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11 February 2014

USA: Row over pharmacists and Plan B

A New York Times article on 7 February asked, 'What Unhealthy Products Should CVS Stop Selling?' - and the American Association of Pro-Life Obstetricians and Gynecologists suggested emergency contraception. Pro-choice advocates have issued a strong response.

The article stated:

CVS announced this week that its stores will stop selling tobacco products, because they are not compatible with the company’s mission as a health care provider. If it wants to be a health care company, what else should CVS stop selling?

Donna J. Harrison, executive director of the American Association of Pro-Life Obstetricians and Gynecologists, published the following response under the headline ‘Dangers of Emergency Contraceptives’:

‘CVS rightly recognizes that tobacco products are incompatible with its mission as a health care provider. There are other products at CVS that also clash with its mission: The over-the-counter availability of Plan B, and the prescription distribution of Ella, are also incompatible with health care provision.

‘Girls will be exposed to unknown doses of hormones, for an unknown duration, under no medical supervision.

‘The unfettered availability of emergency contraception raises serious concerns, not least because access to Plan B does not reduce the number of unintended pregnancies or abortions. Aside from being ineffective, over-the-counter access to emergency contraceptive is harmful to women’s health. It isolates the most at-risk women (teenagers and those in unstable relationships) from getting the medical care they need to diagnose sexually transmitted diseases and access appropriate contraceptive counseling. And in certain situations, emergency contraception may act by blocking a newly conceived embryo from implanting, rather than by preventing fertilization – and not all consumers will be aware of the difference, especially girls and women with limited access to medical care. This is not a product to be sold over the counter, with no more consultation than buying M&M’s.

‘In addition, these drugs have been tested for safety only in women 18 to 45, and under conditions where these women use the drug only once in the cycle. Over-the-counter availability of Plan B puts powerful hormones in the hands of the youngest teens, in whom its safety has never been studied. At a stage when their reproductive organs are maturing, these girls will be exposed to unknown doses of hormones, for an unknown duration, under no medical supervision.

‘For all of these reasons, CVS and all responsible health care providers and pharmacies should rethink how they sell emergency contraceptives.’

In response, International Consortium for Emergency Contraception (ICEC) and American Society for Emergency Contraception (ASEC) wrote:

‘On February 7, the New York Times “Room for Debate” series published an article written by Donna J. Harrison from the American Association of Pro-Life Obstetricians and Gynecologists arguing that emergency contraceptive (EC) pills should not be available over-the-counter at CVS. Providing a public platform for those who hold far-right views about EC despite the fact that they lack scientific merit, while withholding comment from other perspectives, does not make for a balanced or accurate discussion of the issue.

‘Ms. Harrison’s reasoning depended on a number of incorrect assertions: that EC is unsafe and untested in young women, that it is ineffective, that it may inhibit implantation of a fertilized egg, and that it is dangerous to take it more than once in a single menstrual cycle. Her arguments are entirely out of line with the best available scientific research.

‘EC pills are very safe and appropriate for over-the-counter purchase at pharmacies by all women and adolescents. The active ingredient in Plan B One-Step, the product that is available over-the-counter in the U.S., has been studied extensively and widely used for over 30 years. It is well-tolerated, leaves the body quickly, and has demonstrated no toxic reactions. [i, ii, iii] EC pill use has in fact been studied in teens under age 18 with no evidence of harmful effects.[iv] Even use of EC pills like Plan B One-Step more than once in a menstrual cycle does not pose any known health risks to women of any age. [v, vi]

‘The argument that EC pills may be akin to abortion has been repeatedly disproven. EC pills work before pregnancy by preventing ovulation (the release of an egg) or by stopping the egg and sperm from meeting. Plan B One-Step will not keep a fertilized egg from implanting in the uterus [vii, viii] and cannot terminate or interrupt an established pregnancy. The anti-choice community continues to conflate EC with medical abortion only to further their political agenda.

‘EC pills are not the most effective form of contraception, but they certainly cannot be characterized as “ineffective.” Most efficacy estimates for the type of EC pills sold over-the-counter in the U.S. suggest that they prevent between 59% and 95% of expected pregnancies. [ix, x]  In real life terms, that means that if 100 women had unprotected intercourse and then used EC, only 1 to 2 of them would become pregnant; if all 100 women had not used EC, however, about 8 of them would become pregnant.

‘Over-the-counter access to EC pills is critical because they are more effective the sooner they are taken after unprotected intercourse. Requiring a prescription for EC pills often forces women to make two trips: one to a clinic to get the prescription and a second to a pharmacist to fill the prescription. This delays the process and presents a significant barrier for women who lack access to transportation or who live in rural areas without easy access to doctors or pharmacies. Moreover, requiring a prescription makes access to EC pills on weekends and at night (when many contraceptive mishaps occur) more difficult.

‘EC offers women a safe and important second chance to prevent pregnancy when a regular method fails, no method was used, or sex was forced. It should be readily available to women and adolescents as needed.’

(i) Sambol NC, Harper CC, Kim L, Liu CY, Darney P, Raine TR. Pharmacokinetics of single dose levonorgestrel in adolescents. Contraception 2006;74(2):104-109.
[ii] Kook K, Gabelnick H, Duncan G. Pharmacokinetics of levonorgestrel 0.75 mg tablets. Contraception 2002;66(1):73-76.
[iii] Grimes DA, Raymond EG, Scott Jones B. Emergency contraception over-the-counter: The medical and legal imperatives. Obstetrics and Gynecology 2001;98(1):151-155.
[iv] Sambol NC, Harper CC, Kim L, Liu CY, Darney P, Raine TR. Pharmacokinetics of single dose levonorgestrel in adolescents. Contraception 2006;74(2):104-109.
[v] World Health Organization. Emergency contraception fact sheet No. 244. July 2012 (accessed 5 February 2013).
[vi] Halpern V, Raymond EG, Lopez LM. Repeated use of pre- and post-coital hormonal contraception for prevention of pregnancy. Cochrane Database of Systematic Reviews 2010;(1):CD007595.
[vii] Noe G, Croxatto H, Salvatierra AM, Reyes V, Villarroel C, Munoz C, Morales G, Retamales A. Contraceptive efficacy of emergency contraception with levonorgestrel given before or after ovulation. Contraception 2011;84:486-492.
[viii] Novikova N, Weisberg E, Stanczyk FZ, Croxatto HB, Fraser IS. Effectiveness of levonorgestrel emergency contraception given before or after ovulation – a pilot study. Contraception 2007;75(2):112-118.
[ix] Trussell J. Understanding contraceptive failure. Best Practice and Research Clinical Obstetrics and Gynaecology. 2009;23:199-209.
[x] Dada OA, Godfrey EM, Piaggio G, von HH. A randomized, double-blind, noninferiority study to compare two regimens of levonorgestrel for emergency contraception in Nigeria. Contraception. 2010;82:373-378.

What Unhealthy Products Should CVS Stop Selling? New York Times, February 7, 2014