Iowa Pharmacy Law Review 10:00am - 12:00noon & 1:30pm - 2:30pm

Transcription

1 January 20-22, 2012 Des Moines Marrio, 700 Grand Avenue, Des Moines, IA Iowa Pharmacy Law Review 10:00am - 12:00noon & 1:30pm - 2:30pm ACPE UAN L03-P & L03-T 0.3 CEU/3.0 Hr Ac vity Type: Knowledge-Based Program Objec ves for Pharmacists & Technicians: Upon comple on of this CPE ac vity par cipants should be able to: 1. Discuss Iowa laws as they pertain to the prac ce of pharmacy 2. Describe laws specific to pharmacy technicians 3. Recognize laws specific to dispensing controlled substances in the state of Iowa 4. List du es that can only be performed by a pharmacist Speaker: Jane E. DeWi, RPh, PhD, is an Associate Professor in Social and Administra ve Sciences in the Drake University College of Pharmacy and Health Sciences. She earned a BS in Pharmacy from Drake and an MS and PhD in Pharmaceu cal Socioeconomics from the University of Iowa. She joined the faculty at Drake in 2000 and teaches Pharmacy Law and Ethics, as well as courses in health policy and quality improvement for PharmD and Health Sciences students. Prior to receiving her graduate degrees and becoming a faculty member at Drake, Jane prac ced pharmacy at Mercy Hospital in Des Moines, North Iowa Medical Center in Mason City and the University of Iowa Hospitals and Clinics. She is a member of IPA, APhA, the American Associa on of Colleges of Pharmacy and the American Society for Pharmacy Law. Speaker Disclosure: Jane DeWi does not report any actual or poten al conflicts of interest in rela on to this CPE ac vity. Off-label use of medica ons will not be discussed during this presenta on.

2 Jane E. DeWitt, RPh, PhD Drake University College of Pharmacy and Health Sciences MPJE Competencies Pharmacy Practice ~84% Licensure, Registration, Certification and Operational Requirements ~13% Regulatory Structure and Terms ~3% Federal law ~ 50%, State law ~ 50% Controlled Substances ~ 50% or more 90 questions (75 used to calculate score, 15 are pretest items) Iowa Pharmacy Practice Act Iowa Controlled Substances Act Iowa Board of Pharmacy Rules 37 chapters Chapter 2: Pharmacist Licenses Chapter 3: Pharmacist Technicians Chapter 4: Pharmacist Interns Chapter 5: Pharmacy Support Persons Chapter 6: General Pharmacy Practice Chapter 7: Hospital Pharmacy Practice Chapter 8: Universal Practice Standards Members 5 pharmacist members, 2 public members Appointed by the governor for 3 year term, maximum of 3 terms Staff Executive Director Lloyd Jessen, RPh, JD Compliance officers (8 pharmacists) Support staff Protect the health and safety of the public License and regulate pharmacies, pharmacists, technicians, interns, drug wholesalers, controlled substances registrants, and others Set standards for the practice of pharmacy Establish policies and guidelines Propose regulatory changes Enforce pharmacy laws and rules Conduct routine inspections Investigate complaints Disciplinary action Pharmacists, pharmacist interns, pharmacy technicians must report in writing, w/in 10 days: change of name, address, place of employment Pharmacy: change of ownership, location, pharmacistin charge, legal name, permanent closing Sale or transfer of prescription drugs, including controlled substances, when pharmacy permanently closes or changes ownership Theft or significant loss of any controlled substances Disaster, accident and emergency that may affect the strength, purity or labeling of drugs and devices 1

3 Graduate from ACPE accredited college of pharmacy in the U.S. Meet internship requirements Pass NAPLEX, MPJE Renewal every 2 years License transfer/reciprocity Foreign pharmacy graduates must be certified (FPGEC), TOEFL, internship hours Programs sponsored by ACPE (American Council on Pharmaceutical Education) approved providers (live, on line, correspondence) automatically qualify for credit Non ACPE activities may comprise up to 50% of credits Maintain certificates for 4 years, report to Board 3 CEUs (30 contact hours) required each license renewal period minimum of 50% of hours must be drug therapy topics (ACPE designation 01 in program number) New requirements in effect now! 2 hours of CE in pharmacy law (designation 03 ) 2 hours of CE in medication/patient safety (designation 05 ) Exemption for new license holders in first renewal period Licensed pharmacist must display original pharmacist license visible to the public Current license renewal must be displayed with the original (may be photocopy) Pharmacist must wear a badge that includes at least their first name and that clearly identifies them as a pharmacist providing false or fraudulent information for application or renewal of license violation of statutes or regulations pertaining to the practice of pharmacy conviction of a felony conviction of an act involving moral turpitude unprofessional conduct immoral conduct/ character incompetence Possible Actions Against a License Holder Suspension of license Revocation of license Fines Public reprimands 2

