Submission to appeal the NDPSC's preliminary approval for rescheduling Levonorgestrel from Schedule 4 to Schedule 3 when in a two tablet pack, of 0.75mg per tablet, for emergency post-coital contraception
18 August 2003
National Drugs and Poisons Schedule Committee
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606
I write to make a submission to appeal the National Drugs and Poisons Schedule Committee's (NDPSC) preliminary decision to allow Levonorgestrel, marketed as Postinor-2, to be sold without prescription over the counter at pharmacies.
These comments are made noting that we have not had access to all the information that was available to the Committee, including the application and supporting documentation provided by Levonorgestrel's sponsor. We have therefore not had the opportunity to make an assessment of or comment on the sponsor's claims.
Levonorgestrel as an abortifacient
The Committee considered a legal opinion obtained by the Therapeutic Goods Administration (page 119) that Postinor-2 and morning-after pills are not abortifacient. The broad argument put by the TGA's legal opinion is that you cannot have an abortion without a pregnancy and that you cannot have a pregnancy until the embryo implants in the uterus. Therefore drugs that destroy the human embryo before implantation are not abortifacient.
This argument sidesteps the reason that abortion is a controversial procedure. Abortion is not a controversial procedure because it ends a pregnancy, but because it ends a human life. The principle objection of the Australian Federation of Right to Life Associations to Levonorgestrel is that one of its actions can be to end a human embryo's life by preventing implantation.
There is also the implication in the NDPSC's deliberations that because morning-after pills are not legally defined as abortifacient, they must then be contraceptive. This is not correct. Although the drug is frequently described as a contraceptive, this is misleading as Levonorgestrel can act post-conception.
The action of Levonorgestrel post-conception is one of particular ethical concern. It means that women should be given full information on the action of the drug so that they can make a full and informed decision to use or not use Levonorgestrel. They should not be put in a position where they may make a decision that they would not have taken had they been given all the facts. Not informing women of the possibility that the drug will inhibit implantation is a deliberate deception. The Postinor-2 consumer medicine information (CMI) leaflet does not address this issue.
Record of the reasons, meeting 38, June 2003
The National Drugs and Poisons Schedule Committee's Record of the Reasons states that the Committee considered the application and decided that Levonorgestrel should be provided over the counter.
The Therapeutic Goods Act requires the Committee to address nine criteria when looking at a rescheduling application, before making a decision. In a number of criteria the Committee's considerations as described in the Record of the Reasons were inadequate and these instances are detailed below.
Criterion 2: the risks and benefits associated with the use of a substance
Contraindications noted by the manufacturer
The NPSDC argues that the benefits of using the drug Levonorgestrel outweigh the risks. But the manufacturer of Postinor-2 lists a number of contraindications which have not been given adequate consideration by the NPSDC. The manufacturer's Product Information states that:
Conditions which are regarded as relative contraindications include severe hypertension (BP>180+/110+), diabetes mellitus with nephropathy, retinopathy, neuropathy or vascular disease, ischaemic heart disease, stroke, or a past history of breast cancer. Since exposure to levonorgestrel with Postinor-2 is brief, the risks of pregnancy in all women, including those with pre-existing medical conditions, are almost certainly greater than those associated with Postinor-2. In individual cases, the risk-benefit ratio should be assessed by the practitioner in discussion with the patient.
The assessment of the risk-benefit ratio recommended by the manufacturer involves a medical assessment for each patient. This is something that cannot be undertaken by pharmacists, nor reasonably by the NDPSC which concluded "the risk:benefit ratio to be appropriate" (page 127).
The manufacturer also asserts that Postinor-2 should not be given to pregnant women. The exclusion of early pregnancy requires a pathology test. Again, this is a matter of medical referral.
Relative risk of Levonorgestrel
The NDPSC also claims that the health risks of a surgical abortion are higher than use of Levonorgestrel. There is no acknowledgement that the risks of using Levonorgestrel are higher than the unacknowledged option of a test to determine whether the woman concerned is in a fertile phase which may mean that pregnancy is not possible. The NDPSC should consider all possible options to avoid a surgical abortion - not just those provided by the manufacturer of a particular drug.
The NDPSC stated in reasons for its decision that it "accepted there were potentially significant benefits of reducing unplanned pregnancy and abortion rates through timelier access to an effective EC" (page 126). But the Committee had in earlier discussion "acknowledged a reduction in abortion rate was desirable, [but] it may not be easy to link it to the availability of EC through conventional epidemiological data" (page 125). In other words the Committee agreed that a link between use of the morning-after pill and a reduction in the rate of surgical abortion would be difficult to prove and that it did not have evidence to prove a link. The Committee therefore should not "accept there were potentially significant benefits" as a justification for the Committee's decision.
There is in fact evidence from the United Kingdom's experience that family planning services have not reduced the rate of pregnancy or abortion among women under 16 years of age. (1)
Criterion 3: the potential hazards associated with the use of a substance
Pharmacy distribution will be inadequate
The NDPSC "noted that the proposal was associated with a commitment from the distributors to provide training materials for pharmacy" (page 127) and appeared to accept this as an adequate safeguard for consumers. There is no further information given of the strength or detail of this commitment, nor is there an assessment of whether busy pharmacists would have time to consider these training materials.
