pharmacy law review
Download
Skip this Video
Download Presentation
Pharmacy Law Review

Loading in 2 Seconds...

play fullscreen
1 / 115

Pharmacy Law Review - PowerPoint PPT Presentation


  • 1437 Views
  • Uploaded on

Pharmacy Law Review. Jesse C. Vivian Professor Department of Pharmacy Practice April 29, 2008 http://jessevivian.net. Study Resources. Michigan Pharmacy Law: A guide to the Statutes and Regulations , 4rd Ed. (MPA) Pharmacy Law Update Service (CD Rom)

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha
Download Presentation

PowerPoint Slideshow about 'Pharmacy Law Review' - albert


An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript
pharmacy law review

Pharmacy Law Review

Jesse C. Vivian

Professor

Department of Pharmacy Practice

April 29, 2008

http://jessevivian.net

study resources

Study Resources

Michigan Pharmacy Law: A guide to the Statutes and Regulations, 4rd Ed. (MPA)

Pharmacy Law Update Service (CD Rom)

January, 2008 (MPA) In 2005, was in 3rd edition

3. Board of Pharmacy Regulations (Revised February 21, 2007)

4. Pharmacy Law Digest 40th Edition (2006)

5. PharmPrep, 3rd Ed. (2007)ASHP (Federal Law)

6. http://nabp.net

current rules 4 29 08
Current Rules (4/29/08)
  • Bureau of Health Professions
  • Bureau of Health Professions (4/23/2008)
  • Bureau of Health Professions
  • Bureau of Health Professions (4/23/2008)
  • Navigate to site
navigating nabp net

Navigating NABP.NET

Enter “nabp.net” Navigate to it

Select “examination” option on left hand side

Select first “examination” option

Scroll down to see:

MULTISTATE PHARMACY JURISPRUDENCE EXAMINATION™ (MPJE™) The computer-based MPJE combines federal and state-specific law questions to serve as the state law examination in participating jurisdictions. The MPJE is based on a national blueprint of pharmacy jurisprudence competencies; however, the questions are tailored to the specific law in each state.

go back to examination option
Go back to “examination” option
  • Click on NAPLEX/MPJE option
  • Results:

NAPLEX/MPJE Registration Bulletin

  • Now Available in PDF format
  • Click to download NAPLEX/MPJE Registration Bulletin (869 k)
  • Download it
naplex mpje registration bulletin
North

American

Pharmacist

Licensure

Examinationtm

Multistate

Pharmacy

Jurisprudence

Examination®

NAPLEX/MPJE Registration Bulletin
scroll to page 25 to get reformatted computer adaptive mpje what is the mpje
Scroll to page 25 to get (reformatted):Computer-Adaptive MPJEWhat is the MPJE ?

The MPJE is based on a nationally uniform content blueprint, with questions that are tailored to assess the pharmacy jurisprudence requirements of individual states. In cooperation with participating state boards of pharmacy, the MPJE is uniformly developed, administered, and scored under policies and procedures developed by NABP’s Advisory Committee on Examinations and approved by NABP’s Executive Committee.

computer adaptive mpje what is the mpje

Computer-Adaptive MPJEWhat is the MPJE ?

The content of the MPJE is approved by boards of pharmacy, practitioners, and educators from around the country through their service as MPJE Review Committee members, item writers, and board of pharmacy representatives.

what is the mpje
What is the MPJE ?

All candidates are tested on their mastery of pharmacy law as outlined in the MPJE Competency Statements (page 22). Each participating state board of pharmacy approves those questions that are specific to the federal and state laws of the jurisdictions in which candidates are seeking licensure. Candidates must take a separate exam for each state or jurisdiction in which they are seeking licensure.

what is the mpje10
What is the MPJE?

The MPJE is a two-hour, computer-adaptive examination that consists of 90 multiple-choice test questions. Of these, 60 questions will be used to calculate the test score. The remaining 30 items serve as pretest questions, and do NOT affect the MPJE score.

what is the mpje11

What is the MPJE?

