- Email: [email protected]
Requests for emergency contraception in community pharmacy: An evaluation of services provided to mystery patients
Research in Social and Administrative Pharmacy 9 (2013) 114–119
Research Briefs
Requests for emergency contraception in community pharmacy: An evaluation of services provided to mystery patients Samantha J. Higgins, M.Pharm., B.PharmaceutSc.a, H. Laetitia Hattingh, Ph.D., M.Pharm., B.Pharm., G.C.AppLaw., A.A.C.P.A.a,b,* a
School of Pharmacy, Griffith University, Queensland 4222, Australia School of Pharmacy, Curtin University, Perth, WA 6845, Australia
b
Abstract Background: Requests for supply of the emergency contraceptive pill (ECP) through community pharmacies require consideration of a range of factors and the application of professional judgment. Pharmacists should therefore be able to follow a structured reasoning process. Objectives: The research involved an assessment of history taking and counseling by pharmacy staff through mystery patient emergency contraception product requests. Methods: Two challenging ECP request case scenarios were developed with assessment tools. Mystery patients were trained to present the scenarios to pharmacies. A project information package and expression of interest form was posted to 135 pharmacies in the Gold Coast, Australia; 23 (17%) pharmacies agreed to participate. Results: Pharmacy staff was exposed to 1 of 2 scenarios during December 2010. Staff interactions were recorded, analyzed, and rated to evaluate the management of ECP requests. The results identified practice gaps among pharmacy staff with respect to information gathering and the provision of advice. Conclusion: Ongoing training is required to enhance the skills, competence, and confidence of pharmacy staff in managing complicated requests for nonprescription medicines, such as the ECP. The impact of time pressures and financial burdens on the provision of pharmaceutical services needs to be acknowledged. Ó 2013 Elsevier Inc. All rights reserved. Keywords: Pharmacy services; Emergency contraception; History taking; Counseling
Introduction Requests for the supply of the emergency contraceptive pill (ECP) through Australian community pharmacies require consideration of a range
of factors and the application of professional judgment. Pharmacists need to obtain relevant clinical information to be able to make informed decisions about the therapeutic appropriateness.
* Corresponding author. Tel.: þ61 8 9266 7376; fax: þ61 8 9266 2769. E-mail address: [email protected] (H.L. Hattingh). 1551-7411/$ - see front matter Ó 2013 Elsevier Inc. All rights reserved. doi:10.1016/j.sapharm.2012.03.004
Higgins & Hattingh / Research in Social and Administrative Pharmacy 9 (2013) 114–119
Legal requirements need to be considered, and ethical reasoning may be necessary.1-4 The ECP Postinor-2Ò (levonorgestrel; Schering, Alexandria, New South Wales, Australia) was down-scheduled in Australia in 2004 from a prescription (Schedule 4) to a pharmacist-only (Schedule 3) medicine.5 The down-scheduling followed an international trend of making the ECP more readily available. It is currently available as a nonprescription medicine in approximately 60 countries.6 Pharmacy availability of the ECP has not lead to increased or inappropriate use, an increase in unprotected sex, or a decrease in the use of more reliable methods of contraception.7-10 International studies have indicated that nonprescription availability of the ECP enables women to receive the ECP within 24 hours of unprotected sexual intercourse.7,11,12 However, a recent Australian telephone survey of a random sample of 632 women aged between 16 and 35 years indicated that less than half of the participants were aware of it being available without a prescription.13 The ECP supply process is more complex than the supply of most other nonprescription products because it involves specific sensitive and personal information to be gathered and detailed advice to be provided. Australian pharmacists are not required to undergo specific ECP training or credentialing to supply the ECP. However, the Pharmaceutical Society of Australia (PSA) developed an ECP supply protocol to assist
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pharmacists with ECP requests. This protocol provides a structured framework for complying with professional pharmacist duties.14 The aim of this research was to review the quality of services provided by community pharmacy staff associated with requests for the ECP.
