Australia House of Representative Notice Paper
[to Australia Health Minister Tony Abbott, 2June04, with questions about levonorgestrel MAP]
*3613 MR MURPHY: To ask the Minister for Health and Ageing —
(1) In respect of the sale without prescription of the drug Postinor-2, which contains the active ingredient levonorgestrol, is he aware of the article titled “Adverse reactions and emergency contraception” in The Lancet on 14 April 2001, which states that (a) several writers in the United Kingdom have remarked on the scarcity of safety data regarding the adverse reactions from use of the drug levonorgestrel,
(b) 5% of women have a genetic susceptibility to breast and ovarian cancer and another 5% have a genetic susceptibility to thromoembolic disease, and (c) the relevant tests will not generally be done before a pharmacist supplies levonorgestrel to women who may have stopped taking daily hormones because they had adverse reactions.
(2) Can he explain how the women who take levonorgestrel without prescription will be protected against the potential side-effects of the drug.
(3) Is he able to say what scientific evidence his department relies on when deciding on the sale without prescription of products containing levonorgestrel; if not, when will he require the withdrawal from sale of Postinor-2 and, if he will not, why not.
(4) Can he explain how the precautionary principle applies to the supply without prescription of levonorgestrel to women; if not, why not.
*3614 MR MURPHY: To ask the Minister for Health and Ageing —
(1) In respect of the sale without prescription of the drug Postinor-2, which contains the active ingredient levonorgestrel, is he aware of the article by Professor Richards titled “An important drug interaction: an alternative mechanism”, in the British Medical Journal volume 321, December 2000, which concluded that there is potential for serious harm which must be taken into account if levonorgestrel is to be supplied without prescription.
Can he explain how the precautionary principle has been applied to consider the risks described by Professor Richards to women who purchase Postinor-2 without prescription and without undergoing a medical examination, and what measures has he taken to mitigate against the harm as identified by Professor Richards.
When will the precautionary principle be applied to prevent the sale without prescription of Postinor-2.
*3615 MR MURPHY: To ask the Minister for Health and Ageing —
(1) In respect of the sale without prescription of the drug Postinor-2, which contains the active ingredient levonorgestrel, is he aware of the article titled “Drug Points” in the British Medical Journal volume 321, December 2000, which states that women receiving warfarin treatment may be at risk of an interaction between warfarin and levonorgestrel if they are prescribed the progestogen only regimen because of its apparent safety.
(2) What procedures are in place for pharmacists to ensure that women who are currently taking warfarin treatment are not sold Postinor-2 or other levonorgestrel drugs without prescription.
(3) Are pharmacists medically competent to make decisions about the impact on women of the sale of Postinor-2 or levnorgestrel without prescription.
(4) Will he impose regulatory controls to ensure that the drug Postinor-2, and other drugs containing levonorgestrel, cannot be prescribed without prescription and before a full medical examination; if so, when; if not, why not.
*3616 MR MURPHY: To ask the Minister for Health and Ageing —
(1) In respect of the sale without prescription of the drug Postinor-2, which contains the active ingredient levonorgestrel, is he aware of the article titled “Emergency Contraception” in Archer Family Medicine, Volume 9, July 2000, which states that emergency contraception does not interrupt an established pregnancy and that women who obtain emergency contraception should undergo a pregnancy test first.
(2) Did his department consider this finding and can he explain how a pharmacist will determine whether a woman has an established pregnancy at the time of the supply without prescription of Postinor-2 or another drug containing levonorgestrel.
(3) Will he provide a copy of the evidence which supports the claim that emergency contraception drugs can prevent pregnancy by damaging the lining of the womb preventing the implantation of an embryo; if not, why not.
*3617 MR MURPHY: To ask the Minister for Health and Ageing —
(1) Can he confirm that Clause 1.3 of the Pharmaceutical Society of Australia’s Policy – Code of Conduct states that pharmacists must exercise professional judgment to prevent the supply of products likely to constitute an unacceptable hazard to health or the supply of unnecessary and/or excessive quantities of medicines and other products, particularly those which have a potential for abuse or dependency.
(2) Can he confirm that Clause 1.4 states that pharmacists must ensure that all reasonable care is taken when disposing of medicinal products and chemicals.
(3) Can he confirm that Clause 1.5 states that pharmacists shall accept responsibility for their own professional activities and for all activities undertaken under their direct supervision.
(4) Can he explain how pharmacists can protect themselves against the foreseeable and non-negligible risk of harm from the supply without prescription of Postinor-2 and other drugs containing levonorgestrel.
(5) Is he aware that there is authoritative medical opinion to the effect that Postinor-2 and other drugs containing levonorgestrel pose a serious risk to the user when supplied without prescription and a full medical examination, and therefore constitute an unacceptable health hazard to women.
