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