ESSA

ESSA

The Pill; efficacy, accessibility and a conflict of interest?


Edward Meehan

By

October 23rd, 2019


Edward Meehan delves into the policy behind the calls to allow pharmacists to prescribe oral contraceptives and the resulting conflict of interest, that could lead to poorer health outcomes and fail the patients it sought to help.


In a decade of cold war tensions, manned space exploration and the debut of the Beatles, the arrival of the Combined Oral Contraceptive Pill (COCP) to Australian shores in 1961 stands out as a defining cultural moment. Fifty-Eight years on from its release, oral contraceptives remain the most popular form of birth control amongst Australian women.[1] Regulation of the COCP has long been a subject of public policy: in 1961 the law limited prescription of the pill to married women.[2] Over the decades regulations loosened, and today the pill is a Schedule 4 medication, meaning only a doctor’s prescription is required for purchase. Recently, there has been an increasing push to make the pill a Schedule 3 medication which would allow pharmacists to prescribe and dispense the pill without need for a doctor’s appointment.[3] [4] Such a proposal was considered and rejected by the Therapeutic Goods Administration in 2015.[5] Though ostensibly motivated by a desire to increase access to contraception, a move to enable pharmacists to prescribe the pill risks creating a conflict of interest where the financial interests of the pharmacist are placed at odds with their patient’s health. Such a move could stop many women from receiving more effective contraceptives. Furthermore, it could lead to women taking the pill when it is unsafe to do so. It may also allow medical issues in their early stages to go undetected with potentially disastrous outcomes. Regardless of their good intentions, calls to reschedule the COCP may wind up harming the patients they are seeking to help.

A question of efficacy

Despite its cultural ubiquity, the pill is no longer the only means of contraception available to couples. Although less widely used, long acting reversible contraceptives (LARCs) are an alternative with many advantages and have long been recommended as first line birth control by peak medical bodies.[6] [7] In terms of effectiveness, without any form of birth control around 85% of couples will fall pregnant in a given calendar year. Using only the COCP, in typical use, around 9% of women will fall pregnant each year. LARCs are significantly more effective. One type is the hormonal IUD: a small Y-shaped device placed into the uterus. Using the IUD, only 0.2% of women will fall pregnant. If using Implanon, a small hormone containing device inserted into the arm, the figure falls to 0.05%.[8] While all contraceptives have their side effects, LARCs are a safe and effective form of birth control. In recent years, a groundswell has built to encourage the use of LARCs in young people, which has been given the catchy tagline “Get it and Forget it” to highlight the ease of use when compared with the pill.[6] [7]

Conflict of Interest

Rescheduling the COCP to allow for pharmacist prescribing would likely damage the push to encourage the use of LARCs, resulting in a relative increase in unplanned pregnancies. As the law currently stands, pharmacies may only be owned by registered pharmacists.[9] Importantly, doctors are not permitted to hold stocks in or own pharmacies- they cannot profit from any medication being prescribed over another. This is a very important distinction to preserve- the individual who is in charge of choosing the drug will not receive any profit from its sale. The individual who receives the profit from its sale has no ability to prescribe it. Under this system, doctors have no financial motivation to prescribe the pill, so they are left to make the decision based on its impact on patient health. 

Giving pharmacists the power to prescribe the pill would destroy this separation and introduce a powerful conflict of interest into women’s healthcare. Pharmacists are unable to sell Mirena, Implanon or surgical methods of contraception such as tubal ligation, but they earn a profit from the sale of the pill. While many pharmacists certainly have a ‘patient first’ mentality and may prescribe appropriately, in every field there are bad apples and creating a financial incentive to prescribe the COCP would undoubtedly be a powerful impediment against the push for LARCs. Many women would wind up on the pill when they may be better served by LARCs and the consequences of this are substantial. Suppose one thousand patients were prescribed the pill when they would have otherwise used Implanon. In an average year, this would equate to 89.5 extra women experiencing an unplanned pregnancy that would not have otherwise occurred.

It should be noted that an increasingly large subset of GPs have begun offering Mirena and Implanon services in their own clinics. They are responsible for prescribing these and yet also profit from their use, which certainly qualifies as a conflict of interest. However, several important differences exist. Firstly, a financial motivation to prescribe the pill instead of LARCs is in most cases against a patient’s best interests, whereas in the reverse case, the financial motivation if anything pushes GPs to prescribe a more effective treatment. Additionally, small procedures such as LARC insertions, fall within the competencies of GPs in a way that prescribing medicines does not for pharmacists. Alternatives to the GP inserting LARCs are to have specialist Obstetrician Gynaecologists perform the task or to refer to another GP. It is substantially more expensive to the taxpayer to pay O&G’s for the service. Similarly, referring to alternative GPs, while removing the conflict of interest, would disrupt continuity of care which some patients may find undesirable. On the balance, GPs prescribing and inserting LARCs seems a more reasonable, if still imperfect state of affairs.

