Independent Review of Access to the Yellow Card Scheme

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Chapter: Pharmacovigilance: Spontaneous Reporting - UK

In recent years, increasing numbers of requests for access to Yellow Card data have been inundating the MHRA.


INDEPENDENT REVIEW OF ACCESS TO THE YELLOW CARD SCHEME

In recent years, increasing numbers of requests for access to Yellow Card data have been inundating the MHRA. These ranged from requests for reports on classes of medicines, copies of the whole database for genetics research and requests for the data to develop methodologies for identifying potential drug safety signals. While Agency guidelines are in place for responding to basic requests for Yellow Card data, some of these requests fell outside the estab-lished policies on releasing data and it soon became apparent that formalised procedures were required that would allow the data to be used for bona fide research but at the same time protecting the confi-dential data of reporters and patients.These changing demands on the Yellow Card Scheme raised impor-tant ethical, operational and financial issues in rela-tion to public health. The government agreed that the time had come for a review of access to Yellow Card data to consider whether, and under what condi-tions and for what purposes, the data should be made more widely available. An independent review of the Yellow Card Scheme was announced in July 2003 under the lead of Dr Jeremy Metters. Dr Metters convened a small multidisciplinary steering commit-tee to consider the public health, scientific, ethical, genetic, data protection, legal and other issues that would arise from increasing access to Yellow Card data. The steering committee took into account the views of stakeholders during a 12-week public consul-tation before the Report of an Independent Review of Access to the Yellow Card Scheme was published in April 2004. The Review recognised the impor-tance of the Yellow Card Scheme for public health and for the benefit of patients and considered that it was imperative that any changes implemented should not harm the Scheme or deter reporters from submit-ting Yellow Cards. Increasing access to Yellow Card data could be of benefit to public health as long as appropriate controls were set in place. Requests for Yellow Card data were divided into categories, which depended on the level of data requested. The Review recommended that anonymised aggregated ADR data should be proactively published and available via the MHRA website, while requests for data that may potentially identify a reporter or patient or provide an opportunity for the recipient to contact a reporter should be subject to scientific and ethical scrutiny. The Review recommended that an independent scien-tific committee should be established by the Licens-ing Authority to evaluate research proposals for these data to ensure they are scientifically robust. Follow-ing scientific approval, a research proposal would be ethically reviewed under the established framework of the Central Office for Research Ethics Committees (COREC) system. Regardless of scientific and ethi-cal approval of a research proposal, in line with the provisions of the Data Protection Act 1998, consent from a reporter and patient would always be required before access to their data was permitted.

As a separate issue, the Review recognised the value that patient reporting could bring to the Yellow Card Scheme and recommended that the Scheme should be extended to enable patients to report their experi-ences directly to the MHRA (see section on ‘Focus on Patients’ below). In addition, the Review commended the work of the RMCs but put forward that further clarification of the relationship, respective responsi-bilities and working practices between the MHRA and the RMCs was required. A substantial number of the recommendations of the Review focused on strengthening the Scheme to raise awareness of its role and importance and a communication strategy was proposed to provide better information and education about the Scheme for health professionals, patients and the public.

The MHRA welcomed the Review recommendations and launched a public consultation on six key areas identified from the recommendations of the Review, to coincide with the 40th anniversary of the Yellow Card Scheme on 4 May 2004. The CSM and the government accepted the main recommendations of the Report of an Independent Review of Access to the Yellow Card Scheme in January 2005. While procedures were being set in place to establish a permanent, non-statutory scientific committee, an Interim Committee on Yellow Card Data was convened. The remit of this committee, under the chairmanship of Dr Jeremy Metters, was to advise on development of arrange-ments for release of Yellow Card and ADROIT data; to advise on protocols and procedures to underpin the operation of the permanent committee; and to consider and advise on the handling of requests for data that the MHRA had already received.

The Interim Committee acknowledged the extremely valuable research potential of the Yellow Card data and considered the implications of releasing the data under the Freedom of Information Act 2005 (FOIA), while at the same time protecting the confi-dentiality of patients and reporters and their personal data under the Data Protection Act 1998 (DPA). Using the principles of these Acts, requests for Yellow Card and ADROIT data were divided into Category I requests that are generally releasable under the FOIA and not prohibited from release by DPA, and Cate-gory II requests that are subject to FOIA exemptions and the restrictions of the DPA.

As recommended in the Review, from January 2005 the MHRA has published anonymised, aggregated Yellow Card data on specific medicines in the form of Drug Analysis Prints (DAPs) on the Yellow Card website (known as Category Ia data). Other types of data that fit into Category I (known as Category Ib data) are not included in the regular publication Scheme, but can be provided by the Agency to indi-viduals on request, in line with FOIA provisions. These generally include a limited range of data fields from anonymised individual case reports. In 2006, a substantive committee, the Independent Scientific Advisory Committee for MHRA database research (ISAC) was established (www.mhra.gov.uk).

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