2010 pharmacy law review for mpje

Pharmacy Law ReviewPharmacy Law Review20102010

Jesse C. Vivian , RPh, JD

Professor of Pharmacy Practice

(313) 577-5389

[email protected]

http://jessevivian.net

mailto:[email protected]

Today’s Agenda:Today’s Agenda:Prepare for MPJEPrepare for MPJE

Discus MPJE, Study Materials and Resources Reflections by Dr. Kathryn Hurren Basic Constitutional Law Review Statutes and Regulations:

Where to find statutes and RegulationsFDA MichiganControlled Substances

• DEA• Michigan

Food Mock Test Evaluation Open Discussion

MPJEMPJE

Computer Adaptive TestAnswer Question

Can’t go back to prior questions

90 Questions60 questions counted

No way to know which 30 questionsx don’t count

Assume every question counts

MPJE Study MaterialsMPJE Study Materials

Michigan Pharmacy Law, 5th ed., 2nd printingApril 2010Not cover new e-script CS Rule

• Predict Not on MPJE this Summer– DEA and State Boards Not Fully Briefed– Go into effect June, 1, 2010– Can read about them online– Will post summary article on my website

ASHP’s PharmPrep 3rd ed., Federal Pharmacy Law (online or book; Good for NAPLEX)

Mock Questions Reiss and Hall, Guide to Federal Pharmacy Law, 6th ed.

Several example questions: mediocre Feinberg, Pharmacy Law

Practice Test: Pretty Good Abood, Pharmacy Practice and the Law, 5th ed

Very Detailed, Class Textbook, Example Questions Okay.

MPJEMPJEhttp://nabp.net http://nabp.net

Click on PROGRAMS

NABPNABP

Click on MPJE

NABP MPJENABP MPJE

Read entire page and links

Constitutional LawConstitutional LawNot on Exam, per seNeed to know for background

ClausesSupremacy

• Duel Jurisdiction

Due ProcessInterstate Commerce

• Intrastate commerce

Ex Post Facto• Grandfathering

If conflict between Federal and State law exists,Stricter Law Applies

Online Legal ResourcesOnline Legal Resources

Federal Food Drug and Cosmetic ActFederal Food Drug and Cosmetic Acthttp://www4.law.cornell.edu/uscode/21/ch9.html

• Learn to navigate this site to find specific statutes• http://www.law.cornell.edu/topics/food_drugs.html

– search databaseDo your own search with words like:Do your own search with words like:

““food drug and cosmetic act laws and regulations food drug and cosmetic act laws and regulations administration”administration”

Federal RegulationsFederal Regulationshttp://vm.cfsan.fda.gov/~dms/reg-2.html

Online ResourcesOnline Resources

Statutes: Statutes: http://www.lib.umich.edu/libhome/http://www.lib.umich.edu/libhome/Documents.center/michlaw.htmlDocuments.center/michlaw.html

Regulations: http://michigan.govRegulations: http://michigan.gov

First SectionFirst Section

Federal Regulation of Drugs GenerallyAdulterationMisbranding

LabelingAntitrustMedicare

PPPAUSPS

History of Drug RegulationHistory of Drug Regulation

MPJE Questions don’t usually refer to the Names of Acts but focus in on what the Act did at the time.

Pay attention to year law was enacted and effect the law had.

Pure Food and Drug Act of 1906Pure Food and Drug Act of 1906

Prohibited the introduction of adulterated or misbranded drugs and foods into interstate commerce.

Ingredients did not have to be listed

Did not regulate cosmetics of medical devices

Example QuestionExample Question

After 1906, it was illegal to introduce drugs into interstate commerce which were:

I. MisbrandedII. AdulteratedIII. Made with contaminated materialsIV. Not effective for intended purpose

a. I onlyb. II onlyc. All of the aboved. I, II and III only

Food Drug and Cosmetic Act of Food Drug and Cosmetic Act of 19381938

1938: 107 deaths from sulfanilamide elixir mixed with diethylene glycol (anti-freeze)

No “new drug” could be introduced into interstate commerce unless first proven ‘safe’ for labeled indication.

Established New Drug Application/Approval Process (NDA)Required ‘adequate directions for use’

• Unless dispensed pursuant to prescription from state-authorized prescriber

Required labeling for habit-forming drugs Applies to Cosmetics and medical devices as well as food and

drugs Established Food and Drug Administration Labels, labeling, manufacturers label, pharmacy label, patient

information label

ProhibitionsProhibitions

Its is unlawful to introduce into interstate commerce and article that is

Adulterated or

Misbranded

AdulterationAdulteration

Adulterated drugs and devices A drug or Adulterated drugs and devices A drug or device shall be deemed to be adulterated:device shall be deemed to be adulterated:

(1) If it consists in whole or in part of any filthy, (1) If it consists in whole or in part of any filthy, putrid, or decomposed substance; or (2)(A) if putrid, or decomposed substance; or (2)(A) if it has been prepared, packed, or held under it has been prepared, packed, or held under insanitary conditions whereby it may have insanitary conditions whereby it may have been contaminated with filth, or whereby it been contaminated with filth, or whereby it may have been rendered injurious to health.may have been rendered injurious to health.


or (B) if it is a drug and the methods used in, or the or (B) if it is a drug and the methods used in, or the facilities or controls used for, its manufacture, facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or processing, packing, or holding do not conform to or are not operated or administered in conformity with are not operated or administered in conformity with current good manufacturing practice current good manufacturing practice to assure to assure that such drug meets the requirements of this that such drug meets the requirements of this chapter as to safety and has the identity and chapter as to safety and has the identity and strength, and meets the quality and purity strength, and meets the quality and purity characteristics, which it purports or is represented to characteristics, which it purports or is represented to possesspossess


or (4) if (A) it bears or contains, for purposes or (4) if (A) it bears or contains, for purposes of coloring only, a color additive which is of coloring only, a color additive which is unsafe within the meaning of section 379e(a) unsafe within the meaning of section 379e(a) of this title, or (B) it is a color additive the of this title, or (B) it is a color additive the intended use of which in or on drugs or intended use of which in or on drugs or devices is for purposes of coloring only and is devices is for purposes of coloring only and is unsafe within the meaning of section 379e(a) unsafe within the meaning of section 379e(a) of this title.of this title.


(b) Strength, quality, or purity differing from (b) Strength, quality, or purity differing from official compendium official compendium If it purports to be or is If it purports to be or is represented as a drug the name of which is represented as a drug the name of which is recognized in an official compendium, and its recognized in an official compendium, and its strength differs from, or its quality or purity strength differs from, or its quality or purity falls below, the standard set forth in such falls below, the standard set forth in such compendium.compendium.

MisbrandingMisbranding

If an article is alleged to be misbranded because the labeling or If an article is alleged to be misbranded because the labeling or advertising is misleading, then in determining whether the advertising is misleading, then in determining whether the labeling or advertising is misleading there shall be taken into labeling or advertising is misleading there shall be taken into account (among other things) not only representations made or account (among other things) not only representations made or suggested by statement, word, design, device, or any suggested by statement, word, design, device, or any combination thereof, but also the extent to which the labeling or combination thereof, but also the extent to which the labeling or advertising fails to reveal facts material in the light of such advertising fails to reveal facts material in the light of such representations or material with respect to consequences which representations or material with respect to consequences which may result from the use of the article to which the labeling or may result from the use of the article to which the labeling or advertising relates under the conditions of use prescribed in the advertising relates under the conditions of use prescribed in the labeling or advertising thereof or under such conditions of use as labeling or advertising thereof or under such conditions of use as

are customary or usual.are customary or usual.

LabelLabel

The term ''label'' means a display of written, printed, or graphic matter upon the immediate container of any article; and a requirement made by or under authority of this chapter that any word, statement, or other information appear on the label shall not be considered to be complied with unless such word, statement, or other information also appears on the outside container or wrapper, if any there be, of the retail package of such article, or is easily legible through the outside container or wrapper.

LabelingLabeling

The term ''immediate container'' does not The term ''immediate container'' does not include package liners. include package liners.

The term ''labeling'' means all labels and The term ''labeling'' means all labels and other written, printed, or graphic matter (1) other written, printed, or graphic matter (1) upon any article or any of its containers or upon any article or any of its containers or wrappers, or (2) accompanying such article. wrappers, or (2) accompanying such article.

GenerallyGenerally

If a drug is mislabeled—It is Misbranded

If drug not manufactured according to CGMPsIt is adulterated

If Drug does not conform to compendial standards and is labeled “USP”

It is adulteratedDrugs can be both misbranded and

adulterated at the same time

Solid Oral DrugsSolid Oral Drugs

Must be marketed with an imprint that permits identification

Applies to Rx-only and OTC drugs

Exceptions where ‘impracticable’• Sublingual Nitroglycerin tablets

Drug is misbranded without required identification

FDCA of 1938FDCA of 1938

Grandfather ClauseDrugs on market before 1938 were not subject to review and NDA requirements

• Avoided ex post facto clause

Did NOT establish prescription-only/OTC status of drugs

Some drugs were considered ‘safe’ only when used under medical supervision

Did not required drugs to be ‘effective’ for intended purposes

Distinguish “drug” and “new drugDistinguish “drug” and “new drug” ” and Grandpaand Grandpa

The term ''new drug'' means -

(1) Any drug (except a new animal drug or an animal feed bearing or containing a new animal drug) the composition of which is such that such drug 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 under the conditions prescribed, recommended, or suggested in the labeling thereof, except that such a drug not so recognized shall not be deemed to be a ''new drug'' if at any time prior to June 25, 1938, it was subject to the Food and Drugs Act of June 30, 1906, as amended, and if at such time its labeling contained the same representations concerning the conditions of its use.

FDCA of 1938FDCA of 1938

Recognized “Official Compendia,” privately published, that standardized drug quality

USP/NF Monographs• Chemical characteristics and quality standards of

listed drugs• USP/NF merged

Homeopathic Pharmacopoeia of the United States

Anything published in official compendia is a drug

Articles in the FDCAArticles in the FDCA

FoodFoodDrugDrugCosmeticCosmeticDietary SupplementsDietary SupplementsSoapSoap

An Article may be a food, a drug, a An Article may be a food, a drug, a cosmetic and/or a dietary supplementcosmetic and/or a dietary supplement• Depends on distributor’s CLAIMSDepends on distributor’s CLAIMS

Foods and CosmeticsFoods and Cosmetics

The term ''food'' means (1) articles used for food or The term ''food'' means (1) articles used for food or drink for man or other animals, (2) chewing gum, and drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article. (3) articles used for components of any such article.

The term ''cosmetic'' means (1) articles intended to The term ''cosmetic'' means (1) articles intended to be rubbed, poured, sprinkled, or sprayed on, be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of and (2) articles intended for use as a component of any such articles; except that such term shall not any such articles; except that such term shall not include soap. include soap.

DrugDrug

The term ''drug'' means (A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C).

Dietary Supplement Dietary Supplement

A food or dietary supplement for which a claim, A food or dietary supplement for which a claim, subject to sections 343(r)(1)(B) and 343(r)(3) of this subject to sections 343(r)(1)(B) and 343(r)(3) of this title or sections 343(r)(1)(B) and 343(r)(5)(D) of this title or sections 343(r)(1)(B) and 343(r)(5)(D) of this title, is made in accordance with the requirements of title, is made in accordance with the requirements of section 343(r) of this title is not a drug solely section 343(r) of this title is not a drug solely because the label or the labeling contains such a because the label or the labeling contains such a claim. A food, dietary ingredient, or dietary claim. A food, dietary ingredient, or dietary supplement for which a truthful and not misleading supplement for which a truthful and not misleading statement is made in accordance with section 343(r)statement is made in accordance with section 343(r)(6) of this title is not a drug under clause (C) solely (6) of this title is not a drug under clause (C) solely because the label or the labeling contains such a because the label or the labeling contains such a statement.statement.

