Yellow card data, who reviewed it

Summary

The requester asked for correspondence and governance details regarding Yellow Card data for COVID-19 vaccines in the Isle of Man, but Manx Care disclosed that they do not hold this data as it is submitted directly to the UK's MHRA.

Key Facts

• Yellow Card reports are direct one-way communications from patients or staff to the MHRA, not held by Manx Care.
• Manx Care does not currently receive feedback on Yellow Card reports from the Isle of Man.
• No local committee or board reviews Yellow Card information because the data is not available locally.
• The Medicines Optimisation Team was not involved in preparing Minister Ashford's response to Tynwald Question 3.3.
• Manx Care circulates the MHRA's monthly 'Drug Safety Update' newsletter which is informed by national Yellow Card reports.

Data Disclosed

• 2023-10-02
• 2024-12-20
• December 2020
• December 2021
• 15 April 2021
• 25 November 2021
• FOI 21/401
• Question 3.3
• case_id: 3437550

Exemptions Cited

• Information not held by the public authority

Original Request

Hi, It is unclear which board/sub-committee/dept/etc reviewed yellow card data for the Isle of Man. Please provide: 1. All correspondence between DHSC, DfE, Manxcare and Cabinet Office (inc Public Health) related to MHRA, Pharmacovigilance, Yellow Card and adverse reactions to the Covid vaccination sent and received during the months of December 2020 and December 2021. For question 1, to save time in doing a further clarification FOI, could you request that search criteria used be stated. I have done FOI's to other departments and it seems only one or two search terms were used such as 'mhra'. I offered example search criteria, but other search phrases should be done that covers communication referring to any negative outcome from the C19 vaccine. 2. All information used (including correspondence) to prepare Minister Ashford's response to the Tynwald Question 3.3. COVID vaccination - Issues reported through the yellow card system which was answered in the Tynwald sitting of 15 April 2021. Tynwald question is Question 3.3 https://tynwald.org.im/spfile?file=/business/hansard/20202040/k210415.pdf#search="yellow+card+system"                                            3. Kathryn Magson confirmed via email on 25 November 2021, that FOI 21/401 'has gone through the vaccination governance processes'. I have not seen this FOI discussed in minutes of the vaccine board under DHCS/Manxcare. - Please clarify what the 'vaccination governance processes' are and provide documents relating to that process? - If not already answered, please state which committee/sub-committee/dept/board was responsible for discussing and reviewing yellow card information. Please provide minutes of those groups.

Data Tables (1)

Full Response Text

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

Our ref: 3437550 16 December 2024

Dear

We write further to your request, received 2 October 2023, which states:

"Hi,

It is unclear which board/sub-committee/dept/etc reviewed yellow card data for the Isle of Man. Please provide:

1. All correspondence between DHSC, DfE, Manxcare and Cabinet Office (inc Public Health) related to MHRA, Pharmacovigilance, Yellow Card and adverse reactions to the Covid vaccination sent and received during the months of December 2020 and December 2021.

For question 1, to save time in doing a further clarification FOI, could you request that search criteria used be stated. I have done FOI's to other departments and it seems only one or two search terms were used such as 'mhra'. I offered example search criteria, but other search phrases should be done that covers communication referring to any negative outcome from the C19 vaccine.

1. All information used (including correspondence) to prepare Minister Ashford's response to the Tynwald Question 3.3. COVID vaccination - Issues reported through the yellow card system which was answered in the Tynwald sitting of 15 April 2021.

Tynwald question is Question 3.3
https://tynwald.org.im/spfile?file=/business/hansard/20202040/k210415.pdf#search=" yellow+card+system"

1. Kathryn Magson confirmed via email on 25 November 2021, that FOI 21/401 'has gone through the vaccination governance processes'. I have not seen this FOI discussed in minutes of the vaccine board under DHCS/Manxcare.

2. Please clarify what the 'vaccination governance processes' are and provide documents relating to that process?

3. If not already answered, please state which committee/sub-committee/dept/board was responsible for discussing and reviewing yellow card information. Please provide minutes of those groups."

While our aim is to provide information whenever possible, in this instance the public authority does not hold or cannot, after taking reasonable steps to do so, find some of the information that you have requested. Enter the reason why the information requested is not held

I have detailed below the information that is held.

Qu 1: The essence of the response is that Yellow Cards (YC) are a direct communication from the patient or member of staff to the MHRA.

No separate organisation (either here on the IOM or in The UK) don’t hold data on Yellow Cards submitted as it is a direct one-way communication and the owner of the data is the MHRA; therefore Manx Care don’t have access to it.

The MHRA use submitted data to identify and highlight potential risks with medicines on a UK basis. We don’t currently receive feedback on reports from the Island, but we are investigating the possibilities of that going forward.

The requestor would be best directed to submit a request to the MHRA, who own the dataset.

Qu 2: I have search all my email folders and all my saved documents for reference to the question on the previous response which Minister Ashford gave. The Medicines Optimisation Team (primary care pharmacy) were not supporting the Minister in the response. Search terms used: MHRA, Yellow Care, Tynwald question.

Qu 3: For the part of Q3 relating to Yellow Cards, there is no group (current or previous) reviewing locally reported Yellow Cards. We simply don’t get this data from MHRA. This might change in the future.

The MHRA produce a monthly newsletter (Drug Safety Update) which is informed to some degree by Yellow Cards reports nationally, and this newsletter is widely circulated across Manx Care.

The question states: Kathryn Magson confirmed via email on 25 November 2021, that FOI 21/401 'has gone through the vaccination governance processes'. I have not seen this FOI discussed in minutes of the vaccine board under DHCS/Manx care.

• Please clarify what the 'vaccination governance processes' are and provide documents relating to that process?

• If not already answered, please state which committee/sub-committee/dept/board was responsible for discussing and reviewing yellow card information. Please provide minutes of those groups.”

During 2021, Kathryn Magson was CEO of the DHSC, and she held Vaccination Programme Board meetings which were administrated by DHSC. Manx Care, nor my team personally, held or recorded these meetings. Since the inception of Manx Care, we have held Immunisation Committee meetings and Operational Flu group meetings. DHSC hold and administrate Strategic Clinical and Professional Advisory Board.

Please quote the reference number 3437550 in any future communications.

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I will now close your request as of this date.

Yours sincerely