Policy & Practice


EC Behind the Counter

Canada has approved the sale of the emergency contraceptive levonorgestrel 0.75 mg (Plan B) without a prescription. Until now, the product has been available in most provinces by prescription only, except for Quebec, British Columbia, and Saskatchewan, where women can access the product through pharmacists. The Canadian decision comes as the Food and Drug Administration is considering whether to allow the sale of Plan B without a prescription for women aged 16 years and older. “We are pleased that Canadian regulatory authorities have recognized that Plan B is safe and effective for use by women as emergency contraceptive and will make it available without a prescription,” said Bruce L. Downey, chairman and CEO of Barr Laboratories Inc., the company that markets Plan B in the United States. “Canada now becomes the 34th country that enables women to have more timely access to emergency contraception without a prescription.”

Legislating Refusal Clauses

Some federal lawmakers are taking aim at the controversy around pharmacists who refuse to fill prescriptions for birth control and emergency contraception. The Access to Legal Pharmaceuticals Act (S. 809/ H.R. 1652) would ensure that pharmacies fill all prescriptions, while protecting the right of individual pharmacists to refuse to fill a prescription. Although the controversy has revolved around the dispensing of prescription contraceptives, the legislation would apply to all drugs. “A pharmacist's personal beliefs should not come between a patient and [his or her] doctor,” said Sen. Frank R. Lautenberg, (D-N.J.), one of the sponsors of the legislation. “Tomorrow it might be painkillers for a cancer patient. Next year it could be medicine that prolongs the life of a person with AIDS or some other terminal disease.”

Cord Blood Banks

The federal government should establish a new National Cord Blood Policy Board to set rules for the donation, collection, and use of stem cells derived from umbilical cord blood, according to a report from the Institute of Medicine (IOM). The Health Resources and Services Administration should also identify an organization that could serve as a new Cord Blood Coordinating Center to manage the day-to-day operations for cord blood banking and allocation around the country, the report said. The National Marrow Donor Program and other organizations have developed several of the components needed to manage daily coordination of cord blood banking, but no single organization currently has the capability to serve as a Cord Blood Coordinating Center, the IOM said. “The lack of centralized organization, universal quality standards, and uniform matching mechanisms makes it more difficult than it has to be for physicians to provide patients with suitable cells in a timely way,” said Kristine Gebbie, chair of the IOM committee that wrote the report and director of the Center for Health Policy and Doctoral Studies at Columbia University in New York.

Understanding Vitamin D

More than half of women aged over 50 years reported that they have not discussed vitamin D with their physicians, according to a national survey released by the Society for Women's Health Research. The society also found women over 50 may lack an overall understanding of the importance of vitamin D to bone health. About 46% said they felt vitamin D was “extremely important” for bone health, compared with 72% who said they felt that way about calcium. One in six women (16%) said they thought vitamin D was “somewhat important” or “not important at all” for bone health, compared with 4% for calcium. The nationwide survey included 492 women aged 50 years and older. “These survey results should serve as a wake-up call for women over 50 to talk to their doctors about the importance of vitamin D as it relates to overall bone health due to the impact of vitamin D insufficiency on calcium absorption, bone loss, and fracture risk,” said Felicia Cosman, M.D., clinical director of the National Osteoporosis Foundation.

HIV/AIDS Drug Waiting List

The need for HIV/AIDS drugs continues to exceed available resources, according to a report from the National AIDS Drug Assistance Programs Monitoring Project. More than 600 individuals are on waiting lists and 21 state AIDS Drug Assistance Programs report using at least one cost containment measure such as waiting lists and capped enrollment, despite increased federal and state funding. “This is an ongoing, severe crisis in which many states are desperately struggling to provide these life-saving medications to people in need,” said Julie Scofield, executive director of the National Alliance of State and Territorial AIDS Directors.

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