Spontaneous Reporting - UK

Spontaneous Reporting - UK

INTRODUCTION

In the United Kingdom, the Licensing Authority responsible for medicines for human use consists of ministers, including the Secretary of State for Health. The Authority’s executive function in the control of medicines is performed on a day-to-day basis by the UK Medicines and Healthcare products Regula-tory Agency (MHRA). The MHRA was formed on 1 April 2003 from a merger of the Medicines Control Agency (MCA), previously responsible for monitor-ing the safety, quality and efficacy of medicines, and the Medical Devices Agency (MDA). The Agency’s primary objective is to safeguard public health by ensuring that medicines, healthcare products and medical equipment on the UK market meet appro-priate standards of safety, quality, performance and effectiveness, and are used safely.

While the quality and efficacy of a medicine are fairly well defined at the time of licensing, the clini-cal trials conducted in support of a licence application can only provide limited data on a medicine’s safety profile; the safety profile of a medicine in normal clin-ical use can only be fully assessed after it has been marketed. The Vigilance and Risk Management of Medicines of the MHRA is responsible for monitoring the safety of all licensed medicines in the United Kingdom, in order to identify and investigate possible hazards and take appropriate action to minimise the risks and maximise the benefits to users, thus protecting public health. Although data from a wide range of sources are used (Waller, Coulson and Wood, 1996), it is the UK’s spontaneous reporting Scheme (commonly known as the ‘Yellow Card Scheme’) that is the cornerstone of the monitoring process.

The aim of this chapter is to inform the reader about the past, present and future of the Yellow Card Scheme. First, the background to the Yellow Card Scheme since its introduction in the 1960s is outlined, including examples of the safety hazards identified from spontaneous reporting, and some of the problems faced by the Scheme in past years. Secondly, we describe some of the recent initiatives implemented in order to tackle these problems, focusing on areas such as widening the reporting base, facilitation of reporting and optimising the use of the data as a research tool. Finally, we outline some of the possible future directions for the Yellow Card Scheme that are intended to allow it to continue to fulfil its key role in pharmacovigilance in the years to come.