FOI release

Freedom of Information request on how many drugs there are in the iDAPs database and how many reports there are (FOI 21/1070)

Published 27 April 2022

7th October 2021

FOI 21/1070

Dear

Thank you for contacting the MHRA regarding the reports we have received.

In your query, dated 20th July 2021, you have requested the following under the Freedom of Information (FOI) act:

  • I am interested in how many drugs there are in your iDAPs database and how many reports there are.

Regarding the number of drug substances in the iDAPs database, I can confirm that as of the 30th of August, there are iDAPs for 2,372 active drug substances in total. It is important to note that vaccines are not included in the iDAP database. Information regarding suspected adverse reactions to vaccines is not currently available via the iDAPs but is available upon request.

Further to your request concerning how many reports there are, please may you clarify whether you are requesting the total number of reports we have received for each iDAP drug substance individually, or if you require the overall number of reports that are used in the iDAPs for all substances combined. If it is per iDAP substance, this information is available by downloading the individual iDAP from the Yellow Card site at https://yellowcard.mhra.gov.uk/iDAP. However, if you are requesting the overall number of reports, we would be grateful if you could provide some additional clarifying information so that we are able to determine whether we have the resources to extract this information. For example, if you are interested in the number of overall reports received by year, and what time frames you would subsequently be interested in etc. Additionally, it was noted from your enquiry that you have requested this data in the context of comparing different data sources on side effects for your master’s thesis. Please may you provide us with a little more information regarding what these numbers will be used for, just so we can ensure that any further data provided is interpreted correctly.

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