Chapter 7

1. Chapter 7 State Laws and Pharmacy Practice Jahangir Moini, MD, MPH, CPhT

2. 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. 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. 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. 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. 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. 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. Pharmacy Technicians and Processing of Prescriptions • Receive prescription and verify all information is completed and clear • Translate prescription for entry in computer system • Enter information completely and ensure it matches printed labels

9. Pharmacy Technicians and Processing of Prescriptions • Verify patient’s insurance and eligibility • Fill prescriptions and verify it is packaged correctly

10. Points to Remember • Check stock bottle’s labeling and NDCnumber 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. Labeling • Ambulatory or outpatient drug packages must include: • 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 • Name and address of dispensing pharmacy • Name of patient • Name of prescriber • Directions for use • Dispensing date • Any Federal or State cautions

21. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. United States Pharmacopoeia (USP) • USP has consistently updated sterile compounding regulations • USP <795> is an enforceable set of standards for nonsterile compounding • USP <797> is an enforceable set of standards for sterile compounding

33. 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. 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. Gowning • Gowning includes: • Gloves • Gowns or coats • Hair covers • Masks • Shoe covers • Personal protective equipment as required

36. 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. 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. 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