Pharmacovigilance - drug safety

Medicines may affect the body in unintended, harmful ways. These effects, called side effects, adverse events or adverse reactions, represent risks of medicines.

It is important to identify, as quickly as possible, new risks or changes to the known risks associated with the use of medicines. Actions must be taken to minimise the risks, maximise the benefits and promote safe and effective use of medicines by patients.

These activities are known as pharmacovigilance:

• The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.
• An activity contributing to the protection of patients’ and public health.

Discovering new medicines

Historically, new medicines have been made from compounds found in plants, fungi and marine organisms. The molecule responsible for the medicinal properties is then extracted, identified and synthesised. Often many similar molecules are made chemically, these are called analogues. These analogues attempt to improve on the original compound to maximise desired effects and minimise unwanted effects. Now, new medicines can be made using computer aided design based on knowledge from genomics (the study of genes) and proteomics (the study of proteins).

Developing a new medicine often requires research into the mechanisms of disease. This is aided by collaboration between industry and universities or other research institutes.

Preclinical safety

Drugs carry a number of risks and understanding the science behind adverse drug reactions can help increase the safety of new medicines. ABPI member companies work together to share knowledge and experiences in a ‘pre-competitive space’ in order to help maximise drug safety from the earliest point of developing a new medicine.

A vital part of medicines development, particularly preclinical safety research, involves the use of animals. Indeed, UK and European regulations currently require that all new medicines are tested on animals before being used in humans, to ensure patient safety.