Results of pharmacovigilance in a community pharmacy

Introduction: The spanish pharmacovigilance system is based on spontaneous notification of suspected Adverse Drug Reactions (ADRs) by patients, the pharmaceutical industry and healthcare professionals using the yellow card. Pharmacovigilance is one of the activities that the community pharmacy can develop and that, in addition, is contemplated in the legislation as a mandatory task for all healthcare professionals.

The objective of this article is to describe and analyze the suspected ADRs detected by the pharmacists of a community pharmacy and reported to the Andalusian Center for Pharmacovigilance from 2002 to 2018.

Methods: Observational longitudinal study carried out in a community pharmacy in Benalmádena (Málaga) with suspected ADR detected and notified by yellow card to the Andalusian Center for Pharmacovigilance from 2002 to 2018.

Results: The total number of suspicions of ADR reported to the Andalusian Center for Pharmacovigilance since 2002 has been 329. The average age of the patients who presented ADR was 59.3 years (SD: 16.8). The pharmacological groups most frequently involved in ADRs have been lipid modifying agents (9.4%), agents that act on the renin-angiotensin system (9.4%), antibacterials (6.9%), antiinflammatories (6.9%) and psycholeptics (6.4%). The detected ADRs have mainly affected the nervous system (31.7%), the gastrointestinal tract (22.4%) and the skin (14.3%).

Conclusions: More than half of the reported suspicions have been registered in patients over 65 years of age. The pharmaceutical team must remain vigilant in detecting suspected ADRs in this group of patients, especially in newly marketed drugs.

The analysis of the suspicions of ADR detected allows us to have a more complete knowledge of the safety of the medication in our activity.