The ready acceptance by the Committee of pharmacy distribution of Levonorgestrel is inconsistent with the fact that in earlier discussion "members questioned the appropriateness of the pharmacy setting to discuss personal and private issues and a concern was expressed of the readiness of pharmacists to provide such personal advice" (page 126). There is no explanation of how the Committee's earlier concern was resolved.
Consumer medicine information is often ineffective
The Committee also accepted claims that appropriate information will be available via consumer medicine information (CMI) pamphlets to assist in educating consumers in the safe and effective use of Levonorgestrel. No evidence is provided for this claim.
In fact there is evidence that CMI documents have only a limited impact on information received by consumers. Research indicates that there is "irregular provision of CMI to customers" by pharmacists and "few [pharmacists] were actively incorporating CMI in their verbal counselling". (2)
In addition, research has found that consumers are less likely to use CMI documents if they are not provided when the medication is prescribed (as indicated above is likely), if they are not using the drugs to care for someone else, if they don't perceive that they have a severe medical condition and if they are not interested in receiving information. (3) On each of these points it appears that a woman using Levonorgestrel is unlikely to give much attention to the CMI document.
CMI documents are provided in a number of ways: as package inserts, as loose leaflets or as electronic documents printed by the pharmacist. (4) It is not clear which format is used for Postinor-2. However there is anecdotal evidence that in many cases pharmacists do not print out the electronic documents and customers do not know that the information is available.
In addition, the decision does not appear to consider the issue of moral hazard to women who use this drug, but who have not had the opportunity to give their full informed consent because they are not aware how Levonorgestrel works. As detailed earlier, one of the effects of the drug can be to prevent the implantation of a new human embryo, causing its death. The CMI document does not detail how the drug works, displaying contempt for the rights of women to have full information so that they can give informed consent.
Pharmacies unlikely to be developing private areas for counselling
It is also noted in the Record of the Reasons statement that "it was understood that the issue of privacy is currently being addressed by pharmacies and many are establishing private areas for counselling" (page 126). No evidence is provided for this claim, it is not quantified, there are no timelines and it is unclear whether it is anything more than speculation. There are almost 5,000 pharmacies in Australia (5) and it seems extremely unlikely that all of them will be remodelling to increase privacy. It is even less likely they will do so before this drug may become available over the counter.
The Committee notes a number of incidents of ectopic pregnancy associated with the use of Levonorgestrel. It does not note that the World Health Organisation also cautions that morning-after pills have been associated with ectopic pregnancies. (6)
Despite the risk of ectopic pregnancy being widely acknowledged, the manufacturer's CMI document does not explicitly note this risk. It would be appropriate for the consumer to be fully informed of commonly identified risks for morning-after pills.
Criterion 6: the need for access to a substance, taking into account its toxicity compared with other substances available for a similar purpose
Concerns for access overriding safety concerns
There is a concern that the driving force behind the preliminary approval for over the counter access to Levonorgestrel is that it is most effective when used within 72 hours of sexual intercourse. The desire of the sponsor and other Postinor-2 supporters to maximise access to the drug within those 72-hours has been used to sweep aside a precautionary visit to the doctor which would otherwise be standard.
The comment is made in the Record of the Reasons that "levonorgestrel EC was simply another contraceptive option" (page 125), but other pharmaceutical contraceptive options require a prescription and are not available over the counter.
Criterion 7: the potential for abuse of a substance
High teenage use of morning-after pill
The Committee doubts that making Levonorgestrel available without prescription would lead to "more extensive use in women and teenagers" (page 128). Recent media reports indicate that since morning-after pills became available in the UK over the counter in pharmacies in January 2001, morning-after pill use amongst teenagers has more than doubled. It has moved from being used by one in 12 teenage girls to being used by one in five. (7)
Significantly, "women aged under 20 were twice as likely as those aged 20 and over to have used the morning-after pill at least once in the past year." While over 20 percent of 18-19 year olds used the drug, almost a quarter of these had used it more than once in the same year. More broadly, one in seven of all women used the morning-after pill more than once in the same year. (8) These figures directly counter the Committee's statement that "repeated use in women and teenagers was considered unlikely" (page 128).
It is also documented that "teenagers are the most frequent users of emergency contraception at Australian Family Planning clinics" (9), demonstrating that teenagers in Australia are the most likely group to use this drug. Teenagers are therefore likely to be particularly impacted by any over the counter access, while by reason of age having less experience making such important decisions and being more susceptible to peer pressures.
Nausea to teach women a lesson
It is disturbing that the view was put in the Committee "... that possible side effects, such as nausea, would act as a deterrent to routine use of EC as a regular form of contraception" (page 125). This attitude presents the negative side-effects of a drug as an opportunity to teach women a lesson. If the Committee does not think regular use of Levonorgestrel is appropriate it should institute some safeguards to ensure regular use is discouraged, rather than try to make a virtue of the drug's negative side effects.