4 Must wear a badge with the designation pharmacy student or pharmacist intern Intern registration possible after successful completion of one semester in a college of pharmacy (no credit for hours prior to registration) Required hours of internship 1500 hours total 1250 hours college based clinical program 250 hours under the supervision of a preceptor in a licensed pharmacy Must be licensed pharmacist in good standing May supervise no more than 2 interns concurrently Responsible for initialing/dating competencies in internship booklet and certifying dates and hours on internship affidavit Judgmental functions may be delegated to an intern Pharmacist must be on duty in the pharmacy and is responsible for the intern s actions Verification of the accuracy, validity and appropriateness of the filled prescription or medication order Review and assessment of patient records Patient counseling Person who is employed by a licensed pharmacy in Iowa to assist in the technical functions of the practice of pharmacy, under the responsibility of an Iowa licensed pharmacist Pharmacy technicians must wear a badge with at least the first name and the designation technician Any person employed in Iowa as a pharmacy technician shall obtain and maintain during such employment a current registration as a certified pharmacy technician, pharmacy technician trainee, or uncertified pharmacy technician Purpose of registration: identification, tracking and disciplinary action (not competency) Prior to July 1, 2010, certification was voluntary As of July 1, 2010 the certification of pharmacy technicians is required a newly hired technician who is not certified must register as a trainee and become certified within 12 months. Successful completion of any NCCA accredited pharmacy technician certification program and examination fulfills the requirement 3

5 A pharmacy technician who meets requirements for minimum prior employment (at least 2000 hours in the previous 18 months) and minimum continued employment (2000 hours during any 18 months between Jan 1, 2010 and Dec 31, 2013) shall qualify for an extension of the certification requirement until December 31, Pharmacists may delegate technical dispensing functions to technicians, only if the pharmacist is on site when functions are performed (some exceptions; some differences for general vs. hospital practice) Supervising pharmacist is ultimately responsible for the actions of the technician Pharmacy technicians may contact prescribers for, and accept, refill authorizations Pharmacy technicians may accept new prescriptions or medication orders communicated to the pharmacy by a prescriber or a prescriber s agent Technicians must receive appropriate training pursuant to the pharmacy s policies and procedures Responsibility remains with the supervising pharmacists Tasks a pharmacy technician shall not perform Final verification for accuracy, validity, completeness or appropriateness of a filled prescription or medication order Prospective DUR or evaluation of a patient s medication record Provide patient counseling, consultation or patient specific drug information, tender an offer of counseling on behalf of a pharmacist, or accept a refusal of patient counseling Decisions requiring a pharmacists professional judgment such as interpreting or applying information Transfer of prescriptions Pharmacies must develop, implement and periodically review written policies and procedures pertaining to training and utilization of pharmacy technicians Training must be documented and maintained for the duration of employment Policies and procedures and documentation of training must be available for inspection by the Iowa Board of Pharmacy Chapter 40 new rules 10/2011 Purpose: to authorize certified pharmacy technicians to review the work of other certified pharmacy technicians in filling floor stock, including automated medication distribution systems and UD dispensing systems TCT programs may be authorized by the board in hospital pharmacies general pharmacies, for dispensing only to patients in a long term care facility 4

6 A person, other than a licensed pharmacist, a pharmacist intern, or pharmacy technician, who may perform nontechnical duties assigned by the pharmacist, under the pharmacist s supervision, including delivery, billing, cashier and clerical functions. Beginning June 1, 2010 pharmacy support persons must be registered with the board. PSPs MAY perform receipt and processing of incoming drugs updating/changing patient demographic information in the computer receipt of a refill request from a patient PSPs may NOT perform entering Rx information into computer handling Rx drugs as part of dispensing process preparing or affixing Rx labels reconstituting medications Required for all sites where prescription drugs are offered for sale or dispensed under the supervision of a pharmacy and all sites where other cognitive services are provided by a pharmacist General Hospital Limited use nuclear, correctional facility, veterinary Nonresident New pharmacy license application required for changes in pharmacy name, location, ownership, or pharmacist in charge License is renewed annually Inspection by Iowa Board of Pharmacy required in order to obtain a license for a new pharmacy location Written notice to Iowa Board of Pharmacy and DEA at least 2 weeks prior to a pharmacy closing Pharmacist in charge required Responsibilities depend on type of pharmacy license Reference library required May be printed or electronic Iowa Pharmacy Law and Information Manual must be current hard copy; photocopy or computer access are not acceptable Must include a minimum of one current reference from each category, including periodic updates Poison Control Center phone number Apply to all Iowa licensed pharmacies and pharmacists, in addition to rules relating to specific types of pharmacy licenses Pharmaceutical Care defined All Iowa licensed pharmacists are eligible to practice pharmaceutical care 5

