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Raymond Woosley (Chair)
University of Arizona
National Institute on
University of Arizona
University of Arizona
Dartmouth Medical School
This chapter was prepared by extensive
adaptation of the summary of a workshop held March 1989 in conjunction with
the Annual meeting of the American Society for Clinical Pharmacology and
Therapeutics. The Subcommittee gratefully acknowledges Dr. David Nierenberg
who prepared a draft of the workshop report on the behalf of the Council on
Medical Student Education in Clinical Pharmacology, which served as a basis
for this report.
The Subcommittee on Clinical
Pharmacology sought to identify three general subtopics for the teaching of
Clinical Pharmacology to medical students. The Subcommittee recommends a
core of factual and conceptual information, i.e., clinical pharmacology
"facts" that are distinct from the information taught in basic
pharmacology courses. The Subcommittee also recommends clinical
pharmacologic skills that students should master in order that they can effectively
evaluate and prescribe drugs. Lastly, the Subcommittee recommends the
clinical pharmacology attitudes and behaviors which students should develop
as they mature to become prescribing physicians.
These facts, skills and
attitudes/behaviors should be taught throughout the four years of medical
school. Many of the facts and introductory material are initially taught in
the 2nd year Medical pharmacology course but the attitude and skills should
be taught by example throughout medical school. Because the student’s
attitudes may dictate the development of appropriate skills and even facts
throughout their medical education, attention to preferred attitudes on
therapeutics should begin very early in medical school.
Ideally, many of the clinically related
facts should be taught in the fourth year after the students have learned
enough clinical medicine so they can integrate the facts and principles of
rational therapeutics into habits for patient management. However, there
are many different and effective ways to teach the material, and different
schools have developed their own balance of lectures, seminars, patient
based problem solving, rounds, etc.
- Clinical Pharmacologic Facts
a. Principles of clinical
b. Principles of therapeutic drug monitoring
c. Principles of prevention and management of adverse drug reactions,
including drug allergy.
d. Principles and management of drug-drug interactions.
e. Principles and prevention of drug-food and drug- botanical interactions.
f. Pharmacogenetic causes of variable response to drugs.
g. Sex and gender as causes of variable response to drugs.
h. Special problems of prescribing to elderly patients.
i. Special problems of prescribing to pediatric patients.
j. Special problems of prescribing to pregnant or nursing women.
k. Special problems of prescribing to patients with underlying diseases
such as renal or hepatic disease.
l. Principles of evaluation and treatment of the poisoned patient.
m. Rules and regulations affecting drug prescriptions.
n. The process of new drug development and approval.
o. Principles of error prevention in prescribing.
p. Principles of integrating prescribing with the full healthcare team
(pharmacists, nurses, patients and their families).
q. Principles of utilizing modern infomatics and databases in safe and
- Clinical Pharmacologic Skills
a. Pharmacokinetics: Students should be able to quickly and accurately
solve the common pharmacokinetics problems presented by patients. They
should be adept at computing loading doses and maintenance doses using
their knowledge of volume and distribution and clearance when
prescribing drugs. They should be able to anticipate interindividual
differences or changes in pharmacokinetics parameters due to genetics,
sex and cardiac, renal or hepatic function.
b. Therapeutic drug monitoring: Students become skilled at
appropriately ordering the measurement of plasma drug concentrations
(including "free" rather than total drug concentrations)
when indicated. Ability to interpret drug concentration measurements
in the context of the therapeutic window, along with derivation of
dosage adjustments to maintain therapeutic concentrations, should be
mastered. They should become skilled at avoiding the overuse and over
reliance on this technique, and learn to avoid generating misleading
data by ordering drug levels at incorrect times or under inappropriate
c. Adverse drug reactions: Students should develop reasonable skill at
analyzing complicated cases in which patients have several diseases,
several symptoms, and are receiving several drugs. Students should
practice and sharpen their skills at separating symptoms and signs
caused by disease from those caused by the drugs per se. Students should
understand how to access the MedWatch voluntary ABR reporting system
maintained by the FDA.
d. Drug interactions: Students should become skilled in recognizing
and anticipating common drug interactions for the drugs taken by their
patients, especially metabolically based interactions due to genetic
differences (using knowledge of polymorphisms of cytochrome P450
isozymes, etc). The skill should include a multi-faceted approach to
incorporate other healthcare providers and information resources. They
should be skilled in using up to date reference sources and electronic
databases to screen for potential drug interactions for the drugs they
will be prescribing.
e. Special factors in each patient: Students should be able to
recognize patient factors (such as age, sex, underlying disease,
pregnancy, nursing, etc.) which would require alternate therapeutic
plans. In addition, students should have the skills to find available
data in these areas in standard reference and electronic data sources.
f. Obtaining and interpreting drug information: Students should be
skilled at retrieving and understanding scientific data available from
experts, internet sources, books, and other databases. Students should
be able to evaluate a new drug's efficacy and toxicity by reviewing
primary, peer reviewed papers. Students should develop a reasonable
level of competency in accessing web-based or CD-ROM based information
programs that give the latest information about individual drugs, drug
classes, drug interactions, drug information for patients, drugs
listed by indicators or contraindication, etc.
