Pharmacy Law Review 2010

Jesse C. Vivian , RPh, JD Professor of Pharmacy Practice

(313) 577-5389 jessevivian@wayne.edu http://jessevivian.net

Todays Agenda: Prepare 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 Regulations FDA Michigan Controlled Substances
DEA Michigan

Food Mock Test Evaluation Open Discussion

MPJE
Computer Adaptive Test
Answer Question Cant go back to prior questions

90 Questions
60 questions counted No way to know which 30 questionsx dont count Assume every question counts

MPJE Study Materials

Michigan Pharmacy Law, 5th ed., 2nd printing
April 2010 Not 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

ASHPs 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.

MPJE http://nabp.net

Click on PROGRAMS

NABP

Click on MPJE

NABP MPJE

Read entire page and links

Constitutional Law
Not on Exam, per se Need to know for background

Clauses
Supremacy
Duel Jurisdiction

Due Process Interstate Commerce

Intrastate commerce

Ex Post Facto
Grandfathering

If conflict between Federal and State law exists,

Stricter Law Applies

Online Legal Resources

Federal Food Drug and Cosmetic Act
http://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 database Do your own search with words like: food drug and cosmetic act laws and regulations administration

Federal Regulations
http://vm.cfsan.fda.gov/~dms/reg-2.html

Online Resources
Statutes: http://www.lib.umich.edu/libhome/ Documents.center/michlaw.html Regulations: http://michigan.gov

First Section
Federal Regulation of Drugs Generally Adulteration Misbranding Labeling Antitrust Medicare PPPA USPS

History of Drug Regulation

MPJE Questions dont 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 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 Question
After 1906, it was illegal to introduce drugs into interstate commerce which were:
I. II. III. IV. Misbranded Adulterated Made with contaminated materials Not effective for intended purpose
a. b. c. d. I only II only All of the above I, II and III only

Food Drug and Cosmetic Act of 1938

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

Prohibitions
Its is unlawful to introduce into interstate commerce and article that is
Adulterated or Misbranded

Adulteration
Adulterated drugs and devices A drug or device shall be deemed to be adulterated: (1) If it consists in whole or in part of any filthy, putrid, or decomposed substance; or (2)(A) if it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.

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

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

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

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

Label
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.

Labeling
The term ''immediate container'' does not include package liners. The term ''labeling'' means all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article.

Generally
If a drug is mislabeled
It is Misbranded

If drug not manufactured according to CGMPs

It is adulterated

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

It is adulterated

Drugs can be both misbranded and adulterated at the same time

Solid 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 1938
Grandfather Clause
Drugs 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 drug

and

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 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 FDCA

Food Drug Cosmetic Dietary Supplements Soap
An Article may be a food, a drug, a cosmetic and/or a dietary supplement
Depends on distributors CLAIMS

Foods and Cosmetics

The term ''food'' means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article. The term ''cosmetic'' means (1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap.

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

Dietary 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 FDCA

Durham-Humphrey Act of 1951
Created 2 Classes of Drugs
Prescription-only (Rx only, prescription 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-Humphrey
Created 503(b)(1) drugs
(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 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; or (B) is limited by an approved application under section 505 {New Drug} to use under the 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 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 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 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.

Kefauver-Harris Act of 1962

a/ka/ Drug Efficacy Amendment
Thalidomide in Europe caused birth defects in children of pregnant mothers All 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 Subjects Implemented Good Manufacturing Practices
GMPs, CGMPs

Kefauver-Harris
Established DESI class of drugs for those marketed between 1938 and 1962. Drug Efficacy Study Implementation
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 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 products; of these, 2,225 were found to be effective, 1,051 were found not effective, and 167 were pending.
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 Application (ANDA). More about this later

