The dangers of an over-the-counter morning-after drug - 9 October 2003
The Canberra Times
By Mary Joseph
Thursday, 9 October 2003
A new morning-after pill may soon be available without a doctor's prescription, and women's health will be the loser.
The way the drug works is also being obscured in a debate where its supporters are loath to acknowledge its abortion-causing effect.
In June the National Drugs and Poisons Schedule Committee gave preliminary approval to allow over-the-counter sales in pharmacies of Levonorgestrel, marketed as Postinor-2.
Until now it has been available only with a doctor's prescription. The committee will make a final decision next week.
The issue is not whether Postinor-2 should be available. It has unfortunately been on sale in Australia for well over a year. The issue is to ensure that women know how Postinor-2 works and have access to medical advice to minimise its risks if they do use it.
The application to move Levonorgestrel from being prescription-only to being freely available over the pharmacy counter is not unexpected. Drug companies have an interest in turning a profit and less restricted access to the drug would obviously assist them to make more money.
But the interests of pharmaceutical companies are not always the interests of consumers, especially women. There are a number of public health concerns that would arise if this drug were available without prescription.
The morning-after pill is a hormonal preparation 50 times stronger than the mini pill. Prescriptions are necessary for the mini pill and many other hormonal drugs.
Pressure for Postinor-2 to be available without a script is not because this hormonal preparation is any safer than the others. It's to ensure the drug is taken as soon after sexual intercourse as possible to be effective. This 72-hour deadline has caused some people to throw care and caution aside.
When Postinor-2 was initially approved for sale, a spokesperson for Schering said it was only to be used as an emergency contraceptive and one of the reasons it was available on prescription only was so that doctors could regulate how patients used it. The requirement for a prescription ensures a doctor can consider the woman's medical history and carry out a medical examination before making a judgment as to whether Levonorgestrel is a suitable drug for her.
The drug's own product information lists a number of contraindications and recommends that the risk-benefit ratio (of using Postinor-2) should be assessed by the practitioner in discussion with the patient. This involves doctors undertaking a medical examination for each patient.
The manufacturer also states the drug should not be given to pregnant women. The doctor can check if the woman is already pregnant, or whether the woman suffers from a range of conditions such as unexplained vaginal bleeding or hypersensitivity to any of the ingredients of the drug.
Other drugs that a woman might be taking need consideration before Levonorgestrel can be prescribed. The prescribing information also recommends further medical consultation in the event that a woman vomits, suffers nausea or other side-effects after taking Levonorgestrel and that there be a routine medical consultation three weeks later. It is less likely women will take such precautions if their doctor is not involved in prescribing the drug.
Pharmacists have no space for consultation other than their counter, which does not make it likely that a full and frank medical history can be taken.
Many women would not feel comfortable sharing intimate personal information in so public a setting. Pharmacists also are not qualified to undertake a medical examination, so women may not receive the full information they need in order to safely take the drug.
A woman's GP is more likely than a pharmacist to be able to pick up whether a woman is using the drug regularly.
Pharmacists are also unlikely, from their position behind the counter, to notice signs of sexual abuse, which might be prolonged and facilitated by easier access to Postinor-2.
The World Health Organisation has warned that "repeated use of emergency contraceptive pills in any month can expose women to higher doses of steroids than those recommended during one cycle" and that " there may be a higher percentage of ectopic pregnancies among emergency contraceptive pill failure cases than among a normal pregnant population".
Ectopic pregnancy is a serious, potentially life-threatening condition which can jeopardise a woman's ability to conceive and have a healthy pregnancy in the future. Further, the WHO says morning-after pills "are not recommended for routine use, because of the higher possibility of failure compared to regular contraceptives and the increased risk of side-effects".
Drug manufacturer Schering says morning-after pills can prevent or delay ovulation, or inhibit implantation of the embryo. Acting against the implantation of a human embryo happens after conception. It is not a contraceptive action. Use of misleading language like the description "emergency contraception" to describe this drug threatens women's informed consent.
Women need to know this upfront so they can give their full informed consent to use the drug.
Postinor-2's supporters claim that the pill disrupts the implantation of a fertilised egg or even just an egg. These descriptions are also misleading. When an egg and sperm meet, a new human embryo is conceived. Postinor-2 can prevent the implantation of this embryo, causing its death.
Mary Joseph is the spokesperson for the Australian Federation of Right to Life Associations. firstname.lastname@example.org