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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 Activity Type: Knowledge-Based
be able to:

0.2 CEUs/2.0 Hrs.

Program Objectives for Pharmacists & Technicians: Upon completion of this program, participants should 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 Sciences in the Drake University College of Pharmacy and Health Sciences. She earned a B.S. in Pharmacy from Drake 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 Medical Center 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 conicts of interest in relation to this program. The speaker has indicated that off-label use of medications will not be discussed during this presentation.

Federal Pharmacy Law Review 2010 Educational Expo
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)

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

Food and Drug Administration

FDA in the Department of Health and Human Services (DHHS)
Center for Biologics Evaluation and Research Center for Food Safety and Applied Nutrition Center for Drug Evaluation and Research (CDER)

Other federal agencies affecting pharmacy

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

Administrative agency with extensive authority

Regulations/rules Guidance documents

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

Food, Drug & Cosmetic Act (1938)

Focus on SAFETY FDA began to oversee manufacturing and quality of drugs A new drug could not be marketed until proven safe for the proposed use (drugs on the market before 1938 were exempt) Established 2 major offenses: adulteration and misbranding Nearly every violation of the FDCA consists of one or both of these offenses Strict liability applies to these violations

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 it may have been contaminated x exposed to a container that may have contaminated it x manufactured under conditions that do not conform to current GMP


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 the USP/NF or any supplement; 2) intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals; 3) intended to affect the structure or any function of the body of humans or animals and which does not achieve any of its principal intended purposes through chemical action within or on the body...

1) articles recognized in the USP/NF, HPUS or any supplement to them; 2) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease; 3) articles (other than food) intended to affect the structure or any function of the body; and 4) articles intended for use as a component of any articles specified in the above, but does not include devices or their components, parts or accesssories.

Durham-Humphrey Amendment (1951)

Established 2 classes of drugs - Rx and OTC Required a prescription for legend drugs Established provisions for dispensing prescription drugs authorization of oral prescriptions refills of prescription drugs

Behind-The-Counter (BTC) Drugs

Third class of drugs - sold only by a pharmacist or available only in a pharmacy Traditional FDA position has been that there is no 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 since 1938 Established Good Manufacturing Practices (GMP) requirements Transferred jurisdiction of prescription drug advertising from FTC to FDA

Current Good Manufacturing Practice (cGMP)

minimum requirements for the methods, facilities, or controls used in the manufacture, processing, packaging or holding of a drug product intent to ensure drug meets quality and purity standards applies to manufacturers, not pharmacies generally

New Drug
Drug that is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use Newly discovered chemicals An old, established drug offered in a new dosage form, with new therapeutic claims, in new dosage levels, or for a different patient population GRASE: generally recognized as safe and effective

FDA approval process

NDA Phase 1 safety new drug application small # ANDA basic pharmacology, ADME abbreviated new drug Phase 2 safety/efficacy application small #, pts have condition Phase 3 safety/efficacy IND hundreds/thousands investigational new drug clinical setting often double-blinded, RCT Phase 4 postmarketing surveillance

Dietary Supplement Health and Education Act of 1994 (DSHEA)

defined dietary supplements as foods rather than drugs and limited the FDAs role in regulation defined specific claims that manufacturers are permitted to make

Dietary Supplement
A product that contains a dietary ingredient intended to supplement the diet. Dietary ingredients may include one or more of the following:
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 Dietary Supplements

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

USP Certification Program

products may be independently tested as part of the Dietary Verification Program and be allowed to display Dietary Supplement Verified on the label program is voluntary and open to all manufacturers of 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 dietary supplements and conventional foods
Health Claims
Describe a relationship between a dietary supplement ingredient, and reducing the risk of a disease or health-related condition diets high in calcium may reduce the risk of osteoporosis

Structure/Function Claims
Describe 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 regularity

FDA Disclaimer
Claims must be accompanied by a disclaimer that FDA has not evaluated the claim, and state that the dietary supplement is not intended to diagnose, treat, cure or prevent any disease

Homeopathic Drugs
Recognized in the Homeopathic Pharmacopeia of 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

Established in 1965 under an amendment to the Social Security Act of 1935. Federal health insurance for individuals 65 years of age and over, and for certain other individuals with disability, 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)

Medicare Prescription Drug, Improvement, and Modernization Act of 2003

Addition of a prescription drug benefit for Medicare 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

Medication Therapy Management Services

Plans must have MTM program that may be provided by a pharmacist Pharmacists are specifically recognized as Medicare providers Pharmacists to be reimbursed for time spent counseling targeted patients: multiple chronic diseases, multiple medications and high drug expenses

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

Medicare Regulation of Hospital Pharmacy

Under Medicare conditions of participation, a hospital pharmacy, or drug storage area, must meet certain basic requirements a hospital must have a pharmacy directed by a registered pharmacist, or (in some cases) a drug storage area under pharmacist supervision adequate personnel must be employed and accurate records must be maintained.

