The role of drug bulletins

In October 2011, the Geneesmiddelenbulletin published a feature article about the efficacy and effectiveness of flu vaccinations, which led to a great deal of debate about the value of these vaccination campaigns. Questions were raised about the procedure used to select the literature on which the article was based and about whether the Geneesmiddelenbulletin should function as a forum. Some stakeholders used the article to start a debate about the role of the Geneesmiddelenbulletin. Drug bulletins have a different function than medical journals, and they also work in a different way. After a brief historical survey, this article therefore discusses the role of drug bulletins (Gebu 2011; 45: 139-141).

Introduction

The first issue of the Geneesmiddelenbulletin was published on 30 March 1967, and was distributed by the then Ministry of Social Affairs and Public Health free of charge to all practicing physicians and pharmacists in the Netherlands. In view of the rapid developments in pharmacotherapy and the scarcity of objective sources of information available at the time, the Ministry assumed that prescribers were in need of independent information about drugs. The newly established bulletin was modelled on the American Medical Letter on Drugs and Therapeutics (1959) and the British Drug and Therapeutics Bulletin (1962). Whereas the Geneesmiddelenbulletin initially presented many translated articles from sister publications, the need was soon felt to present articles specifically relevant to the Dutch situation.

At the time, the Minister expressed the reasons for initiating the publication as follows: ’Any practising medical doctor is constantly confronted by the need to choose from the multitude of drugs that are available to treat his patients. The current developments in pharmacotherapy have made it more difficult to incorporate new medicinal treatments in everyday practice… Without going into detail about the merits of the sources of information currently available in the Netherlands, many people are of the opinion that the available sources fail to fully meet the need among doctors for a continuous and up-to-date supply of information about drugs’ (Gebu 1967, 30 March 1967). These words have not lost their relevance today.

Drug bulletins and rational pharmacotherapy

The objective of the Geneesmiddelenbulletin Foundation is to promote rational pharmacotherapy, which may be regarded as the practical application of the principles of ‘evidence-based medicine’. Rational pharmacotherapy can be defined as prescribing the right medication to individual patients or populations, at the time when it is needed, using a dosage scheme that corresponds to the most suitable profile in terms of efficacy, side-effects and costs. The Geneesmiddelenbulletin tries to achieve this aim by providing independent and objective information about pharmaceuticals to all those involved in prescribing and providing them.

International Society of Drug Bulletins

Background and history. The Geneesmiddelenbulletin participates in the ‘International Society of Drug Bulletins’ (ISDB), a worldwide network of bulletins on drugs and therapeutics that are financially and intellectually independent of the pharmaceutical industry. The ISDB was founded in 1986 with support from the World Health Organisation (WHO). ISDB’s priorities include stimulating and assisting the development of independent drug bulletins worldwide, and promoting and maintaining cooperation and communications among them.1

After the Medical Letter was founded in the USA in 1959, many other drug bulletins were started in the 1960s, in response to the introduction on the market of large numbers of new drugs. At the time, the thalidomide disaster forced the world to pay serious attention to the risks and harm associated with the use of medications.

Membership. The ISDB has full members, like the Geneesmiddelenbulletin, and associate members, like Pharma Selecta. Full membership requires bulletins to meet a number of criteria. They must be run by an independent editorial team working within an organisational structure that guarantees editorial independence. They must obtain their funding from sources that do not compromise editorial independence, for instance public financing. The bulletin must be published at regular intervals and must aim to promote rational pharmacotherapy. And finally, the bulletin must not carry any advertising relating to therapeutic or diagnostic activities.

Manual on developing and strengthening bulletins. In 2005, ISDB collaborated with the WHO to produce a manual on setting up and strengthening drug bulletins.2 The manual stated that the information on drugs from currently available sources, such as textbooks, medical journals, local or national formularies, professional guidelines, official prescribing information and promotional materials published by the industry, is to a greater or lesser extent biased. The editorial policy of drug bulletins enables them to provide recommendations that deviate from those in other available sources. Their frequency of publication enables them to provide up-to-date information, while their transparent approach and editorial independence, which are core concepts in drug bulletins, enable them to present impartial and unbiased evaluations based on the most reliable type of evidence (randomised double-blind clinical trials), and to enter into debates with the industry about controversial topics that the industry and official government publications tend to avoid. Bulletins can criticise individual advertising claims, therapeutic recommendations and decisions of authorities responsible for drug registration.

Since bulletins are independent, they determine their own terms of reference. Most bulletins base their recommendations on comparative research into efficacy and side-effects, preferably involving direct comparisons with existing drugs. They can stimulate and facilitate process control and supervision by indicating gaps in the available information about certain therapies or interventions.