7 Pharmacist in charge and pharmacy share responsibility for ensuring that all operations of the pharmacy are in compliance with federal and state laws, rules and regulations related to the practice of pharmacy The pharmacist must provide and document the final verification for the accuracy, validity completeness and appropriateness of prescriptions or medication orders prior to delivery of the medication to the patient or patient s representative. The pharmacist is responsible for all functions delegated to pharmacist interns, pharmacy technicians, and other supportive personnel A log of each pharmacist, pharmacist intern and pharmacy technician and their initials or unique identification code must be maintained for a minimum of 2 years. A log of all pharmacists, pharmacy interns and pharmacy technicians who have worked at the pharmacy and who are not regular staff must be maintained for a minimum of 2 years. The log must contain dates and shifts worked. Refrigerator with thermometer Sink with hot and cold water Properly lighted and ventilated, orderly, clean Temperature and humidity compatible with the proper storage of drugs Bulk counting machines pharmacist verification required for accuracy of restocked drugs, calibration and accuracy must occur quarterly and documented Pharmacy department must be closed and secured in the absence of the pharmacist Exception: Temporary absence of the pharmacist PIC may designate who may be in the pharmacy to perform delegated technical and non technical functions not to exceed 2 hours public notification of RPh absence and that no prescriptions will be dispensed until RPh returns Procurement must be from an Iowa licensed drug wholesaler, or on a limited basis, from another licensed pharmacy or licensed practitioner in the U.S. Must maintain sufficient stock to fulfill the foreseeable needs of patients Must have a system for removing from use all drugs and devices subject to product recalls, including unit dose packages Drugs and devices must not be dispensed beyond the expiration date but must be removed from dispensing inventory 6

8 Prescription drug price and non price information may be provided to the public by a pharmacy as long as it is not false or misleading all charges for services to the customer must be stated the effective dates for the prices must be stated no references to controlled substances (II V) may be made CQI = ongoing, systematic program of standards and procedures to detect, evaluate and prevent medication errors, thereby improving medication therapy and the quality of patient care Each pharmacy licensed to provide pharmaceutical services to patients in Iowa shall implement or participate in a CQI program. Preventable medication error, resulting in incorrect dispensing of a prescribed drug that is received by the patient, or administered to the patient; includes, but not limited to: incorrect drug or drug strength incorrect dosage form drug received by the wrong patient inadequate/incorrect packaging, labeling or directions any incident related to a prescription dispensed to a patient that results in or has the potential to result in serious harm to the patient PIC is responsible for ensuring the pharmacy has a CQI program that meets the Board requirements, and is ultimately responsible for the validity and consistency of program activities (PIC may delegate program administration and monitoring) Pharmacy must develop policies and procedures for the operation and management of the CQI program Training of all pharmacy personnel Identification and documentation of reportable events Analysis of data to assess and causes and contributing factors Recommendations for changes Authorized pharmacists may administer adult immunizations requires a written protocol with a physician physician must meet requirements for supervising the pharmacist pharmacist must successfully complete an approved course of study on vaccine administration An authorized pharmacist may only perform CDTM pursuant to protocol with a physician as required by the rule. Physician retains the ultimate responsibility for the patient s care; pharmacist is responsible for all aspects of DTM performed by the pharmacist 7

9 Authorized pharmacist Iowa licensed pharmacist; license in good standing; meets one or more of the following drug therapy management criteria PharmD Board of Pharmaceutical Specialties (BPS) or CCGP certification NISPC credentialing completion of an ASHP accredited residency approval by the Board of Pharmacy Community Practice Protocol agreement undertaken by pharmacist and physician, shall be made available upon request of the Board of Pharmacy or the Iowa Board of Medicine Hospital Practice Protocol scope and extent of practice is determined by the hospital s P&T committee and is valid only when approved by the P&T committee A valid prescriber/patient relationship must exist for a prescription drug order and medication order to be valid When a prescriber moves away from Iowa, ceases practice, or dies, their prescriptions are no longer valid. Pharmacist must cancel prescription and any remaining refills, but should exercise judgment to ensure that the patient is able to obtain a sufficient quantity to continue treatment until they are able to obtain the services of another prescriber and a new prescription can be issued Physicians MD, DO Nurse Practitioners independent prescribers, including controlled substances, and within their specialty Physician Assistants Prescriptions must include name of supervising physician May not prescribe CII depressants Dentists within scope of practice Optometrists, Podiatrists within scope of practice Veterinarians within scope of practice Prescriptions written by prescribers outside of Iowa may be filled in Iowa if the prescriber would be authorized to prescribe if they were practicing in Iowa Prescribers may not prescribe or dispense controlled substances for themselves Prescribers may not prescribe or dispense controlled substances for their immediate family members for an extended period of time Written or electronic Date issued Name and address of patient (or owner of animal) Drug name, strength, and quantity and directions for use Name, address, and written or electronic signature of the prescriber DEA number if a controlled substance Facsimile As above and ID of the fax machine used to transmit, date and time of transmission and name, address, phone#, fax # of pharmacy receiving prescription Verbal As above except not written signature and prescriber address Person authorized to receive verbal prescriptions must record the above requirements in writing 8

