Pharmacy Law Syllabus Spring 2021 Final 01142021 PDF

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MCPHS UNIVERSITY SCHOOL OF PHARMACY-BOSTON COURSE SYLLABUS PHARMACY LAW PSB 411 SPRING 2021

CATALOG INFORMATION Course Number: Course Title: Elective or Required Course: Didactic Lecture hours per week: Self-instruction hours per week: Credit hours per semester: Class Location:

PSB 411 Pharmacy Law Required 3 3-6 3 Monday and Wednesday 8:00AM-9:15AM, White Building Room 300 and via Zoom

Pre-requisite Courses Fourth-year standing, PPB 325 and PPB 335 Co-requisite Courses NA Course Coordinators Frederick M. Frankhauser, JD, MBA, RPh Associate Professor, Department Chair PBAS MCPHS office location: White 319 Office hours: Mondays 10AM12PM and by appointment Email: [email protected] Office phone: (617) 735-1017 Course Description This course examines the state and federal legal requirements associated with pharmacy practice and operations including regulation of pharmacy personnel, pharmacies, pharmacy departments, controlled substances, dispensing functions, and prospective drug review and counseling. Instructional Strategies, Course Materials, Resources Instructional strategies:  Instructional strategies include lecture, demonstration, and case discussions. Methods will vary by topic.  Self-study and regular independent reading of the textbook and course materials are essential for clarifying material and maintaining familiarity with the course material that is generally cumulative in nature.  Blackboard will be utilized for additional lecture information, practice questions, schedules and announcements.  Students are required to check the course Blackboard account on a daily basis.

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Student engagement in class enhances learning and active participation is facilitated by regular class attendance.

ECHO is not a substitute for attendance. Methods for participation/attendance: Polling question? 

Other strategies Virtual delivery options Lecture: Live, Live-recorded (ECHO) Course Materials Laptops, Cameras, Microphones Specify meeting platform (Zoom)

Required readings:

Required:  Abood Richard R, Burns Kimberly A. Pharmacy Practice and the Law 9th edition. Available on reserve in MCPHS Library  Board of Registration in Pharmacy Regulations: 247 CMR The Board’s regulations may be accessed at: http://www.mass.gov/courts/case-legal-res/lawlib/laws-by-source/cmr/200-299cmr/247cmr.html  Board of Registration in Pharmacy: Policies Policies are adopted in an attempt to clarify statutes and/or regulations which may appear unclear, or which may not lend themselves to various practice settings. Circular letters are similar to Board policies, but are published by the Drug Control Program. Both policies and circular letters are enforceable and may be accessed at: http://www.mass.gov/eohhs/gov/departments/dph/programs/hcq/dhpl/pharmacy/pharmacyregs/policies/  Department of Public Health Regulations: 105 CMR Sections 700.00 - 722.00 These regulations pertain to hospital pharmacies, mandated interchange, product labeling, prescription format and security standards: http://www.mass.gov/eohhs/gov/laws-regs/dph/regs-cmr/public-health- regulations-105-cmr700-799.html  Massachusetts General Laws (M.G.L.) Chapters 13, 112 and 94C In addition to the website, Massachusetts General Laws may also be viewed at the State House Library or any public or Massachusetts school/college of pharmacy library: https://malegislature.gov/Laws/GeneralLaws/Search (Insert chapter and section into search field – for example, Chapter 94C, section 33(b))  M.G.L. c. 13 sections 22 – 25A https://malegislature.gov/Laws/GeneralLaws/PartI/TitleII/Chapter13    

M.G.L. c. 112 sections 24 – 42D https://malegislature.gov/Laws/GeneralLaws/PartI/TitleXVI/Chapter1123 M.G.L. c. 94C section 1 - 40 (Massachusetts Controlled Substances Act) https://malegislature.gov/Laws/GeneralLaws/PartI/TitleXV/Chapter94C Massachusetts Board of Registration in Medicine “Prescribing Practices: Policies & Guidelines”: http://www.mass.gov/eohhs/docs/borim/policies-guidelines/policy-15-05.pdf Title 21 of Code of Federal Regulations (CFR) Part 1300 – 1321:

