federal law1

7/28/2019 Federal Law1

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10:15am - 12:15pm

Federal Pharmacy Law Review

ACPE UAN 0107-0000-10-020-L03-P & 0107-0000-10-020-L03-T 0.2 CEUs/2.0 Hrs. Activity Type: Knowledge-Based

Program Objectives for Pharmacists & Technicians: Upon completion of this program, participants should be able to:

1. Describe pertinent federal laws which direct the practice of pharmacy.2. Discuss federal regulations on pharmacy practice.3. Describe the importance of understanding the origin of various federal regulations and how they apply to the practice of pharmacy today.

Speaker: Jane DeWitt, RPh, PhD , is an Associate Professor in Social and Administrative Sciencesin the Drake University College of Pharmacy and Health Sciences. She earned a B.S. in Pharmacy fromDrake and an M.S. and Ph.D. in Pharmaceutical Socioeconomics from the University of Iowa. She joined the faculty at Drake in 2000 and teaches Pharmacy Law and Ethics, as well as other courses for

PharmD and Health Sciences students. Prior to receiving her graduate degrees and becoming a faculty member at Drake, Jane practiced pharmacy at Mercy Hospital in Des Moines, North Iowa MedicalCenter in Mason City and the University of Iowa Hospitals and Clinics. She is a member of IPA, APhA,the American Association of Colleges of Pharmacy and the American Society for Pharmacy Law.

Speaker Disclosure: Jane DeWitt reports she has no actual or potential con icts of interest in relationto this program. The speaker has indicated that off-label use of medications will not be discussed duringthis presentation.


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Federal Pharmacy Law Review2010 Educational Expo

Jane E. DeWitt, RPh, PhD Drake University College of Pharmacy and Health Sciences

MPJE MPJE Competencies

Pharmacy Practice ~78% Licensure, Registration, Certification

and Operational Requirements ~17% Regulatory Structure and Terms ~5%

Federal law ~ 50%, State law ~ 50% Controlled Substances ~ 50% or more 90 questions (75 used to calculate score,

15 are pretest items)

Food and Drug Administration

FDA in the Department of Health and HumanServices (DHHS)

Center for Biologics Evaluation and Research Center for Food Safety and Applied Nutrition Center for Drug Evaluation and Research (CDER)

Administrative agency with extensive authority Regulations/rules Guidance documents

Other federal agencies affectingpharmacy

Centers for Medicare and Medicaid Services(CMS)

Drug Enforcement Administration (DEA) part of the U.S. Department of Justice

Office of Civil Rights (OCR) HIPAA oversight Federal Trade Commission (FTC) OTC

advertising

Pure Food and Drug Act 1906 Focus on PURITY and QUALITY Prohibition of interstate sale of adulterated

and misbranded drugs Recognized USP/NF standards

U.S. Pharmacopeial Convention

Private organization, independent of the FDA, founded in 1820

establish approved titles, definitions,descriptions for drugs

establish standards for identity,quality, strength, purity, packaging,stability and labeling

publishes USP/NF


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Food, Drug & Cosmetic Act (1938) Focus on SAFETY FDA began to oversee manufacturing and qualityof drugs A new drug could not be marketed until proven

safe for the proposed use (drugs on the marketbefore 1938 were exempt)

Established 2 major offenses: adulteration andmisbranding Nearly every violation of the FDCA consists of

one or both of these offenses Strict liability applies to these violations

Adulteration The quality or purity of the product is compromised An adulterated drug does not have the strength,

quality, or purity represented or expected Filthy, putrid or decomposed Pure, however

x prepared, packed or held in conditions where itmay have been contaminated

x exposed to a container that may havecontaminated it

x manufactured under conditions that do notconform to current GMP

Misbranding The classifications for food, drug, device and cosmetic,under the FDCA, are not mutually exclusive.

FOOD: 1) articles used for food or drink; 2) chewing gum,and 3) articles used for components of any such article

DEVICE: any instrument, apparatus, implement, machine,implant, or related article which is 1) recognized in theUSP/NF or any supplement; 2) intended for use in thediagnosis, cure, mitigation, treatment or prevention of disease in man or other animals; 3) intended to affect thestructure or any function of the body of humans or animalsand which does not achieve any of its principal intended

purposes through chemical action within or on the body...

