TECHNICIAN LAW REVIEW Morganne Smyth, Pharm.D. Pharmacy Practice Resident St. Luke s Health System - Boise ISHP 2012 Fall Meeting Objectives At the conclusion of this presentation, the audience should be able to: Identify pharmacy technician registration requirements in the state of Idaho Identify practice limitations of technicians in Idaho Recognize Idaho pharmacy staffing regulations Outline Idaho State Board of Pharmacy Technician Registration Certification Continuing Education Technician Practice Limitations, identification, staffing, counseling, pharmacist absence Prescriptions Expiration, refills, partial filling, invalid orders, order requirements Miscellaneous Pharmacist absence Patient-prescriber relationship Pseudoephedrine 1
Introduction Idaho State Board of Pharmacy Mission: Promote, preserve and protect the health, safety, and welfare of the public by and through the effective control and regulation of the practice of pharmacy. Not to see itself, or be seen as, promoters or advocates for the profession Idaho State Board of Pharmacy, http://bop.idaho.gov/about/about.html Idaho State Board of Pharmacy, http://bop.idaho.gov/consumers/consumers.html Introduction Idaho State Board of Pharmacy Determine minimum qualifications for licensure/registration Regulate standard of conduct and scope of practice of the profession Adopt and administer examinations Adopt and monitor continuing education (CE) requirements Review complaints against licensees/registrants Appropriate disciplinary action against those who violate the laws Idaho State Board of Pharmacy, http://bop.idaho.gov/about/about.html Idaho State Board of Pharmacy, http://bop.idaho.gov/consumers/consumers.html Introduction Idaho State Board of Pharmacy Members Five (5) Board members appointed by the Governor Serve a term of five (5) years Four (4) pharmacists Residents of the state of Idaho Licensed and in good standing Engaged in the practice of pharmacy in the state of Idaho > 5 years of experience in pharmacy after licensure One (1) public member Resident of the state of Idaho > 18 years of age Not currently or ever been in the profession of pharmacy Not have a spouse in the profession of pharmacy Not have any material financial interests in the practice of pharmacy 2
Idaho Board of Pharmacy Newsletter Official journal of the Board Licensees and registrants are presumed to have knowledge of the content on the date of publication Published four (4) times per year March June September December May be used in administrative hearings as evidence of proof of notification National Association of Boards of Pharmacy, http://www.nabp.net/publications/idaho-board-of-pharmacy-newsletters/ Idaho Board of Pharmacy Newsletter National Association of Boards of Pharmacy, http://www.nabp.net/publications/idaho-board-of-pharmacy-newsletters/ Board of Pharmacy Review Members of the Board of Pharmacy serve a term of how many years? a) One (1) year b) Two (2) years c) Three (3) years d) Five (5) years 3
Technician Registration Requirements > 18 years of age High school graduate or equivalent Be of good moral character/temperate habits Obtained and maintained certified technician (CPhT) status through PTCB or ICPT Unless qualify for continuous employment exemption Continuous Employment Exemption Technicians registered with the board and employed prior to June 30, 2009 are not required to obtain or maintain certification Maintain continuous employment with same employer Registration will be inactive on the date of employment termination Must fulfill certification requirements Technician-in-Training Registration Must satisfy requirements for technician registrations, except obtaining CPhT status Technicians-in-Training may perform any of the duties allowed by a technician under the supervision of a pharmacist Registration for technician-in-training expires on June 30 th and is renewable up to two times 2013 Changes: Technician-in-Training must maintain employment or registration will be cancelled 4
Registration Fees Technician: $35 Annually on June 30 th (Technician-in-Training can be renewed twice) Reinstatement fee: (1/2) registration $17.50 Note: Changes to any of the information on initial/renewal application must be reported to the Board within ten (10) days Changes in employment must be reported to the Board within ten (10) days Registration Late application Failure to submit a renewal application prior to the expiration date will result in a lapsed license/registration License/registration is invalid until approved by the board If license/registration is not renewed within thirty (30) days, reinstatement is required Exemption: New licenses/registrations issued within ten (10) weeks or less prior to the renewal date are exempt from renewal for that year Verify A License 5
