Focus on Patients

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Chapter: Pharmacovigilance: Spontaneous Reporting - UK

Since the Yellow Card Scheme was established in 1964, reporting of ADRs has been restricted to health professionals of specific disciplines.


FOCUS ON PATIENTS

Since the Yellow Card Scheme was established in 1964, reporting of ADRs has been restricted to health professionals of specific disciplines. With increasing responsibilities the roles of health professionals, such as pharmacists and nurses described previously, have evolved to place them in more appropriate positions to report suspicions of ADRs and as a result the number of reporters who can contribute to the Scheme has increased. Likewise patients, with easy access to the Internet, have greater knowledge about the medicines they receive and take a more active role in their health. This attitude is also reflected in the govern-ment’s current policy to provide patients with greater choice over decisions affecting their health. As part of this strategy the government launched its NHS Plan in 2000 and within this programme to modernise the National Health Service (NHS) a range of initia-tives to improve patient information, patient choice and patient and public involvement in the NHS are proposed. The government recognises that ‘choice is central to modernising and improving the delivery of services. In essence, it is about treating people as active, responsible citizens, not passive recipients of services, enabling them to exercise genuine choice over key aspects of their lives’ (The NHS Plan – a progress report. The NHS Modernisation Board’s Annual Report 2003). The government also encour-ages wider availability of medicines and the number of drugs that have been reclassified from Prescription Only Medicines (POM) (available only on a prescrip-tion) to Pharmacy (P) (available under the supervision of a pharmacist); and the number of drugs that have been reclassified from P to General Sale List (GSL) (available in general retail outlets such as supermar-kets) has risen in recent years. Before a change in legal status is granted, pharmaceutical companies have to demonstrate levels of safety dependent on specific criteria and provide appropriate prescribing informa-tion. Examples of recent POM to P switches include chloramphenicol 0.5% eye drops for the treatment of acute bacterial conjunctivitis and Zocor Heart Pro (simvastatin 10 mg) to reduce the risk of a first major coronary event in people who are likely to be at a moderate risk of coronary heart disease, while clotri-mazole for the treatment of Candidal vulvovaginitis (thrush) is an example of a P to GSL switch.

The potential benefit of patient reporting to the Yellow Card Scheme was realised by the MHRA prior to the Independent Review of Access to the Yellow Card Scheme, although there were some concerns that the Scheme may become flooded with recognized non-serious ADRs. To investigate this further, the MHRA undertook a pilot study of patient reporting in South East London with NHS Direct in April 2003, involving staff at the NHS Direct call centre making the reports on behalf of patients. This was not partic-ularly successful as by the end of March 2004 only 39 reports had been received from the NHS Direct centre. During the Review, stakeholders criticised the pilot for not collecting the patient perspective directly from patients who would provide their own account of their experience. The Review recommended that ‘A system should be set up for patients to report ADRs directly to the MHRA. Different approaches to patient reporting should be tried but, initially, patient reports should be kept separate from those of health professionals through a parallel system until experi-ence indicates the best method of linking patient and health professional Yellow Card reports to the same ADR. ’The MHRA and the government welcomed this recommendation to introduce direct reporting of ADRs from patients to the Scheme, and in Septem-ber 2004 the CSM Patient Reporting of Adverse Drug Reactions Working Group was established to advise the MHRA and CSM on the development of different arrangements to pilot direct reporting by patients or their carers of suspected ADRs and to communicate about this new initiative. Although patient reporting is still in pilot phase, as from October 2005 patients have been able to report their experiences directly through the Scheme.

Benefits of patient reporting include the identifica-tion of ADRs not previously reported and/or specific features of ADRs that health professionals had not considered. For example, it was patients who identi-fied ‘electric shock’ sensations following the use of selective serotonin reuptake inhibitors (SSRIs). Intro-duction of patient reporting has also increased general awareness about the Scheme.

The MHRA is continuing to focus on involving patients as it looks towards the future. In association with the CSM Patient Information Working Group the report Always read the leaflet – Getting the best information with every medicine was published in July 2005. This report concentrated on strategies to improve the quality and accessibility of medicine information, addressed risk communication and deliv-ered new guidance and recommendations to help improve the quality of Patient Information Leaflets.

Empowering patients with knowledge to understand the risks and benefits of medicines will help patients to make informed choices about the medicines that they are taking. With the introduction of patient reporting, the nature of the Scheme will undoubtedly change in the future.

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