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This section contains federal laws and regulations. For copies, contact the U.S. Government Publishing Office (Tel. (202) 512-1800) or access here: https://www.deadiversion.usdoj.gov/21cfr/cfr/index.html Drug Enforcement Administration (DEA) - Pharmacist’s Manual: https://www.deadiversion.usdoj.gov/pubs/manuals/pharm2/ Poison Prevention Packaging Act 16 CFR 1700: https://www.gpo.gov/fdsys/pkg/CFR-2012-title16-vol2/pdf/CFR-2012-title16-vol2part1700.pdf Prescription Drug Marketing Act: https://www.fda.gov/regulatoryinformation/lawsenforcedbyfda/significantamendmentstothefdc act/prescriptiondrugmarketingactof1987/default.htm Federal Food, Drug and Cosmetic Act (FDCA): https://www.fda.gov/regulatoryinformation/lawsenforcedbyfda/federalfooddrugandcosmeticactf dcact/default.htm FDA regulations governing labeling directions: http://www.ecfr.gov/cgi-bin/text- idx? SID=82ebc98617b5fa36d9ea373775750b48&mc=true&node=pt21.4.201&rgn=div5 FDA regulations governing Patient Package Inserts: http://www.ecfr.gov/cgi-bin/text- idx? SID=82ebc98617b5fa36d9ea373775750b48&mc=true&node=pt21.5.310&rgn=div5 FDA regulations governing Recalls: http://www.ecfr.gov/cgi-bin/text-idx? SID=82ebc98617b5fa36d9ea373775750b48&mc=true&node=pt21.1.7&rgn=div5#sp21.1.7. c FDA statutes governing Misbranding: https://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/html/USCODE-2010-title21- chap9subchapV-partA-sec352.html FDA statutes governing Adulterated Drugs: https://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/html/USCODE-2010-title21-chap9subchapV-partA-sec351.htm4 NABP Pharmacist Resources: https://nabp.pharmacy/initiatives/awarxe/pharmacist-resources/ USP: http://www.usp.org/ Additional resources may be provided by the instructors via Blackboard as needed at least 24 hours before the lecture date.Supplemental readings/materials as assigned

Course Goals and Objectives The goals and learning objectives of this course are to prepare the student for successful completion of the NAPLEX and MPJE licensure exam and for a career in pharmacy practice. This course meets the following ACPE 2016 Standards and Educational (CAPE) and Appendix 1 Curriculum Outcomes, and provides a knowledge base for application of the following Entrustable Professional Activities (EPAs). c o me s :  CAPEOut Up o ns u c c e s s f u lc o mp l e t i ono ft h i sc o u r s e , t h es t u de n twi l lh a v eg a i n e df o u nd a t i on a lkn o wl e d g e , f or me da nu n de r s t a n d i n go fe s s e nt i a l sf orp r a c t i c ea n dc a r e ,d e v e l o p e da na p pr o a c ht op r a c t i c ea nd c a r e ,a n de n g a g e di npe r s on a la n dp r o f e s s i o n a ld e v e l o p me n ti nt h ea r e ao fp h a r ma c yl a wa n d r e g u l a t o r ya ffa i r s .

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1 .Fo unda t i o na lkno wl e dg e–t h es t u d e ntwi l lb ea b l et o : 1 . 1Le a r n e r :De v e l o p, i nt e g r a t e , a nda p pl ykn o wl e d g ef r o mt h ef o u nd a t i o na ls c i e n c e s–t h es t u d e n t wi l lb ea b l et o :  Describe how the American legal system works and to explain sources of law.  Describe the federal and state government’s involvement in the practice of pharmacy.  Explain key Federal and State agencies and their roles in defining, implementing, and monitoring compliance with pharmacy law.  Explain the FDCA amendments and what each Amendment accomplished.  Distinguish between the definitions of food, drug, cosmetic, device, label and labeling.  Explain the situations that may cause a drug to be adulterated or misbranded.  Describe the legal requirements associated with off-label uses, drug recalls, dispensing alcohol, medication guides, restricted and nuclear pharmacies, and consequences of violating pharmacy laws.  Discuss the process for handling drug recalls, counseling requirements under OBRA 90 and Massachusetts laws and regulations, and the use of safety caps in pharmacy.  Describe the pharmacist’s role in processing a prescription/ medication order.  Explain the federal and Massachusetts legal requirements on who may issue a prescription or medication order, associated limitations, proper prescription forms and manner of issuing prescriptions.  Discuss the federal and Massachusetts laws and regulations relating to controlled substances, generic substitution, sale of syringes, transferring prescriptions, OTC sale of pseudoephedrine, and Naloxone.  Discuss the differences between Massachusetts and the Federal Controlled Substances Act.  Explain the corresponding responsibility role of pharmacists in filling prescriptions.  Describe the process of verifying a DEA number.  Explain the basic drug and pharmacy-related provisions of Medicare.  Explain the basic drug and pharmacy-related provisions of Medicaid.  Describe the requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA).  Explain the elements of a professional malpractice claim against a Pharmacist.  Describe the expanding liability of pharmacists for the failure to practice pharmaceutical care.  Recognize the types of prescription processing errors that can lead to pharmacist liability.  Explain restrictions on dispensing prescriptions, procedures for dispensing, people who may obtain medications pursuant to a prescription, regulations regarding hypodermic instruments, and related matters.  With respect to procedures for dispensing prescriptions, explain the procedures for original dispensing of a prescription, refill dispensing, partial dispensing, out-of-state prescriptions, Massachusetts interchange law and mailing prescriptions.  Describe what is required to be included on a Massachusetts pharmacy label and what is required to comply with the counseling laws.  Describe the Massachusetts internship requirements, registration and conduct responsibilities of pharmacists and interns.  Describe the roles and responsibilities of pharmacy managers, pharmacy interns, and pharmacy technicians. 4

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Describe Massachusetts requirements for managing and operating pharmacies and pharmacy departments. Describe the essential requirements for operating a pharmacy or pharmacy department including regulations governing equipment and publications, premises maintenance, public notifications and displays, medication stock and related matters. Explain the role and responsibilities of the pharmacist, technician and intern. De s c r i bewha tame d i c a t i o ne r r o ri sa ndh owc a nap h a r ma c i s t p r e v e n tame d i c a t i o n e r r orf r omo c c u r r i n g .