Drug1) articles recognized in the USP/NF, HPUS or anysupplement to them; 2) articles intended for usein the diagnosis, cure, mitigation, treatment, orprevention of disease; 3) articles (other thanfood) intended to affect the structure or anyfunction of the body; and 4) articles intended foruse as a component of any articles specified inthe above, but does not include devices or theircomponents, parts or accesssories.

Durham-Humphrey Amendment (1951)

Established 2 classes of drugs - Rx and OTC Required a prescription for legend drugs Established provisions for dispensingprescription drugs

authorization of oral prescriptions refills of prescription drugs


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Behind-The-Counter (BTC) Drugs

Third class of drugs - sold only by a pharmacistor available only in a pharmacy

Traditional FDA position has been that there isno rationale for creating such a class of drugs,and that current legislation does not authorize(under the FDCA) any such regulation

FDA is now considering BTC drug status

Kefauver-Harris Amendments (1962)

Focus on SAFETY and EFFICACY Affected all new drugs introduced after 1962 and

all products whose NDAs had been approved since1938

Established Good Manufacturing Practices (GMP)requirements

Transferred jurisdiction of prescription drugadvertising from FTC to FDA

Current Good ManufacturingPractice (cGMP)

minimum requirements for the methods,facilities, or controls used in themanufacture, processing, packaging orholding of a drug product

intent to ensure drug meets quality andpurity standards

applies to manufacturers, not pharmaciesgenerally

New Drug Drug that is not generally recognized, among

experts qualified by scientific training andexperience to evaluate the safety andeffectiveness of drugs, as safe and effective foruse

Newly discovered chemicals An old, established drug offered in a new dosage

form, with new therapeutic claims, in new dosagelevels, or for a different patient population

GRASE: generally recognized as safe and effective

FDA approval process

NDAnew drug application

ANDA

abbreviated new drugapplicationIND

investigational new drug

Phase 1 safetysmall # basic pharmacology, ADME

Phase 2 safety/efficacysmall #, pts have condition

Phase 3 safety/efficacyhundreds/thousandsclinical settingoften double-blinded, RCT

Phase 4 postmarketingsurveillance

Dietary Supplement Health andEducation Act of 1994 (DSHEA)

defined dietary supplements as foods ratherthan drugs and limited the FDAs role inregulation

defined specific claims that manufacturers arepermitted to make


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Dietary Supplement

A product that contains a dietary ingredientintended to supplement the diet. Dietaryingredients may include one or more of thefollowing:

vitamin mineral herb or other botanical an amino acid a dietary substance to supplement the diet by increasing

the total dietary intake a concentrate, metabolite, constituent, extract or

combination of any of these ingredients

Quality Standards for DietarySupplements

Good Manufacturing Practices (GMPs)final rules published in 2007manufacturers required to evaluate purity, quality,strength, composition of products

USP Certification Programproducts may be independently tested as part of theDietary Verification Program and be allowed todisplay Dietary Supplement Verified on the labelprogram is voluntary and open to all manufacturersof dietary supplements

Dietary Supplements

must be labeled as a dietary supplement cannot be represented as conventional food cannot be represented for use as a sole item of

a meal or of the diet

Claims that can be made for dietarysupplements and conventional foodsHealth ClaimsDescribe a relationship between a dietary supplement ingredient, andreducing the risk of a disease or health-related condition diets high in calcium may reduce the risk of osteoporosisStructure/Function ClaimsDescribe the role of a nutrient or dietary ingredient intended to affect normal structure or function

calcium builds strong bones to maintain normal structure or function

fiber maintains bowel regularityFDA DisclaimerClaims must be accompanied by a disclaimer that FDA has not evaluatedthe claim, and state that the dietary supplement is not intended todiagnose, treat, cure or prevent any disease

Homeopathic Drugs

Recognized in the Homeopathic Pharmacopeiaof the United States (HPUS)

Regulated under FDCA presumed safe no proof of efficacy required

Prescription/Non-prescription Must conform with GMP

2 exceptions no assay, no expiration date

MedicareEstablished in 1965 under an amendment to theSocial Security Act of 1935.Federal health insurance for individuals 65 years of

age and over, and for certain other individuals withdisability, regardless of age

Part A: primarily hospital coverage Part B: physicians and other providers (optional) Part C: managed care plans

Medicare Choice, Medicare Advantage Part D: prescription drug benefit (optional)


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Medicare Prescription Drug, Improvement,and Modernization Act of 2003

Addition of a prescription drug benefit forMedicare beneficiaries (Part D)

