Chapter 2

1. Pharmacy Federal Laws and Regulations Chapter 2

2. Introduction Practice of pharmacy is governed by series of laws, regulations, and rules enforced by federal, state, local government; institutions and pharmacy management. Technicians need to understand these laws for passing the PTCB Certification Exam and for employment.

3. FDA History FDA history is important with respect to pharmacy. FDA is under the direction of the department of Health and Human Services. Main function is to enforce guidelines for manufacturers to ensure the safety and effectiveness of medications.

4. Early History of the FDA Investigated the adulteration and misbranding of agriculture goods used for food and drugs. Ability to regulate and enforce was limited. In the 1930s, the FDA gained the right to inspect factories and the control advertising of products.

5. Food, Drug and Cosmetic Act prohibits misbranding and adulteration and ensures following information given to public: Mandatory food labeling Standards of Identity Imitation foods Nutritional information for special dietary foods False or misleading statements about product Early History of the FDA (cont’d)

6. Early History of the FDA (cont’d) Durham-Humphrey Amendment made a distinction between prescription and over-the-counter drugs. Kefauver-Harris Drug Amendments ensured the safety and effectiveness of medications.

7. Early History of the FDA (cont’d) • 1976 Medical Device Amendments allows FDA to: • Regulate and approve devices • Recall ineffective/dangerous devices • Orphan Drug Act created expanded research and availability of new treatments.

8. Description of Laws Act: “A statutory plan passed by Congress or any legislature which is a ‘bill’ until enacted and becomes law” Amendment: A change in the original act or law

9. Enacted to stop the sale of inaccurately labeled drugs. Manufacturers were required to put truthful information on the label before selling their drug. Manufacturers had to prove their drug’s effectiveness. 1906 Federal Food and Drug Act

10. 1914 Harrison Narcotic Act Enacted because of the excessive number of opium addicts in the United States. People could no longer obtain opium without a prescription. Records must be kept about prescriptions. Restrictions are in place for importation and distribution.

11. 1938 Food, Drug, and Cosmetic Act Was enacted because the earlier Food and Drug Act was not worded strictly enough and did not include cosmetics. Required drug companies to include directions to the consumer regarding use and package inserts on drugs. All controlled substances were required to be labeled “Warning: May be habit-forming”.

12. Defined the exact labeling for products and defined misbranding and adulteration as being illegal Proves the legal status for the Food and Drug Administration (FDA) 1938 Food, Drug, and Cosmetic Act (cont’d)

13. 1951 Durham-Humphrey Amendment Required the labeling “Caution: Federal law prohibits dispensing without a prescription.” Made certain drugs require a doctor’s order and supervision. Made the initial distinction between legend drugs (by prescription only), over-the-counter (OTC) medications, and non-legend drugs.

14. 1962 Kefauver-Harris Amendments Enacted in an attempt to ensure the safety and effectiveness of all new drugs on the market. Burden put on manufacturing companies to have good manufacturing practices (GMP). Prevented the sale of thalidomide in the United States because children were born with birth defects after usage in pregnancy.

15. 1970 Comprehensive Drug Abuse Prevention and Control Act The Drug Enforcement Agency (DEA) was formed to enforce the laws concerning controlled substances and their distribution. Created a stair-step schedule of controlled substances.

16. 1970 The Poison Prevention Packaging Act Required all medications to be placed in containers with childproof caps or packaging.

17. Tylenol Poisoning 1982 • Tylenol Extra Strength capsules were emptied and replaced with powdered cyanide. • Seven people were killed. • Case was never solved. • Johnson and Johnson ordered public to immediately stop using TES and medication was pulled of store shelves. • JJ started using the plastic covers “DO NOT USE IF TAMPERED WITH.” • JJ also developed the “caplet” to help relieve concerns.

18. Orphan Drug Act of 1983 The Orphan Drug Act allowed drug companies to bypass the lengthy time requirements of testing a new drug and the cost that accompanied them to provide a medication to persons who had rare disease(s) (disease that affected 1 in every 200,000 people).

19. 1987 Prescription Drug Marketing Act Helps to avoid counterfeit drugs and ingredients in the supply chain. Limits diversion of pharmaceutical samples and prescription drugs.

20. 1990 Omnibus Budget Reconciliation Act (OBRA 90) OBRA 90 deals specifically with practicing pharmacists. Enacted because of reimbursement regulations for people who are covered under Medicaid or Medicare insurance. States that a pharmacist must counsel (at the time of purchase) all patients who receive new prescriptions.

21. 1990 Omnibus Budget Reconciliation Act (cont’d) All patients must be given information on the drug that they are taking, its name, when to take it, how long to take it, and any side effects or possible interactions. Many states adopted OBRA to apply to all new prescriptions; federal law deals only with Medicare and Medicaid.

22. Health Insurance Portability and Accountability Act of 1996 (HIPAA) HIPAA deals with patient’s right to continuance of health insurance even when changing employers Changes for pharmacy: technician has direct knowledge of patient’s medical information on a daily basis, so patients sign a consent form to grant access to this information.

23. Patient Confidentiality Keeps privileged information about a customer from being disclosed without his or her consent. Changes have been made throughout all medical facilities and medical information centers that limit access to patient information.

24. What Information is Protected? All individually identifiable health information is protected. Pertains to information in any form or media.

25. What Does this Mean for the Pharmacy? The physician can call and request information on his/her patient. The patient’s health insurance company can request information. Information can be shared with patients about their own coverage or medications.

