Drug Regulation and Control

1. Drug Regulation and Control Chapter 3

2. Chapter 3 Objectives • Understand the importance and role of drug regulation. • Knowledge of the history of drug regulation. • Understanding of the drug development and approval process. • Become familiar with the Behind-the Counter OTC Medications and regulations for dispensing them. • Knowledge of label and labeling requirements. • Knowledge of controlled substance schedules and requirements for handling controlled substances. • Understand the recall process. • Understand health care provider’s responsibilities under HIPAA.

3. Food and Drug Administration • The leading enforcement agency at the federal level for regulations concerning drug products.

4. Drug Enforcement Administration • The agency which controls the distribution of drugs that may be easily abused.

5. Drug Regulation – A Timeline • Food and Drug Act of 1906: • Prohibited interstate commerce in foods and drugs that have added inferior materials and misbranded drinks and drugs. • 1914 Harrison Tax Act: • In response to growing addiction to opiates and cocaine-containing medicines, the Harrison Tax Act established that manufacturers, pharmacists, importers, and physicians prescribing narcotics should be licensed and required to pay a tax. Timeline begins on page 30

6. Drug Regulation – A Timeline • 1938 Food, Drug and Cosmetic Act: • In response to the fatal poisoning of 107 people, primarily children, by an untested sulfanilamide concoction, this law requires new drugs to be safe before marketing.

7. 1951 Durham-Humphrey Amendment • October 26, 1951:The Durham-Humphrey Amendment is passed. The bill requires any drug that is habit-forming or potentially harmful to be dispensed under the supervision of a health practitioner as a prescription drug and must carry the statement, "Caution: Federal law prohibits dispensing without prescription." • Defines what drugs require a prescription

8. The Thalidomide Lesson • Sleeping pill developed in 1962 that was found to cause severe birth defects when used by pregnant women. • 1962 Kefauver-Harris Amendment • Requires drug manufacturers to provide proof of both safety and effectiveness before marketing a drug. • Now used as a safe and effective treatment for multiple myeloma, prostate cancer, and leprosy. User must under stand risks of taking this Rx.

9. Drug Regulation – A Timeline • 1970 Poison Prevention Packaging Act: • Requires child-proof packaging on all controlled and most prescription drugs dispensed by pharmacies. • 1970 Controlled Substances Act: • Classifies drugs that may be easily abused and restricts their distribution. Enforced by the DEA. • This law established that the DEA is part of the US Justice Department

10. Drug Regulation – A Timeline • 1983 Orphan Drug Act: • Provides incentives to promote research, approval, and marketing of drugs needed for the treatment of rare diseases • 1984 Drug Price Competition And Patent Term Restoration Act (Hatch-Waxman): • Extension of drug patent terms and quicker introduction of lower cost generic drugs • 1990 Anabolic Steroid Control Act: • Passed to address abuse of steroids in children

11. Drug Regulation – A Timeline • 1990 Omnibus Budget Reconciliation Act (OBRA): • Act Requires pharmacists counsel Medicaid patients regarding medication. • 1996 Health Insurance Portability and Accountability Act (HIPAA): • Provided broad and stringent regulations to protect patients’ privacy.

12. Bell Work 1/19, 1/20 • Which act provides incentives to promote research, approval, and marketing of drugs needed for the treatment of rare diseases? • Orphan Drug Act of 1983 • Which act requires drug manufacturers to provide proof of both safety and effectiveness before marketing a drug? • 1962 Kefauver-Harris Amendment

13. New Drug Approval • All new drugs, whether made domestically or imported, require FDA approval before they can be marketed in the United States. • Before it will be approved, a new drug must be shown to be both safe and effective by the manufacturer and that its benefits outweighs the risks. Page 32, 33

14. Clinical Trials • Extensive testing begins in the laboratory doing chemical analysis, animal testing and then clinical trials with people. Trial participants must give their informed consent. Children are only part of the trial after the drug has been fully tested on adults. • Proof that the drug is both safe and effective is based on results of clinical trials.

15. Testing Phases in Humans • Phase 1 20-100 patients Time: several months Purpose: mainly safety Phase 2 Up to several hundred patients Time: several months to two years Purpose: short-term safety but mainly effectiveness Phase 3 Several hundred to several thousand patients Time: one to four years Purpose: safety, dosage, and effectiveness Only about 25% of drugs tested in phase 1 successfully complete phase 3 and are approved for marketing.

16. Clinical Trial Phase • The proposed new drug is called an investigational new drug (IND). • Drug is only available to those in the trial, but sometimes it will be given to groups outside the trial who are critically ill. • Placebo drugs are often used. A placebo is an inactive substance given in place of a medication. • Trials are always “blind.” Patients are not told which group they are in.

17. Marketed Drugs • A patent for a new drug gives its manufacturer an exclusive right to market the drug for a specific period of time under a brand name. A drug patent is in effect for 17 years from the date of the drug’s discovery. • Once a patent expires, other manufacturers may copy the drug and release it under its pharmaceutical or “generic” name. Page 34 and 35

18. Marketed Drugs • Generic drugs must be pharmaceutically equivalent to the patented drug – it must have the same active ingredients, same dosage form, same route of administration, and same strength. And it must be therapeutically equivalent – that the body’s use of the drug is the same.