Pretest questions are administered to evaluate items’ difficulty level for possible inclusion as scored questions in future exams. These pretest questions are dispersed throughout the exam and cannot be identified by the candidate.

the computer adaptive format
The Computer-Adaptive Format

A computer-adaptive exam is inherently different from a paper-and-pencil exam. Like many other tests, the goal of a computer-adaptive test is to measure a candidate’s knowledge and ability. The test selects questions for each candidate based on his or her unique ability level. When you take the MPJE, the computer’s technology will assess your answers before presenting you with the next question.

the computer adaptive format13

The Computer-Adaptive Format

An estimate of your ability level will be determined based on the difficulty level oft he questions you have answered correctly. This determination of the difficulty level will then be used to calculate your MPJE score.

the computer adaptive format14
The Computer-Adaptive Format

Please Note:

Because the computer-adaptive MPJE presents questions to you based on your responses to previous questions, YOU CANNOT CHANGE ANANSWER ONCE YOU HAVE CONFIRMED ANANSWER CHOICE OR GO BACK AND REVIEW AQUESTION ONCE YOU HAVE MOVED ONTOTHE NEXT QUESTION.

the computer adaptive format15
The Computer-Adaptive Format

Remember, the computer-adaptive format of the examinations requires that ALL test questions be answered in the order in which they are presented. Examination questions are selected for you based on your answers to previous questions. You will NOT be allowed to skip a question or return to a previous question to review your answer. Once you have confirmed an answer choice and have moved on to the next question, you CANNOT return to the previous question to change your answer.

the computer adaptive format16
The Computer-Adaptive Format

You must answer ALL questions in the order in which they are presented, and you may NOT skip a question. Your formal education, training, practical experience, and self-study prepare you for the MPJE.

the computer adaptive format17
The Computer-Adaptive Format

The MPJE has been designed to assess how well you apply your knowledge, skills, and abilities to evaluate situations involving the applicable federal and state laws and regulations that govern the practice of pharmacy in the state in which you are seeking licensure.

resources
Resources

Consult the MPJE Competency Statements for a description of possible examination question topics, and familiarize yourself with the specific federal and state pharmacy laws and regulations as they apply in the state conferring eligibility to take the examination.

resources19
Resources

You may wish to consult references such as

Facts and Comparisons’ Pharmacy Law Digest 40th edition (2006)

(Editorial Note: Free bonus points for each student who knows one of the authors of this textbook).

or the United States Pharmacopoeia Dispensing Information Approved Drug Products and Legal Requirements, which contain federal statutes and regulations applicable to the several states.

.

resources20
Resources

Additional information may also be obtained from the state board of pharmacy where you are seeking licensure. Please Note: NO DISTINCTION IS MADE INTHE EXAMINATION BETWEEN FEDERAL AND STATE JURISPRUDENCE QUESTIONS. YOU ARE REQUIRED TO ANSWER EACH QUESTION INTERMS OF THE PREVAILING LAWS OF THE STATE IN WHICH YOU ARE SEEKING LICENSURE

slide21
Go back to home page under the “examinations” options on the left hand side. Scroll down to “Review Guides” to get:

Candidate Review Guides®NOW INTRODUCING

The Pre-NAPLEX

Preparing for the North American Pharmacist Licensure Examination™ (NAPLEX®) is much easier when students use the Pre-NAPLEX™. The only NAPLEX practice exam written and developed by the National Association of Boards of Pharmacy® (NABP®), the Pre-NAPLEX will familiarize students with the NAPLEX testing experience.

click for more information & FAQs ...

however the sad news reports that
However, the sad news reports that:

MPJE™ Candidate's Review Guide, Version 2.0 is no longer available.

http://nabp.net/competency/MPJEGuide/intro.asp no longer works.

slide23
The MPJE has been designed to assess how well you apply your knowledge, skills, and abilities to evaluate situations involving the applicable federal and state laws and regulations that govern the practice of pharmacy in the state in which you are seeking licensure.
irritating limitations to the mjpe exe program
Irritating Limitations to the MJPE.exe program:
  • It is not a true windows application. It will work with Windows 95, NT, 2000 and XP
  • It is always on top
    • This means you cannot cut and paste or print pages individually.
    • You cannot use this program with others with others that run in the background.
  • It is out of date (1999).
  • Questions apply to certain states and not others.
    • Michigan is not mentioned.
    • Some answers would be wrong if Michigan law is used.
  • Exiting is not intuitive.
    • Click the gavel in the upper left hand corner and click on the “close” option.
down to the serious business
Down to the serious business
  • Suggestions for studying for the law exam
    • Make a chart of differing time frame requirements under Michigan and Federal laws
      • Always remember that the stricter law applies
examples
Examples

TIME IS OF THE ESSENCE

a) 90 days b) 6 months c)1 year d) 2 years e) 5 years

1. Federal law requires a controlled substance inventory be completed every ________.

2. Michigan law requires a pharmacy to perform controlled substance inventory at ______ intervals.

3. Federal law requires pharmacies to maintain (keep) controlled substance prescriptions for at least ______.

4 Michigan law requires pharmacies to maintain controlled substances prescriptions for at least ______.

a 90 days b 6 months c 1 year d 2 years e 5 years
a) 90 days b) 6 months c)1 year d) 2 years e) 5 years

5 Federal law requires controlled substances records (invoices, distributions) be maintained (kept) by a pharmacy for at least ______.

