PHARMACEUTICALS MANAGEMENT FOR UNDER-SERVED POPULATIONS Syllabus
Welcome to the Pharmaceutical Management for Underserved Populations Course.
Our goal is for you to develop an operational understanding of pharmaceuticals management in developing countries and underserved populations. This three-credit course will discuss the factors, policies, and regulations influencing drug availability and access, procurement, utilization, distribution, rational use, essential drugs, budgeting, inventory, and financing. We also discuss and describe the role of government, non-governmental organizations, and individual/program pharmaceuticals management.
Students will identify different types of health commodities and their regulation, understand key factors in the drug management cycle, identify potential obstacles to and problems of access, as well as define creative solutions to these problems. Students will also understand the various factors influencing drug selection and the rational use of pharmaceuticals, and explain the relative strengths and weaknesses of alternative ways to raise revenues to pay for pharmaceuticals.
Speakers for the course are drawn from a variety of backgrounds to expose participants to many areas that affect the health and provision of pharmaceutical services to under-served populations, both domestically and abroad.
Contact Information, Course Faculty
Contact Information, Teaching Assistant
Mariana Socal, Teaching Assistant
Course Learning Objectives
Upon successfully completing this course, students will be able to:
- Demonstrate the factors influencing access to, use, management, policies and financing of pharmaceuticals in developing countries and under-served populations in developed countries, an the roles of government, Non-Governmental
- Define key terms and concepts in pharmaceuticals and their management in developing countries and underserved populations in developed countries
- Identify the different types of health commodities and their regulations in developing countries
- Explain the key factors in the Drug Management Cycle, including selection, procurement, distribution and use
- Identify potential obstacles and solutions to problems of acces to pharmaceuticals in developing countries
- Explain factors influencing the selection and rational use of pharmaceuticals
- Identify and explain relative strengths and weaknesses of alternative ways to raise revenues and pay for pharmaceuticals
Course DescriptionStudents analyze problems and develop strategies based on real world drug management issues, including regulations, manufacture, procurement, distribution, safety, policy, financing and the unique aspects of international pharmaceutical trade, the role of the World Trade Organization -- Trade-Related Aspects of Intellectual Property Rights (WTO-TRIPS), government, NGOs and individuals in the selection and use of pharmaceutical products. Course materials are drawn from both developed and developing countries so that the student will be knowledgeable about the role of Essential Medicines and the formation of a National Drug Policy. Uses a multidisciplinary approach to provide students with an operational understanding of factors influencing access to and use of pharmaceuticals and other health commodities. Collectively, these materials and approaches are intended to stimulate critical thinking on how to improve access to and the use of pharmaceutical products.
MPH, MHS, PhD, DrPH candidates of School of Public Health, and graduate degree candidates of Schools of Medicine and Nursing are welcome. Graduate students from the Business Schoo,l as well as part-time and online students, are welcome.
This course requires evaluative health services experience as a prerequisite. Either Applications in Managing Health Organizations in Low and Middle Income Countries (LMICs; 221.602); Health Systems in LMICs (221.646); Comparative Evaluation for Health Policy in International Health (221.647); Problem Solving in Public Health (550.608); or equivalent course or work experience qualifies.
Text and Related Materials
We utilize MDS-3: Managing Access to Medicines and Other Health Technologies (www.msh.org/sites/msh.org/files/mds3-jan2014.pdf) by Management Sciences for Health, 2012; Arlington, VA; and other selected readings. Required and Recommended reading materials, as well as Additional Resources, will be listed in the Syllabus and/or posted on CoursePlus
Methods of Assessment
Course grades will be based on a case study, a group consultant report, and an individual paper written on a relevant topic of the student’s choosing, all of which are intended to require students to explore current and controversial aspects of pharmaceuticals management.
I. Individual Written Assignment 40%
II. Group Project//Consultant Report 30%
III. Case Studies 20%
IV. Participation and Attendance 10%
I. Individual Written Assignment (40%)
- Submit (1) two hard copies of the individual written assignment in class, and (2) the Word document copy to the Teaching Assistant using the DropBox on CoursePlus.
