1. Drug Regulation and the ATC

2. Drug Legislation in the US Federal Food, Drug, & Cosmetic Act of 1906 Federal Food, Drug, & Cosmetic Act of 1906 Food, Drug, and Cosmetic Act of 1938 Food, Drug, and Cosmetic Act of 1938 Durham-Humphrey Amendment of 1952 Durham-Humphrey Amendment of 1952 Kefauver-Harris Amendment of 1962 Kefauver-Harris Amendment of 1962 Controlled Substance Act (Comprehensive Drug Abuse Prevention Act of 1970) Controlled Substance Act (Comprehensive Drug Abuse Prevention Act of 1970) Poison Prevention Packaging Act of 1970 Poison Prevention Packaging Act of 1970 Medical Device Act of 1976 Medical Device Act of 1976 Federal Tampering Act of 1983 Federal Tampering Act of 1983

3. Legislation …. (cont) Fair Packaging and Labeling Act (1983) Fair Packaging and Labeling Act (1983) Drug Price Competition and Patent Time Restoration Act of 1984 Drug Price Competition and Patent Time Restoration Act of 1984 Prescription Drug Marketing Act of 1987 Prescription Drug Marketing Act of 1987 Anti-Drug Abuse Act of 1988 Anti-Drug Abuse Act of 1988 Omnibus Reconciliation Act of 1990 (OBRA) Omnibus Reconciliation Act of 1990 (OBRA) Dietary Supplements Health and Education Act of 1994 Dietary Supplements Health and Education Act of 1994

4. Food & Drug Administration FDAs definition of a drug…. FDAs definition of a drug…. Responsibilities Responsibilities oversee production, labeling, & distribution of medicines, cosmetics, & foods oversee production, labeling, & distribution of medicines, cosmetics, & foods monitor the use of existing drugs monitor the use of existing drugs oversee development of new drugs oversee development of new drugs monitor safety of drugs - existing & new monitor safety of drugs - existing & new monitor effectiveness of drugs monitor effectiveness of drugs Drug Enforcement Agency (DEA) Drug Enforcement Agency (DEA) concerned with controlled substances only; enforce laws relating to illegal drugs concerned with controlled substances only; enforce laws relating to illegal drugs

5. Controlled Substances Schedule 1 Schedule 1 Schedule 2 Schedule 2 Schedule 3 Schedule 3 Schedule 4 Schedule 4 Schedule 5 Schedule 5

6. Phases of Drug Development Preclinical Preclinical Phase I Phase I Phase II Phase II Phase III Phase III Submission of NDA Submission of NDA Phase IV Phase IV Phase V Phase V

7. Clinical Trials Human Guinea Pig Human Guinea Pig CenterWatch Clinical Trials Listing - http://www.centerwatch.com/main.htm CenterWatch Clinical Trials Listing - http://www.centerwatch.com/main.htm CenterWatch Clinical Trials Listing CenterWatch Clinical Trials Listing www.clinicaltrials.com www.clinicaltrials.com www.clinicaltrials.com www.clinicaltrials.gov www.clinicaltrials.gov www.clinicaltrials.gov

8. Prescription Medications Dispensed in limited amounts by R.Ph. on order of MD Designed to protect consumer

9. Info on a Prescription Patients name Patients name Date Date Name of drug and strength Name of drug and strength Amount prescribed Amount prescribed Number of refills Number of refills Directions for use Directions for use DEA # DEA # Other info Other info

11. Name, Address & Phone No. of Dr. Patients Name & Address Date Name of Drug & Strength Amount Directions for use No. of refills DEA No. Doctors Signature

12. Prescription Label Patient name and address Prescribers name Drug name Pharmacy name and date filled Special Precautions/ Instructions

13. Misuse of Prescription Medications Taking too much or too little Taking too much or too little D/C usage before finished w/meds D/C usage before finished w/meds Sharing medications Sharing medications Taking other medicines Taking other medicines

14. Precautions for Prescription Meds Tell physician of previous problems/allergies Tell physician of previous problems/allergies Keep list of ALL meds. currently using Keep list of ALL meds. currently using Understand directions Understand directions Discuss side effects / Interactions Discuss side effects / Interactions Store properly Store properly Never take drugs in the dark Never take drugs in the dark Flush old drugs Flush old drugs Keep in labeled containers Keep in labeled containers Dont use expired medicines Dont use expired medicines

15. Pros & Cons of Advertising Prescription Medicines

16. Over-the-Counter Drugs No prescription required No prescription required Weaker, but those newly classified…. Weaker, but those newly classified…. Provide symptomatic relief - not underlying cause Provide symptomatic relief - not underlying cause FDA Guidelines FDA Guidelines must be safe and effective must be safe and effective no harmful side effects when used properly no harmful side effects when used properly not habit forming not habit forming does not require professional expertise does not require professional expertise Pros & Cons of Prescription Medicines Moving to OTC Status?

