Florida Pharmacy Laws and Regulations: Federal and State Control of Medication Dispensing, Study notes of Pharmacy

Download Florida Pharmacy Laws and Regulations: Federal and State Control of Medication Dispensing and more Study notes Pharmacy in PDF only on Docsity! 1 PHA5239 Pharmacy Law and Ethics Fall 2012 3 Credit Hours Course Purpose: Legal issues are everywhere. An understanding of the American legal system gives one the tools to meaningfully participate in our society. In this course, we will discuss the contours of law, specifically focusing on the area of pharmacy law. We will examine the federal and Florida state laws that impact the practice of pharmacy, while emphasizing the legal and ethical principles applied by pharmacists in their daily decision-making. Students will learn the governmental framework within which pharmacy is practiced, as well as acquire an understanding of the laws, regulations, and the ethical responsibilities applicable to pharmacists so that they will be able to protect the public and ensure patients’ wellbeing. We will also incorporate other broad areas of law into our discussions on pharmacy, such as contracts, criminal law and torts. Furthermore, students will learn legal procedure, legal terminology, and have an opportunity to reflect upon and evaluate the United States legal system, including its impact on the profession of pharmacy, through class readings, videos and discussions. Course Faculty and Office Hours: Professor and Course Coordinator: W. Thomas Smith, Pharm.D., J.D. Clinical Associate Professor Email: tsmith@cop.ufl.edu Office: HPNP 2333A Phone: 352-273-5657 Distance Faculty Facilitators: Campus Professor Instructor Jacksonville Carol Motycka, Pharm.D. Assistant Dean & Campus Director Email: motycka@cop.ufl.edu Steve Pudic, Pharm.D., J.D. Email: stevespudic@aol.com Gary Padgett, Pharm.D., J.D. Email: garypadgett@bellsouth.net Orlando Erin St. Onge, Pharm.D. Assistant Dean and Campus Director Email: stonge@cop.ufl.edu Rick Allen, R.Ph., J.D. Email: rallen@mateerharbert.com St. Petersburg Jennifer Williams, Pharm.D. Assistant Dean and Campus Director Email: williams@cop.ufl.edu 2 Graduate Teaching Assistants: Danijela Stojanovic, Pharm.D., Ph.D. Student Office: HPNP 2314 Email: dstojanovic@ufl.edu Chintan Dave, Pharm.D., Ph.D. Student Office: HPNP 2314 Email: cdave@ufl.edu Yanmin “Zoe” Zhu, BA, Ph.D. Student Office: HPNP 2314 Email: zoe3695@ufl.edu Office Hours: By appointment only Place and Time of Class Sessions:  Gainesville classes and exams will be held in the HPNP Auditorium (Room # 1404). o Classes generally meet on Wednesdays from 10:40 am to 12:20 pm. Please note, however, that class #4 will meet on Friday 9/14 from 1:55-3:35 in room G101 (See Appendix B below).  The faculty facilitators at each distance campus will schedule a day and time in which to conduct class – a time that is convenient for their particular location. However, students at all four campuses will discuss the same material each week, and exams will be conducted at each campus on the same dates and at the same times. How This Course Relates to the Learning Outcomes You Will Achieve in the Pharm.D. Program: This course prepares the Pharm.D. student to accomplish the following abilities and the related Student Learning Outcomes (SLOs) upon graduation:  Perform pharmacist responsibilities within the medication use system and relate to the larger health care systems to assure safe and quality patient care. (SLO 3.1, 3.3)  Communicate effectively with patients, caregivers, peer pharmacists, other pharmacy staff, and other health professionals. (SLO 4.1)  Demonstrate ethical behaviors and adhere to legal requirements in pharmacy practice. (SLO 7.2)  Solve complex practice problems (both patient-specific and general practice) using an evidence- based approach, other aspects of good clinical science, and informatics. (SLO8.1-8.2) Course Objectives: General Objectives: The course will provide students with an understanding of:  Regulations promulgated by federal agencies that directly impact the profession of pharmacy, including the federal Food and Drug Administration and the Drug Enforcement Administration. 