HEALTH: by Richard EganNews Weekly
Over-the-counter sale for morning after pill?
, May 31, 2003
The Australian sponsor of the so-called 'morning after pill', Postinor-2, has applied to the National Drugs and Poisoning Schedule Committee for a change in the scheduling of Postinor-2 (levonorgestrel) 0.75mg tablets in pack of two tablets from Schedule 4 (prescription only medicine) to Schedule 3 (pharmacist only medicine).
The Committee will consider this application at its meeting on June 17-19, 2003.
There are serious risks associated with the use of levonorgestrel in such doses (two tablets of 0.75 mg) as a so-called 'emergency contraceptive'.
These include a significantly increased risk of ectopic pregnancy.
At its meeting held on June 20, 2002 the Medicines Adverse Reactions Committee (New Zealand) considered three case reports of ectopic pregnancies in New Zealand after use of levonorgestrel as an 'emergency contraceptive', and the 12 reports of ectopic pregnancy associated with 0.75 mg levonorgestrel held in the WHO database.
The Committee agreed that 'Given that levonorgestrel can interfere with smooth muscle contraction, there is biological plausibility for the progestogen-only ECP to increase the likelihood of ectopic pregnancy. It was agreed that it was important that doctors are aware of the possible association with ectopic pregnancy.'
In January 2003 the British Chief Medical Officer wrote to all British doctors, informing them that 12 cases of ectopic pregnancy out of a total of 201 unintended pregnancies had been reported to the Committee on Safety of Medicines following use of Schering's Levonelle (levonorgestrel 0.75 mg). The Committee on Safety of Medicines has advised that women using levonorgestrel 0.75 mg as an 'emergency contraceptive' should be told that the treatment can fail, and should be followed up in the event of a missed normal period, so that the possibility of an ectopic pregnancy can be explored, particularly in women with a previous ectopic pregnancy, fallopian tube surgery or pelvic inflammatory disease.
Some advocates of rescheduling of levonorgestrel (0.75 mg) as an over-the-counter medicine are seeking to minimise the seriousness of this risk of ectopic pregnancy. They are suggesting that the six per cent rate of ectopic pregnancy for all unintended pregnancies reported to the UK Committee on Safety of Medicines is an apparent rate, as it is possible that not all unintended pregnancies are reported.
It appears that Schering, the international producer of Postinor-2, is planning to conduct a prospective study to determine the true rate of unintended pregnancy and ectopic pregnancy in women who have taken this product.
If this is the case, then it would seem to be premature for the Schedule Committee to agree to the rescheduling application before this trial is concluded. The approved Australian product information for Postinor-2 (Approved September 28, 2001; amended March 22, 2002) states that 'no ectopic pregnancies or congenital abnormalities were reported'.Reckless
Given the seriousness with which both the New Zealand and British authorities are taking the risk of ectopic pregnancy, it would be reckless to make this drug available over the counter without a prescription.
Pharmacists, especially in the busy all-night pharmacies which are most likely to be used by women seeking an 'emergency contraceptive' after unplanned casual sex, are simply not in a position to explain this risk to women and communicate effective strategies for the necessary follow-up.
It appears that little is known with certainty about the extent to which the various risks, such as venous thromboembolism, and contra-indications for the regular contraceptive pill apply to the taking of levonorgestrel in high, but irregular, doses.
The teratogenic effects on a foetus in the event of Postinor-2 failing to prevent or terminate a pregnancy are unknown.
Another risk of Postinor-2 arises from the attempt to suppress information about its post-fertilisation effects by presenting it as a 'contraceptive' and explicitly denying that it has an 'abortifacient' effect. As reported in the Annals of Pharmacology
, March 2002, Kalhlenborn et al
.('Postfertilisation effect of hormonal emergency contraception')
warn that there is 'a potential for negative psychological impact on women who value human life from conception onward, and ... later learn of the potential postfertilisation effects.
'Their responses could include disappointment, guilt, sadness, anger, rage, depression, or a sense of having been violated by the provider.' It would be more difficult for a pharmacist, than for a doctor during a consultation, to conduct the necessary sensitive discussions with a woman to make sure this potentially damaging psychological impact is avoided.Abuse
In relation to the potential for abuse of a substance, Postinor-2 is being marketed as an 'emergency contraceptive'. The existing Australian product information recommends that prescribing doctors should advise that women presenting for repeated courses of Postinor-2 should consider a 'longer term method of contraception'. Pharmacists are not in a position to know that a woman is using repeated courses of the medication, nor to offer this sort of advice.
Teenagers in particular may resort to the regular use of Postinor-2. Postinor-2 is 'not recommended for children'. It is admitted by the Australian sponsor of Postinor-2 that there are 'limited data' on the specific health risks for young women aged 14-16 years when the female body is still developing.
Even if the scheduling decision were to preclude direct sale by pharmacists to girls under 16 (as in Britain), over-the-counter sales without prescription are more likely to result in a 'black market' or at least informal supply of the medicine to girls under 16 after its purchase by friends 16 or over.
It is noteworthy that the Royal College of Nursing (UK) at its recent annual conference voted 290-108 (72.86%) in favour of a resolution 'that this meeting of the Royal College of Nursing Congress supports the need for regulation of assessment for emergency contraception'.
Speakers to the successful motion questioned whether privacy and confidentiality could be given in a pharmacy environment, and whether patients have sufficient information when they buy over the counter emergency contraception.
This is a development which should be given considerable weight by the Schedule Committee, as it represents the considered of a response of body of health professionals, generally in favour of access to 'emergency contraception' after 16 months' experience with over-the-counter sales of emergency contraceptives in Britain.