On 12 September, the European Commission together with the WHO organised a global summit aiming at reversing the spread of vaccine-preventable diseases and stopping the dissemination of vaccine misinformation. The event, which was also attended by a representative of the European Association of Hospital Pharmacists, discussed the availability of safe and effective vaccines, the lack of access, the problem of vaccine shortages, as well as the growing issue of misinformation and the diminishing public confidence in the value of vaccines.
The following actions were agreed on by the attendees of the summit:
Promote global political leadership and commitment to vaccination and build effective collaboration and partnerships—across international, national, regional and local levels with health authorities, health professionals, civil society, communities, scientists and industry—to protect everyone everywhere through sustained high vaccination coverage rates.
Ensure all countries have national immunisation strategies in place and implemented, and strengthen its financial sustainability, in line with progress towards universal health coverage, leaving no one behind.
Build strong surveillance systems for vaccine-preventable diseases, particularly those under global elimination and eradication targets.
Tackle the root causes of vaccine hesitancy, increasing confidence in vaccination, as well as designing and implementing evidence-based interventions.
Harness the power of digital technologies, so as to strengthen the monitoring of the performance of vaccination programmes.
Sustain research efforts to continuously generate data on the effectiveness and safety of vaccines and impact of vaccination programmes.
Continue efforts and investment, including novel models of funding and incentives, in research, development and innovation for new or improved vaccine and delivery devices.
Mitigate the risks of vaccine shortages through improved vaccine availability monitoring, forecasting, purchasing, delivery and stockpiling systems, and collaboration with producers and all participants in the distribution chain to make best use of, or increase existing, manufacturing capacity.
Empower healthcare professionals at all levels as well as the media to provide effective, transparent and objective information to the public and fight false and misleading information, including by engaging with social media platforms and technological companies.
Align and integrate vaccination in the global health and development agendas, through a renewed Immunization Agenda 2030.
EFCNI roundtable outcome: position on optimal practice in neonatal parenteral nutrition
The roundtable discussions of the European Foundation for the Care of Newborn Infants (EFCNI) brought together a number of experts and healthcare professionals in 2018 to speak about the nutritional emergency of preterm birth. The European Association of Hospital Pharmacists (EAHP) participated in these discussions which reflected on the content of the position paper ‘Addressing the nutritional emergency of preterm birth—Optimal practice in neonatal parenteral nutrition’.
The position paper—which has also been endorsed by the EAHP—is intended to serve as a supplement to and a driving force for the development and implementation of guidelines on a national level based on the newly revised guidelines from the European Society of Paediatric Gastroenterology, Hepatology and Nutrition/the European Society of Paediatric Research/European Society of Paediatric Research/Chinese Society of Parenteral and Enteral Nutrition guidelines. It mainly targets policy makers and hospital administrators. As a next step, a German-speaking round table will be organised with the aim of developing a practical handbook for healthcare professionals based on the position paper.
EU JAMRAI starts #OneHealth social media campaign
Two months before the European antibiotic awareness day, the Joint Action on Antimicrobial Resistance and Healthcare-Associated Infections (European Union (EU) JAMRAI) has commenced a social media campaign seeking to educate the public about the ‘One Health’ approach. The campaign builds on evidence which indicates that the term ‘One Health’ is not being used within online conversations linked to achievements to combat antimicrobial resistance.
Since individual contributions to an effective change in ‘One Health’ can seem overwhelming, the EU JAMRAI has devised a social behaviour change communication strategy using the butterfly effect to empower its audience, communicating how their small individual change can have large effects. Via infographics with attractive images and short key messages, different audiences are being made aware of individual contributions to the ‘One Health’ approach. Have a look at EU JAMRAI’s social media channels (Facebook, Twitter, Instagram) to learn more about the campaign.
