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Head to head: Should the contraceptive pill be available without prescription? Yes

Two areas in London are piloting over the counter oral contraceptives. Daniel Grossman argues that the policy should be widely adopted but Sarah Jarvis thinks it is the wrong approach to reducing unplanned pregnancy

YESOral contraceptives are the most widely used hormonal method of contraception globally and the most commonly used reversible method in less developed countries other than China.¹ The pill is highly effective and with perfect use has a failure rate of 0.3% in the first year.² But in practice failure is much higher—closer to 8% or 9%.³ In most countries, women must have a doctor’s prescription to obtain oral contraceptives, although many developing countries do not enforce this and pills are effectively available over the counter.

Data from the United States suggest that, for at least some women, the prescription requirement represents a barrier to both initiation and continuation of hormonal contraceptives. A US national survey of women in 2004 reported that 41% of women not currently using contraception said they would start using the pill, patch, or vaginal ring if it were available directly in a pharmacy.⁴ Another study found that travel away from home and running out of pill packs were frequent reasons women missed pills,⁵ a common cause of contraceptive failure. Participants in a Scottish study of attitudes to contraception also commented that getting an appointment with a general practitioner can be hard.⁶

Safety

Is it safe for women to access oral contraceptives without a prescription? Over 50 years of experience have shown oral contraceptives to be very safe. In every age group, the risk of cardiovascular death among healthy non-smokers who take the pill is lower than the same risk for women carrying a pregnancy to term.⁷

However, the question remains whether women need to visit a clinician to determine whether oral contraception is appropriate for them. Ideally, doctors or nurses screen women for contraindications to the pill using evidence based criteria, such as those of the World Health Organization.⁸ But in practice this screening does not always take place.⁹

Research from Mexico, where the pill is widely available without a prescription, found that women obtaining the pill without visiting a clinician were no more likely to have contraindications to its use than women who saw a doctor.^{10 11} Two US studies found that women were able to identify if they had contraindications to oral contraceptives using a checklist,^{12 13} although older women were more likely to have unrecognised hypertension.¹³ These data are not surprising, given that, other than hypertension, all of the contraindications are based on history and require little clinical judgment.

Another concern about making oral contraceptives available without a prescription is women will not use them correctly. Again, few data suggest that clinician counselling is useful,¹⁴ and even when a clinic visit is required, compliance is not perfect.¹⁵ Oral contraceptives are available over the counter in Kuwait, and a study there found that compliance and continuation were no different between women who consulted a doctor and those who did not.¹⁶ A recent analysis of data from California found that women given 13 pill packs when they first started continued the method significantly longer and experienced fewer gaps in use than women given only one or three packs,¹⁷ suggesting that freer access improves continuation. Pharmacist provision of hormonal contraception was recently shown to be feasible and acceptable to women in Washington state.¹⁸

Access to care

Would women miss out on other preventive services, such as cervical smear tests or screening for sexually transmitted infections, if they were not required to visit a clinician? Neither of these screening tests is medically required before prescribing oral contraceptives, and there has been a growing movement to unbundle these services in the US.¹⁹ The national survey mentioned above found that among women not currently using contraception, 88% had had a smear test in the previous 24 months.⁴ In fact, given the recent definitive evidence that oral contraceptive use reduces the risk of ovarian cancer,²⁰ it has been argued that the prescription requirement unnecessarily limits access to this effective chemoprophylactic agent.²¹

Although there are concerns in the US about the costs to women of obtaining oral contraceptives over the counter,²² in some states there is a precedent for maintaining government funding for over the counter emergency contraception for women on low incomes.²³

Making oral contraceptives available without a prescription would not eliminate the option of clinician consultation. Indeed, research in Mexico indicates that women move between provision sources, and more than half of women who obtain their pills from a pharmacy began use under a physician’s care.¹¹ Women who value a clinician’s input or have questions about their risk profile would still be able to consult with a physician or nurse—but they would not be required to. The prescription requirement is an out of date, paternalistic barrier to contraceptive use that is not evidence based. If governments are committed to addressing the challenge of unintended pregnancy—and the related problem of maternal mortality in the developing world, health systems must create mechanisms to allow freer access to hormonal contraception for all women at low or no cost.

Competing interests: None declared.

First published in the BMJ (2008;337:a3044).

See Sarah Jarvis’s argument against (http://student.bmj.com/issues/09/02/life/51.php).

