Introduction

The rate of unplanned pregnancy in Australia remains high and nearly half of all Australian women of reproductive age have experienced an unplanned pregnancy.1 Australia is reported to have one of the highest abortion rates of developed countries with an estimated one in five women having an abortion.2 The emergency contraceptive pill (ECP) offers a way of preventing unintended pregnancy after unprotected sex has occurred. It is important to note that many of the previous randomised controlled trials3–6 demonstrating no association between ECP access or its advanced provision and unintended pregnancy or abortion rates have mostly been conducted in postpartum or family management clinics or hospitals, and thus targeted women who were already accessing specialised forms of care. However, one trial has demonstrated that increasing access to the ECP can reduce unintended pregnancy rates during breast feeding,7 highlighting the importance of the culture, setting and context of such trials. Women in general health settings such as community pharmacy may have different attitudes, needs and health-seeking behaviours, and the care they receive may not be as systematic or evidence-based. Further, relationships between women and community pharmacists, and women and general practitioners (GPs), may also be different, with pharmacy being challenged by the consumer's power in the commercial transaction and perceived expertise in the management of minor illness. It is therefore critical to study these populations in greater depth than what has already been investigated,4 ,8 that is, in several countries and different cultural contexts, to determine an effect of enhanced ECP access on unintended pregnancy rates.

While the ECP is safe and has no medical contraindications, there are significant barriers to pharmacy access in Australia and overseas.9 Barriers such as suboptimal acceptance by healthcare providers and the public, and multiple financial and healthcare system barriers to use,10 are preventing the ECP's potential for reducing unintended pregnancies and abortion rates to be realised. The only ECP in Australia, containing levonorgestrel, has been available since 2004 through community pharmacies as a ‘Pharmacist Only Medicine’ without a prescription. In Australia, Pharmacist Only Medicines must be stored in a part of the pharmacy not accessible to the public and supplied only for a therapeutic need after the pharmacist has personally taken reasonable steps to ensure that such a need exists. The Pharmaceutical Society of Australia (PSA) released the first protocol to guide pharmacists’ supply of the ECP in 200311 and released an updated version in 2006.12 In 2011, the PSA revised the 2006 protocol and released another updated practice guideline for levonorgestrel provision that contains the latest scientific evidence regarding its use.13 The revisions address several factors including the time frame that levonorgestrel can be used within, which was changed to allow use up to 96 h after intercourse, compared with the product information that indicated use within 72 h. The revision also established that advance supply does not negatively impact on sexual and reproductive health. Lastly, there was an acknowledgement that there is limited data regarding the use of the ECP in females aged 14–16 years, and the pharmacist needs to refer to a GP where advisable; however, the guideline highlighted that there was no reason for ECP use to be restricted on the basis of age.

Pharmacists’ practices in Australia are variable, commonly not meeting evidence-based recommendations in the PSA guideline and resulting in women being unnecessarily declined ECP supply.14 ,15 Women's experiences of obtaining the ECP from pharmacies are both positive and negative.9 Some positive experiences reported by women include faster and more direct access, convenient location, and feeling of more control over their reproductive health, while some negative experiences reported include lack of privacy, judgemental or indifferent pharmacist attitude, cost of ECP and so on. Compounding this is the unexplained paradox between unplanned pregnancy rates and ECP availability.16

Access to emergency contraception, especially the ECP, is essential as it helps prevent unwanted pregnancies—an important public health goal. If the ECP is refused by a pharmacist or GP, women are placed at risk of having an unwanted pregnancy that may result in an abortion or be carried to term with long-term implications for the woman and her partner. This study seeks to understand the underpinning reasons for refusal of supply that make access to this medicine unnecessarily complex.

The ECP was made available over-the-counter (OTC) in Australia with the view that it would allow women to access the ECP more quickly than from a GP, and therefore lead to a decrease in the unplanned pregnancy rate in Australia. A focus group study suggested that Australian women aged 16–30 years were in favour of pharmacy availability of the ECP, as faster and more direct access is afforded, particularly on Sundays and for women living in rural and remote locations.17 However, a decade later, despite pharmacy availability of the ECP, it seems that Australian women's use of the ECP has neither significantly increased nor has the rate of unplanned pregnancies significantly decreased. A study conducted in Sydney that surveyed 718 women on ECP use concluded that OTC availability and access to the ECP increased women's awareness but did not significantly increase ECP use among abortion seekers.18

