Patient Group Direction

Summary

The requester asked for details on who signed the Patient Group Directions (PGDs) enabling the Isle of Man's COVID-19 vaccination rollout and when. Manx Care disclosed that they adopted UKHSA/NHS PGDs signed by the Medical Director, Director of Nursing, and Lead Pharmaceutical Advisor, and provided specific signing dates for four vaccines.

Key Facts

• Manx Care and the former Department of Health and Social Care adopted UKHSA/NHS/NHSEI PGDs rather than writing their own.
• The PGDs were signed by the Medical Director, Director of Nursing, and Lead Pharmaceutical Advisor.
• Article 12(G) of the Prescriptions and Medicines (Human Use) Regulation 2005 governs the operation and compliance of these protocols.
• The Manx Care Act 2021 transferred protocol approvals from the Department to Manx Care.
• Specific signing dates were provided for Comirnaty 30, Comirnaty 10, Moderna, and AstraZeneca vaccines.

Data Disclosed

• 2288577
• 2022-02-23
• 2022-03-15
• 1st April 2021
• Regulation 174
• 10/02/2022
• 10/01/2022
• 24/02/2022
• Article 12(G)
• 2005
• 2020
• 2021

Original Request

Dear Manx Care, Please can you confirm who signed the Patient Group Direction and in what capacity that enabled the Covid Vaccination roll out and on what date this was signed?

Data Tables (3)

Full Response Text

Manx Care Noble’s Hospital, Strang Braddan, Isle of Man IM4 4R (01624) 650 000

Our ref: 2288577 15 March 2022

Dear ###

We write further to your request which was received on 23 February 2022 and which states:

"Please can you confirm who signed the Patient Group Direction and in what capacity that enabled the Covid Vaccination roll out and on what date this was signed?" Our response: For each of the vaccines there is a Patient Group Direction that is updated every time there are changes to the vaccination cohorts, or when there are changes to the approved vaccines, including changes covered by Regulation 174 which outlines conditional marketing approval (or otherwise) through the Medicines and Healthcare Products Regulatory Agency (MHRA). Manx Care, is a statutory board created on 1st April 2021 and the former Department of Health and Social Care (DHSC), prior to creation of Manx Care, have not written their own PGD’s. Both Manx Care and the former DHSC adopted the UKHSA/NHS/NHSEI PGD’s approvals for use in the Island, signed by the Medical Director, Director of Nursing and Lead Pharmaceutical Advisor. Article 12(G) of the Prescriptions and Medicines (Human Use) Regulation 2005 as updated and amended in 2020, describes the operation and regulatory compliance requirements identified, includes: (a) the classes of persons permitted to administer medicinal products under the protocol; (b) the process by which a person of the specified class is designated, and by whom, as a person authorised to administer medicinal products under the protocol; and (c) requirements as to the recording of the name of a person who, on any particular occasion, administers a medicinal product under the protocol.

It also allows for vaccines to be given without the need to write a separate prescription for every individual vaccine.
Finally, the Manx Care Act 2021 transfers approvals of the Protocol to Manx Care from the Department. Vaccine Date signed Comirnaty 30
10/02/2022 Comirnaty 10 10/02/2022 Moderna(Spikevax) 10/01/2022 AstraZeneca 24/02/2022 Please quote the reference number 2288577 in any future communications. Your right to request a review

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