Date of prep: December 2020
Prescribing information and
adverse events reporting
For healthcare professionals only
The MHRA has launched a public consultation on the reclassification of two progestogen-only contraceptive pills containing desogestrel. This is the first time such a change has been considered.
The consultation affects two products containing desogestrel; Lovima 75 microgram film-coated tablets and Hana 75 microgram film-coated tablets. Lovima and Hana are both oral contraceptives for continuous use to prevent pregnancy in those of childbearing age.
We are asking the public and stakeholders for their views on whether these two products should become a pharmacy medicine and available over the counter, without a medical prescription.
If these two products are reclassified, pharmacists will have access to training materials and a checklist to enable them to identify women who can be supplied this medicine safely.
The Commission on Human Medicines has advised that it is safe for these is products to be made available as a Pharmacy (P) medicines.
The consultations are open until 5 March. As these are 2 products, 2 separate consultation pages are required:
Dr Sarah Branch, Director of Vigilance and Risk Management of Medicines at the MHRA, said:
“Every response received will help us gain a better picture of whether people think the contraceptive pill with desogestrel should be available over the counter.
“We hope to hear from as many people and women’s groups as possible.”
Michelle Riddalls, CEO of the Proprietary Association or Great Britain, the consumer healthcare association, said:
“We fully support these reclassification applications. Switching products from prescription-only to make them available over the counter, once their safety and efficacy has been rigorously assessed and established, is a positive step.
“It enables people to self care where appropriate, minimising inconvenience for individuals and protecting NHS resources such as GP appointments for those who need them most. The applications by Maxwellia and HRA Pharma have particular significance as they are the first to seek over-the-counter licences for any form of daily contraceptive pill, 60 years after the pill in its original form was made available via prescription on the NHS for married women only.
“The MHRA consultation represents a landmark opportunity in women’s health and one which we hope will be viewed positively. Both Maxwellia and HRA Pharma have asked the MHRA to permit the sale of their progestogen-only pill products under the supervision of a qualified pharmacist.
“As expert healthcare professionals, pharmacists are fully equipped to offer advice to anyone seeking information about over-the-counter medicines. As part of any reclassification of desogestrel, they will be given specific training to enable them to identify whether the product is suitable for a particular individual and pinpoint any issues that might warrant further consultation with a GP or specialist.”
Pharmacy in Practice is a UK pharmacy publication with its roots in Scotland.