Pharmacoepidemiology

Stanley Edlavitch

• Publisher: Routledge
• Year: 2018
• ISBN:
  9781351425148
• Edition: 1
• Topic: Medicine
• Subtopic: Epidemiology

This volume is comprised of papers presented at the Third International Conference on Pharmacoepidemiology, held September 9-11, 1987, in Minneapolis, Minnesota. The book is divided into four sections, which reflect the four themes of the conference: Social Impact of Pharmacoepidemiology; Drug Epidemiology and the Law; Drug Surveillance; and Drugs, Populations, and Outcomes: Specific Studies. The collection of papers discusses the social and legal impact of epidemiology, the system of checks and balances that is necessary for the field, the importance of core support for researchers, and the goal of an enlightened and informed public, including the media, consumer advocates, and the courts. Contributing authors offer perspectives from academia, practice, government, industry and the law. Numerous tables and figures are included to illustrate many of the papers within the text. This book offers substantial reading for epidemiologists and individuals interested in the field of pharmacoepidemiology.

SECTION FOUR

Drugs, Populations, and Outcomes: Specific Studies

Introduction

Section Four presents an array of individual studies dealing with specific drugs, populations, and outcomes.

Nonsteroidal antiinflammatory drugs (NSAIDs) are widely marketed in the United States. Drs. Strom and Carson investigated the relative incidence of clinically apparent upper gastrointestinal bleeding by analyzing data from the Computerized On-Line Medicaid Pharmaceutical and Surveillance System (COMPASS). The COMPASS data base is an important resource for Medicaid claims data. This study shows how a historical cohort study can be carefully conducted using these records.

The impact of NSAID use on general GI upset in the elderly was examined by Bigelow and Collins, using Wisconsin Medicaid billing data. The study provides an interesting methodological approach to discerning GI upset by including patients identified by appropriate ICD codes or those receiving histamine antagonists and antacids presumably not prescribed prophylactically.

Dr. David Henry et al. investigated the relationship of NSAIDs and peptic ulcer death in Australia. They present the results of a case-control study. Cases were defined as all patients who died from ulcer complications in Newcastle hospitals between 1980 and 1986. Controls were chosen from peptic ulcer survivors.

Whenever a pharmacoepidemiologic study identifies an apparent drug effect, the investigator must consider whether the effect is due to the underlying condition being treated or the drug (confounding by indication). Dr. Tennis et al. use the Saskatchewan Health automated data files to investigate a possible increased risk of neoplasia with rheumatoid arthritis. Potential confounders considered are disease-modifying drugs (DMARDs), sex, and age.

Acyclovir was marketed in oral formulation in January 1985 for the treatment and suppression of genital herpes. Because of the high exposure potential among women of reproductive age, the manufacturer developed a program to study the drug. Dr. Andrews et al. describe the program, the Acyclovir in Pregnancy Registry, and the joint industry, government, and private sector advisory committee that was established.

Recombinant DNA technology has enabled the production of synthetic human growth hormones, one of which was developed to eliminate the transmission of Creutzfeldt-Jakob disease through pituitary-derived human growth hormone. Dr. Bernad reports on the safety of this synthetic growth hormone.

Without question, the AIDS epidemic has received more publicity and generated more concern by the general public than any other recent public health issue. In March 1987, Retrovir became the first drug approved in the United States for the treatment of HIV infection. Drs. Joseph and Creagh-Kirk briefly review the epidemiology of AIDS, the innovative open-label trial that was conducted jointly by the Burroughs Wellcome Company and the National Institutes of Health, and describe the Retrovir postmarketing surveillance program.

It has been reported that blacks and whites are prescribed psychotropic medications differently. Dr. Batey et al. investigate this question through a retrospective study of black and white patients admitted to a Southern state mental health facility. Medical charts were reviewed and patients interviewed for sociodemographic data, psychological variables, and medications prescribed during hospitalization. Outpatient drug exposure was determined from medication history completed by the patient during the hospitalization.

Though the elderly utilize a disproportionately high percentage of health care resources, premarketing drug studies generally exclude them because of their multiple diseases and concurrent use of “nonstudy” medications. Dr. Stewart et al. have collected longitudinal information on drug use and health in ambulatory elderly subjects, using the Dunedin health screening program in Florida. Data are presented on frequency of drug use, therapeutic indications, hematological and biochemical test results, and symptoms.

Dr. Chrischilles et al. report on an interesting examination of the impact of psychotropic drug use on mortality in nursing home patients. The investigation was part of the Iowa 65 + Rural Health Study, which is a prospective study of all persons aged 65 years and older residing in two rural Iowa counties. Participants in this survey were residents of one of 11 chronic care facilities.

The last chapter in this section provides an example of research in the important area of measuring the economic impact of drugs. Dr. Eisenberg et al. present an interesting nested case-control study conducted at six Philadelphia hospitals that investigated the cost of nephrotoxicity associated with aminoglycosides.

17. Nonsteroidal Antiinflammatory Drugs and Upper Gastrointestinal Bleeding

BRIAN L. STROM
JEFFREY L. CARSON

INTRODUCTION

A number of new nonsteroidal antiinflammatory drugs (NSAIDs) have been marketed in the recent past. The major motivation for the use of these drugs is the known gastrointestinal toxicity of aspirin. From premarketing studies it was known that these drugs, as well, could cause subclinical gastrointestinal bleeding, but there were no controlled studies of the association between NSAIDs and clinically apparent upper gastrointestinal (UGI) bleeding. There also was no information on the re...