2. Es s e nt i a l so fPr a c t i c eandCa r e–t h es t ud e n twi l lbea bl et o : 2 . 1Pa t i e n t c e n t e r e dc a r e  Describe the role of the pharmacist in various practice settings as the medication expert.  Describe what is required to comply with the counseling laws and patient health literacy. 2 . 2Me d i c a t i o nu s ema n a ge me n ts y s t e ms  Interpret a prescription in accordance with applicable laws and regulations focusing on generic interchange.  Describe quality improvement concepts that a pharmacist can utilize to minimize patient harm. 3. Appr o ac ht oPr a c t i c ea ndCa r e-t h es t u d e ntwi l lb ea bl et o: 3 . 1Pr o bl e ms o l v i n g  Complete examinations and assignments throughout the course to demonstrate knowledge of federal and specific state laws, rules and regulations impacting the practice of pharmacy. 3 . 2Ed u c a t i o n  Given a patient case scenario, effectively communicate and develop appropriate counseling points for the patient/caregiver in regards to proper use, medication adherence, expected side effects, and monitoring techniques when appropriate. 3.6 Communication  Student describes appropriate patient counseling. 4. Pe r s o na la ndPr o f e s s i o nal De v e l o pme nt -t h es t u d e n twi l lbea b l et o : 4 . 4Pr o f e s s i o na l i s m  Demonstrate the importance of professional conduct.  Appendix 1 Curriculum Outcomes: https://www.acpe-accredit.org/pdf/Standards2016FINAL.pdf  History of Pharmacy, Pharmacy Law, Regulatory Affairs, and Patient Safety.

 Entrustable Professional Activities (EPAs): 5

Students in this course will learn the foundational knowledge to develop their skills in: 1. 2. 3. 4. 5. 6.

Collaborating as a member of an interprofessional team. Minimizing adverse drug events and medication errors. Educating patients and professional colleagues regarding the appropriate use of medications. Overseeing the pharmacy operations for an assigned work shift. Fulfilling a medication order. Demonstrating the importance of professional conduct.

ACPE APPENDIX 1 CONTENT COVERED: Pharmacy Law, Regulatory Affairs, and Patient Safety. Assessment of Student Learning (and Teaching) Effectiveness; Formative and Summative Examination and Grading Methods 

For mat i v ea s s e s s me n twi l li n c l u d e :I nc l a s s“ p o pq u i z z e s ”a n d/ o r“ Aud i e n c e Re s p o n s eQu e s t i o n s ”ma y b eu s e dt oa s s e s sp r o gr e s si nc o nt e n tc o mp r e h e n s i o n. Th e r ewi l lb en oma k e u pqu i z z e sf ora n yi n c l a s s f or ma t i v ea s s e s s me n t smi s s e dd u et od o c u me n t e do run d o c u me n t e da b s e n c e s , o rn o n f un c t i on i n go r f or g o t t e nc l i c k e r s .St u d e n t sma yn o tg i v et h e i rc l i c k e r st oo t h e rs t u d e n t st o‘ c l i c ki n ’f o rt he m/ t a k ea ni n c l a s sp o pq u i zont h eb e h a l fo fa n yo t he rs t ud e n t . Do i n gt h i si sav i o l a t i o no ft h eAc a d e mi cHo ne s t y Pol i c ya n dt h eSt u d e n tCo d eo fCo n d uc t ,a n dwi l lb er e p o r t e dt ot h eDe a nofSt u d e n t s .

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Summative Assessment: Knowledge and understanding of basic facts and the ability to apply these facts to solve problems will be evaluated through a total of two in semester exams with each exam counting for 25% of the final grade (see schedule below for dates) and a final cumulative exam worth the remaining 50% held during finals week.

Type of assessment Exam #1 Exam #2 Cumulative Final Exam Total

Date 2/17/2021 3/24/2021 TBD

Weightage 25% 25% 50% 100%

Students are expected to maintain a courteous and professional demeanor in the classroom at all times. Late arrival to class, private conversations, cell phones and other inappropriate behaviors are disruptive and disrespectful and they will not be tolerated. No cell phones usage allowed, except for audio recording the lecture. No MP3 players allowed. Furthermore, no electronics of any kind will be allowed during an exam. This includes electronic watches, Fitbits or the like, etc. Please obtain permission from the instructors prior to recording any lecture. 

Minimum passing grade is 70%. 6

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The grade EARNED will be based on the percent of the total points accumulated relative to the maximum achievable points. Grades will NOT be scaled. The minimum percent of the total achievable points necessary for a particular grade is as follows (standard decimal rounding rules apply: http://www.mathwizz.com/fractions/help/help13.htm): Grading Scale A AB+ B B-

93 – 100 90 – 92 87 – 89 83 – 86 80 – 82

C+ C CD F

77 – 79 73 – 76 70 – 72 60 – 69...