10 Original Prescriptions Original prescriptions, whether transmitted orally, electronically or in writing, must be retained by the pharmacy filling the prescription Prescriptions must be dated and assigned a unique ID # that will be recorded on the original prescription Refill Prescriptions Refills must be documented with the date of refill and the initials of the pharmacist Name, strength and manufacturer, or NDC of actual product dispensed must be maintained and readily retrievable A prescription which is not for a controlled substance shall not be filled or refilled more than 18 months after the date it was issued, nor more than 12 times. A pharmacist may refill without prescriber authorization, with professional judgment, if ALL the following are true: RPh is unable to contact prescriber after reasonable effort Failure to refill might result in interruption of therapy, or create patient suffering RPh informs the patient, or patient representative at time of dispensing and the practitioner at the earliest convenience that prescriber authorization is required. Prescription number Pharmacy name, address, telephone number Patient name Animals species of animal, name of owner Prescriber name Date of dispensing Directions for use, including precautions Drug name, strength, and quantity Pharmacist initials Not required: beyond use or expiration date Dispensing a generic when a brand name drug has been prescribed Label must identify the generic name of the drug dispensed and may identify the brand name (generic name) generic for (brand name product) Dispensing a brand name drug when a generic drug has been prescribed Label must identify the brand name drug dispensed and may identify the generic name (brand name) for (generic name) Upon the request of a patient or patient s caregiver, a pharmacy must transfer original prescription and refill information to a designated pharmacy Transfer must be communicated directly between pharmacists, or pharmacist interns under the direct supervision of pharmacists at the respective pharmacies Non controlled substance prescriptions: may transfer as long as the prescription is valid and the number of transfers does not exceed the number of refills originally authorized Controlled substance prescriptions: CIII, CIV, and CV may be transferred one time Data processing system must have a mechanism to prohibit the transfer or refill of controlled substance prescriptions that have been previously transferred 9

11 Transfer between pharmacies electronically accessing the same prescription records via a real time, on line database may transfer up to the maximum refills permitted by law and the prescriber s authorization, including controlled substances prescriptions additional recordkeeping requirements apply Transfers Out Invalidate the prescription Record name, address, DEA # (if CS) of pharmacy Record name of RPh transferring, RPh receiving Record date Transfers Received Indicate the prescription is transferred Record original date of issue and date of dispensing Record original prescription # Record # of valid refills remaining, date of last refill Record other information as above If an authorized prescriber prescribes a drug by its brand or trade name, the pharmacist MAY exercise professional judgment in the economic interest of the patient by selecting a drug product with the same generic name and demonstrated bioavailability as the one prescribed. The pharmacist must inform the patient of the savings which will result from the substitution and pass on no less than 50% of the difference in actual acquisition costs. If the cost of the prescription or any part of it will be paid by expenditure of public funds authorized under chapter 249A, the pharmacist SHALL exercise such judgment by selecting a drug product with the same generic name and demonstrated bioavailability. The pharmacist SHALL NOT exercise drug product selection if either of these is true: The prescriber specifically indicates that no drug product selection be made The person presenting the prescription indicates that only the specific drug prescribed should be dispensed (exception: if cost is paid by public funds..) Record may be print or electronic, and is confidential Full name of patient Patient address and telephone number Age or date of birth Gender Known allergies List of all prescriptions dispensed by the pharmacy including prescription number, drug name and strength, quantity, dispensing date(s), and prescriber name for 2 years preceding most recent entry 10

12 Patient record should include pharmacist comments relevant to drug therapy, including known drug reactions idiosyncrasies known chronic conditions, disease states other prescription drugs, OTCs, herbals, alternative medications or devices currently being used that may relate to prospective DUR Purpose: promoting therapeutic appropriateness and ensuring rational drug therapy Review patient record, information obtained from the patient and each prescription drug or medication order Take appropriate steps to avoid or resolve identified problems Required on all NEW prescriptions, or upon receipt of a change in drug therapy, including but not limited to a change of dose, directions, or drug formulation An offer to counsel does not fulfill requirements a pharmacist SHALL counsel each patient or patient s caregiver A notice must be posted in the prescription pickup area (and also visible in the drive through) that states Iowa law requires a pharmacist or pharmacist intern discuss any new prescription with the patient Pharmacy must contain an area which is suitable for confidential patient counseling easily accessible to both patient and RPh and not allow patient access to prescription drugs maintains privacy and confidentiality If oral counseling is not practicable, alternative forms may be used Not practicable may be: absence of patient or patient s caregiver, hearing impairment, language barrier Not practicable is NOT: inadequate staffing, technology failure, high prescription volume Patient counseling should, in the pharmacist s professional judgment, enhance or optimize drug therapy. Appropriate elements may include: Drug name, description and intended use, if known Dosage form, dose, ROA, expected action of the drug, duration of therapy Special directions and precautions, proper storage Common severe SEs, ADRs, interactions and CIs how to avoid and action required if they occur Alternative forms must advise the patient or caregiver that the pharmacist may be contacted by toll free telephone # or collect call Some acceptable alternative forms of patient information written information pictogram labels videos 11

