It can take about 12 years and over £1 billion pounds to bring a medicine to the market. So with all this time, money and effort you might think that everything would be known about a medicine when it is launched on the market. But is this really the case?
In spite of all the research carried out on a medicine before its launch, it will have been used in only a relatively small number of people and its effects assessed under controlled conditions. Once on the market, the medicine will be more widely used in patients; patients whose characteristics may differ to those used in the clinical trials for the medicine and who may have other diseases for which they are also taking medicines. It is therefore not surprising that effects not previously observed can come to light after a medicine is launched.
To highlight some of these issues the ABPI Pharmacovigilance Network and the Royal Pharmaceutical Society (RPS), with input from other stakeholders, have developed a series of easy to read resources outlining various aspects of pharmacovigilance.
One of the resouces outlining pharmacovigilance
Pharmacovigilance activities involve a range of stakeholders including the pharmaceutical industry, the medicines regulator, healthcare professionals, including pharmacists, and the public. The involvement of all these groups is essential if pharmacovigilance activities are to have the maximum impact on patient safety. However, it can be difficult to work out how all the strands that encompass pharmacovigilance fit together. To help with this an infographic has been developed which highlights the main activities in an easy to understand manner.
Other resources have been produced on the black triangle scheme. When a medicine containing a new active substance or a biological medicine is approved, a black triangle will be assigned to the medicine, typically for five years. The aim of the black triangle is to actively encourage healthcare professionals and patients to report any adverse reactions associated with the medicine. Reports are submitted via the Yellow Card Scheme to either the medicines regulator or the originator pharmaceutical company. The ABPI Pharmacovigilance Network and the RPS will produce resources on the Yellow Card Scheme during 2017.
Another resource on how each role plays a part in patient safety
Although a black triangle denotes that information on all adverse reactions to a medicine are being gathered, it is important to realise that it does not mean the medicine is unsafe for use in patients.
Another important component of pharmacovigilance is risk minimisation activities. The resources that have been developed alert healthcare professionals to what this involves and where risk minimisation resources can be accessed. Risk minimisation activities aim to identify and prevent or minimise the risks related to a medicine. For most medicines, routine risk minimisation activities such as including information on the risk of a medicine in its Summary of Product Characteristics and Patient Information Leaflet are sufficient. However, for some medicines additional risk minimisation activities are necessary such as educational materials, patient screening or monitoring, pregnancy prevention schemes and controlled access programmes.
The ongoing gathering and assessment of safety information on medicines is crucial if we are to continue to improve patient safety. While the pharmaceutical industry and the medicines regulator are the main drivers for pharmacovigilance activities, healthcare professionals and the public play a crucial role in this process. Higher levels of adverse event reporting will lead to safety issues being identified more quickly. Everyone has an important role to play in improving medicines safety for patients.
About the Author
Dr Colin Cable is a pharmacist with a PhD in Drug Delivery. Prior to commencing his PhD studies, Colin spent time in hospital pharmacy and in the pharmaceutical industry working in product development.
On completion of his PhD, Colin joined the Royal Pharmaceutical Society (RPS) where he has remained ever since.
He has had several roles in the RPS including a joint appointment with the RPS and the Western General Hospital in Edinburgh (2002-2008).
Currently Colin works as Assistant Chief Scientist at the RPS, a role which involves promoting pharmaceutical science, developing guidelines for pharmacists, promoting the pharmacy evidence base, responding to media enquiries and assisting in the development of RPS policy which is underpinned by pharmaceutical science.
Dr Cable has been involved in the Handbook of Pharmaceutical Excipients since 1992, initially as a member of the International Steering Committee and currently as an editor. Colin was an honorary lecturer at Strathclyde University (2007 to 2011) and more recently has lectured pharmacy students as a visiting lecturer at King's College London.