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Emergency contraception in Australian community pharmacies: a simulated patient study
Contraception 83 (2011) 176 – 182
Original research article
Emergency contraception in Australian community pharmacies: a simulated patient study Katrina Queddeng, Betty Chaar, Kylie Williams⁎ Faculty of Pharmacy, A15, The University of Sydney, NSW 2006, Australia Received 16 June 2009; revised 13 July 2010; accepted 14 July 2010
Abstract Background: Australia joined the worldwide movement to increase the availability of the emergency contraceptive pill (ECP) by rescheduling from Prescription to Pharmacist Only status in 2004. However a protocol developed to aid in the provision of the ECP placed extensive requirements on the pharmacist. This study investigated the provision of the ECP by community pharmacists in Sydney, Australia. Study Design: Using a simulated patient methodology, 100 community pharmacies were visited over a five week period (Aug–Oct 2008). The simulated patient specifically requested the ECP, and details of the consultation were recorded on a standardised data collection form. Results: The ECP was supplied in 95% of the pharmacies visited. Patient privacy was observed in 90% of consultations, which in general were succinct and friendly. Clinical assessment of the patient that met all the requirements was observed in 18%, partial assessment in 69%, and inadequate assessment in 13% of consultations. Provision of required information to the patient was sufficient in 42%, partial in 55%, and inadequate in 3% of consultations. Conclusions: This study highlighted a need to standardize procedures in regard to the ECP service to present a more consistent level of service to the public. Suggestions to improve the service include complete revision and simplification of the current protocol and improved training. Additionally, mandatory provision of private consultation areas and continuing professional education may facilitate and enhance quality counselling. © 2011 Elsevier Inc. All rights reserved. Keywords: Emergency contraceptive pill; Simulated patient; Community pharmacy; Pharmacy ethics; Standards of practice; Australia
1. Introduction Unwanted pregnancy is a significant public health issue. Australian statistics indicate that more than 84,000 abortions are induced each year [1], and it has further been estimated that one in five pregnancies are terminated [2]. To avoid the risks of invasive procedures and interventions, timely access to a safe and effective contraceptive for emergency use provides a means to reduce the risk of unwanted pregnancy. The levonorgestrel emergency contraceptive pill (ECP) was first made available on prescription in Australia in July 2002 [3]. The ECP is more effective the earlier it is taken following unprotected intercourse, thus timely access is critical [4–7]. Previous international studies have documented a strong need for increased access, with overwhelming
⁎ Corresponding author. Tel.: +61 (02) 93516063. E-mail address: [email protected] (K. Williams). 0010-7824/$ – see front matter © 2011 Elsevier Inc. All rights reserved. doi:10.1016/j.contraception.2010.07.011
support from the public for direct pharmacy provision [8]. To facilitate its timely use and maximize potential public health benefit, Australia joined the worldwide movement to increase ECP availability by rescheduling the levonorgestrel ECP from a Prescription Only (S4) to a Pharmacist Only (S3) medicine in January 2004 [3]. Pharmacists, as respected and trusted health care professionals, are easily accessible and readily available for consultation. Positive experiences have been documented from non-prescription ECP users in pharmacies overseas, with studies in the UK [9], USA [10] and Canada [11] demonstrating that the majority of women receiving the ECP directly from pharmacists were well informed about use of the product, reported satisfaction with the system, and rated pharmacists highly for their personal interactions. Despite this, some consumers express negative opinions about obtaining the ECP from pharmacies, mostly in terms of the lack of privacy in the pharmacy and how pharmacists' personal views may impact on their professionalism [8,12].
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Pharmacy practice standards play an important role in maintaining a high level of service quality and consistency in the profession. Pharmacist-only (S3) medicines by definition are substances or preparations for therapeutic use which, although substantially safe to use, are determined to require professional advice or counselling by a pharmacist [13]. Pharmacists therefore assume a vital role in the provision of such medications to ensure their appropriate supply and use. In Australia, standards of practice for the provision of nonprescription medicines in community pharmacy have been established accordingly, using a consumer-focused and risk management approach [14]. In addition to the standards associated with S3 classified medications, the Pharmaceutical Society of Australia (PSA) has produced a comprehensive protocol with detailed requirements to support pharmacists in providing the ECP. This protocol sets guidelines in relation to respecting patient confidentiality, and ascertaining information about the user, as well as outlining key counselling points. The requirement to address even broader issues such as sexual health education and safe sex practices is also an important part of the protocol [15]. Although not directly relevant to the provision of the ECP, these broader issues were included in the protocol as a result of the environment at the time of deregulation. The decision to reclassify the ECP was not supported by the medical profession at the time [16,17]. One of the arguments put forward in opposition to reclassifying the ECP was that if it became available without prescription, women would miss out on regular health and STI checks that doctors might conduct when prescribing the ECP. Therefore, the protocol developed was all encompassing and included elements not required of pharmacists in other countries. Also in place is the Pharmaceutical Society of Australia's Code of Professional Conduct [18], which sets out nine principles of professional ethics in pharmacy. The code provides guidance in concepts ranging from respect for patient autonomy and privacy, to upholding the reputation of the profession with practical examples. The ninth principle states that in the event of “…conflict with personal moral beliefs” the pharmacist must provide continuity of care for the patient. The right of the pharmacist to refuse supply of the ECP on religious or moral grounds has generated much debate and received considerable media attention, both in Australia and internationally [19–21]. With an increasing number of medications recently deregulated from prescription status, professional practice has come under much scrutiny. Examination of current pharmacy services such as smoking cessation and weight loss management, suggests that a gap exists between the development and application of practice standards across the profession [22,23]. Since 2002, the application of professional practice standards [14] has been self-regulated by the pharmacy profession using a simulated patient approach to assess pharmacy supply of non-prescription medications [24]. In this technique, the researcher enters the pharmacy in the
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guise of a patient for the purpose of observing and testing provision of pharmacy services. Whilst simulated patient methodology has been used in research studies examining ECP protocol adherence on an international level [25–29], there is limited research examining pharmacist provision of the ECP in Australia. A current assessment of the profession's performance in the provision of the ECP service is critical to maintaining appropriate standards of practice. The aim of this project was to examine the ECP service provided in community pharmacies in Sydney, Australia. 2. Materials and methods The research was approved and conducted in compliance with the requirements of the Human Research Ethics Committee of The University of Sydney. Simulated patient methodology was used for this study. The simulated patient was trained to present one standard scenario at each pharmacy. To maintain consistency, a single researcher took the role of the simulated patient. Upon entering the pharmacy and when approached by a member of staff, the simulated patient requested the ECP according to the scenario (Table 1). The scenario was designed to reflect a common, non-complicated situation, which necessitated the supply of the ECP. When purchasing the ECP without prescription in an Australian pharmacy, all costs are covered by the patient. Although the price varies from pharmacy to pharmacy, in this study, the simulated patient paid whatever the pharmacy requested. 2.1. Sample size and selection One hundred pharmacies were selected by systematic random sampling from the NSW Pharmacy Board register of pharmacies. The sample size calculation [30] was based on a precision of 9% and an estimated 34% unsatisfactory pharmacy performance rate (based on results from a previous large Australian study [24] utilizing simulated patients to Table 1 Simulated patient scenario Patient:
