As the Boots chemist chain was told it was unlawful to provide the morning-after pill, under its own protocol, one emergency contraceptive brand became available off prescription from any chemist, writes EITHNE DONNELLAN
LAST MONTH the Boots pharmacy chain, in a blaze of publicity, announced it was to begin making the morning-after pill available without prescription to Irish patients. It appeared it had found a hitherto undiscovered mechanism in Irish law which allowed it provide emergency contraception over the counter in the Republic for the first time.
It said the move was possible under 2005 legislation if patients were dispensed the medicine in accordance with a protocol drawn up by one doctor for the entire Boots chain.
The Department of Health said at the time it was seeking clarifications from Boots with regard to the service. The Irish Medicines Board (IMB), which controls whether medicines are licensed as prescription only or over-the-counter preparations, issued a statement not indicating whether it approved of the Boots move or not, only that there was scope in the legislation for medicinal products “to be dispensed under the direction of a registered medical practitioner”.
Then out of the blue last Tuesday, after obtaining legal advice, the IMB ordered Boots to stop what it had started. It said providing the morning-after pill over the counter under its doctor-driven protocol or “patient group directions” (PGDs) was unlawful. “There is no provision for PGDs in Irish legislation,” it said.
Boots was completely taken aback, given that it had planned to use PGDs to make several other prescription-only drugs, which are sold over the counter in other European countries, freely available here too in the future. It protested that it was confident its interpretation of the law was correct.
All this may have gone unnoticed in recent days given that there will have been no interruption to the supply of the morning-after pill to Boots’ customers who seek it without a doctor’s prescription. That’s because, coincidentally or otherwise, on the same day that Boots was told that it was breaking the law, the IMB gave the go-ahead for one of two morning-after pills licensed for sale in the State to be sold without prescription.
The French-made NorLevo morning-after pill, which had about a 5 per cent share of the emergency contraceptive pill market in Ireland up to this, can now be sold without prescription in every pharmacy in the State. It means Boots’ bid to corner the market in over-the-counter sales of the morning-after pill at €45 a pop, has been scuppered.
But it wasn’t just Boots which was taken by surprise by the IMB decision to make NorLevo available without prescription immediately, and with no age restriction on the product licence. The Pharmaceutical Society of Ireland, which regulates the pharmacy sector, was also caught off guard and had to hastily draft interim guidance for pharmacists on the safe supply of NorLevo to patients.
These were posted on its website on Thursday afternoon and stated that pharmacists should be aware the age of legal consent in Ireland is 17 years, that when a patient is under 16 “it is usual that parental consent is sought”, and “having regard to the age and circumstances of the individual patient, and any child-protection issues arising, pharmacists should consider whether referral to a medical practitioner, other healthcare professional, or other agency or authority, is appropriate”.
So how could the IMB have acted so fast in switching the licence for NorLevo to make it an over-the-counter drug, a process which usually takes months? After all, HRA Pharma, which makes the drug, only applied to have the licence changed in January after it saw the demand for over-the-counter emergency contraception in Boots chemists here.
The IMB said information and data relating to NorLevo had been previously considered and reviewed by the IMB. That’s because HRA Pharma previously applied to the IMB in 2007 to have its product licence switched, but when the IMB sought further information, HRA Pharma withdrew its application altogether. So when it resubmitted the application last month, with the switching fee of €5,000 and the outstanding information which had been sought, the process for approval was speedier than that for a new application.
Mary Rose Burke, chief pharmacist with Boots Ireland, said the end result was that the IMB shared its view that the pharmacy was an appropriate place to make emergency contraception available to patients without prescription.
“We’ve been making that case for a number of years and it seems to have happened now very very quickly . . . without the profession having a chance to get the adequate training and everything,” she said. Boots had provided training for its pharmacists on dispensing the morning-after pill without prescription before it began operating the service, but not all pharmacists would have had this training.
Normally, she added, there would be a lead-in time for the manufacturer of a drug for which the licence was switched to repackage the product. That’s what happened with Alli, the weight-loss drug. “That appears not to have been the case in this case but I don’t understand why,” she said, though the IMB countered that “the normal procedures for notifying an approved application were undertaken”.
Given that Boots believes its interpretation of the law is correct, has it ceased to provide the second morning-after pill licensed here as a prescription-only medicine – Levonelle – over the counter under its PGDs? Ms Burke said she’d prefer not to comment until “we finalise our communication back and over to the IMB”.
Asked if Boots would consider mounting a legal challenge to the IMB’s decision regarding PGDs being unlawful, she said: “We are going to consider our position”.
The Irish Pharmacy Union, which had been planning to get a doctor to draw up PGDs so its member pharmacists could follow in Boots’ footsteps, is also expected to get legal advice on the IMB’s decision.
The Department of Health said it “is currently in consultation with legal counsel concerning the broader issue of PGDs in general”.
Meanwhile, it may seem unusual that the IMB had no problem with Boots providing flu vaccines under its PGD system this winter, when it had a problem with the pharmacy chain using PGDs for dispensing the morning-after pill without prescription.
The IMB responded that it was supportive, from a public health perspective, of the administration of the flu vaccine via pharmacies and other approved outlets. The vaccines are classified as prescription-only medicines, “however there are a range of circumstances that assist us in determining that these vaccines may be supplied and administered without an individual prescription”, it said.
Meanwhile, there have been suggestions the cost of getting the morning-after pill – which must be taken within 72 hours of unprotected sex to prevent pregnancy but the earlier it is taken the better – will come down now that it can be provided over the counter in all pharmacies.
Boots says it is still charging €45 for the medicine and a private patient consultation on its use. Unicare said it could provide it for €9.99, but in most pharmacies it will be a lot more. Up to now it cost about €15 with a prescription, and most believe a €15-€20 consultation fee could be expected to be added on to that by pharmacies around the State.