- No late assignments will be accepted without prior permission from the Course Director.
- All assignments should have a cover page with name, email address, and title of the paper.
- Use 12 point font, double spaced for text. Margins of at least 1 inch; include page numbering.
- Use appropriate reference formatting (e.g. International Committee of Medical Journal Editors: www.icmje.org/manuscript_1prepare.html)
Write a paper on an important controversy in the area of pharmaceuticals or pharmaceuticals management for under-served populations. Your topic must be approved by the Course Director, and may not be another version of the group assignment. Examples of relevant controversies include:
- Effects of international treaties on access to medicines or pharmaceutical policies
- Global price control strategies; impact of generics
- User fees for generic drug reviews
- Drug shortages
- Orphan drugs
- Regulating pharmacy compounding
- Effectiveness of overseas API/drug laboratory and manufacturing inspections
- Internet purchasing of pharmaceuticals
- Medication safety and pharmacovigilance
Paper should be 10-12 pages of text, excluding summary, tables and graphs, annexes and references.
Grades will be based on:
- Description of controversy (importance, specific description of the controversy) (10%)
- Description of the background to the controversy (including literature review of relevant factors and description of the setting) (10%)
- Analysis tools to assess the pharmaceuticals challenge and identify options include any one of the following frameworks - the Strengths Weaknesses, Opportunities Threats (SWOT), stakeholders analysis, or Problem Solving frameworks - integrated with the issues discussed in MSH’s MDS-3, Part III, Chapter 36 (Pharmaceutical Supply Systems Assessment). These frameworks are acceptable approaches for your individual assignment due (40%)
- Discussion and conclusions (implications) (30%)
- Presentation (follows guidelines) (10%)
II. Pharmaceuticals Systems Analysis Consultant Report (30%) Group Work + PowerPoint Presentation
Working in groups of five–six persons, prepare a consultant’s presentation to the Ministry of Health in a country (or region of a country) of your choice. Analyze its pharmaceuticals sector, using the framework described in the course, and provide recommendations for improvement. Each group will select and present one of the three main points of analysis (shown below) for the final 30-minute presentation.
Analysis – Discuss:
1. Pharmaceutical policy and regulations
2. Key factors in drug management cycle, including selection, procurement, distribution, use
3. Key factors influencing access to pharmaceuticals
Either the SWOT, stakeholders analysis, or Problem Solving frameworks - integrated with the issues discussed in MSH’s MDS-3, Part III, Chapter 36 (Pharmaceutical Supply Systems Assessment) - is an acceptable approach for your consultancy report presentation.
Recommendations – The recommendations for action should focus on steps/options for the Ministry of Health and for at least one specific pharmaceuticals control agency in the country to improve the access to safe, effective, and affordable pharmaceuticals for under-served populations.
Group Presentation – The group project will include a 12-15 minute presentation (12 slides max) and the submission of a Power Point presentation, plus additional tables, graphs, annexes and references. A 15-minute discussion from the audience follows each group’s presentation.
Grades will be based upon:
1. Completeness of Analysis (40%)a. Uses appropriate quantitative informationb. Assesses political and stakeholder interestsc. Analyzes each component of the framework
2. Recommendations (30%)a. Assesses risks, benefits, opportunities and threats of optionsb. Relates recommendations to analysisc. Feasibility of actions
3. Group Presentation (30%)a. Clear oral presentationb. Keeping to time allocationc. Simple slides using clear tables and graphsd. Appropriate references, acknowledgements
III. Case Studies / Skills Building (20%)
In-class case study exercises are scheduled and will be lead by a faculty moderator. Students are expected to interact and discuss with the faculty moderator their case study before their respective class presentation. Student groups, composed of two–three students per group, will present their analyses and possible strategies to resolve their particular case study. Refer to your “Case Study Instructions for Students” handout for details.
Before class – Students read the Case Study Scenario, and within their respective Groups, decide their actions for the various issues presented. Group assignments will be posted on CoursePlus. Create a short presentation (not more than 5 ppts; 5-8 minutes per group) which will capture the problem and how each Group will assess the situation, collect further information, address the problems set out for your Group, and set up recommended activities.
