Do pharmacist-prescribing laws give adequate access to OCs?
PHARMACIST-PRESCRIBED contraception laws are an opportunity to safely and easily improve access to contraception for women. While over-the-counter access remains an important goal, there are many practical considerations that must be addressed prior to implementation.
For example, in order to change the status of a medication to OTC, each product's manufacturer needs to apply to the Food and Drug Administration for the change. This application includes studies that demonstrate their product can be safely used by the general public, without guidance from a health professional. The American College of Obstetricians and Gynecologists has already weighed in on the overall safety of oral contraceptives, and some studies have been done that show women can accurately complete a health questionnaire related to their OC eligibility. While these are good steps toward demonstrating safe use, they do not satisfy FDA requirements for OTC status. These initial studies never went to the next step of having women interpret the questions in an "actual use study," an FDA requirement.
On the other hand, there have been studies demonstrating that pharmacists can safely provide hormonal contraception (J Am Pharm Assoc. 2008 Mar-Apr;48:212-21). State laws can't overrule the FDA and make hormonal contraception OTC, but they can change the scope of what pharmacists are permitted to do. In Oregon and California, specific laws allowing pharmacists to prescribe hormonal contraception have already been implemented. Speaking from our experience in Oregon, this change has solved many concerns that have been raised about hormonal contraception going OTC.
Maintaining insurance coverage
Since pharmacists are able to write prescriptions, they can bill insurance plans for the product in the same way as for any other prescription. The majority of OTC medications are not covered by insurance and if a future law required insurance to cover contraception obtained OTC, pharmacists would still be involved in billing.
Patients will continue to get counseling
Pharmacists need to undergo training/certification in order to prescribe hormonal contraception. In Oregon, the certification was developed by pharmacists and physicians with input from the Oregon Health Authority and the Oregon Board of Pharmacy. Having a trained health care professional involved in counseling means that accurate and important information is still conveyed, including ensuring that women are aware that hormonal contraception is not going to protect against sexually transmitted infections, and teaching women about the importance of adherence, but also how to deal with missed pills and problems. The importance of accessing other preventive health services can also be stressed.
Patients will be appropriately screened for their eligibility
Women who are unable to safely use hormonal contraceptives will be referred for more appropriate methods.
We have the opportunity to act now to prevent unintended pregnancy through pharmacist-prescribed hormonal contraceptives.
In addition, allowing pharmacists to directly prescribe hormonal contraceptives provides the opportunity to evaluate the safety, efficacy, and acceptability of the practice.
This evidence can then be used to look at the feasibility and possible mechanisms that could be undertaken to safely move hormonal contraceptives to OTC, which helps the OTC movement rather than distracting from it.
Dr. Anderson is an instructor at the Oregon State University College of Pharmacy in Corvallis. Dr. Rodriguez is an assistant professor of ob.gyn. at Oregon Health & Science University in Portland. Dr. Edelman is a professor of ob.gyn. and director of the Oregon Family Planning Fellowship at OHSU. They reported having no relevant financial disclosures.
NO: Exchanging one barrier for another
BIRTH CONTROL is an essential part of women's health care and the value of contraception has been proven time and again. Not only do oral contraceptives provide women with the ability to choose if, and when, they want to become pregnant, they allow women to have more control over their lives by timing pregnancy around education, careers, and other life goals. Nearly 90% of women in the United States between the ages of 15 and 44 will use a highly effective, reversible method of contraception, such as oral contraceptives, injected contraceptives, cervical rings, contraceptive implants, or intrauterine devices.
Ob.gyns. know from evidence and experience that oral contraceptives are safe enough for OTC access. In fact, oral contraceptives are safer than many other medications that are already available OTC, such as acetaminophen. Of note, thromboembolism, the most common serious risk associated with oral contraceptives, is not only exceedingly low but is also much lower than the risk for thromboembolism during pregnancy and the postpartum period. After all, no diagnosis is required to prescribe oral contraceptives. Of course, ob.gyns. and other women's health care providers do screen for easily recognizable risk factors, such as smoking. However, research shows that women are very adept at self-screening for any potential risks.
For these reasons, ACOG has long been a public supporter of OTC access to oral contraceptives, as it already is in many countries around the world. ACOG supports efforts to increase affordable, reliable access for American women to the contraceptives they need, when they need them.
However, the pharmacist-prescribing laws do not go far enough in expanding access to contraception. A pharmacist's prescription simply exchanges one barrier --a physician's prescription--for another.
Women still need to arrange a consultation with a pharmacist during pharmacy hours and any potential cost associated with that consultation would add out-of-pocket expenses. This will not allow us to reach women who remain underserved by the current prescribing requirements. For example, this may prevent women who are uninsured or underinsured from accessing contraception. For some, the need to visit a health care provider prevents access to contraception.
ACOG continues to stand by full, no-copay coverage of all FDA-approved methods of birth control, under the Affordable Care Act, as we recognize that OTC access to birth control is not a blanket solution. We also continue to strongly advocate for access to long-acting reversible contraceptive methods, the most effective method of preventing pregnancy.
Pharmacists and ob.gyns. alike share a commitment to quality patient care. However, if our shared goal is increasing access to safe, effective contraception, women should be trusted to control their reproductive lives and should be able to do so without barriers.
BY MARK S. DEFRANCESCO, MD
Dr. DeFrancesco is an ob.gyn. In Cheshire, Conn., and the immediate past president of the American College of Obstetricians and Gynecologists. He reported having no relevant financial disclosures.
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|Author:||Anderson, Lorinda; Rodriguez, Maria I.; Edelman, Alison; DeFrancesco, Mark S.|
|Publication:||OB GYN News|
|Date:||Jun 1, 2016|
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