EU MONITOR - EAHP, AEHM, ESCP and ESOP release joint statement on COVID-19
The EAHP EU Monitor is a regular round up of news relevant to hospital pharmacy in Europe.
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Joint statement on treatment of COVID-19 patients released
Yesterday, the European Association of Hospital Pharmacists (EAHP) published a joint statement on the treatment of COVID-19 patients together with the European Association of Senior Hospital Physicians (AEMH), the European Society of Clinical Pharmacy (ESCP) and the European Society of Oncology Pharmacy (ESOP). The joint statement touched on the growing problem of shortages of essential medicines and calls on physicians and pharmacists to closely monitor and evaluate emerging clinical and research data to make use of evidence informed practices when weighing the risks and benefits for each individual case. Also, it encourages colleagues to support and carry out research where possible.
Read the Statement HERE
EJHP accepted by Medline
EAHP is proud to announce that the European Journal of Hospital Pharmacy is now indexed by MEDLINE. MEDLINE is the U.S. National Library of Medicine premier bibliographic database that contains more than 25 million references to journal articles in life sciences from around the world with a concentration on biomedicine.
Access the EJHP HERE
EPHA’s position on medicines shortages
Today, the European Public Health Alliance (EPHA) has released its position paper on medicines shortages outlining the severe threats that this problem poses to patient outcomes, patient safety and patient care.
The following principal recommendations have been put forward by EPHA to address medicine shortages:
- Strengthen the EU pharmaceutical legislative framework to improve notification of medicines shortages and reinforce obligations of the market Authorisation holders (MAHs) and wholesalers to supply the market.
- Require all medicines marketed in more than one EU Member State to have accompanying European shortage management and prevention plans.
- Create early warning systems on medicine shortage at both national and European level.
- Publish new EU guidance elaborating on cases when free movement of medicines may be restricted in order to prevent and address medicine shortages.
- Publish new EU guidance on prudent procurement practices to help prevent occurrence of shortages in generic medicines.
- Set up a permanent system for monitoring of medicine shortages in the EU.
- Assess the impact of shortages on patient health, treatment and care in the EU.
- Develop a comprehensive EU strategy on medicine shortages with the active contribution of the European Parliament.
- Launch an EU Joint Action focusing on the prevention of, and solutions to, medicine shortages.
As one of EPHA’s member organisations, EAHP welcomed the publication of this position. EAHP President Petr Horák remarked that “for over a decade, hospital pharmacists have been engaging with and raising awareness about the impact that medicines shortages have on patients. The implementation of pan-European measures that proactively and reactively address the problem cannot wait any longer. Therefore, the European Association of Hospital Pharmacists stands in full support with the European Public Health Alliance that today puts forward a proposal outlining how Europe can jointly tackle the growing problem of medicines shortages.”
Access EPHA’s position paper on medicines shortages HERE
OECD study on the state of access to oncology medicines
With support from the European Commission, the Organisation for Economic Co-operation and Development (OECD) reviewed the current state of access to oncology medicines across its member countries and the EU. The results of this analysis were recently published and also explored the policies and practices adopted by countries to address several challenges specific to medicines used for cancer treatment.
The report outlines different matters that need to be addressed when introducing novel oncology medicines which include, among others, elements linked to pricing and budget impacts such as affordability, sustainability and uncertainty in clinical benefit as well as problems linked to access. Three policy options have been proposed to address the results of the survey. It has been suggested to countries
- To enable the tracking of use by indication through routinely collected data, registries or post marketing studies;
- To improve the design of performance-based managed entry agreements to support the generation and collection of on-market evidence; and,
- To set cost-sharing arrangements, where unavoidable, as fixed co-payments rather than coinsurance, and ensure that these do not undermine access or impose catastrophic costs on households with cancer patients.