Self (female)
Age Reason for use
25 years Unprotected intercourse (ran out of condoms) last night(within 24 h) None None Condoms No previous ectopic pregnancy No other unprotected sex this cycle No pregnancy test Last period normal: first day of period, 10 days prior 28-day regular cycle Not breastfeeding No recent diarrhea or vomiting
Current health conditions Other medications Regular contraception Other relevant history
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assess the provision of non-prescription medicines). Pharmacies were visited during usual business hours, from August to October 2008. Pharmacies were not advised of the research study to ensure a non-biased response. 2.2. Data collection A standardized data collection form based on the PSA protocol [14], was completed by the simulated patient immediately following the consultation. Documentation included: the staff member involved in the consultation, the information requested prior to the sale of the ECP and any advice or information provided with the ECP. Qualitative descriptions of the experiences of the simulated patient concerning the ECP service, including the attitude of the pharmacist, perceptions of the pharmacist-patient interaction, and the degree of privacy were also recorded. 2.3. Operational definitions Adequate assessment for ECP supply was defined using the following four of the nine items extracted from the protocol, which were considered by the researchers as minimum information required to determine appropriate supply: 1. evidence determining that the patient was within the 72-h timeframe [31], 2. not currently pregnant, 3. not using other medications that may decrease efficacy of the ECP, and 4. no other relevant health conditions (e.g., unexplained vaginal bleeding, breast cancer, etc.). Partial assessment was defined as meeting at least one of the above criteria. The absence of all criteria indicated no assessment was conducted. Adequate provision of information to the patient was based on the criteria essential to the patient's ability to appropriately administer the ECP. This was operationally defined by the following three protocol criteria: 1. evidence of counselling on how to take the ECP, 2. when to take the ECP, and 3. what to do in the event of vomiting within 2 h of taking the ECP. Partial provision of information was similarly defined as meeting at least one of the above criteria, and the absence of all criteria was considered no provision of information. 2.4. Analysis All data input and analysis was performed using the Statistical Package for Social Sciences (SPSS) Version 15.0, and relative frequencies for all variables were calculated. Comments in regard to the general experience were content analyzed for main themes.
3. Results The pharmacies visited were distributed throughout the Sydney metropolitan region. Of the 100 pharmacies, 27 were located within a shopping center, 64 situated on a shopping strip, 2 within a medical center and 8 were relatively isolated in suburban areas. This was broadly in keeping with other reported figures of pharmacy location [32]. 3.1. Supply of the ECP The ECP was supplied in 95 of the 100 pharmacies visited. Of the five pharmacies that did not provide the ECP, one did not stock the ECP, two were out of stock at the time of the visit, and two offered no reason. In only two of these pharmacies did a staff member refer the simulated patient to the nearest pharmacy. In pharmacies that did provide the ECP, counselling was conducted by 85 pharmacists, four pharmacy interns and five pharmacy assistants. During one consultation, the role of the staff member was unclear. Of these staff members, 53% were female and 47% male. 3.2. General perceptions of the pharmacist-patient interaction Consultations in general were succinct, professional, courteous and nonjudgemental. A disapproving attitude was noted in one instance, where a pharmacy assistant attempted to deter the patient from purchasing the ECP. In 10 pharmacies, the simulated patient was asked to complete a checklist prior to consultation with the pharmacist. In pharmacies that implemented checklist procedures, substantially more information about the patient was collected, thus enabling more complete clinical assessment, and the interaction was significantly shortened, but was often impersonal. In some cases, the use of a checklist enabled the disclosure of sensitive information. For example, one checklist ascertained whether unprotected sex was consensual and if referral to a sexual health or assault clinic was necessary. In 16 encounters, personal details were sought for recording purposes and/or a form of identification requested, such that the ECP was dispensed and labelled as if it was a prescription item (S4) item. The quality of counselling was generally not different when dispensed as a prescription. 3.3. Patient privacy In the majority of consultations, efforts to address patient privacy were noted. In some instances the simulated patient was steered toward a seated consultation area or room within the pharmacy to facilitate the counselling process. In other pharmacies, the pharmacist directed the simulated patient to a quiet area away from customers and staff. Pharmacists also attempted to conceal the ECP from view of other customers, provided verbal assurance of confidentiality and demonstrated nonverbal cues and body language indicative of
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discretion. In many cases, privacy was serendipitous due to a lack of customers in the pharmacy. In nine consultations, privacy was considered inadequate, most commonly due to counselling taking place at the counter and in the presence of other customers. 3.4. Pharmacist clinical assessment The frequency of information gathered prior to the sale of the ECP is presented in Fig. 1. The number of questions asked of the patient ranged from one to seven, with the majority asking two to four questions. Pharmacists adequately assessed whether the ECP was appropriate for the patient in 18% of consultations. Partial assessment was evident in 69% of consultations, and in 13% of consultations, the pharmacist failed to assess the patient at all. In addition, some asked questions not covered in the protocol, such as whether the patient had taken the ECP before (21%), whether the patient had any allergies (7%) and whether the patient's last period was normal (3%). 3.5. Pharmacist provision of information The frequency of key counselling points provided with the ECP is presented in Fig. 2. In 42% of consultations, pharmacists provided the simulated patient with adequate information to appropriately administer the ECP. Partial provision of information was communicated to the patient in 55% of pharmacy consultations, and 3% failed to provide any information at all. Of the 55% of consultations in which only partial information was provided, most pharmacists outlined three to four main issues and then referred the patient to written sources if further information was required. As can be seen in Fig. 2, the most common information provided to the patient related to how and when to take the
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tablets. Pharmacists most commonly instructed the patient to take the ECP in the two dose, 12-h regimen, with only 15 pharmacists recommending the single dose alternative. As the simulated patient indicated that unprotected intercourse had occurred within the previous 24 h, some pharmacists suggested delaying the first dose such that the second was at a more convenient time. Others suggested the setting of an alarm as a reminder. Two pharmacists appeared to confuse the 12-h interval between the two doses with the 72-h after unprotected intercourse therapeutic time frame. Their advice was either that the tablets be taken within 12 h of unprotected intercourse, or that there would be loss of efficacy post the 12-h time frame. Almost two thirds of pharmacists discussed possible side effects associated with the ECP. The most frequent side effects described were vomiting and nausea but also included spotting, breast tenderness, headache and tiredness. In 34% of cases, pharmacists discussed the effectiveness of the ECP in preventing pregnancy. However, 11% of pharmacists provided inaccurate figures in relation to effectiveness. Less frequent information was given in relation to how the tablets worked. Of the eight pharmacists who explained how the tablets worked, four outlined the changes to the environment of the uterus and the delaying of ovulation, and four explained that it was a high dose of hormone. The majority of pharmacists did not provide counselling regarding regular contraception or STI screening (Fig. 2), as outlined in the PSA protocol. In only 10 pharmacies (10.5%) was the simulated patient given written information in addition to any verbal counselling. 3.6. Influence of pharmacist characteristics The quality of counselling was unaffected by the gender of the pharmacist. However, female pharmacists tended to be
Fig. 1. Pharmacist clinical assessment.
