Pharmacology and Experimental Therapeutics > Academic Programs > Resident Education

Resident Education

Introduction The Division of Clinical Pharmacology in the Department of Medicine offers a rotation for medical housestaff. The Division’s administrative office is located in 1170 Main Building, and the 165-bed clinical research unit (CRU) is located on 11th floor Thompson Building. Primary activities of the division are phase I-IV and II trials of pharmaceutical agents, and bench research in the pharmaceutical sciences. There is a consult service for inpatient clinical pharmacology. In addition, members of the division are active in teaching at all levels of medical training, including NIH sponsored fellowship program and a K30 grant program in Human Investigation.

Duration: one four-week teaching block

Maximum number of residents: one per teaching block

Resident Responsibilities

Clinical responsibilities of residents on elective will consist of assisting ongoing trials on the inpatient unit. This includes occasional direct subject (normal healthy volunteer or patient) care. However, direct patient responsibilities will be minimal during the month. The resident will also research new topics for investigation, and assist in the formulation of new clinical protocols. Residents will attend Institutional Review Board meetings as an observer. The resident will perform consults requested on the inpatient service, research the topic and present the case and findings to the attending and in a consult conference. In addition, depending upon the time of the year, the resident may also assist in educational programs of undergraduate or graduate medical education. Dr. Scott Waldman (scott.waldman@jefferson.edu or 215/955-6086) is the director of the division and responsible for the elective.

General Goals

• To gain experience in the theory and practice of clinical research, and to become familiar with governmental and institutional regulatory issues of drug development.
• To become familiar with the principles and practice of clinical pharmacokinetics and pharmacotherapeutics, and to disseminate this information on the consult service.
• To become familiar with common issues of drug reactions, interactions, allergies and the procedure for event reporting, and to assist in preventing such occurrences.
• To acquire expertise using electronic information databases concerning clinical pharmacology.
• To appreciate ethical considerations in clinical research.
• To appreciate pharmacoeconomic considerations in clinical medicine.
• To critically assess academic and industry pharmaceutical literature.

Specific Objectives

• To become familiar with the principles and practice of clinical pharmacokinetics.
• To understand and use pharmacokinetic parameters of specific drugs (e.g. clearance, half-life, volume of distribution). To design drug dosage regimens based on specific drug pharmacokinetics with special regard to decreased organ clearance in individual patients.
• To gain experience in the theory and practice of clinical research.
• To become familiar with the different phases of drug testing in humans.
• To gain experience in clinical trial study design and implementation (e.g. subject recruitment, drug administration, data collection, adverse events).
• To gain experience interpreting data from human clinical trials.
• To become familiar with FDA regulations concerning the development of new pharmaceuticals, post-marketing surveillance and the drug development life cycle.
• To become familiar with regulatory/ethical issues concerning enrollment of patients/subjects into clinical studies including informed consent, institutional review board approval.
• To become familiar with the principles and practice of pharmacotherapeutics.
• To learn to formulate therapeutic objectives with the specific aim of rational drug selection and drug dose congruent with these objectives. To appreciate pharmacoeconomic considerations in choosing drugs.
• To understand mode of action of major classes of agents and recognize the issue of therapeutic index.
• To appreciate statistical considerations in critically assessing literature and developing clinical protocols.
• To learn to identify and define clinical parameters and monitor endpoints.
• To gain expertise with specific classes of therapeutic agents (e.g. anticoagulants and antithrombotics, antihypertensives, lipid lowering agents).
• To assess critically literature provided by representatives of the pharmaceutical industry.
• To become familiar with the common issues of adverse drug reactions, drug interactions, and drug allergies.
• To learn the principles and practice of therapeutic drug monitoring.
• To learn approaches to monitoring adverse clinical drug reactions, common drug interactions and the assessment of novel interactions.
• To learn to recognize and evaluate drug allergies.
• To learn to assess variability in the clinical responsiveness of individual patients.
• To learn to assess drug efficacy and adverse clinical events in patients with disease and in special patient groups (e.g. pediatric, geriatric, pregnant).
• To learn the procedure for reporting adverse drug reactions (Medwatch for FDA and local TJU procedure).
• To become familiar with the principles and practice of drug overdose
• To learn to utilize the drug assay laboratory and interpret drug assay results.
• To become familiar with the common drug overdoses and the pharmacological principles underlying clinical intervention.
• To gain expertise using information systems concerning clinical pharmacology.
• To become familiar with library resources and computer-based data bases describing the pharmcokinetics, dynamics, and clinical utility of pharmaceuticals and drugs of abuse.
• To become familiar with resources available through pharmaceutical companies describing the pharmacokinetics, dynamics, and clinical utility of pharmaceuticals and drugs of abuse.
• To become familiar with the regulatory issues in drug development and utilization.
• To review federal, state, and institutional regulations regarding drug utilization, including drug utilization review, local formularies, and regulations by the DEA concerning utilization of controlled substances.
• To review FDA regulations concerning the development of new pharmaceuticals, post-marketing surveillance and the drug development life cycle.
• To become familiar with regulatory/ethical issues concerning enrollment of patients/subjects into clinical studies including informed consent, institutional review board approval.

Consults

Occasional consults will be requested from inpatient services with specific pharmacology questions or to report adverse drug reactions. The resident will review the history and hospital course, and conduct a focused physical exam. The resident will perform a literature search on the topic, present the findings to the attending and members of the division at a consult conference. Findings and conclusions will be discussed with the consulting primary team and documented in the chart.