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 with dependent children; eligibility is determined by an individuals income and assets Dual Eligibles - individuals who are eligible for both Medicaid 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

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 an option 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 included in the U.S. Troop Readiness, Veterans Care, Katrina Recovery, and Iraq Accountability Appropriations Act of 2007 On Sept 29, 2007 legislation was enacted to delay the requirement until April 1, 2008 Does not apply to prescriptions faxed or phoned to the pharmacy

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

Feature designed to prevent unauthorized copying of a completed or blank prescription form Feature designed to prevent the erasure or modification of information written on the prescription by the prescriber Feature to prevent the use of counterfeit prescription forms

OBRA 90: Omnibus Budget Reconciliation Act of 1990

First federal law to directly address pharmacy practice standards Established a federal policy requiring drug use review - to ensure drug therapy is as safe and effective as possible Established standards of practice for pharmacists as a condition of participation in the Medicaid program.

All 3 characteristics were required by Oct 1, 2008

Retrospective Drug Use Review

performed by a DUR board made up of physicians and pharmacists review medication use trends and data over specified time periods attempt to evaluate and improve medication use

Prospective Drug Use Review

Active resolution of drug therapy problems through a comprehensive review of a patients prescription order at the point of dispensing Screening prescriptions Counseling patients Documentation

Federal Regulation of Long-Term Care

Some key elements The facility must develop a comprehensive care plan for each resident through the use of an interdisciplinary team A pharmacist must review the drug regimen of each patient monthly, and report any irregularities to the attending physician and the director of nursing Established standards for drug administration, storage and prescribing and record keeping procedures

Health Insurance Portability and Accountability Act (HIPAA)

Protected health information (PHI) - information relating to a patients health status, health care, or payment Notice of Privacy Practices must be provided to patients When PHI is used for a purpose that is not associated with treatment, payment or operations (TPO), authorization from the patient must be obtained.

Poison Prevention Packaging Act 1970

To protect children from accidental poisonings with household substances (food, drug or cosmetic as defined under
the FDCA; a hazardous substance; a household fuel, when in a portable container)

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

All new and refilled prescriptions must be dispensed in a child-resistant closure unless the prescriber specifies that none is to be used x single prescription only the patient indicates they do not want x single prescription or blanket waiver the container is being used in a hospital or similar institution in which the drugs are maintained and administered by health professionals

Federal Anti-Tampering Act (1982)

makes it a federal offense to tamper with consumer products requires tamper-resistant packaging for certain OTC, cosmetic and device products

Drug Product Selection

the Orange Book Approved Drug Products with Therapeutic Equivalence Evaluations Reference listed drug (RLD) standard against which generic drug products are compared Pharmaceutical equivalents products that contain the same active ingredients, identical strength, same dosage form Therapeutic equivalence bioequivalence; same clinical effect and safety profile when administered

Orange Book Codes

First Letter A therapeutically equivalent to a reference drug product B 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 these exceptions: AA = drugs in conventional dosage forms, NO bioequivalence problems AB = established scientific bioequivalence (actual or potential problems have been identified and resolved)

Drug Recalls
Class I reasonable probability of serious, adverse health consequences or death Class II temporary or medically reversible adverse effects, or remote probability of serious adverse effects Class III not likely to cause adverse health effects

National Drug Code

Used by the FDA for identification purposes Does not indicate approval status Required (with bar code) on label of all drugs (Rx and OTC) and biological products 1st set of digits identify manufacturer/distributor 2nd 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 Pharmacy Practice

Tax-paid alcohol beverage liquor regulated by ATF, IRS community pharmacies Tax-free alcohol hospitals may use only for medicinal, mechanical and scientific purposes and in the treatment of patients

Food and Drug Administration Amendments 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 and Trace Technologies

Prescription Drug Labeling for the Patient

Federal requirement for select drugs Patient Package Inserts (PPI) Medication Guides Pharmacy provided Consumer Medication Information (CMI)

Patient Package Inserts

Some categories of products requires a PPI each and every time the pharmacist dispenses the product In an institutional setting... the PPI must be provided when these products are dispensed prior to the 1st dose, and at least once q 30 days, if therapy continues

Medication Guides (MedGuides)

May be required for drug product if 1) patient labeling could help prevent serious adverse effects 2) the product has serious risks relative to its benefits 3) patient adherence to directions is crucial to the 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 Mitigation Strategies (REMS)

MedGuides and PPIs Communication plans - letters to health care providers, etc May require
x Training/certification of prescriber and/or dispenser x Evidence or other documentation of safe-use conditions x Restricted distribution to certain health care settings x Patient monitoring and/or registry

Side Effects Statement

Required distribution of a 1-800 number and side effects 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 system that allows health care professionals to report any serious adverse events, potential and actual product use errors and product quality problems. An official reporting form can be accessed and completed on the FDA web site

Abood R. Pharmacy Practice and the Law. 5th ed. Jones and Bartlett: Boston MA. 2008. MPJE Competency Statements. NABP Web Site. int1.pdf Accessed Jan 4, 2010. Reiss BS, Hall GD. Guide to Federal Pharmacy Law. 6th ed. Apothecary Press: Boynton Beach, FL. 2009.