systems, reporting criteria, and reporting forms; method ofreporting VAAEs and reasons for not ... vaccine-associated adverse events surveillance system in.
Reporting vaccine-associated adverse
events
Are family physicians aware of criteria and procedures? Philippe Duclos, DVM, PHD Jamie Hockin, MD Robert Pless, MD Beth Lawlor, MD
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OBJECTIVE To determine family physicians' awareness of the need to monitor and report vaccineassociated adverse events (VAAE) in Canada and to identify mechanisms that could facilitate reporting. DESIGN Mailed survey. SETTING Canadian family practices. PARTICIPANTS Random sample of 747 family physicians. Overall response rate was 32% (226 of 717 eligible physicians). MAIN OUTCOME MEASURES Access to education on VAAE; knowledge about VAAE monitoring systems, reporting criteria, and reporting forms; method of reporting VAAEs and reasons for not reporting them; and current experience with VAAEs. RESULTS Of 226 respondents, 55% reported observing VAAEs, and 42% reported the event Fewer than 50% were aware of a monitoring system for VAAE, and only 39% had had VAAE-related education during medical training. Only 28% knew the reporting criteria. Reporting was significantly associated with knowledge of VAAE monitoring systems and reporting criteria (P < 0.01). CONCLUSION Physicians need more feedback and education on VAAE reporting and more information about the importance of reporting and about reporting criteria and methods. OBJECTIF Determiner le niveau de sensibilisation des medecins de famille face au besoin de pharmacovigilance et de declaration des effets secondaires associes aux vaccins (ESAV) au Canada et identifier les mecanismes qui pourraient faciliter la declaration. CONCEPTION Sondage postal. CONTEXTE Pratiques familiales canadiennes. PARTICIPANTS Echantillon aleatoire de 747 medecins de famille. Le taux global de reponses fut de 32 % (226 des 717 medecins admissibles).
PRINCIPALES MESURES DES RESULTATS Acces 'a la formation sur les ESAV, connaissances des systemes de pharmacovigilance des ESAV, criteres de declaration, formules de declaration, methodes de declaration des ESAV, raisons de ne pas les declarer et experience actuelle avec les ESAV. RESULTATS Des 226 repondants, 55 % disent avoir observe des ESAV et 42 % ont declare des incidents. Moins de 50 % etaient au courant d'un systeme de pharmacovigilance des ESAV et seulement 39 % avaient recu une formation reliee aux ESAV pendant leur formation medicale. Seulement 28 % connaissaient les criteres de declaration. On a constate que le niveau de declaration etait significativement associe au niveau de connaissance des systemes de pharmacovigilance des ESAV et des criteres de declaration (p < 0,01). CONCLUSIONS Les medecins ont besoin de formation et de feedback sur la declaration des ESAV et d'etre mieux renseignes sur l'importance de la declaration et sur les criteres et les methodes de declaration. This article has been peer reviewed. Can Fam Physician 1997;43:1551-1560. -,*-
FOR PRESCRIBING INFORMATION SEE PAGE 1664
VOL43: SEPIEMBER * SEPTEMBRE 1997, Canadian Family Physician . Le Medecin defamille canadien 1551
~ ~ ~ ~ .ue .
RESEARCH Reporting vaccine-associated adverse events
approved for marketing in Canada have their safety and efficacy demonstrated in clinical trials and some^ ~ _ times through experience in other countries. No product is completely safe, however, and unexpected adverse events do occur. With biological products, any new batch might not perform as previous batches have. Adverse events are often impossible to predict, but physicians should monitor for them. The cornerstone of national postmarketing surveillance programs of licensed drugs and vaccines is voluntary reporting of adverse events that health care providers think might be due to administration of a drug. These reports are sent either to manufacturers (who must pass them on as directed by regulation) or directly to the national drug regulatory authority or other responsible agency. Vaccine-associated adverse events (VAAE) generally are reported through well established provincial public health networks. Public health authorities are then kept informed of the performance of vaccines used in universal immunization programs and can provide feedback to vaccinators if required. Reports are simultaneously forwarded to the Division of Immunization at Health Canada's Laboratory Centre for Disease Control (LCDC) in Ottawa for aggregation and analysis. Data from these reports become our first line of defence to ensure ongoing vaccine safety. Increasingly, the public and the media are questioning vaccine safety and are demanding not only safer products but also assurance that systems for detecting problems in a timely way are in place and functioning well. Although reporting VAAEs is mandatory only in Ontario, some people are calling for change in other provinces. It is important to remember that fear of VAAEs can affect the success of immunization programs.' Early detection of problems should counteract negative effects on rugs and vaccines
health and immunization programs. One important limitation of surveillance that relies on reporting is underreporting. In Canada, reporting rates vary among jurisdictions from one to nearly Dr Duclos is Chiefof and Dr Pless is responsible for the vaccine-associated adverse events surveillance system in the Division ofImmunization, Bureau of Infectious Diseases, at Health Canada's Laboratory Centre for Disease Control (LCDC) in Ottawa. Dr Hockin is an epidemiologist responsible for the Field Epidemiology Training Program at LCDC. Dr Lawlor practises in the Department of Pathology and Laboratory Medicine at the British Columbia Children's Hospital in Vancouver
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tered). Because of varying poring practices, differences .e .~~~~~~~~... . ..... pretation.;:: Idi toh'aerprti ng stmCanad al.so nhas an active survei lance systemtor serious events, vac.c n fur,a.n ct dis,known as IMPACT (Immunization Mnitoi ProgramACTve).4 Tesysemisoeraedthoug a; contratwith th*e ::Canadian :Paediatric: Society anid invlves. a network of 2000 bieds and more thi.an 85000 )children admitted annualin the country. At each centre a nurse momtor and clinical investig r do. av cbasd .on a, dai review of admission records. They are assisted by a neok tat 5",
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nurses, neurology ward staff and physicians, infectious Cniu on. page.155.
1552 Canadian Family Physician . Le Mddecin defamille canadien * VOL43: SEPTEMBER * SEPIEMBRE 1997
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RESEARCH
Reporting vaccine-associated adverse events
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