Date of prep: December 2020
Prescribing information and
adverse events reporting
For healthcare professionals only
A major new initiative to ensure pregnant and breastfeeding women can make informed decisions about their healthcare was announced recently by the health minister, Nadine Dorries.
The Safer Medicines in Pregnancy and Breastfeeding Consortium brings together 16 leading organisations under a common pledge to meet the information needs of pregnant and breastfeeding women and healthcare professionals, through accessible, clear and consistent advice.
The partnership spans the NHS, regulators, and leading third sector and charitable organisations. Together, this group will develop a long-term programme of work to improve information provision on medicines for women who are thinking about becoming pregnant, are pregnant, or are breastfeeding.
In the UK, hundreds of thousands of babies are born each year, and more than 50% of expectant mums will need to take a medicine of some description when pregnant.
Work on this is already underway. A report published by the Commission on Human Medicines (CHM) Expert Working Group on Optimising Data on Medicines used During Pregnancy has provided recommendations on ways in which data on medicines used in pregnancy and breastfeeding can be better collected and made available for analysis. This will enable more robust evidence to be generated through research and will be important in helping to develop clear and consistent advice about medicines used during pregnancy and breastfeeding – the main aim of the Consortium.
Recommendations of the report include the better capture and linking of existing data, exploring new ways to collect relevant information on exposure to medicines during pregnancy and breastfeeding, and improving access to and quality of data to further enable research. The Consortium welcomes the recommendations of the report.
To support the aims of the Consortium, the MHRA has developed a webpage to assist users in finding information and projects related to medicines use in pregnancy and breastfeeding. This webpage includes links to Consortium members’ websites, which also contain important information.
Healthcare professionals are asked to report important inconsistencies in UK advice on use on individual or classes of medicines in pregnancy or breastfeeding to the Consortium.
Anyone can report suspected side effects with medicines or adverse events with medical devices, including those experienced by the mother or baby during pregnancy or breastfeeding, to the Yellow Card scheme.
Nadine Dorries, Minister of State for Patient Safety, Suicide Prevention and Mental Health, said:
“It is vitally important women are empowered to make informed decisions about their healthcare during pregnancy and this means accessing timely information and answers about any medicines they consider taking while pregnant or breastfeeding.
“I am delighted so many of the health system’s main information providers are working closely together to address this and I look forward to seeing positive results from this new collaboration.”
Dr June Raine, MHRA Chief Executive and Chair of the Consortium said:
“We know that in many cases the information on taking medicines when pregnant or breastfeeding can be improved. I would encourage healthcare professionals to report any important inconsistencies you find on our webpage.
“There is vital work to be done, as started by the EWG report published today and continued by our new Consortium, which is addressing the issue head-on. Today is an important step, and we are proud to have brought this partnership together.”
This circular is being shared under the Open Government Copyright licence.
Pharmacy in Practice is a UK pharmacy publication with its roots in Scotland.