Pharmacy Law Review

1. Pharmacy Law Review Jesse C. Vivian Professor Department of Pharmacy Practice April 29, 2008 http://jessevivian.net

2. 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

3. 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

4. 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.

5. 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

6. North American Pharmacist Licensure Examinationtm Multistate Pharmacy Jurisprudence Examination® NAPLEX/MPJE Registration Bulletin

7. 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.

8. 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.

9. 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.

10. 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.

11. 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.

12. 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.

13. 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.

14. 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.

15. 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.

16. 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.

17. 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.

18. 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.

19. 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. .

20. 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

21. 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 ...

22. 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.

23. 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.

24. 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.

25. 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

26. 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 ______.

27. 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 ____.

28. 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.

29. 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.

30. 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

31. 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.

32. 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.

33. "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.

34. 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.

35. “Electronic Signature” • Applies to ALL Prescriptions • Both CS and Rx-Only

36. 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.

37. 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.

38. 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.

39. 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

40. 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.

41. 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 mapsinfo@michigan.gov

42. 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

43. 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:

44. 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.

45. 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

46. 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.

47. 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

48. 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.

49. 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.

50. 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.