Provision for medication therapy management Required development and implementation of

standards for e-prescribing Medicare Improvements for Patients and Providers Act of

2008 (MIPPA) established incentives for e-prescribers,beginning Jan 1, 2009

Permitted importation of prescription drugs fromCanada (if HHS Secy certifies safety)

Medication Therapy ManagementServices

Plans must have MTM program that may beprovided by a pharmacist

Pharmacists are specifically recognized asMedicare providers

Pharmacists to be reimbursed for time spentcounseling targeted patients: multiple chronicdiseases, multiple medications and high drugexpenses

Medicare Regulation of HospitalPharmacy

Under Medicare conditions of participation, ahospital pharmacy, or drug storage area, mustmeet certain basic requirements

a hospital must have a pharmacy directed by aregistered pharmacist, or (in some cases) a drugstorage area under pharmacist supervision

adequate personnel must be employed andaccurate records must be maintained.

Medicaid Established in 1965 under an amendment to the Social

Security Act of 1935 Provides health care costs for certain categories of

indigents: blind, disabled, aged and families withdependent children; eligibility is determined by anindividuals income and assets

Dual Eligibles - individuals who are eligible for bothMedicaid and Medicare

Medicaid programs are administered by each state but are federally approved and regulated through CMS(Centers for Medicare and Medicaid Services)

Jointly funded by state and federal governments

Medicaid

Covers all or part of these services physician care, dental care, nursing care IP and OP hospitalization home health care optometry lab tests and x-rays

AND outpatient prescription drugs (state has anoption to include)

Tamper Resistant Prescription Pads Beginning Oct 1, 2007, hand-written prescriptions for

Medicaid outpatient drugs will only be reimbursable if written on a tamper-resistant prescription pad

Mandate enacted as a fraud reducing measure includedin the U.S. Troop Readiness, Veterans Care, KatrinaRecovery, and Iraq Accountability Appropriations Act of 2007

On Sept 29, 2007 legislation was enacted to delay therequirement until April 1, 2008

Does not apply to prescriptions faxed or phoned to thepharmacy


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To be considered tamper resistant, a prescriptionpad must contain these 3 characteristics

Feature designed to prevent unauthorized copyingof a completed or blank prescription form

Feature designed to prevent the erasure ormodification of information written on theprescription by the prescriber

Feature to prevent the use of counterfeitprescription forms

All 3 characteristics were required by Oct 1, 2008

OBRA 90: Omnibus BudgetReconciliation Act of 1990

First federal law to directly address pharmacypractice standardsEstablished a federal policy requiring drug usereview - to ensure drug therapy is as safe andeffective as possibleEstablished standards of practice for pharmacistsas a condition of participation in the Medicaidprogram .

Retrospective Drug Use Review

performed by a DUR board made up of physicians and pharmacists

review medication use trends and data overspecified time periods

attempt to evaluate and improve medicationuse

Prospective Drug Use ReviewActive resolution of drug therapy problemsthrough a comprehensive review of a patientsprescription order at the point of dispensing

Screening prescriptionsCounseling patientsDocumentation

Federal Regulation of Long-Term Care

Some key elements The facility must develop a comprehensive careplan for each resident through the use of an

interdisciplinary team A pharmacist must review the drug regimen of eachpatient monthly, and report any irregularities to theattending physician and the director of nursing Established standards for drug administration,storage and prescribing and record keepingprocedures

Health Insurance Portability andAccountability Act (HIPAA)

Protected health information (PHI) - informationrelating to a patients health status, healthcare, or payment

Notice of Privacy Practices must be provided topatients

When PHI is used for a purpose that is notassociated with treatment, payment oroperations (TPO), authorization from the patientmust be obtained.


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Poison Prevention Packaging Act 1970To protect children from accidental poisonings withhousehold substances (food, drug or cosmetic as defined under the FDCA; a hazardous substance; a household fuel, when in a

portable container)All new and refilled prescriptions must be dispensed in achild-resistant closure unless

the prescriber specifies that none is to be usedx single prescription only

the patient indicates they do not wantx single prescription or blanket waiver

the container is being used in a hospital or s imilarinstitution in which the drugs are maintained andadministered by health professionals

Some PPPA Exempt Drug Products sublingual forms of nitroglycerin and isosorbide methylprednisolone and prednisone tablets in

some packages potassium supplements in UD forms aerosol containers intended for inhalation

therapy oral contraceptives and conjugated estrogen

products in dispenser packages

Federal Anti-Tampering Act (1982)

makes it a federal offense to tamper withconsumer productsrequires tamper-resistant packaging forcertain OTC, cosmetic and device products