Registration Recap Technician registration renewal applications are due by which date each year? a) January 1 st b) June 30 th c) September 1 st d) December 31 st Certification Pharmacy Technician Certification Board (PTCB) Develop, maintain, promote, and administer a nationally accredited certification program Goal: Enable pharmacy technicians to work more effectively with pharmacists to offer greater patient care and service To become a certified technician, must pass the Pharmacy Technician Certification Examination (PTCE) Must obtain twenty (20) hours of CE every two (2) years to maintain certification National Association of Boards of Pharmacy, http://www.nabp.net/programs/cpe-monitor/cpe-monitor-service/technicians/ Certification - ICPT Institute for the Certification of Pharmacy Technicians (ICPT) Purpose: to promote high standard of practice for pharmacy technicians and to encourage participation in continuing education to promote safe and effective patient care Required to pass the Exam for Certification of Pharmacy Technicians (ExCPT) Must obtain twenty (20) hours of CE per each two-year certification period National Healthcare Association [Internet], http://www.nhanow.com/pharmacy-technician.aspx 6
Continuing Education Twenty (20) CE hours every 2 years to maintain PCTB certification One (1) hour must be in pharmacy law Ten (10) hours may be earned by in-service projects Fifteen (15) hours may come from completing a relevant college course with a grade of C or better Mathematics Biology Pharmaceutical sciences Pharmacology Pharmacy Technician Certification Board, https://www.ptcb.org/am/template.cfm?section=continuing_education1&template=/cm/htmldisplay.cfm&contentid=4476 Pharmacy Technician Certification Board, https://www.ptcb.org/am/template.cfm?section=continuing_education1&template=/cm/htmldisplay.cfm&contentid=4476 CPE Monitor Continuing Pharmacy Education (CPE) Monitor Service provided by NABP Electronic management of CE credits ACPE-accredited CE programs Sign up and create an e-profile with NABP CPE Monitor Provide NABP ID and date of birth when registering for CPE credit CE programs with verify information with CPE Monitor 2013: Goal to allow Boards of Pharmacy to request CPE Monitor reports Eliminate need to send paper copies of CE credit National Association of Boards of Pharmacy, http://www.nabp.net/programs/cpe-monitor/cpe-monitor-service/index.php 7
Continuing Education Review In order to maintain PTCB certification, every two (2) years, pharmacy technicians must complete: a) Ten (10) hours of in-service projects b) One (1) hour of pharmacy law CE c) A total of thirty (30) hours of CE d) Five (5) hours of live CE Technician Practice Limitations Receive a verbal prescription drug order Consult with prescriber prior to filling if clarification of information is needed regarding the patient or the drug order Perform prospective drug review or interpret clinical data in the patient s medication record Perform professional consultation with a prescriber, nurse, or other healthcare professional Supervise packaging of drugs and checking final product Provide patient consultation on a new/refilled drug or on an over-the-counter drug/supplement Supervise activities of student pharmacists and technicians Technician Identification Clearly visible name badge First name and title of technician When initiating or receiving phone calls Must identify self as technician 8
Pharmacy Staffing Ratio 1:6 One pharmacist for every six student pharmacists or technicians Exception Pharmacist must not operate in/allow the operation of/be required to operate a pharmacy with a ratio that results in, or would be expected to result in, risk of harm to public health, safety, or welfare Counseling Counseling For new prescriptions, or when otherwise deemed necessary, a pharmacist shall counsel the patient or caregiver For refills or renewed prescriptions, a pharmacist or technician shall extend an offer to counsel the patient or caregiver A pharmacist is not required to counsel when a patient/caregiver refuses or if counseling is otherwise impossible Note: Counseling is not required in a hospital/institutional facility when licensed health care professionals administer the medication 9
