Medicines Safety: Benefits and Risks

No effective medicine is without risk and every medicine will have side effects which may occur in some patients. This is why the benefits of a medicine should always be weighed up against its risks to the individual patient and the benefit –versus- risk balance should be acceptable to the patient for their individual circumstances following consultation with their healthcare professional (e.g. doctor or pharmacist).

It is recognised that not all safety issues relating to a medicine will be identified during the trials carried out before it comes on the market. In real life, the medicine may be used in larger numbers of patients, in different types of patients (e.g. older patients, younger patients, patients with more severe or even milder disease, patients on other medications which could interact) and for longer periods of time. The challenge for regulators like HPRA, European Medicines Agency and other European regulatory authorities is to find the right balance between making an effective new medicine available to the patients who would benefit and the fact that knowledge on the safety profile may be limited at the time of marketing authorisation.

This is why it is important to continue to monitor and evaluate both the benefits and risks of the medicine throughout its lifecycle in order to ensure that the balance between benefit and risk remains positive for the patients taking the medicine. An important aspect is managing and minimizing any known or suspected risks associated with the medicine.

HPRA, in conjunction with the other Regulatory Authorities for medicines in other EU Member States, the European Medicines Agency and the pharmaceutical companies who make and market medicines regularly monitor and re-evaluate their benefits and risks in a number of ways; for example through regular signal detection activities and periodic safety update reports (PSURs).  Under new legislation, certain specific types of medicines are also subject to additional monitoring (e.g. medicines that are new to the market or medicines where there is currently a limitation to the data available on its safety). If there are questions relating to the benefit- risk balance in some groups of patients then the issue can be reviewed at European level through a safety referral procedure. In addition, in July 2012, a new scientific Committee was introduced at European level -the Pharmacovigilance Risk assessment committee (PRAC) which now specifically examines and advises on safety issues in relation to medicines in the EU.