Methods The research involved an assessment of history taking and counseling by pharmacy staff to mystery patients through product request scenarios for emergency contraception.15 Ethics approval was granted by the Griffith University Human Research Ethics Committee. Case scenarios Two case scenarios (Table 1) with essential criteria were developed in collaboration with a focus group of 7 pharmacy practice academics. The case scenarios reflected ECP requests that required particular focus on history taking and patient education. Assessment tools were developed for each scenario considering essential criteria, the ECP protocol, professional practice standards and guidelines, and Queensland legislation.1,14,16 Pharmacy recruitment The Gold Coast, a city with a population of approximately 500,000 people in Southeast
Table 1 Mystery patient scenarios Scenario 1 involved an 18-year-old male presenting to the pharmacy requesting the morning-after pill, seeking extra contraception for future use for his young girlfriend. On questioning, he described the circumstances requiring the medication “just in case,” being that the pair were traveling to a remote destination on a camping trip the following day and would not have reasonable access to a pharmacy or doctor’s surgery on the off chance that their usual method of contraception (barrier method) failed. The essential criteria for scenario 1 included to Determine the nature of request and relationship Determine the age of the female patient and attempt to confirm identity Identify that third-party supply is not appropriate Provide continuum of caredreferral to doctor or alternative options to obtain supply Provide the patient with adequate privacy and ensure confidentiality Scenario 2 involved a 30-year-old female presenting to the pharmacy requesting the morning-after pill. She required the medication as a result of a suspected sexual assault. She had gone out for a few drinks the previous evening with friends but blacked out soon after her first drink. She described having no knowledge of events after blacking out and was worried that her drink was spiked and that something might have happened. Essential criteria for scenario 2 required pharmacists to Determine the possibility of sexual assault Provide referral to a doctor and/or the police and/or a sexual health clinic Provide adequate counseling about the medication considering the patient’s lack of knowledge with first-time use Provide the patient with adequate privacy and ensure confidentiality Eliminate the presence of known preexisting contraindications to ECP
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Queensland, Australia, was targeted for participant recruitment, representing a variety of community pharmacy business models. A project information package and expression of interest form was posted to 135 pharmacies, requesting pharmacists to participate in the research by returning the signed consent form. The information package disclosed that a mystery patient would visit the pharmacy to request a nonprescription medication in a specified time period; however, details about the specific product were omitted. Pharmacies also were contacted by telephone 1 week after initial distribution of the information package to encourage participation. Twenty-three pharmacies (17% of 135) agreed to participate. Based on location, these pharmacies were divided into north (11) and south (12) groups and assigned a mystery patient scenario. Mystery patient visits Two mystery patients were selected from a pool of candidates based on their physical characteristics and expertise (Table 2). They had to memorize and act their scenarios in a pharmacy setting and recall relevant information for data collection purposes. Both mystery patients received extensive training in preparation for their being able to assess pharmacy staff interactions. Training also involved going through potential pharmacy staff responses and doing role plays. The scenario 1 and 2 visits were spread 1 week apart; all visits for a specific scenario were conducted on 1 day to maintain the integrity of scenario details. The research team accompanied the mystery patients but remained concealed throughout the pharmacy interactions. The mystery patients provided detailed feedback to the researchers immediately after each interaction, and these details were recorded onto the assessment tool. After the visits, letters were sent to all participating pharmacies about visit details to enable editing of dispensing software to reflect the pseudoscenario.
Data analysis The assessment tools collected information on receiving the request, establishing the patient’s need, appropriateness of therapy, referral or supply, and provision of education. Each category comprised detailed tick box criteria that were completed by the researchers immediately after the pharmacy visits, based on the mystery patient’s recollection of the interaction. The performances in each of the categories were subsequently graded based on the proportion of the tick box criteria that were satisfied: participants addressing R90% of the criteria were deemed to have provided comprehensive services; those addressing approximately 50% were deemed as providing a moderate level of service; and a poor level of service was assigned to participants addressing limited criteria. Performance also was assessed for impact on the patient’s outcome. This process involved a revision of the cumulative performance with particular attention given to criteria that were not addressed.
Results Information gathering This process involved the fundamentals of history taking and included determining the intended user of the ECP, indication for use, current medication, medical and allergy history, history of ECP use, and scenario-specific essential criteria. Five of the 12 scenario 1 pharmacies determined the intended ECP user, whereas 8 of the 11 scenario 2 pharmacies determined the intended user, with the remaining 3 pharmacies assuming that the ECP was for the presenting customer. Five scenario 1 pharmacies determined the relationship of the mystery patient with the intended user, but none of the 12 pharmacies determined the age of the male mystery patient. Staff at 3 pharmacies determined previous ECP use history. According to overall ratings of scenario 1 pharmacies, 2 pharmacies obtained
Table 2 Mystery patient characteristics Mystery patient 1 was an 18-year-old male university student with previous experience as a pseudopatient in the assessment of pharmacy students’ counseling skills Mystery patient 2 was a female in her early 30s with extensive experience as a midwife, an understanding of medicines, patient history taking, and counseling on health interventions
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a moderate history, whereas the remaining 10 pharmacies obtained no or poor history. Ten scenario 1 pharmacies refused to supply the ECP. All 11 scenario 2 pharmacies supplied the ECP to the patient. The overall assessment of the pharmacies showed that staff at 6 pharmacies obtained a comprehensive history, 1 pharmacy obtained a moderate history, and 4 obtained poor patient histories. Information commonly not collected included allergy, breastfeeding status, and details about the patient’s menstrual cycle. Staff at 8 pharmacies used ECP questionnaires for data collection. Six pharmacies determined the mystery patient’s reason for ECP request, thus indicating that 5 pharmacies supplied ECP without detailed information about the scenario. Overall, scenario 2 pharmacies performed better in data collection than did scenario 1 pharmacies.