6 Michigan law requires controlled substances records (invoices, distributions) be maintained (kept) by a pharmacy for at least ______.

7 Under Michigan law, a pharmacy must maintain a copy of a receipt for a controlled substance prescription for at least ______ after the prescription is dispensed.

8 Normally, a Michigan controlled substance license is valid for ______.

9 In Michigan, a Schedule IV controlled substance may be refilled (if authorized) up to _______ from the date issued.

10 In Michigan, a Schedule V controlled substance may be refilled (if authorized) up to _______ from the date issued.

11 In Michigan, a pharmacist must normally complete mandatory Continuing Education credits every ____.

a 30 days b 7 days c 72 hours d 60 days e 48 hours
a) 30 days b) 7 days c) 72 hours d) 60 days e) 48 hours
  • If a Michigan pharmacist dispenses a Schedule II drug pursuant to an oral order in an emergency situation, the prescriber must hand deliver or send the written prescription postmarked within ______.
  • Under Michigan law, a Schedule II prescription cannot lawfully be filled if it is presented to a Michigan pharmacist more than ______ after it is issued.
  • In Michigan, Schedule II prescriptions issued for terminally ill patients with proper documentation may be filled in partial increments up to ______ after the date of original issuance.
  • A controlled substance inventory for a Michigan licensed pharmacy must be submitted to the Board of Pharmacy no more than ______ prior to May 1 of each year.
a 30 days b 7 days c 72 hours d 60 days e 48 hours29
a)30 days b) 7 days c) 72 hours d) 60 days e) 48 hours
  • A controlled substance inventory for a Michigan licensed pharmacy must be submitted to the Board of Pharmacy no more than ______ after May 1 of each year.
  • In Michigan, a Schedule II controlled substance prescription may be partially filled when the pharmacy does not have enough of the medication on hand to dispense the entire amount called for but only if the remaining amount is dispensed within of the initial partial filling.
  • A maximum of 4 ounces of a Schedule V OTC cough syrup may be sold by a Michigan pharmacy to an individual no more than once every ______.
  • The Michigan Board of Pharmacy must be notified within after a Michigan licensed pharmacist or pharmacist-intern changes his or her place of employment.
make comparative charts
Make comparative Charts
  • 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, non-controlled substance 503(b) drug)
  • All of the above
  • None of the above
slide31
A Michigan licensed pharmacist working in a retail pharmacy is required to reveal the selling price for this drug upon request.
  • This drug must be marketed in Michigan with a mark or markings that permit identification of the manufacturer and drug contents.
  • A prescription for this drug may be refilled a maximum of 5 times within 6 months of the date issued if authorized by the prescriber.
  • This drug must be prescribed on an "official prescription form" if prescribed by a Michigan licensed prescriber.
  • This drug may be mailed through the United States Postal Service.
  • This drug is a high risk of physical or psychological addiction or dependence.
  • This drug may lead to limited physical or psychological dependence.
  • This drug has no recognized potential for abuse but must be used under medical supervision to be safe and effective for its intended purpose.
laws that have changed
Laws that have changed

Michigan Automated Prescription System

MAPS

Replaces OPP

333.7333a Electronic monitoring system.

The MAPS program replaced the Official Prescription Program (OPP) effective January 1, 2003.  MAPS requires electronic reporting of all controlled substances in schedules 2 through 5 dispensed by pharmacies, physicians and veterinarians.

