EFA Vice President Erna Botjes attended three important meetings at the European Medicines Agency: a workshop on antimicrobial resistance, the joint and regular meeting of patients and healthcare professionals (PCWP) and the medicines safety monitoring stakeholder forum.
Antimicrobial resistance is relevant for all patients, including allergy, asthma and COPD, because one of the major risks is that when there is a severe exacerbation, antibiotics are needed and if they do not work, we are in trouble. The European Commission (EC) has a joint plan to combat Anti-Microbial Resistance, alongside with a toolkit to do that from the European Centre of Disease Control and Prevention (ECDC) and the World Health Organization (WHO).
The AMR global awareness day will happen next November 18th, just after the World COPD Day this year. There is way to go, for example in animal feeding and the European Union (EU) member states are not equal in progressing in reducing unnecessary use of antibiotic use. The key messages to patients are: 1) when prescribed, take the whole prescription of antibiotics otherwise you risk developing tolerance and 2) antibiotics do not work for a common cold because that is not caused by bacteria. Antibiotics should be used in case of infections caused by bacteria. People very commonly “save” a few pills from their prescription and self-medicate. The toolkit, including easy information for healthcare professionals and patients, is available here.
More information on the meeting here.
EMA Patients and Consumers and Healthcare Professionals working parties planned for 2018-2019
During the September joint meeting, patients, consumers and healthcare professionals we discussed topics proposed for the working parties such as further improving the involvement of patients, consumers and healthcare professionals in EMA committees through training and digital tools, definition of unmet need (for patients), shortages of medicines and vaccines, involvement in developing clinical guidelines, multifactorial design trials (several medicines in one trial), promoting involvement of patients in national medicines agencies and many others. Next step is making priorities.
The eligibility of groups like EFA to work with the EMA is currently assessed annually on the agency’s initiative, based on criteria covering funding arrangements, representativeness, relevance to EMA and transparency. The proposal is to move into annual electronic self-declaration by the organisations.
We also discussed compassionate use of medicines, which means granting the use of medicines even when they are still under investigation to individuals or groups of patients because they have no other options, even without knowing about their safety and efficacy in full. European legislation allows for this use, but it is not very much used. According to Francois Hoyez from EURORDIS, these programmes often come too late, are underused and too difficult to put in place.
Regarding patient registries, a useful resource for research and disease information, Christoph Thalheim presented on the case of multiple sclerosis, and how registries could be useful in all disease areas, including ours, and serve to promote patient reported outcomes.
We of course welcomed the thorough update and risk evaluation from the EMA Deputy Director Noel Wathion on preparedness to move to so far an unknown location after Brexit. Risks are several, including significant loss of EMA’s so competent staff. The new location should be known towards the end of November.
More about PCWP here.
You can see all the document and presentations from the meeting here.
Pharmacovigilance portal soon online
Good news: the portal on pharmacovigilance – monitoring of safety of drugs in Europe – is scheduled to be online 22 November. Every patient will be able to have a look at suspected side-effect report summaries and the advice is of course to not stop or adjust medication without consulting your treating healthcare professional. Patients in Europe can also report suspected side-effects also directly, and not only via doctors. www.adrreports.eu