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Since 21 January, patients in Finland and Estonia are able to use digital prescriptions issued by their physician when visiting a pharmacy. Finland and Estonia have signed an agreement that enables this exchange. In line with the objectives of European Commission’s policy on Digital Health and Care, the ePrescriptions exchanged between Estonia and Finland are visible electronically to participating pharmacists in the receiving country via the new eHealth Digital Service Infrastructure. Due to this novelty, patients will no longer have to provide a written prescription.
The implementation of this ePrescription initiative has been made possible by Directive 2011/24 which ensures continuity of care for European citizens across borders. The exchange of patient summaries of foreign citizens, which is currently tested by Czechia and Luxembourg, as well as eDispensation fall also under the scope of this Directive. By the end of 2021, twenty-two member states will be part of the eHealth Digital Service Infrastructure and are expected to exchange ePrescriptions and patient summaries. In 10 member states, namely Finland, Estonia, Czechia, Luxembourg, Portugal, Croatia, Malta, Cyprus, Greece and Belgium, these exchanges will already be facilitated by the end of 2019.
Romanian Council Presidency programme
On 1 January, Romania has taken over the European Union’s (EU) rotating Council presidency from Austria with a commitment to put an emphasis on cohesion. To achieve this goal, Romania’s presidency will focus on four main priorities: Europe of convergence, a safer Europe, Europe as a strong global actor and Europe of common values.
In relation to public health, the Presidency programme underlines the need to guarantee access to healthcare for all European citizens, to fight antimicrobial resistance (AMR), to enhance vaccination coverage, to reduce medication abuse and to improve the control of transmissible diseases. Patients are at the centre of the actions in the field of health. Consequently, the Romanian Presidency plans to organise debates focusing on patient mobility which encourage cooperation between the different EU member states, especially in the area of rare diseases.
Patient’s access to medicines is one of the cornerstones of Romania’s Presidency programme. The European Association of Hospital Pharmacists (EAHP) welcomes this initiative, in particular since the problem of medicines shortages has become more troublesome in the past 4 years, as outlined in EAHP’s 2018 Medicines Shortages Survey Report. Healthcare digitisation and the continuation of the negotiations on the proposal for a Regulation on the coordination of health technology assessment will also be addressed during the upcoming months. Given the growing threat of AMR, the Romanian Presidency intends to put forward Council conclusions on the fight against AMR and hospital-acquired infections.
During its presidency, Romania will work closely with Finland and Croatia. This trio has set long-term goals until mid-2020 and prepared a common agenda determining the topics and major issues that will be addressed by the Council over this period. In relation to health, the group will be looking at making further efforts in order to guarantee access to healthcare for all EU citizens, ensure patient safety and mobility and take advantage of the opportunities posed by new medical technologies.
European Centre for Disease Prevention and Control survey for healthcare professionals
The European Centre for Disease Prevention and Control (ECDC) carried out a survey between 28 January and 14 February 2019 to assess healthcare workers’ antibiotic use and resistance. The aim was to have a robust return of 10 000+ responses across the EU/European Economic Area member states with representation from healthcare workers (doctors, nurses and midwives, dentists, (hospital) pharmacists, other healthcare workers (eg, hospital managers, allied health professionals, technicians)). ECDC is also seeking responses from health students. The overall objectives of the study for ECDC are:
To fill in gaps in terms of evaluation of communication campaigns targeting healthcare workers.
To gain a better understanding of their knowledge and perceptions to provide a base to support future needs in terms of policy and education changes.
To facilitate participation the survey will be made available in all official languages of the EU as well as in Icelandic and Norwegian.
Consultation on European Medicines Agency’s Regulatory Science Strategy
The European Medicines Agency (EMA) has opened a consultation for its draft ‘Regulatory Science to 2025’ document which seeks to obtain feedback on the agencies’ plan for advancing its engagement with regulatory science over the next 5–10 years. It covers both human and veterinary medicines.
The strategy will help shape the vision for the next EU Medicines Agencies Network Strategy 2020–2025. It aims to offer informed guidance on modern medicines development, facilitate the optimisation of regulatory science and critically assess the benefits and risks of innovative therapies and diagnostics based on new technologies. Stakeholders, such as hospital pharmacists, are invited by the EAHP to send their comments via an online questionnaire by 30 June 2019. For more information please visit the EMA’s website at https://www.ema.europa.eu/
Council recommendation on vaccine preventable diseases
On 7 December, the Health Ministers of the EU adopted a Council Recommendation on strengthened cooperation against vaccine preventable diseases. The Recommendation touches on three key areas, namely tackling vaccine hesitancy and improving vaccination coverage, sustainable vaccination policies in the EU and EU coordination and contribution to global health.
