PHARMACOLOGY 4E03: SOCIAL PHARMACOLOGY
COORDINATOR/INSTRUCTOR: Dr. Renee Labiris
Fridays 11:30 to 14:30
Pharmacology 4E03 Outline
The overall objectives of this course are to provide you with an opportunity to explore
the dimensions of drug use/abuse in society. By now you have completed a number of
courses in pharmacology and I will assume that you have a good understanding of
pharmacodynamics and pharmacokinetics. This course will include a variety of drug
classes but the focus of discussion will not be on their mechanisms of action but on the
context in which they are used or abused.
As a general working model, we would consider the use of drugs from the perspectives
of: the Consumers (patients/buyers), the Prescribers (generally physicians), the
Providers (manufacturers), the Regulators (usually Governmental agencies) and the
Dispensers. Each group brings to the situation, biases and attitudes that colour the
utility of the product. Efficacy, a term that you have struggled through in earlier courses,
takes on newer meanings as we begin to consider effectiveness in the world beyond the
laboratory. Further, the notion of what constitutes "evidence" varies depending on the
perspective chosen and I expect that we will have heated and illuminating discussions
on that issue.
Much of the discussion will involve the general principles of pharmacoepidemiology.
This is a relatively new term which has aroused mixed emotions. Some have argued that
it is "an affront to good English usage" noting that "at 20 letters, it is awkward, pompous
and longer than any other specialized title in medicine" (1). Nevertheless it has become
a legitimate field dealing the "application of epidemiologic knowledge, methods and
reasoning to the study of the effects (beneficial and adverse) and uses of drugs in
human populations" (2) Epidemiologists as a whole are concerned with the who, the
where and the how of disease distributions.
Pharmacoepidemiology began with a focus on one particular source of disease and
illness viz drugs. It has become broader now and is seen to be a bridge science
incorporating elements from pharmacology, therapeutics, epidemiology, statistics,
economics and anthropology, and may be better called Social Pharmacology.
Given that the scope is broad, it would be impossible to cover all aspects. I have been
deliberately selective in the content issues to provide you with a flavour of the field. I
expect that by the end of this 12 week course you would be introduced to the terms
and concepts listed below:
A. Terms commonly used in epidemiology (eg incidence/prevalence/relative
risks/odd ratios/specificity/sensitivity etc.)
B. Epidemiological approaches: particularly relative advantages/disadvantages of
diverse study designs, data collection.
C. Pharmacovigilance
D. Evidence: in Science and the Law
E. Economic Evaluation of Drugs (Pharmacoeconomics)
F. Drug Utilisation in a cross-cultural context
The above issues have been incorporated into the body of several paper problems that
have been specifically written for the course.
Evaluation will comprise the following:
1. Tutorial Participation which will be evaluated at the end of every problem using
prescribed forms. Active participation demands that the student be responsible,
bring in new information, communicate that information effectively, critically
evaluate the information that she/he brings as well as that provided by others,
and finally be able to assess their own performance appropriately. The forms to
be used will provide descriptors for evaluating each of the above qualities.
2. Submission of a Written Summary of discussions. This MUST be handed in
within ONE WEEK after the completion of a given problem. The format of this
submission would be as follows:
i. A listing of issues Generated / Learning tasks defined / Attainment of
Course Objectives.
ii. A brief description (ONE page maximum) of what the student learned
from the problem. This would take the form of a brief summary of her/his
current knowledge on that topic.
iii. A more detailed analysis of ONE of the major issues that arose in the
discussion.
3. Pharmacoepidemiology Paper. At the end of the course students are required to
submit a paper on a pharmacoepidemiology topic. This exercise provides
students an opportunity to explore an area of pharmacoepidemiology in more
depth than what is covered in class. This could include a discussion of prescribing
patterns, the design of a system to improve drug utilization in a specific
environment, an assessment of the impact of a specific law or economic event
had on drug therapy, economic evaluation of a specific drug therapy. Papers
should adequately address methodological issues that arise within the topic. The
objective(s) should be clearly defined and a logical and persuasive discussion
with adequate referencing should be given. The papers will be evaluated by:
1. Letter of Intent - One page outline of the topic selected by the student.
Topic must be approved. DUE DATE:
2. Paper - 10 to 15 pages in length, double-spaced, excluding references.
Students are encouraged to explore challenging issues. A certain
percentage of the marks will be allotted for difficulty level. DUE DATE:
3. Oral Presentation - The student will prepare a 10 minute presentation of
their topic and should be prepared to respond to questions from their
colleagues (Q&A: 5 minute).
The allocation of marks will be as follows:
Class Participation 20%
Written Summaries 15%
Letter of Intent
5%
Paper
45%
Oral Presentation 15%
ACADEMIC DISHONESTY consists of misrepresentation by deception or by other
fraudulent means and can result in serious consequences, e.g. the grade of zero on an
assignment, loss of credit with a notation on the transcript (notation reads: "Grade of F
assigned for academic dishonesty"), and/or suspension or expulsion from the university.
It is your responsibility to understand what constitutes academic dishonesty. For
information on the various kinds of academic dishonesty please refer to the Academic
Integrity Policy specifically Appendix 3.
The following illustrates only three forms of academic dishonesty:
1. Plagiarism, e.g. the submission of work that is not one's own or for which other
credit has been obtained.
2. Improper collaboration in group work.
3. Copying or using unauthorized aids in tests and examinations.
“The instructor and university reserve the right to modify elements of the course during
the term. The university may change the dates and deadlines for any or all courses in
extreme circumstances. If either type of modification becomes necessary, reasonable
notice and communication with the students will be given with explanation and the
opportunity to comment on changes. It is the responsibility of the student to check
their McMaster email and course websites weekly during the term and to note any
changes.”
REFERENCES:
(1) Shapiro. S. (1990) Am. J. Epidemiol 131:379
(2) Porta, MS and Hartzema AG (1991) Chapter 1 in Pharmacoepidemiology 2nd Edition,
edited by Hartzema, Porta, Tilson , Harvey Whitney Books.