1. Pharmacy Agencies Drug Development and Control Health Science Pharmacy Technician Virginia Parker

2. FDA Part of the Department of Health and Human Services Enforces the Food, Drug and Cosmetic Act with guidelines for manufacturers to ensure safety and effectiveness of medications.

3. New Drug Approval All drugs domestic or imported must have FDA approval Drugs must be shown safe and effective with benefits that outweigh its risks The drug company must provide this proof – current process takes up to 14 years Why do you think it takes so long?? Do you think this makes drugs more expensive???

4. New Drug Approval Potentially beneficial compound discovered; patent filed Proof then begins with extensive laboratory testing Then moves to animal trials Then to clinical trials on people How do you feel about using animals for testing?? Video clip – From Molecule to Medicine

5. Clinical Trials in Humans Phase 1 : 20-100 healthy patients; several months; mainly to establish safety. Phase 2 : several hundred patients; several months to 2 years; short term safety but mainly effectiveness Phase 3 : several hundred to several thousand patients; 1-4 years; safety, dosage and effectiveness. Only about 25% of drugs tested make it through all 3 phases.

6. Clinical Trials in Humans Post approval monitoring continues with collection of information about safety, effectiveness and uses and is sometimes called “Phase 4”. Video clip: Intro Drug Development

7. Clinical Trials Called “investigational new drug” or IND during trial phases. Two groups are in trial Treatment group – actually receive drug Control group – receive a placebo “inactive substance given in place of a medication“, a different drug or no drug at all Studies are “blind” – subjects do not know if they are getting med or not – may be “double blind” means subjects and physicians do not know which are receiving drug. Why????

8. Clinical Trials - Ethics Trial subjects must give informed consent before participating in a study. This means they will have risks, benefits and other treatment options explained to them in a language they can understand and then they voluntarily consent to participate in the study. Subjects may leave trials at any time they wish, and no study may be conducted or continued that knowingly causes or allows harm to come to participants. Do you know what the Tuskegee Syphilis study involved??? Do you know where a huge amount of drug trials are being done today?? Video Clips

9. Clinical Trials Children are not included in trials until drugs have been fully tested on adults. If a drug has not been tested on children, the label will indicate safety and effectiveness have not been established in children Pediatric Labeling Rule – requires all drugs that could be used for children have pediatric (child) dosing and safety information on their labels.

10. Brand vs. Generic When a drug is created/discovered - a drug company is given a patent – which means they have the exclusive rights to market a drug for a specific period of time under a brand name that belongs only to the company. This exclusive marketing is for the company to recover costs of research and development. 20 years are allowed from drug discovery to patent expiration. The Hatch-Waxman Act of 1984 allowed for up to 5 year extensions on patents since it took so long to get drugs through FDA process.

11. Brand vs. Generic Once a patent expires, other manufacturers may copy the drug and release it under it’s pharmaceutical or “generic” name that all drugs are assigned at their development. The generic name does not belong to any particular company. Do you think brand and generic drugs work the same??? More on this later….

12. Reporting To FDA The FDA has a 1-800-FDA-1088 number and/or website to report any problems with OTC or prescription drugs. You are expected to report any defects, problems with product packaging or labeling, suspected contamination, defective components, questionable stability.

13. Reporting to the FDA You are also expected to report adverse reactions. Adverse drug reactions are unexpected reactions to a medication, may be mild to life-threatening such as an allergic reaction.

14. MedWatch A program from the FDA that allows consumers and health care professionals to report discrepancies or adverse reactions with medications. Forms are found in PDR, Drug Facts and Comparisons and on- line @ FDA website

15. Drug Recalls FDA will require manufacturers to recall items that have been found to be defective or somehow tainted. Pharmacies will have recall forms and drugs should be pulled from the shelves following manufacturers instructions.

16. Drug Recall Classes Class 1: The highest level of recall dealing with products that could cause serious or even fatal harm. Class 2: The next level with products that could cause serious but reversible harm Class 3: Minor defect or other condition that would not harm patient but drugs cannot be resold.

