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Outcomes From the First 6 Years of Operation of the Central Portugal Pharmacovigilance Unit

Batel-Marques, Francisco PharmD, PhD*†; Penedones, Ana MSc*†; Mendes, Diogo PharmD, MSc*†; Alves, Carlos PharmD, PhD*†

doi: 10.1097/PTS.0000000000000273
Original Article: PDF Only

Objectives The aim of this study was to analyze and characterize the outcomes of the Central Portugal Regional Pharmacovigilance Unit over a 6-year period.

Methods Spontaneous reports received between January 2009 and December 2014 were considered. The annual reporting ratios were estimated. The cases were characterized according to their seriousness, previous description, causality assessment, reporting professional, pharmacotherapeutic groups of the suspected drugs, and type of adverse drug reactions most frequently reported.

Results The Pharmacovigilance Unit received 1277 reports that contained 3222 adverse events. In 2014, the reporting rate was estimated at 124 reports per million inhabitants. Sixty-five percent of the reports were assessed as serious. Seventy-three percent of the cases were assessed as being at least possibly related with the suspected drug. Physicians reported 49% of the cases. The suspected drugs most frequently reported were “anti-infectives for systemic use” (n = 494, 38%). The most frequently reported adverse events were “general disorders and administration site conditions” (n = 667, 21%).

Conclusions Despite the continuous efforts carried out by the Central Portugal Regional Pharmacovigilance Unit in promoting spontaneous reports of suspected adverse drug reactions, the results, although representing a contribution to the postmarketing safety monitoring of drugs, are still modest illustrating the need to promote the adherence of health-care professionals to the pharmacovigilance system and to increase their reporting rates of suspected ADRs.

From the *AIBILI—Association for Innovation and Biomedical Research on Light and Image, CHAD—Centre for Health Technology Assessment and Drug Research; and †University of Coimbra, Faculty of Pharmacy, Coimbra, Portugal.

Correspondence: Francisco Batel-Marques, PharmD, PhD, CHAD—Centre for Health Assessment and Drug Research, AIBILI—Association for Innovation and Biomedical Research on Light, Azinhaga de Santa Comba, Celas 3000–548, Coimbra, Portugal (e-mail: batelmarques@gmail.com).

Conflict of Interest: The authors declare that they have no conflict of interest.

Funding disclosure: The authors declare that they have not received any funding.

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