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3 pharmacies provided comprehensive patient counseling, 4 pharmacies provided moderate counseling, and the remaining 4 pharmacies provided poor counseling. Information about the risk of ectopic pregnancy, the need to be tested for sexually transmitted infections, and the need for medical follow-up were commonly omitted during counseling, and only 1 pharmacist used a Consumer Medicine Information leaflet in the counseling process. Staff at 6 of the pharmacies determined that the ECP request was a result of suspected sexual assault (essential criteria), and 5 offered a referral to the police or another health professional. Overall, scenario 2 pharmacies performed better in the provision of counseling when compared with scenario 1 pharmacies.
Discussion Provision of advice Provision of advice involved giving of relevant medication information including details of dose, adverse effects, advice on management, risks of therapy, follow-up advice, written information, and essential criteria for the specific scenarios. Essential criteria for scenario 1 included information on long-term options for contraception (eg, the combined oral contraceptive pill), education on alternative contraceptive methods, and if not supplying the ECP some information on alternatives to nonprescription ECP (eg, obtaining a prescription from a doctor). The essential criteria for scenario 2 involved referral to the police to report suspected sexual assault and/or a referral to a sexual health clinic or doctor for support, testing of sexually transmittable infections and to follow-up on the drink-spiking claim. The ECP was supplied by only 2 scenario 1 pharmacies. Seven interactions involved a pharmacist in some capacity, whereas the remaining 5 interactions only involved pharmacy support staff. Four pharmacies provided moderate patient counseling, 2 of which supplied the ECP, and the staff at the remaining 8 pharmacies provided no counseling. Staff at 5 of the 10 pharmacies that refused supply advised the mystery patient to either return with or send the female requiring the ECP, whereas the remaining 5 pharmacies did not offer follow-up advice or an alternative to obtaining supply. Most scenario 2 pharmacies (10/11) involved pharmacists in the counseling process. The staff at
The pharmacy interactions were used to evaluate the management of ECP requests by pharmacists and pharmacy staff. The analyzed data provided valuable insight into pharmacy practice and suggested that there were specific identifiable service gaps among pharmacists and pharmacy staff. However, the impact of time pressures and financial burdens on the provision of pharmaceutical services needs to be acknowledged. In terms of history taking, none of the scenario 1 pharmacies and only 6 of the scenario 2 pharmacies obtained a complete patient history. These findings support national and international research, prompting consideration of credentialing pharmacists in the supply of the ECP17 and highlighting the need for specific pharmacist and pharmacy staff training in history taking. The scenario 2 pharmacies rated better than the scenario 1 pharmacies in terms of overall history taking. This outcome was somewhat expected because of the high rate of refusal to supply ECP for scenario 1 (10 of the 12 pharmacies refused to supply). The support staff from 5 of these pharmacies did not involve a pharmacist in their decision-making process. Although the outcome did not involve supply, the mystery patient should have been counseled about alternative options and ongoing management. Additionally, supplying to a third party is a legislative gray area and requires pharmacists’ input and judgment regarding appropriateness of supply, depending on the specific circumstances.18,19 The PSA standards and protocols covering nonprescription medicines
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indeed indicate that pharmacists are responsible for the safe and judicious use of nonprescription medicines.14,16 Patient education is a pivotal pharmacist role to promote the quality use of medicines. The PSA standards specify that pharmacists should work with consumers to provide tailored verbal and written information to ensure that consumers have sufficient knowledge and understanding of their medicines and therapeutic devices to facilitate safe and effective use.16 The counseling required with ECP supply is indeed more detailed than most other nonprescription products.14 However, the majority of both scenario 1 and 2 pharmacies did not provide comprehensive counseling. The results confirm previous research that highlighted pharmacists’ ECP counseling needed to improve 12,20-23 and that patients received better quality information when attending a clinical service.24-28 However, studies have highlighted that some female patients are uncomfortable with pharmacists providing detailed ECP counseling.11,13,25 In contrast, a study of pharmacists’ perceptions of their role when supplying the ECP indicated that they viewed it part of their role to counsel about future contraception and sexually transmitted infections.29 Nevertheless, most pharmacists in this study did not provide detailed counseling. Study limitations There is limited ability to generalize the results to all community pharmacies because the participants represented a relatively small sample of community pharmacy staff and the geographical area was limited. Pharmacies were visited only once, and circumstantial factors occurring on the particular day or time will have impacted on the services provided. A limitation of the mystery patient approach is that staff at the participating pharmacies could have expected the mystery patient visit and this could have influenced their behavior, the so-called Hawthorne effect.30 This effect was minimized through providing limited information during recruitment and conducting all of a specific scenario visits on the same business day. Additionally, although both mystery patients were trained and had experience, there was no mechanism undertaken to assess or ensure interrater reliability between them. The recording performance relied on the mystery patients’ recollection of interactions. To
minimize this limitation, the assessment tool was completed immediately after the interactions to maximize recall.