Education Program The resident will attend weekly noon consult conferences and journal club. Divisional conferences include the following:

• Topics in Clinical Pharmacology (Th) -- didactic review of core concepts
• Journal Club (Th) -- broad base of topics with critical statistical review
• Case Conference (Th) -- case based approach to a pharmacology topic
• Ethics (Th) – didactic and case based review of challenging research theme
• Seminars in Clinical Pharmacology (Tu) -- invited speakers from industry, academics, and governmental regulatory agencies
• Divisional Research Seminars (Tu) -- members of the division and educational program (K30) present their research findings

In addition, the resident will be involved in conference meetings devoted to planning of new clinical trials and documenting the progress of existing trials. Residents will also be encouraged to attend basic science seminars with members of the division. Residents are expected to attend Medical Grand Rounds, morning report and noon conference, as allowed by service obligations on the unit.

Occasionally members of the division will be involved in teaching pharmacology topics to students of various levels. Residents may participate in preparing and delivering lectures and workshops.

Housestaff rotating through may, at their discretion, become involved in a basic research project in the division. Given the constraints of bench research, residents interested must discuss this option well in advance of the rotation with the division director.

Faculty Responsibilities

Faculty responsibilities as the rotation director include the following:

• Orient residents to the rotation and the goals of the division.
• Ensure that the residents' assigned clinical responsibilities are neither excessive nor limited so as to provide an optimal learning experience.
• Organize and present a series of formal educational sessions with the resident which ensure complete coverage of all material he or she is expected to master on this rotation.
• Monitor the residents' directed and required reading.
• Evaluate resident with personal observation, and formal evaluation instruments.
• Document resident performance and provide him/her with appropriate feedback during the rotation and at scheduled interviews at the conclusion of the rotation.

Evaluation

Resident Performance Evaluation

The resident evaluation system consists of the completion of both written assessments of the resident's performance and routine observation and oral feedback to the residents.

Written Evaluation Instrument

A standard performance appraisal questionnaire will be completed by the supervising attending. Both personal and professional characteristics are assessed on this form using rating scales. In addition to completing the rating scales, the evaluator justifies and amplifies upon his/her impressions of the resident through written comments based on the evaluator's daily observation of the resident's performance.

Mid-Rotation Feedback

Faculty will provide a preliminary, overall assessment of the resident's performance in private meetings with each resident approximately midway through the rotation. This is intended to give the resident a clear assessment of their performance to date in the rotation and to plan with each resident areas in which they especially need to focus or improve during the remainder of the rotation.

End-of-Rotation Feedback

At the close of the rotation, the faculty will provide feedback to each resident in a private session as required by the Residency Review Committee for Internal Medicine. At this "exit" interview, the House Officer Performance Evaluation will be reviewed with the resident, and any problems and/or suggestions discussed in depth.

Faculty Evaluation

A faculty performance appraisal questionnaire, the Clinical Experience Evaluation form, is completed by each resident at the end of every clinical rotation. In addition to responding to a series of standard rating scales, the residents will provide written comments, which justify and amplify upon their impressions of their clinical experience and the faculty’s performance. On an annual basis, each faculty member will receive copies of all completed Clinical Experience Evaluation forms for the rotation, which they direct. Any resident identifying information on the evaluation, however, is carefully eliminated in order to protectto protect resident anonymity. Information from these Clinical Experience Evaluation forms is utilized in an effort to continually monitor and upgrade the educational experience provided for residents in this program.

General references
Goodman and Gilman’s The Pharmacological Basis of Therapeutics. 10th edition. Hardman J, Limbird L, Molinoff P, Ruddon R and Goodman Gilman A. McGraw-Hill, New York, 19962001
Basic and Clinical Pharmacology. 6th edition. B. Katzung. Appleton & Lang, Stanford, Connecticut, 1995

Adverse Drug Reactions
Irey NS. When is a disease drug induced? in Riddel, ed. Pathology of Drug-induced and Toxic Diseases. New York: Churchill Livingston, 1982, 1-18.
Kramer M. Difficulties in assessing the adverse effects of drugs. Br J Clin Pharmacol. 1981; 11: 105S-110S.
Classen C, Pestotnik L, Evans R, Lloyd J, Burke J. Adverse Drug Events in Hospitalized Patients. JAMA. 1997; 277:301-306
Bates D, et al. The Costs of Adverse Drug Events in Hospitalized Patients. JAMA. 1997; 277:307-311

Pharmacokinetics
An Introduction to Pharmacokinetics. 2nd edition. Clark B, Smith D. Blackwell Scientific Publications. Boston. 1986
Applied Pharmacokinetic Principles of Therapeutic Drug Monitoring, 3rd edition. Evans W E, Jusko W, et al., Applied Therapeutics, 1992
PharmSim, A Pharmacokinetic Simulation Program Bjornsson T, Greenley L, Manto G, Zeleznik R (Macintosh or PC versions available from division)

Pharmacoeconomics
Letizia C. Pharmacoeconomics: an emerging discipline. Quality Assurance. 1995;4(1):68-74

Clinical Trials
Guide to Clinical Trials. Spiker B. Raven Press, New York, 1991
Handbook of phase I/II clinical drug trials. O'Grady J. Joubert P. CRC Press, Boca Raton, Florida, 1997

Therapeutic drug monitoring
Bochner F, Tonkin A. The clinician and therapeutic drug monitoring in the 1990's. Medical Journal of Australia. 1993; 158(6):422-6
Dzung L, Sevilla R, Donnely K, Rapaport S. The International Ratio for monitoring warfain therapy: Reliability and relation to other monitoring methods. Archives of Internal Medicine. 1994; 154(3):282-8

Pharmacovigilance
Kraft W, Waldman S. Manufacturer’s drug interaction and post-market adverse event data: What are appropriate uses? Drug Safety, 2001;24(9):637-643