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Analysis: Why is the MHRA considering making sildenafil available OTC ?


07 Apr 2017

Sildenafil, used to treat adult men with erectile dysfunction as an alternative to Viagra, could be made available in pharmacies without prescription, according to the medicines regulator.

Pfizer Consumer Healthcare, which holds the license for sildenafil, applied to the Medicines and Healthcare products Regulatory Agency (MHRA) to sell a maximum of eight of the 50mg tablets as a pharmacy medicine.

The MHRA, which regulates UK medicines on behalf of the Government, is now holding a public consultation on whether this change should go through.

The MHRA said: ‘We always want to involve the public and healthcare professionals in decisions that affect them. We want to know what you think about this change.’

The sector is being consulted on the following points:

  • If sildenafil should be made a pharmacy medicine
  • If the pharmacist checklist is useful and sufficient
  • Any other comments on the change

The deadline for comments is Tuesday, 18 April 2017.

Sildenafil tablets, which contain sildenafil citrate, are part of the phosphodiesterase type 5 (PDE%) inhibitors group, which block the breakdown of cGMP (cyclic guanosine monophosphate) in the penis.

Risk to the patient

There are various circumstances in which men should not be dispensed sildenafil. For example, if a patient gets very breathless or feels any pain in the chest with light or moderate activity, then sildenafil may not be suitable for them to use.

Similarly, if they have low blood pressure, take riocigual or ritonavir, or have severe liver problems, then they should not be given the drug.

As there is a link between erectile dysfunction and cardiovascular conditions, it is vital to note when the impotence may be a synptom of a more serious illness.

‘Safe’ for sale without prescription

As set out in the Human Medicines Regulations 2012 Act, a drug may not be sold over the counter if it does not fulfill the criteria for prescription control. Prescription-only status applies where:

• A direct or indirect danger exists to human health, even when used correctly, if used without medical supervision

• There is frequently 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

The MHRA assessed the application against these criteria and concluded that sildenafil would be suitable for over the counter sale as it is ‘safe enough to be made available as a pharmacy medicine in certain circumstances’.

Training and risk assessment

A risk checklist for pharmacists was produced by Pfizer as part of their application, which they can choose to use when supplying sildenafil to help determine whether it is suitable for the patient.

The checklist includes a series of questions around other medicines, other conditions and cardiovascular health. There is also an information leaflet for the patient.

The MHRA found that pharmacy availability of sildenafil tablets would ‘be of value’ to men who suffer from erectile dysfunction and that: ‘The risks of indirect danger arising from missed diagnosis of underlying disease is minimised through the pharmacist using their professional judgement’. Pharmacists will be able to use the checklist to identify patients who should not be given sildenafil and refer them to a doctor.

The MHRA concluded that the ‘low risks’ were ‘outweighed by the benefits that this route of supply can bring – by bringing a hard-to-reach group into healthcare environment with the potential to increase earlier identification of heart disease and also reducing the risks associated with use of counterfeits obtained via the internet.’

What do pharmacists think of the proposals?

Community pharmacists took to Twitter to let The Pharmacist know their views on whether or not making the drug available OTC could lead to its misuse.

Further proposals

The MHRA is also consulting on proposals to reclassify Dovonex Psoriasis 50 microgram/g Ointment (calcipitriol) for the treatment in adults of plaque psoriasis which has been previously diagnosed by a doctor, as a pharmacy medicine.

They also recently consulted on proposals to reclassify Maloff Protect tablets (Atovaquone/proguanil) for the prevention of malaria in adults to be sold over the counter. The results of this consultation are currently under review.


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