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, making it important that the public’s views are heard.
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.
Pharmacists are trained healthcare professionals. 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.
‘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,’ said Dr Sarah Branch, Director of Vigilance and Risk Management of Medicines at the MHRA. ‘We hope to hear from as many people and women’s groups as possible.’
Contraceptive pills containing desogestrel will still be available on prescription from GPs and sexual health clinics.
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 wo products, two separate consultation pages are required:
- Lovima 75 microgram film-coated tablets (Desogestrel)
- Hana 75 microgram film-coated tablets (Desogestrel)
A medicine will be non-prescription unless it fulfils one or more of the criteria for prescription control as set out below and in the Human Medicines Regulations 2012 regulation 62(3). Prescription only (POM) status will apply where:
- a direct or indirect danger exists to human health, even when used correctly, if used without medical supervision
- there is frequent incorrect use which could lead to direct or indirect danger to human health
- further investigation of activity and/or side effects is required
- the product is normally prescribed for parenteral administration.”