Patient-centred approach to pharmacovigilance in Europe
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Patient-centred approach to pharmacovigilance in Europe Patient organisations face both external and internal barriers to being more involved with pharmacovigilance, according to the results of a European study reported in Drug Safety, and an environment where patient organisations "can actively engage and contribute as stakeholders will benefit pharmacovigilance". In the quantitative study phase, a survey of patient organisations resulted in 337 respondents. Results revealed different perspectives about direct patient reporting (DPR). Most respondents who were negative or doubtful about DPR referred to incomprehension of the reporting data process, data treatment, and purpose. Many organisations have very limited budgets and must prioritise their activities. However, they mentioned many safety-oriented activities, primarily education, and mentioned sharing information or supporting initiatives from other stakeholders. Their requirements tended to include very specific information about drugs and their associated adverse events, and about how the pharmacovigilance system works. However, validation and encouragement are needed, as the respondents mentioned their disease or adverse event did not seem to be taken seriously, with problems making themselves heard. Of the 98 survey respondents who agreed to participate in an in-depth interview, quota sampling of those with "interesting opinions" from the open-ended questions resulted in 16 interviews being conducted; participants were from 11 countries. The questions were asked following a tree scheme dependent on previous answers. Patients considered they had a broad contribution to pharmacovigilance, with a big impact, including contributing to drug leaflets. However, the ideological limitations to participation may include patients having no responsibility for drug safety, or not seeing any benefit. Pharmacovigilance activities varied, but included participation in legislation, education, and encouraging adverse event reporting. All noted dissatisfaction with the reporting forms and means of reporting, including that the forms are not designed to meet patient needs, or easy to find. As many staff are volunteers and often also patients, health conditions may limit their participation in the organisation. Much of the informative materiel is in English, which staff and patients may not find comfortable to read, but translation is time-consuming. Suggestions for improvement included changes to pharmacovigilance systems, education in pharmacovigilance, more awareness of pharmacovigilance, and more involvement of patient organisations. A more proactive approach from national competent authorities may help, "involving patient organizations and creating better communication systems where all stakeholders can interact and understand their different points of view". Chinchilla K, et al. Patient Organizations’ Barriers in Pharmacovigilance and Strategies to Stimulate Their Participation. Drug Safety : 28 Sep 2020. Available from: URL: 803506573 https://doi.org/10.1007/s40264-
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