13 Not required to provide patient counseling for inpatients of institutions where other licensed health care professionals administer drugs Not required if patient or caregiver refuses counseling Refusal must be documented Absence of documentation of refusal will be presumed to signify that the offer was accepted and counseling was provided Prescription drugs, including UD packaging, and devices may be returned to the pharmacy for reuse or resale only if the integrity has not in any way been compromised Personal contact items removed from the original package or container may not be reused or resold Pharmacy shall be located in an area that facilitates the provision of services to patients and shall be integrated with the facility s communication and transportation systems Policies and procedures shall identify the minimum amount of time that a pharmacist is available Patient specific drugs shall not be distributed prior to the pharmacist s final verification and approval Leave and discharge medications must be labeled according to requirements for outpatient prescriptions Specific procedures must be met in facilities without 24 hr pharmacy service, when drugs are dispensed to patients as a result of an ER visit (InstyMeds dispensing system may be used in some circumstances) A current drug formulary must be maintained A stop order policy must be established Policies and procedures must govern the use of patient drugs brought into the institution Drug samples are prohibited for inpatient use If investigational drugs are used a pharmacist must be a member of the IRB pharmacy shall be responsible for distributing and control of those drugs The pharmacist, while on duty, shall be responsible for the security of the pharmacy All pharmacy areas where drugs are stored and the pharmacist is not continually present must be locked Drugs stored in patient care areas must be in locked storage unless the area is staffed by health care personnel and the medication area is visible to staff at all times Must have established security against unauthorized entry into the pharmacy computer systems 12

14 When the pharmacist is absent from the facility, the pharmacy is closed. A P&P must identify who will have access to the pharmacy and the procedures for obtaining drugs when it is closed Pharmacist in charge may designate pharmacy technicians who may be in the pharmacy when the pharmacy is closed Pharmacy technicians may assist another authorized, licensed healthcare professional to locate a drug for an emergent need The pharmacy technician may not dispense or deliver the drug Authorized, licensed healthcare professional must comply with established policies and procedures for obtaining drugs when the pharmacy is closed Authorized, licensed healthcare professional must not ask or expect the pharmacy technician to verify that the appropriate drug has been obtained Pharmacy technician present in a hospital pharmacy in the pharmacist s absence must maintain a log identifying each period of time that the technician worked in the pharmacy while it was closed and each activity performed during that time period Pharmacist review and verification of medication orders when the pharmacy is closed Hospital pharmacy MAY contract for remote pharmacist preview and verification; remote pharmacy/pharmacist must be licensed in Iowa Remote pharmacist must have secure, electronic access to the hospital pharmacy s patient information system and all other systems that the on site pharmacist has access to when the pharmacy is open Remote pharmacist must be able to contact prescribers to discuss concerns Standards for use of automated medication distribution systems and for the provision of telepharmacy services AMDS: includes device that prepares and packages a drug for UD dispensing, outpatient prescription vials, or dispenses prepackaged drugs Managing pharmacy: licensed community pharmacy providing telepharmacy services at one or more licensed remote dispensing sites (PIC of Managing pharmacy also serves as the PIC of the Remote site) Remote dispensing site: licensed pharmacy staffed by one or more qualified certified pharmacy technicians Ownership of drugs Pharmacy based services Medical director based services Requirements for control and exchange of drugs, prescribing, disposal and destruction Storage: temperature, expiration Security and control: P&P identifies who has access, safeguards against theft or diversion 13