A research study examining the attitudes and practices of pharmacists in Australia in relation to their increased role in ECP provision following the policy change to OTC availability found that pharmacists’ attitudes and beliefs play a major role in ECP dispensing.15 Australian pharmacists had stronger and more conservative views than overseas pharmacists, and 22% of the pharmacists surveyed felt it was reasonable for a pharmacist's religious faith to influence ECP supply. This seems stark compared with the survey response of pharmacists in Nova Scotia, Canada, where only 1.6% of pharmacists indicated that they had not provided the ECP due to moral, religious or ethical objections.19 In addition, pharmacists’ decision to decline ECP provision in Australia is because of incorrect beliefs regarding advance prescription, the responsible use of ECP and its impact on sexual reproductive health.15 Pharmacists also noted a number of problems with the number of differing written protocols used to dispense the ECP. In another study examining attitudes of pharmacy assistants in Northern Queensland, 22% of those interviewed felt it was reasonable for a pharmacists’ religious faith to influence ECP supply, while 65% of pharmacists interviewed identified young age as the most common reason for refusing to dispense ECP.20

The first random population-based study of Australian women's ECP knowledge, attitudes and use since its availability without a prescription surveyed 632 Australian women aged 16–35 years.9 This study found that less than half were aware that ECP was available from pharmacies without a prescription and 57% did not think they were at risk of getting pregnant. While most women felt the ECP was effective at preventing pregnancy, less than half believed that is was safe or very safe for the health of women. Of the women surveyed, 32% thought that the ECP was an abortifacient, when in fact, it delays ovulation. In addition, more than half the women reported feeling somewhat or very uncomfortable when asking for the ECP at a pharmacy and less than half thought it was the role of the pharmacist to give women advice about contraception and sexually transmissible infections at the time the ECP is obtained. Although Australian women have a high awareness of the ECP, their knowledge about how and when to use it and where to obtain it is inadequate, thus increasing their risk of becoming pregnant.9

A comprehensive barriers analysis to determine pharmacist-related and patient-related barriers to ECP provision has not been done in Australia or overseas, although some light has been indirectly thrown onto this issue in a previous mystery caller study of a sample of pharmacies in Victoria, Australia.14 In this study, 515 pharmacists were randomly allocated one of three scenarios when supplying the ECP and these scenarios exemplified the three major areas of change in the revised PSA guideline: outside the licensed 72 h time frame (scenario 1); by a woman under 16 years (scenario 2); and for future use (scenario 3). These scenarios tested actual performance in situations for which pharmacists’ self-reported responses in a previous study were inappropriate.15 It was found that 55.4% of pharmacists tested for scenario 1 declined supply and most referred to the doctor; and 46.1% and 40% denied supply for scenarios 2 and 3, respectively. The study concluded that Victorian pharmacists’ practices in relation to ECP provision are not always in line with the recommendations in the PSA guideline.

These findings are mirrored by a recent review of workforce interventions that facilitate increased access to ECP in low-income and middle-income countries, revealing that in these countries too, provider knowledge gaps, less than favourable attitudes and practice issues impact access to ECP. The review also highlighted the need to further examine provider performance to inform the development of appropriate workforce interventions.21

We therefore recommend that a formal analysis is required to understand how services such as community pharmacy should be reoriented to ensure they meet the sexual and reproductive health needs of women in Australia. Hence, in-depth interview with key stakeholders—women and pharmacists—is the proposed method to undertake the barriers analysis in this Australian-based study that we have named ACCESS (ACcessing Contraception for Emergency Supply Study). In-depth interviewing will be used to develop an understanding of both individual (attitudinal, knowledge-based, skills-related, risk assessment) and organisational barriers and facilitators. Key informant interviews with pharmacists as well as key informant interviews with women living in Australia will be conducted over a 4-month period. The interview questions have been developed based on the Theoretical Domains Framework (TDF)22 and seek information pertaining to women's interactions with pharmacists when obtaining the ECP, attitudes and beliefs of pharmacists and women, as well as characteristics of those interviewed (gender, age, highest education level, country of birth, primary language spoken, place of residence, employment status, type of health insurance, marital status and other relevant characteristics).

The major significance of ACCESS will be the evidence that it will provide to help inform workforce interventions in community pharmacy that will address barriers to ECP access, promote increased adherence with the PSA national guideline and therefore increase supply of, and enhance access to, the ECP by women. A key focus of the study is to evaluate practice against national guideline evidence in order to facilitate ECP supply. The data from this study will be used to develop and pilot evidence-based interventions that will strengthen the capacity of pharmacists to play a more effective role in reducing unwanted pregnancies and the abortion rate in Australia.