Pacific Rim Bureau (CNSNews.com) - Australia's leading medical body has urged the government to reverse a decision making the "morning-after pill" available without a doctors' prescription.
With effect from Jan. 1, Australian women - and girls as young as 14 - are able to buy the drug Levonorgestrel over the counter from pharmacies, despite strong opposition from some doctors, some pharmacists, and pro-life campaigners.
Medical critics say making the so-called "emergency contraceptive" so easily available is fraught with health risks for women, while pro-lifers oppose the drug, which is marketed in Australia under the brand name Postinor-2, on the grounds it can be an abortifacient.
Postinor's German manufacturer, Schering, says the drug, which contains a large dose the hormone progesterone, prevents 95 percent of pregnancies if taken within 24 hours of intercourse and is 85 percent if taken within 72 hours. Other brand-names for Levonorgestrel include Plan B and Levonelle.
In the United States, an Food and Drug Administration advisory committee recommended last month that emergency contraceptives be available there, too, without a prescription. A final decision is expected within months.
In Britain, the drug has been available over the counter from a pharmacist since 2000.
The Australian decision, taken last year, followed an application by Schering to a national drugs schedule committee comprising state health authorities, experts and a federal regulatory agency, the Therapeutic Goods Administration (TGA).
During a consultation period, the Australian Medical Association (AMA), a body whose members comprise medical practitioners, opposed the move, saying Postinor should only be prescribed in conjunction with consultation about sexually transmitted diseases, regular contraception and related issues.
After many doctors' complained, however, the AMA dropped its opposition last August, and the authorities eventually gave the go-ahead for a Jan. 1 over-the-counter availability.
This week, at the 11th hour, the AMA changed its position once again.
In a statement issued just hours before the change was to take effect, the association called the decision a mistake and called on the government to reverse it.
AMA ethics committee chairwoman Dr. Rosanna Capolingua said pharmacists were not prepared to deal with the sensitive matters arising when a customer wants the morning-after pill.
"A busy pharmacy is not the place for discussion of such a sensitive issue," she said. "Women deserve better than this. They need timely access to confidential care and advice."
'Trivializing women's health'
Reached by phone Friday, Capolingua said the decision to release the statement was taken after pharmacists themselves had raised concerns.
"Pharmacists across the country said 'we don't want this. We are not prepared to counsel customers appropriately ... and we don't understand it well enough, we don't understand the side-effects to be able to do this."
Capolingua said the AMA understood that there may be infrequent cases - for instance, in rural areas - where a woman was unable to obtain a doctor's prescription for emergency contraception in time for its use to be effective.
In cases where a doctor was clearly not available, pharmacists should be able to provide it, on condition the customer return, having seen her doctor and with a prescription.
In all other cases, it should remain a prescription drug, she said.
"The patient must see her doctor, in order to have appropriate counseling and discussion around the fact that unprotected sex has occurred ... and on the need to use appropriate contraception in future."
Capolingua said the idea of a pharmacist being able to have a discussion with a customer about such sensitive matters was absurd.
"There's nowhere to do it. It's a shop-front we're talking about here. This theory that you're making it available to all women because it's a woman's right is actually one that trivializes women's health - not one that actually looks after women in this arena."
She said the AMA was calling on Health Minister Tony Abbott to reverse the decision.
A spokesman for Abbott said Friday the minister was on leave and unavailable to comment about the appeal.
But Kay McNiece, a spokeswoman for the TGA - the government regulatory agency - said Friday the decision wasn't one for the federal government at all, but for health authorities in Australia's five states and two territories.
McNiece noted that the representatives of all states and territories had voted in favor of recommending dropping the prescription requirement for Postinor.
None had since backed away from that.
"If the AMA are concerned about it, they are going to have to take it up with the states and territories."
Although Schering denies that the morning-after pill causes an abortion, pro-lifers dispute this, pointing out that one of its functions is to stop the successful implantation of the embryo by affecting the lining of the womb. For those who believe human life starts at the point of fertilization, this clearly constitutes an abortion.
Levonorgestrel's other functions include preventing ovulation and delaying ovulation.
Pro-life opponents of the morning-after pill say women should be given the full picture of how the drug works before deciding whether they want to take it.
They also argue about health-related concerns relating to its use.
According to the World Health Organization, over-use of the morning-after pill can pose risks. In cases where the drug fails, "there may be a higher percentage of ectopic pregnancies ... than among a normal pregnant population," it says.
Ectopic pregnancy, where a fertilized egg implants itself outside the uterus, is a serious and potentially life-threatening condition.
Mary Joseph, spokeswoman for the Australian Federation of Right to Life Associations, noted recently that when Schering initially got permission to sell Postinor in Australia (with a prescription) the pharmaceutical company had itself stressed the importance of doctors regulating how patients used it.
A doctor would be able to assess a patient's medical history and if necessary examine her before deciding whether Postinor was suitable. A doctor could also check whether the woman was already pregnant (arising from earlier intercourse), and whether she suffers from hypersensitivity to any of the ingredients of the drug.
Joseph said it wasn't surprising that Schering had subsequently applied to have the product available over the counter.
"Drug companies have an interest in turning a profit and less restricted access to the drug would obviously assist them to make more money," she said. "But the interests of pharmaceutical companies are not always the interests of consumers, especially women."
An Australian Christian ethical action group, Salt Shakers, said Friday that easier accessibility to Postinor will "increase promiscuity and sexual risk taking."
It also raised concerns about the health issues. "Once again women are being used as guinea pigs as the long term effects of taking this pill are unknown."
See Related Story:
FDA Panel Recommends Easy Access to 'Morning-After' Pill' (Dec. 17, 2003)
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