5 Course Structure & Outline/Activities: Course Structure: Multiple self-directed learning activities are required (e.g., prerecorded lecture videos for homework, readings that involve critical thinking, and discussion board participation), and each week students come to class for a face-to-face learning session (e.g., case discussion, problem set discussion); students must come to campus for exams. Course Outline/Activities: The outline of course activities is listed at the end of this document in Appendix B. Please note that the dates/times for in-class sessions, as well as the location for such sessions are for Gainesville students only. Distance faculty will post this information for students at their respective campuses. Textbooks: Required:  Abood RR. Pharmacy Practice and the Law, 6th Edition. Sudbury, MA: Jones and Bartlett Publishers5,; 2010. (ISBN-13: 978-0-7637-8129-3).  Veatch RM & Haddad A. Case Studies in Pharmacy Ethics, 2nd Edition. New York, NY: Oxford University Press; 2008. (ISBN-13: 978-0-19-530812-9). Recommended:  Reiss BS & Hall GD. Guide to Federal Pharmacy Law, 7th Edition. Delmar, NY: Apothecary Press; 2010. (ISBN-13: 978-0967633268).  Drug Enforcement Administration Office of Diversion Control. “Pharmacist’s Manual: An Information Outline of the Controlled Substances Act”, 2010 Edition. Available at http://www.deadiversion.usdoj.gov/pubs/manuals/pharm2/pharm_manual.pdf.  Garner BA, ed. Black’s Law Dictionary, 3rd Pocket Edition. St. Paul, MN: West Group; 2001. (ISBN- 10: 0314158626; ISBN-13: 978-0314158628). Active Learning Requirements: During each live, in-class session students are required to answer poll questions (referred to as “test- your-knowledge” questions) over both state law and federal law concepts using their i-devices (e.g. iPhones, iPads, etc.). Accordingly, students must bring their i-devices to each class. Class discussions are heavily based upon students’ responses to these questions. Students are also highly encouraged to participate on the weekly course discussion boards by deliberating and chatting about core concepts assigned for the given week. 6 Student Evaluation & Grading: Evaluation Methods: There are 250 possible points, broken down as follows:  Hourly Examinations (4)…………….…200 points total o Each exam will consist of 50 questions, 1 point per question; 50 points per exam. o Exams 1-3 will reflect federal law and cases/concepts outlined in the reading materials, videos and class discussions. o Exam 4 is NOT cumulative, and will cover Florida state law concepts only. o Students will have 75 minutes to complete each exam. o UF IDs must be blackened/bubbled in on exam scantrons. o Gatorlink IDs must be written on the top right corner of the scantron sheets.  State Law……………………….…..…..…..50 points total o Students will select only one of the following options:  Outlines  10 outlines total; each is worth 5 points.  See below for outline due dates.  Quizzes  10 quizzes total; each consists of 10 multiple-choice questions, and each quiz is worth 5 points total (0.5 points/question).  Students will have 15 minutes to complete each quiz on Sakai.  See below for quiz dates. Grading Scale: 92.5-100% = A 82.5-86.4% = B 69.5-76.4% = C 89.5-92.4% = A- 79.5-82.4% = B- 64.5-69.4% = D 86.5-89.4% = B+ 76.5-79.4% = C+ ≤64.4% = E  See link regarding minus grades: http://www.isis.ufl.edu/minusgrades.html.  No grade of “C-“will be assigned in this course.  See link regarding University grading policies: https://catalog.ufl.edu/ugrad/current/regulations/info/grades.aspx#averaging. Class Attendance Policy: Students will have an opportunity to be involved in this course through class discussion. It is therefore essential that students read all assigned course materials, watch and listen to all prerecorded videos, as well as attend each and every class. Attendance, however, is NOT mandatory; yet, it is highly encouraged. If you choose to come to class, it will be expected that you listen and learn. You will not be permitted to sleep, study material from another course, or play/chat on laptops, cell phones or any other electronic devices. Please note that attendance will be taken every class. 