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Drug RegulationDrug Regulation
and the ATCand the ATC
Drug Legislation in the USDrug Legislation in the US Federal Food, Drug, & Cosmetic Act of Federal Food, Drug, & Cosmetic Act of
19061906 Food, Drug, and Cosmetic Act of 1938Food, Drug, and Cosmetic Act of 1938
Durham-Humphrey Amendment of 1952Durham-Humphrey Amendment of 1952 Kefauver-Harris Amendment of 1962Kefauver-Harris Amendment of 1962
Controlled Substance Act Controlled Substance Act (Comprehensive Drug Abuse Prevention (Comprehensive Drug Abuse Prevention Act of 1970)Act of 1970)
Poison Prevention Packaging Act of 1970Poison Prevention Packaging Act of 1970 Medical Device Act of 1976Medical Device Act of 1976 Federal Tampering Act of 1983Federal Tampering Act of 1983
Legislation …. Legislation …. (con’t)(con’t)
Fair Packaging and Labeling Act (1983)Fair Packaging and Labeling Act (1983) Drug Price Competition and Patent Time Drug Price Competition and Patent Time
Restoration Act of 1984Restoration Act of 1984 Prescription Drug Marketing Act of 1987Prescription Drug Marketing Act of 1987 Anti-Drug Abuse Act of 1988Anti-Drug Abuse Act of 1988 Omnibus Reconciliation Act of 1990 Omnibus Reconciliation Act of 1990
(OBRA)(OBRA) Dietary Supplements Health and Dietary Supplements Health and
Education Act of 1994Education Act of 1994
Food & Drug AdministrationFood & Drug Administration
FDA’s definition of a drug….FDA’s definition of a drug…. ResponsibilitiesResponsibilities
oversee production, labeling, & distribution oversee production, labeling, & distribution of medicines, cosmetics, & foodsof medicines, cosmetics, & foods
monitor the use of existing drugsmonitor the use of existing drugs oversee development of new drugsoversee development of new drugs monitor safety of drugs - existing & newmonitor safety of drugs - existing & new monitor effectiveness of drugsmonitor effectiveness of drugs
Drug Enforcement Agency (DEA)Drug Enforcement Agency (DEA) concerned with controlled substances only; concerned with controlled substances only;
enforce laws relating to illegal drugsenforce laws relating to illegal drugs
Controlled SubstancesControlled Substances
Schedule 1Schedule 1
Schedule 2Schedule 2
Schedule 3Schedule 3
Schedule 4Schedule 4
Schedule 5Schedule 5
Phases of Drug DevelopmentPhases of Drug Development
PreclinicalPreclinical Phase IPhase I Phase IIPhase II Phase IIIPhase III Submission of NDASubmission of NDA Phase IVPhase IV Phase VPhase V
Clinical TrialsClinical Trials
““Human Guinea Pig”Human Guinea Pig” CenterWatch Clinical Trials Listing CenterWatch Clinical Trials Listing - -
http://www.centerwatch.com/main.http://www.centerwatch.com/main.htmhtm
www.clinicaltrials.comwww.clinicaltrials.com www.clinicaltrials.govwww.clinicaltrials.gov
Prescription MedicationsPrescription Medications
Dispensed in Dispensed in limited amounts by limited amounts by R.Ph. on order of R.Ph. on order of MDMD
Designed to Designed to protect consumerprotect consumer
Info on a PrescriptionInfo on a Prescription
Patient’s namePatient’s name DateDate Name of drug and strengthName of drug and strength Amount prescribedAmount prescribed Number of refillsNumber of refills Directions for useDirections for use DEA #DEA # Other infoOther info
Name, Address & Phone No. of Dr.
Patient’s Name & Address Date
Name of Drug &Strength
Amount
Directionsfor use
No. of refills
DEA No.
Doctor’s Signature
Prescription LabelPrescription Label
Patient name and Patient name and addressaddress
Prescriber’s Prescriber’s namename
Drug nameDrug name Pharmacy name Pharmacy name
and date filledand date filled Special Special
Precautions/Precautions/
InstructionsInstructions
Misuse of Prescription Misuse of Prescription MedicationsMedications
Taking too much or too littleTaking too much or too little D/C usage before finished w/medsD/C usage before finished w/meds Sharing medicationsSharing medications Taking other medicinesTaking other medicines
Precautions for Prescription MedsPrecautions for Prescription Meds
Tell physician of previous Tell physician of previous problems/allergiesproblems/allergies
Keep list of ALL meds. currently usingKeep list of ALL meds. currently using Understand directionsUnderstand directions Discuss side effects / InteractionsDiscuss side effects / Interactions Store properlyStore properly Never take drugs in the darkNever take drugs in the dark Flush old drugsFlush old drugs Keep in labeled containersKeep in labeled containers Don’t use expired medicinesDon’t use expired medicines
Pros & Cons of Advertising Pros & Cons of Advertising Prescription MedicinesPrescription Medicines
Over-the-Counter DrugsOver-the-Counter Drugs No prescription requiredNo prescription required Weaker, but those newly classified….Weaker, but those newly classified…. Provide symptomatic relief - not Provide symptomatic relief - not
underlying causeunderlying cause FDA GuidelinesFDA Guidelines
must be safe and effectivemust be safe and effective no harmful side effects when used properlyno harmful side effects when used properly not habit formingnot habit forming does not require professional expertisedoes not require professional expertise
Pros & Cons of Prescription Medicines Moving to OTC Status?