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Fig. 2. Pharmacist provision of information.
more empathic than male pharmacists, making the simulated patient feel more comfortable and showing genuine concern. In a small number of consultations, staff inquired about patient preference regarding the gender of the pharmacist. In one instance, the male pharmacist initially consulted referred the simulated patient to the female pharmacist in charge; in two other instances, prior to consulting the pharmacist, the assistant enquired as to whether the simulated patient would prefer to speak to a male or female pharmacist. Estimations of pharmacists' age were made by visual assessment. Younger looking pharmacists appeared to be more familiar with the PSA protocol and associated key counselling points, using them in the consultation in a rote-learned manner. By contrast, older looking pharmacists did not provide information in the same systematic and orderly manner and were more conservative in their questioning of the patient.
4. Discussion This study provided a valid representation of the provision of ECP by pharmacists in Sydney. In terms of supply of ECP, the study demonstrated that the vast majority of pharmacists (95%) provided access to the medication in a timely manner. However, in relation to the quality of the consultations, inconsistencies were observed. The results suggested that the responsibilities associated with the supply of the ECP were not always met, with some pharmacists failing to adhere to the existing protocol set by the profession and the professional code of ethics. For example, of the five pharmacies that did not provide the ECP, only two offered continuity of care. Thus, three pharmacies failed to uphold their ethical and professional responsibilities to ensure timely access to the ECP.
With adequate clinical assessment of the patient observed in only 18% of consultations, and provision of sufficient information in only 42% of consultations, results are indicative of poor application of the PSA protocol. Although the majority of questions asked were appropriate, findings from the study highlight some pharmacists' inability to ask all the necessary questions to elicit information from the patient. However, the characteristics of the protocol itself may have contributed to this. The protocol is comprehensive in nature with clinically sound criteria which may have been relevant in 2004 but which are excessive according to international standards today. As there are very few contraindications to the use of the ECP [31], only a limited number of questions need to be asked of the patient to determine whether or not the ECP is appropriate. For example, questions regarding regular contraception, breastfeeding and some of the health conditions are unnecessary. Thus, it may be that the protocol requires significant modification and simplification to enable widespread and uniform implementation in Australian pharmacies. With the ECP now firmly established as an S3 medication and few reported issues with this service, this could be an appropriate opportunity for timely revision of the protocol. Whilst results gauged the extent of application of the PSA protocol, this may not necessarily reflect the entirety of the encounter. For example, of the 22% of pharmacists who failed to determine whether the patient was within the 72 h time frame, over three quarters had explained to the patient the necessity of taking the tablet within 72 h of unprotected intercourse. Nevertheless, omitting this enquiry places the onus of appropriate use on the patient, rather than on the pharmacist. Pharmacist provision of information to the patient also did not match well with that outlined in the protocol. However,
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when only counselling points considered necessary to ensure safe and efficacious use of the product were considered, pharmacists scored better. In some cases, pharmacists gave the patient limited verbal information but did refer them to the written information that they provided. Thus, it may be argued that these patients did in fact receive appropriate information, but this would not have been recorded in our data collection. Again, the protocol may be the reason for pharmacist underperformance. Although required by the protocol, only 22% of pharmacists provided information on regular contraception, and even fewer on STI checks, similar to findings made internationally [12,25]. This information, while important, does not need to be provided to ensure appropriate use of the ECP - the primary goal of the consultation. One study from the UK has even reported that patients may not expect this type of information from pharmacists, and in some cases find it inappropriate that pharmacists would provide this information [33]. Thus, this may be a further area for review of the protocol. Physical variability of the pharmacies across the study population may also be another reason for the observed limited application of the PSA protocol or ethical principles of practice. For example, patient privacy, an essential ethical requirement of practice, varied amongst pharmacies. Only a minority of pharmacies were equipped with sufficient physical space to provide a seated consultation area or room, and those lacking in this aspect may have been limited in their ability to address all elements of the protocol. The lack of uniformity in the systems in place across pharmacies may have additionally contributed to the varied levels of performance. For example, differences were observed in the method of ECP provision, reflected by the use of checklists in some pharmacies and dispensing procedures in others. There was evidence to support the use of checklists in terms of efficiency and adequate collection of patient information and thus clinical assessment. Since the completion of this study, the PSA has produced a checklist for use in pharmacies. However, the checklist is based on the existing protocol and thus is unnecessarily comprehensive. The majority of pharmacist–patient interactions were observed to be professional, courteous and nonjudgemental in manner. This is consistent with studies conducted internationally [34] and is an indication that Australian pharmacists respect patient dignity and right to self-determination. This study employed the use of a simulated patient methodology to assess the ECP service. Potential limitations relate to reliance on simulated patient memory recall, and actor “fatigue” from repeated performances. To minimize these limitations, the researchers restricted the number of visits undertaken per day to five in order to avoid fatigue, bias or subtle changes in body language or acting performance. The data collection form was completed immediately post-purchase, outside the pharmacy to maximize recall. To further ensure consistency, only one scenario was utilized. However, pharmacy response may have varied if a different scenario had been used.
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Deidentified data were purposefully utilized to protect the identity of the pharmacies involved, and their staff, as they were not consulted prior to the visit. This, therefore, restricted examination of pharmacy demographics in relation to the ECP service provided. Additionally, as pharmacies were only visited once, circumstantial factors occurring on the particular day or time may have impacted on the counselling processes observed.
5. Conclusions This study highlighted a need to standardize procedures in regard to the ECP service to present a more consistent level of service to the public, and the need to periodically reassess practice protocols. One suggestion is that the protocol be completely revised to enable easier implementation by all pharmacies, and to reflect the safety and function of the ECP. Additionally, in light of the increasing role of the pharmacist in patient care, mandatory provision of private consultation areas may facilitate and enhance quality counselling. This study also highlighted the need for continuing professional education, both clinical and ethical, to ensure that all pharmacists are equipped to meet the needs of the public. Ethical literacy is of prime importance, particularly in the provision of ECP. In the event of personal moral dissent, provision of continuity of care is essential. Simulated patient studies provide useful insight into the current quality of services in pharmacy practice. The incorporation of simulated patient methods into an educational reflective framework as part of continuing professional development in the area of the ECP may lead to vast improvement of the service. Further research could also examine potential barriers to the use of guidelines such as the ECP protocol, to understand what factors may improve implementation and, ideally, to shift performance to improve levels of service. The experience of Australia in establishing extensive requirements for pharmacist-provided ECP may serve as an important lesson for other countries just now introducing ECP through pharmacies. Establishing unnecessarily restrictive standards may lead to noncompliance.