Member states are encouraged to develop and implement vaccination plans and to cooperate with higher education institutions and relevant stakeholders to consider including and strengthening training on vaccine-preventable diseases, vaccinology and immunisation in national medical curricula and any continuing medical education programmes for healthcare workers. Moreover, the Recommendation highlights the importance of targeted outreach towards vulnerable groups and calls for the exploitation of synergies with eHealth and digital technologies to establish electronic vaccination records for all EU citizens.
Council position on the protection of workers from exposure to carcinogens adopted
Last week, the Council adopted its position on the proposal for a Directive amending Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work. The proposal of the European Commission to amend Directive 2004/37/EC seeks to reduce the exposure levels for five carcinogenic chemical agents—cadmium, beryllium, arsenic acid, formaldehyde and 4,4′-methylenebis(2-chloroaniline).
Over 1 million workers in the EU would benefit from the improvement of working conditions and over 22 000 cases of work-related ill health could be prevented. The agreement that was reached by the Council in December will now serve as the basis for negotiations with the European Parliament.
Updates from the EMA: December 2018
In December, the EMA announced the commencement of a review of medicines containing fosfomycin and shared recommendations on the alignment of doses of metamizole medicines and their use during pregnancy and breast feeding. In addition, EMA announced that omega-3 fatty acid medicines are no longer considered effective in preventing heart disease.
EMA begins review of medicines containing fosfomycin
EMA has started a review of medicines containing the antibiotic fosfomycin, which is used in a number of EU member states to treat a range of bacterial infections.
Fosfomycin, an antibiotic that has been in use for many decades, works in a unique way and bacteria resistant to other antibiotics are less likely to be resistant to fosfomycin. There are significant differences between member states in the authorised uses and doses of fosfomycin medicines.
The German medicines authority has requested reappraisal of the role of fosfomycin in the context of increasing resistance to antibiotics. In particular, the indications and dosage of fosfomycin and the adequacy of information on its safety and pharmacological properties will be re-evaluated in the light of up-to-date knowledge on antibacterial therapy.
EMA’s human medicines committee (Committee for Medicinal Products for Human Use, CHMP) will therefore consider the available evidence and make recommendations as to whether the marketing authorisations for fosfomycin-containing medicines should be amended across the EU.
EMA recommends aligning doses of metamizole medicines and their use during pregnancy and breast feeding
Following a review of medicines containing the painkiller metamizole, EMA is recommending that the maximum daily dose of the medicine and the contraindications to its use in pregnancy or women who are breast feeding should be harmonised for all products on the EU market.
The review was carried out by EMA’s human medicines committee (CHMP) at the request of Poland, which was concerned by the substantial differences in the recommendations on the use of metamizole in different EU countries, given that it is known the medicine may occasionally cause severe side effects, such as effects on the blood.
EMA’s recommendations include setting a maximum single dose by mouth of 1000 mg, taken up to four times daily (a maximum daily dose of 4000 mg), in patients from 15 years of age. If given by injection the total daily dose should not exceed 5000 mg. Doses in younger patients should be based on their body weight but some products may be unsuitable because of their strength.
The review found little to suggest problems in early pregnancy, and single doses in the first 6 months might be acceptable if other analgesics cannot be used. However, there is some evidence of effects on the kidneys and circulation of the fetus if the medicine is used in the last 3 months of pregnancy, and the medicine should therefore not be used in this period. As a precaution, metamizole should not be used during breast feeding because the infant may receive high amounts of the medicine in the milk relative to the infant’s weight.
Omega-3 fatty acid medicines no longer considered effective in preventing heart disease
EMA has concluded that omega-3 fatty acid medicines are not effective in preventing further heart and blood vessel problems in patients who have had a heart attack. The conclusion, based on a review of data accumulated over the years, means that these medicines will no longer be authorised for such use.
Omega-3 fatty acid medicines have been authorised for use after a heart attack, in combination with other medicines, in several EU countries since 2000, at a dose of 1 g/day. At the time of their authorisation, available data showed some benefits in reducing serious problems with the heart and blood vessels, although the benefits were considered modest. Further data that have become available since then have not confirmed the beneficial effects of these medicines for this use.
Although there are no new safety concerns, EMA’s human medicines committee (CHMP) concluded that the balance between the benefits and risks of these medicines to prevent recurrence of heart disease or stroke is now negative. These medicines can still be used to reduce levels of certain types of blood fat called triglycerides.
For more information please visit the EMA’s website at https://www.ema.europa.eu/
Competing interests None declared.
Provenance and peer review Commissioned; internally peer reviewed.
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