Daniel Grossman senior associate, assistant clinical professor
DGrossman@ibisreproductivehealth.org
Student BMJ 2009;17:44-45 | February

1. Population Reference Bureau. Family planning worldwide: 2008 data sheet. www.prb.org/pdf08/fpds08.pdf.
2. Trussell J. Contraceptive failure in the United States. Contraception 2004;70:89-96.
3. Kost K, Singh S, Vaughan B, Trussell J, Bankole A. Estimates of contraceptive failure from the 2002 national survey of family growth. Contraception 2008;77:10-21.
4. Landau SC, Tapias MP, McGhee BT. Birth control within reach: a national survey on women’s attitudes toward and interest in pharmacy access to hormonal contraception. Contraception 2006;74:463-70.
5. 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;50:380-5.
6. Glasier A, Scorer J, Bigrigg A. Attitudes of women in Scotland to contraception: a qualitative study to explore the acceptability of long-acting methods. J Fam Plann Reprod Health Care 2008;34:213-7.
7. Schwingl PJ, Ory HW, Visness CM. Estimates of the risk of cardiovascular death attributable to low-dose oral contraceptives in the United States. Am J Obstet Gynecol 1999;180:241-9.
8. World Health Organization. Medical eligibility criteria for contraceptive use. 3rd ed. Geneva: WHO, 2004.
9. Tatum C, Garcia SG, Goldman L, Becker D. Valuable safeguard or unnecessary burden? Characterization of physician consultations for oral contraceptive use in Mexico City. Contraception 2005;71:208-13.
10. Zavala AS, Perez-Gonzales M, Miller P, Welsh M, Wilkens LR, Potts M. Reproductive risks in a community-based distribution program of oral contraceptives, Matamoros, Mexico. Stud Fam Plann 1987;18:284-90.
11. Yeatman SE, Potter JE, Grossman DA. Over-the-counter access, changing WHO guidelines, and contraindicated oral contraceptive use in Mexico. Stud Fam Plann 2006;37:197-204.
12. Shotorbani S, Miller L, Blough DK, Gardner J. Agreement between women’s and providers’ assessment of hormonal contraceptive risk factors. Contraception 2006;73:501-6.
13. Grossman D, Fernandez L, Hopkins K, Amastae J, Garcia SG, Potter JE. Accuracy of self-screening for contraindications to combined oral contraceptive use. Obstet Gynecol 2008;112(3):572-8.
14. Moos MK, Bartholomew NE, Lohr KN. Counseling in the clinical setting to prevent unintended pregnancy: an evidence-based research agenda. Contraception 2003;67:115-32.
15. Grossman D, Ellertson C, Abuabara K, Blanchard K. Barriers to contraceptive use present in product labeling and practice guidelines. Am J Public Health 2006;96:791-9.
16. Shah MA, Shah NM, Al-Rahmani E, Behbehani J, Radovanovic Z. Over-the-counter use of oral contraceptives in Kuwait. Int J Gynaecol Obstet 2001;73:243-51.
17. Foster DG, Parvataneni R, de Bocanegra HT, Lewis C, Bradsberry M, Darney P. Number of oral contraceptive pill packages dispensed, method continuation, and costs. Obstet Gynecol 2006;108:1107-14.
18. 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.
19. 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;285:2232-9.
20. Collaborative Group on Epidemiological Studies of Ovarian Cancer, Beral V, Doll R, Hermon C, Peto R, Reeves G. Ovarian cancer and oral contraceptives: collaborative reanalysis of data from 45 epidemiological studies including 23 257 women with ovarian cancer and 87 303 controls. Lancet 2008;371:303-14.
21. The case for preventing ovarian cancer [editorial]. Lancet 2008;371:275.
22. Gianfrancesco F, Manning B, Wang R. Effects of prescription to OTC switches on out-of-pocket health care costs and utilization. Drug Benefit Trends 2002;14:13-30, 44.
23. National Institute for Reproductive Health. Expanding Medicaid coverage for EC on the state level. www.nirhealth.org/sections/ourprograms/documents/ECMedicaidMemoFormatted.pdf.

NOThe United Kingdom is top of a league in western Europe—and a very undesirable first place it is, too. The league table is that for teenage pregnancies, with rates of teenage motherhood in the UK, at 15%, around twice those of Germany (8%), three times those of France (6%), and almost four times those of Sweden (4%).^{1 2}

The implementation of a national teenage pregnancy strategy in 1999 has gone some way to reversing the rising trend of teenage pregnancies, but only by about 2% a year in the first five years after it was implemented.³ As with other lifestyle diseases such as diabetes, however, the UK still ranks far behind the United States, where 22% of women have a child before the age of 20.²

Nevertheless, action still needs to be taken to address the underlying causes. The Department of Health Social Exclusion Unit has highlighted complex reasons for the high rates of teenage pregnancy in the UK, including lack of education and mixed messages in the media.¹ Societal attitudes, government housing policy for teenage mothers, and media messages are largely beyond the remit of primary care’s influence. Education about contraception, however, is not. And it is contraceptive use, rather than sexual activity, which correlates most closely with rates of unplanned pregnancy.²

Wrong method

In 2005, the National Institute for Health and Clinical Excellence (NICE) guidance highlighted low use of long acting reversible contraception (intrauterine contraceptive devices, intrauterine system, progestogen-only subdermal implants, and progestogen-only injectable contraceptives) compared with user dependent methods such as the contraceptive pill as one of the reasons for high rates of unwanted pregnancy. This claim certainly fits with the evidence—about 8% of women of childbearing age in the UK (with a 15% teenage motherhood rate) use long acting contraceptives compared with about 20% in Sweden, where the rate of teenage motherhood is 4%.