Pharmacist Absence (Temporary) Institutional Facility If pharmacist is not in the pharmacy, but still in the facility, pharmacy students and technicians may remain in the pharmacy as long as: No other person may be allowed access or entrance to the pharmacy Drugs/devices may not leave the pharmacy unless requested by, and delivered, to the pharmacist Neither student pharmacists or technicians may remain in the pharmacy if the pharmacist is absent from the facility Pharmacist Absence (Temporary) Non-institutional Facility Technicians and Interns may remain in the pharmacy pharmacist is within business establishment performing professional services immediately outside the pharmacy A pharmacy must be closed for business and secured during all times a pharmacist is not present in the pharmacy/in the building Prescription expiration Non-controlled substance prescriptions expire no later than fifteen (15) months from the date of issue Schedule II prescription drug orders expire no later than ninety (90) days from the date of issue Schedule III, IV, and V prescription drug orders expire no later than six (6) months from the date of issue A prescription drug order expires no later than ninety (90) days after a prescriber change of status Death, incapacity, suspension, revocation of license, or permanent relocation 10
Refills Non-controlled substances Refill an unlimited number of times CIII CV May be refilled up to five (5) times CII Refills NOT allowed Drug Enforcement Administration {Internet], http://www.deadiversion.usdoj.gov/pubs/manuals/pharm2/index.html Partial Filling Non-controlled substances May be partial filled any number of times, as long as the prescription is valid (within 15 months from date of issue) CIII-CV May be partial filled as long as recorded as a refill and not filled after 6 months from date of issue CII Partial fill allowed, but remainder of partial fill must be filled within 72 hours After 72 hours, must notify prescriber and new rx must be issued Expiration Review A prescription was issued for Lyrica (Schedule V) by a prescriber. When will the prescription expire? a) 90 days from the date of issue b) 90 days from the first fill date c) 6 months from the date of issue d) 15 months from the first fill date 11
Invalid Prescription Drug Orders In order for a prescription to be valid, it must be issued: In good faith For a legitimate medical purpose By a licensed prescriber Within the course and scope of the prescriber s professional practice Pursuant to a prescriber-patient relationship Requiring all elements required by law Invalid Prescription Drug Orders A prescription drug order will be considered INVALID if: Antedated or postdated Different than Do not fill until The prescription has been tampered with Alternation, erasure, or addition of information by someone other than who originally wrote the order Prescriber self-use of a controlled substance For a family member of a prescriber if inconsistent with scope of practice Prescription Drug Order Requirements Patient name Address if for controlled substance (CS)* Date of issue Drug information Name, strength, quantity Dosage form (tablet, capsule) if for a CS* Directions for use Prescriber name Address and DEA number if for a CS* Signature Note: if prescription if for an animal, must include the species (dog, cat) *Additional requirements for controlled substances 12
Drug Order Requirements (Inpatient) Patient name Date of issue Drug information Name, strength, and route of administration Directions for use Prescriber name Signature Prescriber or prescriber s agent signature Prescription Labeling Requirements Non-institutional 1. Dispenser information* Name Address Telephone number of person/business 2. Prescription serial number* 3. Date filled 4. Prescriber name* 5. Name of the patient If animal, species 6. Drug name and strength 7. Quantity 8. Directions for use 9. Cautionary information 10. Expiration 11. Refills* 12. Warning* *Not required for institutional prescriptions Prescription Labeling Requirements Institutional 1. Date filled 2. Name of the patient If animal, species 3. Drug name and strength 4. Quantity 5. Directions for use Route of administration 6. Cautionary information 7. Expiration or beyond use date 8. Initials/unique identifier of pharmacist 13
Valid Prescription Review True or False A prescription is considered valid if issued by a practitioner a patient has never met after the patient fills out a online survey about their medical symptoms Prescriber-patient Relationship Exceptions: Initial admit orders for a new hospital patient Taking call for another prescriber Writing for a patient examined by a physician s assistant, advanced practice nurse, or other licensed practitioner that physician has a supervisory/collaborative relationship For a new patient, small supply, before first appointment In emergency situations, when health of the patient is in danger In emergencies that are an threat to public health Antibiotics to treat STD of partner(s) of patient Labeling Review Which of the following is NOT required on inpatient prescription labels? a) Name of patient b) Name of prescriber c) Expiration d) Date filled 14
