Freedom of Information request on a list of all medical products that have been investigated by the MHRA for adverse effects since March 2020. (FOI 22/493)
March 21, 2022
Thank you for your email of February 21, 2022, in which you requested the following:
• A list of all medical products that have been investigated by the MHRA for adverse effects since March 2020.
• For each investigation, can you describe the effect, its extent, the conclusion and the hours of work involved.
To provide some context, the Yellow Card scheme, which is run by the Medicines and Healthcare Products Regulatory Agency (MHRA), is the UK’s scheme for collecting side effect experiences from healthcare professionals and patients and is used to monitor the safety profile of all medications, including prescription, over-the-counter, and general retail medications. Reports are also received for herbal medicines and other unlicensed medicines. This is a voluntary scheme for healthcare professionals and members of the public; however, there is a legal obligation for drug companies to report any side effects they have received to the diet.
While a significant proportion of the population will benefit from taking a drug 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 medication. Since the difference in individuals’ responses results from differences in their genetic and environmental circumstances, one of the roles of the Medicines and Healthcare Products Regulatory Agency (MHRA) is to ensure that as many As relevant information as possible about a suspected serious adverse drug reaction is collected to allow an informed judgment about causation to be made, i.e. whether the drug might be directly responsible for the reaction.
The MHRA assesses the balance of risks and benefits of all drugs at the time of initial approval 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 into our database for rapid analysis, allowing us to identify potential new security issues. We supplement this form of safety monitoring with clinical trial data, data from other regulatory authorities around the world, literature reports, epidemiological studies and other health data to proactively monitor safety. . When a new side effect is identified, the information is carefully considered in the context of the medicine’s overall side effect profile and how it compares to other medicines used to treat the same condition. We also consider international experience based on data from other countries. In addition to confirming new risks, an equally important goal of surveillance will be to quickly eliminate risks – in other words, to confirm that the drug or vaccine is not responsible for a suspected side effect and to reassure him of his safety.
The MHRA carefully assesses reports of suspected serious side effects as soon as they are received to determine 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 whether we are seeing more events than we expected, based on what is known of baseline rates of disease in lack of vaccination. This is intended to take into account factors such as fortuitous illness.
It is important to understand that possible side effects should be weighed against the benefits of using this drug. Therefore, any potential adverse effects should be considered in light of the number of people who have taken the drug without developing side effects. The safety of all medicines has been closely monitored by the MHRA since first authorisation.
The yellow card system as described above is useful for recognizing any adverse event associated with a medical product and taking action to minimize harm to patients, such as including warnings in the product information (summary of the product characteristics and patient information leaflet) or on the label of the packaging. ; and restricting the indications for use of a drug. 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
Following your specific requests for details of all investigations since March 2020, we believe 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 processing them would exceed the appropriate limit, which for central government is set at £600. This represents the estimated cost of one person spending 24 hours of work determining if the service has the information, locating, retrieving and extracting the information.
I hope you find the information provided useful, but if you are not satisfied with the handling of your request, you have the right to request an internal review. Requests for internal review must be submitted within two months of the date of this response; and can be sent to this e-mail address.
The FOI team,
Drug Vigilance and Risk Management Division