Course outline

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Department of Pharmaceutics
School of Pharmacy
College of Medicine and Health Sciences
University of Gondar
Course Name Code and Credits: Fundamentals of Pharmacoepidemiology (Phar 7041,2 Cr.hrs (3 ECTS)
Instructor Name: Berhanemeskel W.Gerima, aberhaneth@gmail.com
Students’ Category: Year I Pharmaceutical Supply Chain Management Postgraduate students
Semester: Semester I. Academic Year: 2020/2021. Prerequisite: None
Course Description: This course is designed to prepare learners to be competent investigators of questions and
themes concerning pharmacy practice and medicine use. It introduces learners with applications, study designs,
sample size considerations and data collection in pharmacoepidemiology, drug utilization study,
pharmacovigillance, systematic review and meta-analysis so that they can have better understanding of
pharmacoepidemiologic researches.
Course Objective: After completion of this course, learners will be able to discuss pharmacoepidemiologic concepts and
methods and apply pharmacoepidemiologic research principles.
Enabling Objectives: To meet the course objective, at the end of the course, learners will:
 Describe the scope and applications of
pharmacoepidemiology
 Discuss common study designs and methods used in
pharmacoepidemiological studies
 Assess the relevance and limitations of various
pharmacoepidemiological research designs
 Describe qualitative research concepts in
pharmacoepidemiology
 Compute measures of association or risk
 Identify errors in pharmacoepidemiologic studies
 Explain sampling issues in pharmacoepidemiology
 Explain data sources and data collection techniques in
pharmacoepidemiology
 Discuss drug utilization research
 Describe systems for the reporting of adverse effects
and their use for pharmacoepidemiology.
 Discuss Pharmacovigilance
 Differentiate systematic review and meta-analysis
 Practice stages of systematic review and meta-
analysis
 Assess heterogeneity in meta-analysis and handle it
 Assess reporting bias in systematic review and meta-
analysis
 Apply pharmacoepidemiologic principles in practice
Course Contents
Contents Journal articles Reading materials assignments
1. Introduction (2 hrs)
1.1. What is pharmacoepidemiology  Lawson D. H. (1984). Pharmacoepidemiology: a new
discipline. British medical journal (Clinical research ed.),
289(6450), 940–941.
 Bégaud B. (2019). A history of pharmacoepidemiology.
Therapie, 74(2), 175–179.
 Wertheimer A and Andrews K (1995). An overview of
pharmacoepidemiology. Pharm World Sci., 17(3):61-6.
 Gutterman, E. M. (2004). Pharmacoepidemiology in
safety evaluationsof newlyapproved medications. Drug
information journal: DIJ/Drug Information Association, 38(1),
61-67.
 Laughren T. (1998). Premarketing studies in the drug
approval process: understanding their limitations
1.2. Potential contributions of
pharmacoepidemiology
1.3. Reasons to perform pharmacoepidemiology
studies

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regarding the assessment of drug safety. Clinical
therapeutics, 20 Suppl C, C12–C19.
https://doi.org/10.1016/s0149-2918(98)80003-9
2. Basic ConceptsinPharmacoepidemiology(10 hrs)
2.1. Overview  Etminan, M., & Samii, A. (2004). Pharmacoepidemiology
I: a review of pharmacoepidemiologic study designs.
Pharmacotherapy:The Journal of Human Pharmacology and
Drug Therapy, 24(8), 964-969.
2.2. Study designs in pharmacoepidemiology
2.3. Qualitative research in
pharmacoepidemiology
2.4. Measures ofassociation or risk
2.5. Evaluation of evidence and errors in
pharmacoepidemiologic studies
2.6. Sampling considerations in
pharmacoepidemiology
2.6.1. Sample size determination  Sathian, B., Sreedharan, J., Baboo, S. N., Sharan, K.,
Abhilash, E. S., & Rajesh, E. (2010). Relevance ofsample
size determination in medical research. NepalJournal of
Epidemiology, 1(1), 4-10.
 Chadha, V. K. (2006). Sample size determination in health
studies. NTI bulletin, 42(3&4), 55-62.
 Sharma, G. (2017). Pros and cons of different sampling
techniques. International journal of applied research, 3(7),
749-752.
2.6.2. Sampling techniques
2.7. Data sources and data collection techniques
in pharmacoepidemiology
2.7.1. Data sources in pharmacoepidemiology  Harpe, S. E. (2009). Using Secondary Data Sources for
Pharmacoepidemiology and Outcomes Research.
Pharmacotherapy, 29(2), 138–153.
 Petri H (1993). The prescription drug history in
pharmacoepidemiology. Pharm World Sci ; i5(3): 176-7.
 Takahashi Y et al. (2011). Utilization of health care
databases for pharmacoepidemiology. Eur J Clin
Pharmacol.
 Brownstein J et al. (2010). Geographic Information
Systems and Pharmacoepidemiology: Using spatial
cluster detection to monitor local patterns of
prescription opioid abuse. Pharmacoepidemiol Drug Saf. ;
19(6): 627–637.
2.7.2. Data collection techniques in
pharmacoepidemiology
3. Drug Utilization Research (6 hrs)
3.1. What is drug utilization research?  Pradhan, S. C., Shewade, D. G., Shashindran, C. H., &
Bapna,J. S. (1988). Drug utilization studies. NationalMed
J India, 1(4), 185-189.
 Truter, I. (2008). A reviewofdrug utilization studies and
methodologies. Jordan journal of pharmaceutical
sciences, 1(2), 91-103.
 Gidebo, K. D., Summoro, T. S., Kanche, Z. Z., & Woticha, E.
W. (2016). Assessment of drug use patterns in terms of
the WHO patient-care and facility indicators at four
hospitals in Southern Ethiopia: a cross-sectional
study. BMC health services research, 16(1), 1-8.
3.2. Why drug utilization research is needed?
3.3. Type of drug use information: Drug-based
information, Health problem-based
information, Patient information, Prescriber
information, Drug cost.
3.4. Data sources on drug utilization
3.5. Investigating drug use in health facilities:
WHO drug use indicators, Health problem-
based studies, drug-specific studies, others….
3.6. Investigating drug use in communities

