The Pharmacovigilance Risk Assessment Committee (PRAC), set up by the European Medicines Agency (EMA) for assessing and monitoring safety issues for human medicines informed that they have pro actively grasped the opportunities of the new pharmacovigilance legislation to strengthen European drug safety. The PRAC was established under the new pharmacovigilance legislation that came into effect in July 2012 to improve public health promotion and protection by strengthening the EU pharmacovigilance system.

Dr June Raine, chair of the PRAC stressed that they have achieved this by involving patients and healthcare professionals in their decision-making process, thus strengthening the science base of risk assessment, and working transparently for protecting public health. Officials informed that over its first year of operation, the PRAC has worked to enhance public health protection by pro actively monitoring the safety of medicines and making recommendations to manage and minimise their risks from the granting of marketing authorisation and throughout their lifecycle. This included a number of milestone recommendations on the safe and effective use of some widely used medicines, ensuring that doctors and patients have the best information to take appropriate healthcare decisions.

With a view to ensure wide spectrum of inputs, PRAC now includes among its members patient and healthcare representatives who participate fully in the discussions and provide their input into the decision-making process, especially since the EU pharmacovigilance legislation has given the committee additional tools to engage stakeholders in pharmacovigilance. PRAC now asks the general public to submit relevant evidence so that their contributions can be considered during the review of medicines.

It is understood that as next step towards openness and public involvement they are planing to open up the discussion on safety issues, where appropriate, via public hearings — another tool foreseen by the pharmacovigilance legislation. The new pharmacovigilance legislation includes an explicit commitment to openness and transparency in the European medicines safety-monitoring system. Highlights of the PRAC meetings are published directly after the committee meets and the detailed minutes of each meeting are published a few weeks later.

For EU-wide safety reviews, the Agency now provides more information than ever before at the beginning of a safety review. The announcement of the start of a procedure, the notification of a referral made by the Member State, the list of questions drawn up by the PRAC to be addressed by the marketing-authorisation holders and the timetable for the procedure are systematically published.

The committee had recommended the use of Diane 35 (cyproterone acetate 2 mg, ethinylestradiol 35 micrograms) and its generics for patients and healthcare professionals, saying that these medicines should be used solely in the treatment of moderate to severe acne related to androgen-sensitivity and/or hirsutism (excessive unwanted growth of hair) in women of reproductive age. The PRAC also recommended that these medicines should not be taken in combination with hormonal contraceptives, because this will expose women to a higher dose of estrogen and increase the risk of thromboembolism.

With respect to restrictions to the use of codeine-containing medicines when given to children for pain relief to reduce the risk of serious side effects such as respiratory depression, the committee recommended that these medicines should not be used in children under 12 years. They should also not be used in children and adolescent between ages 12 and 18 following surgical removal of tonsils and adenoids. On new warnings and a contraindication for the painkiller diclofenac, PRAC found that the effects of diclofenac on the heart and circulation are similar to those of selective COX-2 inhibitors, another group of painkillers and that therefore the precautions already in place to minimise the risks of blood clots in the arteries with selective COX-2 inhibitors should also be applied to diclofenac.

The PRAC’s full range of work includes pre-authorisation activities, such as the assessment of risk-management plans for medicines under evaluation, as well as post-authorisation activities, such as the evaluation of periodic safety update reports (PSURs) to re-assess the benefit-risk balance of a medicine throughout its lifecycle on the basis of new data collected and the evaluation of safety signals, which ensures that regulatory authorities have the most up-to-date information on a medicine’s benefits and risks. In its first year the PRAC has looked at a total of 92 signals. The PRAC also carries out scientific assessments when a European Union (EU) referral procedure is triggered by a Member State or the European Commission to review issues related to the safety or the benefit-risk balance of a medicine or a class of medicines. Since July 2012, the Committee has initiated 21 referral procedures of medicines or classes of medicines to assess safety concerns, and issued 10 recommendations on their safe and effective use.