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

Rx-Only and OTC drugs to the FDA Dietary Supplements to the FTC Federal Trade Commission
The Federal Trade Commission is the nation's consumer protection agency. The FTC's Bureau of Consumer Protection works For The Consumer to prevent fraud, deception, and unfair business practices in the marketplace. http://www.ftc.gov/bcp/index.shtml

Points to Remember
Not all drugs on US market have an NDA
Pre-1938 drugs grandfathered
Examples:
digoxin, 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 drugs
Can remove and replace by prescription labeling on pharmacy label

Poison Prevention Packaging Act of 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 packaging
Immediate container or wrapping With exceptions, ALL DRUGS are hazardous household products subject to special packaging requirements

PPPA
Know drugs to which Act applies
Examples:
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

PPPA
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 manufacturers mnemonic packaging Packages of less than 105 mg prednisone tablets One size of OTC line with label indicating package is not child-resistant

PPPA
Failure to Comply with PPPA is an act of misbranding Patient may ASK for blanket waiver of childresistant 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 didnt happen

Federal Anti-Tampering Act of 1982

Not part of FDCA Somewhat related to, but independent of PPPA Enacted after intentional cyanide contamination of OTC products on drugstore shelves
Tylenol (TYMURS), Chicago http://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 1976

Pre-Market Approval GMP manufacturing standards Performance Standards Classified according to intended Use Records and Reporting Requirements
Not a major focus of exam

Orphan 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 Patent Term Restoration Act of 1984

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 Act
FDA published Orange Book
Approved Drug Products with Therapeutic Equivalence Evaluations.

Is Guideline Only
Some 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 of 1987

PDMAVery 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 samples
In Michigan, term is complimentary starter doses Hospital pharmacies may hold samples and dispense them at request of a staff physician Community 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 emergency
Hospitals usually get special discount pricing

Robinson-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 othersprimarily community pharmacies Own Use Doctrine Bone fide emergency exception http://uwacadweb.uwyo.edu/PHARMACYNOTES/Ca sey%20Wood/unit%205%20core%20ctw.pdf

OBRA 90
Applied originally only to Medicaid prescriptions
Most states enacted regulations making OBRA standards applicable to all prescriptions

Drug Utilization Review

Necessary and Appropriate

Offer to Counsel
Counseling only by RPh or intern

Record-keeping

Prescription Drug User Fee Act of 1992

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

FDA Modernization Act of 1997

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 labeling Provides incentives for SNDAs Mandates pediatric testing of pediatric drugs

Medicare Prescription Drug Improvement and Modernization Act of 2003

NOT part of FDCA Medicare Modernization Act or MMA) produced the largest overhaul of Medicare in the public health program's 38-year history.

Medicare Part D
Its most touted change is the introduction of an entitlement benefit for prescription drugs, through tax breaks and subsidies. 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 expensive drugs have come into use, patients, particularly senior citizens for whom Medicare was designed, have found prescriptions harder to afford. The MMA, is meant to address this problem.

Related Federal Issues

Off-label Prescribing Off-Label Marketing Labeling Package Inserts Patient Package Inserts Drug Recalls I, II, III Who initiates FDA limitations

Postal Regulations

New Drug Issues

NDA ANDA SNDA IND
Clinical Trials, Phase 1, 2, 3 Post-Marketing Surveillance

Second Section

Michigan Pharmacy Law

The Practice of Pharmacy

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

What does engage mean?

No Public Health Code Definition, therefore, use ordinary meaning. http://www.dictionary.com/search?q=engage 1. 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 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 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.

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

License
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.

Titles
1. 2. 3. 4. R.Ph. (Registered Pharmacist Chemist Apothecary Doctor

License
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

Article 15 Occupations

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
(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.

Sec. 17711

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

Professional Conduct

Rule 20

Professional 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 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)
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 true, the opposite must also 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)
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 Charge "Personal charge" means the immediate physical presence of a pharmacist or dispensing prescriber.

