Patient reporting of suspected adverse drug reactions: a review of published literature and international experience

Abstract

AimsTo synthesize data from published studies and international experience to identify evidence of potential benefits and drawbacks of direct patient reporting of suspected adverse drug reactions (ADRs) by patients. MethodsStructured search of MEDLINE, CINAHL and PsycINFO supplemented by internet searches and requests for information to key contacts. ResultsSeven studies (eight papers) were included in the review. None of the studies concerned spontaneous reporting by patients. Information on patient reporting systems was obtained for six countries, with summary data repor ted by four. Patient reports identified possible new ADRs that had not previously been repor ted by health professionals. The quality of patient reports appears to be similar to that of health professional reports. There is some evidence that patients report an ADR when they consider their health professional has not paid attention to their concerns. Patient reports may, at least initially, be more time consuming to process. ConclusionsOverall, the evidence indicates that patient reporting of suspected ADRs has more potential benefits than drawbacks. Evaluation of patient reporting systems is needed to provide further evidence.

Knowledge, Attitude and Practice of Adverse Drug Reaction Reporting among Healthcare Workers in a Tertiary Centre in Northern Nigeria

“…Another way to increase the reporting of ADRs is through the promotion of patient self-reporting. The benefits of this idea have been confirmed in different studies [26,27]. Patient self-reporting has a complimentary role to play in increasing the level of ADR reporting in a developing country such as Nigeria.…”

Development and Initial Validation of a Patient-Reported Adverse Drug Event Questionnaire

“…Patient self-reports of adverse drug events (ADEs) are an important additional source of information on the safety of drugs because they differ from healthcare professional reports [2][3][4][5][6][7]. Healthcare professionals often underestimate symptomatic ADEs experienced by patients [7,8].…”

Farmacovigilância em Portugal: Atividade da Unidade Regional do Centro

“…40 Os utentes já estavam autorizados a notificar suspeitas de reações adversas há alguns anos noutros países, por exemplo na Dinamarca, na Holanda ou no Reino Unido. 41,42 Apesar dos primeiros estudos dedicados a avaliar o contributo da Tabela 3 -Eventos adversos, classificados no PT do MedDRA, mais frequentemente notificados (frequência ≥ 0,5%) notificação por utentes para a Farmacovigilância terem sugerido que a sensibilidade da notificação de suspeitas de reações adversas era baixa, a evidência mais recente considera que a contribuição dos utentes para a identificação da iatrogenia medicamentosa é valiosa, uma vez que estes poderão reportar suspeitas de reações adversas até então desconhecidas. [41][42][43] Dado que os profissionais de saúde e os utentes fornecem diferentes perspetivas no que diz respeito à notificação de suspeitas de reações adversas, em que os primeiros estão mais focados na causalidade e os últimos na severidade e impacto sobre a qualidade de vida, é importante receber notificações de ambos os grupos para avaliar melhor a natureza dos eventos.…”