ACOG Suggests OTC Birth Control Pills

Last month, the American College of Obstetricians and Gynecologists (ACOG) suggested that oral contraceptive pills be made available over the counter. Though 30 countries make birth control pills available to women without a prescription, in this country they remain available only with a prescription from a health care provider. After looking at the most recent research and science, ACOG’s Committee on Gynecologic Practice concluded:

“Weighing the risks versus the benefits based on currently available data, OCs should be available over-the-counter.”

In its opinion, the committee declared that unintended pregnancy remains unacceptably high in this country and has not changed significantly in the last 20 years. It noted that access to and cost of contraception contribute to this public health crisis and pointed out that women who become pregnant unintentionally are more likely “…to smoke or drink alcohol during pregnancy, struggle with depression, experience domestic violence, and are less likely to obtain prenatal care or breast-feed.”

The committee also took on the possible criticisms of making oral contraception available over the counter including concerns about the safety of the pill, contra-indications for some women, and continued adherence without a doctor.  

It noted that no medication—whether prescription or OTC—is completely safe and that the risks associated with the birth control pill may be smaller than those with some common drugs such as aspirin and acetaminophen. Moreover, while it is true that some women should not use the pill, studies have found that by using a simple checklist, women are able to figure out whether they are good candidates for this method without a physician. For example:  

“In one study that compared current family planning clients’ self-assessment of contraindications with clinical assessment, 392 of the 399 participant (females aged 15–45 years) and health care provider pairs obtained agreement on medical eligibility criteria.” 

Research also suggests that compliance may actually improve for women who are able to get their pills over the counter. In one study women in the United States were assigned to two groups—one group got their pills from a public clinic and the other got them from Mexican pharmacies. Though adherence rates were similar, the women who went to the pharmacies were slightly more likely to continue with their pills.   

Health care providers may also fear that women who get the pill the at the drug store will no longer come into the office for other preventive services and may forgo more effective methods that are only available by prescription such as IUDs and Implants. The committee dismissed this last concerned suggesting that:

“…efforts to improve use of long-acting methods of contraception should not preclude efforts to increase access to other methods.“

It went on to note:

“In one study, 68% of the women who might avail themselves to over-the-counter OCs reported not currently using any contraceptive method”

As for preventive services, the committee once again pointed to the research in which some women went to Mexican pharmacies and others to clinics and noted that the both groups received pap smears and STI screenings at similar rates (though those going to the clinic were slightly more likely to received other services). 

The final concern, however, is cost. As of August of this year, the Affordable Care Act required insurers to pay for contraception. Though there are still some questions, it is likely that OTC contraceptive methods such as condoms will not be covered. Tait Sye, a spokesperson for the Department of Health and Human Services, agreed that if the pill were sold without a prescription, it would not be covered under the provision which could ultimately make the pill more expensive.

Despite this important opinion by ACOG, it will likely be many years before we see birth control pills in the feminine hygiene aisle at the local Walgreens. The ultimate decision would have to be made by the Food and Drug Administration (FDA) which did say it would be willing to sit down with any company that was interested in making the pill available without a prescription to discuss what additional studies might be needed. That said, it’s unclear if any manufacturer would want to take this one on especially after watching the application process for making Emergency Contraception available over the counter which became highly political—spanning two administrations—and is, in fact, still going on. 

AAP Urges Providers to Give Teens EC Scripts Ahead of Time

With this latest decision ACOG launched what may be the first strike in the debate about  making birth control pills available over the counter but last month its members also weighed in on the ongoing controversy over doing the same thing for Emergency Contraception (EC). The Committee on Health Care for Underserved Women released an opinion recommending steps to improve access to EC including removing age restrictions on its OTC availability, encouraging insurers to cover the method whether obtained by prescription or OTC, and launching media campaigns to increase knowledge of this important pregnancy prevention method. 

This week their colleagues at the American Academy of Pediatrics (AAP) also took on access to EC when they suggested that health care providers give young women prescriptions for the drug even before they need it.

Emergency Contraception is a high dose of hormones that can prevent pregnancy (by preventing ovulation) if taken within three to five days of unprotected intercourse. The sooner it is taken, however, the better it works. This is why health care providers have sought to make EC as accessible as possible and continue to argue that over-the-counter access is important. The efforts to do so have taken the better part of a decade.

The makers of Plan B first requested OTC status from the FDA in 2003. That same year an FDA advisory panel voted 23-4 in favor of the application but in a very delayed decision, the FDA rejected the request citing a lack of information on EC use in those under 16. A report to Congress found this to be a “highly unusual” decision.

In 2005, the company that made Plan B submitted a new application that asked for OTC access only for those over 16. The FDA delayed the decision on this amended application for quite some time and then asked the company to submit a third application this time making EC available OTC to consumers 18 and over and by prescription for those 17 and under.  In the summer of 2006, the FDA agreed to this and OTC sales began at the end of that year. 

The debate did not end there, however, a federal judge ruled in March 2009 that the FDA had to make EC available to consumers 17 and older within 30 days and urged the agency to remove all age restrictions. That change took place in August of 2009 and the FDA began to consider evidence about removing the age restriction. The FDA was set to remove the age restriction in 2011 when, in a completely unprecedented move, Secretary of Health and Human Services stepped in and overruled its decision.

This brings us to today; Plan B is available behind the counter without a prescription for women 17 and older and by prescription only for anyone younger than that. As Kirsten Moore explains in her article this had caused a lot of confusion over the years with doctors and teens being given misinformation about the age restrictions and men being told by pharmacists that they can’t buy the drug at all. The end result is delays in access for many women and complete lack of access for others. Moore began a petition asking for this rule to be overturned once and for all. 

In the meantime, however, the AAP is now urging providers to routinely hand out prescriptions to those under 17 so that they can have immediate access when needed. The decision, written by the AAP’s Committee on Adolescents will be published in the Journal of Pediatrics in December. According to the committee the goal of the decision is:

“…to (1) educate pediatricians and other physicians on available emergency contraceptive methods; (2) provide current data on safety, efficacy, and use of emergency contraception in teenagers; and (3) encourage routine counseling and advance emergency-contraception prescription as 1 part of a public health strategy to reduce teen pregnancy.”

In writing the decision, the committee pointed to research that suggests that young people are more likely to use EC when it is prescribed in advance. It also noted the important role that pediatricians can play in preventing unintended pregnancy among young women. 

Both of these new opinions are very encouraging as physicians are coming forward to help increase access to contraception even if it means they will see their patient’s a little less.