Guidance

Template wording for Call for Reporting sections for UK Direct Healthcare Professional Communications (DHPCs)

Updated 4 April 2023

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This publication is available at https://www.gov.uk/government/publications/how-to-draft-a-direct-healthcare-professional-communication/template-wording-for-call-for-reporting-sections-for-uk-direct-healthcare-professional-communications-dhpcs

1. Template wording for Call for Reporting sections for UK Direct Healthcare Professional Communications (DHPCs)

Direct healthcare professional communication letters should always include a ‘Call for reporting’ section to outline national arrangements for reporting suspected adverse drug reactions.

The below text is the text recommended by MHRA for typical UK DHPCs.

1.1 Call for reporting

Please continue to report suspected adverse drug reactions (ADRs) to the MHRA through the Yellow Card scheme.

Please report:

  • all suspected ADRs that are serious or result in harm. Serious reactions are those that are fatal, life-threatening, disabling or incapacitating, those that cause a congenital abnormality or result in hospitalisation, and those that are considered medically significant for any other reason
  • all suspected ADRs associated with new drugs and vaccines identified by the black triangle ▼

You can report via:

  • the Yellow Card website
  • the free Yellow Card app available from the Apple App Store or Google Play Store
  • some clinical IT systems (EMIS/SystmOne/Vision/MiDatabank) for healthcare professionals

Alternatively, you can report a suspected side effect to the Yellow Card scheme by calling 0800 731 6789 for free, Monday to Friday between 9am and 5pm.

When reporting please provide as much information as possible, including information about medical history, any concomitant medication, timing onset, treatment dates, and product brand name.

1.2 Additional sections

If the medicine is subject to additional monitoring, please also include:

  • [name]▼ is subject to additional monitoring. This will allow quick identification of new safety information
  • Please report ANY suspected adverse drug reactions (ADRs) to drugs and vaccines identified by the black triangle▼ to the MHRA through the Yellow Card Scheme.

If the letter relates to a vaccine or biological/biosimilar medicine, please also include:

The non-identical nature of biological medicines and vaccines means it is very important that safety surveillance is carried out on a brand/product-specific basis. When reporting a suspected ADR to a biological medicine (such as blood products, antibodies and advanced therapies [such as gene and tissue therapy]) or vaccine, please ensure that you provide the brand name (or product licence number and manufacturer), and the specific batch-number.

Additionally, when providing patients with details of the vaccine or biological medicine administered, it is good practice to give them details of the brand and batch number. This will allow patients and carers to more accurately report suspected ADRs to the Yellow Card scheme.

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