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 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 Distinctions

Personal Charge 17707 (1) Supervision 16109(2) Delegation 16215 and Rule 20(5)

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 individuals functions. (c) The provision by the licensed supervising health professional of
predetermined procedures and drug protocol.

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

(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
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
(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 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)

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)
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 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 institutional pharmacy practice?

Institution hospital skilled 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
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 may also contract with a nursing home or other medical institution to provide pharmacy 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 institutional practice has unique responsibilities.

develop, implement, supervise and coordinate all pharmacy services

minimizes additional preparation before administration to the patient, including the admixture of parenterals adopt a process that will permit the pharmacy to obtain the prescribers original medication order, a direct carbonized copy or an electromechanical facsimile
an order for a drug or device in the patients chart constitutes the original prescription

monitoring medication orders to evaluate clinically significant chemical and therapeutic incompatibilities

Institutional Director of Pharmacy

providing educational programs for the medical institutions 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.

Institutional Director of Pharmacy

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 institutions 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

Institutional Director of Pharmacy

devising methods of interpreting and reviewing the prescribers 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 Stock

stored in a manner that ensures immediate availability Secured
sealed or secured medication kits, carts or treatment trays a pharmacist routinely inspects the medications

Non-24 hour Institutional Pharmacies

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

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 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 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 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 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

Licenses
Pharmacy Pharmacist Intern
Generally Valid 2 Years
Sometimes only 1 year initially

Renew on July 1

DEA Registration
Generally Valid 3 Years

Pharmacist 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: 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 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 center Not required for complimentary starter dose (samples-PDMA)

Labeling, recordkeeping, storage

CE 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: 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 pharmacists ability to deliver competent pharmacy services

Preceptors
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

Preceptors
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

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 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 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 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 graduation
Pay renewal fee annually Lapses: leave of absence for 1 year

See Text for other requirements

Michigan Pharmacy Law

Part E: Drugs Compare how drugs are regulated in Michigan with Federal law
Adulteration Misbranding
Especially Note Labeling Differences
Community Institution

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

Identical PPPA preempts inconsistent state law Request for Non-Safety Caps
Law: Does not have to be in writing LAWYER: MUST BE IN WRITING

Michigan Pharmacy Law

Chapter 4
Dispensing and Prescribing

Part A
The Prescription

What is a Prescription?
An order
for 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?
Do not be confused about whether a drug is Rx-only or OTCWith whether a third-party will pay for it or not
Dont confuse regulatory laws with Contract laws

Third 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 Order
traditional handwritten or typed piece of paper telephone fax (facsimile) electronic prescribing
e-prescribing e-script

Communication 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 and Prescribing

Prescribing is act of ordering Communication of a prescription is not prescribing

Uniform

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 prescribers name differently.

Dont confuse this information with labeling

Unique 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 and National Commerce Act of 2000

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-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 Requirements

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 Requirements

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

Refills
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 months C-V: as written (up to 1 year

90 days for C-IIs with date of next fill

Pre-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 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 substance prescription drugs appear on the same written prescription form?

No Fix it.

Mail-Order Rx
Old Law: Cant dispense by mail if Rx received by mail Current Law: Whatever
Federal Post Office Regulations Locum Tenens

Why you cant find this in the statutes or regulations

Vending 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-theart InstyMeds technology ensures safe and secure dispensing of prescription medications directly to patients at the point-of-care

Vending 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 prescribers office [1] General Rule 19; R 338.489 and Controlled Substance Rules 32; R 3383132 and 54 (4); R 338.3154

Prescription Copies
Transfer Between Pharmacies
Independents Chains linked by on-time real-time databases

Controlled vs. Rx-only

CS: 1x only

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

Rx Record-Keeping
Michigan
Rx: 5 years minimum from date of last fill or refill ALL PRESCRIPTIONS
Could be 6 years Dont confuse 3rd party contracts
Medicaid, Blue Cross: 7-8 years

