What is Pharmacy Access to Hormonal Contraception (HC)?
Map of States with Regulatory Environments for Pharmacy Access to HC
Why Pharmacy Access to HC?
Who supports and would use pharmacy access to HC?
Are pharmacists interested and ready to provide pharmacy access to HC?
What is Pharmacy Access Partnership doing? Why Pharmacy Access to HC in California?
What is Pharmacy Access to Hormonal Contraception (HC)?
Hormonal birth control methods like oral contraceptives, the contraceptive patch and vaginal ring all require a prescription. Whereas the federal government (under the U. S. Food and Drug Administration) has sole authority to determine or change a drug’s status from prescriptive to over-the-counter (OTC), states have considerable power deciding who can prescribe. As such, states can allow pharmacists through regulation or legislation to initiate a prescription for certain drugs through collaborative protocol arrangements. Depending on the state, pharmacists may voluntary collaborate with a licensed prescriber (e.g. physician, nurse practitioner) to allow the pharmacist to assess the suitability of a drug for a person requesting presenting at the pharmacy, and if medically appropriate, provide it to the patient without an advance prescription from a doctor or authorizing prescriber. For example, nine states currently allow pharmacists to provide pharmacy access to EC for all women, regardless of age, and ten other states have introduced similar legislation in the last few years. Currently, one in five states has a regulatory environment that would permit pharmacists to provide pharmacy access to HC.
Map of States with Regulatory Environments for Pharmacy Access to HC*
* Data was adapted from a report conducted by American Pharmacists Association and commissioned by Pharmacy Access Partnership: Pharmacists’ Authority to Initiate, Adjust, and/or Administer Hormonal Contraception Therapy As of January 15, 2005. Review was based on information from state laws and regulations, state pharmacy associations, and the National Board of Pharmacy Survey of Pharmacy Law.
Why Pharmacy Access to HC?
Expanding access to HC in pharmacies may help mitigate existing contraceptive access barriers. For example, a national survey of women conducted by Pharmacy Access Partnership showed that one in four women experience problems obtaining or refilling a prescription for HC.[i] This number is even higher in California with over a third of women (37%) saying they had problems getting their HC. Obstacles included long waits to get an appointment, inconvenient physician/clinic office hours, costly physician office appointments, difficulty to get time off from work or school and not wanting to get a pelvic exam. Women who have fewer resources to prevent or manage an unintended pregnancy – uninsured, single, or younger women and women of color – are significantly more likely to have experienced problems getting HC.
Changes in medical guidelines opens the door for pharmacy based initiation of HC. While research has shown that a Papanicolaou (Pap) smear and pelvic examination are not medically necessary to assess appropriate candidacy for HC, some providers make them a pre-requisite for prescribing HC. Although these exams are indeed important to women’s health, they should not be used as roadblocks to access contraceptives.[ii],[iii],[iv],[v] In fact, the American College of Obstetricians and Gynecologists, the World Health Organization, the US Food and Drug Administration and Planned Parenthood Federation of America have all published guidelines or recommendations stating that a Pap smear and pelvic examination are not necessary prerequisites to prescribing HC and that these exams are no longer required annually for many women.[vi],[vii],[viii] The removal of these barriers opens the door for pharmacy-based initiation of HC use.
Pharmacies are widely distributed and provide convenient access to healthcare services during evening and weekend hours when other healthcare services are closed. As such, widespread support and interest exists among women across ethnic, economic and religious backgrounds for direct pharmacy access to HC and for pharmacist involvement in contraceptive screening.[ix]
Who supports and would use pharmacy access to HC?Executive Summary
Two out of three women (63%) in the United States agree that pills, patches and rings should be available without a prescription if a pharmacist screens a woman first.
Moreover, four in ten women not currently using contraception said they would start HC if it were available directly in a pharmacy.
For more information and data on women’s attitudes and interest in pharmacy access to hormonal contraception, see our published research.
Are pharmacists interested and ready to provide pharmacy access to HC?
Pharmacists throughout the United States have expressed interest, comfort and capability to provide HC pharmacy access. According to a national survey conducted by the American Pharmacists Association and Pharmacy Access Partnership the majority of pharmacists (85%) were interested in providing pharmacy access to HC.
