EFA at the European Medicines Agency

EFA participates in the joint meeting of the EMA Patient and Consumer Working Party (PCWP) & Health Care Professionals Working Party

At the end of February EFA Board member Lina Buzermaniene attended the joint meeting of the Patient and Consumer & Health Care Professionals Working Parties organised by the European Medicines Agency (EMA) in London. This joint meeting with representatives from patients’, consumers’ and healthcare professionals’ organisations aimed at discussing the new legislation on falsified medicines, updates on the implementation of the new EU pharmacovigilance legislation, the communication on safety referrals, patient involvement in EMA activities and clinical trials data.

S. Fuehring from the European Commission (EC) updated the participants on the implementation of the new legislation on falsified medicines. The new law adopted two years ago mainly affects on-line pharmacies, aiming at ensuring patients of the legality of the seller. All legally operating pharmacies will need to have a trust mark connected to the national registry. The form of this trust mark is to be decided by the EC this year and the Commission will ask PCWP for comments.

Discussion then followed on risk communication on medicines and dissemination of new information on pharmaceuticals. Following the transparency requirements of new pharmacovigilance legislation, which came into force in summer last year, EMA PRAC (Pharmacovigilance Risk Assessment Committee) now publishes detailed information on its activities here. Patients will be also getting involved in preparation of safety communications from PRAC according to their area of expertise. They will be asked to give an input on a few days notice, with approximately 24 hours to review the communication. At this stage, EFA is ready to give an input when requested.

EMA also considers opening more detailed clinical trials data accessible to everyone. EMA will have to take into account legal aspects regarding patients’ confidentiality protection and decide on the most user friendly format. Patient representatives will also take part in this process.

At the meeting, the appointment of patients’ representatives Nikos Dedes from European AIDS Treatment Group and Wim Wientjens from International Diabetes Federation as members of the EMA Management Board was also announced. After the meeting, the appointments of the patient representive, Albert van Zejden from the International Alliance of Patient Organisations, and his alternate, Marco Greco, from the EPF to the PRAC were made public. EFA warmly congratulates these excellent patient experts and looks forward to collaborate with them on our disease areas.


EFA took part in the European Medicines Agency workshop on medication errors

Overdose by mistake, prescribing errors or wrong administration in hospitals cost hundreds of patients’ lives every year. These medication errors are the most common single preventable causes of adverse events in medication practice. To improve understanding of such errors, enhance their prevention and facilitate the implementation of new legal provisions at the EU level, the European Medicines Agency (EMA) organised a two-day EU regulatory workshop on medication errors in London.

The main objectives of the workshop, attended from February 28th to March 1st by EFA Board Secretary Per-Ake Wecksell, were to clarify the definition of medication errors and share the best practices for their prevention through raised awareness among the stakeholders. The workshop also focused on the new EU pharmacovigilance legislation, in force since July 2012, which explicitly foresees reporting of suspected adverse events and liaison with national patient-safety organisations to improve public health [Directive 2001/83/EC Articles 1(11), 101(1) and 107a(5)].Thanks to this new Directive, patients can not only report to their doctors, but they can also contact regulatory authorities directly.

EFA representative was surprised to learn that there are so many questions about medication prescription, packaging and labelling of drugs without satisfactory answers. “The system of reporting medication errors also differs from country to country. Some of them don’t have such a system in place yet at all,” Wecksell pointed out.

As the organizers highlighted, better understanding and focused dialogue between regulators and stakeholders will improve medication practice and reduce public-health burden from medication errors. Thanks to improved understanding of errors management at the national level, the EU regulatory network will also be able to enhance stakeholders’ cooperation at the international level.

The workshop brought together experts from regulatory and public bodies, national patient-safety organisations, healthcare professional and patient and consumer organisations, academia and the pharmaceutical industry. Speakers were from the EMA, the European Commission, organisations and universities from the EU, the United States and China. “Some of the presentations were really touching and warning. For example, we heard a story of a seven-month-old boy who died after the doctor gave him twelve-times the correct dose of anti-epileptic drug,” said Wecksell.

Speakers pointed out harmful effects of medication errors, stressing the need to improve general understanding and clarification of the common definition. “We all agreed that international harmonization and standardization of practices, terminology and definitions will bring great benefits to all patients,” said Wecksell. Raising awareness among patients and healthcare professionals, as well as minimising harm through education were also identified as important factors in the discussion.

You may find more information about the European Union regulatory workshop on medication errors  here. For the programme, main objectives and all the presentations, please visit this link.

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