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What do I need to know about the new Viagra regulations?


15 Mar 2018

With the well-known erectile dysfunction drug set to become available without a prescription this spring, Kathy Oxtoby gives
a refresher on points that pharmacists should consider

It’s a first for the UK pharmacy profession and a move that could help treat many more patients for what is a debilitating condition.
From spring, pharmacists can sell the male impotence drug Viagra without a prescription.

The Medicines and Healthcare Products Regulatory Agency (MHRA) hopes that making this medication more widely available ‘will help direct men who might not otherwise seek help into the healthcare system and away from the risks that come with buying medicines from websites operating illegally’.

Viagra Connect (containing sildenafil 50mg) will be formally reclassified from a prescription-only medicine (POM) to
a pharmacy medicine (P). The decision was made after a reassuring assessment of the safety of Viagra Connect, advice from the Commission on Human Medicines (CHM) and positive responses to a public consultation in 2017.

The MHRA says the drug can only be sold without prescription in a pharmacy after the pharmacist has determined whether treatment is appropriate for the patient. The pharmacist can also give advice on erectile dysfunction (ED), usage of the medicine, potential side effects, and whether or not further consultation with a general practitioner is required, the regulatory agency says.

Good for patients, good for pharmacy

It will not be sold to men with severe cardiovascular disorders or at high cardiovascular risk, or to patients with liver failure or taking certain interacting medicines. In such cases, they will still
need to see their GP. The drug’s manufacturer Pfizer also recommends that pharmacists should advise all men to follow up with their doctor within six months of first being supplied the product.

Mick Foy, the MHRA’s group manager in vigilance and risk management of medicines, says that ED ‘can be a debilitating condition, so it’s important men feel they have fast access to quality and legitimate care, and do not feel they need to turn to counterfeit online supplies which could have potentially serious side effects’.

Terry Maguire, community pharmacist at Maguire Pharmacy in Belfast, also views the switch to over the counter (OTC) for Viagra as ‘good news’ for pharmacy.

Also welcoming the switch is Lila Thakerar, superintendent pharmacist at Shaftesbury Pharmacy in Harrow, who
says that any changes from POM to P ‘is a fabulous change for pharmacy – it gives it a more clinical outlook’. She believes the switch is good news for patients too. ‘Patients will not have to wait for prescriptions, or necessarily have to make an appointment to see their doctor,’ she says.

The introduction of OTC Viagra will give ‘a better quality of life’ for men with ED, as well as ‘helping with social health, such as improving relationships, and reducing depression’, says Sid Dajani, contractor at Wainrights Chemist in Bishopstoke, Hampshire.

Given that ED is linked to diabetes, heart disease and high blood pressure the switch to OTC also offers pharmacists a chance to give men health advice. ‘It offers huge possibilities to make positive lifestyle changes,’ says Mr Maguire.

A sensitive topic

To help deal sensitively with men who ask for the drug, pharmacists say they and their staff will require training. Kristie Sourial, senior medical manager for Pfizer, says Pfizer has been implementing ‘an extensive training and education programme within pharmacies’ since February.

She says that the training, available since 12 March, features a variety of resources and training methods to accommodate a diverse range of learning styles, such as face-to-face sessions, regional meetings, and resources including trade press, articles and advertising.

‘Tailored educational content will also be provided for pharmacy assistants, who may be the first point of contact for men seeking help for the symptoms of ED,’ she says.

Recognising the need to support pharmacists to make the most of these potentially new consumers, she says that Pfizer is ‘rolling out an extensive consumer awareness programme to support the pharmacy training package’, that aims to ‘demystify the process of purchasing Viagra Connect from a pharmacist, and empower men to seek advice and treatment for their symptoms of ED’.

As 95% of counter staff at Ms Thakerar’s pharmacy are female, she believes they will need training on how to ensure men feel comfortable when initially asking for the drug, and for them to be aware of the importance of ensuring customers receive advice from the pharmacist in the privacy of a consulting room.

‘Everything in our pharmacy is open plan so it requires a lot of sensitivity to direct people to the consulting room in a manner that is not embarrassing for them,’ she says.

She points out that pharmacists will need to carry out ‘background checks’ in the consultation room on patients requesting Viagra Connect, such as why they have chosen to visit the pharmacy and not their GP, and whether they have, say, cardiovascular conditions, or are on medications that could interact with the drug.

Educating patients

To help encourage conversations about ED in general, Ms Sourial suggests that strategically-placed patient information materials may provide encouragement to men who are considering raising the subject of ED with pharmacy staff.

‘Placing items near popular men’s health and hygiene products, such as razors and shaving cream, condoms or men’s deodorant, can provide men with a prompt to head to the counter and help start the conversation,’ she says.

To help highlight the fact that a pharmacy offers the drug without
a prescription and help men understand more about ED and the product, Ms Sourial says Pfizer will also be providing ‘a broad range of shop floor merchandising and point-of-sale assets’. The assets will include hotspot displays, shelf barkers and window posters.

Pharmacies can also help direct men seeking treatment for their ED symptoms to the pharmacy by clearly outlining the services they offer on their website, including the availability of Viagra Connect, she suggests.

By selling Viagra OTC, a pharmacy also has the opportunity to sell related products. The introduction of OTC Viagra will result in ‘a lot of link-selling prompted by staff or pharmacists for customers to also condoms or lubricants’, says Ms Thakerar.

And once customers are used to going to pharmacy for treatment for ED, pharmacists can also encourage them to make healthier lifestyle choices, Mr Maguire believes.

There are many opportunities for pharmacy to support customers with ED and to enhance their health. Now they are just waiting for it to happen — and it’s about time too, says Mr Dajani: ‘There’s
a mystery about ED and a taboo around it. Viagra should have been available over the counter years ago.’

Digital training on Viagra Connect is available via hcp.viagraconnect.co.uk

Kathy Oxtoby is a freelance journalist

Resources

1 Fisher, William A., et al. “The multinational Men’s Attitudes to Life Events and Sexuality (MALES) Study Phase II: Understanding PDE5 inhibitor treatment seeking patterns, among men with erectile dysfunction.” Journal of sexual medicine 2004;1(2): 150-160

2 Miner M, Erectile dysfunction: a harbinger or consequence: does its detection lead to a window of curability? J Androl 2011; 32(2): 125-34


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