Pharmacovigilance, or drug safety, is described by the World Health Organisation (WHO) as the ‘science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem”.
The pharmacovigilance marketsize is set to exceed US$ 8 billion by 2024; according to a new research report by Global Market Insights.
What is driving the growth of pharmacovigilance?
Across Europe, a decrease in fertility rate together with a decrease in mortality rate as well as a higher life expectancy has resulted in a decrease in the proportion of the working-age population and an increase in the retired population.
Not only is this population trend putting an increasing strain on the economy, it is also putting a strain on the health care system.
Together with the aging population, sedentary life styles and a rise in obesity is leading to an increase in the number of chronic and non-communicable diseases – such as asthma, cancers, diabetes, Alzheimer’s and Parkinson’s disease.
The increasing number of people with long-term disability, chronic conditions and multiple health conditions is increasing the need and demand for new and innovative drugs, all of which need to be put through the rigours of pharmacovigilance.
An adverse drug reaction – where a side effect occurring with a drug is known to exist – and an adverse event – where the causal relationship of a side effect occurring with a drug is unknown are naturally increasing due to the aging population and increasing number of non-communicable diseases. It is not sufficient to limit pharmacovigilance to clinical trials only. Post market surveillance is crucial to the practice of monitoring the safety of a drug after it has been released on the market and it is an important part of the science of pharmacovigilance.
Post-market surveillance takes many forms which continue to evolve with digital disruption:
Voluntary (spontaneous) reporting: Where manufacturers, health professionals and consumers are able to report adverse events to medicines authorities such as the European Medicines Agency (EMA).
Patient registries: Databases for the collection of information about people affected by a particular condition.
Active surveillance: The use of very large existing electronic health databases to ‘keep an eye on the safety of approved medical products in real time’.
Sentiment monitoring: Another method for monitoring adverse event reporting post market is to use sentiment monitoring on social media which tracks what consumers are sating about drugs on these channels.
Personalised medicine is the treatment and care of patients with a particular condition which takes into account their individual and unique set of circumstances and uses targeted therapies to achieve the best outcomes in the management of a patient’s disease or predisposition to disease.
It is believed that personalised medicine will increase benefits, reduce risks and improve the efficacy of many products for individuals. In particular, the progress in regenerative medicine and stem cell research will allow see the development of some of the most personalised products imaginable. However, these developments raise the bar for the pharmacovigilance industry, bringing a whole new paradigm of drug safety to the table.