Drug Regulation

and the ATC

     

Drug Legislation in the US

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

Legislation ….

(con’t)       Fair Packaging and Labeling Act (1983) Drug Price Competition and Patent Time Restoration Act of 1984 Prescription Drug Marketing Act of 1987 Anti-Drug Abuse Act of 1988 Omnibus Reconciliation Act of 1990 (OBRA) Dietary Supplements Health and Education Act of 1994

Food & Drug Administration

  FDA’s definition of a drug….

Responsibilities     oversee production, labeling, & distribution of medicines, cosmetics, & foods monitor the use of existing drugs oversee development of new drugs monitor safety of drugs - existing & new  monitor effectiveness of drugs  Drug Enforcement Agency (DEA)  concerned with controlled substances only; enforce laws relating to illegal drugs

Controlled Substances

 Schedule 1  Schedule 2  Schedule 3  Schedule 4  Schedule 5

Phases of Drug Development

       Preclinical Phase I Phase II Phase III Submission of NDA Phase IV Phase V

Clinical Trials

    “Human Guinea Pig” CenterWatch Clinical Trials Listing http://www.centerwatch.com/main.htm

www.clinicaltrials.com

www.clinicaltrials.gov

Prescription Medications

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

Info on a Prescription

        Patient’s name Date Name of drug and strength Amount prescribed Number of refills Directions for use DEA # Other info

Name, Address & Phone No. of Dr

.

Patient’s Name & Address Date Amount Name of Drug & Strength Directions for use No. of refills DEA No

.

Doctor’s Signature

Prescription Label

     Patient name and address Prescriber’s name Drug name Pharmacy name and date filled Special Precautions/ Instructions

Misuse of Prescription Medications

    Taking too much or too little D/C usage before finished w/meds Sharing medications Taking other medicines

Precautions for Prescription Meds

         Tell physician of previous problems/allergies Keep list of ALL meds. currently using Understand directions Discuss side effects / Interactions Store properly Never take drugs in the dark Flush old drugs Keep in labeled containers Don’t use expired medicines

Pros & Cons of Advertising Prescription Medicines

Over-the-Counter Drugs

    No prescription required Weaker, but those newly classified….

Provide symptomatic relief - not underlying cause FDA Guidelines  must be safe and effective    no harmful side effects when used properly not habit forming does not require professional expertise Pros & Cons of Prescription Medicines Moving to OTC Status?

OTC Labels

      Statement of identity Active ingredients & amount Net quantity of contents Name & Address of Manufact./Distrib.

Indications for use Directions for use / Dosage information     Warnings - contra indications Cautionary statements Drug interaction precautions Expiration Date / Lot No.

Warnings/Caution Statement Product Name Quantity Expire Date Identity Dosage/Directions Lot No.

Active Ingred. & Amount Indications Manufacturer

Safe Use of OTC

       Read label carefully Length of use Dosage Side effects / Adverse reaction / Interactions Storage Disposal Look-alikes  Don’t expect a miracle  Self - Care

Activity: Analyze a OTC Label

   Everyone brings a OTC medication in original package to class Analyze you’re your label Swap with classmates and analyze 2 others OTC meds

Nutraceuticals

       Vitamins and dietary supplements Vague claims allow no FDA testing Drug-like effects Safe…. Effective….?

Purity + drug tests Interactions w/ other drugs

Drug Names

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

  Orphan Drugs   drugs developed to treat rare disorders approved more quickly  incentives for drug companies Experimental Drugs  American companies sell drugs in foreign countries before gain approval in U.S.

 Approval for OTC drugs  must meet standards for category

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

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

Single ingredient products vs. Combination products

Transportation of Medications

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

When traveling also ….

   Bring     Insurance card Medical history Enough prescription med Banned drug list Syringes?

Be wary of supplements and foreign meds

Medical Kit

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

Guidelines for Use of Therapeutic Medications

Guidelines…

        ATCs dispense?….administer?

  Prescription drugs?

OTC’s?

In Colleges vs. High Schools….?

Allergic?

Directions for use?

Recordkeeping?

Follow up?

Overdose Other notes

More Guidelines….

        Take as directed No combination Labels Full glass of water Food?

Childproof containers State Laws Banned Substance?

     Read label Dose schedule No sharing Interactions?

Side Effects

Information on Medicines

     Physician Desk Reference (PDR) Drug Handbook for Health Professionals Nurse’s Drug Handbook Drug Information Database http://pharminfo.com/drg_mnu.html

www.fda.gov