Dietary SupplementsDietary Supplements

The term ''dietary supplement'' - (1) means a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: (A) a vitamin; (B) a mineral; (C) an herb or other botanical; (D) an amino acid; (E) a dietary substance for use by man to supplement the diet by

increasing the total dietary intake; or (F) a concentrate, metabolite, constituent, extract, or combination of

any ingredient described here. Except for purposes of paragraph (g), a dietary

supplement shall be deemed to be a food within the meaning of this chapter.

Important Amendments to Important Amendments to FDCAFDCA

Durham-Humphrey Act of 1951Created 2 Classes of Drugs

• Prescription-only (Rx only, prescription legendprescription legend)– Rx-only legend must appear on manufacturer label

– Safe only when used under medical supervision

– ‘adequate directions for use not required if dispensed pursuant to prescription using a pharmacy label in its place

• OTC – Safe to use without medical supervision and when accompanied by

‘adequate directions for use’

Allowed oral transmission of prescriptions

Allowed prescription refills

Durham-HumphreyDurham-Humphrey

Created § 503(b)(1) drugsCreated § 503(b)(1) drugs

(b)(1) A drug intended for use by man which—(b)(1) A drug intended for use by man which—

(A) because of its toxicity or other potentiality for harmful effect, or the method of its use, or the (A) because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to administer such drug; orpractitioner licensed by law to administer such drug; or

(B) is limited by an approved application under section 505 (B) is limited by an approved application under section 505 {New Drug} {New Drug} to use under the to use under the professional supervision of a practitioner licensed by law to administer such drug; shall be professional supervision of a practitioner licensed by law to administer such drug; shall be dispensed only (i) upon a written prescription of a practitioner licensed by law to administer dispensed only (i) upon a written prescription of a practitioner licensed by law to administer such drug, or (ii) upon an oral prescription of such practitioner which is reduced promptly to such drug, or (ii) upon an oral prescription of such practitioner which is reduced promptly to writing and filed by the pharmacist, or (iii) by refilling any such written or oral prescription if writing and filed by the pharmacist, or (iii) by refilling any such written or oral prescription if such refilling is authorized by the prescriber either in the original prescription or by oral order such refilling is authorized by the prescriber either in the original prescription or by oral order which is reduced promptly to writing and filed by the pharmacist. The act of dispensing a drug which is reduced promptly to writing and filed by the pharmacist. The act of dispensing a drug contrary to the provisions of this paragraph shall be deemed to be an act which results in the contrary to the provisions of this paragraph shall be deemed to be an act which results in the drug being misbranded while held for sale.drug being misbranded while held for sale.

Kefauver-Harris Act of 1962Kefauver-Harris Act of 1962

a/ka/ ‘Drug Efficacy Amendment’Thalidomide in Europe caused birth defects in children of pregnant mothersAll new drugs put on market after 1962 must be proven ‘effective’ for intended purposes

• Now ‘new drugs’ must be safe and effective before given an NDA

• Applied to drugs marketed between 1938 and 1962– Established Drug Efficacy Study Initiative (DESI)– Burden on FDA to prove 1938-1962 drugs not effective

Established Informed Consent for Human Research SubjectsImplemented Good Manufacturing Practices

• GMPs, CGMPs

Kefauver-HarrisKefauver-Harris

Established Established DESIDESI class of drugs for those marketed class of drugs for those marketed between 1938 and 1962.between 1938 and 1962.

Drug Efficacy Study ImplementationDrug Efficacy Study Implementation The DESI program was intended to classify all pre-1962 drugs that were already The DESI program was intended to classify all pre-1962 drugs that were already

on the market as either effective, ineffective, or needing further study. The Drug on the market as either effective, ineffective, or needing further study. The Drug Efficacy Study Implementation (DESI) evaluated over 3000 separate products and Efficacy Study Implementation (DESI) evaluated over 3000 separate products and over 16,000 therapeutic claims. By 1984, final action had been completed on 3,443 over 16,000 therapeutic claims. By 1984, final action had been completed on 3,443 products; of these, 2,225 were found to be effective, 1,051 were found not products; of these, 2,225 were found to be effective, 1,051 were found not effective, and 167 were pending.effective, and 167 were pending.

http://en.wikipedia.org/wiki/Drug_Efficacy_Study_Implementation http://en.wikipedia.org/wiki/Drug_Efficacy_Study_Implementation

One of the early effects of the DESI study was the development of the Abbreviated New Drug One of the early effects of the DESI study was the development of the Abbreviated New Drug Application (ANDA). Application (ANDA). More about this laterMore about this later

Kefauver-Harris ActKefauver-Harris Act

Another aspect of this act is that it gave Another aspect of this act is that it gave authority to regulate Advertising and authority to regulate Advertising and Marketing of:Marketing of:

Rx-Only and OTC drugs to the FDARx-Only and OTC drugs to the FDA

Dietary Supplements to the FTCDietary Supplements to the FTC

• Federal Trade CommissionFederal Trade Commission– The Federal Trade Commission is the nation's consumer protection agency. The Federal Trade Commission is the nation's consumer protection agency.

TheThe FTC's Bureau of Consumer Protection FTC's Bureau of Consumer Protection works works For The ConsumerFor The Consumer to to prevent fraud, deception, and unfair business practices in the marketplace. prevent fraud, deception, and unfair business practices in the marketplace.

– http://www.ftc.gov/bcp/index.shtml http://www.ftc.gov/bcp/index.shtml

Points to RememberPoints to Remember

Not all drugs on US market have an NDAPre-1938 drugs grandfathered

• Examples:Examples:– digoxin, nitroglycerin, levothyroxine (thyroid products), phenobarbitaldigoxin, nitroglycerin, levothyroxine (thyroid products), phenobarbital

Important because not all drugs have an Orange Book rating even though there may be equivalents available

All drugs on US market must be manufactured according to GMPs (CGMPs)

Drugs put on market in US between 1938 and 1962 are safe and effective for labeled indications

“Adequate Directions for Use” applies to ALL drugsCan remove and replace by prescription labeling on pharmacy label

Poison Prevention Packaging Act Poison Prevention Packaging Act of 1970of 1970

Not Part of FDCA Administered by Consumer Product Safety

Commission (CPSC) since 1973 Purpose to prevent accidental poisoning of children

under age five Requires “Hazardous Household Products” to be

marketed in child-resistant packagingImmediate container or wrappingWith exceptions, ALL DRUGS are ‘hazardous household products’ subject to special packaging requirements

PPPAPPPA

Know drugs to which Act appliesExamples:

• All oral dosage forms of – Aspirin

– Controlled substances

– Prescription drugs

Know drugs that have limited application:Examples

• Packages with more than 250 mg of non-injectable iron• Packages with more than 50 mg elemental fluoride or 0.5%• fluoride

PPPAPPPA

Know ALL Exceptions for drugs not required to be in child-resistant packaging

Examples:• Packages of less than 8 grams of erythromycin

ethylsuccinate• Sublingual nitroglycerin tablets• Oral contraceptives dispensed in manufacturer’s

mnemonic packaging• Packages of less than 105 mg prednisone tablets• One size of OTC line with label indicating package

is not child-resistant

PPPAPPPA

Failure to Comply with PPPA is an act of misbranding

Patient may ASK for blanket waiver of child-resistant packaging for all dispensed prescription medication

Physician may ASK for non-child-resistant packaging only for single prescriptions

Request does NOT have to be in writing• BUT: “if its not documented, it didn’t happen’

Federal Anti-Tampering Act of Federal Anti-Tampering Act of 19821982

Not part of FDCA Somewhat related to, but independent of PPPA Enacted after intentional cyanide contamination of

OTC products on drugstore shelvesTylenol (TYMURS), Chicagohttp://en.wikipedia.org/wiki/Chicago_Tylenol_murders

Most ORAL OTC drug products and many dietary supplements must have tamper-proof indicator or barrier that shows if package has been opened or tampered with

Medical Device Act of 1976Medical Device Act of 1976

Pre-Market ApprovalGMP manufacturing standardsPerformance StandardsClassified according to intended UseRecords and Reporting Requirements

Not a major focus of exam

Orphan Drug Act of 1983Orphan Drug Act of 1983

Limited reasons for manufacturers to invest in research and development because potential for return on investment limited or non-existent

Rare Disease < 20,000 persons in US Tax incentives to manufactures

Not a major focus of exam

Drug Price Competition and Drug Price Competition and Patent Term Restoration Act of Patent Term Restoration Act of

19841984

a/k/a “Hatch-Waxman Act” Established Standards for marketing of ‘generic’

drugs without necessity of NDA process Replaced with Abbreviated New Drug

Application/Approval (ANDA) Generics have to be ‘therapeutically equivalent’ to

pioneer drugs Generally, adds about 5 years of exclusivity (patent)

rights to pioneer (innovator) company

Hatch-Waxman ActHatch-Waxman Act FDA published “Orange Book”

“Approved Drug Products with Therapeutic Equivalence Evaluations.”

Is Guideline OnlySome States Require Following it

• Positive Formularies• Negative Formularies

Michigan is NOT and Orange Book State• If generic is chemically/pharmaceutically equivalent to Brand name

prescribed generic interchange is permitted• DO NOT use term ‘generic substitution’ for DPS

– Substitution is illegal in Michigan» Means to dispense a drug other than the drug prescribed» i.e., a different chemical entity» erythromycin vs. erythromycin ethylsuccinate » E-Par vs. EES

Prescription Drug Marketing Act Prescription Drug Marketing Act of 1987of 1987

PDMA—Very Important

Prohibits re-importation of drugs produced in the US after they have left the US

Wholesalers must be licensed under state law according to federal standards

Bans the sale, trade or purchase of ‘drug samplesIn Michigan, term is “complimentary starter doses”Hospital pharmacies may ‘hold’ samples and ‘dispense’ them at request of a staff physicianCommunity pharmacies can NEVER have samples on premises or face large fine.Distribution of samples are strictly regulated

• Record-keeping and storage mandates Institutions (hospitals) cannot sell drugs to community pharmacies unless

there is a ‘bone fide’ emergencyHospitals usually get special discount pricing

Robinson-Patman Act of 1936Robinson-Patman Act of 1936

NOT an amendment to FDCA Is part of the Antitrust Laws a/k/a/ ‘Anti-Price Discrimination Act’ Prohibits institutions (hospitals) that buy drugs at

favorable discounted rates from selling drugs at cost to others—primarily community pharmacies

“Own Use” Doctrine ‘Bone fide emergency’ exception http://uwacadweb.uwyo.edu/PHARMACYNOTES/

Casey%20Wood/unit%205%20core%20ctw.pdf

OBRA ‘90OBRA ‘90

Applied originally only to Medicaid prescriptions

Most states enacted regulations making OBRA standards applicable to all prescriptions

Drug Utilization ReviewNecessary and Appropriate

Offer to Counsel Counseling only by RPh or intern

Record-keeping

Prescription Drug User Prescription Drug User Fee Act of 1992 Fee Act of 1992

Transformed FDA from a public Transformed FDA from a public watchdog agency funded by taxpayer watchdog agency funded by taxpayer money that should be protecting the money that should be protecting the interests off the population of the USA.interests off the population of the USA.

