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
Name of Drug &
Strength
Amount
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 - contraindications
Cautionary
statements
Drug interaction
precautions
Expiration Date / Lot
No.
Warnings/Caution Statement
Product Name
Quantity
Expire
Date
Identity
Dosage/Directions
Lot No
Indications
Active Ingred. & Amount
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


Generic Name


patented
Chemically Equivalent Drug


shortened form of chemical name; assigned
during testing
Brand Name


describes chemical structure
same active ingredient as brand name drug
Bioequivalence (Therapeutically equivalent)

same action, dissolution, etc. as brand name drug

Orphan Drugs




Experimental Drugs


drugs developed to treat rare disorders
approved more quickly
incentives for drug companies
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