A Big Change in How Women Get the Pill? : Health: Some family-planning experts and drug makers want oral contraceptives to be sold over the counter. Opponents fear the change would keep women from getting gynecological checkups.

During the past few years, a growing number of drugs have moved from prescription to over-the-counter status: ibuprofen, hydrocortisone cream, vaginal yeast preparations and some ulcer remedies, to name a few.

Most made the switch without controversy. Now, however, the stage is set for what may be a contentious application for the transition of oral contraceptives.

And the debate has begun.

Drug manufacturers and some health experts say they plan to request a meeting with Food and Drug Administration officials later this year to discuss the issue. A switch of oral contraceptives to over-the-counter, or OTC, status could be accomplished in as little as three to five years, one proponent predicts. Major supporters, among them some drug manufacturers and family-planning professionals, say benefits far outweigh possible costs, noting that more than 30 years of use has shown the Pill to be extraordinarily safe. And, if improved instructions are included in the packaging, they say, women will use the drug correctly.

But opponents, including some physicians and consumer organizations, say the Pill poses too many dangers to be sold over the counter, especially to women at risk for complications because of high blood pressure and diabetes.

Further, they criticize any move that would sever some women’s only connection to regular gynecological care. Many young women, they say, seek health care only when they want a prescription for the Pill. And poor women, who receive the drug at little or no cost, might have to pay for it over the counter.

Oral contraceptives can be obtained only with a prescription. And, under federal labeling guidelines, clinicians may not prescribe the pills without first taking a medical history and performing a pelvic examination and any needed blood tests for sexually transmitted diseases.

Obtaining the contraceptives without such procedures would represent a stunning change in the control of a woman’s reproductive health, experts on both sides acknowledge.

“It would be a godsend for some women. To be freed from the expense and trouble of obtaining a prescription would be a tremendous convenience,” says Dr. Michael Rosenberg, president of Health Decisions Inc., a North Carolina-based research consulting firm. “And most people feel the medication is quite safe. The real question is about the secondary impact this might have, such as (disrupting) the access a young woman has to the medical system.”

Oral contraceptives have become a candidate for non-prescription status for several reasons:

* Increasingly, the FDA is allowing drugs to switch to OTC status. About 50--such as some smoking deterrents, anti-arthritic drugs and medications to control blood pressure and lower cholesterol--are expected to switch in the next few years.

* Oral contraceptives are among the most thoroughly evaluated drugs ever and have a proven safety record if used appropriately.

* The high rate of teen-age pregnancies has prompted health officials to seek ways to improve the accessibility of the Pill to younger women. The Pill is the most popular form of contraceptive among females ages 15 to 29, and almost half of sexually active teens ages 15 to 19 rely on it.

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While many distrusted oral contraceptives when they were introduced in 1960, studies have been generally reassuring of the Pill’s safety. For example, cardiovascular disease is not related to use of a low-dose Pill, experts say, a risk associated with the early higher-dose Pill. (A low-dose Pill refers to the amount of hormones present.) And a fear that the drug may increase the risk of breast cancer has not been proven.

Moreover, oral contraceptives have been shown to confer many health benefits, such as protection against endometrial and ovarian cancer. However, women with high blood pressure, diabetes and those over age 35 who smoke are advised not to take the Pill because of possible complications. Women with high blood pressure, a history of stroke or heart attack or smokers over 35 may be at increased risk of a heart attack or blood clots by taking oral contraceptives. And in some diabetic women, higher doses of oral contraceptives can affect blood-sugar metabolism.

“The lower-dose oral contraceptives are very well (tested) for safety. The question is whether this drug could be used effectively,” says Carol R. Scheman, FDA deputy commissioner for external affairs. “The question the agency will ask is, ‘Is this a drug that can be taken safely and effectively by a consumer in an over-the-counter setting? Are there directions for use that can be understood by the consumer in this setting?”

Scheman says the agency will look hard at all sides of the issue. A meeting scheduled earlier this year on the topic was canceled when top FDA officials feared a cross-section of viewpoints would not be included. But some experts predict the FDA will eventually approve the switch to non-prescription status once pharmaceutical companies apply.