Pseudoephedrine sales Combat Methamphetamine Act of 2005 Eliminate the use of pseudoephedrine in illegal production of methamphetamine May not sell unless purchaser presents a photo ID issued by a state/federal government Pseudoephedrine must be kept behind the counter or in a locked cabinet Distribution must come from an employee, and not from a self-service machine Idaho Administrative Code. Chapter 33 Retail Sales of Pseudoephedrine Products. Sudafed [Internet]., http://www.sudafed.com/products Pseudoephedrine sales May not sell >3.6 gm of pseudoephedrine in a single day May not sell >9 gm of pseudoephedrine in a 30-day period Sudafed Congestion (30 mg/tablet) Max of 120 tabs in 1 day Max of 300 tabs in 30 days Sudafed 12-hr (120 mg/tablet) Max of 30 tabs in 1 day Max of 75 tab in 30 days Sudafed 24-hr (240 mg/tablet) Max of 15 tabs in 1 day Max of 37 tabs in 30 days Idaho Administrative Code. Chapter 33 Retail Sales of Pseudoephedrine Products. Sudafed [Internet]., http://www.sudafed.com/products Pseudoephedrine sales Must use electronic sales system with stop alerts Records purchaser information and signature NPLEx (National Precursor Log Exchange) tracking system Online, paperless system No cost to pharmacies NOTE: Does not apply to pseudoephedrine dispensed pursuant to a valid prescription Idaho Administrative Code. Chapter 33 Retail Sales of Pseudoephedrine Products. Sudafed [Internet]., http://www.sudafed.com/products 15
Summary Purpose of the Board of Pharmacy Protect the public Technician registration requirements 18 years of age High school graduate or equivalent Good moral character and temperate habit CPhT Status (unless exempt) Technician certification PTCB or ICPT CE requirements 20 hours in a two-year period 1 hour of law Summary Practice Limitations Verbal orders Consult with prescriber for clarification Prospective drug review/interpret clinical data Professional consultation with healthcare professionals Supervise packaging and checking final product Patient counseling (rx or OTC) Supervise other employees Staffing 1:6 ratio Summary Counseling New prescription requires counsel Refill/renewal requires offer to counsel Prescription expiration and refills Non-controlled 15 months Unlimited refills CIII CV 6 months 5 refills CII 90 days NO refills 16
Summary Partial Filling CII: complete order within 72 hours CIII CV: count as refill Non-controlled: unlimited Pseudoephedrine < 3.6 gm in a single day < 9 gm in 30 days Professional Pharmacy Organizations/ Resources American Society of Health-System Pharmacists (ASHP) Idaho Society of Health-System Pharmacists (ISHP) National Community Pharmacists Association (NCPA) National Association of Chain Drug Stores (NACDS) American Pharmacists Association (APhA) Pharmacist s Letter/Pharmacy Technician s Letter Pharmacy Technician Certification Board (PTCB) Institute for Certification of Pharmacy Technicians (ICPT) Idaho State Board of Pharmacy Contact Information Street address: 1199 Shoreline Lane, Suite 303, Boise, ID Office hours: Monday Friday 8 a.m. to 5 p.m. (excluding state holidays) Mailing address: P.O. Box 83720, Boise, ID 83720-0067 Telephone/Fax (208) 334-2356/(208) 334-3536 Website: http://bop.idaho.gov 17
References Drug Enforcement Administration [Internet]. 2010 Pharmacist s Manual. U.S. Department of Justice [cited 2012 August 30]. Available from: http://www.deadiversion.usdoj.gov/pubs/manuals/pharm2/index.html Idaho State Board of Pharmacy [Internet]. About Us [cited 2012 August 26]. Available from: http://bop.idaho.gov/about/about.html Idaho State Board of Pharmacy [Internet]. Information for Consumers [cited 2012 August 26]. Available from: http://bop.idaho.gov/consumers/consumers.html National Association of Boards of Pharmacy [Internet]. CPE Monitor Service [cited 2012 August 20]. Available from: http://www.nabp.net/programs/cpe-monitor/cpe-monitor-service/index.php National Association of Boards of Pharmacy [Internet]. CPE Monitor Service Technicians [cited 2012 August 20]. Available from: http://www.nabp.net/programs/cpe-monitor/cpe-monitorservice/technicians/ National Association of Boards of Pharmacy [Internet]. Idaho Board of Pharmacy Newsletters [cited 2012 August 20]. Available from: http://www.nabp.net/publications/idaho-board-of-pharmacynewsletters/ National Healthcare Association [Internet]. Pharmacy Technician Certification [cited 2012 August 29]. Available from: http://www.nhanow.com/pharmacy-technician.aspx Pharmacy Technician Certification Board [Internet]. Continuing Education [cited 2012 Aug 27]. Available from: https://www.ptcb.org/am/template.cfm?section=continuing_education1&template=/cm/htmldispla y.cfm&contentid=4476 Sudafed [Internet]. Learn About Products. McNEIL-PPC, Inc. 2012 [cited 2012 August 28]. Available from: http://www.sudafed.com/products Questions? 18