 Q1: Which DEA form is used when CIIs are lost or stolen? A) Form 41 B) Form 106 C) Form 222 D) Form 222a E) Form 222b Q2: According to Nebraska Pharmacy Law, all emergency boxes shall be inspected: (Select ALL that apply.) A) By a pharmacist designated by the supplying pharmacy B) Within 48 hours after opening C) At least once every 30 days D) At least once every 90 days E) Can be inspected by a pharmacy technician Q3: Who can be a witness for destruction of controlled substances in a long-term care facility? (Select ALL that apply.) A) A licensed physician B) A licensed pharmacist C) A licensed nurse practitioner D) A licensed massage therapist E) Any two people credentialed under the UCA and designated by the facility

231 219 Q4. Which of the following actions is (are) permissible under the FDA rules for prescription compounding by pharmacies? I. Advertising to eye doctors that the pharmacy can compound sterile, isotonic ophthalmic solutions II. Sending brochures to nurse practitioners that indicate the pharmacy compounds topical ointments for the treatment of skin rashes III. Informing an allergy specialist that the pharmacy can economically manufacture a specific product A) I only B) III only C) I and II D) II and III E) I, II and IIII Q5. Disaster Preparedness and Management plans and procedures must include how the pharmacy will: (Select ALL that apply.) A) Secure the drugs, devices, and biologicals from the public B) The pharmacy has no role in securing the drugs, devices, and biologicals from the public C) Maintain patient records and inventory records D) Obtain drugs, devices, and biologicals in the event of a natural disaster E) Provide for the disposal of drugs, devices, and biologicals that have been adversely affected Q6. Which of the following may be considered by the FDA, a violation of its compounding requirements? I. Compounding of drugs in anticipation of receiving prescriptions II. Compounding a product pursuant to an order III. Compounding drug products that are commercially available in the marketplace IV. Compounding in a hospital for in hospital use A) I and III B) I and IV C) II and IV D) III E) III and IV

232

233 AREA1: PHARMACY PRACTICE 1.05 Identify the conditions for making an offer to counsel or counseling appropriate patients, including the requirements for documentation.

234

235 223 FEDERAL LAWS Omnibus Budget Reconciliation Act 1990 (OBRA) Drug Utilization Review Prospective (done by a pharmacist) Retrospective (done for state Medicaid program) Counseling requirements offer to discuss medications with patient/caregiver Obtain patient specific information Goal is to save government money; but elevated the standard of care given to Medicaid patients by pharmacists.

236 224 PHARMACIST DUTIES, PROSPECTIVE DRUG UTILIZATION REVIEW Prospective drug utilization review; requirements Therapeutic duplication Incorrect drug dosage or duration of therapy Drug-disease contraindications Drug-drug interactions Drug-allergy interactions Clinical abuse/misuse Nebraska Revised Statute

237 225 PATIENT RECORDS (b) A pharmacist conducting a prospective drug utilization review shall ensure that a reasonable effort is made to obtain from the patient, his or her caregiver, or his or her practitioner and to record and maintain records of the following information to facilitate such review: (i) The name, address, telephone number, date of birth, and gender of the patient; (ii) The patient's history of significant disease, known allergies, and drug reactions and a comprehensive list of relevant drugs and devices used by the patient; and (iii) Any comments of the pharmacist relevant to the patient's drug therapy. Nebraska Revised Statute (1)(b)

238 226 PATIENT COUNSELING (2)(a) Prior to the dispensing or delivery of a drug or device pursuant to a prescription, the pharmacist shall ensure that a verbal offer to counsel the patient or caregiver is made. The counseling of the patient or caregiver by the pharmacist shall be on elements which, in the exercise of the pharmacist's professional judgment, the pharmacist deems significant for the patient. Such elements may include, but need not be limited to, the following: (i) The name and description of the prescribed drug or device; (ii) The route of administration, dosage form, dose, and duration of therapy; (iii) Special directions and precautions for preparation, administration, and use by the patient or caregiver; (iv) Common side effects, adverse effects or interactions, and therapeutic contraindications that may be encountered, including avoidance, and the action required if such effects, interactions, or contraindications occur; (v) Techniques for self-monitoring drug therapy; (vi) Proper storage; (vii) Prescription refill information; and (viii) Action to be taken in the event of a missed dose. (b) The patient counseling provided for in this subsection shall be provided in person whenever practical or by the utilization of telephone service which is available at no cost to the patient or caregiver. (c) Patient counseling shall be appropriate to the individual patient and shall be provided to the patient or caregiver. (d) Written information may be provided to the patient or caregiver to supplement the patient counseling provided for in this subsection but shall not be used as a substitute for such patient counseling. Nebraska Revised Statute (2)

239 227 PHARMACIST PATIENT COUNSELING DUTIES, NOT REQUIRED When is pharmacist counseling not required? Patient is in a facility when other appropriate healthcare professionals administer When refused by patient/caregiver If pharmacist determines (using professional judgment) that counseling may be detrimental to the patient s care or to the relationship between the patient and practitioner When prescriber specifies no counseling unless the prescriber is contacted prior to the counseling Prescriber shall specify in an oral prescription or in writing on the face of the prescription If communicated orally, pharmacist shall note contact before counseling on face of prescription Nebraska Revised Statute