PHRMA now funds most of FDA activitiesPHRMA now funds most of FDA activities

FDA Modernization Act of FDA Modernization Act of 19971997

Established ‘fast track’ NDA process for drugs intended to treat life-threatening diseases

Established guidelines to allow pharmacy compounding of drugs without adhering to GMPs or NDAs

Changed ‘prescription-legend’ to ‘Rx only’Eliminated Habit-forming warning labelingProvides incentives for SNDAs Mandates pediatric testing of pediatric drugs

Medicare Prescription Drug Medicare Prescription Drug Improvement and Improvement and

Modernization Act of 2003Modernization Act of 2003

NOT part of FDCANOT part of FDCA Medicare Modernization ActMedicare Modernization Act or or MMAMMA) produced ) produced

the largest overhaul of Medicare in the public health the largest overhaul of Medicare in the public health program's 38-year historyprogram's 38-year history..

Medicare Part DMedicare Part DIts most touted change is the introduction of an entitlement benefit for Its most touted change is the introduction of an entitlement benefit for prescription drugs, through tax breaks and subsidies.prescription drugs, through tax breaks and subsidies.

In the years since Medicare's creation in 1965, the role of prescription In the years since Medicare's creation in 1965, the role of prescription drugs in U.S. patient care has significantly increased. As new and drugs in U.S. patient care has significantly increased. As new and expensive drugs have come into use, patients, particularly senior expensive drugs have come into use, patients, particularly senior citizens for whom Medicare was designed, have found prescriptions citizens for whom Medicare was designed, have found prescriptions harder to afford. The MMA, is meant to address this problem.harder to afford. The MMA, is meant to address this problem.

Related Federal IssuesRelated Federal Issues

Off-label Prescribing Off-label Prescribing Off-Label Marketing Off-Label Marketing LabelingLabeling

– Package Inserts Package Inserts – Patient Package Inserts Patient Package Inserts

Drug Recalls Drug Recalls – I, II, IIII, II, III– Who initiatesWho initiates– FDA limitationsFDA limitations

Postal RegulationsPostal Regulations

New Drug IssuesNew Drug Issues

NDAANDASNDAIND

Clinical Trials, Phase 1, 2, 3

Post-Marketing Surveillance

Second SectionSecond Section

Michigan Pharmacy LawMichigan Pharmacy Law

The “Practice of Pharmacy”The “Practice of Pharmacy”

A A personperson shall not shall not engageengage in the in the practice practice

of pharmacyof pharmacy unless unless licensedlicensed or or otherwise otherwise

authorizedauthorized by this by this articlearticle..

Know This:Know This:

What does “engage” mean?What does “engage” mean?

No Public Health Code Definition, therefore, use No Public Health Code Definition, therefore, use ordinary meaning.ordinary meaning.

http://www.dictionary.com/search?q=engagehttp://www.dictionary.com/search?q=engage1. To obtain or contract for the services of; employ:

engage a carpenter. 2. To arrange for the use of; reserve: engage a

room. To pledge or promise, especially to marry. 3. To attract and hold the attention of; engross: a

hobby that engaged her for hours at a time. 4. To win over or attract: His smile engages

everyone he meets.

Practice of PharmacyPractice of Pharmacy

"Practice of pharmacy" means a health service, the clinical application of which includes the encouragement of safety and efficacy in the prescribing, dispensing, administering, and use of drugs and related articles for the prevention of illness, and the maintenance and management of health.

Practice of PharmacyPractice of Pharmacy

Professional functions associated with the practice of pharmacy include:(a) The interpretation and evaluation of the prescription.(b) Drug product selection.(c) The compounding, dispensing, safe storage, and distribution of drugs and devices.(d) The maintenance of legally required records.(e) Advising the prescriber and the patient as required as to contents, therapeutic action, utilization, and possible adverse reactions or interactions of drugs.

LicenseLicense

"License," except as otherwise provided in this subsection, means an authorization issued under this article to practice where practice would otherwise where practice would otherwise be unlawfulbe unlawful..

LicenseLicense

License includes an authorization to use a designated title which use would otherwise be prohibited under this article and may be used to refer to a health profession subfield license, limited license, or a temporary license.

TitlesTitles

1. R.Ph. (Registered Pharmacist

2. Chemist

3. Apothecary

4. Doctor

LicenseLicense

For purposes of the definition of “prescriber” contained in section 17708(2) only, license includes an authorization issued under the laws of another state, or the country of Canada, to practice in that state, or the country of Canada, where practice would otherwise be unlawful, and is limited to a licensed doctor of medicine, a licensed doctor of osteopathic medicine and surgery, or another licensed health professional acting under the delegation and using, recording, or otherwise indicating the name of the delegating licensed doctor of medicine or licensed doctor of osteopathic medicine and surgery.

““this article”this article”

Article 15

Occupations

““otherwise authorized”otherwise authorized”

Under the circumstances and subject to the limitations stated in each case, the following individuals are not required to have a license issued under this article for practice of a health profession in this state:

(a) A student in a health profession training program, which has been approved by the appropriate board, while performing the duties assigned in the course of training.

““otherwise authorized”otherwise authorized”

(c) An individual who by education, training, or experience substantially meets the requirements of this article for licensure while rendering medical care in a time of disaster or to an ill or injured individual at the scene of an emergency.(d) An individual who provides non-medical nursing or similar services in the care of the ill or suffering or an individual who in good faith ministers to the ill or suffering by spiritual means alone, through prayer, in the exercise of a religious freedom, and who does not hold himself or herself out to be a health professional.(e) An individual residing in another state or country and authorized to practice a health profession in that state or country who, in an exceptional circumstance, is called in for consultation or treatment by a health professional in this state.(f) An individual residing in another state or country and authorized to practice a health profession in that state or country, when attending meetings or conducting lectures, seminars, or demonstrations under the auspices of professional associations or training institutions in this state, if the individual does not maintain an office or designate a place to meet patients or receive calls in this state.

A person shall not engage in the practice of pharmacy unless licensed or otherwise authorized by this article.

Sec. 17711

Professional ConductProfessional Conduct

Rule 20

Professional responsibilityProfessional responsibility

A pharmacist has a professional responsibility for the strength, quality, purity, and the labeling of all drugs and devices dispensed under a prescription. In discharging this responsibility, a pharmacist shall utilize only those drugs and devices that are obtained from manufacturers and wholesale distributors licensed under section 17748 of the code or from other lawful channels of distribution.

The “Long-Arm” StatuteThe “Long-Arm” Statute

A pharmacy, manufacturer, or wholesale distributor of prescription drugs, whether or not located in this state but doing business in this state, shall be licensed by the board in accordance with this part. Licenses shall be renewed biennially. A pharmacy, manufacturer, or wholesale distributor may designate an individual to be the licensee for the pharmacy, manufacturer, or wholesale distributor and the licensee is responsible for compliance with this part.

Rule 20 (2)Rule 20 (2)

A pharmacist shall not fill a prescription order if, in the pharmacist's professional judgment, any of the following provisions apply:

(a) The prescription appears to be improperly written.

(b) The prescription is susceptible to more than 1 interpretation.

(c) The pharmacist has reason to believe that the prescription could cause harm to the patient.

(d) The pharmacist has reason to believe that the prescription will be used for other than legitimate medical purposes.

Logic: for a statement to be Logic: for a statement to be true, the opposite must also true, the opposite must also

be true.be true.

1. Does that mean that if those 4 conditions are not present, the pharmacist SHALL fill all other prescriptions? Can a pharmacist refuse to fill a prescription for any reason or even for no reason?

2. Is Professional Judgment subjective or objective?

Rule 20 (3)Rule 20 (3)

A prescription drug shall only be dispensed when the pharmacy is open and under the personal charge of a pharmacist.Sec. 17763. In addition to the grounds set forth in part 161, the disciplinary subcommittee may fine, reprimand, or place a pharmacist licensee on probation, or deny, limit, suspend, or revoke the license of a pharmacist or order restitution or community service for a violation or abetting in a violation of this part or rules promulgated under this part, or for 1 or more of the following grounds:(d) Permitting the dispensing of prescriptions by a pharmacist intern, except in the presence and under the personal charge of a pharmacist.

Personal ChargePersonal Charge

"Personal charge" means the immediate physical presence of a pharmacist or dispensing prescriber.

Rule 20 (4)Rule 20 (4)

To encourage intended, positive patient outcomes, a pharmacist shall communicate, to the patient or the patient's caregiver, necessary and appropriate information regarding safe and effective medication use at the time a prescription is dispensed. As used in this subrule, "caregiver" means the parent, guardian, or other individual who has assumed responsibility for providing a patient's care. All of the following provisions apply to communicating medication safety and effectiveness information:

Shall CommunicateShall Communicate

(a) The information shall be communicated orally and in person, except when the patient or patient's caregiver is not at the pharmacy or when a specific communication barrier prohibits oral communication. In either situation, providing printed material designed to help the patient use the medication safely and effectively satisfies the requirements of this subrule.

(b) The information shall be provided with each prescription for a drug not previously prescribed for the patient.

(c) If the pharmacist deems it appropriate, the information shall be provided with prescription refills.

(d) The information shall be provided if requested by the patient or patient's caregiver or agent for any prescription dispensed by the pharmacy. This subrule does not require that a pharmacist provide consultation if a patient or a patient's caregiver refuses consultation. This subrule does not apply to prescriptions dispensed for administration to a patient while the patient is in a medical institution.

Important DistinctionsImportant Distinctions

Personal Charge §17707 (1)

Supervision §16109(2)

Delegation §16215 and Rule 20(5)

Supervision §16109(2)Supervision §16109(2)

“the overseeing of or participation in the work of another individual by a health professional licensed under this article in circumstances where at least all of the following conditions exist:

(a) The continuous availability of direct communication in person or by radio, telephone, or telecommunication between the supervised individual and a licensed health professional.

(b) The availability of a licensed health professional on a regularly scheduled basis to review the practice of the supervised individual, to provide consultation to the supervised individual, to review records, and to further educate the supervised individual in the performance of the individual’s functions.

(c) The provision by the licensed supervising health professional of

predetermined procedures and drug protocol.”

Delegation Rule 20 (5)Delegation Rule 20 (5)

Pharmacist delegation of acts, tasks, or functions shall be in compliance with section 16215 of the code and under the personal charge of the delegating pharmacist, except as provided in R 338.486(3).

§16215§16215

(1) A licensee who holds a license other than a health profession subfield license may delegate to a licensed or unlicensed individual who is otherwise qualified by education, training, or experience the performance of selected acts, tasks, or functions where the acts, tasks, or functions fall within the scope of practice of the licensee's profession and will be performed under the licensee's supervision. An act, task, or function shall not be delegated under this section which, under standards of acceptable and prevailing practice, requires the level of education, skill, and judgment required of a licensee under this article.

§16215§16215

Except as otherwise provided in this subsection, a licensee under part 170 or 175 shall delegate an act, task, or function that involves the performance of a procedure that requires the use of surgical instrumentation only to an individual who is licensed under article 15. This subsection does not apply if the unlicensed individual is 1 or more of the following and if the procedure is directly supervised by a licensed physician or osteopathic physician who is physically present during the performance of the procedure or if the unlicensed individual is performing acupuncture:(a) A student enrolled in a school of medicine or osteopathic medicine approved by the Michigan board of medicine or the Michigan board of osteopathic medicine and surgery.(b) A student enrolled in a physician's assistant training program approved by the joint physician's assistant task force created under part 170.

§16215§16215

(3) A board may promulgate rules to further prohibit or otherwise restrict delegation of specific acts, tasks, or functions to a licensed or unlicensed individual where the board determines that the delegation constitutes or may constitute a danger to the health, safety, or welfare of the patient or public.(4) To promote safe and competent practice, a board may promulgate rules to specify conditions under which, and categories and types of licensed and unlicensed individuals for whom, closer supervision may be required.(5) An individual who performs acts, tasks, or functions delegated pursuant to this section does not violate the part which regulates the scope of practice of that health profession.