“My sense of it has been that the manufacturers have been hesitant to apply. But, I think that’s really changing,” says Dr. Felicia Stewart, a Sacramento gynecologist and co-author of a recent article in the American Journal of Public Health favoring the switch. “I really see a chance now. At least there will be some changes in the way we make oral contraceptives available.”

The first indication of interest in switching the drug was a request by pharmaceutical giant Johnson & Johnson that the FDA hold a meeting on the topic. However, drug companies have been reticent in revealing their plans on applying for a switch.

Says Clare Castaldo, a spokeswoman for Ortho, a Johnson & Johnson subsidiary that makes the Pill: “Concerned parties on both sides have raised a number of questions. We believe these questions require much study and evaluation to determine what is in the best interest of women’s health.”

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Among the objections raised by OTC opponents is that some women who should not take the Pill will do so, either because they fail to read the package labeling or misinterpret the information.

In Scandinavia, a study of women purchasing the Pill over the counter found that they often failed to comply with instructions.

Moreover, opponents suggest that the strategy of making the Pill more accessible to reduce unintended pregnancies may backfire. If women suffer side effects, they may simply stop using the Pill instead of consulting a doctor about another product or method.

Stewart says major objections are resolvable.

Usage directions could be dramatically improved, she says, and various products would have to abide by standard packaging guidelines to eliminate confusion if a woman changes products. In addition, a toll-free hot line could be set up for questions.

“Now, in a busy doctor’s practice, there is no time to teach women about the Pill,” Stewart says. “Women now teach themselves what they need to know. And we could make it a lot easier if we had better information enclosed with the Pill or make video or audio tapes available.”

Because of the Scandinavian experience, however, Rosenberg says he favors a trial use of oral contraceptives provided over the counter: “In this country, I think we should introduce it on a small scale and be able to look at the effects of that experiment.”

Another option pharmacists propose would allow such contraceptives to be regulated under a new “third class” of drugs that would not require a prescription but would require the pharmacist to release the drug to the consumer with counseling.

Pharmacists have long pushed for this third class--also called a pharmacists’ class or transition class--but the FDA has opposed its creation.

“This is a classic example of where there should be a third class of drugs, where there is debate,” says Marsha Holloman, director of professional affairs and policy for the American Pharmaceutical Assn. in Washington. She says a drug might be moved to a transitional class for a year or two to be monitored for its safety. “It gives the manufacturer and the FDA the chance to decide if these are truly safe enough to go over the counter.”

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Separating the Pill from regular medical care may represent the harshest criticism of the proposal to switch it to non-prescription status.

Doctors find it convenient to perform annual physical exams, Pap smears and blood tests when a woman comes in for contraception.

And, notes Rosenberg, “The only contact a young woman might have to the health system is through obtaining a birth control prescription.”

Moreover, Medicaid covers all or most costs of oral contraceptives for poor women. But the drug would probably not be covered if it moved to OTC status. (Experts predict that the cost of a monthly package of pills, now about $25 and rarely covered by insurance plans, would probably decline if the drug went non-prescription.)

“People are worried about the practical impact on health resources for poor women. And I am too,” says Stewart. “I wouldn’t advocate we make any change that jeopardizes the clinical services that are now available. That is, without a doubt, the biggest issue.”

But while she and others agree regular health care is important for women, they argue it is unfair and coercive to tie contraceptive use to other health services.

“The provision of oral contraceptives should not be contingent on unrelated screening services,” says Dr. David Grimes, in an editorial in this month’s American Journal of Public Health. “Preventive health care services are important in their own right.”

Grimes, a reproductive health expert at San Francisco General Hospital, says he favors a controlled study to examine effects of dropping or relaxing current requirements.

But the first step in demedicalizing the Pill may have already been taken.

An FDA advisory committee in May approved a recommendation by Planned Parenthood Federation of America to allow clinicians to provide the contraceptives without first performing a pelvic exam. The recommendation still awaits final FDA approval. Some health experts suggest that dropping such a requirement will encourage more teen-age women to obtain the contraceptive.

“Nearly half of all pregnancies in this country are unintended,” Stewart notes. “The cost of that is astounding. I really believe that if we want to control the cost of health care, then we have to use everything we can, including oral contraceptives, as effectively as possible.”