15 Standards and procedures for preparation, labeling and distribution of sterile preparations Low risk, medium risk, high risk preparations Immediate use preparations Use of single dose and multiple dose containers Labeling requirements patient specific, batch Equipment and apparel QA and training Patient name Name and quantity of all contents Preparer s and reviewing pharmacist s initials or unique identifiers Stability (beyond use date) Prescribed flow rate in ml/hr, if applicable Auxiliary labels as needed for home care patients (unique serial # or prescription #) Nuclear pharmacy pharmacy providing radiopharmaceutical services Qualified nuclear pharmacist licensed pharmacist who has met established requirements for training in medical use of radioactive materials (e.g. clinical nuclear pharmacy training, completion of a nuclear pharmacy residency, completion of a certificate program in nuclear pharmacy, certified as a BCNP) Standards for centralized prescription drug order filling or centralized prescription processing. Central fill pharmacy: pharmacy contracting with an originating pharmacy that provides prescription drug order filling on its behalf Originating pharmacy: pharmacy that receives a prescription for a patient or prescriber, outsources the filling or processing functions to another pharmacy and dispenses the prescription to the patient General requirements for equipment, procedures, records and quality control Prescriber/patient/pharmacist relationship must exist Compounding commercially available product only if the compounded product is changed to produce for the patient a significant difference Pharmacists shall not compound a drug that has been withdrawn or removed from the market because it was unsafe or ineffective System security and safeguards Verifying authenticity of an electronically transmitted prescription On line storage and retrieval of prescription information Verification of controlled substances refills daily printout or logbook 14

16 New Iowa rules effective Feb 1, 2012 (Chapter 24) Requirements for Internet sale of prescriptions and for accreditation by NABP as verified Internet pharmacy practice site (VIPPS) Consultant pharmacist licensed pharmacist who is responsible for developing, coordinating and supervising pharmaceutical services in a long term care facility on a regularly scheduled basis Freedom of choice resident s right to choose provider of pharmacy services Standards for medication orders, stop orders, emergency drugs, return and reuse of drugs and devices Accountability of controlled substances Impairment: inability to practice pharmacy or perform related technical functions with reasonable safety and skill as a result of alcohol or drug abuse, dependency or addiction Iowa Pharmacy Recovery Network (IPRN) A monitoring and advocacy peer review program created for the purpose of assisting impaired pharmacists, technicians and pharmacy students Federal vs. state law Don t base your answers on what you do in the workplace Recent changes in the law Read the questions carefully! Pharmacist vs. pharmacy tech, prescription vs. prescription label toll free IPRN confidential e mail: iprn@iarx.org Iowa Pharmacy Law and Information Manual. Iowa Pharmacy Association MPJE Competency Statements. NABP Web Site. je/mpje blueprint/ Survey of Pharmacy Law. National Association of Boards of Pharmacy Pharmacists Technicians 15

17 Iowa Pharmacy Law Review Controlled Substances 2012 Educational Expo Iowa Pharmacy Association January 20, 2012 Controlled Substances Act of 1970 Administered jointly by the FDA and U.S. Dept of Justice (Drug Enforcement Agency) Iowa Uniform Controlled Substance Act Iowa Board of Pharmacy Rules Chapter 10: Controlled Substances Chapter 21: Electronic Data in Pharmacy Practice Chapter 37: Iowa Prescription Monitoring Program Chapter 100: Iowa Real Time Electronic Pseudoephedrine Tracking System Federal DEA Registration Prescribers, hospitals and pharmacies are required to register Individual pharmacists are NOT required to register Registration is renewed every 3 years Iowa Registration with Board Prescribers, hospitals and pharmacies are required to register Individual pharmacists are NOT required to register Registration is renewed every 2 years Numbers are 2 letters followed by 7 digits first letter A or B, or M (midlevel practitioner) second letter is 1 st letter of prescriber s last name first 6 digits are randomly assigned, last is check digit Checking authenticity of number check letters add digits 1, 3 and 5 add digits 2, 4 and 6, multiply this sum x2 add the results of the first 2 calculations the last digit should correspond to the check digit High abuse potential No currently accepted medical use in the U.S. Lack accepted information for safety of use, even with medical supervision Examples: heroin, LSD, ecstasy High abuse potential Currently accepted medical use in the U.S. Abuse may lead to severe physical dependence Abuse may lead to severe psychological dependence Examples: cocaine, codeine, fentanyl, meperidine, methylphenidate, pentobarbital 1

18 Potential for abuse less than Schedules I or II Currently accepted medical use in the U.S. Abuse may lead to moderate to low physical dependence Abuse may lead to high psychological dependence May contain Schedule II substances in lower doses or in combination with other medications Examples: acetaminophen w/ codeine, anabolic steroids, dronabinol Potential for abuse less than Schedule III Currently accepted medical use in the U.S. Abuse may lead to limited physical dependence relative to Schedule III medications Abuse may lead to limited psychological dependence relative to Schedule III medications May contain Schedule II or III substances in lower doses or in combination with other medications Examples: alprazolam, diazepam, phenobarbital, zolpidem, AND carisoprodol (Soma) as of 1/12/12 Potential for abuse less than Schedule IV Currently accepted medical use in the U.S. Abuse may lead to limited physical dependence relative to Schedule IV medications Abuse may lead to limited psychological dependence relative to Schedule IV medications May contain Schedule II, III, or IV substances in lower doses or in combination with other medications Examples promethazine (Phenergan) w/codeine elixir, diphenoxylate w/ atropine (Lomotil), pseudoephedrine Commercial containers must be identified as controlled substances Symbol must be prominently located on the label and clear and large enough to be easily read without removal from the shelf or easily seen on inspection of the labeling Prescription for a controlled substance may be issued only by an individual practitioner 1) authorized to prescribe controlled substances in Iowa 2) registered or exempt from registration under the CSA an order for medication which is dispensed to or for an ultimate user, but does not include an order for medication which is dispensed for immediate administration to the ultimate user 2

