OTC ‘morning after’ pill hard to swallow

Schering Healthcare, the UK’s only manufacturer of the emergency contraceptive “morning after” pill, is refusing to make a move which could boost its sales.

Women who want to take the contraceptive must either go to a birth control clinic or get a doctor’s prescription. Schering says it has no plans to apply for a non-prescription licence, which would enable women to buy the drug over the counter (OTC).

A coalition of pressure groups – comprising the Birth Control Trust, the Family Planning Association (FPA), the Royal Pharmaceutical Society and the Royal College of General Practitioners – started a campaign last week to lobby the Government to remove the “morning after” pill from the prescription-only list. Their motives vary, but include reducing unwanted pregnancies and cutting down on the 180,000 abortions performed in Britain every year.

The groups are lobbying Parliament and the Department of Health (DoH) over the issue, and plan to encourage women, GPs and pharmacists to write to their local MPs.

A spokesman for The Birth Control Trust says: “So far we have been pleased with the response from individuals within the DoH.”

But a spokeswoman for Schering, which turns over about 1 million packs of its PC4 emergency contraceptive pill a year, says there are important issues to address first.

Trials must be undertaken and data compiled to apply for an OTC licence. There is also the question of price – the pill is free at the moment, but women would have to pay if it was taken off prescription. For Schering, one of the main issues is liability. As the spokeswoman says: “Who is at fault if something goes wrong?”

It’s a good question. At the moment responsibility lies with the health professional prescribing PC4. If a doctor is not involved and a woman takes the drug unwisely, causing side-effects, the manufacturer could be liable.

The product is not simple to take: two pills must be taken within 72 hours of intercourse, and then two more exactly 12 hours later. Nausea is common and if the pills are vomited, the drug is ineffective. It should not be prescribed to women with thrombosis or focal migraines.

Even so, a spokeswoman for the FPA says: “It is thoroughly safe and effective when appropriately given.” But one argument against PC4 being available over the counter is that careful instructions are needed to understand the drug. A doctor is in a position to explain these at length, whereas a pharmacist working behind a busy counter may not be. But the FPA spokeswoman adds: “Women are perfectly able to read a packet and can ask a pharmacist if they want to. They don’t need to be spoon-fed.”

Myths surround the pill. Firstly it is often said that it can be taken up to three mornings after unprotected sex, belying its nickname of “the morning after” pill. Some claim it is also safe to take PC4 repeatedly – up to twice a month, according to the FPA spokeswoman. And then, if it is taken and pregnancy still ensues (it is only 95 per cent reliable), it won’t damage the baby.

Any marketing campaign would have to counter these misconceptions. This was the intention of a joint initiative for PC4 run by the FPA and the Health Education Authority in 1995 and 1996.

The campaign explained what the product is and where it can be obtained. According to the spokeswoman from Schering, consumption of the drug “virtually doubled” during the push, while HEA research showed awareness rose by nine per cent to 76 per cent.

Both figures suggest women are very receptive to advertising for emergency contraception. But any ad campaign runs the risk of being seen as supporting unprotected sex.

Mike Lees, chief executive of Bates Healthcom, claims the task of successfully launching the product into the OTC market would not be as difficult as it appears: “You could have a highly responsible ad campaign to promote it in a highly responsible way. It’s no different to any other form of contraceptive advertising.

“We’re talking about a heavy medicine and it would be necessary to talk about it in a heavy way. You could not use humour. You’d have to use the kind of taste which society expects.”

If the drug is reclassified, it would fit with the Government’s Primary Healthcare initiative – cutting costs at GP’s surgeries by getting the public to use the pharmacist for straightforward health complaints.

If the campaigners manage to convince the Government to change the licensing of the emergency contraceptive pill, Schering would be forced to rethink its strategy.

The move would open the market to other manufacturers, which so far have steered away from producing it as a prescription drug.

Sales worth 3m a year to Schering may not sound much, but the cash value is likely to increase if the pill is given pharmacy status.

Through its reluctance to apply for a pharmacy licence, Schering could find it is encouraging rivals to enter the market.

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