Students need to send their presentation to their faculty moderator, the TA, and Drs. Eng and Lyles by 9 pm the day before their respective presentation.
During class – The student group(s) will have a chance to present their approach to solving the problems in the Case Study Scenario and entertain comments and questions.
IV. Participation and Peer Review (10%)
Individual (5%): The rubric for this determination is consistent with developing management skills - each student is responsible for keeping data on her/his attendance and participation. At the end of the term, each student posts her/his score, supported by the data, according to the following rubric:10 = attended all classes and contributed to the discussions in each class8 = attended all classes and contributed to the discussions in most classes6 = attended most classes and of those attended participated in all of them4 = attended most classes and of those attended participated in most of them2 = missed most classes0 = missed all classes
In addition, each student must discuss and provide data to support her/his rationale for the score they determine for themselves.
Peer Review (5%): Since group work is a significant component of this course, each student will assess their group dynamics and productivity based upon their interaction for their Group Project/Consultant Report as well as their Case Study. Students will complete two peer evaluations utilizing the “Peer Evaluation Form”, found under the Grading section of CoursePlus.
Please see the course Session for a full list of dates and items for this course.
Files from the Online Library
- Case Study 3 Med Adh Marta Wilson Diana Rodriguez 2014
- Case Study 4 Raheem Juli Farheen 2014
- Session 10 Bill Brieger Patent Medicine Vendors
- Session 11 Chris Larson UPS 2014
- Session 11 Drug Donations In Emergencies Gil Burnham 2014
- Session 12 Assess Drug Use in Health Facilities_An Exercise 2014
- Session 12 Drug Facility Survey Data_Worksheets 2014
- Session 13 Lisa Ludeman Pharmacovigilance 2014
- Session 13 Maria Miralles Donor Perspective 2014
Academic Ethics Code
Students enrolled in the Bloomberg School of Public Health of The Johns Hopkins University assume an obligation to conduct themselves in a manner appropriate to the University's mission as an institution of higher education. A student is obligated to refrain from acts which he or she knows, or under the circumstances has reason to know, impair the academic integrity of the University. Violations of academic integrity include, but are not limited to: cheating; plagiarism; knowingly furnishing false information to any agent of the University for inclusion in the academic record; violation of the rights and welfare of animal or human subjects in research; and misconduct as a member of either School or University committees or recognized groups or organizations.
Students are required to abide by the school’s standards in terms of academic integrity, as discussed in the JHSPH Academic Ethics Policy and Procedure Memorandum, October 26, 2006: https://my.jhsph.edu/Resources/PoliciesProcedures/ppm/PolicyProcedureMemoranda/Students_01_Academic_Ethics.pdf.
JHSPH Students assume an obligation to conduct themselves in a manner appropriate to The JHU’s mission as an institution of higher education. A student is obligated to refrain from acts which he or she knows, or under the circumstances has reason to know, impair the academic integrity of the University. Violations of academic integrity include, but are not limited to: cheating; plagiarism; knowingly furnishing false information to any agent of the University for inclusion in the academic record; violation of the rights and welfare of animal or human subjects in research; and misconduct as a member of either School or University committees or recognized groups or organizations. Violations of academic integrity will be investigated.
All sources must be properly cited using a generally accepted citation format of the student’s choosing. The Student Referencing Handbook: Avoiding Plagiarism is recommended:
How to Give an Academic Talk: www.cs.berkeley.edu/~jrs/speaking.html
Public Speaking Guide for Students: www.aresearchguide.com/3tips.html
Citing Sources (AMA): http://www.lib.jmu.edu/citation/amaguide.pdf
Citing Sources (APA): http://owl.english.purdue.edu/owl/resource/560/02/
JHSPH Presentation templates: http://www.jhsph.edu/identity/downloadResources/downloadResources.shtml
Disability Support ServicesIf you are a student with a documented disability who requires an academic accommodation, please contact Betty H. Addison in the Office of Student Life Services: firstname.lastname@example.org, 410-955-3034, or 2017 E. Monument Street.