Safety first

Furthermore, a danger also exists that if the COCP were re-scheduled, women may not be adequately screened for risk factors which make the pill an unsafe treatment for them. Despite its routine use, it should be remembered that the pill is a medication and has side effects like any other. The pill contains two hormones known as oestrogen and progesterone, which can cause wide ranging effects from nausea and headaches to, in the worst cases, blood clots, cancers and strokes.[10] For the average patient, these risks are small and outweighed by the pill’s many benefits. However, there are many patient groups for whom the pill is unsafe and ought not be prescribed. The job of assessing a patient’s suitability for the pill has until now been the subject of a formal doctor’s appointment, and with good reason. For patients with a high risk of clotting such as smokers over the age of 35, the pill presents an unacceptable risk and should not be prescribed. For other patients, such as diabetics and those who experience migraines, the decision is more complex and must be weighed in the light of an overall medical history.[11] It is certainly possible that some pharmacists would be able to weigh these risks competently and effectively. Importantly however, while contraception counselling is a core learning outcome for GPs during their training, pharmacists have been neither trained nor assessed for this skill. When considered also in light of the financial motivation that would be attached to prescribing the pill, the potential for bad operators in the industry to forge ahead despite unsafe circumstances would almost certainly be realised.

Apart from this, requiring patients to see their GP to discuss birth control carries benefits over and beyond those related to contraception itself, benefits which would be lost in a rescheduling of the COCP. Young patients between the ages of 15 and 24 have the lowest rates of GP attendance of all age groups.[12] A Doctor’s appointment to discuss birth control creates an opportunity to promote preventative health which may be highly cost effective in the long term. Beyond merely discussing the pill and its alternatives, a GP may use the time to find out about a patient’s mental health, smoking status, discuss safe sex practices or initiate an STI check. The Royal Australian College of General Practitioners (RACGP) recommends that all females under 25 be screened for Chlamydia, an asymptomatic condition which is often otherwise missed. Without early screening and treatment, Chalmydia can go on to cause infertility as well as Pelvic Inflammatory Disease. Obliging patients to see their doctor for the pill is the nudge which can open up a raft of preventative health interventions to improve their wellbeing, all of which could be lost if the requirement were dispensed with.

Accessibility

While proponents of switching suggest that it will make contraceptives more widely available, there is little evidence to back up this notion and the benefit that it may or may not cause should carry far less weight than the clear, large scale harms that could result. A 2019 article published in the “Australian Journal of Pharmacy” reported that a US study had shown “expansion of…. prescribing authority to pharmacists helps women obtain better access and prevent unintended pregnancy”.[3] Despite its name, the “journal” is in reality a pharmacy news website run by PDL, an interest group which “advocates on behalf of pharmacists”.[13] [14] Indeed, the study, which was based in Colorado, showed nothing of the sort. A descriptive study of visits to pharmacists prescribing contraceptives, the study did not record nor analyse access to contraception or unintended pregnancy as outcomes at all.[15] Thus, it cannot in any way be considered evidence that pharmacist based contraceptive prescribing would create improvements on these fronts. However, the study did find that of the women who came to the studied pharmacies, 93% were prescribed hormonal contraceptives while none received referrals for LARCs.[15] If anything, the study demonstrates that allowing pharmacy-based prescription would harm the promotion of LARCs and damage efforts to decrease rates of unintended pregnancy.

The argument for pharmacy-prescribing seems to boil down to the idea that the need to see a GP is a barrier to women obtaining contraception. In support of this argument, a survey in the US found 13% of respondents who were using contraception had “challenges related to obtaining an appointment or getting to a clinic”.[16] However, it is not clear that these barriers would be entirely removed by pharmacy-based prescription. The pill by its nature requires regular trips to obtain repeats and this will always be a challenge for its users. Conversely, LARCs obviate the need for regular appointments: the “Get it and Forget it” motto reflecting that after the initial appointment, patients can kick back and relax, challenge free for years to come. In the absence of convincing evidence exists to suggest that pharmacy-based prescribing would improve access to contraception, the many potential risks it could expose patients to should give pause for concern to its proponents.