17. Drug Withdrawals If during “Phase 4” monitoring a drug is found to have more risk than benefit, it may be withdrawn from the market. This may be done voluntarily by manufacturer or required by the FDA

18. Drug Shortages Shortages of critical medications and/or IV fluids may occur because the FDA stops production by a company for safety violations, because there is a major increase in consumption, or because a company decides to stop making a particular product decreasing its supply in the marketplace. The FDA addressed the second issue by requiring all manufacturers to notify the FDA in advance of impending interruptions or termination of production. However, many products still end up in short supply due to other manufacturers not being able to “pick up the slack” due to the specialized nature of making sterile products. This requirement was part of the 2012 FDA Safety and Innovation Act (FDASIA).

19. Package Inserts (Monographs) Part of FDA labeling requirements Are contained in reference book PDR – Physician’s Desk Reference Use for prescribing information by providers

20. Package Inserts Information contained: Description of med including chemical structure Clinical Pharmacology that includes action, interactions Indications and usage – what this drug is used to prevent or treat. Often side effects of drugs are used to treat some diseases.

21. Package Inserts Information contained: Contraindications – reasons why a person should not take a given drug Warnings – serious side effects Precautions – “Do not drink alcohol with this drug”, etc. Drug Abuse and Dependence Adverse Reactions

22. Package Inserts Information contained: Dosage – strength, time, interval How Supplied – Dosage forms, strengths available, special precautions for storage such as protect from light or refrigerate Special Labeling – info on possible genetic harm to fetus (teratogenic)

23. Medication Guides Some drugs that require more involved information and/or monitoring to ensure safe use may require the patient to receive a medication guide each time they fill a prescription for the drug. This is a plain language information sheet about the drugs action, potential problems and safe use guidelines.

24. REMS – Risk Evaluation and Mitigation Strategy A strategy to manage a known or potential serious risk associated with a drug or biological product. Will be required if the FDA determines that a REMS is necessary to ensure the benefits of the drug or biological product outweigh its risks. Can include a Medication Guide, Patient Package Insert, a communication plan, elements to assure safe use, and an implementation system.

25. Drug Labeling See handout regarding reading labels NDC number – 3 sets of numbers 1 st set of numbers indicates manufacturer 2 nd set of numbers indicates medication, strength and dosage form 3 rd set of numbers indicates package size

26. Drug Labeling A medication label must contain the drug’s expiration date – Exp. 1/2017 would mean expires last day of January, 2017. A medication label will give warnings, instructions for safe storage. A label will list the drug manufacturer and lot number of drug for recalls.

27. Drug Labeling Black box warning an alert that appears on the package insert and/or package for certain prescription drugs. The U.S. FDA can require a pharmaceutical company to place a boxed warning on the labeling of a prescription drug, or in literature describing it. It is the strongest warning that the FDA requires, and signifies that medical studies indicate that the drug carries a significant risk of serious or even life- threatening adverse reactions.

28. USP United States Pharmacopoeia – non-profit agency that establishes standards for drug and related product manufacture and distribution in the US. These standards are directly referred to by Federal and State laws and are published in the “United States Pharmacopoeia and the National Formulary”. Enforced by FDA.

29. DEA Drug Enforcement Administration Part of Department of Justice Prevent illegal distribution and use of controlled substances. Issues licenses to practitioners, pharmacies and manufacturing companies for controlled substances. Works with FDA to determine schedule ratings for new drugs.

30. JCAHO Joint Commission for Accreditation of Healthcare Organizations Voluntary accrediting agency that inspects hospitals and health care facilities to ensure they are meeting pre-set standards. Why should an outside agency inspect health care facilities???

31. CDC Centers of Disease Control Federal agency that deals with the control of disease, most often associated with communicable (infectious) diseases in US Main office in Atlanta, Georgia

32. OSHA Occupational Safety and Health Administration Federal agency that mandates guidelines and oversees regulation of workplace safety in the US