Federal
2 years CS scripts 2 years CS Invoices 2 Years C-II Form 222 orders

Record Retention Policy

Confidentiality of Rx Records
not public
Patient permission Another pharmacist assisting patient Government (inspectors, police Court order Approved research

HIPAA
No PHI except for TPO

Beware confidentiality vs. privilege

Prescribing
Who can Prescribe 503(b) drugs in Michigan? Prescribing is limited to a Prescriber
Distinguish prescribing and dispensing

Depends on
Location of prescribers license
Michigan Other state Canada

Which kind of prescriber

Independent: MD, DO, DP, DDS, DV, special OD Dependant: MD or DOs: PA or NP

Prescribers scope of practice Kind of drug being prescribed

Non-Controlled Controlled

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

Vivians 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 Prescribing vs. Dependent Prescribing

Independent---Because of Scope of Practice
Physician
RDs: State and Canada MDs, DOs, FDs: DDSs, DPMs ,some ODs (special license), DVMs DCs: cant prescribe anything in Michigan
Is a Chiropractor a Real Doctor? http://ezinearticles.com/?Is-a-Chiropractor-a-Real-Doctor?&id=1911538

DependentDelegated to Prescribe by MD or DO only

Pas: 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

Dispensing
Drug Product Selection (DPS)
Generic Interchange Substitution---illegal Brand exchange

Brand Name Drugs

Patent medicines Proprietary medicines Ethical medicines

Generic Drugs
ANDA

Brand Name Prescribed

When a pharmacist receives a prescription for a brand name drug product, the pharmacist may, or when a purchaser requests a lower cost, generically equivalent drug product, the pharmacist shall, 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----DAWin own handwriting
Dont confuse 3rd partys 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 Interchange
Notice
if and when drug product selection or generic interchange has occurred:
the statute and rule state that the purchaser shall be notified 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 LABEL Generics dont have Brand names; therefore manufacturer name

Confusion about GEq

Only applies to multi-ingredient drugs

Generic Interchange
Post Policy
display 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

Generic Interchange
Michigan is NOT an Orange Book state
Some states are:
Positive or negative Orange Book authorized

There is no MI STATE authorized formulary

Some states: negative or positive formulary Dont confuse 3rd party contracts that do have formularies Dont confuse Medical Institutions or Health Facilities that may have formularies

Generic Interchange
Cost savings must be passed on to purchaser
Who is purchaser?
Cash customer Beneficiary of cost savings3rd party payor

Cost Savings
Difference between cost of generic drug and cost of brand name drug
Problem: What is cost and how to determine it?

Labeling
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

Labeling
Drug is misbranded if not properly labeled

Manufacturer's label
Michigan and Federal law consistent

Community Pharmacy Labeling

Vial 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 Labeling

(a) Pharmacy name and address (b) Prescription number (c) Patients name (d) Date the prescription was most recently dispensed (e) Prescribers name (f) Directions for use (g) The name of the medication, unless the prescriber indicates do not label Remember the altered labeling requirements if DPS occurs

Community 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-5 Standard of practice: many pharmacies include warning on all dispensed labels
Is not required except as above

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 Labeling
C-5 OTCs Vending Machines Hospice Boxes Institutional Labeling
Multidose vials Unit of Use Packaging
Unit Dose

Refills Documentation
Three options Select one and use only one
Back of script Hardcopy log Electronic (Computer) recording

Remember different records needed if DPS occurs

Complimentary 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 law
Remember 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 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 Dispensing
For gray area btw community and institutional practice. See Text for Special Rules

Miscellaneous Provisions
Returns of drugs to pharmacies
Max 5% distribution and compounding

Section Three
Controlled Substances Statutes and Regulations
Federal Law and Michigan Law

Federal 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 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 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 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 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 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 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 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 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 practitioners 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 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.

Punishment
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.

Violations
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 practitioners 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

Violations
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
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 Means

DEA is forced to allow electronic transmission of all CS scriptsincluding C-IIs.

