Register of pregnant patients taking acne drug isotretinoin under consideration by NHS Digital

NHS Digital clinical lead Paul Brown told delegates at the Clinical Pharmacy Congress that other high-risk medicines are also being considered.
pharmacist typing on desktop computer

NHS Digital is considering developing a register of patients prescribed isotretinoin — an acne medication — as well as other high-risk medicines during pregnancy, its clinical lead has confirmed.

Speaking at the Clinical Pharmacy Congress in London on 14 May 2022 on the benefits of collecting data through electronic prescribing and medicines administration (ePMA) systems at NHS trusts, Paul Brown said that these include the ability to link ePMA data to other datasets.

Funding for trusts to set up ePMA systems was first announced in 2018, with the expectation that they would build an electronic record, while ensuring fast access to potentially life-saving information on prescribed medicines and reducing medication errors by up to 50%.

Brown said the data collected through ePMA “fills a huge gap in what we don’t have at the moment”.

“For the first time, we really will have good knowledge about the medicine use when a patient comes into hospital, during their stay, and discharge,” he said, adding that it will provide “confidence that the patient has taken the medicine, rather than [it just being] supplied”.

“Where I think this dataset really comes into play is the ability, because we have the patient identified, to link it to other datasets — something we’ve been doing with the primary care data for a while, the medicines safety work,” he added.

“We are currently working on medicines in pregnancy registries on the back of the Cumberlege report,” Brown said, highlighting NHS Digital’s publication in February 2021 of a registry of patients taking sodium valproate during pregnancy.

“We’re looking at other anti-seizure medicines as we speak. The ambition is to look at other high-risk medicines as well shortly — isotretinoin being an example.

“This data will fill in lots of gaps that we have around initiation of valproate, certainly covering the gap of inpatient stay. It all adds to that journey for the patient in our understanding of medicine use.”

In July 2020, the Independent Medicines and Medical Devices Safety Review, chaired by Baroness Cumberlege, called for a register of all women taking any antiepileptic drugs who become pregnant, which would include mandatory data reporting on both them and their children over their lifetimes.

Following the publication of the sodium valproate register, the Department of Health and Social Care said in March 2021 that it was prioritising extending the register to include all antiepileptic drugs.

While isotretinoin is not an antiepileptic, the Medicines and Healthcare products Regulatory Agency (MHRA) published a reminder for healthcare professionals in August 2020 that the medicine, which is used to treat severe acne, is “a powerful teratogen associated with a high frequency of severe and life-threatening birth defects if there is exposure in utero”.

When asked when the register of pregnant patients taking isotretinoin would be published, NHS Digital said in a statement on 17 May 2022 that Brown was “giving examples of the kind of things that are being considered rather than anything definite”.

“We’re working with the MHRA to develop comprehensive national medicines and pregnancy registries, which will give a better understanding of the use, benefits and risks of medicines taken in pregnancy,” it said.

Last updated
The Pharmaceutical Journal, PJ, May 2022, Vol 308, No 7961;308(7961)::DOI:10.1211/PJ.2022.1.143339

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