Washington State Board of. Act & 18.64A RCW. Donald H. Williams, RPh, FASHP Affiliate Professor, UW School of Pharmacy

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1 Washington State Board of Pharmacy and Pharmacy Practice Act & 18.64A RCW Donald H. Williams, RPh, FASHP Affiliate Professor, UW School of Pharmacy 1

2 Pharmacists Pharmacy Assistants Regulation of Health Professions Uniform Disciplinary Act Abuse of Children and Adult Dependent Persons Administrative Procedures es Act Public Disclosure Department of Health Uniform Food, Drug and Cosmetic Act Washington Caustic Poison Act of 1929 Poisons - Sales and Manufacturing Poisons and Dangerous Drugs Legend Drugs... Prescription Drugs Precursor Drugs Drug Samples Uniform Controlled Substances Act Controlled Substances Therapeutic Research Act Medical Marijuana Imitation Controlled Substances 2

3 Use of Buildings for Unlawful Drugs Over-the-Counter Medications - Imprinting Medical Records-Health Care Information Access and Disclosure Drug Injection Devices Prescription Monitoring Program Abuse of Vulnerable Adults 3

4 Pharmacy Practice Act Board of Pharmacy 7 members (5 Pharmacists, 2 Public) Representative of geographic & practice areas Appt. by Governor, Confirm by Senate (Advice & Consent) Citizen/Resident of WA, Lic for 5 years Public members NOT affiliated w/phcy. Four year terms; Two term limit 4

5 Rx Act, cont RCW Meetings, chair, etc. Meet PRN Officers Compensation $ per day Travel expenses paid 5

6 Rx Act,cont Board Powers & Duties 1. Regulate practice & Enforce Rx Laws 2. Examinations 3. Establish qualifications for RPh & Interns 4. Conduct hearings 5. Issue subpoenas & administer oaths 6. Assist law enforcement agencies re: Rx 6

7 Rx Act, cont. 7. Promulgate rules re: dispensing, distribution, wholesaling, manufacturing of drugs & devices Violation of rules constitutes grounds for refusal, suspension, revocation of licenses granted by Board. 8.May adopt rules for Continuing Education 7

8 Rx Act, cont. 9. Be immune, collectively & individually from suit in any action based upon disciplinary proceedings or other official acts performed as members. Employees are also immune when acting in the course of disciplinary proceedings. 8

9 Rx Act, cont. Sub-sections 10 thru 13 authorize the Board to assist other Agencies in dealing with drug abuse issues. The Board concentrates on the abuse of legal drugs rather than street drugs. 9

10 Rx Act, cont Board may designate DOH enforcement officers as Peace Officers Vested with authority to enforce Drug Laws (see list) 10

11 Questions???? 11

12 Rx Act, cont Definitions (See lawbook for full definitions and complete list.) 1. Administer i - Apply drug to a person in any manner oral, topical, etc. 2. Board = Board of Pharmacy 3. Compounding = combining 2 or > ingredients in preparing p a prescriptionp 4. Controlled Substance = anything designated in UCSA RCW 5.Deliver = transfer a drug to another person Department = Dept. of Health

13 Definitions, cont. 7. Device = same as in FD&C Act 8. Dispense = Interpretation of prescription or order for drug/device and the proper selection, measuring, compounding, labeling, or packaging to prepare the Rx for delivery 9. Distribute = delivery of drug other than by administering or dispensing 13

14 Definitions, cont. 10. This EXCLUDES a whole bunch of things that are NOT included in the Drug or Device definition: (e.g., surgical/dental instruments, lab materials, gas & oxygen, X-ray, pesticides, medicated animal feed, etc. This keeps the Board from trying to regulate these items. 14

15 Definitions, cont. 11. Drugs = Same as FD&C definition 12. Health Care Entity = provides health care but not otherwise licensed (e.g. ambulatory surgery center, etc.) See also to 470. Allows these facilities to purchase and use prescription drugs and controlled substances. 15

16 Definitions, cont. 23. Practice of Pharmacy = Interpreting Rx orders, compounding, dispensing, labeling, administering, distributing drugs and devices Monitoring drug therapy Initiating or modifying drug therapy per protocols/agreements with prescribers DUR, drug product selection, keep records, provide information regarding Rx value, hazards, uses, etc. (bold items added in 1979 re-write of definition) 16

