Direct Patient Reporting of Adverse Drug Reactions - Cochrane ...

Costs1. The pharmacovigilance systems must be restructured to enable direct patient reportsto be appropriately handled. That will require more staff, new training and time. To beable to analyse patient reports, pharmacovigilance staff need to learn to analysequalitative data.2. Physicians, pharmacists, nurses and other health professionals will need to improvetheir roles as 'information intermediaries' with patients and the public, both in teachingpatients and carers and in learning from them. They need to focus particularly onteaching people how to think about medicines and to use them well, for example howto weigh their expected benefits against possible harms and disadvantages; they alsoneed to take their role of learning from patients and public more seriously andconcertedly..Policy RecommendationsPromotion of reporting by patients and consumers• Those with experience in running patient reporting systems should assess whichtechniques to promote their systems have been most effective, with particular attention tomechanisms for encouraging reporting by the elderly and by users of minority languages.• Piloting ways of stimulating and encouraging patients and professionals to prepare ADRreports in collaboration with one another, but without losing the directness thatpatients provide, ensuring that the patient remains the primary author.Connecting information from patient reports to adversereaction data held by pharmaceutical companies• Authorities and organisations active in the field of patient reporting should provideupdates on their interactions with the pharmaceutical industry (exchange of data andanalyses) and circulate the outcomes of any engagement with industry, be it in jointworking groups or other multi-stakeholder platforms.Ensuring high-quality data analysis and data compatibility• Certain core quantitative data should be pooled across different countries and futuresystems should be designed with such compatibility in mind;18