7 Students who actively participate in class by asking insightful questions and/or listening intently will be awarded 0.5 points per class (which will be added to the student’s final grade). Students who merely attend class, but fail to be attentive, will not be awarded the participation points. The awarding of such points is at the discretion of the instructor. Generally, students must be in attendance to earn the bonus for participating; however, students excused for professional development who provide proof of event participation will be awarded the bonus at the discretion of the instructor. Quiz/Exam Policy: Quizzes:  As mentioned above (and in the letter I sent you in June), students will select the way in which they will earn the 50 available state law points – one way is to complete 10 outlines and the other way is to complete 10 multiple-choice quizzes. Quizzes are discussed here, and outline assignments are discussed below in the section entitled “Assignment Deadlines.”  During the 10 weeks that outlines are assigned, quizzes will be given to those students choosing the quiz option. Each quiz, taken on Sakai, consists of 10 questions over the state laws assigned to be outlined during the given week.  Quiz questions are randomly taken from a bank of questions. Thus, no two students will take the exact same quiz.  Each question will be worth 0.5 points; thus, each quiz will be worth 5 points (the same weight as an outline). Students will be quizzed only on the material assigned for that week; and quizzes are not cumulative.  The quiz will open at 11:59 pm on the Thursday before outlines are due on Monday, and the quiz will close at 8 am on Monday (at the time outlines are due). Students will have 15 minutes to take the quiz, and the student can take the quiz during any 15 minute window between late Thursday night and early Monday morning. Once the quiz is started, however, the student will have to complete it – there will only be one opportunity (unless there is an unforeseen technical glitch, which, thankfully, happens very rarely).  Please note that by the end of the first week of classes, students will have to decide whether to take the quizzes or complete the outlining assignments. Students will NOT be permitted to switch between options. Once a student makes a decision, it is final. There are no exceptions.  Quiz questions will not be made available to students; however, throughout the course of the semester, about 100 questions over Florida pharmacy law will be made available for students to use to help prepare for both Exam 4 and the board exam.  Please refer to page 8 for quiz dates and times. 10 written in shorthand – whatever works best for you works for me! If you feel that you want to include in your outline submissions the exact (word-for-word) language featured in these laws, this is acceptable ONLY IF you include, with EACH law, notes summarizing the takeaway point(s) of the law. This tells me that you’ve processed the law and have an understanding of it. We will look to see that you have interpreted the more verbose legalese into clear and concise language.  You will earn no credit for simply cutting-and pasting the law and doing nothing else.  As a rule of thumb, please try to keep each outline to a maximum of 10 pages. Documents of greater than 10 pages are sometimes rejected by Sakai. If your document contains more than ten pages, please email the TA assigned to you to let him/her know so that if Sakai indeed rejects your document, your TA will know to request the document from you. Note: An announcement will be sent to students alerting them of the TA assigned to them. Please keep an eye out for this announcement.  Please see Appendix C for the weekly state outlining assignments.  Please see the table below for the outline due dates. Outline number Date due (by 8 am) Outline number Date due (by 8 am) 1 8/27 6 10/8 2 9/3 7 10/22 3 9/10 8 10/29 4 9/24 9 11/5 5 10/1 10 11/12 General College of Pharmacy Course Policies: The College of Pharmacy has a website that lists course policies that are common to all courses. This website covers the following: 1. University Grading Policies 2. Academic Integrity Policy 3. How to request learning accommodations 4. Faculty and course evaluations 5. Student expectations in class 6. Discussion board policy 7. Email communications 8. Religious holidays 9. Counseling & student health 10. How to access services for student success Please see the following URL for this information: http://www.cop.ufl.edu/wp-content/uploads/dept/studaff/policies/General%20COP%20Course%20Policies.pdf 11 Complaints: Should you have any complaints with your experience in this course please visit: http://www.distancelearning.ufl.edu/student-complaints to submit a complaint. Appendix A: Directions for Contacting Faculty & Course Faculty List Directions for Contacting Course Faculty:  Please post on the discussion board questions regarding the substantive material covered in this course.  