1. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Chapter 7 State Laws and Pharmacy Practice Jahangir Moini, MD, MPH, CPhT

2. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Overview State laws vary widely They regulate pharmacy practice, minimum requirements, and how pharmacists and pharmacy technicians are qualified to legally practice Pharmacists and pharmacy technicians must learn and understand how their state laws differ from federal law

3. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. State Laws Affecting Pharmacy Practice State agencies, including state boards of pharmacy, regulate pharmacy practice on a daily basis National Association of Boards of Pharmacy (NABP) has created tables of information that enable personnel to quickly find their state’s position on various pharmacy-related activities

4. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Model Pharmacy Practice Act Developed and published by NABP to promote, preserve, and protect public safety, health, and welfare by effectively controlling and regulating pharmacy Addresses licensure, registration, and controls that focus on manufacturers, sellers, and distributors of drugs and related equipment and materials

5. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Minimum Requirements for a Pharmacy Required to have enough space to conduct needed activities Must have designated patient counseling areas Must supply educational reference materials for patients Facilities, equipment, and personnel must adhere to OSHA requirements

6. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Minimum Requirements for a Pharmacy Patients must be able to privately disclose PHI Pharmacist must be on duty while pharmacy is open, though a sign may be placed at counter for short periods if pharmacist is temporarily unavailable Licensure must be maintained continually

7. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Processing of Prescriptions Role of pharmacy technicians in processing of prescriptions requires concentration to ensure all steps are completed properly Next slide shows a list of activities pharmacy technician must complete when prescription is submitted for processing

8. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Pharmacy Technicians and Processing of Prescriptions 1.Receive prescription and verify all information is completed and clear 2.Translate prescription for entry in computer system 3.Enter information completely and ensure it matches printed labels

9. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Pharmacy Technicians and Processing of Prescriptions 4.Verify patient’s insurance and eligibility 5.Fill prescriptions and verify it is packaged correctly

10. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Points to Remember Check stock bottle’s labeling and NDC number and compare to prescription Never physically touch medication Verify correct type of lid is used Check labels for accuracy before applying Apply auxiliary labels if required Verify packaging is correct and initial it Arrange packaged medication with original prescription so the pharmacist can check

11. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Patient Counseling After pharmacy technician completes packaging prescription, pharmacist can counsel patient Pharmacist is the only person allowed to counsel patient Pharmacy technicians must always refer patients to pharmacist with questions about prescriptions

12. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Computerized Dispensing Can greatly improve dispensing time and accuracy Contain many built-in functions that cross-check and verify information Also interact with computer inventories and robotic dispensing equipment to ensure better accuracy

13. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Prescribing Regulations State law regulates prescribers of medications Each practitioner must be state-licensed They may also have to register with DEA if they prescribe controlled substances

14. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Prescription Drug Orders Prescription drug orders should be written by prescribers for diseases and conditions they directly deal with Pharmacists should be aware of any prescription that appears to be outside scope of practice of prescriber Prescription drug orders for controlled substances should contain standard prescription information plus prescriber’s DEA number

15. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Electronic Files Most states have adopted their own regulations for electronic transmission of prescriptions Most states now allow faxed controlled substance prescriptions, and require prescriber’s full information to appear Regulation of computer transmission of prescriptions is changing as they become more popular

16. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Drug Product Selection Drug product selection, drug product substitution, and generic substitution laws designed to regulate ability of pharmacists to dispense different drug product than prescribed drug Cost savings can be attained by substitution of generic drugs for brand name drugs

17. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Generic vs. Brand Name Law requires that generic drug must be identical to drug contained in brand-name drug for substitution to be allowed If generic drug is prescribed, pharmacist can dispense any product pursuant to generically written prescription

18. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Labeling Single-unit packages of individual-dose or unit-dose drug products must include: – Drug’s generic or trade name – Route of administration if other than oral – Strength and volume of drug – Drug’s control number and expiration date – Re-packager’s name or license number – Any special storage conditions

19. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Labeling Multiple-use drug packages must include: – Identifying information for dispensing pharmacy – Patient’s name – Dispensing date – Generic and/or trade name of drug – Strength of drug

20. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Labeling Ambulatory or outpatient drug packages must include: – Name and address of dispensing pharmacy – Name of patient – Name of prescriber – Directions for use – Dispensing date – Any Federal or State cautions – Prescription number – Name or initials of dispensing pharmacist – Generic or trade name of drug – Strength of drug – Manufacturer or distributor of drug – Beyond-use date of drug

21. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Patient Records and Drug Review Maintenance of patient medication records is intended to facilitate monitoring of patient’s drug therapy Good record keeping is important Patient records should contain full name, address, telephone number, age or date of birth, and gender

22. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Patient Records and Drug Review Each pharmacy should make sure every patient record shows entire available drug history, at least past 5 years, with most recent prescriptions listed first Any comments by pharmacists should be included, including information about allergies, reactions, diseases, and conditions

23. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Patient Records and Drug Review –Pharmacist is responsible for reviewing each patient’s medication use and verifying no abuse or misuse of medications –Allergies must always be verified to avoid medication errors –Drug dosages must be checked for effectiveness

24. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Patient Counseling Patient counseling to be performed only by licensed pharmacists Under OBRA-90, most states have enacted “mandatory” patient counseling requirements for pharmacists

25. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Patient Counseling OBRA-90 requires pharmacists to offer counseling to all Medicaid patients –Pharmacist must explain the name of drug, dosage form, route of administration, duration of drug therapy, directions for use, and side effects –Pharmacist should also emphasize how to properly store medication, and discuss refill information if required

26. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Computer Regulations Secure computer systems required more than ever for pharmacy record keeping NABP publishes rules for use of computer systems for protection and confidentiality of PHI PHI must be retrievable online for all refillable prescriptions

27. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Computer Regulations Pharmacists have final authority and responsibility to ensure correct decisions are made for patient refills if automated computer system is not properly operating Any prescriptions filled or refilled during computer “downtime” must be entered in system within four business days of it becoming operable

28. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Pharmacy Ownership In general, anyone who has proven their qualifications and is of good moral character may own a pharmacy in most states Unlicensed or untrained individuals should not manage the pharmacy Business practices must be ethical, dignified, correct, informed, and have no conflicts of interest

29. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Sale of Hypodermic Needles and Syringes Sale of hypodermic needles and syringes must be carefully controlled by pharmacist to prevent illegal use Individual states regulate sale of OTC needles and syringes Some states require physician's prescription

30. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Compounding Both state and federal law regulate practice of pharmacy compounding Supreme Court has ruled advertising of compounding services cannot be prohibited because of rights to commercial free speech FDA has stepped in regarding cases of community pharmacies compounding certain drugs available in commercial preparations

31. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Compounding Pharmacists must closely follow state laws as well as FDA’s guidelines concerning compounding Pharmacy technicians will be affected and see duties increase in assisting pharmacists with compounding activities, and will need to follow FDA guidelines

32. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. United States Pharmacopoeia (USP) USP has consistently updated sterile compounding regulations USP is an enforceable set of standards for nonsterile compounding USP is an enforceable set of standards for sterile compounding

33. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. USP Guidelines USP guidelines cover retail, hospital, and even home health care compounding Main goals of continually improving regulation are to reduce contamination potential and keep unwanted particles in air from infiltrating compounded mixtures

34. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Sterile Compounding Sterile compounding of eye drops and parenterals requires barrier isolators that use positive pressure to keep airflow from less sterile areas into more sterile areas Buffer areas or “anterooms” that must maintain certain “clean” levels are used for putting on and removing protective garb and equipment, and for disinfection of equipment

35. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Gowning Gowning includes: –Gloves –Gowns or coats –Hair covers –Masks –Shoe covers –Personal protective equipment as required

36. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. State Regulation of Long-Term Care Both state and federal law regulate certain components of long-term care Licensing of operators of long-term care pharmacies regulated by state law in most cases Certain states require pharmacists to have a more specialized license to practice in a long- term care pharmacy

37. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Ultimate Goals Ultimate goal of state laws concerning pharmacy practice is to provide quality therapeutic care and prevent patient harm Pharmacists must remember they have ultimate responsibility for patient’s health

38. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Ultimate Goals Pharmacy technicians must remember there are more regulations than ever before, which can affect their careers Complete understanding of state laws and strict ethical practice is required