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Make EHC GSL, says bpas

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IT’S 15 years since the progestogen-only emergency contraceptive, Levonelle, was first made available to women to buy from behind the counter in pharmacies. The price was set high from the outset by the then distributor Schering, who said at the time it was making it expensive in order to deter women from using it.

It’s hard to think of any other medicine where this would be an acceptable approach – yet, this is the one that is still in place today.

Costing up to £30, women in the UK pay more for retail provision than women in any other European country with the exception of Ireland, a country you don’t particularly strive to be bedfellows with when it comes to issues of women’s reproductive choice. ‎

Women pay five times more than their counterparts in France for pharmacy access, and nearly three times as much as women in the Netherlands, where they can also pick it up off the shelf.

While women can obtain it for free from their GP, sexual health clinic or a local pharmacy scheme, the difficulty obtaining a timely appointment, or the fact that many women may fall outside the upper age limit for free pharmacy access, means many women have little choice but to purchase it – or take a risk. Which is what many do – we see them in our centres, dealing with an unplanned pregnancy, every day of the week.

Despite ongoing promotion of long-acting reversible contraceptives like the implant and IUS/IUDs – the majority of women (70 percent) depend on the user-reliant methods‎ – pills and condoms. They need swift access to a back-up when those methods fail or are forgotten.

Emergency contraception provides women with that option, yet we have created a framework which makes it unnecessarily difficult for them to avail themselves of it. We have stigmatised and problematised a product that gives women a second chance, wrapping it up in an expensive parcel of shame.

Cost control
Cost is a key problem. But the obligatory consultation with a pharmacist – even when delivered in the most non-jud‎gmental, supportive manner imaginable, as we know is often the case – is another.

We need to ask ourselves why other countries (in North America and Europe for example) whose drug safety protocols are not known to be less rigorous than our own, feel that women can be sufficiently trusted to pick this product off the shelf and use it safely and effectively without a mandatory discussion with a healthcare professional.

We know women on occasion have to make multiple requests in the shop before they speak to the right person, and can find the whole process embarrassing, off-putting and unnecessary.

As it goes, bpas believes that 15 years on from Levonelle becoming a P-medicine, it meets all the clinical criteria for GSL status. There are no known health risks associated with the use of progestogen-based emergency hormonal contraception.

No deaths or serious complications have been causally linked to this product, and the World Health Organisation classifies it as a Level One medication – indicating there should be no restrictions on its use‎.

It can be used repeatedly, including within the same cycle. The UK Medical Criteria for Contraceptive Use (UKMEC) advises that there are no medical contraindications to its use, including breastfeeding.

It cannot disrupt an existing pregnancy, there is no evidence it causes any congenital malformations or any other pregnancy complications, so it can be used for an episode of unprotected sex even when there has been an earlier episode outside the treatment window.

The relevant drug interactions relate to liver enzyme inducing drugs, and the issue here is one of reduced efficacy of EHC. This could be clearly stated in the Patient Information Leaflet.

Other GSL medicines
When we consider other GSL medicines now available, it is clear that progestogen-only EHC has an equally, if not significantly more favourable, risk profile. AstraZeneca’s Nexium tablets recently went to GSL after just a year as a P-medicine.

Notwithstanding the fact that its use can mask serious underlying gastric conditions such as cancer, that it has the potential to interact with other medicines, and that long-term use can increase the risk of Clostridium difficile and fractures, the MHRA felt patients could be trusted to use it safely and seek advice for worrying symptoms without the need for pharmacist intervention. It added that the risk of clinically important interactions ‎with other medicines was minimised by advice in the Patient Information Leaflet to consult their doctor or pharmacist if they were taking any of the medicines listed.

So, this patient group can be trusted, but sexually-active women? They apparently need supervision.

Another useful example comes in the form of Nicotine Replacement Therapy (NRT), which could be fatal if ingested by children. Nicotine has long been known to be a cause of poisoning in young children, but the attractive nature of NRT products – which are easier to chew and swallow in greater quantities than traditional cigarettes – may makes them more likely to be ingested by young children.

The estimated fatal dose for a 2 year old would be 3 pieces of 4mg nicotine gum. Again, the PIL carries clear warnings that doses of nicotine tolerated by adults can produce severe toxicity in small children that can be fatal. But it was clearly felt any risks posed by widening access to NRT were overwhelming outweighed by helping people give up an exceedingly harmful habit. There are no circumstances in which it is safer to smoke than to use an NRT.

Well, do you know what? There are no circumstances where it is safer to be pregnant than to take emergency contraception. There are immense public and, moreover, individual health benefits from widening access to emergency contraception and enabling more women to avoid an unplanned pregnancy – whatever the outcome of that pregnancy. And no-one, incidentally, has ever been at risk of death from the accidental ingestion of EHC.

Advice essential?
And the provision of NRT speaks to another point – access to professional advice. Placing medicines on the shelves of pharmacies does not prevent people asking for advice and signposting to further sources of support, as many people do for example when trying to stop smoking. Research by bpas shows many women find the information provided in an EHC consultation with a pharmacist helpful and praised the service they received.

“‎When I got it for free from a GP he was patronising and judgmental. I am in the lucky position of being able to afford to pay £25 to £30 for the convenience and better service of pharmacists” and “It was quick and simple and solved a problem.”

But others feel differently.

“I simply don’t understand why a woman of over 30 needs to be asked such intrusive questions” and “The man was very understanding and non-judgmental but I would personally rather not have to explain my sex life to someone I don’t know.”

‎And this is precisely the point. Information and advice should be there for those women who want it, but why should those who do not, be subject to a consultation they have not requested when there is no clinical need for this in order for the product to be sold safely?

We believe the time has come to seriously engage with how we deliver retail provision of emergency contraception. In an ideal world, all women would have access to local NHS-funded scheme through a local pharmacy, but in the absence of that, and in a climate of cuts which make it even less likely, and in the knowledge that for some women purchase will be preferable‎, we must do better.

The cost issue is an important one – and our hope is that with the arrival of generic versions of Levonelle after the loss of its patent this year – perhaps one manufacturer will be moved to provide a significantly more affordable product. But the whole framework needs re-evaluating – from the location of the product in the shop to the consultation that goes with it.

There will be people who raise concerns about access for under 16s which would of course need to be explored, particularly in regard to safeguarding – although it should be remembered that condoms can of course be purchased by people of any age without consultation or safeguarding protocols attached.

As it happens, Levonelle in its P forms is not currently licensed for under 16s (although EllaOne is). GSL products are not universally licensed for use in under 16s, and others can only be sold in pharmacies but are still available for self-selection.

Licensing and provision for under-16s must of course be a key component of any discussion, but an entire system of access for women of all reproductive ages needs to meet the needs of all women, not just younger ones. Nearly 8 times more women aged 25 needed abortion services last year than women aged 15.

Above all, we need to make crystal clear that use of EHC is not a marker of moral malaise nor a slut’s charter, but an extremely safe medication that can protect women’s health and that women can be trusted to use without supervision. It needs to be within women’s reach – quite literally.

At a time when Boots won’t even put a laminated medicines card illustrating EHC on display that women can take to the counter – as they do with other P medications – we are under no illusion that there is a long way to go. But we are determined to start that journey.

Clare Murphy is Director of External Affairs at the British Pregnancy Advisory Service (bpas)

bpas is a sexual and reproductive healthcare charity that sees 70,000 women a year for advice about unplanned pregnancy, or a pregnancy the feel they cannot continue. We provide abortion care if they decide to end that pregnancy or swift referral into antenatal care if they decide to continue. The majority of our services are provided under contract to the NHS

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