Please contact Dr. Smith and your faculty facilitator for personal matters that may affect your performance in this course.  Please contact the TA assigned to you for questions about the outlining assignments.  Please contact Dr. Smith for issues involving the quizzes. Appendix B: Schedule of Course Activities/Topics: Week of Class number Gainesville Class Day/Date/Time (10:40 am – 12:20 pm) Exam Day/Date/Time Reading* 8/19 1 Wednesday 8/22  Abood pp. 1-24 8/26 2 Wednesday 8/29  Abood pp. 39-46 (stop before “Defining & Distinguishing…”)  Abood pp. 72-84 (stop before “Drugs Intended…”)  Abood pp. 117-123  Abood pp. 142-151(start with “[PDMA] of 1987” & stop before “Drug Advertising…”) 9/2 3 Wednesday 9/5  Abood pp. 58-72 (stop before New Drug Approval”)  Abood pp. 128-133 (stop before “Pharmacy Compounding…”) 9/9 4 Friday 9/14 in G101  Abood pp. 46-58 (stop before “Prohibited Acts…)  Abood pp. 84-100 9/16 5 Wednesday 9/19 Thursday 9/20 (over Classes 1 -4); 7 pm – 8:15 pm  Abood pp. 124-128 (stop before “Prescription Drug Labeling…)  Veatch/Haddad pp. 52-54  Veatch/Haddad pp. 174-179  Veatch/Haddad pp. 236-254 9/23 6 Wednesday 9/26  Abood pp. 133-142 (stop before “[PDMA] of 1987”  Abood pp. 151-154 12 9/30 7 Wednesday 10/3  Abood pp. 171-202 10/7 8 Wednesday 10/10  Abood pp. 217-249 10/14 9 Wednesday 10/17 Monday 10/15 (over Classes 5 – 8); 7 pm – 8:15 pm  Veatch/Haddad pp. 86-100  Veatch/Haddad pp. 255-266 (stop before Case 15-4)  Veatch/Haddad pp. 268-273 10/21 10 Wednesday 10/24  Veatch/Haddad pp. 274-289 10/28 11 Wednesday 10/31  Veatch/Haddad pp. 102-133 11/4 12 Wednesday 11/7  Abood pp. 267-283 through HIPAA 11/11 13 Wednesday 11/14  Abood pp. 370-405 11/18 No class on Wednesday 11/21! Monday 11/19 (over Classes 9 – 13); 7 pm – 8:15 pm 11/25 14 Wednesday 11/28  Florida State Statutes  Abood pp. 329-40 12/2 15 Wednesday 12/5  Florida State Rules  Abood pp. 340-53 12/9 Monday 12/10 (over Classes 14 – 15); 3:30 pm – 4:45 pm *The reading assignments above are subject to change as necessary throughout the semester. Appendix C: Weekly State Outline Assignments Assignment 1 (continued on p. 13) Background of Florida Pharmacy Laws and Definitions  465.001 Short title  465.002 Legislative findings; intent  465.003 Definitions The Florida Board of Pharmacy  465.004 Board of pharmacy  465.005 Authority to make rules  465.006 Disposition of fees; expenditures  465.0155 Standards of practice  465.017 Authority to inspect; disposal Assignment 2 (continued on p. 13) Pharmacy Permits  465.0156 Registration of nonresident pharmacies  465.0161 Distribution of medicinal drugs without a permit  465.018 Community pharmacies; permits  465.0181 Community pharmacy permit required to dispense CII or CIII controlled substances  465.019 Institutional pharmacies; permits  465.0193 Nuclear pharmacy permits  465.0196 Special pharmacy permits  465.0197 Internet pharmacy permits  465.022 Pharmacies; general requirements; fees  465.023 Pharmacy permittee; disciplinary action 15 Assignment 7 Pharmacy practice standards cont.  64B16-27.210 General terms and conditions to be followed by a pharmacist when ordering and dispensing approved medicinal drug products  64B16-27.211 Prescription refills  64B16-27.220 Medicinal drugs which may be ordered by pharmacists  64B16-27.230 Fluoride containing products  64B16-27.300 Standards of practice – continuous quality improvement program  64B16-27.410 Registered pharmacy technician to pharmacist  64B16-27.420 Registered pharmacy technician responsibilities  64B16-27.430 Responsibilities of the pharmacist  64B16-27.440 Policies and procedures  64B16-27.500 Negative drug formulary  64B16-27.510 Identification of manufacturer  64B16-27.520 Positive drug formulary  64B16-27.530 Duty of pharmacist to inform regarding drug substitution  64B16-27.615 Possession and disposition of sample medicinal drugs  64B16-27.700 Definition of compounding  