19 Dated as of the date of issuance Signed on the day of issuance* Must include full name, address of the pt drug name, strength, dosage form, quantity prescribed, directions for use prescriber name, address and DEA number Must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice Responsibility is upon the prescribing practitioner, but corresponding responsibility rests with the pharmacist who dispenses * not preprinted or stamped; prescription may be prepared by an agent of the prescriber but prescriber must sign and is responsible for accuracy, completeness, and validity of the prescription CII prescriptions must be written Exception for faxed CII prescriptions under certain circumstances CIII, CIV, and CV prescriptions may be written, verbal, or faxed DEA issued Final Rule effective June 1, 2010 to allow e prescribing of Schedule II V controlled substances by appropriately credentialed prescribers. Iowa: new rules, effective Jan 18, 2012 further define electronic prescribing and establish requirements (Chapter 8, 10, 21, 23). These are consistent with DEA rules. Individual practitioners must obtain a 2 factor authentication credential from a government approved service provider or use a digital certificate Prescriber s electronic signature must be verified by 2 of the following forms of authentication biometric (something the practitioner IS) iris scan, fingerprint knowledge factor (something only the practitioner KNOWS) password or response to a challenge question device separate from the computer (something the practitioner HAS) a hard token or flash drive Pharmacist is responsible for verifying the authenticity of CII prescriptions when neither the prescriber nor the patient is known to the pharmacist Must record how the prescription was verified and include the pharmacist s name who verified prescription 3

20 Generally, faxed prescriptions are permitted ONLY if the pharmacist receives the original written, signed prescription before actual dispensing Exceptions (fax = original) 1. Narcotic CII to be compounded for direct parenteral (IV, IM, SC, epidural) administration to a patient 2. For resident of a long term care facility 3. For a hospice patient All controlled substance prescriptions are valid for six months from date of issue Refills CII refills not allowed CIII, CIV, and CV Not refilled more than six months after date of issue Not refilled more than five times No limit on quantity of controlled substance that may be prescribed or dispensed at one time Permitted for the same drug and patient with these restrictions total quantity cannot exceed 90day supply practitioner must determine legitimate medical purpose and act in the usual course of professional practice practitioner must write instructions on each script (other than 1 st ) as to the earliest date on which it may be dispensed no undue risk of diversion or abuse must be permissible under state law practitioner must comply with all other CSA and state law requirements Pharmacist may add patient s address to CII prescriptions Pharmacist may make these changes to CII prescriptions after consultation with prescriber Drug strength and dosage form Quantity Directions for use Date the prescription was issued Pharmacist may NOT change the patient name, controlled substance prescribed (except for generic substitution), or prescriber s name or signature Emergency Situation exists when... Immediate administration of the Schedule II drug is necessary for the proper treatment of the patient No appropriate alternative treatment is available It is not reasonably possible for the prescriber to provide a written prescription to the pharmacist before dispensing Limit quantity prescribed and dispensed to amount necessary Reduce prescription to writing immediately Make a reasonable good faith effort to verify, if prescriber unknown Written prescription must be received within 7 days Prescription must have Authorization for Emergency Dispensing and date of oral order written on it If prescription not received, must notify the Board and the DEA 4

21 Partial filling is allowed if the pharmacy does not have a sufficient supply to fill the prescription. Must be documented on the face of the prescription If prescription is only partially filled, the remainder must be filled within 72 hours If unable to completely fill in 72 hours notify prescriber a new Rx is needed Exceptions for LTCF, terminally ill patients Prescription label must include the following cautionary statement or Caution label Caution: Federal law prohibits the transfer of this drug to any person other than the person for whom it was prescribed Dispensing of Schedule V OTC drugs is limited to pharmacists and pharmacist interns under direct supervision of preceptor Dispensing may not be delegated to a pharmacy technician or other non pharmacist employee The payment transaction and delivery may be delegated to a non pharmacist employee Dispensing to the same purchaser in any 48 hour period is limited to no more than 1 of the following quantities: 8 oz of any controlled substance containing opium 4 oz of any other controlled substance [codeine containing cough syrup not more than 200mg/100ml] 48 dosage units of any controlled substance containing opium 24 dosage units of any other controlled substance Purchaser must be at least 18 years of age A government issued photo ID, including proof of age, if purchaser is not known by the pharmacist A bound record book (pages must be sewn or glued to the spine) of CV OTC dispensing must be maintained and must contain the following information: Purchaser name and address Name and quantity of controlled substances purchased Date of purchase Name or unique identification of the pharmacist or pharmacist intern who approved the dispensing Maximum of 3600 mg of pseudoephedrine to the same purchaser within a single calendar day Maximum of 7500 mg of pseudoephedrine to the same purchaser within a 30 day period Pseudoephedrine exceeding the maximum 7500mg / 30 days may be dispensed for a legitimate medical purpose with a prescription 5