Topics. Bulletins frequently discuss the medicinal treatment of a particular disorder, or a group of medicines, by comparing new and existing drugs in terms of the balance between efficacy and side-effects and trying to determine their place in the pharmacotherapeutic repertory. Many bulletins also discuss the marketing and authorisation processes.

All currently existing bulletins publish articles exposing misleading promotional campaigns, or warning about therapeutic or pharmaco-economic problems.

Editorial committee. Membership of the editorial committee of a drug bulletin is subject to various requirements. Editors must strongly agree with the bulletin’s objectives. They must have no conflicts of interest with any institution, organisation or company that might jeopardise the bulletin’s editorial independence. Some bulletins, including the Geneesmiddelenbulletin, therefore ask editors to sign a statement to this effect (see website). Editors should not only have a general interest in public health, but also have relevant experience with the rational approach to prescribing, preparing or delivering drugs. In addition, they must be able to critically analyse articles and other texts, and to synthesise data, as well as having a reasonably good knowledge of English. The editorial committee consist of practitioners from various medical and pharmaceutical disciplines. In the Geneesmiddelenbulletin the editorial committee determines the editorial policy and an editorial office deals with the everyday running of the bulletin.

Editorial committees are responsible for selecting and defining the scope of articles and topics, editorial planning, ensuring the necessary documentary resources, assisting authors if necessary, ensuring the progress and quality of the articles, organising the various review rounds by internal and external reviewers and analysing the feedback from readers. The editorial committee has the overall responsibility for the articles published in the bulletin and for the bulletin itself. There is usually one chief editor, who is ultimately responsible for any decisions on the content of the bulletin.

Advisory board. The advisory board plays a crucial role in providing guidance to the editorial committee, for instance about issues of article content and topic selection, and in promoting the bulletin. Candidates for membership of the advisory board must not have any conflicts of interest.

External reviewers. Any bulletin is advised to build up a database of critical reviewers, who must not have any conflicts of interest either, such as financial ties with a pharmaceutical company. The Geneesmiddelenbulletin asks any reviewer who is invited to evaluate a draft article to complete a questionnaire about their possible conflicts of interest.

Authors. Articles are written by external authors or by members of the bulletin’s editorial team, or may be adapted from articles in sister bulletins. Authors have to meet a number of criteria, including expertise, a capacity for critical analysis and the willingness to change their text in response to critical feedback from reviewers and editors. The ‘perfect’ author is rarely available, and collective work with the editorial team is inevitable. Nearly all editorial teams of most of the Western-European drug bulletins write their own articles. In some cases, the first draft is written by an external author, after which the editorial team rewrites the text in consultation with the author.

Procedure. Editorial procedures differ in each country, but one essential step involves consultations between editorial committees, advisory boards, regular and incidental external reviewers, and in some countries the pharmaceutical industry. The comments raised are categorised and discussed by the editorial committees, which may lead to changes being made to the draft articles. The committee always justify the way they process the comments, after which there may be a new review round.

Letters to the editor. Drug bulletins do not function as a forum, like the British Medical Journal or the Nederlands Tijdschrift voor Geneeskunde. Nor do they offer a platform to any third parties, whether stakeholders or not. The function of drug bulletins is solely to promote rational pharmacotherapy. Since articles are submitted to many reviewers, most of the relevant aspects and opinions of independent experts will have been discussed during the review process. Should some new crucial issue be raised after an article has already been published, the bulletin may publish a supplementary article or addendum.

 

Conclusion

Drug bulletins have been established by private initiative, or as in the Dutch case, by national authorities, to promote rational pharmacotherapy. Rational pharmacotherapy can be defined as prescribing the right medication to individual patients or populations, at the time when it is needed, using a dosage scheme that corresponds to the most suitable profile in terms of efficacy, side-effects and costs.

The Geneesmiddelenbulletin and its sister bulletins have their own, unique approach, in which editorial committees collaborate with editorial office staff and internal or external authors to write articles based on scientific research. Their editorial committees and advisory boards consist entirely of people with no conflicts of interest. The bulletins do not function as discussion forums.

Its transparent approach and editorial independence enables the Geneesmiddelenbulletin to present neutral and unbiased evaluations of drugs, criticise public statements and advertisements and formulate therapeutic recommendations, as well as occasionally initiating debates on controversial topics, such as the efficacy and effectiveness of flu vaccinations, pandemic flu vaccines and HPV vaccination.

References

  1. Anonymous. ISDB Information Booklet. Via: http://www.isdbweb.org/documents/uploads/ Booklet2008English2.pdf.
  2. Starting and strengthening a drug bulletin. Via: http://www.isdbweb.org/documents/uploads/manual_full_text.pdf.