What is pharmacovigilance? Who on earth are the MHRA?

FF Schwartz, IA Selvanathar, AW Hitchings, CW Wells, EH Baker, DO Lonsdale. St George\'s University, London, London, UK

Introduction: In the United Kingdom, responsibility for assessing the efficacy, safety and quality of medicines lies with the Medicines and Healthcare products Regulatory Agency (MHRA). This includes responsibility for monitoring adverse drug reactions (ADRs). The MHRA Yellow Card Scheme allows anyone to report a suspected ADR using a simple online proforma. Doctors registered with the UK General Medical Council are required to report suspected ADRs as specified by the Yellow Card Scheme [1]. This includes reporting all serious suspected ADRs, such as those that result in hospital admission. In 2011, our hospital admitted many thousands of patients, but reported only 16 ADRs using Yellow Cards. As approximately 5% of hospital admissions are associated with an ADR [2], we reviewed the rate of ADRs associated with acute medical admissions to our hospital. We also surveyed healthcare professionals to explore their knowledge of ADRs, the MHRA and Yellow Card reporting.

Methods: A point prevalence study of patient notes was performed. In this, we reviewed the presenting symptoms and drug history of all patients on the acute medical unit on the study day. A list of drug-symptom permutations was generated. The Naranjo algorithm [3] was used to determine whether these were probable or definite ADRs. For ADRs identified, their contribution to admission was assessed.

A paper-based questionnaire was administered to foundation, core and specialty trainee doctors and pharmacists during training sessions or team meetings to assess experience of ADRs and knowledge of reporting requirements.

Results: 57 patients on the acute medical unit were included in the point prevalence study. 2147 possible drug-symptom permutations were identified. Using the Naranjo algorithm, 4 (7%) were found to be probable or definite ADRs. In all four cases the ADR contributed to the admission but this was explicitly documented in only two cases, one of which was an overdose.

50 healthcare professionals (100% response rate from attendees) completed the survey. Key findings were:

• 63% of doctors reported having ever been involved in the care of a patient with an ADR

• 12% of doctors and 44% of pharmacists reported having ever completed a Yellow Card

• 22% of doctors correctly identified types of therapeutic product monitored by the Yellow Card Scheme from a list (e.g. blood products, contrast media, herbal products)

• 19% of doctors recognised that a ‘black triangle’ next to a drug in the British National Formulary identified it as a new product or its use for a new indication

More respondents had heard of NICE (100%) or the FDA (90%) than the MHRA (60%, p<0.001)

Conclusions: Serious ADRs are underreported in our trust. Doctors’ knowledge of when, how and what to report is likely to be a significant factor in this problem. Lack of awareness of the MHRA was a surprising finding and perhaps relates to a lower public profile when compared to similar organisations.

References:

1.GMC 2013 http://www.gmc-uk.org/Prescribing_guidance_update.pdf_51250626.pdf.

2.Kongkaew C et al. Ann Pharmacother. 42:1017, 2008. 3.Naranjo CA et al. Clin Pharmacol Ther. 30:239 1981.