Information

May 2004

Morning after pill

Health Canada is proposing an amendment to the Food and Drugs Regulations, to remove levonorgestrel when sold in a concentration of 0.75mg per oral dosage (also known as the morning-after-pill) and intended for use as an emergency contraceptive (EC) from Schedule F. This will allow the drug in the 0.75mg dosage to be available without a prescription from a physician.

Timely access to levonorgestrel is important. For it to be effective as a contraceptive, levonogestrel 0.75mg needs to be taken within the first 72 hours after unprotected intercourse or a contraceptive accident. Because a prescription is currently required for access to the drug, levonorgestrel 0.75mg is not always available within the recommended time period, especially during weekends and holidays.

Once a drug has been removed from Schedule F, the provincial and territorial pharmacy regulatory authorities decide on the conditions for its sale in consultation with the National Drug Scheduling Advisory Committee (NDSAC) of the National Association of Pharmacy Regulatory Authorities (NAPRA). NDSAC has recommended that the provinces and territories adopt Schedule II status (behind-the-counter) for levonorgestrel 0.75 mg, which would require professional intervention from the pharmacist at the point of sale.

A Letter to Stakeholders was sent on June 16, 2003 outlining the proposal, with a 30-day comment period (required before publishing in Canada Gazette I). The letter and proposal were also posted on the Therapeutic Products Directorate (TPD) website.

Once the amendment is pre-published in Canada Gazette, Part I, there will be a 75-day consultation period for stakeholders to provide comments. After that, the amendment will be published in Canada Gazette, Part II, signifying final approval.

Frequently Asked Questions:

What is an emergency contraceptive pill?

An emergency contraceptive (EC) pill is a product that a woman can take after unprotected intercourse to prevent pregnancy. The drug must be taken within 72 hours of unprotected intercourse in order to be effective.

Is levonorgestrel an abortion pill?

No. Levonorgestrel is not the abortion pill. Levonorgestrel will not work if a woman is already pregnant.

The ways in which levonorgestrel 0.75mg can act to prevent a pregnancy are provided on the drug labelling. This allows Canadian women to have the information they need to make a personal, informed choice.

Is the non-prescription EC pill the same as the prescription EC product?

Yes, it is the same drug. Levonorgestrel 0.75mg is already available in Canada as a prescription drug. Health Canada is currently consulting Canadians to learn whether there are any issues or concerns regarding its use as a non-prescription emergency contraceptive drug.

Is the EC drug available as a non-prescription drug in other countries?

Yes. Levonorgestrel for emergency contraception is available without a doctor's prescription in at least 28 countries; including the United Kingdom, Australia, France, Denmark and Norway. The United States is also in the process of switching levonorgestrel from prescription to non-prescription status.

Will teens be able to buy the EC pill without their parents' consent?

Provincial laws guide health care professionals in providing medications for minors in the absence of consent from their parents or legal guardians. Other forms of over-the-counter birth control, such as condoms and spermicides are widely available to minors without parental notification or consent.

Can the EC pill prevent sexually transmitted infections (STI's)?

No. The labelling for levonorgestrel will clearly state that it does not provide any protection against contracting STI's. None of the regular birth control methods, with the exception of condoms, prevent STI's.

Is the cost of emergency contraceptives covered by drug plans?

Cost coverage for non-prescription drugs is determined on a case-by-case basis by private and publicly funded drug benefit plans. Your drug plan office should be contacted directly for information on cost coverage.

Will pharmacists be required to dispense emergency contraceptives even if they have moral objections to its use?

No. Most provinces and territories have adopted a policy whereby a pharmacist has the right to refuse to dispense medication for moral reasons. However, it is expected as a standard of care for that pharmacist to refer the woman to another pharmacist, physician, or health facility where the medication can be readily obtained.

Why is the federal government proposing this amendment if the drug is already available without a prescription in three provinces?

Health Canada's proposal to amend the federal regulations allows for a national, harmonised approach to access to emergency contraceptives for all women in Canada. Currently three provinces have already made the product available behind the counter, and the National Association of Pharmacy Regulatory Authorities has recommended that levonorgestrel be availble behind the counter across the country.

Health Canada considered these recommendations, along with levonorgestrel's long history of safe and effective use as an emergency contraceptive before proposing to make it available to all Canadians without a prescription.

The proposed amendment is an important step towards giving all women in Canada timely access to emergency contraceptive.