The Committee notes "concerns relating to its use in conjunction with sexual assaults and rape had not materialised" (page 126). Evidence for this claim was not cited. There is great potential for Levonorgestrel to be used to cover up for sexual abuse. Sexual abuse and abortion are frequently associated. (10) A visit to a medical practitioner may be more likely to lead to that abuse being detected and there being an opportunity to assist the woman to escape an abusive situation. This is much less likely to occur in a pharmacy as there is less privacy, less time for counselling given the imperatives of running a pharmacy and no possibility of a physical examination. A person other than the abused woman may also purchase the morning-after pill.
Committee not confident Levonorgestrel is not abortifacient
The Committee claims Levonorgestrel is not an abortifacient drug. This claim appears to be based on legal rather than medical advice. However, the Committee is apparently not confident of this position, noting Levonorgestrel "may be ineffective post implantation" (page 128). The Committee cannot claim the drug is not abortifacient unless it is confident the drug is ineffective post implantation.
Criterion 8: the purposes for which a substance is to be used
The Committee notes that "the condition (unprotected intercourse) does not require the diagnosis or management of a medical practitioner" (page 128). This statement is true as far as it goes. However a medical practitioner's management is necessary if, as a response to unprotected intercourse, a woman is considering using a morning-after pill such as Levonorgestrel.
It is the recommendation of the manufacturer itself that "the risk-benefit ratio [of using Levonorgestrel] should be assessed by the practitioner in discussion with the patient" and that Levonorgestrel should not be given to pregnant women. Each of these precautions cannot be taken effectively without the assistance of a medical practitioner.
The consideration of the NDPSC as recounted in the Record of the Reasons has been inadequate because it:
- Inappropriately accepts claims that the morning-after pill is not an abortifacient or of ethical concern, based on a legal opinion;
- Accepts that Levonorgestrel is a contraceptive, despite the fact that it can act post-conception to destroy an embryo;
- Does not address contraindications detailed by Levonorgestrel's manufacturer, including the manufacturer's indication that a medical practitioner should assess the risk-benefit ratio and whether a woman is pregnant or not;
- Acknowledges and accepts the risks of Levonorgestrel but claims that they are less than for surgical abortion, yet it does not consider other alternatives including checking whether a woman is in a fertile phase and whether pregnancy is even a possibility;
- Accepts that the distributors will provide training materials to pharmacies, but does not detail whether that is a contractual commitment, what the training materials are or even the likelihood that a busy pharmacist will look at them;
- Asserts that consumer medicine information (CMI) leaflets will also assist, despite research showing that they can assist, but are not a reliable method of getting information to the public;
- Ignores the issue of moral hazard and the right of women to give their full informed consent to the use of a drug when the CMI pamphlet for Postinor-2 does not specify how the drug works;
- Glosses over the difficulty of privacy for women receiving counselling in a pharmacy, making vague claims that "many are establishing private areas";
- Does not mention World Health Organisation cautions regarding the use of morning-after pills and ectopic pregnancy;
- Promotes ease of access as a higher concern than the risks of not consulting with a medical practitioner;
- Does not acknowledge that over the counter availability has been associated with increased use in the UK, particularly for teenage women; and,
- Does not acknowledge the potential for Levonorgestrel, without prescription, to be used to cover up sexual abuse.
In brief, the issue is whether Levonorgestrel should be transferred from a prescription-only category to an over the counter category. When considering this matter, the overall task of the Committee is to assess whether such a transfer would be to the overall benefit of the community. It is our submission, for the reasons we have stated, that such a transfer would lead to significantly greater risks for no proven benefits.
I ask that you change your provisional decision and reject the application to have Levonorgestrel moved from Schedule 4 to Schedule 3.
(1) Paton, D (2002), The economics of family planning and underage conceptions. Journal of Health Economics, Vol. 21(2), pages 207-225.
(2) Aslani, P, Benrimoj, C and Krass, I (1997) CMI use by community pharmacists. The Australian Journal of Pharmacy, vol 78, December, p1380.
(3) Koo, M, Krass, I and Aslani, P (2001), The use of CMI by consumers. The Australian Journal of Pharmacy, vol. 82, January. p18.
(4) Op. cit.
(5) Department of Health and Ageing, Annual Report, 2001-2002.
(6) Emergency Contraception: A Guide for Service Delivery (WHO, Geneva, 1998)
(7) Doughty, S (2003), Morning-after pill lures teens. Herald Sun, 28 March.
(8) Office for National Statistics (UK) (2003), Contraception and Sexual Health, 2001. Office for National Statistics. http://www.doh.gov.uk/public/contracepts2001_v2.pdf
(9) Skinner, S and Hickey, M (2003), Current priorities for adolescent sexual and reproductive health in Australia. Medical Journal of Australia, vol. 179(3), page 158-161.
(10) Russo, N and Denious, J (2001), Violence in the lives of women having abortions: implications for practice and public policy. Professional Psychology, Research and Practice, vol. 32(2), page 142-150.