Although making the combined oral contraceptive pill available without prescription may be safe, it would not help. Those using the service would not, as the NICE guidance recommends, be offered a full range of contraception on every occasion. Oral contraceptives require daily compliance on the part of the patient, whereas all long acting contraceptives are effective for at least three months, are at least as cost effective at one year as the oral contraceptives, and have similar satisfaction rates.⁴

The major difference between long acting and oral contraceptives is their reliability in practice. Compliance is low with oral contraceptives. In one study of women using oral contraception, 47% missed one or more pills per cycle, and 22% missed two or more.⁵ These women have almost a threefold increase in unintended pregnancy compared with women who take the pill consistently, and teenagers are the group with the highest non-compliance.⁶

Long acting contraceptives such as the intrauterine contraceptive device, intrauterine system, and the progesterone-only subdermal implant, are effective for at least three years.⁴ Even the progestogen-only injectable contraceptive (depot contraception), which requires attendance for repeat injection every three months, is significantly more reliable than oral contraceptives. In a US study of teenagers offered contraception after termination, repeat pregnancy rate was 29.7% for girls given the oral contraceptive compared with 14.2% for those given depot contraception.⁷

Availability

Access to primary care services is less of a problem in the UK than in some other countries, particularly the United States. Over 99% of the UK population is registered with a general practitioner, and 85% of the population see a general practitioner at least once a year.⁸ Although 16-19 year olds are more likely than other groups to use family planning clinics (rather than general practitioners) for contraception,⁹ 72% of teenagers still express a preference for attending the general practitioner for contraceptive services.¹⁰

There is great untapped opportunity for general practitioners to encourage young women to use long acting contraceptives—an analysis of the general practice records of 13-19 year olds who had had a termination showed that half had sought contraceptive advice from the general practitioner in the previous year and that 40% of these had been prescribed oral contraception. In addition, compared with matched controls, girls who had become pregnant were significantly more likely to have requested emergency contraception.¹¹ This does not include the many chances for opportunistic discussion during attendances for other reasons.

The availability of emergency contraception without prescription has done little to change the rate of teenage pregnancies. This is hardly surprising, when among under 25s, only 37% use emergency contraception on every occasion that they have unprotected intercourse.¹² Increased uptake of reliable, non user-dependent methods has to be the key. Rather than making a potentially unreliable method of contraception more easily available, our best avenue for reducing unplanned pregnancies is to encourage general practitioners to help their patients to make the best choices.

Competing interests: SJ has been paid by Bayer for speaking at symposiums and writing educational articles.

First publishes in the BMJ (2008;337:a3056).

See Daniel Grossman’s argument for (http://student.bmj.com/issues/09/02/life/52.php).

Sarah Jarvis women’s health spokesperson Royal College of General Practitioners, London SW7 1PU
Sarah.jarvis@gp-e85016.nhs.uk
Student BMJ 2009;17:44-45 | February

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3. Wilkinson P. Teenage conceptions, abortions, and births in England, 1994-2003, and the national teenage pregnancy strategy. Lancet 2006;368:1879-86.
4. National Institute of Clinical Excellence. Long acting reversible contraception. Clinical guideline 30. 2005. www.nice.org.uk/Guidance/CG30.
5. Rosenberg MJ, Waugh MS, Burnhill MS. Compliance, counseling and satisfaction with oral contraceptives: a prospective evaluation. Fam Plann Perspect 1998;30:89-92.
6. Rosenberg MJ, Waugh MS, Meehan TE. Use and misuse of oral contraceptives: risk indicators for poor pill taking and discontinuation. Contraception 1995;51:283-8.
7. Thurman AR. Preventing repeat teen pregnancy: postpartum depot medroxyprogesterone acetate, oral contraceptive pills, or the patch? J Pediatr Adolesc Gynecol 2007;20:61-5.
8. Department of Health. National survey of local health services 2006. www.dh.gov.uk/en/Publicationsandstatistics/Statistics/StatisticalWorkAreas/Statisticalhealthcare/DH_073494.
9. Botting B, Dunnell K. Trends in fertility and contraception in the last quarter of the 20th century. www.statistics.gov.uk/articles/population_trends/fertconttrends_pt100.pdf.
10. McMillan HM. Spotlight on teenage pregnancy—defining the demographics and the family planning requirements. Ir Med J 2004;97:276-7.
11. Churchill D. Teenagers at risk of unintended pregnancy: identification of practical risk markers for use in general practice from a retrospective analysis of case records in the United Kingdom. Int J Adolesc Med Health 2002;14:153-60.
12. Free C. Contraceptive risk and compensatory behaviour in young people in education post 16 years: a cross-sectional study. J Fam Plann Reprod Health 2004;3:91-4.

   

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