FOI release

Freedom of information request on a list of all medical products which have been investigated by MHRA for adverse effects since March 2020. (FOI 22/493)

Published 1 June 2022

FOI 22/493

21st March 2022

Dear

Thank you for your email dated 21st February 2022, where you asked for the following:

• A list of all medical products which have been investigated by MHRA for adverse effects since March 2020.

• For each investigation can you please describe the effect, its extent, the conclusion and the man hours involved.

To provide some background, the Yellow Card scheme, which is run by the Medicines and Healthcare products Regulatory Agency (MHRA), is the UK programme for collecting experiences of side effects from healthcare professionals and patients and is used to monitor the safety profile of all medicines, including those from prescriptions, over-the-counter or general retail sales. Reports are also received for herbal medicines and other unlicensed medicines. It is a voluntary scheme for healthcare professionals and members of the public; however, there is a legal requirement for pharmaceutical companies to report side effects that they have received to the scheme.

While a significant proportion of the population will gain benefit from taking a medicine and experience no serious adverse effects, there will always be a proportion of individuals who will suffer a side effect as a direct result of taking a medicine. Since the difference in individuals’ responses results from differences in their genetic and environmental circumstances one of the Medicines and Healthcare products Regulatory Agency (MHRA’s) roles is to ensure that as much relevant information as possible about a serious suspected adverse drug reaction is gathered to enable an informed judgement about causality to be made i.e. whether the medicine could be directly responsible for causing the reaction.

The MHRA assesses the balance of risks and benefits of all medicines at the time of initial licensing and throughout their use in clinical practice. Where appropriate, the MHRA seeks advice from the independent Commission on Human Medicines (CHM). All reports received are entered onto our database for rapid analysis, allowing us to identify potential new safety concerns. We supplement this form of safety monitoring with clinical trial data, data from other regulatory authorities worldwide, literature reports, epidemiology studies and other healthcare data to proactively monitor safety. When a new side effect is identified, information is carefully considered in context of the overall side effect profile for the medicine, and how it compares with other medicines used to treat the same condition. We also consider the international experience based on data from other countries. As well as confirming new risks, an equally important objective of monitoring will be to quickly rule out risks – in other words, to confirm that the medicine or vaccination is not responsible for a suspected side effect and to provide reassurance on its safety.

The MHRA carefully evaluates reports of serious suspected side effects as soon as they are received to consider whether the medicine/vaccine may have caused the event, or whether the event was likely to be purely coincidental. Additionally, we apply statistical techniques and epidemiological analysis that can tell us if we are seeing more events than we would expect to see, based on what is known about background rates of illness in the absence of vaccination. This aims to account for factors such as coincidental illness.

It is important to understand that the possible adverse effects must be balanced against the benefits of using this medicine. Therefore, any potential adverse effects need to be viewed in light of the numbers of people who have taken the medicine without developing side effects. The safety of all medicines has been closely monitored by the MHRA since first authorisation.

The Yellow Card scheme as described above is valuable in recognising any adverse events associated with a medical product and taking steps to minimise harm to patients such as including warnings in the product information (Summary of Product Characteristics and Patient Information Leaflet) or on the package label; and by restricting the indications for use of a medicine. Further information on some case studies where Yellow Card reports have helped improve patient safety can be found here https://yellowcard.mhra.gov.uk/casestudies

Further to your specific requests for details of all investigations since March 2020, we deem that this falls under Section 12 of the FOI Act. 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. This represents the estimated cost of one person spending 24 working hours in determining whether the department holds the information, locating, retrieving, and extracting the information.

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