……under personal charge.. except as under personal charge.. except as provided in R 338.486(3)provided in R 338.486(3)

R 338.486 "Medical institution" and "pharmacy services" defined; pharmacy

services in medical institutions.

Rule 16(3) Pharmacy personnel who assist the pharmacist by performing delegated functions in the care of inpatients shall be supervised by a pharmacist who is on the premises of the medical institution.

Delegation Rule 20(5)Delegation Rule 20(5)

A pharmacist who delegates acts, tasks, or functions to a licensed or unlicensed person shall do all of the following:

(a) Determine the knowledge and skill required to safely and competently complete the specific act, task, or function to be delegated.

(b) Before delegating an act, task, or function, make a determination that the delegatee has the necessary knowledge and skills to safely and competently complete the act, task, or function.

(c) Provide written procedures or protocols, or both, to be followed by the delegatee in the performance of the delegated act, task, or function.

(d) Supervise and evaluate the performance of the delegatee.(e) Provide remediation of the performance of the delegatee if

indicated.Note: Inclusive, all 5 requirements

Rule 20 (6)Rule 20 (6)

A delegating pharmacist shall bear the ultimate responsibility for the performance of delegated acts, tasks, and functions performed by the delegatee within the scope of the delegation.

“While a task may be delegable, the responsibility associated with the proper performance of it is never delegable.”

The Practice of PharmacyThe Practice of Pharmacy

The pharmacists on duty are responsible for compliance with federal and state laws regulating the distribution of drugs and the practice of pharmacy.

The pharmacist “in charge” has ultimate responsibility.

Are there any special rules for Are there any special rules for “institutional” pharmacy “institutional” pharmacy

practice?practice?

Institutionhospitalskilled nursing facilities county medical care facilities, nursing homes other health facilities licensed or approved by the state that:

– directly or indirectly provide or include pharmacy services.

Not “Institutions”Not “Institutions”

assisted living homes, adult foster care facilities, group homes for the physically or mentally

impaired, other unique settings

Governed under the standard community pharmacy rules

Many community-based retail pharmacies Many community-based retail pharmacies may also contract with a nursing home or may also contract with a nursing home or

other medical institution to provide other medical institution to provide

pharmacy servicespharmacy services the retail portion of the business would be

governed by the typical community pharmacy rules

the institutional part of the practice is governed by the institutional rules.

The director of pharmacy services in an The director of pharmacy services in an institutional practice has unique institutional practice has unique

responsibilities.responsibilities.

develop, implement, supervise and coordinate all pharmacy services

minimizes additional preparation before administration to the patient, including the admixture of parenteralsadopt a process that will permit the pharmacy to obtain the prescriber’s original medication order, a direct carbonized copy or an electromechanical facsimile

• an order for a drug or device in the patient’s chart constitutes the original prescription

monitoring medication orders to evaluate clinically significant chemical and therapeutic incompatibilities

Institutional Director of Institutional Director of PharmacyPharmacy

providing educational programs for the medical institution’s personnel and patients regarding medications and their safe use

establishing the specifications for the procurement of all pharmaceuticals, biologicals and chemicals approved for use in the medical institution.


institutions are required to establish an interdisciplinary practitioners’ committee (usually called the Pharmacy & Therapeutics or P&T Committee) that makes recommendations for formulary or approved drugs

the pharmacist director is required to adopt written policies and

procedures that promote safe medication practices, to conduct medication utilization reviews and to approve medications for the medical institution’s formulary or medication list

director also is required to meet with the committee at least quarterly to address these responsibilities

make the policies, procedures and written reports required under these provisions available to the Board of Pharmacy, if requested


devising methods of interpreting and reviewing the prescriber’s medication orders and communicating this interpretation before administration of the first dose

however, if communicating this interpretation will cause a medically unacceptable delay, a limited number of medications and their doses, ordinarily called “floor stock,” may be kept in the patient care areas

Institutional Floor StockInstitutional Floor Stock

stored in a manner that ensures immediate availability

Securedsealed or secured medication kits, carts or treatment trays

a pharmacist routinely inspects the medications

Non-24 hour Institutional Non-24 hour Institutional PharmaciesPharmacies

establish a method by which medications can be obtained during the absence of a pharmacist that minimizes the potential for medication errors.

the services of a pharmacist are available on an on-call basis a limited number of medications that are packaged in “unit of use” (or unit-dose

packaging) may be made available in a securely locked, substantially constructed cabinet in an area of limited access in a centralized area outside the pharmacy

list of medications kept in this “after hours” lock box has to be approved and reviewed at least quarterly by the P&T Committee

Each medication kept in the after hours box has to be labeled to include the name of the medication, the strength, the expiration date (if dated) and the lot number

A written order and a proof of removal and use document have to be obtained for each medication unit removed.

order has to be reviewed by a pharmacist within 48 hours of the removal of the medication from the cabinet.

director is required to designate which practitioners will be permitted to remove the medications from the box.

an audit of the box as often as needed to guarantee control, but not less than once every 30 days.

Central Fill Pharmacies Central Fill Pharmacies

processing by a pharmacy of a request from another pharmacy to fill or refill a prescription drug order or to perform processing functions such as dispensing, performing drug utilization review, completing claims adjudication, obtaining refill authorizations, initiating therapeutic interventions, and other functions related to the practice of pharmacy

Central Fill Pharmacies RecordsCentral Fill Pharmacies Records

(a) the date the request for centralized prescription processing services was received from the originating pharmacy;

(b) the name and address of the originating pharmacy from which the request for centralized prescription processing services was received;

(c) the date the prescription was processed, verified, or filled; (d) the identification of any pharmacist who was responsible

for processing the prescription and shipping a filled prescription to an originating pharmacy or delivering a filled prescription to a patient or a patient's agent;

(e) the date the filled prescription was shipped to the originating pharmacy or was shipped or delivered to the patient or the patient's agent;

(f) if shipped, the name and address of the patient to whom the filled prescription was shipped; and

(g) the method of delivery, such as private, common, or contract carrier, if shipped.

Pharmacy OwnershipPharmacy Ownership

25% rule unenforceable any legal entity that is not disqualified from

ownership may own a pharmacy Sole proprietorship

Corporation• Public• Private

Designation of “licensee” required

Changes in OwnershipChanges in Ownership

A partnership, corporation or entity operating under an assumed name must provide the Board with written notification of a change in any of the partners, stockholders, officers or members of the board of directors.

The reporting requirement does not apply to publicly held corporations.

A change in the individual pharmacist who is designated as the pharmacy licensee of a licensed pharmacy must be reported.

30 days. Pharmacy licenses are not transferable between

owners

Pharmacy LicensesPharmacy Licenses

The application for a new pharmacy license must describe the premises and include pictures of both the interior and exterior of the pharmacy.

A Self-Inspection Form must be obtained, completed and sent in with the application. If an existing licensed pharmacy moves to a new location, it also must apply and be approved for a new license before moving.

DEA Notification

LicensesLicenses

PharmacyPharmacistIntern

Generally Valid 2 Years• Sometimes only 1 year initially

Renew on July 1DEA Registration

Generally Valid 3 Years

Pharmacist LicensePharmacist License

At least 18 “Good Moral Character”

propensity to serve the public in a fair, open, and honest manner

Moral turpitude

Education: Accredited College Working Knowledge of English Language Fingerprints, Criminal Background Check

Reciprocity: Reciprocity: “Licensure by Endorsement” “Licensure by Endorsement”

Transfer of license between states (or Canada until 2012)

Other state must reciprocate with state to which transfer is sought.

• Assumes pass NAPLEX in one state

Must take MPJE for transfer state (75%)• Six Tries or Go To Back to Jail (School)

Drug Control LicenseDrug Control License

Prescribers (other than Vets) that dispense drugs directly to own patients must apply for license from Board of Pharmacy.

Not required for emergency hospital/trauma centerNot required for “complimentary starter dose” (samples-PDMA)

Labeling, recordkeeping, storage

CE RequirementsCE Requirements

30 accredited hours during two year license period (Not 15o/yr)

Theory only: “proficiency exam” One CE: pain and symptom management 10 hours “live” May 12o/24o

Must receive Date Earned Certification before Renewal Date

Waivers

CE Requirements: TopicsCE Requirements: Topics

(a) social, psychological, economic and legal aspects of healthcare delivery;

(b) properties and actions of drugs and dosage forms; (c) etiology, characteristics and therapeutics of the

disease state; (d) emergency skills; (e) specialized professional services; and (f) other areas of study that the board finds are designed

to maintain or enhance a pharmacist’s ability to deliver competent pharmacy services

PreceptorsPreceptors

A pharmacist who is approved by the Board of Pharmacy to direct the training of a pharmacy intern in a pharmacy that is Board-approved to provide such training

One year license as RPh required Intern Responsible to Make Sure Preceptor License

is Current at Time of Certifying Internship Hours and Affidavit of Qualification to Become Pharmacist

PreceptorsPreceptors

Responsible for the overall internship training program in a pharmacy

Internship training and hours only need by under personal charge of a pharmacist

does not have to be the preceptor (who supervises)

no more than two interns per pharmacist may be on duty in a pharmacy at any given time

• Tech ratio repealed

Preceptor must Train Intern” Preceptor must Train Intern”

pharmacy administration and management; drug distribution, use and control; legal requirements; provision of health

information services, consultations with patients; pharmacists’ ethical and professional

responsibilities; and knowledge of drug and product information

Preceptor Signature RequiredPreceptor Signature Required

annual internship training affidavits certify the number of hours an intern has worked over a given period of time and that the intern is receiving training and experience in the required areas of practice

required to issue an opinion on the ability of the intern to practice pharmacy without supervision at end of internship

Internship RequirementsInternship Requirements

an educational program of professional and practical experience

licensed by the Board for the purpose of obtaining instruction in the practice of pharmacy from a preceptor

“limited pharmacist license”educational pharmacist license

Internship RequirementsInternship Requirements

when eligible, a student must apply for licensure as an intern eligible at the beginning of the first professional year (requirement for this course)

Must submit application and pay fee Prove Enrolled in Pharmacy School

we do dat License NUMBER good until become RPh or up to one year

after graduationPay renewal fee annuallyLapses: leave of absence for 1 year

See Text for other requirements


Part E: DrugsCompare how drugs are regulated in

Michigan with Federal lawAdulteration

Misbranding• Especially Note Labeling Differences

– Community– Institution

Do drugs sold in Michigan have to be Do drugs sold in Michigan have to be marked with special numbers or marked with special numbers or

symbols?symbols?

All solid oral dosage forms of prescription-only drugs manufactured or distributed in Michigan must be prominently marked or imprinted with an individual symbol, number, company name, words, letters, marking, national drug code or a combination of any of these that identifies the prescription drug and the manufacturer or distributor of the drug

Distributor must give key to MDCH $25,000 penalty Same sort of federal law

““Harmful Drug” = §503(b)Harmful Drug” = §503(b)(1)(1)

Intended to be used by “human beings” Is harmful because of its toxicity, habit-forming nature, or other

potential adverse effect, the method of its use, or the collateral measures necessary to its safe and effective use, and which is designated as harmful by the board

A “harmful drug” may be dispensed only as a “prescription drug”

drug dispensed pursuant to a prescription, a drug bearing the federal legend “CAUTION: federal law prohibits dispensing without a prescription,” or a drug designated by the board as a drug that may only be dispensed pursuant to a prescription. Caution: Rx only

Deleterious Drug Deleterious Drug

a drug, other than a proprietary medicine, that is likely to be destructive to adult human life in quantities of 3.88 grams or less.

