Challenges to the consolidation of pharmacovigilance practices in Brazil: limitations of the hospital pharmacist

Abstract

Aims: The aim of this study was to present the needs of hospital pharmacists in pharmacovigilance practices. Methods: This study has a cross-sectional design and was carried out with hospital pharmacists in Brazil. The sample was obtained by voluntary recruitment. Pharmacists who worked at Brazilian hospitals and were registered in their respective regulatory councils were invited to participate in the present study. A personalized questionnaire was developed by the authors and was electronically filled out by the respondents on the platform ‘Google forms’. The questionnaire was nationally available on the digital platform of the Pharmacy Federal Council, the Brazilian Society of Hospital Pharmacy and Health Services, four Pharmacy regional councils and the social network farmacêuticoclínico®. Quantitative variables were analyzed by mean and standard deviation. The qualitative variables were analyzed by means of absolute and relative frequency. Difficulties related to pharmacovigilance activities are presented in an Ishikawa diagram in the Supplemental Material online. Results: Of the 27 federative units of Brazil, we obtained answers from pharmacists located in 85.2% ( n = 23) of them. Among the pharmacovigilance practices developed by Brazilian pharmacists, the adverse drug reaction investigation (55.4%) and notification activities (47.0%) were worthy of note. Numerous difficulties were reported by the pharmacists, highlighting the difficulty in monitoring the medication and imputation of causality (27.7%). After categorizing the difficulties reported, it was observed that the category ‘people involved’ (45.1%) stood out from the others. Conclusion: This study pointed out numerous challenges to pharmacovigilance practices involving pharmacists in Brazil. It is believed that the correction of certain difficulties may impact on the better consolidation of pharmacovigilance activities in the country. However, regulatory agencies at all hierarchical levels of pharmacovigilance must work together to make it possible. Plain language Summary Challenges to the consolidation of pharmacovigilance This is a study that seeks to present the needs of Brazilian hospital pharmacists in relation to pharmacovigilance activities. Through online interviews, pharmacists answered a questionnaire, presented the pharmacovigilance activities they develop and expressed their anxieties and difficulties for the development of these activities. With this study, it was concluded that numerous activities of active search, investigation and notification of adverse drug reaction are developed by Brazilian pharmacists. However, each pharmacist performs a different method of pharmacovigilance. In addition, it was observed that among the interviewees there was a perception of insufficient professional training and a shortage of professionals to assist in pharmacovigilance activities. These were the main difficulties reported. Therefore, the search for models or agile solutions to solve problems involving adverse drug reactions seems necessary for a better consolidation of pharmacovigilance services in Brazil.

Hospital distribution in Polish provinces as a factor of smart living

“…It is also noteworthy that enhanced healthcare services can lead to reduced healthcare costs for city residents, thereby enhancing their quality of life and stimulating economic activity (Bulajic et al, 2020;Andrade et al, 2020). A healthier and more motivated workforce can drive higher productivity and efficiency, ultimately contributing to GDP growth (Huerta, 2021;Bogataj et al, 2021).…”

Causality assessment of adverse drug reactions by applying a global introspection method in a high complexity hospital

“…Although there are few data available, investments in pharmacovigilance are hypothesized to be scarce in LMICs with particular restriction for human resources. 7 , 13 Regarding the Brazilian pharmacovigilance system, 259 sentinel hospitals ( https://www.gov.br/anvisa ) are the main source for ADRs report to Anvisa. The notification system has been recently adapted to a new version, including the WHO-UMC system as an option for ADRs causality assessment.…”

“…In this scenario, pharmacists are traditionally the main healthcare professionals involved in the pharmacovigilance process. 13 Nevertheless, there are remarkable challenges for Brazilian pharmacists, as low scientific production and dissemination of information, poor patient safety culture, insufficient support to healthcare professionals involved in this practice, mainly direct to human resources that hinder the imputation of causality and the communication with other healthcare professionals. 13 …”