Drug Regulation

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Drug Regulation

• and the ATC

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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

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Legislation . (cont)

• 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

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Food Drug Administration

• FDAs 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

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Controlled Substances

• Schedule 1
• Schedule 2
• Schedule 3
• Schedule 4
• Schedule 5

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Phases of Drug Development

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

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Clinical Trials

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

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Prescription Medications

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

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Info on a Prescription

• Patients name
• Date
• Name of drug and strength
• Amount prescribed
• Number of refills
• Directions for use
• DEA
• Other info

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

• Patient name and address
• Prescribers name
• Drug name
• Pharmacy name and date filled
• Special Precautions/
• Instructions

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Misuse of Prescription Medications

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

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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
• Dont use expired medicines

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Pros Cons of Advertising Prescription
Medicines
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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?
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OTC Labels

• Warnings - contra-indications
• Cautionary statements
• Drug interaction precautions
• Expiration Date / Lot No.

• Statement of identity
• Active ingredients amount
• Net quantity of contents
• Name Address of Manufact./Distrib.
• Indications for use
• Directions for use / Dosage information

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Product Name
Warnings/Caution Statement
Quantity
Expire Date
Identity
Dosage/Directions
Lot No.
Indications
Active Ingred. Amount
Manufacturer
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Safe Use of OTC

• Read label carefully
• Length of use
• Dosage
• Side effects / Adverse reaction / Interactions
• Storage
• Disposal
• Look-alikes

• Dont expect a miracle
• Self - Care

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Activity Analyze a OTC Label

• Everyone brings a OTC medication in original
  package to class
• Analyze youre your label
• Swap with classmates and analyze 2 others OTC
  meds

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Nutraceuticals

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

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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

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• 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

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Minimum guidelines for handling drugs in the
training room

• Locked cabinet
• Discard expired meds
• Record
• Athlete
• Medication
• Dose
• Date
• Initials
• Review patient info

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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

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Single ingredient products vs. Combination
products
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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

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When traveling also .

• Bring
• Insurance card
• Medical history
• Enough prescription med
• Banned drug list
• Syringes?
• Be wary of supplements and foreign meds

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Medical Kit

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

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Guidelines for Use of Therapeutic Medications
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Guidelines

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

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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

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Information on Medicines

• Physician Desk Reference (PDR)
• Drug Handbook for Health Professionals
• Nurses Drug Handbook
• Drug Information Database - http//pharminfo.com/d
  rg_mnu.html
• www.fda.gov