iDAP Release Notes

New Features & Changes

Product search functionality

This functionality allows users to search for specific substances they wish to view, offering a more efficient route to locate substances of interest. Users can also still use the ‘Browse A-Z’ function to locate substances should they wish.

Categorisation by product type

Products are now categorised into product types, such as medicines and vaccines. This allows users to only view certain product types, for example restricting the search to vaccines only.

Yellow Card overview tab

Each iDAP now contains the ‘Yellow Card Overview’ tab which only presents suspected ADR reports which are submitted directly to the MHRA via the Yellow Card scheme by patients, members of the public, and healthcare professionals. It does not include reports received through pharmaceutical companies. For information on all reports, which includes those received from pharmaceutical companies, please use the ‘Total report profile’ and ‘Total reaction profile’ tabs.

Dynamic graphs/tables

IDAPs now display 3 sections that contain suspected ADR data:

• Yellow Card Overview 

• Total Report Profile 

• Total Reaction Profile 

The graphs and tables within the ‘Total Report Profile’ and ‘Total Reaction Profile’ tabs are dynamic for all products. The filters on the left-hand side allow you to interact and filter the data as you wish. This offers a more interactive and visually appealing way of navigating through the published ADR data. 

Ethnicity breakdown

The breakdown by ethnicity is now being published for Yellow Card reports using the NHS ethnicity categories as defined in the NHS Data Dictionary. The total number of Yellow Card reports received is broken down by the ethnicity of the patient. Please note, the MHRA began to collect ethnicity data within Yellow Card reports in 2010, and therefore reports prior to 2010 are not included in this breakdown. A patient’s ethnicity may not be reported, so the data may be recorded as “not known”. The MHRA is committed to ensuring the data is representative, and uses this information as part of initiatives to include access to Yellow Card.

Reporter categorisation

Previously a suspected ADR report could contain more than one reporter, such as a patient and a healthcare professional, therefore it could be included in both respective reporter categories. Following the implementation of new systems as part of our SafetyConnect programme, the concept of ‘Primary Reporter’ has been introduced in alignment with updated data standards. Although a case may contain multiple reporters, only one can be marked as the ‘Primary Reporter’. This is now used in our reporter filter on the ‘Total Report Profile’ and ‘Total Reaction Profile’. You therefore may see a decrease in the number of reports for each category compared to previous publications.

Drug structural changes

We now have the ability to display suspected adverse drug reaction data within our interactive Drug Analysis profiles at different levels of the MHRA drugs dictionary hierarchy to better reflect how medicines and vaccines are made available in the UK. For example ingredients for vaccines are now grouped as per the current vaccination programme e.g Measles, Mumps and Rubella (MMR vaccine).

To note the inclusion of reports in different iDAPs is dependent upon how the reporter has reported the suspect drug or vaccine in their Yellow Card report; where individual ingredients have been listed these will not appear in the grouped entries.

The ability to search for substances you wish to view an iDAP for, using the free text search or the A-Z browser, is unaffected by this change.

Product specific considerations

Pneumococcal Vaccine(s)

• Please note iDAPs for pneumococcal vaccines are listed as Pneumococcal Conjugate Vaccine and Pneumococcal Polysaccharide Vaccine. In the UK, the pneumococcal vaccine is recommended for several age groups and individuals with certain risk factors. For infants, the routine childhood vaccination schedule includes Pneumococcal Conjugate Vaccine, starting at 12 weeks of age. For adults aged 65 and over, the Pneumococcal Polysaccharide Vaccine is recommended.

Varicella Virus

• Varicella-zoster vaccines protect against chickenpox and shingles. Reports of suspected adverse effects for these vaccines are contained within three iDAPs: Varicella Zoster Virus Vaccine (Shingrix 1), Varicella Zoster Virus Vaccine (Shingrix 2) (both of these iDAPs contain reports relating to shingles vaccine), and Varicella Zoster Virus Vaccine (containing reports relating to shingles vaccines and chickenpox vaccines). If you are interested in data specifically for the indication of chicken pox or shingles we suggest that users filter the iDAPs by age to review information for vaccinations of interest.

Upcoming Improvements

Yearly breakdowns

The MHRA is aware of differences in the number of suspected ADR reports received when broken down by year, when compared to our previous publications. Our new system uses the date the most recent revision of the ADR report was received, in order to determine the received year. This means the year the report was received can change if updated information is received. Our legacy system determined year using the date we first received the ADR report. Please note that we will be amending this logic in the future in order to align with our previous publication.

Seriousness

There are known differences in the number of suspected ADR reports per serious (non fatal) and non-serious categories when compared to our previous publications. In order to explain this, it is important to understand how seriousness is determined. A case is considered serious (Non fatal) if it meets the below criteria:

• Any CIOMS seriousness flag* is marked as yes or the ADR report contains a ‘dictionary serious’ term.

• The ADR report does not contain a fatal outcome.

Previously ‘dictionary serious’ terms were determined by the most up-to-date list. However, our new system utilises the serious list at the time the report was received. Therefore, reaction terms which were present on the MHRA’s ‘dictionary serious’ term list at the time of completion, but have since been removed due to routine clinical reassessment of terms, will still be marked as serious. This also applies to terms which have been added to the ‘dictionary serious’ term list since the report was received. These reports may therefore be marked as non-serious despite containing a term which is now considered serious.

Please be assured we are planning a future enhancement to determine ‘dictionary serious’ terms based on the most recent list, in alignment with our legacy system. Please note that fatal counts are not impacted.

CSV downloads

To note, downloading drug data via CSV is currently disabled as we continue to make enhancements. Please be assured that these will be made available as soon as possible.

Route

Route of administration, or ‘Route’, is currently displaying a field which can be populated with free text. Therefore, you may find routes which do not align with our pre-determined list of values. This will be amended in the near future to utilise a structured list of reference terms.

Product types

A small number of products have been identified as incorrectly linking to more than one product type, such as both medicine and vaccine. This causes duplication of the product in the product list as well as the duplication of text in the ‘Information’ tab and at the start of the ‘Total Report Profile’ and ‘Total Reaction Profile’ tabs.

Please see a list of products affected by this below:

ALUMINIUM HYDROXIDE, DENGUE FEVER VACCINE, HEPATITIS A VACCINE, HEPATITIS B VACCINE, HPV VACCINE, PNEUMOCOCCAL CONJUGATE VACCINE, RABIES VACCINE, RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINE (AREXVY), VARICELLA ZOSTER VIRUS VACCINE (SHINGRIX 1), ROTAVIRUS VACCINE, TYPHOID VACCINE, COVID-19 VACCINE NOVAVAX, COVID-19 VACCINE UNSPECIFIED, TICK BORNE ENCEPHALITIS VACCINE, COVID-19 VACCINE PFIZER/BIONTECH MONOVALENT, YELLOW FEVER VACCINE

Please note this does not affect case counts or numerical displays of the data. Improvements are currently underway to ensure each product only has one associated product type.

*The seriousness criteria for ADR reporting were determined by a working group of the Council for International Organizations of Medical Sciences (CIOMS) and are defined as 6 possible categories which are documented on the Yellow Card. Reporters can select one or more of the following criteria by ticking the appropriate box on the Yellow Card. The criteria are: (1) patient died due to reaction (2) life threatening (3) resulted in hospitalisation or prolonged inpatient hospitalisation (4) congenital abnormality and (5) involved persistent or significant disability or incapacity or (6) if the reaction was deemed medically significant.

Comments & Feedback

If you have any comments or feedback about our new Yellow Card interactive Drug Analysis Profiles (iDAPs), please do not hesitate to contact us.