17 Definitions, cont. 24. Practitioner = physician, dentist, veterinarian, nurse, or other person authorized by law in WA to prescribe drugs. Who are the other persons that may prescribe drugs but are NOT included in the above definition? 17

18 Definitions, cont. 25. Prescription = Order for drugs or devices issued by an practitioner, authorized to prescribe in the course of his/her professional practice for a legitimate purpose 18

19 Definitions, cont. Wholesaler = entity that purchases drugs for resale and distribution to entities OTHER THAN A CONSUMER 19

20 Rx Act, cont Licensing required Need license to practice pharmacy OR operate a pharmacy. Must place lic. Pharmacist in charge This section does not apply to wholesalers or manufacturers or their employees IF acting within the scope of their license. 20

21 Rx Act, cont License Fee You must pay a fee to take the licensing exam. Secretary of Health sets the fee BUT National Association of Boards of Pharmacy (NABP) tells the Secy. how much to charge. 21

22 Rx Act, cont Pharmacy Licenses Must submit application and pay fee Must pay renewal fee ON Time Must advise of change of location Must declare who owns the pharmacy Subject to discipline for violations 22

23 Rx Act, cont Shopkeeper s registration Anyone who wants to sell OTC drugs in the original package must register and pay annual fee Shopkeepers include: grocery stores, mini-marts, marts hotel giftshops, vending machines, etc. 23

24 Note: on Shopkeepers Until precursor control laws were enacted, shopkeepers were the largest source of pseudoephedrine products in WA. Now their pseudo sales may not exceed 10% of fotc sales in March-October ho and 20% in November-February (I.e., cold season) Other restrictions ti apply same as pharmacies (e.g., behind the counter, identification, signature, individual quantity limits, etc.) 24

25 Rx Act, cont Manufacturers License required to manufacture drugs in WA 25

26 Rx Act Wholesalers License is required to sell drugs in WA Legend, Controlled Substances & OTC Out of State Wholesalers License required if ship to WA customers Pharmacies, hospitals, doctors, etc. No license if only ship to subsidiaries (e.g., Cardinal in CA ships to Cardinal in WA, Wal-Mart AR ships to Wal-Mart in WA, etc.) NOTE: Pseudoephedrine sales restrictions also 26

27 Rx Act Itinerant Vendors Sell OTC s door to door Formerly: Watkins Products, Fuller Brush, etc. Now: mostly Veterinary OTC Drugs Delivered to dairy farms 27

28 Rx Act, cont Licensing of Pharmacists 18 years old Good moral and professional character Not unfit due to Drugs, Alcohol, CS, mental BS or PharmD from Accredited S/C Complete Internship (IPPE & APPE +) Pass Examinations NAPLEX & MPJE See rules at WAC

29 Rx Act, cont Licensing of Pharmacists Procedures Exams are computerized offered at contract computer centers. Results in a week or so Scaled score of 75 needed to pass May transfer scores to other States to get licenses at the same time - States may have a time limit. Will have to take their law exam But most states use MPJE so you can take it at same center. Alternatively, you may Reciprocate license to another State EXCEPT California. May NOT practice until your license is in your hand! 29

30 Rx Act, cont Licensing of Pharmacists Procedures, cont. Reciprocity is through NABP Most States will only reciprocate a license that you have received BY EXAMINATION NOT by reciprocity. See DHW example 30

31 Rx Act, cont License fees etc. Renewals are on your birth day Allow plenty of time Must post license in your pharmacy May obtain an Inactive Lic. If leave practice - No CE required BUT reactivation may be a problem. If too long may need internship hours etc. Advice: Keep pyour license active even if you are not! 31

32 Rx Act, cont ,180 Refusal, suspension, & revocation of Pharmacist and Intern licenses. See also RCW (Uniform Disciplinary Act) This will be covered in the Discipline lecture. 32

33 Rx Act Prescription Records Keep records for at least 2 years but other agencies may require longer time (Medicaid, Insurance, children s records) Produce in Court if required Comply with CS record requirements Confidential for Pharmacy use only Open for inspection by BoP, Law Enforcement, DEA, etc. 33

34 Rx Act, cont Prescription Labels Name/Address of pharmacy, Rx No., prescriber, directions, name/strength of drug, CRC cap (WAC ) generic or trade name, ID pharmacist on label or in pharmacy records This section does NOT apply to hospital patients. 34