Access the OECD study addressing challenges in access to oncology medicines HERE
New European Vaccines Information Portal
During the European Immunisation week the new European Vaccines Information Portal (EVIP) – developed by the (ECDC) in close cooperation with the European Medicines Agency and the European Commission – was launched. The setup of EVIP follows from the Council Recommendation on strengthened cooperation against vaccine-preventable diseases of December 2018.
EVIP provides reliable and evidence-based information on vaccines and vaccination, including national vaccination schedules. This includes how vaccines are developed, authorised and monitored in the EU, as well as general information on the benefits of vaccination and five disease factsheets (HPV, Flu, Measles, Pertussis and Rubella – more will be added in due course). The portal is available in all EU languages and the information is provided in an easily accessible language, enriched with many visuals.
Access the EVIP HERE
Updates from the EMA
In the past two weeks, the European Medicines Agency (EMA) issued communications on the conclusions of the Picato review, reminding about the risk of serious side effects with chloroquine and hydroxychloroquine and on the importance of reporting suspected side effects of medicines in patients with COVID-19.
Reporting suspected side effects of medicines in patients with COVID-19
EMA and the national competent authorities are reminding patients with confirmed or suspected coronavirus disease (COVID-19) to report suspected side effects that they experience with any of the medicines they are taking. This includes medicines to treat COVID-19, as well as medicines taken by patients to manage long-term, pre-existing conditions. It also includes medicines that patients might be using off-label to treat COVID-19.
Patients are reminded that there are currently no medicines authorised to treat COVID-19. However, in the context of the pandemic, several treatments authorised for other diseases are being used in patients with COVID-19.
Patient reporting complements the information received from healthcare professionals who have continued to report suspected patient side effects with medicines taken during the pandemic.
Understanding of the new virus is still incomplete, including possible interactions with medicines patients might be taking. By reporting suspected side effects of medicines used in the context of COVID-19, patients and healthcare professionals can help gather valuable evidence to inform decisions on the safe and effective use of medicines as the pandemic evolves.
Information provided by patients and healthcare professionals through their reports will add to the knowledge currently being generated through clinical trials and other studies. Patients and healthcare professionals should report suspected side effects directly to their national authority via the contact details available in EudraVigilance or to the manufacturer of the medicines using the instructions in the patient leaflet. Patients can also report side effects to their doctor, nurse or pharmacist who will then pass on the information to regulators. When reporting suspected side effects, patients and healthcare professionals are encouraged to provide as accurate and complete information as possible. Patients should speak to their doctor, nurse or pharmacist if they are worried about any suspected side effect.
More information is available HERE
Please check EMA’s dedicated webpage on COVID-19 for the latest updates.
COVID-19: reminder of risk of serious side effects with chloroquine and hydroxychloroquine
Chloroquine and hydroxychloroquine are known to potentially cause heart rhythm problems, and these could be exacerbated if treatment is combined with other medicines, such as the antibiotic azithromycin, that have similar effects on the heart. Recent studies have reported serious, in some cases fatal, heart rhythm problems with chloroquine or hydroxychloroquine, particularly when taken at high doses or in combination with the antibiotic azithromycin.
Chloroquine and hydroxychloroquine are currently authorised for treating malaria and certain autoimmune diseases. In addition to side effects affecting the heart, they are known to potentially cause liver and kidney problems, nerve cell damage that can lead to seizures (fits) and low blood sugar (hypoglycaemia).
These medicines are being used in the context of the ongoing pandemic for treating patients with COVID-19 and investigated in clinical trials. However, clinical data are still very limited and inconclusive, and the beneficial effects of these medicines in COVID-19 have not been demonstrated. Results from large, well-designed studies are needed to make any conclusions.
EMA and the national competent authorities are monitoring the situation closely and have enhanced their safety monitoring of medicines used in the treatment of COVID-19 in order to take timely action when necessary. This EMA public health statement has been issued by the COVID-19 EMA pandemic Task Force (COVID-ETF) in consultation with EMA’s safety Committee (PRAC), in light of the ongoing discussions on the use of chloroquine and hydroxychloroquine in the treatment of COVID-19.