electronic signature r 338 3101 definitions rule 1
"Electronic signature“R 338.3101 Definitions; Rule 1
  • "Electronic signature" means an electronic sound, symbol, or process attached to or logically associated with a record and executed or adopted by a person with the intent to sign the record. An electronic signature also is a unique identifier protected by appropriate security measures such that it is only available for use by the intended individual and ensures non-repudiation so that the signature may not be rejected based on its validity.
rule 2 f patient identifier
Rule 2(f) "Patient identifier"
  • (f) "Patient identifier" includes all of the following information about a patient: (i) Full name. (ii) Address, including zip code. (iii) Date of birth. (iv) Any 1 of the following: (A) A Michigan driver's license number. (B) An identification number obtained from a photo identification card issued by the state of Michigan. (C) The number zero. Zeroes shall be entered as the identification number, if the positive identification presented by the patient or the patient's agent or caregiver does not include a license number or an identification number, as listed in subparagraphs (A) and (B) of this paragraph.
electronic signature
“Electronic Signature”
  • Applies to ALL Prescriptions
    • Both CS and Rx-Only
rule 2 g positive identification
Rule 2(g) "Positive identification"
  • (g) "Positive identification" means identification that includes a photograph of an individual in addition to his or her date of birth. Positive identification shall include an identification card issued by a governmental agency, provided the identification card meets the requirements of this rule.
rule 4 a readily retrievable
Rule 4(a) "Readily retrievable"
  • "Readily retrievable" means a record which is kept in such a manner that it can be separated from all other records within 48 hours and in which a listed controlled substance shall be marked with an asterisk, redlined, or in some other manner be visually identifiable apart from the other substances listed in the record.
rule4 c sign
Rule4(c) "Sign"
  • (c) "Sign" means to affix a signature manually in the same manner as signing a check or legal document or to use an electronic signature, as defined in subdivision (d) of R 338. 3101. Stamped signatures are not valid for any controlled substance prescription.
slide39

MAPS

Controlled substance samples and those administered to patients are exempt from reporting.  Also exempt are controlled substances dispensed by a physician in a health facility or agency licensed under article 17 for no more than a 48 hour supply

slide40

MAPS

The MAPS program does not require the physician to use security paper or serialized forms for prescribing controlled substances.  The Department will not supply serialized prescription forms after January 1, 2003.

slide41

MAPS

Reporting of controlled substances dispensed is required by the 15th of the month following the month the controlled substances are dispensed.Questions regarding the MAPS program should be directed to [email protected]

name changes
Name Changes

OLD: DEPARTMENT OF CONSUMER AND INDUSTRY SERVICES

is now

MICHIGAN DEPARTMENT OF COMMUNITY HEALTH (MDCH)

OLD: BUREAU OF HEALTH SERVICES

is now

BUREAU OF HEALTH PROFESSIONS

bureau of health professions

BUREAU OF HEALTH PROFESSIONS

Filed with the Secretary of State on December 30, 2002.

These rules take effect 7 days after filing with the Secretary of State.

(By authority conferred on the director of the department of consumer and

industry services by 1978 PA 368 and Executive Reorganization Order

No. 1996-2, MCL 333.7201, 333.7301, 333.7333, 333.7333a, 333.16145, and 445.2001)

R 338.3101, R 338.3102, R 338.3104, R 338.3161,R 338.3162,

R 338.3164, R 338.3165, R 338.3166, R 338.3167, and R 338.3168 of

the Michigan Administrative Code are amended, and R 338.3162b,

R 338.3162c, R 338.3162d, and R 338.3162e are added to the Code as follows:

general rule 9b
General Rule 9b
  • Patient must agree that physician can communicate to a pharmacy of the patient’s choosing a prescription that is transmitted electronically.
  • Security Provisions
  • Complies with HIPAA Privacy Requirements
  • Electronic prescriptions must be filed for at least 5 years as any other prescription records.
drug returns general rule 2
Drug ReturnsGeneral Rule 2
  • Drugs that have “left the control of the pharmacist” cannot be exchanged or returned to inventory for resale
  • Exception: Drugs dispensed to inmate of a county jail or Department of Corrections
internship hours rule 3a
Internship Hours Rule 3a
  • Must have internship license while doing the required number of hours.
  • Interns who are no longer enrolled in a degree program at an accredited college or school of pharmacy must notify the Board.
    • Can’t work as an intern unless licensed.
licensure applicants rule 4
Licensure applicants Rule 4
  • NAPLEX 75%
  • Must pass an examination (MPJE) which measures an applicants knowledge of the rules and regulations governing the practice of pharmacy.
    • All transfers must also pass MPJE
drug vending machines
Drug Vending Machines
  • Rule 19 Mechanical Automated Devices
  • Must be approved by Board for a specific location within the pharmacy.
  • Policies for Refilling the machine safely.
  • Documentation- long new rules for labeling. Read them.
r 338 3102 definitions i to p rule 2 1 as used in these rules

R 338.3102 Definitions; I to P.Rule 2. (1) As used in these rules:

"Inventory” means all stocks in finished form of a controlled substance that is manufactured or otherwise acquired by a licensee, whether in bulk or commercial containers or contained in pharmaceutical preparations in the possession of the licensee.

