Freedom of Information request on adverse drug reaction reports from Opioid medication (FOI 22/797)
Published 4 January 2024
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FOI 22/797
28th July 2022
Dear
Thank you of your email dated 03 July 2022, where you requested the below information:
• Number and types of adverse side effects reported due to Opioid i.e. Morphine, Oramorph, Oxynorm for each year from 2019 through till 2021 and associated age ranges.
• Number of deaths reported, due to and/or including Opioid i.e. Morphine, Oramorph, Oxynorm, for each year from 2019 through till 2021 and associated age ranges.
• Number of deaths reported by Coroners due to Opioid i.e. Morphine, Oramorph, Oxynorm, for each year from 2019 through till 2021 and associated age ranges.
As my colleague stated previously much of this information is available online on the Yellow Card website via our interactive Drug Analysis Profiles (iDAPs). The filters on the left-hand side of the page can be used to select a subset of reports. The filters may also be stacked to allow further specificity. For example, for your first request you can select the iDAP for Morphine, filter the age group to 20-29, select the year received as 2019 and set the seriousness to fatal which will give a total number of Yellow Card reports received as 3. The filtering options within the iDAPs will also maintain the display of a list of all UK spontaneous Adverse Drug Reactions for all reports within the defined parameters or filtered options.
It is important to note that information within the iDAPs is presented based on the active substance of a medicine, however reports can also contain information on the specific brand of the medicine received. Unfortunately, we are unable to provide the information requested above by opioid brand as your request is exempt from disclosure under Section 40 (personal information) and Section 41 (information provided in confidence) of the Freedom of Information Act. Providing you with the age band data alongside information relating to specific brands, year reported, type of adverse effect as well as outcome could lead to patient identification.
Members of the public and healthcare professionals voluntarily submit reports of suspected side effects to the MHRA through the Yellow Card Scheme. As outlined in our Privacy Policy, the MHRA will not share the identity of anyone submitting a Yellow Card report with any person outside the MHRA without their explicit consent, unless we are required or permitted to do so by law. The Policy also states that we may receive requests for Yellow Card report data under the Freedom of Information Act. While we are legally obliged to provide some of the requested information, we only provide high-level summary information with all person-identifiable data excluded.
The MHRA has been working proactively to encourage members of the public or health professionals across the UK to immediately alert us to any concerns they have without a formal diagnosis using the Yellow Card scheme. The information and data provided to us by these third parties are shared in confidence and, as above, are personal data. Sharing the information and data received with yourself would not reflect the commitments in MHRA’s confidentiality agreements, potential safety signals which would be of detriment both to the application of the Agency’s regulatory function and public health more widely. As this is personal data in relation to an individuals’ health, this would be of detriment to them and may damage the engagement with the scheme.
As explained previously we are able to provide category 1b data which can include specific opioid brands in addition to the following information:
- Aggregated patient age
- Aggregated patient gender (number of males and females)
- Suspect drug(s)
- Dose of suspect drug
- Route of administration
- Duration of treatment
- Suspected adverse drug reaction(s)
- Outcome of reaction
- Reaction onset times
- Patient medical history
- Year of receipt
If this is something that would interest you, please provide the specific opioid products you are interested in, and we can log an additional FOI request on your behalf.
For ease of reference, please see the iDAPs for both morphine and oxycodone below:
As you are already aware it is not possible to view the reporter’s qualification, for example, coroner, within an iDAP. This is information that we can provide whilst considering our requirements to comply with data protection laws and protect patient/reporter confidentiality. As the number of reports submitted by coroners is less than 5 for both morphine and oxycodone within the years you have requested, we are unable to provide the exact number in order to protect patient/reporter confidentiality.
As explained previously, when considering spontaneous Adverse Drug Reaction (ADR) data, it is important to be aware of the following points:
• A reported reaction does not necessarily mean it has been caused by the drug, only that the reporter had a suspicion it may have. The fact that symptoms occur after use of a drug, and are reported via the Yellow Card scheme, does not in itself mean that they are proven to
have been caused by the drug. 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. ADR reporting rates are influenced by the seriousness of ADRs, their ease of recognition, the extent of use of a particular drug, 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. For these reasons the enclosed data should not be used as a basis for determining incidence of side effects.
I hope the information provided is helpful. The MHRA encourages the use of Yellow Card data however wishes to ensure that the data is studied and applied appropriately, and any conclusions/interpretations take into account the above information. For this reason, if you wish to use this information for a publication, we request that you engage with the MHRA during this process and provide a copy of the report.
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