Acknowledgment No specific funding was received for this research.
References [1] Chan A, Sage LC. Estimating Australia's abortion rates 1985-2003. Med J Aust 2005;182:447–52. [2] Grayson N, Hargreaves J, Sullivan EA. Use of routinely collected national data sets for reporting on induced abortion in Australia. AIHW Cat. No. PER 30. Sydney: AIHW National Perinatal Statistics Unit (Perinatal Statistics Series No. 17); 2005.
182
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[3] Therapeutic Goods Administration. National Drugs and Poisons Schedule Committee. TGA [online] 2008. http://www.tga.gov.au/ndpsc/ record/rr200306b/pdf (accessed 11 October 2008). [4] Task Force on Postovulatory Methods of Fertility Regulation. World Health Organization. Randomised controlled trial of levonorgestrel versus the Yuzpe regimen of combined oral contraceptives for emergency contraception. Lancet 1998;352:428–33. [5] Von Hertzen H, Piaggio G, Ding J, et al. Low dose mifepristone and two regimens of levonorgestrel for emergency contraception: a WHO multicentre randomised trial. Lancet 2002;360:1803–10. [6] Rodrigues I, Grou F, Joly J. Effectiveness of emergency contraceptive pills between 72 and 120 hours after unprotected sexual intercourse. Am J Obstet Gynecol 2001;184:531–7. [7] Piaggio G, von Hertzen H, Grimes DA, Van Look PFA. Timing of emergency contraception with levonorgestrel or the Yuzpe regimen. Lancet 1999;353:721. [8] Gainer E, Blum J, Toverud EL, et al. Bringing emergency contraception over-the-counter: experiences of nonprescription users in France, Norway, Sweden and Portugal. Contraception 2003;68:117–24. [9] Killick SR, Irving G. A national study examining the effect of making emergency hormonal contraception available without prescription. Hum Reprod 2004;19:553–7. [10] Sommers SD, Chaiyakakunapruk N, Gardner JS, Winkler J. The emergency contraception collaborative prescribing experience in Washington State. J Am Pharm Assoc 2001;41:60–6. [11] Dunn S, Brown TE, Cohen MM, et al. Pharmacy provision of emergency contraception: the Ontario emergency contraception pilot project. J Obstet Gynaecol Can 2003;25:923–30. [12] Black KI, Mercer CH, Kubba A, Wellings K. Provision of emergency contraception: a pilot study comparing access through pharmacies and clinical settings. Contraception 2008;77:181–5. [13] Australian Health Ministers Advisory Council. Guidelines for National Drug and Poisons Schedule Committee. Canberra: Australian Health Ministers' Advisory Council; 1997. [14] Benrimoj SI, Wilson F. Standards for the provision of pharmacy medicines and pharmacist only medicines in community pharmacy. Revised, November 2005. Professional practice standards (Version 3). Canberra: Pharmaceutical Society of Australia; 2006. [15] Pharmaceutical Society of Australia. Supply of levonorgestrel as a pharmacist only medicine for emergency contraception (EC). In: Sansom EL, editor. Australian Pharmaceutical Formulary and Handbook. Curtin: The Pharmaceutical Society of Australia; 2006, pp. 404–6. [16] Royal Australian College of General Practitioners. Access to emergency contraception: The College position [online]. July 2003. Available at http://www.racgp.org.au/policy/emergency_contraception.pdf (accessed 16 February 2010). [17] McLean B. OTC morning-after pill concerns AMA. Australian Doctor [online], January 2004. Available at http://www.australiandoctor.com. au/news/05/0c01ca05.asp (accessed 16 February 2010).
[18] Pharmaceutical Society of Australia. Code of Professional Conduct [online]. March 1998. Available at http://www.psa.org.au/site.php? id=628 (accessed 15 March 2009). [19] Anonymous. Pharmacy bans pregnancy pill. City News [online]. Available at http://city-news.whereilive.com.au/news/story/ pharmacy-bans-pregnancy-pill (accessed 9 June 2009). [20] Baergen R, Owens C. Revisiting pharmacists' refusals to dispense emergency contraception. Obstet Gynecol 2006;108:1277–82. [21] Card RF. Conscientious objection and emergency contraception. Am J Bioeth 2007;7:8–14. [22] Chiang PPC, Chapman S. Do pharmacy staff recommend evidencebased smoking cessation products? A pseudo patron study. J Clin Pharm Ther 2006;31:205–9. [23] CHOICE. Xenical shadow shop. CHOICE [online] 2007. Available at http://www.choice.com.au/viewArticle.aspx?id=105435&catId= 100231&tid=100008 (accessed 15 October 2008). [24] Benrimoj SI, Werner J, Raffaele C, Roberts A, Costa FA. Monitoring quality standards in the provision of non-prescription medicines from Australian community pharmacies: results of a national programme. Qual Saf Health Care 2007;16:354–8. [25] Anderson C, Bissell P. Using semi covert research to evaluate an emergency hormonal contraception service. Pharm World Sci 2004;26:102–6. [26] Cohen MM, Dunn S, Cockerill R, Brown TER. Using a secret shopper to evaluate pharmacist provision of emergency contraception: satisfaction levels high, with privacy a concern. Can Pharm J 2004;137:28–33. [27] Bennett W, Petraitis C, D'Anella AD, Marcella S. Pharmacists' knowledge and the difficulty of obtaining emergency contraception. Contraception 2003;68:261–7. [28] French AC, Kaunitz AM. Pharmacy access to emergency hormonal contraception in Jacksonville, FL: a secret shopper survey. Contraception 2007;75:126–30. [29] Nelson AL, Jaime CM. Accuracy of information given by Los Angeles County pharmacies about emergency contraceptives to sham patient in need. Contraception 2009;79:206–10. [30] Kalton G. Introduction to survey sampling. Sage University Paper Series on Quantitative Applications in the Social Sciences, 07-035. Beverly Hills (Calif): Sage Publications Inc; 1983. [31] Bayer Schering Pharma. Postinor-2 Product Information. [online] http:// www.appgonline.com.au/drug.asp?drug_id=00072425&t=cmi 2003 (accessed 15 October 2008). [32] Berbatis CG, Sunderland VB, Joyce A, Bulsara M, Mills C. Characteristics of Australia's community pharmacies: National Pharmacy Database Project. Int J Pharm Pract 2007;15:265–71. [33] Bissell P, Anderson C. Supplying emergency contraception via community pharmacies in the UK: reflections on the experiences of users and providers. Soc Sci Med 2003;57:2367–78. [34] Anderson C, Blenkinsopp A. Community pharmacy supply of emergency hormonal contraception: a structured literature review of international evidence. Hum Reprod 2006;21:272–84.