“Licensee” means a person who is licensed pursuant to section 7303 of the act.

rule 2 maps
Rule 2 MAPS
  • (c) “Michigan automated prescription system (maps) claim form” means a term, to be determined by the department, that is in the format and includes the information as specified by the American Society for Automation in Pharmacy (ASAP) and contains the information specified in R 338.3162b.
r 338 3102 definitions i to p rule 2 1 as used in these rules51
R 338.3102 Definitions; I to P.Rule 2. (1) As used in these rules:
  • (d) "National drug code number (NDC)” means an 11-digit, 3-segment number that identifies the labeler/vendor, product, and package size and is assigned to each drug product listed under section 510, registration of producers of drugs and devices, of the federal food, drug, and cosmetic act.
  • (e) “Officer” means a state, county, or local law enforcement officer who has a duty to enforce the laws of this state.
r 338 3102 definitions i to p rule 2 1 as used in these rules52
R 338.3102 Definitions; I to P.Rule 2. (1) As used in these rules:

(g) “Prescriber” or “practitioner” means any of the following individuals who are licensed to prescribe by the laws of this state:

(i) A dentist.

(ii) A doctor of medicine.

(iii) A doctor of osteopathic medicine and surgery.

(iv) A doctor of podiatric medicine and surgery.

(v) A veterinarian.

(2) As used in part 5 of these rules:

(a) “Medical institution” means an inpatient health facility which is

licensed or approved by the state and which directly or indirectly provides or includes pharmacy services.

(b) “Pharmacy services” means the direct and indirect patient care services associated with the practice of pharmacy.

338 3161 prescriptions rule 61

338.3161 Prescriptions. Rule 61

(1) A prescription that is issued for a controlled substance shall be dated and signed when issued and shall contain all of the following information: (a) The full name and address of the patient for whom the substance is being prescribed. (b) The prescriber's drug enforcement administration (dea) registration number, printed name, address, and professional designation. (c) The drug name, strength, and dosage form. (d) The quantity prescribed. For a prescription received in writing, the prescription shall contain the quantity in both written and numerical terms. A written prescription is in compliance if it contains preprinted numbers representative of the quantity next to which is a box or line the prescriber may check. (e) The directions for use. (f) In addition, if the prescription is for an animal, then the species of the animal and the full name and address of the owner.

r 338 3161 prescriptions rule 61

R 338.3161 Prescriptions. Rule 61

(2) A written prescription for a controlled substance in schedules 2 to 5 shall be written legibly with ink or an indelible pencil, or prepared using a printer and shall be signed by the prescriber. (3) An agent of the prescriber may prepare a prescription for the signature of the prescriber, but, pursuant to the act, the prescriber is liable if the prescription does not conform to these rules. A pharmacist who dispenses a controlled substance pursuant to a prescription not prepared in the form required by these rules is liable pursuant to the act.

rule 61

Rule 61

(4) If the controlled substance prescription or order in a medical institution is issued pursuant to delegation under R 338.2304, R 338.2305, R 338.108a, or R 338.108b then the printed name of the delegatee, the licensure designation, the delegating prescriber, and the signature of the delegatee shall be on the written prescription. In medical facilities, orders shall contain the signatures of the delegatee and the printed name of the delegating prescriber. (5) A prescription shall not be issued by a prescriber to obtain a stock of a controlled substance for the purpose of dispensing or administering the substance to patients.

rule 6156
Rule 61
  • (6) A prescriber shall not prescribe a controlled and non-controlled substance on the same prescription form.
  • History: 1954 ACS 77, Eff. Sept. 26, 1973; 1979 AC; 1992 MR 5, Eff. June 13, 1992; 1994 MR 4, Eff. Apr. 21, 1994; 2002 MR 7, Eff. Apr. 11, 2002; 2002 MR 24, Eff. Jan. 7, 2003; 2007 MR 4, Eff. Feb. 21, 2007.
rule 62

Rule 62

A controlled substance shall be dispensed by a pharmacist or a pharmacy intern in the presence, and under the immediate supervision, of a pharmacist.

A pharmacist shall require positive identification of individuals to whom controlled substances are dispensed or delivered when the individual is not known to the pharmacist or pharmacy employees.EXCEPT…….

rule 6258
Rule 62
  • The following provide for waiver of this requirement: (a) When positive identification is not available and a pharmacist, who in exercising his or her professional judgment, determines that a delay in dispensing the controlled substance may be detrimental to a patient. (b) Subdivision (a) of this subrule does not exempt a pharmacist from the requirement to submit a patient identifier, as defined in R 338.3102(1)(f).
rule 6259

Rule 62

(3) The dispensing pharmacist and pharmacy are responsible for compliance with this rule.

