Morning After Pill Becomes Available Over The Counter in Ireland

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Image 1: (POM) NorLevo 1.5mg Packaging.

On the 15th of February 2011, after having rejected the manufacturer's first application for a POM to P switch only a year before, and much to everyone's surprise, the Irish Medicines Board (IMB) approved the morning after pill NorLevo for over the counter supply by a pharmacist.

The switch caught much of the profession off guard, causing a lot of confusion in the first few weeks following this announcement. At the same time the IMB also launched a legal challenge to Boots' Emergency Contraception Service which launched only a month earlier.

Boots have been providing prescription only contraception tablets Levonelle and NorLevo under their in-house developed patient group direction (PGD). This is a protocol, authorised by a doctor, through which a pharmacist may supply a prescription only medicine without the need for the customer to see the doctor first.

PGDs are drawn up under the Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2005 (S.I. 510 of 2005), Regulation 4A (c) which states that it is not a contravention of the 2003 Regulations for:

“(c) any person, other than a registered medical practitioner or registered dentist, to administer to a patient, in accordance with the directions of a registered medical practitioner or registered dentist, any medicinal product subject to control by virtue of these Regulations.”

This overrides the need for a prescription where a PGD has been put in place.

Boots have used this same legal principle to provide flu vaccinations thought the 2010-11 winter season, without any objections from the IMB. It is therefore somewhat puzzling why now, after all this time, the IMB have made a U-turn on the PGDs.

One of the shortcomings of the Boots Emergency Hormonal Contraception (EHC) Service was that it required the patient to present personally for a structured consultation and more importantly to take the tablet in the pharmacy. It was also only available to patients 18 years and over and carried a hefty €45 price tag.

Thankfully, with the switch to the over the counter (OTC) status, it is now possible to obtain the NorLevo tablet (Levonelle continues to be prescription only, as the company has not yet applied for an OTC licence) in most pharmacies without a prescription and without having to take the tablet then and there. It can also be considerably cheaper (we suggest shopping around) and the age limit will in most cases be reduced to 17 or perhaps even as low as 16 years of age.

If you're wondering whether the "morning after pill" is appropriate for you or not, you should ask yourself the following questions:

Has the unprotected sex taken place within the last 72 hours? If YES proceed.
Is this the first time this has happened since your last period? If YES proceed.
Is there any chance you could already be pregnant? If NO proceed.
Are you taking any prescription or herbal medications? There are some exclusions, so if you are, you will need to consult your doctor or pharmacist before proceeding.
Are you suffering form current vomiting, diarrhoea, Crohn's disease or some other condition that could affect the absorption of the pill? If NO proceed.
Are you suffering from severe liver disease or porphyria? If NO proceed.
Do you have a history of fallopian tubes infection (Salpingitis) or ectopic pregnancies? If NO proceed.
Do you or someone in your immediate family (parents, siblings) have a history of thrombosis (blood clotting)? If NO proceed.
Are you allergic to levonorgestrel, galactose or lactose. If NO proceed.
If you made it this far you should be OK to take the pill, but always consult your doctor or pharmacist before starting any new medication, as this is only a guide and is not meant to replace medical advice or treatment.

The most common side effect is nausea. If you vomit within three hours of taking the pill, you will need to return for a second one, as there is a chance the first one did not absorb completely. You should ideally take it with or after food.

The morning after pill is not a regular form of contraception and will not protect you against pregnancy if you were to have unprotected sex again. You will need to use another form of contraception such as a condom and/or contraceptive pill to protect yourself from unwanted pregnancy in the future.

If you're using a contraceptive pill or patch as a form of contraception you will also need to use a barrier method in addition to it until your next period.

L.G.

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