22 Purchaser must be at least 18 years of age and present a government issued photo ID, including proof of age Pharmacist is responsible for verifying name and that photo on the ID matches the purchaser Dispensing record must contain Name, address and (electronic) signature of the purchaser Date and time of purchase Name and quantity of product Name or unique identification of the pharmacist or pharmacistintern who approved dispensing Effective in 2010, purchase records shall be recorded in the real time electronic pseudoephedrine tracking system (PTS) called the National Precursor Log Exchange (NPLEx). The pharmacy shall be able to produce a hard copy printout of transactions recorded in the PTS upon request by the board or its representatives or those authorized by law to receive such information. Required for CII substances Only registrants can obtain Form 222 from the DEA Forms are serially numbered and issued with the name, address and registration number of the registrant Triplicate form final distribution of copies copy 1 Supplier copy 2 DEA copy 3 Purchaser The Controlled Substance Ordering System (CSOS) is an electronic alternative to DEA Form 222 Controlled substances from all schedules may be ordered on the electronic form Purchaser must have a CSOS digital certificate for identity verification Inventory records must be kept for 2 years Initial inventory for new registrants Annual inventory Change of ownership Change of pharmacist in charge Change of registered location Discontinuing registered activity Newly designated controlled substances All records must be kept for 2 years Records of receipt Invoices, DEA 222 forms Records of disbursement prescriptions record books DEA 222 forms invoices institutional records disposal records records of theft and loss 6

23 CII controlled substance records must be kept separate from all other records CIII, CIV, and CV records must either be separate from all other records or kept in such a way that the records are readily retrievable from other records CII CV substances must be stored in a securely locked, substantially constructed cabinet OR Dispersed throughout the stock of noncontrolled substances in such a manner as to obstruct theft or diversion Theft or significant loss of controlled substances must be reported to the Iowa Board of Pharmacy Report within 2 weeks of discovery, on forms provided by the Iowa Board of Pharmacy Copy of the report must be maintained in the registrant s files Theft or significant loss of controlled substances or DEA form 222 must also be reported immediately upon discovery to the nearest DEA office, via phone, fax or in writing Registrant stock supply of controlled substances may be disposed of using one of these procedures DEA registered and Iowa licensed disposal firm ( reverse distributor ) As authorized by the Iowa Board of Pharmacy Delivery to Board of Pharmacy office or agent of the board Destruction in the presence of a Board of Pharmacy authorized individual Other Board of Pharmacy instructions by special request and approval Previously dispensed controlled substances may be destroyed or otherwise disposed of by a pharmacist in witness of one other responsible adult. A readily retrievable record of the destruction shall include: source of the controlled substance name, strength and dosage form quantity returned and destroyed date and signatures of the pharmacist and witness A tool for determining appropriate prescribing and treatment of patients without fear of contributing to a patient s abuse or dependence, or diversion Mandatory electronic monitoring of all prescription records of CII, CIII and CIV controlled substances dispensed in Iowa transactions MUST be submitted at least twice monthly Designed to provide authorized prescribers and pharmacist with information regarding their patients use of controlled substances review of information is NOT required 7

24 Iowa Pharmacy Law and Information Manual. Iowa Pharmacy Association Pharmacist s Manual. Drug Enforcement Administration web site. arm2/index.htm Pharmacists Technicians 8

25 2012 Educational Expo Iowa Pharmacy Law Review Jane E. DeWitt, RPh, PhD Post Assessment Questions 1. Pharmacy support persons in Iowa are now required to be A. licensed B. certified C. registered D. b and c 2. Iowa law requires Continuous Quality Improvement programs in hospital pharmacies only. A. true B. false 3. A pharmacy may compound an OTC product for a specific patient. A. true B. false 4. What is the current status of marijuana in Iowa? A. Schedule I no approved medical use B. Schedule II C. Schedule III D. none of these 5. Which of the following statements are true with regard to tracking pseudoephedrine purchases and controlled substance prescriptions in Iowa? A. There is a single electronic database to track these products. B. Pharmacists are required to check the database prior to filling prescriptions for controlled substances. C. Pharmacies are required to submit information. D. All of these are true E. None of these are true