OTC LabelsOTC Labels
Statement of identityStatement of identity Active ingredients & Active ingredients &
amountamount Net quantity of Net quantity of
contentscontents Name & Address of Name & Address of
Manufact./Distrib.Manufact./Distrib. Indications for useIndications for use Directions for use / Directions for use /
Dosage informationDosage information
Warnings - contra-Warnings - contra-indicationsindications
Cautionary Cautionary statementsstatements
Drug interaction Drug interaction precautionsprecautions
Expiration Date / Expiration Date / Lot No.Lot No.
Product Name
Identity
Quantity
Manufacturer
Warnings/Caution Statement
Indications
Dosage/Directions
Lot No.
ExpireDate
Active Ingred. & Amount
Safe Use of OTCSafe Use of OTC
Read label carefullyRead label carefully Length of useLength of use DosageDosage Side effects / Side effects /
Adverse reaction / Adverse reaction / InteractionsInteractions
StorageStorage DisposalDisposal Look-alikesLook-alikes
Don’t expect a Don’t expect a miraclemiracle
Self - CareSelf - Care
Activity: Analyze a OTC LabelActivity: Analyze a OTC Label
Everyone brings a OTC medication in Everyone brings a OTC medication in original package to classoriginal package to class
Analyze you’re your labelAnalyze you’re your label Swap with classmates and analyze 2 Swap with classmates and analyze 2
others OTC medsothers OTC meds
NutraceuticalsNutraceuticals
Vitamins and dietary supplementsVitamins and dietary supplements Vague claims allow no FDA testingVague claims allow no FDA testing Drug-like effectsDrug-like effects Safe…. Effective….?Safe…. Effective….? PurityPurity + drug tests+ drug tests Interactions w/ other drugsInteractions w/ other drugs
Drug NamesDrug Names
Chemical NameChemical Name describes chemical structuredescribes chemical structure
Generic Name Generic Name shortened form of chemical name; assigned shortened form of chemical name; assigned
during testingduring testing Brand NameBrand Name
patentedpatented Chemically Equivalent DrugChemically Equivalent Drug
same active ingredient as brand name drugsame active ingredient as brand name drug Bioequivalence (Therapeutically equivalent)Bioequivalence (Therapeutically equivalent)
same action, dissolution, etc. as brand name same action, dissolution, etc. as brand name drugdrug
Orphan Drugs Orphan Drugs drugs developed to treat rare disordersdrugs developed to treat rare disorders approved more quicklyapproved more quickly incentives for drug companiesincentives for drug companies
Experimental DrugsExperimental Drugs American companies sell drugs in foreign American companies sell drugs in foreign
countries before gain approval in U.S.countries before gain approval in U.S.
Approval for OTC drugsApproval for OTC drugs must meet standards for categorymust meet standards for category
Minimum guidelines for handling Minimum guidelines for handling drugs in the training roomdrugs in the training room
Locked cabinetLocked cabinet Discard expired medsDiscard expired meds Record Record
AthleteAthlete MedicationMedication DoseDose DateDate Initials Initials
Review patient info Review patient info
Storing MedsStoring Meds
In Training Room – In Training Room – locked cabinetlocked cabinet
No sharingNo sharing Most stored at room Most stored at room
temptemp Not in the bathroomNot in the bathroom Observe the shelf life / Observe the shelf life /
expiration datesexpiration dates Discard meds w/out Discard meds w/out
labels / Flush down labels / Flush down toilettoilet
Single ingredient products Single ingredient products vs. vs.
Combination productsCombination products
Transportation of MedicationsTransportation of Medications
Athletes carry own meds, in carry-onAthletes carry own meds, in carry-on Original containersOriginal containers If you need a refill while traveling (in US)If you need a refill while traveling (in US) If athlete injured at away competitionIf athlete injured at away competition Fill controlled substances before you Fill controlled substances before you
leaveleave Take enough when traveling abroadTake enough when traveling abroad Aerosol cans Aerosol cans
When traveling also ….When traveling also ….
BringBring Insurance cardInsurance card Medical historyMedical history Enough prescription med Enough prescription med Banned drug listBanned drug list
Syringes?Syringes? Be wary of supplements and foreign Be wary of supplements and foreign
medsmeds
Medical KitMedical Kit
Locked - not accessible w/out Locked - not accessible w/out approvalapproval
ContentsContents Nonprescription pain killerNonprescription pain killer Local anestheticLocal anesthetic Topical pain relieverTopical pain reliever Antiseptic ointmentAntiseptic ointment Antibiotic ointmentAntibiotic ointment Antifungal agentAntifungal agent
Guidelines for Use of Guidelines for Use of Therapeutic MedicationsTherapeutic Medications
Guidelines…Guidelines… ATCs dispense?….administer?ATCs dispense?….administer?
Prescription drugs?Prescription drugs? OTC’s?OTC’s?
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 notesOther notes
More Guidelines…. More Guidelines….
Take as directedTake as directed No combinationNo combination LabelsLabels Full glass of waterFull glass of water Food?Food? Childproof Childproof
containerscontainers State LawsState Laws Banned Substance?Banned Substance?
Read labelRead label Dose scheduleDose schedule No sharingNo sharing Interactions?Interactions? Side EffectsSide Effects
Information on MedicinesInformation on Medicines
Physician Desk Reference (PDR)Physician Desk Reference (PDR) Drug Handbook for Health ProfessionalsDrug Handbook for Health Professionals Nurse’s Drug HandbookNurse’s Drug Handbook Drug Information DatabaseDrug Information Database - -
http://pharminfo.com/drg_mnu.htmlhttp://pharminfo.com/drg_mnu.html www.fda.govwww.fda.gov