19. Bell 1/25 What is Med Watch? Why is generic ibuprofen the same as Motrin?

20. OTC Labels • Over-The-Counter (OTC) are drugs that do not require a prescription. • OTC medications are not without risks. Package inserts and labels are designed so the consumer can take them without medical advice. • The label should include: • The product name • Name & address of the manufacturer • List of all active and other ingredients • Amount of contents • Adequate warnings • Adequate directions for use

22. Behind-The-Counter OTC Meds • While most OTC medications are not kept behind the pharmacy counter, some are, even if a prescription is not required. • Combat Methamphetamine Epidemic Act (CMEA) Federal law that sets daily and monthly limits on OTC sale of pseudoephedrine and ephedrine. • Records of sales must be kept for 2 years • Exempt narcotics. (pg 37) • Emergency contraception Page 36, 37

23. Bell Work 1/24, 25 • Limits on the sale of pseudoephedrine are monitored _______ and _________. • Daily and monthly • Name two Behind the Counter OTC medications. • Plan B and pseudoephedrine

24. Prescription Drug Labels • Manufacturer Stock Label includes: • Generic and brand name • NDC number – National Drug Code • Manufacturer's name and address • Drug form • Package quantity • Warnings • Lot number and expiration date • Storage requirements • Dispensing container required • Active ingredients and strength Page 38, 39

25. Sample Labels

26. Bell Work 1/25, 1/26 • What is the generic name of this drug? • What is the dosage form? • What is the package quantity?

27. Controlled Substances • Controlled Substances Act of 1970 (CSA) established by US Congress, identifies 5 groups or schedules of drugs as controlled substances and put strict guidelines on their distribution. • This act also requires dispensers of these substances register with the DEA. Page 40, 41

28. The Five Schedules Are: • Schedule I – High potential for abuse and no accepted medical use in the US. • Heroin, some opium derivatives, and hallucinogenic substances • Schedule II – High potential for abuse and may lead to physical or psychological dependence, but also has a currently accepted medical use in the US. • Amphetamines, cocaine, methadone, and various opiates • Schedule III – Potential for abuse is less than those in Schedules I and II and there is a currently accepted medical use in the US, but abuse may lead to moderate or low physical dependence or high psychological dependence. • Anabolic steroids , compounds that contain codeine

29. The Five Schedules con’t • Schedule IV – Low potential for abuse relative to Schedule III and current accepted medical use in the US, but abuse may lead to limited physical dependence or psychological dependence. • Phenobarbital, sedative chloral hydrate, and some anesthetics • Schedule V – Low potential for abuse relative to Schedule IV and current accepted medical use in the US, but abuse may lead to limited physical dependence or psychological dependence. • Limited amounts of codeine included in this group • Exempt narcotics are in this group

30. In case you were wondering? Opiates and Opioids are drugs that are most commonly used for their euphoric and/or analgesic effects. Opiates are drugs that are derived from the Opium poppy plant. The term 'Opioid' is used to describe a compound that binds opioid receptors in the brain, and produces effects characteristic of naturally occurring opiates.

31. Opiate drug names. Some of the more well known semi-synthetics opiates, that is to say narcotic drugs, created from morphine, codeine and thebaine are heroin, hydrocodone, hydromorphone, oxycodone, oxymorphone, and there are many others.

32. Medical Marijuana Debate Medical marijuana is not approved by the FDA Federal law does not recognize the difference between medical and recreational use of the drug MM is treated like cocaine or heroin by the federal government and users can be imprisoned by federal drug enforcement agents

33. Public Safety The FDA process is thorough but it is impossible to fully prove that a drug is safe for use. To monitor this the FDA has a monitoring system called MedWatch. Prescribers are encouraged to voluntarily report any adverse effects by approved drugs. Page 44, 45

34. Recalls • Action to remove a drug from the market and are voluntary on the part of manufacturer • Class I – strong likelihood that the product will cause serious adverse effects or death • Class II – product may cause temporary but reversible adverse effects, little likelihood of serious adverse effect • Class III– the product is not likely to cause adverse effects

35. Law and the Technician • Federal law provides a foundation for state laws that govern pharmacy practice. • These laws guarantee patient rights including rights to privacy, confidentiality, right to file complaints, right for informed consent and the right to refuse treatment. Page 46, 47

36. Law and the Technician • State Law is responsible for licensing all prescribers and dispensers. • Many states have stricter regulations than federal law. • A few states allow pharmacists to prescribe under limited conditions. • States regulate pharmacy technician by holding the pharmacist responsible for the technicians performance.

37. Liability • Legal liability means you can be prosecuted for misconduct. • You can be guilty of misconduct by simply failing to do something you should have done. • You are liable even if you are directed to do something by your supervisor. • Misconduct is called negligence

38. Liability • Ways the pharmacy tech can be negligent: • Incorrectly labeling the prescription • Breaking confidentiality • Failing to recognize expired drugs • Calculation errors • Dispensing the wrong medication • Incorrect handling of a controlled substance • Inaccurate record keeping

39. Other standards ASHP – American Society of Health- System Pharmacists USP – United States Pharmacopeia JCAHO – Joint Commission on Accreditation of Health Care Organizations ASCP – The American Society for Consultant Pharmacists.