As the two OTC oral contraceptive products arrive in community pharmacy following MHRA approval, there are high hopes that the switch will both benefit women and present a significant opportunity for the sector
A recent inquiry by the All Party Parliamentary Group on Sexual and Reproductive Health found that women in England have difficulty accessing contraception, resulting in unplanned pregnancies and increased demand for maternity and abortion care.
In 2018, 45 per cent of pregnancies and one-third of births in England were unplanned or associated with feelings of ambivalence, and around 10 per cent of births were unintended, according to data from the National Survey of Sexual Attitudes and Lifestyles.
Public Health England estimates that one-third of women cannot access contraception from their preferred setting and the Covid-19 pandemic has exacerbated a marked reduction in services – all of which suggests a serious unmet need for contraception. So the MHRA’s decision to allow two progestogen-only contraceptive pills (POPs) containing desogestrel to be available to buy in pharmacies without the need for a prescription is surely good news all round.
Benefits for women
Although still available free of charge on prescription from doctors and from sexual health clinics, Lovima 75mcg film-coated tablets (from POM to P specialist Maxwellia; rsp 28 tablets £14.28, 84 tablets £28.56) and Hana 75mcg tablets (HRA Pharma; 28s £9.48, 84s £20.90) have both been reclassified following a consultation earlier this year and are now available from pharmacies.
Both manufacturers cite overcoming the barriers to accessing contraception as a key driver for the development of the products, giving women a greater choice in how they manage their contraceptive needs.
“It is clear that the limited and restricted way women can currently access contraception isn’t working for many of them,” says Maxwellia chief executive Anna Maxwell, while HRA Pharma’s chief strategic operations and innovation officer, Frederique Welgryn, suggests that the availability of Hana in pharmacies will help to improve women’s access to contraception in a variety of ways. “For those using barrier or natural methods, there could potentially be increased use of a more effective contraceptive,” she says.
Healthcare organisations are all broadly in agreement about the benefits for women. Michelle Riddalls, PAGB chief executive, says being able to access two different brands of contraceptive pill over-the-counter under the supervision of a pharmacist is a “landmark moment” for women’s health in the UK.
“We would welcome that at any time at PAGB but it is particularly important when NHS resources generally are overstretched because of the Covid-19 pandemic,” she says.
The timing of the switch has also been welcomed by the Faculty of Sexual and Reproductive Healthcare (FSRH) and the Royal College of Obstetricians and Gynaecologists (RCOG), which have both lobbied for the reclassification.
“The fragmented sexual and reproductive healthcare system is notoriously difficult for women to navigate, and successive cuts to public health budgets have made it harder for women to get the contraception they need,” says FSRH president Dr Asha Kasliwal. “Availability over the counter in pharmacies will make it easier for women to access essential contraception to avoid unplanned pregnancies during and beyond Covid-19.”
Meanwhile, Dr Edward Morris, president of the Royal College of Obstetricians and Gynaecologists says the RCOG is “delighted” that all those who need the POP can now access it in pharmacy, adding that the body “has called for this for some time and it was a key recommendation of the college’s Better for Women report”.
Opportunity for pharmacy
As well as being a potential game-changer for women, the reclassification also shines a very public light on pharmacy’s potential to make an enhanced contribution in this area.
Michelle Riddalls says reclassifying medicines from POM to P status “recognises the hugely important role that pharmacists play within the health system as a whole” and gives community pharmacy an opportunity “once again to demonstrate not only its value but its potential”.
This potential could prove vital for supporting customers’ sexual health as we come out of the pandemic, Frederique Welgryn says, as “early indications show sexual activity increasing as restrictions ease”, and “31 per cent of people say they are now more likely to visit a pharmacy first before seeking help elsewhere, since the start of the pandemic”.
While the cash margin for the new pharmacy-only POPs will be higher than for the dispensed versions, Anna Maxwell suggests that the switch can also bring growth to pharmacy in other ways by “opening up the opportunity to offer other products and services such as advice on breast awareness, BMI and cervical screening”.
The great unknown, however, is whether the retail price proves to be a barrier for women in terms of affordability. “While this reclassification is a positive move, cost will be a barrier for some, [so] we would like to see the pills available for free through NHS community pharmacies too,” says Simphiwe Sesane, contraceptive nurse and faculty registered trainer at MSI Reproductive Choices. And she is not alone in taking this view:
- RPS president Professor Claire Anderson says that although pharmacy should “embrace” the switch because of the ease of access it promotes, “ultimately these products should be available free from pharmacy as they are from GPs, so we have a level playing field”
- The FSRH is also calling for the pills “to be available to everyone for free in community pharmacies, as well as the reclassification of other contraceptives moving forward”
- The British Pregnancy Advisory Service (BPAS) says “we firmly believe that all contraception should be free”
- The Primary Care Women’s Health Forum (PCWHF) goes so far as to say that it “would be very concerned if the option of access to free contraception was ever altered”.