More information is available HERE
Please check EMA’s dedicated webpage on COVID-19 for the latest updates.
EMA review of Picato concludes medicine’s risks outweigh its benefits
EMA’s safety committee (PRAC) has confirmed that Picato (ingenol mebutate), a gel for treating the skin condition actinic keratosis, may increase the risk of skin cancer and concluded that the risks of the medicine outweigh its benefits.
The conclusions are based on a review of all available data on the risk of skin cancer in patients using Picato, including results of a study comparing Picato with imiquimod (another medicine for actinic keratosis). The study showed a higher occurrence of skin cancers, especially squamous cell carcinoma, in areas of skin treated with Picato than in areas treated with imiquimod. The Committee also considered that Picato’s effectiveness is not maintained over time and noted that other treatment options are available for actinic keratosis.
Picato is no longer authorised in the EU. In January 2020, Picato was suspended as a precaution while the review was underway. On 11 February 2020, the marketing authorisation was withdrawn at the request of LEO Laboratories Ltd, the company that marketed the medicine.
Patients who have been treated with Picato should look out for unusual skin changes or growths, which may occur from weeks to months after use, and seek medical advice if any occur. Patients who have questions or concerns about their treatment should consult their doctor or pharmacist.
More information is available HERE
EJHP: May issue is available!
The May issue of the European Journal of Hospital Pharmacy (EJHP) has been published. The new issue includes two editorial on the COVID-19 pandemic. Its original articles touch on medicines reconciliation in primary care, the pharmaceutical care of patients with cancer treated on non-cancer wards in the UK, vasopressin antagonist efficacy and safety in volume-overloaded critically ill patients and the perception and practices of public hospital pharmacists towards the antimicrobial stewardship programme in the State of Selangor, Malaysia. Also, a systematic review of the evaluation of a clinical pharmacist consultation service for patients with infectious diseases in China has been included.
Read the May issue HERE
[COVID-19 Updates]
EAHP’s COVID-19 Resource Centre
To assist its member associations and individual hospital pharmacists in this critical time with the provision of the best possible care for patients, EAHP has decided to gather and make available information on COVID-19 relevant for the hospital pharmacy profession.
Access the Resource Centre HERE
FIP’s call for support for pharmacists on the coronavirus frontline
The International Pharmaceutical Federation (FIP) has issued 23 urgent measures that governments and other stakeholders must put in place to ensure the continuity of pharmaceutical care to people around the world and so that pharmacists can play an even greater part in the fight against COVID-19.
Learn more about FIP’s call to action HERE
European COVID-19 Data Platform
Together with several partners, the European Commission has launched a European COVID-19 Data Platform to enable the rapid collection and sharing of available research data.
Access the Data Platform HERE
Fill out your self-assessment!
EAHP’s self-assessment tool (SAT) allows hospital pharmacists to assess the level of implementation of the European Statements within their hospitals. It also provides the means for hospital pharmacists and other healthcare professionals to address areas needing improvement with the help of a tailor-made action plan and a broad range of evidence-based resources. Progress can be tracked by individual hospital pharmacies as the assessment can be updated at any time. Also, individual results can be compared to those of other hospitals. Complete your self-assessment with EAHP’s SAT!
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Consultations
Commission – Europe’s Beating Cancer Plan
The public consultation for Europe’s Beating Cancer Plan is seeking to collect feedback on the pillars of the plan which include cancer prevention, diagnosis, treatment, follow-up care and research from individual citizens, patients, and carers replying in their personal capacity as well as health professionals and organisations.
Deadline – 7th May 2020
Access consultation HERE
Commission – White Paper on Artificial Intelligence
The European Commission is seeking input on its White Paper on Artificial Intelligence (AI) via a public consultation. Stakeholders are encouraged to review the measures and policy options put forward in the AI White Paper.
Deadline – 14th June 2020
Access consultation HERE