g. Prevention and management of drug overdoses: Students should be
skilled in recognizing presentations of common drug overdose, and in
initiating therapy when appropriate. In addition, they should develop
an approach to such problems that can be used in any such patient even
before the casual agent has been confirmed. Finally, students also
should be skilled in the use of common reference sources for rapidly
obtaining accurate information enabling the diagnosis and treatment of
h. Substance abuse: Students should become skilled in recognizing the
presentations of intoxication, withdrawal, and medical complications
of the common drugs of abuse. They should also develop facility with
taking a substance abuse history, and should learn techniques for
uncovering unsuspected substance abuse problems.
i. Prescribing: Students should master the paradigm for rational
therapeutic decision making, that assures selection of appropriate
drug therapy only when drug therapy is warranted, at effective
individualized and safe dosages, and commit to monitoring therapy with
appropriate dosage adjustments and changes or termination of drug
therapy. Students should also master the requirements for complete
drug prescription. They should be skilled in prescribing complete,
accurate, safe and legible written or electronic prescriptions for
drugs used in both in patients and out patients, including drugs with
special restrictions such as those requiring a DEA license. Students
should understand the special requirements for prescribing 1) drugs
that are investigational, 2) those which are being used for a non
approved indication, and 3) those which are available only from
physicians granted an IND.
j. Communications skills: Students should become skilled in talking
with their patients to assess and stimulate drug compliance, and to
ascertain history (including prescription and nonprescription drugs,
topical preparations, dietary supplements, botanicals, etc.). Students
should know how to use the various written materials that are
available as patient inserts (medication guides).
k. Integrating basic and clinical science: Students should develop the
essential skills to enable them to incorporate principles of basic
pharmacology into their clinical decision making patterns, as well as
incorporate clinical factors into their approach to evaluating the
pharmacology of medications.
l. Recognition of pressures to prescribe irrationally: Students should
develop the ability to recognize in themselves tendencies to
irrational prescribing, and recognize the forces encouraging such
habits. They should understand the potential for being misled by
biased information when they learn about medications from
advertisements, detail personnel, colleagues (word of mouth), special
sponsored symposia, etc. Although some useful information can be
imparted in these ways, students must place the information in
context. They should neither blindly accept information from
potentially biased sources nor should they refuse to consider the
merit of the information. They should also recognize that anecdotal
experiences, even their own, can be misleading.
- Clinical Pharmacologic Attitudes:
a. Balanced approach to drug prescribing: Students should avoid the
extremes of therapeutic nihilism and gross over prescribing. Students
should be impressed by the power of drugs to help cure and treat
disease, but this should be balanced by respect for the power of drugs
to cause serious and even fatal adverse reactions. They should embrace
their ethical commitment to monitor the outcome of each prescription
in each patient until the intended effect is achieved or a change in
therapy is warranted.
b. Conscious attempt to optimize benefit and minimize risk: Students
should recognize that each patient is a special case for drug therapy
until proven otherwise. They should also be aware that the best drug
for a particular patient may change as the dynamic process of the
patient's disease unfolds.
Students should recognize that treatment of any disease or syndrome
can often involve several or many combinations of drug choices and
treatment regimens. The best choice for a given patient must be sought
in a specific effort to maximize the chance of a therapeutic outcome,
and minimize the chances of drug induced toxicity or failure. Those
factors which make each patient unique should be consciously sought
and considered. This attitude is essentially the opposite of the
"cookbook" approach to drug therapy.
c. Balanced approach to the introduction of new drugs: Students should
not refuse to prescribe a new drug product just because it is new, nor
should they enthusiastically embrace all new drugs as being the latest
and the best. Rather, students should understand that the place of a
new drug in the current pharmacopoeia may not initially be clear, and
that subsequent data may radically change the manner in which the drug
is prescribed. Students should be willing to take responsibility for
developing their own approach to learning about new drugs as they are
approved by the FDA and marketed.
d. Importance of the therapeutic contract: Students should understand
that at the heart of drug prescribing is a contract between the
physician and the patient. Communication is essential so that the
physician can learn enough information to prescribe optimally, and
then again to ensure optimal compliance. In addition, the physician
must understand that the contract requires him or her to follow the
patient over time to see whether the therapeutic trial results in
beneficial or unwanted effects.
e. Acceptance of the need to prescribe as a team leader with
responsibility to the patient to utilize all resources available to
maximize the benefits of therapy. This requires the student to accept
the fact that they cannot memorize all of the facts required for
optimal prescribing and must rely on computerized databases, nurses,
pharmacists, the patient and the patient’s family as members of the
Some schools have chosen to provide the
bulk of this teaching in a fourth year course; others have incorporated the
teaching of clinical pharmacology in the second year Medical Pharmacology
course (Peck, CC and Halkin, H, J. Med. Ed. 56:1024-6, 1981). Much of the
material of clinical pharmacology cannot be taught effectively during the
second year because the students have usually not had an adequate clinical
experience to fully integrate and appreciate the material or principles
involved. Therefore, a formal course, problem solving instruction and/or
small group discussions are often incorporated in the third and fourth
years to reinforce the principles and expand upon the database of clinical
pharmacology (Cantilena and Woosley, Clin. Pharm. Ther. 60:1-7, 1996).
Most courses in the fourth year require
20 25 hours focusing on general principles and core topics with commonly
used drugs. Some schools have devoted over 70 hours to courses that
include, not only core material, but also detailed discussion of a variety
of therapeutic topics. An innovative fourth year course at Georgetown
University was recently described (Knollman, B. et al,
Naunyn-Schmeideberg’s Archives of Pharmacology, March, 2002).