[House of Representatives Notice Paper to Australia Health Minister Tony Abbott 2June04, with questions about levonorgestrel MAP: www.cha.org.au/chinfo/04/154H1102.PDF]
Australian Gov’t Aims to Reverse ‘Morning-After Pill’ Decision (6/04) – Six months after the “morning-after pill” was made available over the counter in Australia, the federal government plans to return the controversial drug to its former prescription-only status.
Health Minister Tony Abbott told a Sydney newspaper Sunday he was especially concerned about reports of girls as young as 13 asking for the drug — a powerful dose of hormones promoted as an “emergency contraceptive” for use after sexual intercourse.
“The obvious thing is simply to restore the situation that existed before the de-scheduling” of the drug by a government regulatory body, Abbott was quoted as saying.
“I am by no means convinced that that was the right decision to make, and I’m looking at what the government can do to reconsider the matter.”
The announcement comes a month after the Food and Drug Administration overruled a Dec. 2003 decision by an FDA advisory panel to allow over-the-counter sales in the U.S. of a morning-after pill made by Barr Laboratories and marketed as “Plan B.”
It also coincides with a recommendation by the American College of Pediatricians, released in a statement on June 11, strongly opposing “unsupervised child and adolescent access to the morning after pill.”
In Australia, the product sells as “Postinor-2” and is manufactured by Schering.
Around the world, critics of the decision to ease access to the morning-after pill cite a broad range of reasons, including the pro-life concern that, in some cases, the drug works as an abortifacient; fears about health risks to women; and worries that the product may encourage promiscuity.
Hailing Abbott’s com
pharmacist and pro-lifer John Wilks Monday voiced another concern, pointing to the practical difficulties entailed in pharmacies, rather than physicians, supplying women with the morning-after pill.
The last six months had highlighted the difficulties, he said.
According to guidelines or “protocols” put in place by a governing body for the industry, the Pharmaceutical Society of Australia, pharmacists are expected to ask customers questions about their sexual history.
“We’re meant to find out from a woman when her last intercourse was, when her last period was. Was a condom used? Did it break? — very personal questions that I think most women would quite rightly object to answering.
“A busy pharmacy is not the appropriate place to be asking those questions.”
Wilks, a board member of Pharmacists for Life, has refused to supply the morning-after pill.
He said he had heard from colleagues that requests for the drug had risen enormously since the policy change six months ago. His own pharmacy, too, had received a substantially higher number of requests for the morning-after pill.
Turning to the health concerns, Wilks pointed to the large dose of hormones contained in the MAP — the equivalent of a full cycle of the contraceptive pill.
“Giving a month’s supply of the [birth control] pill in two days, particularly to young girls, is a form of pharmaceutical abuse of a young girl’s body,” he said.
Similar views were expressed last Friday by the American College of Pediatricians, which said it was especially concerned about the ability of children and adolescents “to judge the need for, and deal with the consequences of, repeated use of these hormones to terminate an unimplanted but developing infant.”
Other health issues included the possibility of dangerous drug interactions and ectopic pregnancies (one occurring outside the womb).
Another concern is that easy availability of the morning-after pill could help an abuser to cover up evidence of rape or incest by forcing a victim to take the drug.
Wilks said there was currently no restriction on a man buying the morning-after pill from a pharmacy without a physicians’ prescription.
Wilks said Abbott’s move to reverse the earlier decision would help to advance the health of women, and especially young women.
He said the original committee decision was made — despite the majority of public submissions being against the move — “basically to support an ideological position; it was not a scientific decision.”
He said he would not be surprised if “vested interests” were involved.
“It’s about money and profits which feeds into share prices and happy shareholders. The consequences for women are rarely taken into account.”
Proponents of morning-after pill argue that freer availability of the pill will cut down on the number of surgical abortions.
Australian family-planning experts said any attempt to restrict access would likely increase the abortion rate.
Judi St Clair, spokeswoman for Sexual Health and Family Planning Australia (SH&FPA), challenged the claim that the emergency contraceptive (EC) was being sold to young girls without consultation.
“Pharmacists are required to follow a strict protocol to ensure EC is appropriate prior to supplying it, and steps are in place to ensure patients receive appropriate care,” she said.
St Clair said the protocol had been developed “in close consultation with family planning doctors” and that thousands of pharmacists around Australia participated in “special training” before the drug was made available over the counter at the start of the year.
Wilks derided the claims of proper preparation. The training session he attended had been over in two hours, which wasn’t anywhere near long enough to adequately deal with the issues involved, he said.
He also pointed out that the protocol is completely voluntary. And pharmacists are not even required to take the customer’s name and address, he added.
Abbott, the federal health minister, sparked a row earlier this year when he said during a speech that abortion was a “national tragedy” and asked why it was that Australian society discouraged youngsters from smoking or driving too fast, but not from sexual activity. [By Patrick Goodenough CNSNews.com June 14, 2004]
See earlier stories:
No Over-the-Counter Sales of ‘Morning-After Pill’ – for Now (May 07, 2004)
Australian Doctors’ Group Wants ‘Morning-After Pill’ Decision Reversed (Jan. 02, 2004)