FOI release

Freedom of Information request on the Number and types of adverse side effects and deaths reported due to opioids, for each year from 2019 through until 2021 and associated age ranges. (FOI 22/530)

Published 1 June 2022

FOI 22/530

25 March 2022

Dear

Thank you for your email dated 10th March 2022, where you asked for the following information from the Yellow Card scheme:

• • • Number and types of adverse side effects reported due to opioids, for each year from 2019 through until 2021 and associated age ranges.
• • • Number of deaths reported, due to and/or including opioids, for each year from 2019 through until 2021 and associated age ranges.
• • • Number of deaths reported by coroners due to opioids, for each year from 2019 through until 2021 and associated age ranges.

Much of the information you have requested is available via our interactive Drug Analysis Profiles (iDAPs), which are available here: What is being reported making medicines and medical devices safer (mhra.gov.uk). There is an iDAP for each licensed medicine by drug substance. Within an iDAP you can see all suspected side effects, known as suspected adverse drug reactions, that are reported to the MHRA. With regards to your first two points, data within the iDAPs can be filtered by age group and you can filter the iDAPs to include only reports associated with a fatal outcome.

When considering the spontaneous data provided within the iDAPs, it is important to be aware of the following points:

• • • A reported reaction does not necessarily mean it has been caused by the medicine or vaccine in question, only that the reporter had a suspicion it may have. The fact that symptoms occur after use of a vaccine or medicine, and are reported via the Yellow Card Scheme, does not in itself mean that they are proven to have been caused by it. Underlying or concurrent illnesses may be responsible and such events can also be coincidental.

• • • It is also important to note that the number of reports received via the Yellow Card scheme does not directly equate to the number of people who suffer adverse reactions and therefore cannot be used to determine the incidence of a reaction or compare the safety profile of different medicines or vaccines. ADR reporting rates are influenced by the seriousness of ADRs, their ease of recognition, the extent of use of a particular medicine, and may be stimulated by promotion and publicity about a drug. Reporting tends to be highest for newly introduced medicines during the first one to two years on the market and then falls over time.

As these data do not necessarily refer to proven side effects, you should refer to the product information which can be found here: MHRA Products Home for details on the known possible side effects of any particular medicine or vaccine.

With regards to your final point, we can provide the data you have requested in the form of 1b data. FOI 1b data fields that can be released are:

• • Patient age categories
• • Patient gender categories
• • Suspect drug(s)
• • Dose of suspect drug(s)
• • Route of administration
• • Duration of treatment
• • Suspected adverse drug reaction(s)
• • Adverse drug reaction outcome(s)
• • Time to onset
• • Past medical history
• • Year of receipt

Section 12 of the FOI Act specifies that a public authority may refuse requests where the cost of dealing with them would exceed the appropriate limit, which for central government is set at £600. In this instance your request falls under Section 12 of the FOIA. Please can you refine your request by providing a list of the specific opioid active substances you are interested in. Once you have provided this information, we will be able to provide the data you have requested, provided it does not fall under the section 12 exemption. Please note that the provision of 1b data depends on the number of cases held by the Agency. The MHRA will not release any data subset in which there are five or fewer cases per cell as this is necessary to prevent identification of patients and/or reporters. Where there are fewer than five cases the data will be aggregated.

I hope the information provided is helpful, but if you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date of this response; and can be addressed to this email address.

Yours sincerely,

FOI Team,

Vigilance and Risk Management of Medicines Division

The MHRA information supplied in response to your request is subject to Crown copyright. The FOIA only entitles you to access to MHRA information. For information on the reproduction or re-use of MHRA information, please visit https://www.gov.uk/government/publications/reproduce-or-re-use-mhra-information/reproduce-or-re-use-mhra-information

If you have a query about this email, please contact us. If you are unhappy with our decision, you may ask for it to be reviewed. That review will be undertaken by a senior member of the Agency who has not previously been involved in your request.

If you wish to pursue that option please write to the Communications Directorate, 4-T, Medicines and Healthcare products Regulatory Agency, (via this email address). After that, if you remain dissatisfied, you may ask the Information Commissioner at:

The Information Commissioner’s Office

Wycliffe House

Water Lane

Wilmslow

Cheshire

SK9 5AF

Copyright notice

The information supplied in response to your request is the copyright of MHRA and/or a third party or parties, and has been supplied for your personal use only. You may not sell, resell or otherwise use any information provided without prior agreement from the copyright holder.