Original research article
Emergency contraception in Australian community pharmacies: a simulated patient study Katrina Queddeng, Betty Chaar, Kylie Williams⁎ Faculty of Pharmacy, A15, The University of Sydney, NSW 2006, Australia Received 16 June 2009; revised 13 July 2010; accepted 14 July 2010
Abstract Background: Australia joined the worldwide movement to increase the availability of the emergency contraceptive pill (ECP) by rescheduling from Prescription to Pharmacist Only status in 2004. However a protocol developed to aid in the provision of the ECP placed extensive requirements on the pharmacist. This study investigated the provision of the ECP by community pharmacists in Sydney, Australia. Study Design: Using a simulated patient methodology, 100 community pharmacies were visited over a five week period (Aug–Oct 2008). The simulated patient specifically requested the ECP, and details of the consultation were recorded on a standardised data collection form. Results: The ECP was supplied in 95% of the pharmacies visited. Patient privacy was observed in 90% of consultations, which in general were succinct and friendly. Clinical assessment of the patient that met all the requirements was observed in 18%, partial assessment in 69%, and inadequate assessment in 13% of consultations. Provision of required information to the patient was sufficient in 42%, partial in 55%, and inadequate in 3% of consultations. Conclusions: This study highlighted a need to standardize procedures in regard to the ECP service to present a more consistent level of service to the public. Suggestions to improve the service include complete revision and simplification of the current protocol and improved training. Additionally, mandatory provision of private consultation areas and continuing professional education may facilitate and enhance quality counselling. © 2011 Elsevier Inc. All rights reserved. Keywords: Emergency contraceptive pill; Simulated patient; Community pharmacy; Pharmacy ethics; Standards of practice; Australia
1. Introduction Unwanted pregnancy is a significant public health issue. Australian statistics indicate that more than 84,000 abortions are induced each year [1], and it has further been estimated that one in five pregnancies are terminated [2]. To avoid the risks of invasive procedures and interventions, timely access to a safe and effective contraceptive for emergency use provides a means to reduce the risk of unwanted pregnancy. The levonorgestrel emergency contraceptive pill (ECP) was first made available on prescription in Australia in July 2002 [3]. The ECP is more effective the earlier it is taken following unprotected intercourse, thus timely access is critical [4–7]. Previous international studies have documented a strong need for increased access, with overwhelming
⁎ Corresponding author. Tel.: +61 (02) 93516063. E-mail address: [email protected] (K. Williams). 0010-7824/$ – see front matter © 2011 Elsevier Inc. All rights reserved. doi:10.1016/j.contraception.2010.07.011
support from the public for direct pharmacy provision [8]. To facilitate its timely use and maximize potential public health benefit, Australia joined the worldwide movement to increase ECP availability by rescheduling the levonorgestrel ECP from a Prescription Only (S4) to a Pharmacist Only (S3) medicine in January 2004 [3]. Pharmacists, as respected and trusted health care professionals, are easily accessible and readily available for consultation. Positive experiences have been documented from non-prescription ECP users in pharmacies overseas, with studies in the UK [9], USA [10] and Canada [11] demonstrating that the majority of women receiving the ECP directly from pharmacists were well informed about use of the product, reported satisfaction with the system, and rated pharmacists highly for their personal interactions. Despite this, some consumers express negative opinions about obtaining the ECP from pharmacies, mostly in terms of the lack of privacy in the pharmacy and how pharmacists' personal views may impact on their professionalism [8,12].
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Pharmacy practice standards play an important role in maintaining a high level of service quality and consistency in the profession. Pharmacist-only (S3) medicines by definition are substances or preparations for therapeutic use which, although substantially safe to use, are determined to require professional advice or counselling by a pharmacist [13]. Pharmacists therefore assume a vital role in the provision of such medications to ensure their appropriate supply and use. In Australia, standards of practice for the provision of nonprescription medicines in community pharmacy have been established accordingly, using a consumer-focused and risk management approach [14]. In addition to the standards associated with S3 classified medications, the Pharmaceutical Society of Australia (PSA) has produced a comprehensive protocol with detailed requirements to support pharmacists in providing the ECP. This protocol sets guidelines in relation to respecting patient confidentiality, and ascertaining information about the user, as well as outlining key counselling points. The requirement to address even broader issues such as sexual health education and safe sex practices is also an important part of the protocol [15]. Although not directly relevant to the provision of the ECP, these broader issues were included in the protocol as a result of the environment at the time of deregulation. The decision to reclassify the ECP was not supported by the medical profession at the time [16,17]. One of the arguments put forward in opposition to reclassifying the ECP was that if it became available without prescription, women would miss out on regular health and STI checks that doctors might conduct when prescribing the ECP. Therefore, the protocol developed was all encompassing and included elements not required of pharmacists in other countries. Also in place is the Pharmaceutical Society of Australia's Code of Professional Conduct [18], which sets out nine principles of professional ethics in pharmacy. The code provides guidance in concepts ranging from respect for patient autonomy and privacy, to upholding the reputation of the profession with practical examples. The ninth principle states that in the event of “…conflict with personal moral beliefs” the pharmacist must provide continuity of care for the patient. The right of the pharmacist to refuse supply of the ECP on religious or moral grounds has generated much debate and received considerable media attention, both in Australia and internationally [19–21]. With an increasing number of medications recently deregulated from prescription status, professional practice has come under much scrutiny. Examination of current pharmacy services such as smoking cessation and weight loss management, suggests that a gap exists between the development and application of practice standards across the profession [22,23]. Since 2002, the application of professional practice standards [14] has been self-regulated by the pharmacy profession using a simulated patient approach to assess pharmacy supply of non-prescription medications [24]. In this technique, the researcher enters the pharmacy in the
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guise of a patient for the purpose of observing and testing provision of pharmacy services. Whilst simulated patient methodology has been used in research studies examining ECP protocol adherence on an international level [25–29], there is limited research examining pharmacist provision of the ECP in Australia. A current assessment of the profession's performance in the provision of the ECP service is critical to maintaining appropriate standards of practice. The aim of this project was to examine the ECP service provided in community pharmacies in Sydney, Australia. 2. Materials and methods The research was approved and conducted in compliance with the requirements of the Human Research Ethics Committee of The University of Sydney. Simulated patient methodology was used for this study. The simulated patient was trained to present one standard scenario at each pharmacy. To maintain consistency, a single researcher took the role of the simulated patient. Upon entering the pharmacy and when approached by a member of staff, the simulated patient requested the ECP according to the scenario (Table 1). The scenario was designed to reflect a common, non-complicated situation, which necessitated the supply of the ECP. When purchasing the ECP without prescription in an Australian pharmacy, all costs are covered by the patient. Although the price varies from pharmacy to pharmacy, in this study, the simulated patient paid whatever the pharmacy requested. 2.1. Sample size and selection One hundred pharmacies were selected by systematic random sampling from the NSW Pharmacy Board register of pharmacies. The sample size calculation [30] was based on a precision of 9% and an estimated 34% unsatisfactory pharmacy performance rate (based on results from a previous large Australian study [24] utilizing simulated patients to Table 1 Simulated patient scenario Patient:
Self (female)
Age Reason for use
25 years Unprotected intercourse (ran out of condoms) last night(within 24 h) None None Condoms No previous ectopic pregnancy No other unprotected sex this cycle No pregnancy test Last period normal: first day of period, 10 days prior 28-day regular cycle Not breastfeeding No recent diarrhea or vomiting
Current health conditions Other medications Regular contraception Other relevant history
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assess the provision of non-prescription medicines). Pharmacies were visited during usual business hours, from August to October 2008. Pharmacies were not advised of the research study to ensure a non-biased response. 2.2. Data collection A standardized data collection form based on the PSA protocol [14], was completed by the simulated patient immediately following the consultation. Documentation included: the staff member involved in the consultation, the information requested prior to the sale of the ECP and any advice or information provided with the ECP. Qualitative descriptions of the experiences of the simulated patient concerning the ECP service, including the attitude of the pharmacist, perceptions of the pharmacist-patient interaction, and the degree of privacy were also recorded. 2.3. Operational definitions Adequate assessment for ECP supply was defined using the following four of the nine items extracted from the protocol, which were considered by the researchers as minimum information required to determine appropriate supply: 1. evidence determining that the patient was within the 72-h timeframe [31], 2. not currently pregnant, 3. not using other medications that may decrease efficacy of the ECP, and 4. no other relevant health conditions (e.g., unexplained vaginal bleeding, breast cancer, etc.). Partial assessment was defined as meeting at least one of the above criteria. The absence of all criteria indicated no assessment was conducted. Adequate provision of information to the patient was based on the criteria essential to the patient's ability to appropriately administer the ECP. This was operationally defined by the following three protocol criteria: 1. evidence of counselling on how to take the ECP, 2. when to take the ECP, and 3. what to do in the event of vomiting within 2 h of taking the ECP. Partial provision of information was similarly defined as meeting at least one of the above criteria, and the absence of all criteria was considered no provision of information. 2.4. Analysis All data input and analysis was performed using the Statistical Package for Social Sciences (SPSS) Version 15.0, and relative frequencies for all variables were calculated. Comments in regard to the general experience were content analyzed for main themes.
3. Results The pharmacies visited were distributed throughout the Sydney metropolitan region. Of the 100 pharmacies, 27 were located within a shopping center, 64 situated on a shopping strip, 2 within a medical center and 8 were relatively isolated in suburban areas. This was broadly in keeping with other reported figures of pharmacy location [32]. 3.1. Supply of the ECP The ECP was supplied in 95 of the 100 pharmacies visited. Of the five pharmacies that did not provide the ECP, one did not stock the ECP, two were out of stock at the time of the visit, and two offered no reason. In only two of these pharmacies did a staff member refer the simulated patient to the nearest pharmacy. In pharmacies that did provide the ECP, counselling was conducted by 85 pharmacists, four pharmacy interns and five pharmacy assistants. During one consultation, the role of the staff member was unclear. Of these staff members, 53% were female and 47% male. 3.2. General perceptions of the pharmacist-patient interaction Consultations in general were succinct, professional, courteous and nonjudgemental. A disapproving attitude was noted in one instance, where a pharmacy assistant attempted to deter the patient from purchasing the ECP. In 10 pharmacies, the simulated patient was asked to complete a checklist prior to consultation with the pharmacist. In pharmacies that implemented checklist procedures, substantially more information about the patient was collected, thus enabling more complete clinical assessment, and the interaction was significantly shortened, but was often impersonal. In some cases, the use of a checklist enabled the disclosure of sensitive information. For example, one checklist ascertained whether unprotected sex was consensual and if referral to a sexual health or assault clinic was necessary. In 16 encounters, personal details were sought for recording purposes and/or a form of identification requested, such that the ECP was dispensed and labelled as if it was a prescription item (S4) item. The quality of counselling was generally not different when dispensed as a prescription. 3.3. Patient privacy In the majority of consultations, efforts to address patient privacy were noted. In some instances the simulated patient was steered toward a seated consultation area or room within the pharmacy to facilitate the counselling process. In other pharmacies, the pharmacist directed the simulated patient to a quiet area away from customers and staff. Pharmacists also attempted to conceal the ECP from view of other customers, provided verbal assurance of confidentiality and demonstrated nonverbal cues and body language indicative of
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discretion. In many cases, privacy was serendipitous due to a lack of customers in the pharmacy. In nine consultations, privacy was considered inadequate, most commonly due to counselling taking place at the counter and in the presence of other customers. 3.4. Pharmacist clinical assessment The frequency of information gathered prior to the sale of the ECP is presented in Fig. 1. The number of questions asked of the patient ranged from one to seven, with the majority asking two to four questions. Pharmacists adequately assessed whether the ECP was appropriate for the patient in 18% of consultations. Partial assessment was evident in 69% of consultations, and in 13% of consultations, the pharmacist failed to assess the patient at all. In addition, some asked questions not covered in the protocol, such as whether the patient had taken the ECP before (21%), whether the patient had any allergies (7%) and whether the patient's last period was normal (3%). 3.5. Pharmacist provision of information The frequency of key counselling points provided with the ECP is presented in Fig. 2. In 42% of consultations, pharmacists provided the simulated patient with adequate information to appropriately administer the ECP. Partial provision of information was communicated to the patient in 55% of pharmacy consultations, and 3% failed to provide any information at all. Of the 55% of consultations in which only partial information was provided, most pharmacists outlined three to four main issues and then referred the patient to written sources if further information was required. As can be seen in Fig. 2, the most common information provided to the patient related to how and when to take the
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tablets. Pharmacists most commonly instructed the patient to take the ECP in the two dose, 12-h regimen, with only 15 pharmacists recommending the single dose alternative. As the simulated patient indicated that unprotected intercourse had occurred within the previous 24 h, some pharmacists suggested delaying the first dose such that the second was at a more convenient time. Others suggested the setting of an alarm as a reminder. Two pharmacists appeared to confuse the 12-h interval between the two doses with the 72-h after unprotected intercourse therapeutic time frame. Their advice was either that the tablets be taken within 12 h of unprotected intercourse, or that there would be loss of efficacy post the 12-h time frame. Almost two thirds of pharmacists discussed possible side effects associated with the ECP. The most frequent side effects described were vomiting and nausea but also included spotting, breast tenderness, headache and tiredness. In 34% of cases, pharmacists discussed the effectiveness of the ECP in preventing pregnancy. However, 11% of pharmacists provided inaccurate figures in relation to effectiveness. Less frequent information was given in relation to how the tablets worked. Of the eight pharmacists who explained how the tablets worked, four outlined the changes to the environment of the uterus and the delaying of ovulation, and four explained that it was a high dose of hormone. The majority of pharmacists did not provide counselling regarding regular contraception or STI screening (Fig. 2), as outlined in the PSA protocol. In only 10 pharmacies (10.5%) was the simulated patient given written information in addition to any verbal counselling. 3.6. Influence of pharmacist characteristics The quality of counselling was unaffected by the gender of the pharmacist. However, female pharmacists tended to be
Fig. 1. Pharmacist clinical assessment.