240 228 PATIENT PACKAGE INSERTS (PPIS) Educate patient about proper use and potential dangers of using certain products Primarily focused on oral contraceptives and estrogenic substances When should PPIs be included? Ambulatory: initial fill and every refill Institutions: prior to first administration and every 30 days thereafter Applies to anyone who dispenses drugs Including hospital pharmacies and LTCF Doctors in their own practice Failure to distribute a PPI is considered misbranding

241 229 MEDGUIDES FDA requires when Patient labeling could prevent serious adverse effects Product has serious risks relative to benefits Patient adherence to directions is crucial FDA must approve language before distribution Dispenser required to give to outpatients Medguides and PPIs are not the same thing A complete list of Medguides can be found on the FDA website: Common classes Antidepressants/SSRIs ADHD NSAIDs Fluoroquinolones Thiazolidinediones Dispenser is required to give Medguides to patients on all new and refill prescriptions on certain medications Medguides are not required for OTC NSAIDs, however, if a prescription for an OTC NSAID is filled, a Medguide is required.

242 230 VOLUNTARY REPORTING TO FDA FDA Form 3500 (MedWatch) should be used by healthcare professionals and consumers for voluntary reporting of adverse events noted spontaneously in the course of clinical care.

243 231 Q1: Under which of the following sections of the law is it the pharmacist's duty to offer to counsel Medicaid patients? A) Kefauver-Harris B) Durham-Humphrey C) OBRA-90 D) Prescription Marketing Act E) Food, Drug, and Cosmetic Act Q2: Checking for therapeutic duplication by pharmacists before dispensing is generally classified as: A) Introspective DUR B) Retrospective DUR C) Triospective DUR D) Prospective DUR E) Concurrent DUR Q3: A pharmacist shall ensure that a reasonable effort is made to record and maintain which of the following information about a patient: (Select ALL that apply.) A) Patient occupation B) Patient telephone number C) Patient disease history D) Comments of the pharmacist relevant to patient s drug history E) Patient medication allergies Q4: Which of the following is/are TRUE about the verbal offer to counsel a patient? (Select ALL that apply.) A) A verbal offer to counsel shall be made to each patient or caregiver on each new or refill prescription. B) A mail order pharmacy shall make the verbal offer to counsel by telephone for the filled prescription. C) If the pharmacist, in the exercise of professional judgment in the interest of a patient, believes that an oral offer would be less effective than a written offer, the pharmacist may substitute a written offer. D) A patient or caregiver can refuse counseling. E) A pharmacist is not required to offer to counsel when the patient is in a facility where medications are administered by health professionals.

244 232 Q5: A pharmacist is not required to counsel under which of the following circumstance(s)? (Select ALL that apply.) A) When selling OTC products for self treatment B) When a prescriber verbally specifies no counseling unless the prescriber is contacted prior to counseling C) When a prescriber specifies on a written prescription no counseling unless the prescriber is contacted prior to counseling D) When the patient is in a facility with healthcare professionals administering medications E) When a pharmacist determines (using professional judgment) that counseling may be detrimental to the patient s care Q6: Which of the following should be part of a patient s counseling? (Select ALL that apply.) A) The name and description of the drug B) The manufacturer of the drug C) Techniques for self-monitoring of therapy D) Action to be taken in the event of a missed dose E) The mechanism by which the drug exerts its effect Q7: When should a pharmacist offer patient counseling? I. Upon a new prescription drug order II. Upon refill of a prescription drug order III. Once yearly on maintenance drugs IV. Only when prompted to do so by the patient/caregiver A) I only B) IV only C) I and II D) II and III E) I, II and III Q8: Which of the following requires a PPI when dispensed? A) Corticosteroids B) Ophthalmic drops C) Estrogen containing products D) Oral hypoglycemics

245 AREA1: PHARMACY PRACTICE 1.06 Identify the requirements for the distribution and/or dispensing of nonprescription pharmaceutical products, including controlled substances.

246

247 235 NONPRESCRIPTION DRUGS, DEFINED Nonprescription drugs means nonnarcotic medicines or drugs which may be sold without a medical order and which are prepackaged for use by the consumer and labeled in accordance with the requirements of the laws and regulations of this state and the federal government. Nebraska Revised Statute

248 236 FEDERAL LAW, OVER-THE-COUNTER Federal Anti-Tampering Act 1982 Tamper-Resistant or Tamper-Evident Packaging Food, drugs, devices, cosmetics, and any other household product that is consumed by individuals or that is used for personal care or for household services. Provides barrier-to-entry Protects against intentional contamination of OTCs Alerts consumer to tampering Example: safety seals

249 237 DRUG FACTS LABEL (1999) Created standard order of information Active ingredients Purpose (antihistamine) Uses (sneezing, etc.) Warnings Ask your doctor or pharmacist about food or drug interactions Directions for use (adequate directions for use: those which the layperson can follow) Other information Inactive ingredients Notes: Must appear in specified order. If any of these components are missing, the product is misbranded. Don t confuse purpose with uses. Other labeling requirements have been established for pregnancy, sodium content, certain minerals.

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