Pharm.D. Program

PHP542 Evaluation of Controversies in Drug Literature

Detailed Course Description

Drug-induced diseases (or adverse drug reactions - ADRs) is one of the leading causes of morbidity/mortality in health care.  The use of increased number of drugs, as well as drug combinations, leads to more opportunity for ADRs to occur, as a result of additive effects of or drug interactions between concomitant medications.  Pharmacists need a solid understanding of the frequency & mechanisms by which drug-induced disease occurs to minimize/prevent ADRs as they pertain to commonly used and/or high risk medications.  The recognition of rare & unexpected ADRs is also important.

The first portion of this course is designed to teach students with how to identify, scrutinize, and utilize the information from the medical literature.  Development of these skills will provide students with the ability to evaluate validity of existing literature in the area of drug-induced disease.  It will also allow the successful student to stay abreast of therapeutic advances not found in textbooks. 

The second portion of this course focuses on special topics in drug-induced disease. 
Emphasis is placed on the mechanisms by which drugs cause disease (e.g., pharmacologic, allergic, idiosyncratic and toxicologic), risk factors, the clinical markers and signs and symptoms of these conditions, and recommendations regarding preventative strategies and treatment.  The medical literature is used to augment the lectures and to facilitate discussions.

Activities/Class format
Didactic lectures: Several lectures will be provided throughout the semester covering drug-induced disease topics beyond that of required courses.  Topics that have been discussed in past curriculum include NSAID-induced peptic ulcer disease, nephrotoxicity related to aminoglycoside use, drug allergies/cross-sensitivities, antibiotic-induced C. difficile, pregnancy categorization of drugs for teratogenic potential, and antipsychotic-related hyperglycemia.

Class activities:  There are several assignments and/or in-class activities in which you will be required to participate.  If you are not present, you cannot receive credit.  Past examples include:  MedWatch reporting, clinical drug consult, journal article presentations.

Examinations:  Two exams will be given during the semester.  Exams are not cumulative and will cover lecture material noted in the syllabus.  Exam questions will be taken from the material covered in didactic lectures, assigned readings & journal club articles.  Students are responsible for attending each examination.

Grading format (subject to change):
Attendance and participation - 10%
Assignments - 30%
Journal Club Presentation - 20%
Midterm exam – 20%
Final exam – 20% 

Learning Objectives:

1. Distinguish between different research study designs & their inherent strengths & weaknesses.
2. Evaluate primary literature for the validity of research design, results & make conclusions about the clinical significance of drug-induced disease in question.
3. Be able to select the appropriate resource(s) – textbook, drug database, primary literature, etc – to answer a specific drug-induced disease question. 
4. Learn how to participate in the drug therapy decision-making process as it pertains to drug-induced disease:

1. Obtain & evaluate relevant patient information (eg. thorough medication history)
2. Discuss the mechanisms by which drugs cause disease.
3. Describe the signs/symptoms associated with specific drug-associated illnesses & the typical timeframe of onset.
4. Identify the factors that increase risk of drug-induced disease.
5. Evaluate case studies & published adverse drug reaction literature
6. Recommend a treatment plan for management of the drug-induced disease & outline strategies for prevention in the future, based on evaluation of published literature on ADRs.