Following the MHRA’s recent finasteride evidence review, we look at new safety measures, and what pharmacy teams need to know to supply the medicine safely to patients.
Finasteride- an overview
Finasteride is in a class of medications called 5-alpha reductase inhibitors. According to the British National Formulary (BNF), finasteride is a prescription only medicine (POM), licensed for benign prostatic hyperplasia (5mg dose) and androgenic alopecia in men (male pattern hair loss, 1mg dose).
Finasteride has been reported to be associated with depressed mood, depression, suicidal thoughts and sexual dysfunction (including decreased sex drive and inability to get and maintain an erection).
In some cases, sexual dysfunction has persisted in patients even after they have stopped taking finasteride. However, there is a lack of awareness of these potential side effects.
Finasteride can’t be prescribed for androgenic alopecia in men under NHS primary care services, but can be available to the public via a number of private healthcare providers or through private services, including registered pharmacies.
Registered pharmacies are able to supply finasteride for androgenic alopecia under a Patient Group Direction or via a private prescribing service.
See the information about finasteride on the NHS website
Find out about benign prostate enlargement on NHS inform
The MHRA evidence review and actions
The Medicines and Healthcare products Regulatory Agency (MHRA) recently reviewed the available evidence about finasteride, following patient concerns about a lack of awareness of psychiatric and sexual side effects amongst patients and healthcare professionals.
To help make sure patients are able to make an informed decision about their treatment and know what to do if they experience adverse effects:
- a patient alert card is being introduced in all packs of finasteride to raise awareness of the risk of psychiatric and sexual side-effects associated with finasteride, including the potential for sexual dysfunction (decreased libido and erectile dysfunction) which can continue after stopping treatment
- healthcare professionals are now being advised to ask patients if they have a history of depression or suicidal ideation before providing finasteride
- patients should be monitored for psychiatric and sexual side-effects from the start of their treatment
Yellow card scheme
Any suspected adverse drug reactions associated with finasteride should be reported via the Yellow Card scheme
Aligning GPhC principles, standards and guidance to providing finasteride safely to patients
Our standards for registered pharmacies require pharmacy professionals and owners to identify the risks associated with providing a pharmacy service. Given the identified risks associated with finasteride, pharmacy professionals and owners should consider within their risk assessments how they will ensure that finasteride will be prescribed and supplied safely, and in the person’s best interest.
Online pharmacies, and other pharmacies that provide services at a distance, sometimes also provide these medicines. Providing finasteride at a distance carries particular risk. Our guidance for registered pharmacies providing services at a distance including on the internet explains what pharmacy professionals should consider before deciding if any parts of their service can be provided safely and effectively at a distance including on the internet.
In line with our standards and guidance and the drug safety update, pharmacy professionals should ensure they can adequately gather the information they need in relation to prescribing and/or supplying finasteride and ensure that appropriate monitoring, follow up and support is available to patients and users of their service.
Keeping up to date
We expect pharmacy professionals to keep up to date on information and learning in line with the services they provide to help keep patients and the public safe. This includes but is not limited to drug safety updates, alerts from the MHRA, the BNF, the Specialist Pharmacy Services (SPS) and the National Institute for Health and Clinical Excellence (NICE).
Considerations for pharmacy teams
When incorporating these updates around finasteride into a pharmacy service, pharmacy teams should review the training requirements of team members to undertake good quality consultations, provide adequate counselling and prescribe and supply finasteride safely to patients.
When providing prescribing services, the pharmacy’s risk assessments for the service should include consideration of robust systems to verify the medical history of the patient to ensure that prescribers receive reliable, accurate and up to date information. The pharmacy’s policies and procedures should consider appropriate timeframes to review a patient when issuing repeat prescriptions and factor in how they will ensure appropriate monitoring of adverse side effects.
Find out more
Below is a list of resources to help you make sure you are meeting our regulatory standards and guidance and working in line with good practice.
GPhC resources
- Our standards for registered pharmacies set out the requirements for the provision of pharmacy services at or from a registered pharmacy.
- Our guidance for registered pharmacies providing pharmacy services at a distance, including on the internet, explains what pharmacy owners should consider before deciding whether any parts of their pharmacy service can be provided safely and effectively at a distance (including on the internet).
- Our prescribing guidance provides guidance to pharmacist prescribers in applying the standards when prescribing. The guidance applies whatever setting pharmacist prescribers work in. It sets out the key areas pharmacist prescribers should consider when applying the standards to their prescribing practice.
Additional resources
- See the Drug safety update from April 2024, which provides advice on the introduction of a patient card for men taking finasteride as well as providing further information to healthcare professionals
- Find out more about the review of the available evidence into finasteride by the MHRA
- Find out about reporting suspected side effects to medicines, vaccines, e-cigarettes, medical device incidents, defective or falsified products to the MHRA
- See the summary of product characteristics for finasteride 5mg tablets
- See the summary of product characteristics for finasteride 1mg tablets
- See the British National Formulary finasteride monograph