26. How is Information Protected via the Computer? • Encryption converts the information into a nonreadable format. • Must be approved by the National Institute of Standards and Technologies.

27. What are the Rights of the Patient? Ask to see and get a copy of your health records. Have corrections added to your health information. Receive a notice that tells you how your health information may be used and shared. Elaine being difficult

28. What are the Rights of the Patient? (cont’d) Decide if you want to give your permission before your health information can be used or shared for certain purposes, such as for marketing. Get a report on when and why your health information was shared for certain purposes.

29. What are the Rights of the Patient? (cont’d) • If you believe your rights are being denied or your health information isn’t being protected, you can: • File a complaint with your provider or health insurer. • File a complaint with the U.S. Government.

30. Examples of what a Technician cannot Do Give out any personal or medical information pertaining to the patient to any entity not covered under HIPPA Share any information with any family member or friend, coworker, manager, or any entity not covered under HIPAA Box 2-3

31. Examples of what is not Covered under the HIPAA Patient Rights If you work for a health plan or covered healthcare provider, the Privacy Rule does not apply to your employment records. news cast

32. Public Health Activities • PHI may be disclosed to: • Public health authorities • Entities subject to FDA regulation • Those who have been exposed to a communicable disease • Employers regarding work-related illness/injury in order to comply with OSHA

33. Law Enforcement Purposes • PHI may be disclosed to law enforcement, including: • As required by law, such as court orders • To identify or locate a suspect, fugitive, material witness, or missing person • Information about a victim • If criminal activity caused a victim’s death

34. 2000 Drug Addiction Treatment Act (Data 2000) • Physicians can prescribe controlled substances to persons suffering from opioid addiction. • For the purpose of maintenance or detoxification treatments. Methadone on the brain

35. 2003 Medicare Modernization Act (MMA) MMA provides a drug discount card to those with low incomes who require pharmacy company assistance for obtaining medications.

36. 2005 Combat Meth Act Bill addresses all areas of manufacturing, law enforcement, and sale of pseudoephedrine, which is used as an ingredient in the preparation of methamphetamine. Strict guidelines: only a licensed pharmacist or technician may dispense, sell, or distribute this drug. Nplex

37. FDA/DEA DEA was created under the Department of Justice. Its function is to prevent the illegal distribution and misuse of narcotics. The DEA issues licenses to practitioners, pharmacies, and manufacturers of controlled substances.

38. FDA Reporting Process and Adverse Reactions There is toll-free number (1-800-FDA-1088) for reporting any defect found in OTC medications and any other drug problems. Any medication reaction that might cause disability, hospitalization, or death should be reported. Patient’s identity must be kept confidential.

39. MedWatch: program under the FDA that allows consumers and healthcare professionals to report any discrepancies in medication or adverse reactions to medications. See Figure 2-3. FDA Reporting Process and Adverse Reactions (cont’d)

40. Recalled Drugs • Three classes of recalls: • Class 1: Products that could cause serious or even fatal harm • Class 2: Products found to cause a temporary health problem or a slight threat of serious harm • Class 3: Products that may have a minor defect or other condition that would not harm the patient

41. Controlled Substances Are commonly known as narcotics and are addictive. Narcotics are derived from opium or opium-like substances. Opium comes from the poppy seed plant and has analgesic effects and also affects mood and behavior.

42. Controlled Substances (cont’d) Opioids, such as codeine and morphine, are substances created from opium. Each type of narcotic is assigned a rating that depends on its addiction and abuse potential.

43. Ratings of Scheduled (Controlled) Substances Letter “C,” meaning controlled substances, is used in addition to Roman numerals to indicate the addictiveness or abuse potential of narcotics. Are five levels based on potential for abuse. C-I: strongest potential for abuse; no medicinal use in the United States (e.g., LSD, heroin)

44. Ratings of Schedules (Controlled) Substances (cont’d) C-II, C-III, C-IV, C-V: all medicinal narcotic drugs C-V: kept OTC in some states because of low potential abuse C-II: must be locked up because of high potential abuse Attorney General decides under which schedule to place a drug Refer to Table 2-2, Typical Controlled Substances.

45. Tamper-Proof Prescriptions • New scripts have up to 8 different tamper-proof security marks on them. • Prevents forgery and fraud. • Different types of prescription security

46. Registration Required for Maintaining Narcotics DEA—three main registration forms: Form 224: needed by pharmacy to dispense controlled substances Form 225: to manufacture or distribute controlled substances Form 363: to run a narcotic treatment program or compound narcotics

47. Refilling Controlled Substances Strict guidelines C-III through C-V: can be refilled a maximum of five times or within 6 months from the original order, whichever comes first. Record must be kept with pharmacist’s initials and date it was dispensed.

48. Ordering Controlled Substances Pharmacy obtains C-II substances from a distributor Form 222 must be filled out by the receiving pharmacy in pen, typewriter, or indelible pencil Top copy and middle copy with carbon paper are sent to the supplier or manufacturer

49. Top and middle copy with carbon paper: returned to distributor or wholesaler Filing electronically is also possible but not for CI or CII Pharmacy retains bottom copy Invoice and form retained for 7 years Ordering Controlled Substances (cont’d)

50. C-III, C-IV, C-V: ordered on normal invoice forms but must be filed and retained for DEA or BOP inspection Should be kept separate from other nonscheduled drugs Forms kept for 2 years Ordering Controlled Substances (cont’d)