1. © Paradigm Publishing, Inc. 1 Chapter 2 Pharmacy Law, Regulations, and Standards

2. © Paradigm Publishing, Inc. 2 Learning Objectives Discuss the roles of the –Food and Drug Administration –Drug Enforcement Administration –Occupational Safety and Health Administration –National and state boards of pharmacy

3. © Paradigm Publishing, Inc. 3 The Need for Drug Control Laws Regulations Standards

4. © Paradigm Publishing, Inc. 4 Discussion What might happen without adequate drug control?

5. © Paradigm Publishing, Inc. 5 Laws Laws are rules passed and enforced by the legislative branch of government. Laws offer a minimum level of acceptable standards. Violations may result in various punishments.

6. © Paradigm Publishing, Inc. 6 Regulations A regulation is a written rule and procedure to carry out a law. Many regulations are published by federal agencies. When a law and regulation conflict, the more strict one applies.

7. © Paradigm Publishing, Inc. 7 Standards A standard is a set of criteria to measure product quality or professional performance against a norm. Organizations set standards that must be met before their approval can be earned. Ethics provide standards of personal conduct within a profession.

8. © Paradigm Publishing, Inc. 8 History of US Statutory Pharmacy Law

9. © Paradigm Publishing, Inc. 9 Pure Food and Drug Act of 1906 Passed to fight abuses in drug formulation, labeling, and marketing Forbade drug labels from containing false information Proved to be unenforceable

10. © Paradigm Publishing, Inc. 10 Food, Drug, and Cosmetic Act of 1938 Response to manufactured drugs that were more powerful and potentially dangerous Created the FDA Required drug makers to –File new drug applications (NDAs) –Prove that the product was safe for human use –Conduct studies and submit results Required drugs to be safe, but not necessarily effective

11. © Paradigm Publishing, Inc. 11 Food, Drug, and Cosmetic Act of 1938 The Act expanded the definitions of adulterated and misbranded drugs.

12. © Paradigm Publishing, Inc. 12 Terms to Remember Controlled Substances Act (CSA) laws created to combat and control drug abuse controlled substance a drug with potential for abuse; organized into five schedules that specify the way the drug must be stored, dispensed, recorded, and inventoried

13. © Paradigm Publishing, Inc. 13 Poison Prevention Packaging Act of 1970 Passed to prevent accidental childhood poisonings Applies to both prescription and OTC drugs Requires child-resistant containers that –Cannot be opened by 80% of children –Can be opened by 90% of adults

14. © Paradigm Publishing, Inc. 14 Poison Prevention Packaging Act of 1970 The Act allows some drugs to be dispensed in non- childproof packages.

15. © Paradigm Publishing, Inc. 15 Drug Listing Act of 1972 Gives FDA authority to compile a list of currently marketed drugs Each drug given unique National Drug Code (NDC) Allows FDA to maintain a database of drugs by –Use –Manufacturer –Active ingredients

16. © Paradigm Publishing, Inc. 16 Terms to Remember brand name the name under which the manufacturer markets a drug; also known as the trade name

17. © Paradigm Publishing, Inc. 17 Terms to Remember generic name a common name that is given to a drug regardless of brand name; sometimes denotes a drug that is not protected by a trademark; for example, acetaminophen is the generic drug name for Tylenol

18. © Paradigm Publishing, Inc. 18 Drug Price Competition and Patent- Term Restoration Act of 1984 Was a response to pressure to reduce drug costs Encouraged the creation of generic drugs Extended patent licenses to allow manufactures to recoup research and development costs

19. © Paradigm Publishing, Inc. 19 Drug Price Competition and Patent- Term Restoration Act of 1984 Generics are comparable to brand name drugs in –Dosage form –Safety –Strength –Quality –Performance Generics must demonstrate bioequivalence to brand name product. Over 60% of prescriptions in community pharmacies are filled with generics.

20. © Paradigm Publishing, Inc. 20 Health Insurance Portability and Accountability Act of 1996 HIPAA has wide-ranging provisions. For pharmacies, impact is mostly on confidentiality of patient records: –Must document and provide to patient information on how health information is safeguarded –Must have an employee training program with yearly renewals

21. © Paradigm Publishing, Inc. 21 Food and Drug Administration Modernization Act Passed to update labeling on prescription medications Authorizes new drug application (NDA) fees which are used by FDA to accelerate review of new drugs

22. © Paradigm Publishing, Inc. 22 Medicare Prescription Drug, Improvement, and Modernization Act of 2003 Better known as Medicare Part D Provides prescription drug coverage to patients eligible for Medicare –Voluntary program –Patients pay an extra premium –Usually have a deductible Also established health/savings accounts (HSAs)

23. © Paradigm Publishing, Inc. 23 Combat Methamphetamine Epidemic Act of 2005 Methamphetamine –Highly addictive stimulant –Made from OTC products Restricts the availability of products used to make it: –Pseudoephedrine –Phenylpropanolamine –Ephedrine Products must be stored “behind the counter” and purchases must be documented.

