HSS(MD) 2/2021 - DEPLOYMENT OF COVID-19 VACCINE OXFORD / ASTRAZENECA GOVERNANCE, HANDLING AND PREPARATION IN GENERAL PRACTICE
This letter provides further detail around the expectations for governance, handling and preparation of the Oxford / AstraZeneca vaccine in general practice, to supplement the overview of the primary care programme as set out in HSS(MD) 93/2020.
Legal basis and expectations of HMR regulation 174 (temporary) authorisation for supply of the vaccine products
– see circular
In practice, the professional expectations for the primary care vaccination programme are as follows:
Regulatory compliance by the doctor/GP under reg.3 of the Human Medicines Regulations 2012 means they have to understand the process being done in their name and be accountable for it. However, it is not essential that the preparation of the vaccine prior to administration is undertaken by a GP or by pharmacy professionals. What is essential is that it is being done by doctors acting within their professional competence or by someoneacting on the doctor’s behalf who is acting within their professional competence.
Ordinarily the skills in question would be the skills one would expect to find amongst pharmacy professionals, but there will for example be nurses who have the right qualifications, skills and experience.
Supporting deployment of the COVID-19 Oxford / AstraZeneca vaccine
General practice will be used to handling vaccines with storage conditions of 2-8 degrees Centigrade, as well as the use of multidose vials of other medicines. However, a multidose vaccine with no preservative, as is the case with this vaccine, is unusual, and so good aseptic technique will be important in order to maintain the safety, quality and effectiveness of the vaccine.
Good systems of medicines management remain critical to ensure safe deployment and use of vaccines, particularly as more specially trained vaccinators come on stream, and so it is important that practices work with the Health and Social Care Board and their GP Federation pharmacy team to ensure that pharmaceutical expertise and oversight is in place to support the safe handling and use of the vaccine in general practice. General practice pharmacists are well placed to play a leading role in providing pharmaceutical advice on vaccine management as well as ensuring that robust systems are in place for pharmacovigilance including reporting of adverse events to the MHRA through the Yellow Card scheme. To underpin the use of the COVID-19 Vaccine Oxford/AstraZeneca, the NHS Specialist Pharmacy Service has produced a suite of resources which general practice pharmacy teams may find helpful to utilise for this purpose, and which are available here.
Information for healthcare professionals and the conditions for the temporary authorisation of COVID-19 Vaccine Oxford/AstraZeneca can be found here. Please familiarise yourselves and your teams with these as soon as possible. The Regional Patient Specific Direction for COVID-19 Vaccine Oxford / AstraZeneca has been developed by the Public Health Agency, and is available on the HSC Primary Care Intranet.