Keep OCs off the shelves, say family planners
As you enter the exam room, a quick check of the chart shows your new patient is 36, smokes seven to 10 cigarettes a day, and has requested oral contraceptives (OCs). What are you going to do? Most Contraceptive Technology Update readers would say no to combined OCs for healthy smokers over 35. Seventy-four percent of those who participated in the 1997 Pill Survey said they would not provide pills to healthy smokers ages 35 to 39, and a resounding 90% said they would deny pills to healthy smokers over 40.
Most family planners are not wavering in their stance against providing combined OCs to smokers over 35. In the 1996 survey, 72% voted no to OCs for healthy smokers ages 35 to 39, while 27% said yes. When questioned about pills for healthy women smokers 40 years and up, 94% said they would not prescribe, and 6% said they would.
Robert A. Hatcher, MD, MPH, professor of obstetrics and gynecology at Emory University in Atlanta and chairman of the CTU Editorial Advisory Board, finds the percentage of clinicians willing to prescribe pills to smokers over 35 of some concern. "I am interested that as many as 10% would provide combined pills to a healthy patient over 40 who smokes," he says. "I personally do not do this. In fact, I don’t do it for very long for a woman 35 to 39. Now, I may temporize and use combined pills for a short period of time, or even for a longer period of time, if they smoke very little. But this finding surprises me a little bit."
A 1995 conference convened by the Association of Reproductive Health Professionals (ARHP) in Washington, DC, studied the implications of smoking and oral contraceptive use. The findings of the panel, published by ARHP (see resource box, p. 138), were:
• Women over 35 who smoke 15 or more cigarettes per day should not use combined OCs because of a possible increased risk of cardiovascular disease.
• Women over 35 who smoke fewer than 15 cigarettes a day, insist on taking oral contraceptives, and understand the risks may be advised to use an OC with the lowest dose of estrogen available or a progestin-only preparation. Not all panel members agreed on this point, with one noting that smokers should be treated uniformly with no differentiation between light and heavy smoking and no pills for smokers over age 35.1
The panel noted that caution should be exercised even with 20 mcg pills, since the risk associated with such low-dose pills is unknown. "There are no studies of smokers over 35 using low-dose OCs; the absence of data showing risk is not the same as no risk," the panel advised.
The majority of CTU readers maintain the need for prescription dispensing of oral contraceptives. Seventy-two percent say pills should remain on a prescription-only status, while 27% believe OCs should be available over the counter (OTC). This finding is unchanged from the 1996 survey.
The question of OTC availability first appeared in the 1993 Pill Survey and included responses of "yes, with reservations" and "no opinion." Sixty-five percent of respondents were against OTC pills, 15% approved of ready access, 17% approved with reservations, and 3% had no opinion on the subject. Since that time, the response choices have been shortened to positive or negative stances, and the percentages have been more polarized.
A survey of nurse practitioners and certified nurse midwives published in 1996 showed that 69% of respondents favored making birth control pills available over the counter with some restrictions, says lead author Ellis Quinn Youngkin, PhD, RNC, WHCNP, professor and graduate program coordinator in the College of Nursing at Florida Atlantic University in Boca Raton.2 Survey participants also were asked to solicit responses from physician and pharmacist colleagues.
"These restrictions were primarily safety and education requirements, along with system constraints, such as evidence of risk screening, current exam and Pap proof, and pharmacists providing the pills from behind the counter as they do today with certain nonprescription medications," Young-kin says. "A main concern was that the educational materials would need to be much clearer, with better package inserts and pamphlets including information on pregnancy, smoking, casual use, starting and stopping the pill, side effects, danger signs, symptoms, and contraindications."
James Trussell, PhD, director of the Office of Population Research at Princeton (NJ) University and associate dean of the university’s Woodrow Wilson School of Public and International Affairs, and other co-authors of Contraceptive Technology. also stress the need for better materials. "We still think that the benefits of making OCs available without prescription outweigh the risks," he says. "But that switch should not be made without extensive changes to the package labeling."
References
1. Association of Reproductive Health Professionals. Implications of smoking and oral contraceptive use. Clinical Proceedings March 1996; 10.
2. Youngkin EQ, Davis MR, Kolb KW. Making oral contraceptives available over-the-counter. Nurse Pract 1996; 21:13.
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