Thank you for the opportunity to comment. The Canadian Women's Health Network (CWHN) is writing to strongly endorse the move from prescription to non-prescription status. However, we disagree with the recommendations that levonorgestrel for use as an emergency contractive (EC) be given Schedule II status at the provincial level.
The change in regulatory status is a critically important, albeit small, step in implementing a comprehensive reproductive health strategy in Canada and is long over due. The high rates of unintended pregnancy and the failure rates for contraceptives highlight this need. We are sensitive to the fact that the move to non-prescription status will engage the attention of those who seek to limit reproductive and therefore human rights for women but expect that this decision will be based on evidence not politics.
However, a change in regulatory status alone will be insufficient unless access issues are also addressed. Equitable access to credible information about EC and awareness of EC by providers, intermediaries (e.g., teachers, social workers), and the public are essential. As well, the extent of distribution by commercial and public health services and the pricing of this drug will be very relevant to its availability and appropriate use. I refer you to the excellent report prepared by the Reproductive Health Alliance on the United Kingdom's experience with the non-prescription status of EC with compulsory contact with a pharmacist.[1]
The World Health Organization and professional organizations recognize that ECP is medically safe, requires no physical assessment, and that the dosage is the same for all women. In this light, maintaining prescription status for it is no longer appropriate -- or efficient, so long as ready access to credible information is assured. A recent review by the Guttmacher Institute summarizes the medical evidence and the international experience to date.[2] Along with de-regulation, we recommend that special care be taken with the content of the advertising and patient information insert to ensure clear information is provided. This includes:
- advertising, label and use information in multiple languages, not just English and French.
- a www address where one can obtain detailed instructions on use in a variety of languages as well as information on access points, including reproductive health services and pharmacies that carry the drug outside of urban areas.
- the use of pictures and other communication methods for women who have limited literacy skills.
- a warning that if the woman is already pregnant, the product will not be effective.
- a clearly-marked statement of contraindications.
- effectiveness and failure rates of the product.
- a statement stressing that the greatest likelihood of preventing an unintended pregnancy occurs the sooner the first tablet is taken, and that the first EC tablet should be taken no more than 72 hours after intercourse, with the second tablet taken 12 hours later.
- that emergency contraception provides no protection against sexually transmitted infections, including HIV.
- a statement that EC is for emergency use only, and should not be used in place of regular contraception since it is not as effective as regular contraception.
- a recommendation to follow up with a physician or reproductive health centre if a woman misses her next regular period.
- side effects and possible drug interactions.
- phone numbers for provincial health information lines and/or Planned Parenthood organizations for obtaining further information and referral.
- a statement recognizing that sexual assault and coercion can be reasons to need EC and that services to help those having these experiences can be obtained through the provincial health lines, the numbers of which are provided.
However, non-prescription status with accurate advertising and product inserts is not sufficient to address existing concerns regarding improved access. This has been noted in a variety of jurisdictions including the United Kingdom.[3] Other factors which affect access include:
- the proposed status as a Schedule II drug.
- the extent of distribution by retail, community, emergency and public health services. Depending on the retail distribution system will not be adequate.
- keeping EC's listing on provincial drug formularies and other means of access for low income women and teens.
- pricing at the retail and wholesale level.
Therefore, we wish to communicate our strong disagreement with the recommendation from the National Drug Scheduling Advisory Committee (NDSAC) of the National Association of Pharmacy Regulatory Authorities (NAPRA) for Schedule II status for levonorgestrol. (Schedule II drugs require professional intervention from the pharmacist at the point of sale and the drugs must be retained within an area of the pharmacy where there is no public access and no opportunity for patient self selection. This is also referred to as behind the counter status)
Schedule II status will create a needless barrier, increase costs and reduce women's privacy. We see no compelling medical argument to require contact with the pharmacist. These are safe drugs which are used for a short period of time. A study published in the August 2002 issue of Obstetrics & Gynecology of over 660 women (including many young and minority women and women of low literacy) was designed to evaluate how well women understood a prototype over-the-counter package label for emergency contraceptives. The vast majority (85%) understood key messages about indications for use, contraindications, instructions, possible side effects and management of serious complications, and almost all women (97%) understood that the first pill should be taken within 72 hours or as soon as possible after unprotected intercourse in order to prevent pregnancy.
We believe that the information requirements can be well met with an effective patient insert and links to existing health information phone lines such as Health Links and the Facts of Life Line here in Manitoba or Planned Parenthood Federation of Canada's 800 line. Canadians should not be compelled to undergo individual counselling unless there are clear risks to their health.
Requiring explicit pharmacist involvement would create extra costs and delays in implementation due to special training required. For example, the recent statement by the Canadian Pharmacists Association states that pharmacists "should be reimbursed for the consultation" with a fee "from $15 and up depending on the pharmacy and province". [4] Other health services including provincial nursing health information lines, reproductive health information lines such as the Facts of Life line and primary care providers are readily available within Medicare should consultation be required. We also note that most pharmacies are not set up for a conversation of the intimate nature required.
There are instances where women or governments have been charged a counselling fee by pharmacists prior to women being able to purchase the drug. Indeed, this issue has complicated provincial initiatives to delegate the ability to prescribe EC to pharmacists here in Canada. As well to maintain, if not increase, access the provinces and territories will need to put in place mechanisms to subsidize the costs for low income women and teens.
As of September 2002, countries which have already approved the switch to over-the-counter availability of emergency contraceptives included the United Kingdom, Morocco, Norway, Sweden, Finland, Israel, France, Belgium, Denmark and Portugal.[5] Organizations such as the American College of Obstetricians and Gynecologists are in support of over-the-counter status and in fact promote women maintaining an advance supply of EC.
Although this is not within the jurisdiction of Health Canada, we urge Health Canada to provide leadership regarding the issue of over-the-counter vs behind-the-counter status and other issues of access when communicating with provinces. We view this as a component of the yet to be initiated Reproductive Health Strategy committed to after the Royal Commission on Reproductive and Genetic Technologies.
We also suggest that the Patented Medicine Prices Review Board (PMPRB) be requested to monitor the retail and wholesale costs before and after the regulatory change is made. Reports from other jurisdictions suggest that pricing did not come down even when non-prescription status is established. We would expect the retail costs to drop considerably once the dispensing fee is no longer needed.
We hope that these recommendations will contribute to your decision on changing the regulatory status of EC so that it can be made properly and safely accessible to Canadian women.
Sincerely,
Madeline Boscoe,
Executive Director
Canadian Women's Health Network
c.c Honourable Anne McLellan, Minister of Health
Honourable Jean Augustine, Secretary of State (Status of Women)
Women's Health Bureau, Health Canada
Public Advisory Committee, Office of Consumer and Public Involvement, Food and Health Products Branch, Health Canada
Provincial and Territorial Ministers of Health and Responsible for the Status of Women
Society of Obstetricians and Gynaecologists of Canada
Pharmacists Association of Canada
Sharon Camp, CEO, Women's Capital Corporation
Valerie Boyer, Paladin Labs
National Drug Scheduling Advisory Committee (NDSAC)