35 Rx Act, cont Unlawful Practices This section makes it a violation to do things that are considered to be the practice of pharmacy. Includes using titles/signs - Pharmacy, Drug Store, Pharmacist. Pharmacy Symbols - apothecary jars etc. 35

36 Rx Act Authorized Practices Keeps the Pharmacy Act and Board from controlling other professions Can t restrict other practitioners Allows designated d RN in HOSPITAL to enter hospital pharmacy in absence of pharmacist to get drug in emergency. Must leave a proper record Can t stop OTC sales by other licensees if properly labeled l & in original i packaging. 36

37 Rx Act, cont Drugs for Dialysis Allows Medicare approved dialysis centers to purchase & dispense shelf lots of legend drugs approved by the Board by rule. Heparin, Dialysate, NaCL, etc. See WAC 37

38 Rx Act, cont Responsibility for drug purity Proprietor is responsible for the quality of drugs EXCEPT those sold in the original manufacturer s package or patent or proprietary medicines (i.e.,former name for OTC drugs) 38

39 Rx Act, cont Limitations on liability for dispensing a prescription. The law was changed due to a Tacoma DES case, Pharmacist is NOT liable to a person to whom he/she dispenses a product in the form manufactured by a commercial manufacturer if the person is injured and makes one or more of the following claims: 39

40 Rx Act, cont Limitations on liability for dispensing a prescription, p continued. Claims: Strict liability in tort Implied warranty under Uniform Commercial Code 40

41 Rx Act, cont Limitations on liability for dispensing a prescription, continued. Pharmacist must comply with record keeping rules Pharmacist could be liable if the patient s claim was proximately caused by: Pharmacists negligence Breach of an express warranty made by RPh Intentional ti misrepresentation ti of facts about the product made by the RPh Intentional misrepresentation of facts about the product or concealment of information about the product by the pharmacist 41

42 Questions Under the above law, is a pharmacist protected from liability when he/she dispenses a compounded prescription and a patient is injured? 42

43 Rx Act Dept of Health Powers/duties In 1989 the previously independent BoP was merged into the new DOH. The new department assumed some of the Board duties: Establishing fees, hiring staff, investigating complaints, inspecting licensees, etc. 43

44 Rx Act, cont to Non-Resident Pharmacies Requires licensing of out-of-state pharmacies that send prescriptions to patients in Washington In 2005 the Legislature extended these provisions i to pharmacies licensed in Canada but the Canadian provisions have not been implemented. 44

45 Rx Act, cont Cost Disclosure to Health Care Providers All Washington pharmacies are required to establish a procedure to disclose costs of all prescriptions to prescribers related to their prescribing on request. This section has not been implemented! 45

46 Rx Act, cont, Tamper Resistant Prescription Pads or Paper Oi Originally i the Congress required all llhard copy Medicaid prescriptions to be on this kind of paper. Prescribers were confused and non- compliant and it was the pharmacist who was on the hook for not getting paid if an auditor found a non-compliant prescription. The WSPA requested a WA law that required ALL hard copy prescriptions be on TRP 46

47 Rx Act, cont, Tamper Resistant Prescription Pads or Paper May not fill written Rx unless on approved TRPP If hard copy of electronic Rx given to patient & manually signed must meet requirements Characteristics of Board approved TRPP Industry recognized features to prevent copying To prevent erasure or modification of information 47

48 Rx Act, cont. Tamper-resistant Rx Practitioners reasonable safeguards to prevent theft/unauthorized use of Rx pads Vendors of pads must get Board approval Board must create a seal of approval to be affixed to each Rx Board may adopt rules to implement 48

49 Rx Act, cont. Tamper-resistant Rx Requirements DO NOT APPLY to: Rx s transmitted to pharmacy via: phone, Fax, or electronic means In-patient Rx s - hospitals, nursing homes, chart orders, etc. where patient does NOT have the opportunity to handle the Rx. 49

50 Pharmacy Technician Law A WA technicians licensed since 1977 Manipulative non-discretionary functions C & P & L & S and Computer data entry 580 hours of Board Approved training Ratio (by Rule) up to 3 techs to 1 RPh Originally, community phcy was 1:1 and Hospital pharmacy was 1:3 but later Legislature allowed BoP to establish ratio. Pharmacy must submit a Tech Utilization plan 50

51 Questions 51