Drug Product Selection

the Orange Book Approved Drug Products withTherapeutic Equivalence Evaluations

Reference listed drug (RLD) standard against which generic drug products are

compared Pharmaceutical equivalents

products that contain the same activeingredients, identical strength, same dosageform

Therapeutic equivalence bioequivalence; same clinical effect and safety

profile when administered

Orange Book CodesFirst LetterA therapeutically equivalent to a reference drug productB not considered to be therapeutically equivalent

may have documented bioequivalence problems

potential for such problems insufficient data, no adequate studies demonstrating

bioequivalence; product still under review quality standards are inadequate

Second Letter usually designates dosage form, with theseexceptions:

AA = drugs in conventional dosage forms, NO bioequivalenceproblems

AB = established scientific bioequivalence (actual orpotential problems have been identified and resolved)

Drug Recalls

Class I reasonable probability of serious, adverse

health consequences or deathClass II

temporary or medically reversible adverseeffects, or remote probability of seriousadverse effects

Class III not likely to cause adverse health effects


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National Drug Code

Used by the FDA for identification purposesDoes not indicate approval statusRequired (with bar code) on label of all drugs (Rxand OTC) and biological products1st set of digits identify manufacturer/distributor2nd set of digits identify drug name, pkg size,dosage form

Prescription Drug Samples Prescription Drug Marketing Act of 1987 -

prohibits the sale, purchase or trade of samples restriction of distribution to prescribers or to

pharmacies of hospitals or health systems the prescriber must submit a written request for

samples, each time retail pharmacies are prohibited from receiving

any sample drug

Use of Alcohol in PharmacyPractice

Tax-paid alcohol beverage liquor regulated by ATF, IRS community pharmacies

Tax-free alcoho l hospitals may use only for medicinal,

mechanical and scientific purposes and in thetreatment of patients

Food and Drug AdministrationAmendments Act (FDAAA) 2007

Postmarketing safety initiatives Risk Evaluation and Mitigation

Strategies (REMS) MedGuides, PPIs DTC advertising review Toll-free ADR reporting

Drug supply chain security - Track andTrace Technologies

Prescription Drug Labeling for thePatient

Federal requirement for select drugsPatient Package Inserts (PPI)

Medication Guides Pharmacy provided

Consumer Medication Information (CMI)

Patient Package Inserts

Some categories of products requires a PPI eachand every time the pharmacist dispenses theproductIn an institutional setting... the PPI must beprovided when these products are dispensedprior to the 1st dose, and at least once q 30days, if therapy continues


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Medication Guides (MedGuides)

May be r equired for drug product if

1) patient labeling could help prevent seriousadverse effects2) the product has serious risks relative to itsbenefits3) patient adherence to directions is crucial tothe drugs effectiveness

Risk Management Programs FDA has implemented restricted distribution

programs for some very high risk drugs Examples of special prescribing and dispensing

requirements isotretinoin (Accutane) iPLEDGE clozapine (Clozaril) Clozaril National

Registery (CNR) thalidomide (Thalomid) S.T.E.P.S.

Risk Evaluation and MitigationStrategies (REMS)

MedGuides and PPIsCommunication plans - letters to health careproviders, etcMay require

x Training/certification of prescriber and/or dispenserx Evidence or other documentation of safe-use

conditionsx Restricted distribution to certain health care settingsx Patient monitoring and/or registry

Side Effects Statement

Required distribution of a 1-800 number and sideeffects statement with prescription medications

on attached sticker on preprinted prescription vial cap on a separate sheet of paper in consumer medication information in appropriate FDA-approved Med Guide

Enforcement date July 1, 2009

MedWatch Program

FDA maintains a voluntary reporting systemthat allows health care professionals to report

any serious adverse events, potential andactual product use errors and product qualityproblems.

An official reporting form can be accessed andcompleted on the FDA web site

References Abood R. Pharmacy Practice and the Law . 5 th ed.

Jones and Bartlett: Boston MA. 2008. MPJE Competency Statements. NABP Web Site.

http://www.nabp.net/ftpfiles/NABP01/MPJEBlueprint1.pdf Accessed Jan 4, 2010.

Reiss BS, Hall GD. Guide to Federal Pharmacy Law.6th ed. Apothecary Press: Boynton Beach, FL. 2009.

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