Transcript Drug Regulation
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