In response, the manufacturers point out that women still very much have the option of getting these oral contraceptives from their GP or other sexual health service provider at no cost to them.
“It is important to note that desogestrel will continue to be available on prescription free of charge, giving women the choice to visit the GP or family planning clinic if they wish,” says Frederique Welgryn. “The reclassification means there is increased choice and accessibility for some women who, because of lifestyle preferences and/or convenience, are willing to pay for their contraceptive choices.”
HRA Pharma says its research shows the price is “in line with what women will be happy and willing to pay”, with Maxwellia’s research putting a figure of 44 per cent on the number of women it says are “willing to pay for convenience”.
Training and support
Clare Murphy, BPAS chief executive, calls the reclassification “an uncontroversial move” and says pharmacists can learn from the reclassification of emergency hormonal contraception in the early 2000s, “eschewing needlessly intrusive consultations” to ensure any consultation is “swift and straightforward”.
While acknowledging that “it is absolutely right that women should be able to talk to pharmacists as the experts in medicines to support them with their sexual health”, RPS EPB chair Thorrun Govind says it is vital that the consultation process is thorough.
“We are not second-rate doctors; we are healthcare professionals in our own right who work in the interest of patients,” she says, “so when a customer goes into a community pharmacy to obtain any medication, pharmacists need to be prepared to go through all the necessary questions as part of usual care.”
“People are much more aware about safety of medicines now than they have ever been,” adds Claire Anderson, “so pharmacy staff should be prepared for customers who might be asking if the products are safe”. Her advice to pharmacy teams is to complete not only the manufacturers’ training but “any additional training you think you need, so you can explain how the product works and its safety”.
Maxwellia has created a Lovima pharmacy training guide, which is available in various formats across multiple platforms, along with an optional suitability checklist to support the consultation process. Anna Maxwell says this will enable pharmacy teams to “provide a better service to women than they might get from GPs”.
Similarly, HRA Pharma has developed online and print training materials to support pharmacy teams – accredited by the NPA – along with an optional pharmacy supply checklist to use during the consultation.
The process would be made even easier if there was increased pharmacist input into patient records, says Michelle Riddalls. Schemes like the Community Pharmacist Consultation Service in England are helping to make that happen but there is more that could be done, she says.
“For example, we’d like pharmacists to have the right to update as well as read medical records, and we think they should be able to refer individuals to another healthcare professional if that is judged appropriate – not just to a GP but to a physiotherapist, for example.”
And it seems there is increasing public support for this argument. PAGB’s recent self care survey found that 69 per cent of respondents thought it was a good idea for GPs to be able to refer people to pharmacists for self-treatable conditions, as happens under the CPCS.
Almost a third said they would be more likely to consult a pharmacist first if the pharmacist had the mechanism to refer them onto another healthcare professional where necessary. Also, a quarter said they’d be persuaded to use a pharmacist as their first option if the pharmacist could read and update their medical records.
Now is the time to capitalise on these opportunities for joined-up care, says Dr Anne Lashford, vice president of the FSRH. “A positive outcome of the changes to service provision during the Covid-19 pandemic is increased collaboration between pharmacies, GP practices, and sexual and reproductive healthcare clinics.
“Maintaining and improving these links is vital to ensure that women can continue to access contraception during and after the Covid-19 pandemic.”
FAQs on OTC pill consultations
- What happens if a woman forgets/misses a pill?
Less than 12 hours late: The missed tablet should be taken as soon as it is remembered and the next tablet taken at the usual time — this may mean taking two tablets in one day.
The woman is still protected from pregnancy.
More than 12 hours late: She may not be completely protected against pregnancy — the more consecutive tablets missed, the higher the risk of pregnancy. See the SmPC and the pharmacy training guide for advice on what to do if the woman is more than 12 hours late.
- How many can I supply?
For a first supply of Lovima from a pharmacy, up to three months' supply (84 tablets) can be provided. This ensures that those starting treatment with Lovima do not receive it for prolonged periods without a follow-up consultation.
For a repeat supply: Up to 12 months (4 x 84 tablets) could be considered in women over 18 years. Supply to women under 18 years should be limited to three months to ensure there is a regular opportunity to assess safeguarding, compliance and counselling on sexual health.
- What if the customer is switching from using another pill?
Changing from a COC: Start taking Lovima on the day after the last active tablet from the present pill pack.
Changing from another POP: Start taking Lovima without a break, on any day of changing from another POP.
Taken from the Lovima pharmacist training guide on the Pharmacy Magazine website.
- Lovima pharmacy training and optional suitability checklist: lovima.com
- CIG Lovima learning
- Hana pharmacy training guide
- WHO Medical Eligibility Criteria for Contraceptive Use, MEC Wheel. The Faculty of Sexual and Reproductive Healthcare (FSRH) UK Medical Eligibility Criteria for Contraceptive Use (UK MEC). The FSRH has extended qualifications in sexual and reproductive health to pharmacists, enabling them to provide counselling to women on a range of contraceptive methods.