Importance ?????

Michigan Version of PPPAMichigan Version of PPPA

IdenticalPPPA “preempts” inconsistent state lawRequest for Non-Safety Caps

Law: Does not have to be in writing

LAWYER: MUST BE IN WRITING


Chapter 4 –Dispensing and Prescribing

Part A–The Prescription

What is a What is a Prescription?Prescription?

An orderfor drugs (both Rx-only and OTC) or devices written and signed or transmitted by other means of communication, including oral telephone orders and those received electronically

for drugs or devices written and signed or transmitted by other means of communication, including oral telephone orders and those received electronically

What is a Prescription?What is a Prescription?

Do not be confused about whether a drug is Rx-only or OTC-

With whether a third-party will pay for it or notDon’t confuse regulatory laws with—

Contract laws

Third Class of DrugsThird Class of Drugs

Behind the Counter (BTC)Emergency Contraceptives

• Plan B for women over 17 y/o

Pseudoephedrine

OTC Schedule V• Cough Syrups• Anti-diarrheals

Communication of an OrderCommunication of an Order

traditional handwritten or typed piece of paper telephone fax (facsimile) “electronic prescribing”

e-prescribing

e-script

Communication of an OrderCommunication of an Order

Information on order depends on:How communicated

What Kind of drug is ordered• Controlled• Non-controlled

Where order comes from

Type of pharmacy order goes to

Distinguish Communication Distinguish Communication and Prescribingand Prescribing

Prescribing is act of orderingCommunication of a prescription is not

prescribing

Uniform RequirementsUniform Requirements

name of the patient, name of the drug being ordered, dosage of the drug, date the prescription is being originated (also called the date the

prescription was “issued”) and directions for use of the drug,

number of times a day the drug is to be administered to or by the patient over a 24-hour day.

The name, address and phone number of the prescriber must appear on the vast majority of prescriptions;

this is not always required for prescriptions that originate in an institutional setting, such as a hospital, if there have been arrangements for recording the prescriber’s name differently.

Don’t confuse this information with “labeling”

Unique Prescribing SituationsUnique Prescribing Situations

Electronic prescribing encouraged because many of the prescription drug errors made in the healthcare spectrum are caused by poor communication

But: “Junk in-Junk out” problem• Especially dangerous with refills

Electronic Signatures in Global Electronic Signatures in Global and National Commerce Act of and National Commerce Act of

20002000

ESIG PL 106-229 enacted June 30, 1999, (SB 761) and

(HB 1714 IH); 15 USC 7001 and effective October 1, 2000

See Vivian, JC, “E Signatures in Pharmacy Practice,” U.S. Pharmacist, Vol. 26: 02, February 2001

E-SIGE-SIG

A signature cannot be denied legal effect solely because it is in electronic form

DEA has been developing standards for electronic transmission of prescriptions using digital security technology.

Not yet for C-IIs Centers for Medicare and Medicaid Services (CMS) has

adopted standards for electronically transmitted prescriptions that are subject to Medicare Part D benefits

Other Prescribing Other Prescribing RequirementsRequirements

Noncontrolled substances federal legend electronic prescriptions in community (retail) pharmacies

Controlled substance federal legend electronic prescriptions

Handwritten, noncontrolled substances prescriptions in the community setting

PA or NP name and delegating physician name

Handwritten, controlled substances prescriptions in the community setting

Oral nonemergency federal legend controlled substances prescriptions in community pharmacy

Other Prescribing Other Prescribing RequirementsRequirements

Nonemergency federal legend prescriptions in medical institutions (both controlled substance and noncontrolled substance drugs)

Delegated prescribing in medical institutions Emergency controlled substance prescriptions in

medical institutions Emergency controlled substance prescriptions in

medical institutions Federal legend controlled substances prescriptions

for terminally ill patients

RefillsRefills

Refills for federal legend controlled substance prescriptions

No C-II Refills• Partial Fills

– Out-of-stock:72 hours– Terminally Ill: 60 days

C-III and C-IV: 5x in 6 monthsC-V: as written (up to 1 year

90 days for C-IIs with date of next fill

Pre-Printed Rx Blanks-Rule 9bPre-Printed Rx Blanks-Rule 9b

(3) A prescriber shall not prescribe more than the following on a single prescription form as applicable: (a) For a prescription prescribed in handwritten form, up to 4 prescription drug orders.

(b) For a prescription prescribed on a computer-generated form or a preprinted list or produced on a personal computer or typewriter, up to 6 prescription drug orders.

(4) A prescriber shall not add handwritten drugs to a preprinted form and shall clearly designate which drugs are to be dispensed.

(5) A prescriber shall not prescribe a controlled and noncontrolled substance on the same prescription form

What if Prescriber Deviates What if Prescriber Deviates from Rule 9b Requirements?from Rule 9b Requirements?

Fix it. The rule was adopted to avoid pharmacy errors

caused by messy handwriting and attempts by prescribers to cram the most amount of information into the smallest area.

If there are any doubts about the accuracy of any prescription order caused by these kinds of issues, the prescriber should be consulted before dispensing.

Can controlled substance and noncontrolled Can controlled substance and noncontrolled substance prescription drugs appear on the same substance prescription drugs appear on the same

written prescription form?written prescription form?

NoFix it.

Mail-Order RxMail-Order Rx

Old Law: Can’t dispense by mail if Rx received by mail

Current Law: WhateverFederal Post Office Regulations

Locum Tenens

Why you can’t find this in the statutes or regulations

Vending MachinesVending Machines

http://www.instymeds.com/“The Future of Physician Dispensing is Here!”

The safety and security of an ATM with the simplicity of a soda machine! InstyMeds is the solution for providing outpatient prescription medication services 24 hours a day, 7 days a week, at the point-of-care.The InstyMeds Prescription Medication Dispenser is the health care industry's first fully-automated, ATM-style dispenser of acute prescription medications. State-of-the-art InstyMeds technology ensures safe and secure dispensing of prescription medications directly to patients at the point-of-care

Vending MachinesVending Machines

The use of any mechanical device that is designed for the specific purpose of selling, dispensing or otherwise disposing of any drug or device ordered by a prescription is regulated by the Board in two different ways. There is one General Rule that applies to all automated drug vending devices. There are separate provisions in the Controlled Substance Rules applying to vending devices used to dispense controlled substances in medical institutions, as well as nursing homes, county medical care facilities, hospices and the office of a dispensing prescriber.[1] The rule expressly prohibits a pharmacy from owning, controlling or operating a device used to dispense federal legend drugs located within a prescriber’s office [1] General Rule 19; R 338.489 and Controlled Substance Rules 32; R 3383132 and 54 (4); R 338.3154

Prescription CopiesPrescription Copies

Transfer Between PharmaciesIndependents

Chains linked by on-time real-time databases

Controlled vs. Rx-onlyCS: 1x only

Procedures and Record-Keeping Non-Transfer: “For informational or reference

purposes only”

Rx Record-KeepingRx Record-Keeping

MichiganRx: 5 years minimum from date of last fill or refill ALL PRESCRIPTIONS

• Could be 6 years• Don’t confuse 3rd party contracts

– Medicaid, Blue Cross: 7-8 years

Federal2 years CS scripts2 years CS Invoices2 Years C-II Form 222 orders

Record Retention Policy

Confidentiality of Rx RecordsConfidentiality of Rx Records

“not public”Patient permissionAnother pharmacist assisting patientGovernment (inspectors, policeCourt orderApproved research

HIPAANo PHI except for TPO

Beware “confidentiality” vs. “privilege”

PrescribingPrescribing

Who can Prescribe §503(b) drugs in Michigan?“Prescribing is limited to a Prescriber”

Distinguish prescribing and dispensing

Depends on Location of prescriber’s license

–Michigan–Other state–Canada

Which kind of prescriber–Independent: MD, DO, DP, DDS, DV, “special” OD–Dependant: MD or DO’s: PA or NP

Prescriber’s scope of practiceKind of drug being prescribed

–Non-Controlled–Controlled

Prescribing TerminologyPrescribing Terminology

qd hs bid tid Qid au, as, ad ou, os, od http://en.wikipedia.org/wiki/

List_of_abbreviations_used_in_medical_prescriptions

Vivian’s CommandmentVivian’s Commandment

Thou shalt not dispense without prescriptive authority.Prescriptive authority dies with the prescriber No rule is a good rule unless there are exceptions to the rule

•unless you need to

Independent PrescribingIndependent Prescribingvs.vs.

Dependent PrescribingDependent Prescribing

Independent---Because of Scope of Practice“Physician”

• RDs: State and Canada MDs, DOs, • FDs: DDSs, DPMs ,some ODs (special license), DVMs• DCs: can’t prescribe anything in Michigan

– “Is a Chiropractor a Real Doctor?”– http://ezinearticles.com/?Is-a-Chiropractor-a-Real-Doctor?&id=1911538

Dependent—Delegated to Prescribe by MD or DO onlyonlyPas: Max 4 PAs supervised @ 2locations; 2 @ 1 location NPs (dx: LPN, RN, NP), NMs (Nurse Midwife): No ratio

• Name of delegator (physician) AND name of prescriber (NP, NM, PA) on Rx

MAYBE: PharmD (BTC drugs); delegatee?Written protocol (Pharmacy get copy)

All must be “licensed,” not just Degreed

DispensingDispensing

Drug Product Selection (DPSDPS)Generic InterchangeSubstitution---illegalBrand exchange

Brand Name DrugsPatent medicinesProprietary medicinesEthical medicines

Generic DrugsANDA

Brand Name PrescribedBrand Name Prescribed

When a pharmacist receives a prescription for a “brand name” drug product, the “pharmacist maymay, or when a purchaser requests a lower cost, generically equivalent drug product, the pharmacist shallshall, dispense a lower cost but not higher cost generically equivalent drug product if available in the pharmacy” unless the prescriber has prevented a generic interchange----DAW—in own DAW—in own handwritinghandwriting

Don’t confuse 3Don’t confuse 3rdrd party’s that mandate generic interchange party’s that mandate generic interchange

The term “brand name” is defined to mean “the registered trademark name given to a drug product by its manufacturer,” §17702(1)

The term “generically equivalent drug product” is not defined in the statutes or rules. However, based on the definitions of “drug” and “generic name” as used in the statutes, it is understood that the term is referring to a drug that is the exact same chemical entity in the same dosage form and strength as the prescribed drug.

Generic InterchangeGeneric Interchange

Noticeif and when drug product selection or generic interchange has occurred:

• the statute and rule state that the purchaser shall be notified and and the prescription label shall indicate both the name of the brand prescribed and the name of the brand dispensed.

Two levels• the “purchaser” (i.e., the patient or caregiver) be notified that a

generic alternative has been dispensed. Neither the statute nor the rule addresses the issue of whether this particular notice should be oral or in writing.

• Label needs to indicate the “name of the brand [drug] prescribed and the name of the brand dispensed.” UNLESS DO NOT LABELUNLESS DO NOT LABEL

• Generics don’t have Brand names; therefore manufacturer name

Confusion about “GEq”Only applies to multi-ingredient drugs


Post Policydisplay a written notice concerning pricing and generic interchange policies in a “conspicuous” place where it can be read by patients and consumers.