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3.7. Drug utilization in aggregate data: Defined
Daily Dose (DDD), Prescribed Daily Dose
(PDD)
 Odusanya, O. O. (2004). Drug use indicators at a
secondary health care facility in Lagos, Nigeria. Journal
of Community medicine and primary health care, 16(1), 21-
24.
4. Pharmacovigillance (6 hrs)
4.1. What is pharmacovigilance?  Montastruc, J. L., Sommet, A., Lacroix, I., Olivier, P.,
Durrieu, G., Damase-Michel, C., ... & Bagheri, H. (2006).
Pharmacovigilance for evaluating adverse drug
reactions: value, organization, and methods. Joint Bone
Spine, 73(6), 629-632.
 Edwards, I. R. (2017). Causality assessment in
pharmacovigilance: still a challenge. Drug safety, 40(5),
365-372.
 Hauben, M., Madigan, D., Gerrits, C. M., Walsh, L., & Van
Puijenbroek, E. P. (2005). The role of data mining in
pharmacovigilance. Expert opinion on drug safety, 4(5),
929-948.
4.2. What is adverse drug reactions?
4.3. Pharmacovigilance methods
4.4. Case-causality assessment
4.5. Data assessment in pharmacovigilance
4.6. Pharmacovigilance case studies
5. Systematic Review and Meta-analysis (8 hrs)
5.1. Definition systematic reviewand meta-
analysis
 Aromataris, E., & Pearson, A. (2014). The systematic
review: an overview. AJN The American Journal of
Nursing, 114(3), 53-58.
 Khan, K. S., Kunz, R., Kleijnen, J., & Antes, G. (2003). Five
steps to conducting a systematic review. Journal of the
royal society of medicine, 96(3), 118-121.
 Mangiapane S et al. (2008). Aspirin use and breast cancer
risk: a meta-analysis and meta-regression of
observational studies from 2001 to 2005.
Pharmacoepidemiology and Drug Safety, 17: 115–124.
 Mahmud S et al. (2010). Use of nonsteroidal anti-
inflammatory drugs and prostate cancer risk: A meta-
analysis. International Journal of Cancer, 127: 1680–1691.
5.2. Rationale ofsystematic reviewand meta-
analysis
5.3. Characteristics ofsystematic reviewand
meta-analysis
5.4. Scope ofsystematic reviewand meta-
analysis
5.5. Stages of systematic review and meta-
analysis
5.5.1. Defining of review question
5.5.2. Setting inclusion and exclusion criteria
5.5.3. Developing search strategy and
searching
5.5.4. Selecting primary studies
5.5.5. Assessing quality of studies
5.5.6. Extracting data
5.5.7. Analyzing data
5.5.8. Interpreting outputs
5.5.9. Writing review report
5.6. Meta-analysis models and their assumptions
5.6.1. Types of models (fixed effect
model, random effect model)
5.6.2. Assumptions associates with models
5.7. Assessment of heterogeneity
5.8. Handling of heterogeneity
5.8.1. Sub-group analysis
5.8.2. Meta-regression
5.9. Assessment of reporting bias
5.10. Management of reporting bias
5.11. Interpretation of effect sizes

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Teaching-Learning Methods: Assessment Methods:
Illustrated Lecture
Group Discussion
Individual and group exercises and assignments
Presentation
Case studies
Assignment: 20%
Seminar Presentation: 20%
Written final-exam: 60%
Teaching-Learning Materials:
1. Storm BL. Pharmacoepidemiology. 4th ed. England: John Wiley and Sons Ltd; 2005.
2. Waning B, Montagne M. Pharmacoepidemiology: Principles and Practice. USA: McGraw-Hill Education,
LLC; 2001.
3. World Health Organization and The Uppsala Monitoring Centre. Safety Monitoring of
Medicinal Products: Guidelines for Setting up and Running a Pharmacovigilance Center. Uppsala, Sweden:
The Uppsala Monitoring Centre; 2000.
4. World Health Organization. Introduction to Drug Utilization Research. Geneva,
Switzerland: World Health Organization; 2003.
5. Remington’s: The Science and Practice of Pharmacy. 21st ed. Philadelphia, USA:
Lippincott Williams & Wilkins; 2005
6. World Health Organization. How to investigate drug use in health facilities: selected drug use indicators. No.
WHO/DAP/93.1 Unpublished. World Health Organization, 1993.