17. OTC Labels Statement of identity Statement of identity Active ingredients & amount Active ingredients & amount Net quantity of contents Net quantity of contents Name & Address of Manufact./Distrib. Name & Address of Manufact./Distrib. Indications for use Indications for use Directions for use / Dosage information Directions for use / Dosage information Warnings - contra- indications Cautionary statements Drug interaction precautions Expiration Date / Lot No.

18. Product Name Identity Quantity Manufacturer Warnings/Caution Statement Indications Dosage/Directions Lot No. Expire Date Active Ingred. & Amount

19. Safe Use of OTC Read label carefully Read label carefully Length of use Length of use Dosage Dosage Side effects / Adverse reaction / Interactions Side effects / Adverse reaction / Interactions Storage Storage Disposal Disposal Look-alikes Look-alikes Dont expect a miracle Self - Care

20. Activity: Analyze a OTC Label Everyone brings a OTC medication in original package to class Everyone brings a OTC medication in original package to class Analyze youre your label Analyze youre your label Swap with classmates and analyze 2 others OTC meds Swap with classmates and analyze 2 others OTC meds

21. Nutraceuticals Vitamins and dietary supplements Vitamins and dietary supplements Vague claims allow no FDA testing Vague claims allow no FDA testing Drug-like effects Drug-like effects Safe…. Effective….? Safe…. Effective….? Purity Purity + drug tests + drug tests Interactions w/ other drugs Interactions w/ other drugs

22. Drug Names Chemical Name Chemical Name describes chemical structure describes chemical structure Generic Name Generic Name shortened form of chemical name; assigned during testing shortened form of chemical name; assigned during testing Brand Name Brand Name patented patented Chemically Equivalent Drug Chemically Equivalent Drug same active ingredient as brand name drug same active ingredient as brand name drug Bioequivalence (Therapeutically equivalent) Bioequivalence (Therapeutically equivalent) same action, dissolution, etc. as brand name drug same action, dissolution, etc. as brand name drug

23. Orphan Drugs Orphan Drugs drugs developed to treat rare disorders drugs developed to treat rare disorders approved more quickly approved more quickly incentives for drug companies incentives for drug companies Experimental Drugs Experimental Drugs American companies sell drugs in foreign countries before gain approval in U.S. American companies sell drugs in foreign countries before gain approval in U.S. Approval for OTC drugs Approval for OTC drugs must meet standards for category must meet standards for category

24. Minimum guidelines for handling drugs in the training room Locked cabinet Locked cabinet Discard expired meds Discard expired meds Record Record Athlete Athlete Medication Medication Dose Dose Date Date Initials Initials Review patient info Review patient info

25. Storing Meds In Training Room – locked cabinet No sharing Most stored at room temp Not in the bathroom Observe the shelf life / expiration dates Discard meds w/out labels / Flush down toilet

26. Single ingredient products vs. Combination products

27. Transportation of Medications Athletes carry own meds, in carry-on Athletes carry own meds, in carry-on Original containers Original containers If you need a refill while traveling (in US) If you need a refill while traveling (in US) If athlete injured at away competition If athlete injured at away competition Fill controlled substances before you leave Fill controlled substances before you leave Take enough when traveling abroad Take enough when traveling abroad Aerosol cans Aerosol cans

28. When traveling also …. Bring Bring Insurance card Insurance card Medical history Medical history Enough prescription med Enough prescription med Banned drug list Banned drug list Syringes? Syringes? Be wary of supplements and foreign meds Be wary of supplements and foreign meds

29. Medical Kit Locked - not accessible w/out approval Locked - not accessible w/out approval Contents Contents Nonprescription pain killer Nonprescription pain killer Local anesthetic Local anesthetic Topical pain reliever Topical pain reliever Antiseptic ointment Antiseptic ointment Antibiotic ointment Antibiotic ointment Antifungal agent Antifungal agent

30. Guidelines for Use of Therapeutic Medications

31. Guidelines… ATCs dispense?….administer? ATCs dispense?….administer? Prescription drugs? Prescription drugs? OTCs? OTCs? In Colleges vs. High Schools….? In Colleges vs. High Schools….? Allergic? Allergic? Directions for use? Directions for use? Recordkeeping? Recordkeeping? Follow up? Follow up? Overdose Overdose Other notes Other notes

32. More Guidelines…. Take as directed Take as directed No combination No combination Labels Labels Full glass of water Full glass of water Food? Food? Childproof containers Childproof containers State Laws State Laws Banned Substance? Banned Substance? Read label Dose schedule No sharing Interactions? Side Effects

33. Information on Medicines Physician Desk Reference (PDR) Physician Desk Reference (PDR) Drug Handbook for Health Professionals Drug Handbook for Health Professionals Nurses Drug Handbook Nurses Drug Handbook Drug Information Database - http://pharminfo.com/drg_mnu.html Drug Information Database - http://pharminfo.com/drg_mnu.html Drug Information Database http://pharminfo.com/drg_mnu.html Drug Information Database http://pharminfo.com/drg_mnu.html www.fda.gov www.fda.gov www.fda.gov