State standards on size and wording

Not apply to institutions


Michigan is NOTNOT an Orange Book stateSome states are:

• Positive or negative Orange Book authorized

There is no MI STATE authorized formulary

Some states: negative or positive formularyDon’t confuse 3rd party contracts that do have formulariesDon’t confuse Medical Institutions or Health Facilities that may have formularies


Cost savings must be passed on to “purchaser”

Who is “purchaser?”• Cash customer• Beneficiary of cost savings—3rd party payor

Cost SavingsDifference between cost of generic drug and cost of brand name drug

• Problem: What is “cost” and how to determine it?

LabelingLabeling

Recall dx bw “label” and “labeling”Discussed in Federal Law Section

Know difs here• ‘label” means “a display of written, printed,

or graphic matter on the immediate container of a drug or device, but does not include package liners

• “labeling” means the labels and other written, printed or graphic matter on a drug or device or its container or wrapper, or accompanying the drug or device

LabelingLabelingDrug is “misbranded” if not properly labeledDrug is “misbranded” if not properly labeled

Manufacturer's labelMichigan and Federal law consistent

Community Pharmacy LabelingVial or Format dispensed to the patient

• name of the medication in the container, unless the prescriber writes ‘do not label’ on the prescription

• “Discard this medication one year after the date it is dispensed,” unless the medication expires on another date under applicable state or federal law or rules or regulations or other state or federal standards. If the medication expires on another date, the pharmacist dispensing the prescription has to strike or omit the statement and, instead, specify on the label the actual expiration date of the medication.

Community Pharmacy LabelingCommunity Pharmacy Labeling

(a) Pharmacy name and address (b) Prescription number (c) Patient’s name (d) Date the prescription was most recently

dispensed (e) Prescriber’s name (f) Directions for use (g) The name of the medication, unless the

prescriber indicates “do not label” Remember the altered labeling requirements Remember the altered labeling requirements

if DPS occursif DPS occurs

Community Pharmacy LabelingCommunity Pharmacy Labeling

If C-2, C-3 or C-4 Controlled Drug:Transfer Warning:

• “Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.”

Not Required for C-5Standard of practice: many pharmacies

include warning on all dispensed labelsIs not required except as above

Community “Labeling:” Receipts Community “Labeling:” Receipts

all prescriptions dispensed in community pharmacies must be accompanied by prescription drug receipts

may appear on the prescription label, on the receipt or on a combination of the receipt and the label

Name of drug unless “do not label”Remember generic interchange labeling

Date most recently dispensed Price paid by patient (not insurer) Retain copy of receipt for 90 days

Other LabelingOther Labeling

C-5 OTCsVending Machines

Hospice BoxesInstitutional Labeling

Multidose vials

Unit of Use Packaging• “Unit Dose”

Refills DocumentationRefills Documentation

Three optionsSelect one and use only one

Back of script

Hardcopy log

Electronic (Computer) recording

Remember different records needed if DPS occurs

Complimentary Starter DosesComplimentary Starter Doses

“prescription drugs packaged, dispensed and distributed in accordance with state and federal law that are provided to a dispensing prescriber free of charge by a manufacturer or distributor and dispensed free of charge by the dispensing prescriber to his or her patients.”

Called “samples” under federal lawRemember PDMA

Recall limitations on what kind of pharmacies can have samples and under what conditions and what the penalties are for illegal possession

Customized Patient Customized Patient Medication Packages Medication Packages

For “gray area” Unique Living Situations that do not clearly fit “community” or “institutional” practice.

Applies only to solid oral dosage forms Must have consent of patient (or caregiver) and

prescriber Follow special labeling, restocking, recordkeeping

rules

Hospice DispensingHospice Dispensing

For “gray area” btw community and institutional practice.

See Text for Special Rules

Miscellaneous ProvisionsMiscellaneous Provisions

Returns of drugs to pharmacies

Max 5% distribution and compounding

Section ThreeSection Three

Controlled Substances Statutes and Regulations

Federal Law

and

Michigan Law

Federal CS LawsFederal CS Laws

DEA implements the Comprehensive Drug Abuse Prevention and Control Act of

1970, often referred to as the Controlled Substances Act (CSA) and the Controlled Substances Import and Export Act (21 U.S.C. 801-971).

DEA publishes the implementing regulations for these statutes in Title 21 of the Code of Federal Regulations (CFR), Parts 1300 to 1399.

Federal CS LawsFederal CS Laws

These regulations are designed to ensure an adequate supply of controlled substances for legitimate medical, scientific, research, and industrial purposes, and to deter the diversion of controlled substances to illegal purposes.

The CSA mandates that DEA establish a closed systemclosed system of control for manufacturing, distributing, and dispensing controlled substances.

Any person who manufactures, distributes, dispenses, imports, exports, or conducts research or chemical analysis with controlled substances must register with DEA (unless exempt) and comply with the applicable requirements for the activity.

Controlled SubstancesControlled Substances

Drugs and other substances that have a potential for abuse and psychological and physical dependence;

These include opioids, stimulants, depressants, hallucinogens, anabolic steroids, and drugs that are immediate precursors of these classes of substances.

• Notice word “narcotic” is not present

Five SchedulesFive Schedules

Schedule I substances have a high potential for abuse and have no currently accepted medical use in treatment in the United States. These substances may only be used for research, chemical analysis, or manufacture of other drugs.

Schedule II – V substances have currently accepted medical uses in the United States, but also have potential for abuse and psychological and physical dependence that necessitate control of the substances under the CSA. The vast majority of Schedule II, III, IV, and V controlled substances are available only pursuant to a prescription issued by a practitioner licensed by the State and registered with DEA to dispense the substances.

Overall, controlled substances constitute between 10 percent and 11 percent of all prescriptions written in the United States.

Written and Oral PrescriptionsWritten and Oral Prescriptions

The CSA provides that a controlled substance in Schedule II may only be dispensed by a pharmacy pursuant to a “written prescription,” except in emergency situations (21 U.S.C. 829(a)).

In contrast, for controlled substances in Schedules III and IV, the CSA provides that a pharmacy may dispense pursuant to a “written or oral prescription.” (21 U.S.C. 829(b)).

Where an oral prescription is permitted by the CSA, the DEA regulations further provide that a practitioner may transmit to the pharmacy a facsimile of a written, manually signed prescription in lieu of an oral prescription (21 CFR 1306.21(a)).

Legitimacy of a CS RxLegitimacy of a CS Rx

For a prescription for a controlled substance to be valid, it must be issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice (United States v. Moore, 423 U.S. 122 (1975); 21 CFR 1306.04(a)).

Corresponding ResponsibilityCorresponding Responsibility

“The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription.”

(21 CFR 1306.04(a)). It is the individual practitioner (e.g., physician, dentist, veterinarian, nurse

practitioner) who issues the prescription authorizing the dispensing of the controlled substance.

This prescription must be issued for a legitimate medical purpose and must be issued in the usual course of professional practice.

The individual practitioner is responsible for ensuring that the prescription conforms to all legal requirements.

The pharmacist, acting under the authority of the DEA-registered pharmacy, has a corresponding responsibility to ensure that the prescription is valid and meets all legal requirements.

The PrescriptionThe Prescription

A prescription is much more than the mere method of transmitting dispensing information from a practitioner to a pharmacy.

The prescription serves both as a record of the practitioner’s determination of the legitimate medical need for the drug to be dispensed, and as a record of the dispensing, providing the pharmacy with the legal justification and authority to dispense the medication prescribed by the practitioner.

The prescription also provides a record of the actual dispensing of the controlled substance to the ultimate user (the patient) and, therefore, is critical to documenting that controlled substances held by a pharmacy have been dispensed legally.

The maintenance by pharmacies of complete and accurate prescription records is an essential part of the overall CSA regulatory scheme.

Unique LawUnique Law

The Controlled Substances Act is unique among criminal laws in that it stipulates acts pertaining to controlled substances that are permissible. That is, if the CSA does not explicitly permit an action pertaining to a controlled substance, then by its lack of explicit permissibility the act is prohibited.

PunishmentPunishment

Violations of the Act can be civil or criminal in nature, which may result in administrative, civil, or criminal proceedings.

Remedies under the Act can range from modification or revocation of DEA registration, to civil monetary penalties or imprisonment, depending on the nature, scope, and extent of the violation.

ViolationsViolations

It is unlawful for any person knowingly or intentionally to manufacture, distribute, or dispense, a controlled substance or to possess a controlled substance with the intent of manufacturing, distributing, or dispensing that controlled substance, except as authorized by the Controlled Substances Act (21 U.S.C. 841(a)(1)).

It is unlawful for any person knowingly or intentionally to possess a controlled substance unless such substance was obtained directly, or pursuant to a valid prescription or order, issued for a legitimate medical purpose, from a practitioner, while acting in the course of the practitioner’s professional practice, or except as otherwise authorized by the CSA (21 U.S.C. 844(a)).

It is unlawful for any person to knowingly or intentionally acquire or obtain possession of a controlled substance by misrepresentation, fraud, forgery, deception, or subterfuge

ViolationsViolations

It is unlawful for any person knowingly or intentionally to use a DEA registration number that is fictitious, revoked, suspended, expired, or issued to another person in the course of dispensing a controlled substance, or for the purpose of acquiring or obtaining a controlled substance (21 U.S.C. 843(a)(2)).

It is unlawful for any person to refuse or negligently fail to make, keep, or furnish any record (including any record of dispensing) that is required by the CSA (21 U.S.C. 842(a)(5)).

It is unlawful to furnish any false or fraudulent material information in, or omit any information from, any record required to be made or kept (21 U.S.C. 843(a)(4)(A)).

Change is A-Comin’Change is A-Comin’

American Recovery and Reinvestment Act. On February 17, 2009, the President signed the American Recovery and Reinvestment Act of 2009 (Recovery Act) (Pub. L. 111-5, 123 STAT. 115).

Among its many provisions, the Recovery Act promotes the "meaningful use" of electronic health records (EHRs) via incentives.

What that MeansWhat that Means

DEA is forced to allow electronic transmission of all CS scripts—including C-IIs.

DEA Regulations and DEA Regulations and Pharmacy PracticePharmacy Practice

The Providers The Providers Dilemma:Dilemma:

Balancing Good Care and Gatekeeper

Duties

Drug LawsDrug Laws

Food and Drug Administration (FDA)Determines if “drug” is “safe” and “effective” and if “prescription” is required for access

Drug Enforcement Agency (DEA)/St. Bd. of Pharmacy

Determines if a “substance” has “abuse” potential and assigns “controlled substance” to a “schedule” (I through V)

FDA and DEA/Bd. Rx jurisdiction is concurrent and independent

“prescription,” “drug” and “controlled substance” status are independent

Policy GoalPolicy Goal

Find way to Maximize Legitimate Medical Use of Abusable Drugs

• minimal intrusion on those with need to access these drugs

While Minimizing Ability of Abusers to Obtain These Drugs

• keep the “bad guys” off drugs

Controlled Substance AccessControlled Substance Access

““Closed” Distribution SystemClosed” Distribution Systemfrom Manufacturer to “Ultimate User”from Manufacturer to “Ultimate User”

total accountabilitytotal accountability

Access determined by LicenseesAccess determined by LicenseesPrescriber at first levelPrescriber at first level

Pharmacist at last levelPharmacist at last level• (Caregiver intervention)(Caregiver intervention)

The Federal Controlled Substances Act The Federal Controlled Substances Act (CSA):(CSA):

21 USC § 829: 21 USC § 829: Written or oral Written or oral ““prescription” prescription”

required required to dispense to dispense controlled substances.controlled substances.

““Prescription” Prescription” Defined:Defined:

21 CFR § 1306.02(f): 21 CFR § 1306.02(f):

An order for medication An order for medication

which is dispensed to or which is dispensed to or

for an ultimate user for an ultimate user

(non-institutional).(non-institutional).

