Andrade Paulo Henrique Santos, de Almeida Amanda Carvalho Barreiros, Dos Santos Ana Keilla Santana, Lobo Iza Maria Fraga, da Silva Francilene Amaral, da Silva Wellington Barros
Departamento de Farmácia, Universidade Federal de Sergipe, Núcleo de Pesquisa em Produtos Naturais e Assistência Farmacêutica (NUPPNAF), Av. Marechal Rondon, S/n - Jardim Rosa Elze, São Cristóvão, SE 49100-000, Brazil.
Nucleus of Research in Natural Products and Pharmaceutical Care, Federal University of Sergipe, São Cristóvão, Sergipe, Brazil.
Ther Adv Drug Saf. 2020 Jul 31;11:2042098620933748. doi: 10.1177/2042098620933748. eCollection 2020.
The aim of this study was to present the needs of hospital pharmacists in pharmacovigilance practices.
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.
Of the 27 federative units of Brazil, we obtained answers from pharmacists located in 85.2% ( = 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.
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.
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.
本研究旨在呈现医院药剂师在药物警戒实践中的需求。
本研究采用横断面设计，在巴西的医院药剂师中开展。样本通过自愿招募获得。邀请在巴西医院工作并在各自监管委员会注册的药剂师参与本研究。作者编制了一份个性化问卷，由受访者在“谷歌表单”平台上以电子方式填写。该问卷在巴西药学联邦委员会、巴西医院药学与卫生服务协会、四个药学区域委员会以及社交网络“临床药师”的数字平台上全国通用。定量变量通过均值和标准差进行分析。定性变量通过绝对频率和相对频率进行分析。与药物警戒活动相关的困难在在线补充材料的石川图中呈现。
在巴西的27个联邦单位中，我们收到了来自其中85.2%（即23个）单位药剂师的回复。在巴西药剂师开展的药物警戒实践中，药品不良反应调查（55.4%）和报告活动（47.0%）值得关注。药剂师报告了诸多困难，其中突出的是监测用药和因果关系判定方面的困难（27.7%）。在对报告的困难进行分类后，发现“相关人员”类别（45.1%）比其他类别更为突出。
本研究指出了巴西涉及药剂师的药物警戒实践面临的诸多挑战。相信纠正某些困难可能会对该国药物警戒活动的更好巩固产生影响。然而，药物警戒各级监管机构必须共同努力才能实现这一点。
这是一项旨在呈现巴西医院药剂师在药物警戒活动方面需求的研究。通过在线访谈，药剂师回答了一份问卷，介绍了他们开展的药物警戒活动，并表达了他们在开展这些活动时的担忧和困难。通过这项研究得出结论，巴西药剂师开展了大量主动搜索、调查和报告药品不良反应的活动。然而，每位药剂师开展药物警戒的方法各不相同。此外，观察到受访者中存在专业培训不足以及协助药物警戒活动的专业人员短缺的看法。这些是报告的主要困难。因此，寻求解决涉及药品不良反应问题的模式或灵活解决方案，对于巴西更好地巩固药物警戒服务似乎是必要的。
