The Yellow Card scheme why are GPs under-reporting?

Transcription

1 The Yellow Card scheme why are GPs under-reporting? Steve Chaplin MSc, MRPharmS Total number of reports The effectiveness of the Yellow Card scheme has been limited by underreporting of ADRs. Here, Steve Chaplin describes a new BMA report that suggests how the problem can be overcome Year general practitioner hospital doctor pharmacist nurse other healthcare professionals Figure 1. Submitted Yellow Card reports by professional group (data from MHRA) The UK s Yellow Card scheme has a relatively high reporting rate in relation to prescription volume among the best in Europe according to the BMA s Board of Science. It s good it detected, for example, the risk of seizures associated with bupropion (Zyban) but not good enough it failed to warn of the increased risk of myocardial infarction with COX-2 selective NSAIDs, the biggest drug safety issue in a decade. The BMA s new guide for health professionals, Reporting Adverse Drug Reactions ( org.uk/ap.nsf/attachmentsby Title/PDFADR/$FILE/ADR Final.pdf), reviews the systems used to detect and respond to adverse drug reactions (ADRs). Its main focus is the Yellow Card scheme, now over 40 years old, but it also reviews other pharmacovigilance measures. In its view, improving reporting rates of ADRs is primarily about improving awareness of the need to report and the mechanisms used to submit a Yellow Card. Research in Liverpool has shown that ADRs account for about 6 per cent of hospital admissions (there were 4.4 million emergency admissions in England in 2004/05). 1 The BMA notes that ADRs are much more common in secondary care: 16 per cent of inpatients experience an ADR, with a mortality of per cent. Under-reporting Under-reporting has long been the major failing of the Yellow Card scheme and it is estimated that only 10 per cent of serious ADRs and 2-4 per cent of nonserious reactions are reported. In 2004, GPs in England wrote 660 million NHS prescriptions for drugs but the CSM received only Yellow Cards. This report aims to address that shortfall. GPs have long been the biggest single source of Yellow Card reports but, after consistently submitting about reports a year throughout the 1990s, for the past three 18 Prescriber 5 August

2 years they have been sending in around 6000 (see Figure 1). By contrast, hospital doctors have maintained a steady 5000 cards per year. There has been only a small increase in total reporting since professions other than medicine began to report ADRs. The contribution that nurses can make to the Yellow Card scheme was particularly evident during the meningitis C vaccination campaign in 2000 (see Figure 1). Pharmacists, nurses and other health professionals now each submit reports per year and it is tempting to attribute the decline in GP reporting to their activities, though the evidence is only circumstantial. Wider ADR reporting was intended to supplement medical reporting, not replace it. The BMA suggests several other reasons why doctors do not report ADRs (see Table 1). It emphasises that it is a professional duty to report ADRs, even if others are reporting the same case. The Medicines and Healthcare products Regulatory Agency (MHRA) collates the data and detects duplication, and reports from different sources will help to provide a more detailed picture of events. Improving the quality of reported information is crucial to increasing the specificity of the system. The same applies to causality: the success of the Yellow Card scheme depends on reporting suspected ADRs to generate a large warning signal that is, to achieve high sensitivity. This would have increased the odds of identifying the cardiovascular risks of COX-2 selective NSAIDs sooner. If clinicians had a lower threshold for action, the true scale of the increase in myocardial infarction and stroke would have been apparent. As it was, comment from the CSM seems, in hindsight, complacent (see Table 2). Health professionals in primary and secondary care should be more proactive about ADRs, the report recommends (see Table 3). This means paying more attention to drugs that carry the black triangle, which denotes drugs (usually newer agents) for which all ADRs should be reported. Healthcare professionals should be aware that patients are also now able to report ADRs spontaneously. They should advise patients that they may experience an ADR, and explain how to report this or fill in an online yellow card ( They should provide written information and routinely ask about use of Prescriber 5 August

3 lethargy too busy lack of availability of Yellow Cards believe should report only when causality certain serious ADRs will be identified in clinical trials do not need to report well-known ADRs fear of legal liability for ADR (especially for off-licence use in children) ADR too trivial system too bureaucratic do not know how to report not aware of need to report Table 1. Reasons given why doctors do not fill in Yellow Cards complementary therapies because they may interact with prescribed medicines. Structured databases The UK has several structured databases that offer a testing ground for hypotheses generated by Yellow Cards. The MHRA is now responsible for the General Practice Research Database (GPRD; with three million active patient records from 300 practices across the UK it is the world s largest anonymised longitudinal primary care database. Other databases in the UK include the Tayside Medicines Monitoring Unit ( the Health Improvement Network ( and QResearch ( ~mczqres). Prescription Event Monitoring ( is another form of observational analysis that is able to monitor the safety of specific drugs. While the quality of the information held in these databases has

4 great potential, their use is limited by cost: a single research question costs and online access costs up to annually. The Medical Research Council now offers UK researchers easier access to the GPRD (see Solutions The BMA does not believe that mandatory ADR reporting would solve the problem of underreporting on Yellow Cards. Instead, it favours more education at undergraduate and continuing 2001: The CSM has received a small number of reports of myocardial infarction or ischaemia in association with COX-2 inhibitors. This is to be expected as large numbers of elderly, high-risk patients have been exposed to these drugs. It should be remembered that a report of a suspected ADR does not necessarily mean that the drug caused the reaction. (Committee on Safety of Medicines. Current Problems 2001;27:7) 2004: Our cumulative meta-analysis of randomised controlled trials indicates that an increased risk of myocardial infarction [with rofecoxib] was evident from 2000 onwards. At the end of 2000, the effect was both substantial and unlikely to be a chance finding. (Juni P, Nartey L, Reichenbach S, et al. Risk of cardiovascular events and rofecoxib: cumulative meta-analysis. Lancet 2004;364:2021-9) Table 2. Comments on the cardiovascular risk of the COX-2 selective NSAIDs

5 professional development level. More research is needed to identify the barriers to reporting and particularly to investigate the recent decline in Yellow Cards from GPs. The NHS IT programme offers a significant opportunity to integrate ADR reporting with patient electronic records. There is no practical alternative to Yellow Cards but other forms of pharmacovigilance are complementary. Summary The Yellow Card scheme remains the principal means of detecting all ADRs experienced by children all ADRs to black triangle drugs all serious ADRs to established drugs: fatal life-threatening disabling or incapacitating resulting in or prolonging hospitalisation congenital abnormalities medically significant Table 3. What to report on a Yellow Card ADRs at an early stage but its effectiveness is gravely compromised by under-reporting. This can be remedied only when health professionals give ADRs a higher priority. They need to react to events more readily, raise the awareness of patients and involve them in reporting, and maximise the use of new technologies. References 1. Pirmohamed M, James S, Meakin S, et al. Adverse drug reactions as cause of admission to hospital: prospective analysis of 18,820 patients. BMJ 2004;329:15-9. Steve Chaplin is a pharmacist who specialises in writing on therapeutics 22 Prescriber 5 August