Issuance of a CS Issuance of a CS PrescriptionPrescription

21 CFR § 1306.03: 21 CFR § 1306.03:

AA CS prescription may be CS prescription may be

issued only by an issued only by an

individual practitioner who individual practitioner who

is authorized by state license is authorized by state license

to prescribe and is registered to prescribe and is registered

or exempted from or exempted from registration with the DEAregistration with the DEA

““Corresponding Responsibility” Corresponding Responsibility” 21 CFR § 1306.04: The purpose of a 21 CFR § 1306.04: The purpose of a prescription:prescription:

To be effective, the CS Rx must be To be effective, the CS Rx must be issued for a legitimate medical issued for a legitimate medical purpose by a practitioner acting in the purpose by a practitioner acting in the usual course of professional practice.usual course of professional practice.

The pharmacist has a “corresponding The pharmacist has a “corresponding responsibility” with the prescriber for responsibility” with the prescriber for proper prescribing and dispensing.proper prescribing and dispensing.

An order purporting to be a An order purporting to be a “prescription” is not a “prescription” is not a “prescription”(21 USC §829) if not “prescription”(21 USC §829) if not issued in the usual course of issued in the usual course of professional treatment.professional treatment.

““Corresponding Responsibility” Corresponding Responsibility” 21 CFR § 1306.05: The “form” of a 21 CFR § 1306.05: The “form” of a prescription:prescription:

CS prescriptions must be dated CS prescriptions must be dated and signed that day, have and signed that day, have patient’s name and address, patient’s name and address, prescriber's DEA number and prescriber's DEA number and written in ink, indelible pencil or written in ink, indelible pencil or typewritten.typewritten.

The pharmacist has a The pharmacist has a corresponding corresponding

responsibility to determine that responsibility to determine that prescriptions are issued in this prescriptions are issued in this form.form.

What Does it All MeanWhat Does it All MeanWhat Does it All MeanWhat Does it All Mean

????????????????????????????????????????????????????

A Prescription is NOT a A Prescription is NOT a duck duck !!A Prescription is NOT a A Prescription is NOT a duck duck !!

Dr. Doyou Wanna FeelGood, M.D., F.A.C.S.American Board of Surgical Diplomats

Discount C.S. Pain Clinic1234 Cass Ave., Detroit, Mich.. 48201

Patient's Name: George Fuller Address: 1234 Rivard, Detroit, Mich..

Demerol 100mg#100

SIG: 2-4 tablets every 4-6 hours as needed for pain.

No refills

Dr. Doyou FeelGoodDEA No. 1234563

What is a Duck?What is a Duck?The “see, hear and feel” approach to The “see, hear and feel” approach to defining a thing:defining a thing:

If it looks like a duck...If it looks like a duck...

If it waddles like a duck...If it waddles like a duck...

If it quacks like a duck...If it quacks like a duck...

..Its A Duck!..Its A Duck!

What is a CS What is a CS “Prescription?”“Prescription?”A “Process” DefinitionA “Process” Definition an order for a CS drugan order for a CS drug issued by an individual state issued by an individual state

licensed prescriberlicensed prescriber who is registered with the DEAwho is registered with the DEA for a “patient”for a “patient” for a legitimate medical purposefor a legitimate medical purpose in the usual course of in the usual course of

professional treatmentprofessional treatment in the right “form”in the right “form”

What isWhat is NOT NOT A CS A CS Prescription?Prescription?

Dr. Doyou Wanna FeelGood, M.D., F.A.C.S.American Board of Surgical Diplomats

Discount C.S. Pain Clinic1234 Cass Ave., Detroit, Mich. 48201

Patient's Name: George Fuller Address: 1234 Rivard, Detroit, Mich.

Demerol 100mg#100

SIG: 2-4 tablets every 4-6 hours as needed for pain.

No refillsDr. Doyou FeelGoodDEA No. 1234563

an order for a CS an order for a CS drug...drug...

that “purports” to BE that “purports” to BE a prescription...a prescription...

looks like a prescriptionlooks like a prescriptionhas all the right informationhas all the right informationcorrect formcorrect formnot a “forgery”not a “forgery”from a licensed prescriberfrom a licensed prescriberfor a “patientfor a “patient

not issued in the not issued in the usual course of usual course of professional professional treatment.treatment.

The Policy Question:The Policy Question:

Drawing The Line Drawing The Line Between Patients Between Patients With Legitimate Pain With Legitimate Pain and Drug Seekersand Drug Seekers

If Life is not Perfect, On Which Side Do We Err?

DEA Orientation: DEA Orientation: Drug CopsDrug Cops

Health Care Providers are “gatekeepers” Health Care Providers are “gatekeepers” who should keep bad people from who should keep bad people from getting addictive drugs.getting addictive drugs.

All CS prescriptions are “suspect” and All CS prescriptions are “suspect” and should be scrutinized carefully.should be scrutinized carefully.

Providers should “Just Say No” to drugs. Providers should “Just Say No” to drugs. Turn away CS prescriptions.Turn away CS prescriptions.

Healthcare is a secondary concern to Healthcare is a secondary concern to keeping bad drugs off the streetkeeping bad drugs off the street

DEA/St. Bd. Actions Against DEA/St. Bd. Actions Against Health Care ProvidersHealth Care Providers

The “Too Much” ProsecutionPrescription/Prescribing Volume

The “Corresponding Responsibility” Quagmire

Pit Dr. against R.Ph.

The “Never-ending” ProsecutionCriminal, DEA, State Adman. (License)

Malpractice (Orzel v. Scott Drugs), Mi. S. Ct, 8/15/95

Health and Human Health and Human Services Perspective:Services Perspective:

U.S. is U.S. is NOTNOT aggressive in aggressive in pain control pain control management.management.

Fear of patient addiction Fear of patient addiction and legal entanglement and legal entanglement prevents practitioners prevents practitioners from good pain controlfrom good pain control

HHS Policy ManualFebruary, 1992

Health Care Providers’ Health Care Providers’ Orientation:Orientation:

Health Care:Health Care:taking care of patient needs to maximize taking care of patient needs to maximize

“outcomes”“outcomes”recognizing CS Drugs have therapeutic recognizing CS Drugs have therapeutic

value, pain is a legitimate disease and its value, pain is a legitimate disease and its treatment is necessary and appropriatetreatment is necessary and appropriate

““Gatekeeper” Function:Gatekeeper” Function:keep “bad” people from getting keep “bad” people from getting ““bad” drugsbad” drugs

The Dilemma of Decision The Dilemma of Decision Analysis: Consequences Analysis: Consequences

Dispense Script Refuse Script

GoodScript

Bad Script

Right Decision--Everybody’sHappy!

Wrong Decision--Patient Harm

DEA Says, “Very Bad Decision-Bad Pharmacist”

“Good Job, R.Ph.--Keep Bad Drugs Off Street

The Policy Dilemma: The Policy Dilemma: Government Agencies in Government Agencies in ConflictConflict

What are Health Care Providers

supposed to do?

“ “ Is it Legitimate? Is it Legitimate?

Strategies for Assessing Strategies for Assessing Questionable Prescriptions Questionable Prescriptions and DEA Considerations”and DEA Considerations”

Most Commonly Forged Most Commonly Forged PrescriptionsPrescriptions

Hydrocodone ProductsVicodin, Lortab, Lorcet, Anexsia

OxycodonePercodan, Percocet, OxyContin

MethylphenidateRitalin

Benzodiazepinesalprazolam, diazepam, lorazepam

Characteristics of Forged Characteristics of Forged PrescriptionsPrescriptions

Prescription looks “too good” Quantities, directions or dosages differ from usual

medical usage Prescription does not comply with acceptable

standard abbreviations Prescription appears to be photocopied Directions for use written in full with no abbreviations Prescription written in different-color inks or written in

different handwriting

Pharmacist’s ResponsibilityPharmacist’s Responsibility

The responsibility for the proper prescribingThe responsibility for the proper prescribingand dispensing of controlled substances isand dispensing of controlled substances isupon the prescribing practitioner, but aupon the prescribing practitioner, but acorresponding responsibility rests with thecorresponding responsibility rests with thepharmacist who fills the prescription.pharmacist who fills the prescription.

21 CFR Sec. 1306.04(a)

Prevention TechniquesPrevention Techniques

Know the prescriber and his signatureKnow the prescriber’s DEA registration

numberKnow the patientCheck the date on the prescription order.

When there is a question about any aspect of the prescription order, call the prescriber for verification or clarification.

Proper Controls

Common Sense

Sound Professional Practice

Using Proper Dispensing Procedures and Controls

Electronic PrescriptionsElectronic Prescriptions

Advantagesreduce forgeriesreduce mistakesimprove healthcare efficiency

Digital Signatureauthenticitynon-repudiationmessage integrity

Allowance, not a mandate

o Application Formso new and renewal

o Laws and Regulations

o List of Controlled Substances

o Frequently Asked Questions

o Federal Register Notices

o List of Local DEA offices

Supporting documents are published on DEA’s Internet Web Site

The Pharmacists ManualThe Pharmacists Manual

Your Responsibilities The abuse of prescription drugs—especially controlled

substances—is a serious social and health problem in the United States today. As a healthcare professional, you share responsibility for solving the prescription drug abuse and diversion problem.

You have a legal responsibility to acquaint yourself with the state and Federal requirements for dispensing controlled substances. You also have a legal and ethical responsibility to uphold these laws and to help protect society from drug abuse.

You have a personal responsibility to protect your practice from becoming an easy target for drug diversion. You must become aware of the potential situations where drug diversion can occur and safeguards that can be enacted to prevent this diversion.


The dispensing pharmacist must maintain a constant vigilance against forged or altered prescriptions. The law holds the pharmacist responsible for knowingly dispensing a prescription that was not issued in the usual course of professional treatment.


Types of Fraudulent Prescriptions• The practiced forger of prescriptions is usually very adept at the

job. The forger knows what information is needed on the prescription to make it appear authentic. Pharmacists should be aware of the various kinds of forged prescriptions that may be presented for dispensing.

• Some patients, in an effort to obtain additional amounts of legitimately prescribed drugs, alter the physician’s prescription. They will also have prescription pads printed using a legitimate doctor’s name, but with a different call back number that is answered by an accomplice to verify the prescription. Also, drug seeking individuals will call in their own prescriptions and give their own telephone number as a call back confirmation.

• Legitimate prescription pads are stolen from physicians’ offices and hospitals and prescriptions are written using fictitious patients names and addresses. In addition, individuals will go to emergency rooms complaining of pain in the hopes of receiving a controlled substance prescription. The prescription can then be altered or copied to be used again. Computers are often used to create prescriptions for nonexistent doctors or to copy legitimate doctors’ prescriptions.


Note: The quantity of drugs prescribed and frequency of prescriptions filled are not alone indications of fraud or improper prescribing especially if the patient is being treated with opioids for pain management. Pharmacists should also recognize that drug tolerance and physical dependence may develop as a consequence of the patient’s sustained use of opioid analgesics for the legitimate treatment of chronic pain.


The following criteria may indicate that a prescription was not issued for a legitimate medical purpose.

The prescriber writes significantly more prescriptions (or in larger quantities) compared to other practitioners in your area.The patient appears to be returning too frequently. Prescription which should last for a month in legitimate use, is being refilled on a biweekly, weekly or even a daily basis.The prescriber writes prescriptions for antagonistic drugs, such as depressants and stimulants, at the same time. Drug abusers often request prescriptions for "uppers and downers" at the same time.Patient appears presenting prescriptions written in the names of other people.A number of people appear simultaneously, or within a short time, all bearing similar prescriptions from the same physician.Numerous "strangers," people who are not regular patrons or residents of your community, suddenly show up with prescriptions from the same physician.