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Fig. 2. Pharmacist provision of information.
more empathic than male pharmacists, making the simulated patient feel more comfortable and showing genuine concern. In a small number of consultations, staff inquired about patient preference regarding the gender of the pharmacist. In one instance, the male pharmacist initially consulted referred the simulated patient to the female pharmacist in charge; in two other instances, prior to consulting the pharmacist, the assistant enquired as to whether the simulated patient would prefer to speak to a male or female pharmacist. Estimations of pharmacists' age were made by visual assessment. Younger looking pharmacists appeared to be more familiar with the PSA protocol and associated key counselling points, using them in the consultation in a rote-learned manner. By contrast, older looking pharmacists did not provide information in the same systematic and orderly manner and were more conservative in their questioning of the patient.
4. Discussion This study provided a valid representation of the provision of ECP by pharmacists in Sydney. In terms of supply of ECP, the study demonstrated that the vast majority of pharmacists (95%) provided access to the medication in a timely manner. However, in relation to the quality of the consultations, inconsistencies were observed. The results suggested that the responsibilities associated with the supply of the ECP were not always met, with some pharmacists failing to adhere to the existing protocol set by the profession and the professional code of ethics. For example, of the five pharmacies that did not provide the ECP, only two offered continuity of care. Thus, three pharmacies failed to uphold their ethical and professional responsibilities to ensure timely access to the ECP.
With adequate clinical assessment of the patient observed in only 18% of consultations, and provision of sufficient information in only 42% of consultations, results are indicative of poor application of the PSA protocol. Although the majority of questions asked were appropriate, findings from the study highlight some pharmacists' inability to ask all the necessary questions to elicit information from the patient. However, the characteristics of the protocol itself may have contributed to this. The protocol is comprehensive in nature with clinically sound criteria which may have been relevant in 2004 but which are excessive according to international standards today. As there are very few contraindications to the use of the ECP [31], only a limited number of questions need to be asked of the patient to determine whether or not the ECP is appropriate. For example, questions regarding regular contraception, breastfeeding and some of the health conditions are unnecessary. Thus, it may be that the protocol requires significant modification and simplification to enable widespread and uniform implementation in Australian pharmacies. With the ECP now firmly established as an S3 medication and few reported issues with this service, this could be an appropriate opportunity for timely revision of the protocol. Whilst results gauged the extent of application of the PSA protocol, this may not necessarily reflect the entirety of the encounter. For example, of the 22% of pharmacists who failed to determine whether the patient was within the 72 h time frame, over three quarters had explained to the patient the necessity of taking the tablet within 72 h of unprotected intercourse. Nevertheless, omitting this enquiry places the onus of appropriate use on the patient, rather than on the pharmacist. Pharmacist provision of information to the patient also did not match well with that outlined in the protocol. However,
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when only counselling points considered necessary to ensure safe and efficacious use of the product were considered, pharmacists scored better. In some cases, pharmacists gave the patient limited verbal information but did refer them to the written information that they provided. Thus, it may be argued that these patients did in fact receive appropriate information, but this would not have been recorded in our data collection. Again, the protocol may be the reason for pharmacist underperformance. Although required by the protocol, only 22% of pharmacists provided information on regular contraception, and even fewer on STI checks, similar to findings made internationally [12,25]. This information, while important, does not need to be provided to ensure appropriate use of the ECP - the primary goal of the consultation. One study from the UK has even reported that patients may not expect this type of information from pharmacists, and in some cases find it inappropriate that pharmacists would provide this information [33]. Thus, this may be a further area for review of the protocol. Physical variability of the pharmacies across the study population may also be another reason for the observed limited application of the PSA protocol or ethical principles of practice. For example, patient privacy, an essential ethical requirement of practice, varied amongst pharmacies. Only a minority of pharmacies were equipped with sufficient physical space to provide a seated consultation area or room, and those lacking in this aspect may have been limited in their ability to address all elements of the protocol. The lack of uniformity in the systems in place across pharmacies may have additionally contributed to the varied levels of performance. For example, differences were observed in the method of ECP provision, reflected by the use of checklists in some pharmacies and dispensing procedures in others. There was evidence to support the use of checklists in terms of efficiency and adequate collection of patient information and thus clinical assessment. Since the completion of this study, the PSA has produced a checklist for use in pharmacies. However, the checklist is based on the existing protocol and thus is unnecessarily comprehensive. The majority of pharmacist–patient interactions were observed to be professional, courteous and nonjudgemental in manner. This is consistent with studies conducted internationally [34] and is an indication that Australian pharmacists respect patient dignity and right to self-determination. This study employed the use of a simulated patient methodology to assess the ECP service. Potential limitations relate to reliance on simulated patient memory recall, and actor “fatigue” from repeated performances. To minimize these limitations, the researchers restricted the number of visits undertaken per day to five in order to avoid fatigue, bias or subtle changes in body language or acting performance. The data collection form was completed immediately post-purchase, outside the pharmacy to maximize recall. To further ensure consistency, only one scenario was utilized. However, pharmacy response may have varied if a different scenario had been used.
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Deidentified data were purposefully utilized to protect the identity of the pharmacies involved, and their staff, as they were not consulted prior to the visit. This, therefore, restricted examination of pharmacy demographics in relation to the ECP service provided. Additionally, as pharmacies were only visited once, circumstantial factors occurring on the particular day or time may have impacted on the counselling processes observed.
5. Conclusions This study highlighted a need to standardize procedures in regard to the ECP service to present a more consistent level of service to the public, and the need to periodically reassess practice protocols. One suggestion is that the protocol be completely revised to enable easier implementation by all pharmacies, and to reflect the safety and function of the ECP. Additionally, in light of the increasing role of the pharmacist in patient care, mandatory provision of private consultation areas may facilitate and enhance quality counselling. This study also highlighted the need for continuing professional education, both clinical and ethical, to ensure that all pharmacists are equipped to meet the needs of the public. Ethical literacy is of prime importance, particularly in the provision of ECP. In the event of personal moral dissent, provision of continuity of care is essential. Simulated patient studies provide useful insight into the current quality of services in pharmacy practice. The incorporation of simulated patient methods into an educational reflective framework as part of continuing professional development in the area of the ECP may lead to vast improvement of the service. Further research could also examine potential barriers to the use of guidelines such as the ECP protocol, to understand what factors may improve implementation and, ideally, to shift performance to improve levels of service. The experience of Australia in establishing extensive requirements for pharmacist-provided ECP may serve as an important lesson for other countries just now introducing ECP through pharmacies. Establishing unnecessarily restrictive standards may lead to noncompliance.
