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Over-the-counter Access to Oral Contraceptives

August 1, 2013
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By Rebecca H. Allen, MD, MPH, Assistant Professor, Department of Obstetrics and Gynecology, Warren Alpert Medical School of Brown University, Women and Infants Hospital, Providence, RI. Dr. Allen reports no financial relationships relevant to this field of study.

Synopsis: In this global survey, investigators found that in nearly 70% of countries, oral contraceptives (OCs) are available without a prescription. The United States, Canada, Australia, and most of western Europe require prescriptions for OC use, while OCs are available over-the-counter informally in most of Central
and South America and legally over-the-counter in Southern Asia.

Source:Grindlay K, et al. Prescription requirements and over-the-counter access to oral contraceptives: A global review. Contraception 2013;88:91-96.

In this cross-sectional study from april 2011 to september 2012, the investigators collected data on prescription requirements and over-the-counter (OTC) availability of oral contraceptives (OCs) worldwide by distributing an online survey to ministries of health, pharmacy boards, family planning organizations, pharmaceutical companies, and other reproductive health specialists. The survey addressed countries’ prescription requirements, health screening requirements for obtaining OCs without a prescription, and the informal commercial availability of OCs. Besides the survey, the authors searched country drug registries and other government websites for official documentation of OC prescription requirements. Countries were assigned to one of four groups: 1) OCs informally available without prescription, 2) OCs legally available without a prescription (no screening required), 3) OCs legally available without a prescription (screening required), and 4) OCs only available with a prescription. Countries were also classified as low to middle income, or high income as defined by the World Bank.

The authors obtained data from 147 countries. In 38% of countries, OCs were available informally without a prescription, and in 24% of countries, OCs were legally available without a prescription. OCs were legally available without a prescription but required health screening in 8% of countries and available only with a prescription in 31% of countries. Eighty-eight percent of the countries where OCs did not require a prescription were low and middle income. In sum, the United States, Canada, Australia, and most of western Europe require prescriptions for OC use, while OCs are available OTC informally in most of Central and South America and legally OTC in Southern Asia.

COMMENTARY

In the United States, approximately half of pregnancies are unintended, and 40% of these end in abortion.1One contributing factor to the unintended pregnancy rate is lack of access to contraception. Initiating OCs is associated with increased barriers in the United States because women must have access to a health care provider who can provide a prescription. Cost is an additional burden and women must either use existing (but often lacking) prescription insurance coverage or pay out-of-pocket for the prescription. In addition, continuing OCs can be a challenge for women, a factor that impacts the failure rates of oral contraception. Although OCs are highly effective if used perfectly, with failure rates of 0.3% in the first year, typical use is associated with a failure rate of 9%. Although missed pills often contribute to this higher failure rate,2 another factor may be access to pill refills in order to start the next cycle on time. Studies have shown that running out of pill packs and needing a new prescription are reasons for missed pills.3,4,5,6

This survey shows that in the majority of the world, OCs are available without a prescription. Many reproductive health advocates are exploring the option of making oral contraception — either progestin-only or estrogen-progestin combination pills — OTC in the United States. In this way, women will be able to initiate and continue OCs by visiting their local pharmacy, rather than waiting for an appointment and prescription from their health care provider. A pilot project in Washington State using pharmacist provision of oral contraception was found to be feasible and acceptable to women.7The American College of Obstetrician Gynecologists recently released a committee opinion endorsing OTC status of OCs.8 The only concern was the adverse effect that changing to OTC status might have on the cost of OCs for women both with and without insurance.

However, one criterion for OTC status of OCs is safety. The FDA would require that women are able to use the product safely without the supervision of a licensed health care provider. Therefore, women must be able to self-prescribe for appropriate use and self-diagnose for adverse effects and contraindications. While OCs are very safe, there are some contraindications to OC use. Nevertheless, there is good evidence that women can self-screen for contraindications.8 The most recent study evaluating this issue compared the proportion of contraindications among women obtaining prescription OCs from a provider and women who obtained OCs from pharmacies in Mexico.9 The authors found that the proportion of any category 3 or 4 contraindication was 18%. More women in the OTC group had category 3 contraindications (13%) compared to women with prescriptions (9%). However, there was no difference in category 4 contraindications between the two groups (7% OTC vs 5% prescription). The authors concluded that with a self-screening tool and blood pressure measurement, OTC availability of OCs was feasible in the United States. However, they also stated that progestin-only pills, with inherently fewer contraindications, may be a better choice for the first contraceptive to switch to OTC status. In the meantime, it is important that we make OCs more available to women who are candidates for their use. For example, I try to give patients a 1-year prescription for OCs. In addition, when I am called to refill prescriptions for patients, I tend to allow refills, even if the patient has not been seen by our clinic for more than a year. Although we try to encourage women to present for annual gynecologic exams, we do not withhold pill refills if they are not able to present in a timely fashion.

References

  1. Finer LB, Henshaw SK. Disparities in rates of unintended pregnancy in the United States, 1994 and 2001. Perspect Sex Reprod Health 2006;38:90-96.
  2. Potter L, et al. Measuring compliance among oral contraceptive users. Fam Plann Perspect 1996;28:154-158.
  3. Smith JD, Oakley D. Why do women miss oral contraceptive pills? An analysis of women's self-described reasons for missed pills. J Midwifery Womens Health 2005;50:380-385.
  4. Frost JJ, et al. U.S. women's one-year contraceptive use patterns, 2004. Perspect Sex Reprod Health 2007;39:48-55.
  5. Potter JE, et al. Continuation of prescribed compared with over-the-counter oral contraceptives. Obstet Gynecol 2011;117:551-557.
  6. Foster DG, et al. Number of oral contraceptive pill packages dispensed and subsequent unintended pregnancies. Obstet Gynecol 2011;117:566-572.
  7. Gardner JS, et al. Pharmacist prescribing of hormonal contraceptives: Results of the Direct Access study. J Am Pharm Assoc (2003) 2008;48:212-221; 5 p following 221.
  8. Committee on Gynecologic Practice, American College of Obstetricians and Gynecologists. Committee Opinion No 544: Over-the-counter access to oral contraceptives. Obstet Gynecol 2012;120:1527-1531.
  9. Grossman D, et al. Contraindications to combined oral contraceptives among over-the-counter compared with prescription users. Obstet Gynecol 2011;117:558-565.