A plan to allow pharmacists to prescribe oral contraceptives would create a conflict of interest, which in the context of a minority of rogue operators, could cause poorer outcomes for patients. Such a policy could cause an increase in unplanned pregnancy, medical complications from unsafe prescribing and a decrease in preventative health promotion, and overall would likely fail the patients it sought to help.


[1] Set and forget’: a new era of women’s contraception. (2019). Retrieved 19 October 2019, from http://www.roymorgan.com/findings/6542-new-era-of-womens-contraception-201511112207

[2] The pill | National Museum of Australia. (2019). Retrieved 19 October 2019, from https://www.nma.gov.au/defining-moments/resources/the-pill

[3] Paola, S., & Staff, A. (2019). Should pharmacists be able to prescribe contraceptives? | AJP. Retrieved 19 October 2019, from https://ajp.com.au/news/should-pharmacists-be-able-to-prescribe-contraceptives/

[4] McCauley, D. (2019). ‘Ridiculous’ to force women to visit GP for a repeat pill prescription, pharmacists say. Retrieved 19 October 2019, from https://www.smh.com.au/politics/federal/ridiculous-to-force-women-to-visit-gp-for-a-repeat-pill-prescription-pharmacists-say-20190905-p52oda.html

[5] Part A – Final decisions on matters referred to an expert advisory committee. (2019). Retrieved 19 October 2019, from https://www.tga.gov.au/book/part-final-decisions-matters-referred-expert-advisory-committee-3

[6] Temple-Smith, M., & Sanci, L. (2019). RACGP – LARCs as first-line contraception – What can general practitioners advise young women?. Retrieved 19 October 2019, from https://www.racgp.org.au/afp/2017/october/larcs-as-first-line-contraception/

[7] RACGP – Contraception – common issues and practical suggestions. (2019). Retrieved 19 October 2019, from https://www.racgp.org.au/afp/2012/october/contraception/

[8] Trussell, J. (2011). Contraceptive failure in the United States. Contraception83(5), 397-404. doi: 10.1016/j.contraception.2011.01.021

[9] Ownership a foundation stone. (2019). Retrieved 19 October 2019, from https://www.guild.org.au/news-events/news/forefront/v08n16/ownership-a-foundation-stone

[10] UpToDate. (2019). Retrieved 19 October 2019, from https://www.uptodate.com/contents/combined-estrogen-progestin-contraception-side-effects-and-health-concerns

[11] UK Medical Eligibility Criteria for combined oral contraceptive use. (2019). Retrieved 19 October 2019, from https://bpac.org.nz/magazine/2008/april/docs/bpj12_ukmec_pages_28-29.pdf

[12] Dow, A. (2019). GP clinics could open longer to give young people better health care. Retrieved 19 October 2019, from https://www.theage.com.au/national/victoria/gp-clinics-could-open-longer-to-give-young-people-better-health-care-20180726-p4ztpf.html

[13] PDL (Pharmaceutical Defence Limited). (2019). Retrieved 19 October 2019, from https://au.linkedin.com/company/pharmaceutical-defence-limited

[14] About The AJP | AJP. (2019). Retrieved 19 October 2019, from https://ajp.com.au/about-the-ajp/

[15] Lu, S., Rafie, S., Hamper, J., Strauss, R., & Kroon, L. (2019). Characterizing pharmacist-prescribed hormonal contraception services and users in California and Oregon pharmacies. Contraception, 99(4), 239-243. doi: 10.1016/j.contraception.2018.12.002

[16] Grindlay, K., & Grossman, D. (2016). Prescription Birth Control Access Among U.S. Women at Risk of Unintended Pregnancy. Journal Of Women’s Health25(3), 249-254. doi: 10.1089/jwh.2015.5312


The views expressed within this article are those of the author and do not represent the views of the ESSA Committee or the Society's sponsors. Use of any content from this article should clearly attribute the work to the author and not to ESSA or its sponsors.

  • barmypharmy

    While I agree with most of this article, this statement “while contraception counselling is a core learning outcome for GPs during their training, pharmacists have been neither trained nor assessed for this skill. ” is completely misinformed. On the contrary, the very core of a pharmacist’s education is counselling on medication and contraceptive counselling and knowledge should be quite standard for any pharmacist. They are also examined on this knowledge in order to register. I have seen many doctors prescribe inappropriate pills for patients as well… but that is a story for another day. Other than that, good article. Regards (a pharmacist) :)

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