Judith K. Jones

Assessing potential risk of drugs: the elusive target.

Excerpt Multiple drug use has been consistently associated with increased risk of adverse drug reactions in the elderly. However, the complex interaction of pharmacologic and patient risk factors m...

An investigation of the safety of midazolam use in hospital.

Objective—To investigate whether an association exists between midazolam use and serious cardiorespiratory events or death.

A view from the drug utilization review management organization sector

Clinical Pharmacology and Therapeutics (1991) 50, 620–625; doi:10.1038/clpt.1991.195

Adverse Drug Reaction Considerations in Geriatric Drug Research

Given the high amount of drug use in geriatric patients, there are inherent concerns about adverse drug reactions. Statistical and methodological difficulties in surveillance, lack of spontaneous reporting, lack of consistency in clinical identification, and limited groups for cohort studies are discussed.

Foreword and Introduction

South Africa, despite high standards of specialist training in internationally recognized schools of excellence, has but a handful of dedicated subspecialty obstetric anaesthetists, solely in tertiary training institutions. Their passion for obstetric anaesthesia is, however, often passed onto their trainees who incorporate this into their everyday generalist specialist practice, mostly in the private sector.

Pharmacoepidemiology: defining the field and its core content

Emerging interests in pharmacoepidemiology make it important to define the professions core content. The International Society for Pharmacoepidemiology (ISPE)s Education Committee sought to develop a consensus on its core disciplines. This report recapitulates their efforts and conclusions.

Epidemiologic Perspective on Causality Assessment for Drug Associated Events

The study of causality of suspected adverse drug reactions (ADRs) forces us to look at our state of knowledge about drugs. Frequently, effects associated with a drug in the product label or literature are variably related to that drug and sometimes are only an expected event for the population exposed to the drug. Frequency and likelihood of causation are seldom known. Examples of this imperfect state of knowledge and the reasons for it are elaborated, citing the standard sources of information: clinical trials, spontaneous reports, and epidemiologic methods — cohort and case control studies. Each method generates data not amenable to standard statistical analysis. It is proposed that these data can be evaluated using Bayesian methods, which in turn would provide guidance for improved study design.

Approaches to Evaluating Causation of Suspected Drug Reactions

Knowledge about an adverse drug effect typically starts out as a signal of a possible problem, usually identified through spontaneous reports of a suspected adverse drug reaction. As diagrammed in Figure 1, this signal is verified in an iterative fashion, either through further reports or studies of its biological plausibility and, if important, it is quantitated with epidemiological or, rarely, experimental studies (clinical trials). Although often taken for granted, the driving force for this iteration is often based on the assumption or determination, through some means, that there is a cause-effect relationship between the purported risk and the pharmaceutical. This qualitative part of risk assessment which evaluates a signal is an important initial part of the process.

Assessing Adverse Drug Experiences

Excerpt To the editor: The Active Permanent Workshop of Imputologists (APWI) was established in 1981 as an informal organization of professionals interested in methods to assess causality of suspec...

Discussion Panel: The Future of Causality Assessment: Is it Wise: Will it Help? What Effect Could it Have on the Analysis of Clinical Trial Data or in Pharmacoepidemiology?

Panelists: Dr Hyman Zimmerman VA Medical Center, Washington, DC; Dr Bruce Wintroub, Department of Dermatology, VA Medical Center, San Francisco, California; Dr Winifred M. Castle, Medical Advisor, Product Safety Group, Medical Department, Imperial Chemicals Industries PLC, Pharmaceuticals Division, Macclesfield, Cheshire, United Kingdom; Dr Bruce Hill, Professor, Department of Statistics, University of Michigan, Ann Arbor, Michigan; Dr David Lane, Department of Theoretical Statistics, University of Minnesota, Minneapolis; Dr Tom A. Hutchinson, Nephrology Division, Royal Victoria Hospital, Montreal, Quebec, Canada; Dr Michael Kramer, Department of Epidemiology & Biostatistics, Montreal, Quebec; Professor Rolf Hoigné, Head, Medical Division, Ziegerspital, Switzerland; Dr David J. Spiegelhalter, Medical Research Council, MRC Centre, United Kingdom; and Dr. Jan Venulet, Ciba-Geigy Medical Department, Basel, Switzerland