Valproate Medicines - Prevent Programme
Are you acting in compliance with the pregnancy prevention measures?
The Valproate Pregnancy Prevention Programme (Prevent) Guide for Healthcare Professionals has been updated (November 2019). The changes made are to clarify the existing Regulatory situation and are not due to new advice. The main changes made from the previous May 2018 version are as follows (and can be found in the Drug Safety Update February 2020):
- Clarification that the provisions of the Prevent programme need to be maintained throughout the period of use of valproate
This also applies when a patient is being switched from valproate to another treatment – the conditions of Prevent should be continued until valproate is discontinued.
- New section: “Definition of Specialist Prescribers”
Provides clarity on responsibilities when initiating therapy and implementing the Prevent programme. The updated guidance now clarifies that activities to implement Prevent may be carried out by other healthcare professionals as part of a consultant led team, for example, specialist nurses.
The guidance now includes consultant paediatricians in their definition of specialist prescribers.
- New section “Contraception”
Progestogen-only injections may be considered as highly effective if repeat injections are documented as having been administered on schedule by a healthcare professional.
The contraceptive advice: valproate medicines blog has been revised to reflect this new advice.
Pregnancy testing is advised when starting valproate treatment. The updated guideline now advises that pregnancy tests may not detect an early pregnancy that has occurred after unprotected sex in the preceding 3 weeks. Repeat pregnancy testing is advised 3 weeks after starting a new contraceptive method if there was any risk of pregnancy at the start of the contraceptive method, even if the first test was negative.
- New section “Does Prevent apply to my patient?”
Acknowledges that the only exception to Prevent is where a specialist considers that there are compelling reasons to indicate that there is no risk of pregnancy. These reasons should be documented on the Annual Risk Acknowledgement Form.
This section also highlights that in some circumstances, absence of risk may not be permanent and may change. Where absence of risk is not permanent, patients or the patients' family/carers need to be fully informed on risk and how to contact the specialist rapidly if the situation changes.
Temporary advice for management during the COVID-19 pandemic
The MHRA has made some temporary amendments to the pregnancy prevention programme for valproate products during the COVID-19 pandemic. For initiation in patients of childbearing potential, a face-to-face consultation (with appropriate social distancing) is required, except where the patient is shielding, where a remote consultation should be considered based on an individual risk assessment.
Annual reviews should not be delayed due to the pandemic, and specialist prescribers should undertake video virtual consultation (preferably) or telephone consultation (if video is not possible) with the patient.
MHRA advice available here describes the processes to be used when undertaking reviews, including advice on pregnancy testing, for situations where face-to-face review is not possible.
Published 08/06/2020. Medicines Update blogs are correct at the time of publication.