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Chronic Diseases in Canada


Volume 23
Number 4
2002

[Table of Contents]


  Public Health Agency of Canada (PHAC)

Book Review 

Pharmacovigilance from A to Z:
Adverse Drug Event Surveillance 


Barton Cobert and Pierre Biron 

Malden, Mass., USA, Blackwell Science Inc., 2001
256 pp; ISBN 0 63 204586 8; $92.30 (CDN) 


Cobert and Biron's Pharmacovigilance is a welcome addition to the dictionaries that help us to cope with an ever-expanding world of ‘Babylonian priest languages': our ways of communicating within our specialties, often strange and impenetrable to the outside world. The authors offer us a reader-friendly dictionary, particularly interesting to anyone involved in clinical pharmacology and drug research. 

Dictionaries, like any specialty book, may be written either by an extended number of contributors, as are Last's Dictionary of Epidemiology, Armitage and Colton's Dictionary of Biostatistics or Gail and Benichou's Encyclopedia of Epidemiologic Methods, or by one or two writers, like this volume or Paul Vogt's Dictionary of Statistics and Methodology: A Nontechnical Guide for the Social Sciences. The former approach produces high-quality information, which is sometimes more detached from some unifying concept. The latter allows the authors to put more of their souls into their writing and produce, in a more harmonized state of mind, a better line of thought throughout the whole message. As always, the product depends more heavily on the experience of its authors. 

Pharmacovigilance appears to me to be a very informative text. Its major asset is its originality in covering the growing field of drug surveillance, which is known to the authors from within and in many subtle details. However, any reader of book reviews is interested not only in kudos but also in drawbacks and in at least some major aspects where there is space for improvement. 

This dictionary covers pharmacovigilance as a part of the domain of pharmacoepidemiology, which itself is a part of fundamental and clinical epidemiology. The authors should stress the definitions or concepts that are more specific to this sub-domain and that are different from those used in the outside world of clinical epidemiology and biostatistics in particular. 

Some entries are not specific enough. For example, epidemiologic studies (p. 74) are seen solely as observational. While discussing phases of clinical trials and assessment of drugs, the authors might be more clear about what is covered by pharmacovigilance itself. Pharmacovigilance also covers what may be called “phase V” assessment of drugs. In phase V, as in Phase IV, there are no pre-selected patients, but instead of desired treatment effect, phase V focuses on any rare consequences resulting from the administration of a drug. 

Elsewhere, I was puzzled by what “statistical causality” means. Levels of causality, as proposed by the authors, are solely conceptual and not operational. For example, what distinguishes a “probable” causal relationship from a “possible” one in clear and usable terms? Categories of causality are defined in the book by their field of use, such as medicine or law, rather than by their substance. Do the authors perceive different concepts as identical to different domains of use? The same applies to other entries, where it is not clear whether the definition and field of use are within some more general concept or if they are different. 

Some other entries describe situations of their use rather than definitions of terms themselves. For example, “case reports” or “case series” are not defined at all! If some terms are not defined well enough, the authors should guide the reader to their definitions elsewhere, for example, the abovementioned Dictionary of Epidemiology, endorsed by the International Epidemiological Association. Hence, the reader should not expect that Pharmacovigilance will provide an essential dictionary of epidemiological and other terms without pairing this reading with other ad hoc references. 

Some more than ubiquitous terms, such as “epidemiology” or “evidence-based medicine” are not mentioned and defined. The “Introduction” section of this book might be improved by the addition of a reference to other dictionaries and basic reading, which might help the reader to expand and complete his or her understanding of pharmacovigilance terms as they are gathered in this volume. I would like to find definitions of “efficacy”, “effectiveness” or “efficiency of treatment”, as well as a cost/benefit assessment including non-monetary considerations. Adverse effects represent one of the costs of treatment. 

What about evidence-based principles to be kept in mind in pharmacovigilance and how might we define “evidence-based pharmacovigilance” itself? A word about “evidence-based pharmacology” would also merit a place in this book. 

Even if we dislike or disagree with some term or domain, it is not a sufficient reason to exclude it from a dictionary. 

All this reviewer's ramble should not blur the relevance and the originality of Pharmacovigilance. This dictionary will stand as a useful and very original tool for years to come. It will also help health professionals who are farther away from clinical pharmacology to better understand the domain it covers.

Overall Rating:
Original contribution 

Strengths:
Easy to read and informative, particularly for readers from outside the field of pharmacoepidemiology 

Weaknesses:
Lack of bridging with mainstream dictionaries in connected domains 

Audience:
All health professionals interested in the evaluation of drugs 

Milos Jenicek, MD 

Professor, Clinical Epidemiology and Biostatistics
Faculty of Health Sciences
McMaster University
1200 Main Street West
Hamilton ON L8N 3Z5 

 


Book Review 

A Veritable Scoff: Sources on Foodways and Nutrition in Newfoundland and Labrador 


Maura Hanrahan and Marg Ewtushik 

St. John's, Nfld, Flanker Press Ltd., 2001
100 pp: ISBN 1 894463-21-8; $14.95 (CDN) 


A Veritable Scoff presents summaries of 170 writings on Newfoundland and Labrador foodways and nutrition for the past several centuries. Is the popularity of boiled dinner – salt beef or pork with root crops – on the wane? Why do the Innu of Davis Inlet call Social Services “the food boss”? How prevalent was beriberi in pre-Confederation Newfoundland? What are dietitians and food scientists in the province concerned about now? The only book of its kind in Canada, this bibliography answers these questions and asks others that are equally compelling.” [Text from the book jacket.] 

Overall Rating:
This book was both enjoyable and interesting to read, which for a bibliography is very good. I confess to my bias towards the subject as a nutritionist from this province. 

It provides a fascinating historical review capturing the highlights of foodways and nutrition from 1600–2000. It is applicable to today's decisions regarding health and nutrition policy and provides a transferable guide to other jurisdictions where such a review is being considered. 

Strengths:
The studies have been well-analyzed and the summaries are succinct and relevant. They provide a picture of the real nutrition issues facing people over time and they are grouped together well. 

Weaknesses:
Lack of bridging with mainstream dictionaries in connected domains 

Audience:
The range of topics covered would be of interest to many professions and interested individuals as the perspectives are quite broad. It links studies from a variety of disciplines and jurisdictions including anthropology, biochemistry, education, agriculture and government. It would be a very useful reference for libraries and governments. 

Eleanor Swanson 

Director, Planning and Evaluation
Government of Newfoundland and Labrador
Department of Health and Community Services
P.O. Box 8700
St. John's, Newfoundland, A1B 4J6 

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