(4) Except as provided by R 338.3162a, a pharmacist may dispense a controlled substance which is listed in schedules 3 to 5 and which is a prescription drug pursuant to the provisions of the federal food, drug, and cosmetic act of 1991, 21 U.S.C. §201.100(b)(i) et seq., only pursuant to a written, electronically transmitted, or oral order of a prescriber that contains all of the required information under R 338.3161, except that the signature of the prescriber is not required if the controlled substance is obtained pursuant to an oral order.

rule 6260
Rule 62

(5) If an oral order for a controlled substance listed in schedule 3 to 5 is transmitted by the prescriber's agent under delegation then all of the following shall be recorded on the prescription generated at the pharmacy: The information required by R 338.3161. The transmitting agent's identity. The individual who received the prescription at the pharmacy.

(6) Only an order that is issued in the usual course of professional treatment or in the course of legitimate and authorized research is a prescription.

rule 62a

Rule 62a

As used in this rule, "electronically transmitted prescription drug order" means a prescription drug order that is communicated from the prescriber directly to the pharmacy by electronic means, so that the data cannot be altered, modified, extracted, viewed, or manipulated in the transmission process.

(2) An electronically transmitted prescription order shall be transmitted to the pharmacy of the patient's choice and shall occur only at the option of the patient.

rule 62a62

Rule 62a

(3) A pharmacist may dispense an electronically transmitted prescription drug order only if both of the following conditions are satisfied:

The electronically transmitted prescription drug order includes all of the following information: (i) The name and address of the prescriber. (ii) An electronic signature or other board-approved means of ensuring prescription validity. (iii) The prescriber's telephone number for verbal confirmation of the order. (iv) The time and date of the transmission. (v) The name of the pharmacy intended to receive the transmission. (vi) All other information that is required to be contained in a prescription under the provisions of R 338.3161.

(b) The pharmacist exercises professional judgment regarding the accuracy or authenticity of the transmitted prescription. Technological devices shall not be used to circumvent any applicable prescription documentation and verification requirement

rule 62a63
Rule 62a

(4) An electronically transmitted prescription drug order that meets the requirements of subrule (3) of this rule shall be deemed to be the original prescription.

(5) This rule does not apply to the use of electronic equipment to transmit prescription orders within inpatient medical institutions.

rule 62b
Rule 62b

1) A pharmacist, dispensing prescriber, and veterinarian licensed under Part 177 who dispenses a prescription drug which is a controlled substance listed in schedules 2 to 5 or a pharmacy licensed by the state that dispenses in this state or dispenses to an address in this state a controlled substance listed in schedules 2 to 5 shall report to the department or the department's contractor by means of an electronic data transmittal process the following information for each prescription of a schedules 2 to 5 controlled substance prescription dispensed:

rule 62b65
Rule 62b
  • The patient identifier, as defined in R 338.3102(1)(f). The following apply: (i) An identification number, as specified in R 338.3102(1)(f)(iv)(A) or (B), is not required for patients under the age of 16. (ii) If the patient is under 16 years of age, zeroes shall be entered as the identification number. (iii) If the patient is an animal, positive identification of the animal's owner that meets the requirements of R 338.3102(1)(f)(iv). (b) The name of the controlled substance dispensed. (c) The metric quantity of the controlled substance dispensed. (d) The national drug code number (ndc) of the controlled substance dispensed. (e) The date of issue of the prescription. (f)The date of dispensing. (g)The estimated days of supply of the controlled substance dispensed. (h) The prescription number assigned by the dispenser. (i)The dea registration number of the prescriber and the dispensing pharmacy. (j) The Michigan license number of the dispensing pharmacy.
  • (2) A pharmacist, dispensing prescriber, or veterinarian may presume that the patient identification information provided by a patient or a patient's representative is correct.
rule 62c

Rule 62c.

(1) A pharmacist, dispensing prescriber, or veterinarian who dispenses a prescription drug which is a controlled substance listed in schedules 2 to 5 shall transmit the data, as specified under R 338.3162b, by electronic media or other means as approved by the department or the department's contractor.

(2) The data shall be transmitted in the format established by the american society for automation in pharmacy (asap) telecommunications format for controlled substances.

rule 62c67

Rule 62c.

(3) A pharmacist, dispensing prescriber, or veterinarian who dispenses controlled substances and who does not have an automated record-keeping system capable of producing an electronic report in the format established by subrule (2) of this rule may request a waiver from electronic reporting. The request shall be made in writing to the department.

(4) A pharmacist, dispensing prescriber, or veterinarian may be granted a waiver, if he or she demonstrates an inability to report as required by R 338.3162b and he or she agrees in writing to report the data to the department or the department's contractor by submitting a completed maps claim form as defined in R 338.3102(c) or transmitting data via an internet web portal that is provided by the Department or the Department's contractor for this purpose.

rule 62d

Rule 62d.

