EMA meets to review evidence that body weight affects efficacy of emergency contraceptives
Review prompts call for revised pharmacy guidance on EHC
The European Medicines Agency (EMA) is meeting this week to review the evidence on how bodyweight affects the emergency hormonal contraceptives (EHC) levonorgestrel and ulipristal acetate (ellaOne).
The agency’s Committee for Medicinal Products for Human Use (CHMP) is meeting on 19–22 May to decide whether changes need to be made to the products’ literature, after announcing the review in January 2014.
Levonorgestrel can currently be bought as a pharmacy medicine or obtained free-of-charge through a patient group direction (PGD) up to 72 hours after unprotected sex. EllaOne is a prescription-only medicine and is effective up to 120 hours after unprotected sex.
HRA Pharma lodged an application with the EMA in February 2013 to change ellaOne’s status from a prescription-only to a non-prescription medicine, but matters were put on hold because of events relating to its other EHC product, levonorgestrel (Norlevo). In November 2012, the company had volunteered data to national agencies where Norlevo was marketed to show that it was affected by high bodyweight. Norlevo is not available in the UK, but the product’s literature was updated in affected countries in November 2013. This led Sweden’s medicines regulator to refer the issue to the EMA in January 2014, prompting the current review.
The company claims that the effectiveness of ellaOne, which was launched in 2009, is not affected by bodyweight, although the company says there is some decrease in its efficacy in women weighing more than 95kg. The product literature for Norlevo states that in clinical trials, its contraceptive efficacy was reduced in women 75kg or more, and that it was not effective in women who weighed more than 80kg.
Pharmacists need revised EHC guidance
Pharmacists will need guidance on how to deal with women weighing 75kg or more who are seeking OTC emergency contraceptives, once the European safety review completes, thinks one expert pharmacist. Pharmacy is proving to be a significant supplier of EHC (see Panel). “The educational material [for pharmacy] needs to be in the form of an algorithm to ensure appropriate EHC choice and use in the right patient profile — both under and over 75kg,” says Nuttan Tanna, consultant pharmacist in women’s services for North West London NHS Trust.
“[This] will help with clinical governance should CCGs [clinical commissioning groups] consider commissioning of EHC [services] from community pharmacies,” she adds.
Tanna suggests that the UK Clinical Pharmacy Association’s women’s health pharmacists group could help develop guidance.
HRA Pharma plans to fund resources for pharmacists to support the provision of ellaOne, should the product gain OTC status from the EMA. “It is important there is continuity of service because these women [who are 75kg or more] have come to pharmacy for a [EHC] solution. Pharmacy is the best place to get emergency contraception,” says Alison Slingsby, marketing manager for HRA Pharma.
It has already had talks with a number of pharmacy organisations preparing them for the possible OTC status of ellaOne, including Pharmacy Voice, the Royal Pharmaceutical Society and the National Pharmacy Association.
The Royal Pharmaceutical Society says it plans to update its existing guidance on emergency oral contraception once the outcome of the EMA review is confirmed.
Proportion of levonorgestrel provided by pharmacies
Each month in 2013, 74,267 individual packs of levonorgestrel were supplied in the UK as emergency contraception, according to HRA Pharma. Of these, 10,352 were supplied through special clinics (such as family planning centres); 15,359 through general practice; and 48,558 through pharmacy.
When the pharmacy numbers are broken down, 27,350 packs of levonorgestrel were supplied via local enhanced services (eg, PGDs) and 21,288 over the counter.
HRA Pharma estimates that, if one-fifth of women weigh 75kg or more, supply of 14,853 packs of levonorgestrel will be affected; 5,470 through pharmacy local enhanced services and 4,242 over the counter.
Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2014.11138505
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