Characteristics of Forged Prescriptions1. Prescription looks "too good"; the prescriber’s

handwriting is too legible; 2. Quantities, directions or dosages differ from usual

medical usage; 3. Prescription does not comply with the acceptable

standard abbreviations or appear to be textbook presentations;

4. Prescription appears to be photocopied; 5. Directions written in full with no abbreviations; 6. Prescription written in different-color inks or written

in different handwriting. 7. Apparent erasure marks


Prevention Techniques Know the prescriber and his/her signature; Know the prescriber’s DEA registration number; Know the patient; Check the date on the prescription order. Has it been presented to

you in a reasonable length of time since the prescriber wrote it? When there is a question about any aspect of the prescription order,

call the prescriber for verification or clarification. Should there be a discrepancy, the patient must have a plausible reason before the prescription medication is dispensed.

Any time you are in doubt, require proper identification. Although this procedure isn’t foolproof (identification papers can also be stolen/forged), it does increase the drug abuser’s risk.

If you believe that you have a forged, altered, or bogus prescription--don’t dispense it--call your local police.

If you believe that you have discovered a pattern of prescription abuses, contact your State Board of Pharmacy or your local DEA office. Both DEA and state authorities consider retail-level diversion a priority issue.


Proper ControlsDispensing procedures, without control and professional caution, are an invitation to the drug abuser. Proper controls against bogus prescriptions can best be accomplished by following common sense, sound professional practice, and proper dispensing procedures and controls.Have your pharmacy staff help protect your practice from becoming a source of prescription drug diversion. Become familiar with which drugs are popular for abuse and resale on the streets in your area. Drug abuse prevention must be an ongoing staff activity.Encourage local pharmacists and physicians to develop a network, or at least a working relationship, which promotes teamwork and camaraderie. Discuss abuse problems with other pharmacists and physicians in the community. Most drug abusers seek out areas where communication and cooperation between health professionals are minimal because it makes their work so much easier.

Message from the AdministratorMessage from the Administrator

Dear Pharmacist:Your role in the proper dispensing of controlled

substances is critical to the health of the patient and to safeguard society against drug abuse and diversion. Your adherence to the Controlled Substances Act, together with your voluntary compliance with its objectives, are a powerful resource for protecting the public health, assuring patient safety, and preventing the diversion of controlled substances and drug products containing listed chemicals.

Sincerely, Donnie R. Marshall

AdministratorDrug Enforcement Administration

DEA Check Digit AlgorithmDEA Check Digit Algorithm

AB1234563

Digits 1, 3, and 5 are added together 1 + 3 + 5 = 9

Digits 2, 4, and 6 are added together and multiplied by two 2 + 4 + 6 = 12 x 2 = 24

The sums of the two calculations are added together 9 + 24 = 33

The last digit of the DEA registration number should be

the same as the last digit of the sum 3

If you believe that you have a If you believe that you have a forged, altered, or counterfeited forged, altered, or counterfeited prescriptionprescription

Do not dispense itDo not dispense it

Call your local police Oh Sure!Call your local police Oh Sure!

““Out of Stock”Out of Stock”

• If you believe that you have If you believe that you have discovered a pattern of prescriptiondiscovered a pattern of prescriptionabusesabuses

• ContactContact• State Board of Pharmacy orState Board of Pharmacy or• Local DEA office.Local DEA office.

Problem?

MAPSMAPS

Michigan Automated Prescription System–Replaces the OPP (Official Prescription

Program)

January 1, 2003 Dx: “form” and “format”

–No Form–Just format

Maps: Applies to Maps: Applies to AllAll Scheduled DrugsScheduled Drugs

Patient IdentifiersPatient Identifiers

Required by StatuteSec. 7333a

Defined in RegulationBP CS Rule 2(1)(f)

Required with other information set forth in BP CS Rule 62b.

"Patient identifier" "Patient identifier" includesincludes the the following information about a patient:following information about a patient:

(i) Full name.

(ii) Address, including zip code.

(iii) Date of birth.

(iv) Any of the following: (A)Social security number.

(B)Driver's license number.

(C)State-issued identification number.

(v) If a patient is an animal, any (v) If a patient is an animal, any of the following:of the following:

(A) The owner's social security number.

(B) The owner's driver's license number.

(C) The owner's state-issued identification number.

What if the Patient or the Animal What if the Patient or the Animal Does not have a ‘patient Does not have a ‘patient

identifier?’identifier?’

Newborns, pediatric patients Seniors without driver’s licenses or state

identification number Immigrants or aliens Adopted animals Adopted children

Alternatives?

Reporting AlternativesReporting Alternatives

BP CS Rule 62cData required in BP CS Rule 62b

Electronic format, state approved• Computer disk, tape or cartridge

Waiver if no electronic communication is available

Requires waiver in writing.

When to reportWhen to report

Minimum of ever 30 daysNo later than the 15th of the month following the month in which the prescription was dispensed.

Subject to discipline if fail to report timely

Reporting ExceptionsReporting Exceptions

A pharmacist, a dispensing prescriber (i.e., one who had a BP Drug Control License and a veterinarian

Who administers a C-2 to C-5 drug directly to a patient.When the C-2 to C-5 drug is dispensed in a health facility or agency by a dispensing prescriber in an amount needed to treat a patient for 48 hours or less.

How to Determine How to Determine if an Rx is valid?if an Rx is valid?

TheThe

Good FaithGood Faith

StandardStandard


Sec. 7333. (1) As used in this section, “good faith” means the

prescribing or dispensing of a controlled substance by a practitioner licensed under section 7303 in the regular course of professional treatment to or for an individual who is under treatment by the practitioner for a pathology or condition other than that individual's physical or psychological dependence upon or addiction to a controlled substance, except as provided in this article.


Application of good faith to a pharmacist means the dispensing of a controlled substance pursuant to a prescriber's order which, in the professional judgment of the pharmacist, is lawful.


The pharmacist shall be guided by nationally accepted professional standards including, but not limited to, all of the following, in making the judgment:

(a) Lack of consistency in the doctor-patient relationship.

(b) Frequency of prescriptions for the same drug by 1 prescriber for larger numbers of patients.

(c) Quantities beyond those normally prescribed for the same drug.

(d) Unusual dosages. (e) Unusual geographic distances between patient,

pharmacist, and prescriber

§ 7333(2)§ 7333(2)

Except as otherwise provided in this section, a practitioner, in good faith, may dispense a controlled substance included in schedule 2 upon receipt of a prescription of a practitioner licensed under section 7303 on a prescription form. A practitioner shall not issue more than 1 prescription for a controlled substance included in schedule 2 on a single prescription form.

§ 7333 (4)§ 7333 (4)

A practitioner, in good faith, may dispense a controlled substance included in schedule 3, 4, or 5 that is a prescription drug as determined under section 503(b) of the FD&CA upon receipt of a prescription on a prescription form or an oral prescription of a practitioner. A prescription for a controlled substance included in schedule 3 or 4 shall not be filled or refilled without specific refill instructions noted by the prescriber. A prescription for a controlled substance included in schedule 3 or 4 shall not be filled or refilled later than 6 months after the date of the prescription or be refilled more than 5 times, unless renewed by the prescriber in accordance with rules promulgated by the administrator.

Emergency C-II ScriptsEmergency C-II Scripts

§ 7333(3)(3) In an emergency situation, as described in R

338.3165 [R 65] of the Michigan administrative code, a controlled substance included in schedule 2 may be dispensed upon the oral prescription of a practitioner if, the prescribing practitioner promptly fills out a prescription form and forwards the prescription form to the dispensing pharmacy within 7 days after the oral prescription is issued. \

Emergency C-II DrugsEmergency C-II Drugs

Except for a terminally ill patient whose terminal illness the pharmacist documents pursuant to rules promulgated by the administrator, a prescription for a controlled substance included in schedule 2 shall not be filled more than 60 days after the date on which the prescription was issued. A prescription for a controlled substance included in schedule 2 for a terminally ill patient whose terminal illness the pharmacist documents pursuant to rules promulgated by the administrator may be partially filled in increments for not more than 60 days after the date on which the prescription was issued.

Emergency C-II ScriptsEmergency C-II Scripts

Rules 64 and 65 Know conditions for dispensing an emergency C-II drug

(a) The prescriber advises the (a) The prescriber advises the pharmacist of the following:pharmacist of the following:

(i) Immediate administration of the controlled substance is necessary for proper treatment of the intended ultimate user.

(ii) Appropriate alternative treatment is not available, including administration of a drug that is not a controlled substance under schedule 2.

ANDAND

(iii) It is not reasonably possible for the prescriber to provide a written prescription to be presented to the person dispensing the substance before the dispensing. (iv) The quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period and pursuant to a written prescription.

Emergency ConditionsEmergency Conditions

(b) The prescription shall be immediately reduced to writing by the pharmacist and shall contain all information that is required to be contained in a prescription under provisions of R 338.3161, except for the prescriber's signature.

Emergency ConditionsEmergency Conditions

(c) If the prescriber is not known to the pharmacist, then the pharmacist shall make a reasonable effort to determine that the oral authorization came from a prescriber by returning the prescriber's call, using the telephone number listed in the telephone directory and other good faith efforts to assure the prescriber's identity.

More Conditions: More Conditions: BP CS Rule 65BP CS Rule 65

Within 7 days after authorizing an emergency oral prescription of a controlled substance listed in schedule 2, the prescriber shall reduce the prescription to writing and have recorded on the prescription's face "Authorization for Emergency Dispensing" and the date of the oral order.

More Conditions: More Conditions: BP CS Rule 65BP CS Rule 65

The written prescription shall be delivered to the pharmacist in person or by mail within 7 days after the oral prescription is issued. Upon receipt, the dispensing pharmacist shall attach this prescription to the oral order which earlier had been reduced to writing. The pharmacist shall notify the department of consumer and industry services if the prescriber fails to deliver a written prescription to him or her.

BP CS Rule 65BP CS Rule 65

The failure of a pharmacist to notify the department if the prescriber fails to deliver a written prescription voids the authority conferred by this rule to dispense without a written prescription of a prescriber.

If no Prescriptive authority:

Dispensing to AddictsDispensing to Addicts

BP CS Rule 63No dispensing to continue addiction except:

• If prescriber is licensed to run a drug dependency program

• The individual is enrolled in a treatment facility• The individual who is hospitalized

Cf: Federal Law: 3 days grace

TIMINGTIMING

90 days 90 days

6 months6 months

1 year1 year

2 years2 years

5 years5 years

TIMINGTIMING

a.a. 30 days30 days

b.b. 7 days7 days

c.c. 72 hours72 hours

d.d. 60 days60 days

e.e. 48 hours48 hours

What Factors are important?What Factors are important?

Valium 5mg tablets (a non-narcotic Schedule Valium 5mg tablets (a non-narcotic Schedule IV 503(b) drug)IV 503(b) drug)

Demerol 50mg tablets (a narcotic Schedule Demerol 50mg tablets (a narcotic Schedule II 503(b) drug)II 503(b) drug)

Dyazide capsules (a non-narcotic, non-Dyazide capsules (a non-narcotic, non-controlled substance 503(b) drug)controlled substance 503(b) drug)

All of the aboveAll of the above None of the aboveNone of the above

2010 pharmacy law review for mpje

Documents

drug act

federal pharmacy law

drug administrationlabels

onlyfood drug

state law

pharmacy law review2010jesse

pharmacy label

year law