PDA guidance on informed consent during the COVID-19 vaccination programme

The PDA has compiled a brief guide to assist you with ensuring that suitable consent is obtained prior to administering the COVID-19 vaccination.

Fri 8th January 2021 The PDA

Definition

“Compliance in or approval of what is done or proposed by another”

Importance of consent

All patients who possess the capacity to give informed consent are required to do so in order to receive a COVID-19 vaccination. The process of granting consent is of paramount importance, as to do so without would be technically classified as an assault. As stated in the COVID-19 standard operating procedures, there is no legal requirement for consent to immunisation to be in writing and a signature on a consent form is not conclusive proof that consent has been given, but serves to record the decision and the discussions that have taken place with the patient or the person giving consent on a child’s behalf.

Health care professionals offering the vaccine to someone who may lack the mental capacity to consent should take all practicable steps to support the person to make the decision for themselves. If a pharmacy professional is unsure about a person’s capacity, they must get advice from other healthcare professionals or from people involved in their care. Where it has been established that the person lacks the capacity to consent, a best interests decision should be taken in line with the best interest checklist in section 4 of the MCA. This means that the decision-maker must consider all the relevant circumstances, including the person’s wishes, beliefs and values, the views of their family where appropriate and what the person would have wanted if they had the capacity to make the decision themselves.

According to the workload at any given time, each vaccination site may have different minimum requirements for information recording and consent requirements. We have therefore compiled a brief guide to assist you with ensuring that suitable consent is obtained prior to administering the COVID-19 vaccination:

  1. Time: Allow the patient time to think and consider whether they wish to proceed with the procedure. If for any reason they cannot have the vaccination on a given day, if possible, give them the opportunity to attend an appointment at a later date
  2. History taking: Be sure to take as full a patient medical and social history as is required to ensure any material risks to the patient are identified. Ensure all questions are fully completed and clarify any unclear answers, to allow consideration of an alternative vaccination should the Summary of Product Characteristics for a particular one list an absolute contraindication.
  3. Record keeping: All documentation must be fully completed and any discrepancies clarified before commencing with the vaccination. Any omitted data can potentially lead to adverse outcomes for patients so full record-keeping is of paramount importance. For example, it is vital that information is gathered as to whether a patient has had any other vaccinations in the 7 days prior to receiving the COVID-19 vaccine, as this would preclude them from receiving it at the first instance.
  4. Patient information leaflets: Must be provided post-vaccination, along with post-vaccination record cards. The purpose of patient information leaflets is to make patients aware of any possible side effects they may experience and to give them an additional understanding of what they are being vaccinated with. The leaflets also contain key information to remind patients on steps to take for effective aftercare

For further guidance on consent, refer to the guidance and SOP documents available below.

 

The Pharmacists' Defence Association is a company limited by guarantee. Registered in England; Company No 4746656.

The Pharmacists' Defence Association is an appointed representative in respect of insurance mediation activities only of
The Pharmacy Insurance Agency Limited which is registered in England and Wales under company number 2591975
and is authorised and regulated by the Financial Conduct Authority (Register No 307063)

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