Make Emergency Contraceptives GSL In The UK, Urge HRA Pharma And The British Pregnancy Advisory Service
Executive Summary
EllaOne manufacturer HRA Pharma supports the British Pregnancy Advisory Service's (BPAS') calls to scrap mandatory consultations for emergency contraceptives by switching these medicines from pharmacy-only to general sales list status.
EllaOne manufacturer HRA Pharma SA has come out in support of a possible pharmacy-only-to-general-sales-list (P-to-GSL) switch of emergency contraceptives in the UK, in response to a recent call by the British Pregnancy Advisory Service (BPAS) to scrap mandatory consultations for the medicine.
“Recent research amongst UK women by HRA Pharma confirms the BPAS research findings and highlights there is still a huge opportunity to bring more women into the Emergency Hormonal Contraception (EHC) category,” Kate Evans, marketing director for HRA Pharma UK and Ireland said in response to the research.
“Our recent survey indicated that 46% of women have had unprotected sex in the last year. However, only 27% of those women took the morning after pill,” Evans noted. “There are many reasons for this, including embarrassment, misinformation and lack of accessibility.”
“HRA Pharma also wants to ensure that any woman who needs the morning after pill has access to it,” Evans explained, “so we support simpler pharmacy consultations – and have already launched a new consultation checklist to facilitate this – and the GSL switch of the EHC category for self-selection.”
“It should be highlighted that we believe any GSL switch should be applied to the whole EHC category, and not just by individual active ingredient,” she insisted, “in order to ensure that women are not penalized in more easily accessing the most effective option for them.”
Scrap mandatory consultation, says BPAS
Evans was responding to an intervention in December last year by BPAS, which based on new research had called for mandatory consultation for emergency contraceptives to be “scrapped” in the UK.
“BPAS calls for emergency contraceptives to be reclassified as a GSL products and made available for women to purchase directly,” the organization urged, “seeking advice only if they need it, enabling pharmacists to focus their expertise on those requesting additional support.”
Noting that the pill was “sold straight from the shelf without consultation in countries with robust medicines regulatory regimes such as Sweden and the US”, BPAS added that there were “no risks which outweigh its use and it is considerably safer than many medicines sold straight from the shelf in the UK”.
According to a poll of 1,001 UK women aged 18 to 45 conducted by BPAS in November, the organization claimed that “most women” in the country would “prefer to buy emergency contraception without a mandatory consultation with a pharmacist”.
Almost two-thirds of women polled “said they believed the consultation should be optional”, BPAS reported, “with 57% wanting to see it sold directly from the shelf”.
While some women reported positive experiences of the consultation process, BPAS quoted some “mixed experiences”, including: “Quizzed and made to feel slightly slutty”.
“Women also describe instances of being denied the medication they requested,” BPAS continued, “including one case ending in unplanned pregnancy and abortion.”
Some women also described the price of emergency contraceptives as “exploitative”, it added.
The results of the poll were supported by a BPAS-commissioned mystery shopper study of 30 UK-based pharmacies, which the organisation said had revealed that “current arrangements for the sale of emergency contraception can put women at risk of unwanted pregnancy by putting needless barriers in their way”.
While the study had shown that “many pharmacists provided a swift, non-judgmental service”, BPAS pointed out that there were “notable exceptions”.
One case, the organization reported, involved a 22-year-old shopper who was “asked to show ID”, to be “tested on her date of birth” and “take a pregnancy test”, only to be “refused progestogen-based emergency contraception because she said she had already used it once in that cycle”. “This refusal has no basis in evidence or guidance,” BPAS added.
Just under half of pharmacies visited by mystery shoppers offered a private room for consultation, BPAS noted, resulting in conversations about sexual activity being “sometimes held near other pharmacy users”, which the organisation argued created a “significantly more awkward experience for the shopper”.
In addition to showing problems with the consultation process for these medicines, the study also revealed that emergency contraception was “hidden from view in the vast majority of pharmacies”.
Only 17% of pharmacies visited “had any indication on the shop floor or within the window that emergency contraception was available”, BPAS said.
Furthermore, no information about emergency contraception was provided in the women’s health section, according to the study.
“This is in sharp contrast to other products, which are often advertised in store (such as erectile dysfunction medication) or with placeholders for customers to take to the pharmacy counter,” BPAS explained.
With regards to the cost of emergency contraceptives, the study revealed that the price of the same product could vary “from £11.49 to £24.99”, with “no relationship between the cost and the length or quality of the consultation”.
Quoting online pharmacy Chemist4U, BPAS claimed that women were currently being charged “up to 650%” times the cost price of emergency contraceptives.
MHRA responds
Any emergency contraceptive P-to-GSL switch in the UK would need to go through the country’s medicines agency, the Medicines and Healthcare products Regulatory Agency (MHRA).
Asked by HBW Insight whether there was any scope for such a change, the agency confirmed that the “usual procedure” would be for a company owning the marketing authorization for such a medicine to “submit a reclassification application to the MHRA”.
“The MHRA website provides all the details about how this is done – the regulatory basis, the procedure that needs to be followed and the data and evidence needed to be submitted by the company,” it continued. “In considering the application the agency would need to be satisfied that the product meets the legal requirements for GSL classification.”
With regards to the current issues with dispensing these medicines through pharmacy identified by BPAS, the MHRA said that this was a “professional matter for the pharmacist”.