Immunomodulatory drugs Pregnancy Prevention Programme – temporary amendments to guidance during COVID-19 pandemic

22 May 2020

The Medicines and Healthcare products Regulatory Agency (MHRA) has agreed to temporary amendments to the Pregnancy Prevention Programmes for the following immunomodulatory drugs where clinically appropriate, during the coronavirus (COVID-19) pandemic:

These amendments are:

  • Thalidomide (Thalidomide Celgene)
  • Lenalidomide (Revlimid)
  • Pomalidomide (Imnovid)

Pregnancy prevention programmes are required for these medicines because they are teratogenic and can cause severe birth defects.

What are the temporary amendments made to the pregnancy prevention programmes for these three drugs?

  • It is acceptable for the patient to carry out pregnancy testing at home – this is at the discretion of the clinician and only if certain criteria are met.
  • Electronic editable versions of the Treatment Initiation Form (TIF) and Prescription Authorisation Form (PAF) have been made available to use for remote consultations.
  • These temporary amendments are in place until the recommended shielding measures have been lifted.

What are pharmacists dispensing prescriptions for these medicines required to do?

  • Be fully aware of the requirements of the Pregnancy Prevention Programme and the temporary amendments that are currently in place.
  • Ensure they have received the PAF from the prescriber before they dispense any prescriptions for these three drugs.
  • Check that the patient has been advised by the prescriber about the risks of teratogenicity, and the importance of continuing effective pregnancy prevention measures.
  • Confirm with the patient that they have received an educational booklet and a hard copy of the TIF.
  • Advise the patient to continue to report suspected side effects using the Yellow card Scheme.

Pharmacists are advised to read the full details and the letter issued to healthcare professionals, available on the MHRA website.

For further information on this or any other query, please contact the NPA Pharmacy Services team on 01727 891 800 or email pharmacyservices@npa.co.uk.