DEA Regulations and Pharmacy Practice The Providers Dilemma:

Balancing Good Care and Gatekeeper Duties

Drug 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 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 Access

Closed Distribution System
from Manufacturer to Ultimate User total accountability

Access determined by Licensees

Prescriber at first level Pharmacist at last level
(Caregiver intervention)

The Federal Controlled Substances Act (CSA):

21 USC 829: Written or oral prescription required to dispense controlled substances.

Prescription Defined:
21 CFR 1306.02(f): An order for medication which is dispensed to or for an ultimate user (non-institutional).

Issuance of a CS Prescription
21 CFR 1306.03:

A CS prescription may be issued only by an individual practitioner who is authorized by state license to prescribe and is registered or exempted from registration with the DEA

Corresponding Responsibility
21 CFR 1306.04: The purpose of a prescription:

To be effective, the CS Rx must be issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. The pharmacist has a corresponding responsibility with the prescriber for proper prescribing and dispensing. An order purporting to be a prescription is not a prescription(21 USC 829) if not issued in the usual course of professional treatment.

Corresponding Responsibility
21 CFR 1306.05: The form of a prescription:

CS prescriptions must be dated and signed that day, have patients name and address, prescriber's DEA number and written in ink, indelible pencil or typewritten. The pharmacist has a corresponding responsibility to determine that prescriptions are issued in this form.

What Does it All Mean

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

A Prescription is NOT a duck !

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

Discount C.S. Pain Clinic

1234 Cass Ave., Detroit, Mich.. 48201

Patient's Name: Address:

George Fuller
1234 Rivard, Detroit, Mich..

Demerol 100mg #100 SIG: 2-4 tablets every 4-6 hours as needed for pain.

No refills
Dr. Doyou FeelGood
DEA No. 1234563

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

If it looks like a duck... If it waddles like a duck... If it quacks like a duck...

..Its A Duck!

What is a CS Prescription?
A Process Definition
an order for a CS drug issued by an individual state licensed prescriber who is registered with the DEA for a patient for a legitimate medical purpose in the usual course of professional treatment in the right form

What is NOT A CS Prescription?

an order for a CS drug... that purports to BE a prescription...
looks like a prescription has all the right information correct form not a forgery from a licensed prescriber for a patient

Dr. Doyou American Board of Surgical Diplomats F.A.C.S. Wanna FeelGood, M.D., DiscountAve., Detroit, Mich. 48201 C.S. Pain Clinic 1234 Cass
Patient's Name: Address:

George Fuller
1234 Rivard, Detroit, Mich.

SIG: No refills

Demerol 100mg #100 2-4 tablets every 4-6 hours as needed for pain.
Dr. Doyou FeelGood
DEA No. 1234563

not issued in the usual course of professional treatment.

The Policy Question:

Drawing The Line Between Patients With Legitimate Pain and Drug Seekers
If Life is not Perfect, On Which Side Do We Err?

DEA Orientation:
Drug Cops

Health Care Providers are gatekeepers who should keep bad people from getting addictive drugs. All CS prescriptions are suspect and should be scrutinized carefully. Providers should Just Say No to drugs. Turn away CS prescriptions. Healthcare is a secondary concern to keeping bad drugs off the street

DEA/St. Bd. Actions Against Health Care Providers

The Too Much Prosecution
Prescription/Prescribing Volume

The Corresponding Responsibility Quagmire

Pit Dr. against R.Ph.

