pharmacoepidemiology and drug safety 2002; 11: 253–254DOI: 10.1002/pds.720

EDITORIAL

The International Society of Pharmacovigilance

The International Society of Pharmacovigilance(ISoP) was born last year in Verona and came of ageat its first annual meeting in Tunis-Carthage this fall.The meeting itself was enormously successful thanksto the dedicated efforts of many people, particularlyProfessors Chalbi Belkahia and Mohamed Lakhaland their colleagues on the local organising commit-tee, and Dr Ron Meyboom, chairperson of the scien-tific sub-committee. ISoP had a previous life as aEuropean society (ESoP), the brainchild of ProfessorRene Royer and several French colleagues. AsFounding President Rene Royer and his colleaguesdeveloped the spirit, vision and goals of ISoP.

So what does ISoP stand for and what is its uniquevalue in the pharmacological and medical world?Pharmacovigilance is both easy and difficult to define.It is easy and accurate to say that it is ‘ . . . the scienceand activities relating to the detection, evaluation,understanding and prevention of adverse drug reac-tions or any other drug related problems’ (the cur-rently proposed WHO definition). Within thedefinition, lie many matters: ‘evaluation’ shouldinclude both analysis of the strength of evidence andthe clinical relevance of the findings, thus opening theissue of comparative benefit and harm evaluation;‘prevention’ must deal with the communication andapplication of evidence and understanding to clinicalpractice; ‘other drug related problems’ must includethose of interaction, poisoning, misuse, and therapeu-tic error, insofar as it can be related to the character-istics of the medicinal products. Even the issue ofwhat constitutes a ‘drug’ is problematic. Does itinclude traditional medicines, vaccines, recreationaldrugs and so-called ‘food additives’? Also, currentadvances in medicine offers new therapeutic uses forold drugs, as well as a vista of new clinical possibili-ties for drug therapy as genetic and other mechanismsare elucidated. In each of these pharmacovigilancemust play a role. The scope of pharmacoviligilanceis thus broad. On the detection and evaluation side itoverlaps with pharmacoepidemiology and on the out-put and prevention side has clear links with therapeu-tics, rational drug use and drug regulation.

Pharmacoepidemiology has been defined simply byStrom, in his book,1 as: ‘the study of drugs in largenumbers of people’. In elaborating on this definition

he clearly differentiates between controlled studiesexamining whether a particular adverse outcomeoccurs more often in an exposed versus a non-exposedpopulation, and the clinical judgement of whether anadverse event is caused by antecedent drug exposure.The International Society of Pharmacoepidemiology(ISPE) has the use of controlled studies in populationsas its main thrust and interest. The focus is primarilythat of public health and probabilities of group out-comes. ESoP (and now ISoP ) was conceived afterISPE with very much the clinical patient focus onstudying and minimising the risks of therapy. Just asclinical pharmacology and therapeutics depends heav-ily upon pharmacology, so does pharmacovigilanceboth depend upon the work of pharmacoepidemiol-ogy, and yet is more. ISoP will naturally cooperatewith ISPE and with clinical pharmacology societiessuch as the EACPT and CPT.

The founders of ISoP were much concerned thatthey should not start a new society for its own sake.It is no accident that the founders were nearly all prac-tising clinicians teaching clinical pharmacology andhaving involvement in adverse reaction reporting pro-grammes. There was a strong view that therapeuticseducation to medical undergraduates was very limitedconsidering the complexities of therapeutic decisions.Clinical pharmacology tells one how drugs mightwork: it has little to say about overall effectivenessin clinical practice, the comparison between possibletherapies, nor about the risks of therapy. There is littleinformation about patients who do not fit the clinicaltrial norms, about the diagnosis and management ofADRs and how to monitor patients for an optimal out-come, to foresee and prevent bad outcomes from ther-apy, and to optimise the good. The intention of ISoPthen is to fill the gaps, particularly concentrating itsgaze on the well considered and balanced applicationof all our knowledge on drugs to the end of safest indi-vidual patient therapy.

In practical terms what has ISoP been doing?

