Emergency contraceptive access to grow in Canada
The condom breaks or the pill pack stays at home on a weekend vacation. What will happen next? In Canada, women in all provinces will be able to go directly to the drug store for behind-the-counter access to emergency contraception (EC), based on the direction of regulatory wheels now set in motion.
Health Canada, Canada’s Ottawa, Ontario-based health regulatory agency, is proposing to amend its Food and Drug Regulations to remove levonorgestrel from its prescription-only Schedule F drug list. The move to amend the drug list would allow levonorgestrel in the 0.75 mg dosage to be available without a prescription from a physician.
The place of sale for a drug once it is removed from Schedule F is determined by provincial and territorial pharmacy regulatory authorities, reports Paige Raymond Kovach, Health Canada spokes-woman. However, the National Drug Scheduling Advisory Committee (NDSAC) of the National Association of Pharmacy Regulatory Authorities in Ottawa makes recommendations to the provincial/territorial pharmacy regulatory authorities on the appropriate conditions of sale of a drug in Canada, she explains.
"NDSAC has recommended that 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," says Kovach.
A letter to stakeholders was sent on June 16 outlining the proposal with a 30-day comment period. The letter and proposal also were posted on the agency’s Therapeutic Products Directorate web site, states Kovach. Once the amendment was published May 25, 2004, in the Canada Gazette, the official newspaper of the Canadian government, a 75-day consultation period was allotted for stakeholders to provide comments. These comments will in turn be incorporated into the regulatory proposal, with the final amendment published in the Gazette, which signifies final approval, Kovach reports.
Groups push for access
Levonorgestrel EC, distributed as Plan B in Canada by Paladin Labs of Montreal, already is available through pharmacists in three Canadian provinces: British Columbia, Saskatchewan, and Quebec, says Kovach. The switch to nonprescription status will provide for uniform behind-the-counter access across the country, she states.
The move to expand EC access began in earnest in November 2001, when members of the National Advisory Committee on Emergency Contraception began working with Health Canada to move the drug to behind-the-counter status. Members of the committee include the Society of Obstetricians and Gynaecologists of Canada, the Canadian Pharmacists Association, the Planned Parenthood Federation of Canada, the Canadian Public Health Association, and the National Association of Pharmacy Regulatory Authorities, all in Ottawa, and the College of Family Physicians of Canada in Mississauga, Ontario.
Results from a 2001-2002 Toronto pilot project, which linked 146 pharmacists in 40 pharmacies to 34 physicians through collaborative prescribing authority, showed that direct pharmacist provision of EC could make an impact on pregnancy prevention.1 A total of 6,931 prescriptions for EC were provided, and 54% of the women accessed EC within 24 hours of intercourse. Most of the women who used the service were pleased with it. In fact, 21.1% indicated that had they not obtained EC through the pharmacy, they would not have obtained it elsewhere.1
Will it be adequate?
While advocacy groups are applauding the move to expanded access for EC, some are calling for even broader measures. Such groups as the Winnipeg, Manitoba-based Canadian Women’s Health Network would like to see the drug given over-the-counter status, similar to what is being sought in the United States.
The Canadian Women’s Health Network sees levonorgestrel’s move to Schedule II status as a "half-measure," says Abby Lippman, PhD, co-chair of the network board and professor at McGill University in Montreal. If the drug is moved from prescription-only status to Schedule II, pharmacists may be able to charge a consultation fee, which may limit access if such fees are not covered by government or private insurance, she adds.
If credible information about EC is provided at the point of sale, with information that is understood by women at all literacy levels and languages, there is no need for pharmacist intervention, states Lippman. The Canadian Women’s Health Network is working with other advocacy groups to make sure when EC access is broadened, the educational information provided is easily understood by women of many backgrounds.
"There needs to be a good education program and to make sure the package insert are completely comprehensible to people," she states.
1. Dunn S, Brown TE, Cohen MM, et al. Pharmacy provision of emergency contraception: The Ontario emergency contraception pilot project. J Obstet Gynaecol Can 2003; 25:923-930.