Obstetricians Predict Problems If Reproductive Drugs Go Behind The Counter

Pharmacists may realize they "have grabbed the tiger by the tail" if behind-the-counter status is given to what are now prescription reproductive medicines, according to an American College of Obstetricians and Gynecologists official.

At FDA's Nov. 14 public meeting to discuss the BTC concept, ACOG representative Dr. Michael Greene questioned whether pharmacists are prepared to counsel women about birth-control drugs and other reproductive medicines (¹ (Also see "BTC Proponents Cite Pharmacists’ Role; Opponents Question Need" - Pink Sheet, 19 Nov, 2007.), p. 4).

"How would this counseling be documented to be sure that the process has been adequate to fully discharge the pharmacist's obligation to a perceived standard of care? The pharmacist may realize with respect to professional liability and pregnancy, they may have grabbed the tiger by the tail," Greene said.

"This is a liability problem [ACOG] has been dealing with for decades," added Greene, a professor of obstetrics, gynecology and reproductive biology at Harvard Medical School and director of obstetrics at Massachusetts General Hospital in Boston.

ACOG also questions how pharmacies would store information to ensure patient privacy and what methods pharmacists would use to provide appropriate counseling and confidentiality.

"We do have questions about protection of confidentiality, privacy and the unique risks when women change status from non-pregnant to pregnant," Greene said.

Greene explained decisions on all prescriptions for women of child-bearing age must be influenced by the possibility patients may be pregnant when they are not aware of it. He noted that 50 percent of all pregnancies in the United States are unplanned and that many are not recognized until or after "organogenesis."

The American Society of Reproductive Medicine also opposes moving prescription drugs to BTC status in part because of the complexities of prescribing reproductive medicines.

The society's public affairs director, Sean Tipton, said BTC status would make some medicines more difficult to obtain because pharmacists could refuse to distribute birth-control and other drugs based on their personal beliefs.

"Physician involvement is necessary for many drugs," Tipton said. "If the drug is safe enough for an individual to take on his or her own initiative, it should be available over the counter. If it is not, it should be available by prescription only."

Consumer Advocates Back BTC Status

Representatives of consumer health and women's advocacy groups said they support BTC status for some drugs.

Rebecca Burkholder, VP for health policy at the National Consumers League, said "this class of drugs could improve access for patients, but we do have numerous concerns about how this system would work safely and effectively."

Burkholder expressed concerns about privacy for consumers when discussing medications with pharmacists, specifically oral contraceptives.

"Establishment of a truly private pharmacy counseling area should be required for a BTC class to ensure that access would increase and not decrease," she said.

While the National Women's Health Network supports moving Rx products to BTC, a "poorly executed BTC system could make existing problems worse and even create new barriers for women," said the group's program director, Amy Allina.

Allina said oral contraceptives are examples of prescription drugs that could be safely distributed behind the counter to expand access to health care for women. "Eliminating the need to visit a prescriber when having a prescription written is the reason for the appointment" would create convenience and cost benefits for women, she added.

"The prescription requirement is a barrier to access or compliance for some women who discontinue pill use because they don't have time or don't get around to scheduling an appointment with a health care provider before their prescription runs out," Allina said.

Plan B Cited As Poor Example

Multiple speakers at the public meeting referred to BTC sales of Barr's emergency contraception Plan B to consumers ages 18 and older (² (Also see "Plan B Pioneers OTC “Pharmacy Counter” Approval, Dual-Status Marketing" - Pink Sheet, 28 Aug, 2006.), p. 3).

According to the Reproductive Health Technologies Project, the switch increased weekly Plan B sales from 17,000 prescriptions to 40,000 BTC and Rx units.

Removing the "unnecessary prescription barrier has improved consumer's ability to obtain the product and potentially improve health outcomes," said project President Kristen Moore.

Moore said discussions with pharmacists are "an opportunity for a consumer or client to get more information" and "feel confident about the decisions they are making about which medications they are using."

Greene, who was on the advisory panel that advised FDA on the Plan B switch, said ACOG is "disappointed" with FDA's decision. He noted the possibility of BTC status limiting access, citing the "intimidation factor" of patients having to ask pharmacists for the product.

"There is no more rationale for emergency contraception behind the counter than other minimal risk contraceptive measures such as spermicidal foams and jellies and condoms which are now readily available over the counter," Greene said.

Moore said Plan B is "a cautionary tale for the agency." While consumers now have more timely access to prevent unplanned pregnancies, FDA should consider additional strategies to enhance consumers' access to pregnancy prevention options.

Allina noted Plan B is not actually distributed on BTC status because it is prescription for consumers under 18. The switch was "a limited advance," she said.

"If FDA goes forward with a plan to create a behind the counter class of drugs for the United States, it can't be used in that way," Allina said. "Drugs that meet the medical and scientific criteria for OTC drug distribution should not be restricted to behind-the-counter distribution because of political concerns rather than a science-based assessment of the best outcome for patients."

- Katie Stevenson ([email protected])