24. © Paradigm Publishing, Inc. 24 Terms to Remember Food and Drug Administration (FDA) the agency of the federal government that is responsible for ensuring the safety and efficacy of food and drugs prepared for the market

25. © Paradigm Publishing, Inc. 25 Food and Drug Administration (FDA) Primary responsibility and authority to enforce the law No legal authority over the practice of pharmacy in each state FDA activities –Requires manufactures to file applications for investigative studies and drug approvals –Provides guidelines for packaging and advertisement –Oversees the recall of dangerous products –Produces annual Orange Book reference

26. © Paradigm Publishing, Inc. 26 Drug Enforcement Administration (DEA) Most of its effort spent on illegal drug trafficking, but also supervises legal use of controlled substances Inspects medical facilities and pharmacies; usually just those where suspicious activity has been detected Maintains an audit trail of narcotics from manufacturer to warehouse to pharmacy to patient

27. © Paradigm Publishing, Inc. 27 Drug Enforcement Administration (DEA) CSA defines who may prescribe controlled substances. Prescriptions must be written for a legitimate reason related to the physician’s practice (e.g., dentist can prescribe narcotics for dental pain but not for back pain). Except for emergencies, prescription must be written rather than phoned or faxed.

28. © Paradigm Publishing, Inc. 28 Occupational Safety and Health Administration (OSHA) Ensures the safety and health of US workers OSHA’s role in pharmacies, hospitals, and home health care is to –Protect against inadvertent needle sticks –Ensure safe disposal of syringes –Oversee policies to protect employees from unnecessary drug exposures

29. © Paradigm Publishing, Inc. 29 National Association of Boards of Pharmacy (NABP) Has no regulatory authority Primary role is to develop national pharmacist license examination Coordinates reciprocation of pharmacists practicing in other states Provides guidance to state boards of pharmacy Developed Model State Pharmacy Practices Act for national continuity

30. © Paradigm Publishing, Inc. 30 State Boards of Pharmacy Consist of leaders from the pharmacy community and also consumer members Review applications and administer examinations developed by NABP Maintain a database of active pharmacists Inspect all new pharmacies Provide regulations regarding refilling of prescriptions

31. © Paradigm Publishing, Inc. 31 Legal Duties of Pharmacy Personnel Role of the pharmacy tech –Not defined by federal statute –Not uniformly defined from state to state –Constantly changing Some states limit the ratio of pharmacy techs to pharmacists.

32. © Paradigm Publishing, Inc. 32 Legal Duties of Pharmacy Personnel Duties not required to be done by pharmacists may be carried out by the pharmacy technician. All technicians’ duties must be carried out under the direct supervision of the pharmacist.

33. © Paradigm Publishing, Inc. 33 Duties Typically Performed by Pharmacy Technicians Preparing Doses of Extemporaneously Compounded, Sterile Medications –retrieving medications from shelf or supply cabinet –selecting equipment for the compounding operation –using aseptic equipment and procedures –weighing and measuring –admixing parenteral products –preparing labels –selecting containers –packaging –maintaining and filing records of extemporaneous compounding –cleaning area and equipment (See Table 2.6)

34. © Paradigm Publishing, Inc. 34 Duties Typically Performed by Pharmacy Technicians Transporting Medications to and from floors/units –preparing cart, tray, or other means of conveyance –delivering controlled drugs –maintaining delivery records –distributing medications to wards –organizing medications for administration to patients –retrieving, reconciling, and recording credit for medications not administered –returning unused medications to unit dose bins and injectables to stock (See Table 2.6)

35. © Paradigm Publishing, Inc. 35 Violation of Laws and Regulations Civil laws Torts Law of agency and contracts

36. © Paradigm Publishing, Inc. 36 Violation of Laws and Regulations Plaintiff must prove his or her case – burden of proof. Punishments may include –Fines –Probation –Incarceration Licensed healthcare providers may have licenses revoked.

37. © Paradigm Publishing, Inc. 37 Civil Laws Concern wrongs against another citizen, but not necessarily against local, state, or federal law Derived from English common law Defendant may face both civil and criminal proceedings for the same act

38. © Paradigm Publishing, Inc. 38 Torts A tort refers to personal injuries. Governments (local, state, federal) do not take part in these lawsuits. Examples of torts include –Broken contracts –Negligence –Malpractice –Slander

39. © Paradigm Publishing, Inc. 39 Terms to Remember malpractice a form of negligence in which the standard of care was not met and was a direct cause of injury standard of care the usual and customary level of practice in the community

40. © Paradigm Publishing, Inc. 40 Terms to Remember law of agency and contracts the general principle that allows an employee to enter into contracts on the employer’s behalf

41. © Paradigm Publishing, Inc. 41 Professional Organizations Mission statements are to set high standards and advance practice of pharmacy Seek to provide a standard of care beyond the minimum required by law

42. © Paradigm Publishing, Inc. 42 Professional Organizations Set standards for –Postgraduate residency training American Pharmacists Association (APhA) American Society of Health-System Pharmacists (ASHP) American Society of Consulting Pharmacists (ASCP) –Online electronic billing National Council for Prescription Drug Programs (NCPDP) –Certification in specialty areas National Institute for Standards in Pharmacist Credentialing (NISPC) –Internet pharmacies Verified Internet Pharmacy Practice Sites (VIPPS)

43. © Paradigm Publishing, Inc. 43 Professional Organizations Professional organizations for pharmacy techs focus on certification and acquisition of advanced knowledge and skills: –Pharmacy Technician Certification Board (PTCB) –Institute for Certification of Pharmacy Technicians (ICPT)