The Never-ending Prosecution

Criminal, DEA, State Adman. (License) Malpractice (Orzel v. Scott Drugs), Mi. S. Ct, 8/15/95

Health and Human Services Perspective:

U.S. is NOT aggressive in pain control management. Fear of patient addiction and legal entanglement prevents practitioners from good pain control

HHS Policy Manual February, 1992

Health Care Providers Orientation:

Health Care:
taking care of patient needs to maximize outcomes recognizing CS Drugs have therapeutic value, pain is a legitimate disease and its treatment is necessary and appropriate

Gatekeeper Function:
keep bad people from getting bad drugs

The Dilemma of Decision Analysis: Consequences

Dispense Script Good Script Right Decision-Everybodys Happy! DEA Says, Very Bad Decision-Bad Pharmacist Refuse Script Wrong Decision-Patient Harm

Bad Script

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

The Policy Dilemma: Government Agencies in Conflict

What are Health Care Providers supposed to do?

 Is it Legitimate?

Strategies for Assessing Questionable Prescriptions and DEA Considerations

Most Commonly Forged Prescriptions

Hydrocodone Products
Vicodin, Lortab, Lorcet, Anexsia

Oxycodone
Percodan, Percocet, OxyContin

Methylphenidate
Ritalin

Benzodiazepines
alprazolam, diazepam, lorazepam

Characteristics of Forged Prescriptions

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

Pharmacists 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 Sec. 1306.04(a)

Prevention Techniques
Know the prescriber and his signature Know the prescribers DEA registration number Know the patient Check 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 Prescriptions
Advantages
reduce forgeries reduce mistakes improve healthcare efficiency

Digital Signature
authenticity non-repudiation message integrity

Allowance, not a mandate

Supporting documents are published on DEAs Internet Web Site

o Application Forms
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

The Pharmacists Manual

Your Responsibilities The abuse of prescription drugsespecially controlled substancesis 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 Pharmacists Manual

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.

The Pharmacists Manual

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 physicians prescription. They will also have prescription pads printed using a legitimate doctors 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.

The Pharmacists Manual

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 patients sustained use of opioid analgesics for the legitimate treatment of chronic pain.

The Pharmacists Manual

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.

The Pharmacists Manual

Characteristics of Forged Prescriptions 1. Prescription looks "too good"; the prescribers 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

The Pharmacists Manual

Prevention Techniques

Know the prescriber and his/her signature; Know the prescribers 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 isnt foolproof (identification papers can also be stolen/forged), it does increase the drug abusers risk. If you believe that you have a forged, altered, or bogus prescription-dont 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.

The Pharmacists Manual

Proper Controls Dispensing 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 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 Administrator Drug Enforcement Administration

DEA 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

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

Do not dispense it Call your local police

Out of Stock

Oh Sure!

Problem?
If you believe that you have discovered a pattern of prescription abuses
Contact State Board of Pharmacy or Local DEA office.

MAPS
Michigan Automated Prescription System
Replaces the OPP (Official Prescription Program)

January 1, 2003 Dx: form and format

No Form Just format

Maps: Applies to All Scheduled Drugs

Patient Identifiers
Required by Statute
Sec. 7333a

Defined in Regulation
BP CS Rule 2(1)(f) Required with other information set forth in BP CS Rule 62b.

"Patient identifier" includes the 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 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 Does not have a patient identifier?
Newborns, pediatric patients Seniors without drivers licenses or state identification number Immigrants or aliens Adopted animals Adopted children Alternatives?

Reporting Alternatives
BP CS Rule 62c
Data 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 report
Minimum of ever 30 days
No 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 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 if an Rx is valid?

The Good Faith Standard

Good Faith
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.

Good Faith
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.

Good Faith
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)
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)
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 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 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 Scripts

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

(a) The prescriber advises the 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.

AND
(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 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 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: BP 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: BP 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 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 Addicts
BP CS Rule 63
No 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

TIMING
90 days 6 months 1 year 2 years 5 years

TIMING

a. 30 days b. 7 days c. 72 hours d. 60 days e. 48 hours

What Factors are important?

Valium 5mg tablets (a non-narcotic Schedule IV 503(b) drug) Demerol 50mg tablets (a narcotic Schedule II 503(b) drug) Dyazide capsules (a non-narcotic, noncontrolled substance 503(b) drug) All of the above None of the above