PGD addendum published for the Flu Vaccination Service 2018/19

PGD addendum published for the Flu Vaccination Service 2018/19

October 15, 2018

Public Health England (PHE) has published an addendum to the community pharmacy Flu Vaccination Service 2018/19 Patient Group Direction (PGD).

This addendum provides the legal basis for two activities to take place:

  1. For pharmacists to administer the recommended vaccine to patients who have inadvertently received the non-recommended vaccine for their age group during the 2018/19 Flu Vaccination Service, for example, patients aged 65 years or over who have received a quadrivalent vaccine (QIV) instead of the recommended adjuvanted trivalent inactivated vaccine (aTIV); and
  2. For pharmacists to re-vaccinate patients who have received an incomplete dose of vaccine, for example, if some of the vaccine was spilled in the process of administering the vaccine.

It is important to note, that NHS England has advised that the addendum is not advocating active recall of patients who have been given the non-recommended vaccine, but where a patient presents requesting re-vaccination with the recommended vaccine, and they have been advised of the risks and benefits of doing so, the addendum will allow for this to take place.

FAQs

Do I need to sign the addendum?
No. Pharmacists are not required to sign the addendum, but it is important that they are aware of it so, if either of the above circumstances occur, pharmacists are aware that the PGD allows them to re-vaccinate a patient.

Do I need to print a copy of the addendum and attach it to the PGD?
Contractors/pharmacists are strongly encouraged to print a copy of the addendum and attach it to the PGD in the pharmacy to ensure that new pharmacists signing up to the service are made aware of the addendum.

What should I do if a patient returns to the pharmacy and says she was given a non-recommended vaccine for her age group, for example, the patient is  65 years old and received the QIV instead of the recommended aTIV?
Pharmacists should follow the process in PHE’s recently updated Inactivated influenza vaccine guidance for healthcare practitioners, which states:

  • Inform the patient of the error and its potential implications;
    • Advise the patient that although the QIV and aTIV will offer some protection to all age groups, individuals aged 65 years and over (particularly those more than 75 years of age) may not respond as well to the QIV as they would to the aTIV, and individuals aged under 65 years will not benefit from the opportunity to make protection against an additional flu strain if they have been given aTIV;
  • Following a discussion about the risks and benefits, advise the patient that they could, if they wish, be given a second dose of the vaccine they should have had;
    • The clear benefit is the additional protection that may be offered by the correct vaccine, but they should be alerted to the potential increased risk of a local or systemic reaction. Although there is no data available on the safety and effectiveness of administering a second flu vaccine shortly after the first in adults, this advice is based on general principles of vaccination, experience of flu revaccination following cold chain and administration incidents and information about the high dose flu vaccine used in the United States (which contains four times the amount of antigen that is in a single dose of QIV or aTIV);
  • If a decision is made to offer the vaccine the patient should have received, it is recommended that this is done as soon as possible after the first dose was given and ideally within a week. This will enable protection to be made as soon as possible. It can, however, still be given if more than a week has elapsed.

This advice also applies to those who have inadvertently been given non-adjuvanted trivalent influenza vaccine (TIV).



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