A pharmacist, pharmacy, dispensing prescriber, or veterinarian shall report all schedules 2 to 5 controlled substances dispensed beginning on the date that these amendatory rules take effect.

(2) The data required by R 338.3162b shall be forwarded by on-line transmission, computer diskette, compact disk, or other approved medium, as specified in R 338.3162c to the department or the department's contractor twice monthly, by the first calendar day and the 15th calendar day of each month immediately following the month in which the prescription was dispensed, and shall include the data for all controlled substances dispensed since the previous transmission or report. A pharmacist, pharmacy, dispensing prescriber, or veterinarian may choose 2 different dates to report each month, provided that they are within 2 calendar days of the first calendar day and the 15th calendar day of each month and they include all controlled substances dispensed since the previous transmission or report.

rule 62d69
Rule 62d

(3) For each pharmacist, pharmacy, dispensing prescriber, or veterinarian who does not have the capacity to forward the information as specified in R 338.3162b, the information shall be mailed or delivered to a location specified by the department or the department's contractor twice monthly by the first calendar day and the 15th calendar day of the month following the month in which the prescription was dispensed, and shall include the data for all controlled substances dispensed since the previous transmission or report. The pharmacist, pharmacy, dispensing prescriber, or veterinarian may choose 2 different dates to report each month provided they are within 2 days of the first calendar day and the 15th calendar day of each month and they include all controlled substances dispensed since the previous transmission or report.

rule 62d70

Rule 62d.

(4) The department or the department's contractor shall notify a pharmacist, pharmacy, dispensing prescriber, or veterinarian of an error in data reporting. Upon receiving notification of an error in data reporting, a pharmacist, pharmacy, dispensing prescriber, or veterinarian shall take appropriate measures to correct the error and transmit the corrected data to the department or the department's contractor within 15 days of being notified of the error.

rule 62d71

Rule 62d.

(5) A pharmacist, pharmacy, dispensing prescriber, or veterinarian who fails to report the dispensing of a prescription for a controlled substance listed in schedules 2 to 5 as required, beginning on the date that these amendatory rules take effect, shall be subject to the penalty provisions in sections 16221, 17741, or 17768 in article 15 of the act.

r 338 3162e exemption from reporting requirements

R 338.3162e Exemption from reporting requirements.

Rule 62e. A pharmacist, dispensing prescriber, or veterinarian shall be exempt from the reporting requirements under the following circumstances: (a) When a controlled substance in schedules 2 to 5 is administered directly to a patient. (b) When a controlled substance in schedules 2 to 5 is dispensed from a health facility or agency licensed under article 17 of the act by a dispensing prescriber in a quantity adequate to treat a patient for not more than 48 hours.

end of life care legislation

“End of Life Care”Legislation

333.7333 “Good faith” defined; dispensing controlled substances included in schedule 2; prescription form; emergency; filling and refilling prescription; dispensing controlled substance included in schedule 3, 4, or 5; requirements and use of written prescription; dog pound, animal shelter, or class B dealer practicing euthanasia on animals; “class B dealer ” defined.

333 7333 good faith defined

333.7333 “Good faith” defined

Sec. 7333. (1) As used in this section, “good faith” means the prescribing or dispensing of a controlled substance by a practitioner licensed under section 7303 in the regular course of professional treatment to or for an individual who is under treatment by the practitioner for a pathology or condition other than that individual's physical or psychological dependence upon or addiction to a controlled substance, except as provided in this article. Application of good faith to a pharmacist means the dispensing of a controlled substance pursuant to a prescriber's order which, in the professional judgment of the pharmacist, is lawful.

sec 7333 good faith

Sec. 7333. “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:

Lack of consistency in the doctor-patient relationship.

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.

sec 7333 good faith76

Sec. 7333. “good faith”

(2) Except as otherwise provided in this section, a practioner, 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.

emergency schedule 2 rx

Emergency Schedule 2 Rx

(3) In an emergency situation, as described in R 338.3165 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 {was 72 hours} days after the oral prescription is issued.

333 7334 official prescription form

333.7334 Official prescription form;

REPEALED JANUARY 2003

Old Law: 5 days to get CS-II script filed from date of issuance

New Law: 60 days from date of issuance

slide79

333.7339 Dispensing, selling, or giving product to individual less than 18 years of age; violation as misdemeanor; penalty.