64B16-27.797 Standards of practice for compounding sterile preparations (CSPs)  64B16-27.800 Requirement for patient records  64B16-27.810 Prospective drug use review Assignment 8 Pharmacy practice standards cont.  64B16-27.820 Patient counseling  64B16-27.830 Standards of practice – drug therapy management  64B16-27.831 Standards of practice for the dispensing of controlled substances for treatment of pain  64B16-27.850 Standards of practice for orthotics & pedorthics  64B16-27.851 Record-keeping for orthotics and pedorthics Standards for pharmacy permits  64B16-28.101 Prescription area accessible to inspection  64B16-28.102 Sink and running water, sufficient space, refrigeration, sanitation, equipment  64B16-28.1035 Patient consultation area  64B16-28.108 All permits – labels and labeling of medicinal drugs  64B16-28.1081 Regulation of daily operating hours  64B16-28.109 Prescription department; padlock; sign: “prescription department closed”  64B16-28.110 Outdated pharmaceuticals  64B16-28.113 Permits; single entity; single location  64B16-28.118 Unit dose and customized patient medication package returns by in-patients  64B16-28.1191 Unclaimed prescriptions  64B16-28.120 All permits – storage of legend drugs; prepackaging  64B16-28.140 Record maintenance systems for community, special-limited community, special-closed systems, special parenteral/enteral, and nuclear permits  64B16-28.141 Requirements for an automated pharmacy system in a community pharmacy Assignment 9 (continued on p.16) Standards for pharmacy permits cont.  64B16-28.202 Closing of a pharmacy; transfer of prescription files  64B16-28.2021 Change of ownership  64B16-28.203 Transfer of medicinal drugs; change of ownership; closing of a pharmacy  64B16-28.301 Destruction of controlled substances – institutional pharmacies  64B16-28.303 Destruction of controlled substances all permittees (excluding nursing homes)  64B16-28.450 Centralized prescription filling, delivering and returning  64B16-28.451 Pharmacy common database  64B16-28.501 Institutional permit – consultant pharmacist of record Assignment 10 (continued on p.16) Standards for pharmacy permits cont.  64B16-28.606 Remote medication order processing for Class II institutional pharmacies  64B16-28.607 Automated pharmacy system – long term care, hospice, and prison  64B16-28.702 Modified Class II institutional pharmacies  64B16-28.800 Special pharmacies  64B16-28.810 Special pharmacy – limited community permit  64B16-28.820 Sterile products and special parenteral/enteral compounding  64B16-28.830 Special – closed system pharmacy  64B16-28.840 Special – nonresident (mail service)  64B16-28.850 Special pharmacy – ESRD  64B16-28.860 Special pharmacy – parenteral/enteral extended scope permit 16 Assignment 9 cont.  64B16-28.502 institutional permit and Class II institutional permit – labels and labeling of medicinal drugs for inpatients of a nursing home  64B16-28.503 Transmission of starter dose prescriptions for patients in Class I institutional or modified II B facilities  64B16-28.602 Class II Institutional dispensing  64B16-28.6021 Class II institutional pharmacy – emergency department dispensing  64B16-28.603 Class II Institutional pharmacy operating hours  64B16-28.604 Class II Institutional pharmacy department security  64B16-28.605 Class II Institutional pharmacies – automated distribution and packaging Assignment 10 cont.  64B16-28.870 Special-ALF  64B16-28.900 Definitions – nuclear pharmacy  64B16-28.901 Nuclear pharmacy – general requirements  64B16-28.902 Nuclear pharmacy – minimum requirements Prescriber rules related to pharmacy practice  64B8-9.012 Standards for the prescription of obesity drugs  64B8-9.014 Standards for telemedicine prescribing practice ***If you choose to submit an outline, please simply submit your first outline on Sakai by 8 am Monday (8/27). Please be sure to submit your outline according to the group you've been assigned (see spreadsheet under 'Resources' tab for group assignments). If you choose the quiz option, please simply take the first quiz (which opens on 8/23 at 11:59 pm, & closes at 8am Monday the 27th). Either submitting your first outline or taking (or simply even attempting) your first quiz alerts Dr. Smith to the choice that you've made. Once your choice is made, it is final!