Facilitation of Reporting - New Technology and Media

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Chapter: Pharmacovigilance: Spontaneous Reporting - UK

It seems self-evident that making reporting easier may increase levels of reporting; this is demonstrated by the rise in reporting in the mid-1980s following the move to make Yellow Cards readily available by including them in the BNF and in GP’s prescription pads.


FACILITATION OF REPORTING - NEW TECHNOLOGY AND MEDIA

It seems self-evident that making reporting easier may increase levels of reporting; this is demonstrated by the rise in reporting in the mid-1980s following the move to make Yellow Cards readily available by including them in the BNF and in GP’s prescription pads. This is supported by the fact that lack of time has been found to be one of the main factors in deterring ADR reporting in various studies (Bateman, Sanders and Rawlins, 1992; Belton et al., 1995; Sweis and Wong, 2000), including the MHRA’s work with GP focus groups.

In addition to increasing time pressures on health professionals, the recent expansion in the use of infor-mation technology means that the majority of GP practices, hospitals and pharmacies are now using computers as a routine tool in their daily work. In the light of this, it is recognised that the paper Yellow Card is no longer the most convenient method of reporting for many healthcare professionals. Work-ing with GP practice software companies, electronic reporting was made available to all users of these particular systems, by either the electronic submission of reports via a modem or semi-automated comple-tion of an electronic Yellow Card which is printed out and posted to the MHRA. This pilot Scheme was introduced in mid-1998 (Anon, 1997b); to date over 4000 GP electronic reports have been received, and in 2005, approximately 2% of UK reports were received by this route.

Electronic reporting of suspected ADRs to the MHRA became routine for a small number of phar-maceutical companies who have been submitting reports via the MHRA’s Adverse Drug Reactions On-line Information Tracking (ADROIT) Electronically Generated Information Service (AEGIS) since 1995. Electronic reporting became mandatory for companies under Directive 2004/27/EC from 20 November 2005.

Following on from electronic reporting for compa-nies, the MHRA piloted the use of electronic report-ing for health professionals under the direction of the CSM’s Electronic Reporting Working Group, in 2002 resulting in the launch of the electronic Yellow Card on the MHRA website. To date the MHRA has received over 2500 electronic Yellow Cards and as the move towards a paperless society continues, reporting by this means will undoubtedly continue to rise.

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