Expert panel opinion on task shifting and health system design
Over the past decades much has changed in the professional lives of healthcare workers throughout Europe. More complex treatments, an ageing society, new advanced therapies and the problems caused by medicines shortages are only a few advancements and issues that have entered into the lives of today’s health workforce. A recently released expert panel opinion on task shifting and health system design is addressing these changes, which have however not yet led to adjustments in European health systems.
The traditional roles of different types of health workers are put into focus, in particular the practice of reserving the responsibility for certain tasks for those with particular qualifications based on custom and practice rather than on evidence. The expert opinion argues that this situation must appropriately be changed to provide better care in ways that are more responsive to the needs of users.
The Expert Panel on effective ways of investing in health is an interdisciplinary and independent group. It was established by the European Commission to develop non-binding advice which aims to provide the necessary evidence that will support European Union countries in delivering high-quality care and making their health systems more resilient and efficient while improving accessibility to all.
Updates from the European Medicines Agency
The European Medicines Agency (EMA) released information on the review of data on skin cancer with Picato, a communication on the updated restrictions for Gilenya, as well as information on new measures to avoid potentially fatal dosing errors with methotrexate for inflammatory diseases.
Review of data on skin cancer with Picato
The EMA is reviewing data on skin cancer in patients using Picato (ingenol mebutate), a gel for treating actinic keratosis, a skin condition caused by too much sunlight exposure. The review was triggered by data from several studies showing a higher number of skin cancer cases, including cases of squamous cell carcinoma, in patients using Picato.
The product information for Picato already contains a warning about reports of one type of skin tumour (keratoacanthoma) and, following a separate review, this warning is currently being updated to mention skin cancers called basal cell carcinoma, Bowen’s disease and squamous cell carcinoma.
Healthcare professionals are advised to use Picato with caution in patients who have had skin cancer in the past. In addition, patients should continue to watch out for any skin lesions and inform their doctor immediately if they notice anything unusual. Patients who have questions or concerns about their treatment should contact their doctor.
In order to conclude on whether Picato increases the risk of skin cancer, EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) will now carry out a thorough review of all available data, including from ongoing studies. The Committee will assess the impact of the data on the benefit–risk balance of Picato and recommend whether the medicine’s marketing authorisation in the European Union should be amended.
Updated restriction for Gilenya: multiple sclerosis medicine not to be used in pregnancy
The EMA has recommended that the multiple sclerosis medicine Gilenya (fingolimod) must not be used in pregnant women and in women able to have children who are not using effective contraception. If a woman becomes pregnant while using Gilenya, the medicine must be stopped and the pregnancy will have to be closely monitored. This is because the active substance in Gilenya, fingolimod, can harm the unborn baby and may cause birth defects.
To minimise this risk, women able to have children must have a pregnancy test before starting treatment with Gilenya to ensure they are not pregnant, and must use effective contraception during treatment and for 2 months after stopping the medicine.
These recommendations follow a review triggered by reports suggesting that the risk of birth defects in infants who have been exposed to Gilenya during pregnancy is twice as high as the 2%–3% risk observed in the general population. The most frequently reported birth defects in infants exposed to Gilenya were those affecting the heart, kidneys, bones and muscles.
New measures to avoid potentially fatal dosing errors with methotrexate for inflammatory diseases
The EMA has recommended new measures to prevent serious and potentially fatal errors with the dosing of methotrexate for treating inflammatory diseases such as rheumatoid arthritis, psoriasis and Crohn’s disease. The recommendations result from a review of reports that patients are using methotrexate incorrectly despite previous measures to prevent errors.
For inflammatory conditions, methotrexate must be used just once a week. Using methotrexate more frequently than intended can result in serious side effects. The review found that the error in dosing frequency can occur at any step from prescribing the medicine to the patient taking it.
The new measures to prevent errors include restricting who can prescribe these medicines, making warnings on the packaging more prominent and providing educational materials for patients and healthcare professionals.
For more information please visit EMA’s website at https://www.ema.europa.eu.
Footnotes
Competing interests: None declared.
Provenance and peer review: Commissioned; internally peer reviewed.