(1) A person shall not dispense, sell, or otherwise give a product described in section 7220(1)(c)(ii) {C-V} to an individual less than 18 years of age. This section does not apply to a physician or pharmacist who prescribes, dispenses, administers, or delivers a product described in section 7220(1)(c)(ii) to an individual less than 18 years of age, to a parent or guardian of an individual less than 18 years of age who delivers the product to the individual, or to a person authorized by the individual's parent or legal guardian who dispenses or delivers the product to the individual.

slide80
333.7339 Dispensing, selling, or giving product to individual less than 18 years of age; violation as misdemeanor; penalty.

(2) In the course of selling, offering for sale, or otherwise distributing a product described in section 7220(1)(c)(ii), a person shall not advertise or represent in any manner that the product causes euphoria, ecstasy, a “buzz” or “high”, or an altered mental state, heightens sexual performance, or, because it contains ephedrine alkaloids, increases muscle mass.

(3) A person who violates this section is guilty of a misdemeanor punishable by imprisonment for not more than 93 days or a fine of not more than $100.00, or both.

slide82

Sec. 17711A person shall not engage in the practice of pharmacy unless licensed or otherwise authorized by this article.

this article

“this article”

Article 15

Occupations

read the definitions
Read the Definitions
  • What is a person?
    • Sec. 1106. "Person" means an individual, partnership, cooperative, association, private corporation, personal representative, receiver, trustee, assignee, or any other legal entity. It does not include a governmental entity unless specifically provided.
what does engage mean

What does “engage” mean?

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

http://www.dictionary.com/search?q=engage

To obtain or contract for the services of; employ: engage a carpenter.

To arrange for the use of; reserve: engage a room. To pledge or promise, especially to marry.

To attract and hold the attention of; engross: a hobby that engaged her for hours at a time.

To win over or attract: His smile engages everyone he meets.

To draw into; involve: engage a shy person in conversation.

To require the use of; occupy: Studying engages most of my time.

To enter or bring into conflict with: We have engaged the enemy.

To interlock or cause to interlock; mesh: engage the automobile's clutch.

To give or take as security.

?????????

engage

engage

v.intr.

To involve oneself or become occupied; participate: engage in conversation.

To assume an obligation; agree.

To enter into conflict or battle: The armies engaged at dawn.

To become meshed or interlocked: The gears engaged

practice of pharmacy

Practice of Pharmacy

Sec. 17707 (5) "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. 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

Sec. 16106(2) "License," except as otherwise provided in this subsection, means an authorization issued under this article to practice where practice would otherwise be unlawful. 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. 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.

otherwise authorized

“otherwise authorized”

Sec. 16171. 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 authorized92

“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.

otherwise authorized93
“otherwise authorized”
  • (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.
slide94
Sec. 17711.

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

17748 the long arm statute

17748The “long-arm” statute

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

rule 20 2

Rule 20 (2)

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

(a) The prescription appears to be improperly written.

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

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

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

logic for a statement to be true the opposite must also be true

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

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?

Is Professional Judgment subjective or objective?

rule 20 1 professional responsibility

Rule 20 (1) 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.

rule 20 3

Rule 20 (3)

A prescription drug shall only be dispensed when the pharmacy is open and under the personal charge of a pharmacist.

Sec. 17763. In addition to the grounds set forth in part 161, the disciplinary subcommittee may fine, reprimand, or place a pharmacist licensee on probation, or deny, limit, suspend, or revoke the license of a pharmacist or order restitution or community service for a violation or abetting in a violation of this part or rules promulgated under this part, or for 1 or more of the following grounds:

(d) Permitting the dispensing of prescriptions by a pharmacist intern, except in the presence and under the personal charge of a pharmacist.

personal charge

personal charge

Sec. 17707 (1) "Personal charge" means the immediate physical presence of a pharmacist or dispensing prescriber.

rule 20 4

Rule 20 (4)

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

shall communicate

Shall Communicate

(a) The information shall be communicated orally and in person, except when thepatient 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

Important Distinctions

Personal Charge §17707 (1)

Supervision §16109(2)

Delegation §16215 and Rule 20(5)

supervision 16109 2

Supervision §16109(2)

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

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

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

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

delegation rule 20 5

Delegation Rule 20 (5)

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

16215

§16215

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

16215108

§16215

(2) 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.

16215109

§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

…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 5111

Delegation Rule 20(5)

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

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

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

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

(d) Supervise and evaluate the performance of the delegatee.

(e) Provide remediation of the performance of the delegatee if indicated.

Note: Inclusive, all 5 requirements

rule 20 6

Rule 20 (6)

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

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

ad