A precedent also exists for pharmacists initiating prescriptions and provision of HC. A pilot project of pharmacist-initiated HC, including oral contraceptives, the patch and ring, demonstrated patient satisfaction with pharmacist delivered services on a local level.
Between 2002 and 2004, participating pharmacists in Seattle, WA, served 200 women with pharmacy-based access to HC as part of a study funded by National Institute of Child Health and Human Development. The study found that the majority of women who sought HC from the pharmacist did so because the pharmacy was a convenient point of access and/or they did not have a regular provider. [x]
Most recently, England launched a pharmacy access to HC pilot.
What is Pharmacy Access Partnership doing? Why Pharmacy Access to HC in California?
The question remains whether the HC pharmacy access model could be adapted and implemented in pharmacies outside of Washington State. California is well-positioned to initiate a pharmacy access to HC program and lead the nation in creating paradigm shifts in contraceptive access for women. Since research shows that California pharmacists provide pharmacy access to EC more than any other clinical services, they are primed to offer women even greater timely access to contraceptive services. In California, we also have an opportunity to improve the delivery of services to women underrepresented by Washington State’s program, including poor women, teens and women of color. Moreover, we have the opportunity to model system change in policy and practice that would promote and facilitate collaborative partnerships between the pharmacy, medical, reproductive health and public health communities.
As California and our nation grapples with a dynamic and stressed healthcare system, it is important that we put in place systemic policy changes that will make a difference in how consumers access quality and affordable reproductive healthcare that gives them more control over their choices. We believe pharmacy access to hormonal contraception has real potential for meeting that mark.
Pharmacy Access Partnership is developing a pharmacy access pilot, building on the lessons learned in Washington State and leveraging our expertise in facilitating new pharmacy access programs. We have convened a workgroup of key experts and interested stakeholders to guide the pilot development. We are also actively involved in a national working group to make the public case for over-the-counter access to oral contraceptives and to educate the public and health professionals around unbundling pelvic and Pap exams as prerequisites to initiating HC.
By broadening access in delivery and service, widening the array of healthcare professions trained and able to respond to the reproductive healthcare needs of diverse communities, and by pursuing evidenced-based data around these issues, we believe that access to HC in pharmacies is now more than ever, within our reach.
[i] Landau SC, Parker MT, Taylor-McGhee B. Birth control within reach: a national survey on women’s attitudes toward and interest in pharmacy access to hormonal contraception. Contraception, 2006; 74:463-470.
[ii] Leeman, L. Medical barriers to effective contraception. Obstetrics and Gynecology Clinics of North America, 2007;34:1 Pages 19-29
[iii] Harper C, Balistreri E, Boggess J, Leon K, Darney, P. Provision of hormonal contraceptives without a mandatory pelvic examination: the First Stop demonstration project. Fam Plann Perspect 2001; 33:13–8.
[iv] Scott A, Glasier AF. Are routine breast and pelvic examinations necessary for women starting combined oral contraception? Hum Reproduc Update 2004;10: 449–52.
[v] Stewart FH, Harper CC, Ellertson CE, Grimes DA, Sawaya GF, Trussell J. Clinical breast and pelvic examination requirements for hormonal contraception: Current practice vs evidence. JAMA 2001;285(17):2232-9.
[vi] World Health Organization (WHO). Improving access to quality care in family planning: medical eligibility criteria for initiating and continuing use of contraceptive methods. Geneva7 WHO; 1996.
[vii] American College of Obstetricians and Gynecologists. Cervical Cytology Screening. ACOG Practice Bulletin No. 45. Washington, DC: ACOG; 2003. Int J Gynaecol Obstet. Nov 2003;83(2):237-247.
[viii] US Food and Drug Administration. Labeling guidance text for combination oral contraceptives, prescribing information, physician labeling; 1994. Available at: http://www.fda.gov/ohrms/dockets/dailys/04/may04/050604/050604.htm [accessed July 14, 2006].
[ix] Landau SC, Parker MT, Taylor-McGhee B. Birth control within reach: a national survey on women’s attitudes toward and interest in pharmacy access to hormonal contraception. Contraception, 2006; 74:463-470.
[x] Gardner JS, Miller L, Downing DF, Le S, Blough D, Shotorbani S. Pharmacist prescribing of hormonal contraceptives: results of the direct access study. J Am Pharm Assoc 2008;48:212-21.