Acknowledgment No specific funding was received for this research.
References [1] Chan A, Sage LC. Estimating Australia's abortion rates 1985-2003. Med J Aust 2005;182:447–52. [2] Grayson N, Hargreaves J, Sullivan EA. Use of routinely collected national data sets for reporting on induced abortion in Australia. AIHW Cat. No. PER 30. Sydney: AIHW National Perinatal Statistics Unit (Perinatal Statistics Series No. 17); 2005.
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[3] Therapeutic Goods Administration. National Drugs and Poisons Schedule Committee. TGA [online] 2008. http://www.tga.gov.au/ndpsc/ record/rr200306b/pdf (accessed 11 October 2008). [4] Task Force on Postovulatory Methods of Fertility Regulation. World Health Organization. Randomised controlled trial of levonorgestrel versus the Yuzpe regimen of combined oral contraceptives for emergency contraception. Lancet 1998;352:428–33. [5] Von Hertzen H, Piaggio G, Ding J, et al. Low dose mifepristone and two regimens of levonorgestrel for emergency contraception: a WHO multicentre randomised trial. Lancet 2002;360:1803–10. [6] Rodrigues I, Grou F, Joly J. Effectiveness of emergency contraceptive pills between 72 and 120 hours after unprotected sexual intercourse. Am J Obstet Gynecol 2001;184:531–7. [7] Piaggio G, von Hertzen H, Grimes DA, Van Look PFA. Timing of emergency contraception with levonorgestrel or the Yuzpe regimen. Lancet 1999;353:721. [8] Gainer E, Blum J, Toverud EL, et al. Bringing emergency contraception over-the-counter: experiences of nonprescription users in France, Norway, Sweden and Portugal. Contraception 2003;68:117–24. [9] Killick SR, Irving G. A national study examining the effect of making emergency hormonal contraception available without prescription. Hum Reprod 2004;19:553–7. [10] Sommers SD, Chaiyakakunapruk N, Gardner JS, Winkler J. The emergency contraception collaborative prescribing experience in Washington State. J Am Pharm Assoc 2001;41:60–6. [11] Dunn S, Brown TE, Cohen MM, et al. Pharmacy provision of emergency contraception: the Ontario emergency contraception pilot project. J Obstet Gynaecol Can 2003;25:923–30. [12] Black KI, Mercer CH, Kubba A, Wellings K. Provision of emergency contraception: a pilot study comparing access through pharmacies and clinical settings. Contraception 2008;77:181–5. [13] Australian Health Ministers Advisory Council. Guidelines for National Drug and Poisons Schedule Committee. Canberra: Australian Health Ministers' Advisory Council; 1997. [14] Benrimoj SI, Wilson F. Standards for the provision of pharmacy medicines and pharmacist only medicines in community pharmacy. Revised, November 2005. Professional practice standards (Version 3). Canberra: Pharmaceutical Society of Australia; 2006. [15] Pharmaceutical Society of Australia. Supply of levonorgestrel as a pharmacist only medicine for emergency contraception (EC). In: Sansom EL, editor. Australian Pharmaceutical Formulary and Handbook. Curtin: The Pharmaceutical Society of Australia; 2006, pp. 404–6. [16] Royal Australian College of General Practitioners. Access to emergency contraception: The College position [online]. July 2003. Available at http://www.racgp.org.au/policy/emergency_contraception.pdf (accessed 16 February 2010). [17] McLean B. OTC morning-after pill concerns AMA. Australian Doctor [online], January 2004. Available at http://www.australiandoctor.com. au/news/05/0c01ca05.asp (accessed 16 February 2010).
[18] Pharmaceutical Society of Australia. Code of Professional Conduct [online]. March 1998. Available at http://www.psa.org.au/site.php? id=628 (accessed 15 March 2009). [19] Anonymous. Pharmacy bans pregnancy pill. City News [online]. Available at http://city-news.whereilive.com.au/news/story/ pharmacy-bans-pregnancy-pill (accessed 9 June 2009). [20] Baergen R, Owens C. Revisiting pharmacists' refusals to dispense emergency contraception. Obstet Gynecol 2006;108:1277–82. [21] Card RF. Conscientious objection and emergency contraception. Am J Bioeth 2007;7:8–14. [22] Chiang PPC, Chapman S. Do pharmacy staff recommend evidencebased smoking cessation products? A pseudo patron study. J Clin Pharm Ther 2006;31:205–9. [23] CHOICE. Xenical shadow shop. CHOICE [online] 2007. Available at http://www.choice.com.au/viewArticle.aspx?id=105435&catId= 100231&tid=100008 (accessed 15 October 2008). [24] Benrimoj SI, Werner J, Raffaele C, Roberts A, Costa FA. Monitoring quality standards in the provision of non-prescription medicines from Australian community pharmacies: results of a national programme. Qual Saf Health Care 2007;16:354–8. [25] Anderson C, Bissell P. Using semi covert research to evaluate an emergency hormonal contraception service. Pharm World Sci 2004;26:102–6. [26] Cohen MM, Dunn S, Cockerill R, Brown TER. Using a secret shopper to evaluate pharmacist provision of emergency contraception: satisfaction levels high, with privacy a concern. Can Pharm J 2004;137:28–33. [27] Bennett W, Petraitis C, D'Anella AD, Marcella S. Pharmacists' knowledge and the difficulty of obtaining emergency contraception. Contraception 2003;68:261–7. [28] French AC, Kaunitz AM. Pharmacy access to emergency hormonal contraception in Jacksonville, FL: a secret shopper survey. Contraception 2007;75:126–30. [29] Nelson AL, Jaime CM. Accuracy of information given by Los Angeles County pharmacies about emergency contraceptives to sham patient in need. Contraception 2009;79:206–10. [30] Kalton G. Introduction to survey sampling. Sage University Paper Series on Quantitative Applications in the Social Sciences, 07-035. Beverly Hills (Calif): Sage Publications Inc; 1983. [31] Bayer Schering Pharma. Postinor-2 Product Information. [online] http:// www.appgonline.com.au/drug.asp?drug_id=00072425&t=cmi 2003 (accessed 15 October 2008). [32] Berbatis CG, Sunderland VB, Joyce A, Bulsara M, Mills C. Characteristics of Australia's community pharmacies: National Pharmacy Database Project. Int J Pharm Pract 2007;15:265–71. [33] Bissell P, Anderson C. Supplying emergency contraception via community pharmacies in the UK: reflections on the experiences of users and providers. Soc Sci Med 2003;57:2367–78. [34] Anderson C, Blenkinsopp A. Community pharmacy supply of emergency hormonal contraception: a structured literature review of international evidence. Hum Reprod 2006;21:272–84.