* ISoP is very conscious of the need to be more than atoken international organisation. Most internationalorganisations take their operating procedures,attitudes, majority membership, goals and focusfrom the developed countries from which most of

Copyright # 2002 John Wiley & Sons, Ltd.

them spring. ISoP is not exceptional at its point oforigin, but it is determined to pursue a path ofmaking the Society accessible and valuable globally.In particular the ISoP will address the problems ofkeeping the costs to members within reason giventheir country’s economic status, and still be able toprovide benefits beyond meetings which will beuseful to all. The ISoP will aim to hold meetingsoutside Europe and North America and do its utmostto ensure that they are well supported by attendanceby people within those 2 areas. Many of these issuesare problems due to limited and differential financialresources and local self interest. ISoP will pursuenovel and flexible solutions to these issues. Inparticular it will create links with national groupsand determine how they should like to benefit fromISoP . ISoP will also try to maintain good relation-ship with the WHO Programme for InternationalDrug Monitoring, which already links 65 countries.

* Its annual meetings have had programmes whichclearly reflect the overall goals and aims. At thelatest meeting in Tunis-Carthage there were thefollowing topics

— The impact of the way the science based

pharmaceutical industry has expanded and itsinfluence has been discussed at a previousmeeting. At this meeting the response by WHOwas presented

— Vaccine vigilance— Signal testing— Global differences in the epidemiology of

adverse reactions— The science and politics of medicines control— Drug induced liver injury— Drug safety in children— Drug induced sexual dysfunction— Herbal medicines and complementary therapy— The impact of regulation on clinical practice— Gastrointestinal adverse reactions to drugs—

an analysis of some interesting studies andtheir implications for public health decisionmaking and therapy

— Medication error— Many specific clinical and methodological

issues were presented in posters

The attendees questionnaire from the meeting atteststo the success of this programme. Almost every ses-sion had those who voted strongly in support of it,as well as some who found particular sessions of nointerest. Yet the overall feeling about the professionalvalue of the conference was high, showing the broadcoverage was attractive overall. We also learned,

however, that people want programmes less full ofpresentation with more time for discussion and thatdrop-out presenters are not at all tolerated even underthe exceptional events of an unprecedented air/terror-ist disaster just before our meeting.

* Workshops have been held on causality assess-ments of adverse drugs reactions and basic ADRmonitoring tools

* Its policy over membership fees has been to keepthem as low as possible. It is hoped that this willencourage younger health professionals to beinvolved even when pharmacovigilance is not amain part of their health care practice

* It has a regular newsletter; the ‘ISoP Star’and a webpage, both of which will be developed further.

* It is constantly looking for ways to offer newbenefits to members.

Whilst ISoP has its clinical focus, it would be a mis-take to believe that its work and meetings do not holdinterest for epidemiologists, academics, regulatorsand CROs and industry. On the contrary we hope toprovide the best opportunities for feedback to all ofthose groups on how their work impacts on patientcare, and vice versa. Not only do we believe that itis always essential to involve all the disciplines thathave an input into pharmacovigilance, but also believethat consumer and patient group interest is equallywelcome in our scientific debates. In the end it isthe patient that is the subject of what we do and isthe ultimate evaluator!

Finally, the success of any society depends upon itsmembers. Not only must they feel that they receivesomething useful from membership, but real involve-ment comes from what members want to do for thesociety. We are therefore keen that anyone who hasan interest in the work and challenges proposed byISoP should not only join and let us know what theywant, but also be active in the important work ofpharmacovigilance.

REFERENCE

1. Strom B. Pharmacoepidemiology, 3rd edn. John Wiley: NewYork, NY, 2000.

Ralph EdwardsPresident of ISoP

The next ISoP annual meeting is in Amsterdam,16–19 October, 2002. Contact www.isop2002.org.Conference fee also includes one year’s member-ship of IsoP, (www.isoponline.org)

254 editorial

Copyright # 2002 John Wiley & Sons, Ltd. Pharmacoepidemiology and Drug Safety, 2002; 11: 253–254