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23 diciembre 2020

EAHP Opinion on COVID-19 Vaccine Programmes and their Implementation

 

 

The European Medicines Agency (EMA) is interacting with developers of potential COVID-19 vaccines to enable promising medicines to reach patients, healthcare workers and the population as soon as possible. A conditional marketing authorisation for the first vaccine was issued and vaccination programmes are expected to start across the EU by the end of 2020. With the approval of a vaccine, the challenges that the COVID-19 pandemic has posed to healthcare professionals all across Europe for the past year are however not over yet. Mass vaccinations which need to be carried out to decrease the impact that the virus has on Europe will confront health systems and healthcare professionals with new challenges. The European Association of Hospital Pharmacists (EAHP) would like to draw attention to the challenges that the distribution of COVID-19 vaccines and their administration will present, even more, when more vaccines become available. 

 

The transport and storage conditions of the different vaccines in the development pipeline differ greatly with some requiring low temperatures between 2 to 8 degrees Celsius while others need to be kept at minus 20 or even minus 70 degrees Celsius. Not all hospital pharmacies, especially those operating in small hospitals, are equipped with cooling facilities that can meet the conditions needed for some of the vaccines in development. But even those that have these facilities might not be able to cope with the storage quantities needed to support mass vaccination of the population against COVID-19. For EAHP and its members, it is consequently of uttermost importance that national vaccination programmes take into account the local storage conditions to ensure a smooth roll-out of the vaccination activities across the healthcare sector. These considerations should not only focus on the transport of the vaccines and the storage facilities in hospitals and hospital pharmacies but also look at the conditions at other points of distribution that are tasked with providing COVID-19 vaccinations, such as vaccination centres and healthcare professionals in the communities. Furthermore, information on the preparation and the stability of the product in accordance with temperature should be provided to all healthcare professionals handling the vaccines.

 

At the point of administration, there will have to be good logistics in place for both goods and persons receiving the vaccine. Some of the vaccines in the approval process require the administration of an additional dose. The timing between doses can vary per vaccine. Using a consistent interval for all two-dose vaccines simplifies the messaging to the public and arrangements within distribution points where alternative vaccines may be supplied at short notice. Citizens should be advised to visit the same vaccination centre for receiving additional doses of a vaccine. Since different vaccines are being approved, healthcare professionals that administer the vaccine should ensure that sufficient stock of a specific type of vaccine is kept to guarantee that the first and the second dose for each individual that receives the vaccine comes from the same manufacturer.  

 

Equally important to providing advice to citizens and establishing adequate logistic processes is the record keeping. To track which person receives which vaccine and which dose of the vaccine the setting up and utilisation of a database will be essential. Such a database, which should be linked to existing systems, is important for monitoring pharmacovigilance and adherence as well as for other purposes such as batch level registration for side effects monitoring and re-calls. Data collected via such a database could also be useful for much-needed research purposes. To facilitate this process the use of scannable codes on the primary packaging is indispensable. Vaccination records should be an integral part of the medication record, so they can be used throughout the healthcare system. EAHP calls on European and national authorities to ensure the inclusion of scannable codes on the primary packaging of COVID-19 vaccines to support the vaccination process and the pharmacovigilance activities of hospital pharmacists. 

 

Combatting vaccine hesitance is another important issue that EAHP would like to address in the context of the COVID-19 vaccine distribution. Like any medicine, vaccines have benefits and risks. Although highly effective, no vaccine is one hundred per cent effective in preventing disease or one hundred per cent safe in all vaccinated people. Effectiveness in an individual depends on several factors, including age, other diseases or conditions that an individual might have, such as allergies, or previous contact with the disease. To adequately inform European citizens about the benefits of the COVID-19 vaccines that are being reviewed and approved in accordance with legal requirements for pharmaceutical quality, safety and efficacy, awareness programmes are needed. EAHP encourages national competent authorities to set up national vaccination awareness programmes for the COVID-19 vaccines which involve the expertise of healthcare professionals as trusted sources of information. Materials prepared by the EMA and for the European Vaccination Information Portal – an initiative of the European Union – are useful sources of information that should be shared at national level with citizens across Europe. For its members and other interested parties, EAHP has compiled information about COVID-19 vaccines and vaccination in its COVID-19 Resource Centre: https://www.eahp.eu/hp-practice/hospital-pharmacy/eahp-covid-19-resource-centre

 

Hospital pharmacists, as part of the vaccination team, are committed to raise awareness and to share clear information with citizens. They are prepared through their training to ensure the safe handling of vaccines and are in a position to support traceability and vigilance of COVID-19 vaccines.

 

 

 

 

 

 

 

 

 

 

 

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