Conclusion Community pharmacy staff may not be sufficiently prepared for challenging ECP requests. Ongoing training is required to enhance the skills, competence, and confidence of pharmacy staff in managing complicated requests for nonprescription medicines, such as the ECP.29,30 More studies could enable development of training tools and support mechanisms to address identified practice shortcomings. Acknowledgments This project was supported by a Griffith Health Institute grant. The authors gratefully acknowledge the support from the 2 mystery patients, the input from the 7 focus group members, and the willingness of the 23 community pharmacies to participate. References 1. Health (Drugs and Poisons) Regulation 1996 (Qld), Office of the Queensland Parliamentary Counsel. Available at: http://www.legislation.qld.gov.au/LEGISLTN/ CURRENT/H/HealDrAPoR96.pdf/. Accessed 23.07.11. 2. Wisewoulds Lawyers correspondence to Pharmaceutical Defence Limited. The parameters of reporting a minor’s request to dispense MAP. 2005; July 26. 3. Position Statement: Ethical Issues in Declining to Supply. Canberra: Pharmaceutical Society of Australia; 2003. 4. Cooper RJ, Bissell P, Wingfield J. Ethical, religious and factual beliefs about the supply of emergency hormonal, contraception by UK community pharmacists. J Fam Plann Reprod Health Care 2008;34: 47–50. 5. Edited Minutes of National Drugs and Poisons Scheduling Committee Meeting 39-October 2003, Available at: http://www.tga.gov.au/ndpsc/record/ rr200310c.pdf/. Accessed 07.07.11. 6. International Consortium for Emergency Contraception. Available at: http://www.cecinfo.org/. Accessed 15.07.11. 7. Killick S, Irving G. A national study examining the effect of making emergency hormonal contraception available without prescription. Hum Reprod 2004;19: 553–557. 8. Fontes E, Guerreiro J, Costa T, Miranda A. Pattern of use of emergency oral contraception among Portuguese women. Pharm World Sci 2010;32:496–502.
Higgins & Hattingh / Research in Social and Administrative Pharmacy 9 (2013) 114–119 9. Harper CC, Weiss DC, Speidel JJ, Raine-Bennett T. Over-the-counter access to emergency contraception for teens. Contraception 2008;77:230–233. 10. Marston C, Meltzer H, Majeed A. Impact on contraceptive practice of making emergency hormonal contraception available over the counter in Great Britain: repeated cross sectional surveys. BMJ 2005;331:271–275. 11. Anderson C, Blenkinsopp A. Community pharmacy supply of emergency hormonal contraception: a structured literature review of international evidence. Hum Reprod 2006;21:272–284. 12. Gainer E, Blum J, Toverud E-L, et al. Bringing emergency contraception over the counter: experiences of nonprescription users in France, Norway, Sweden and Portugal. Contraception 2003;68: 117–124. 13. Hobbs MK, Taft AJ, Amir LH, et al. Pharmacy access to the emergency contraceptive pill: a national survey of a random sample of Australian women. Contraception 2011;83:151–158. 14. Direct Product Request Protocol. Supply of Levonorgestrel as a Pharmacist Only Medicine for Emergency Contraception (EC). 2008, Pharmaceutical Society of Australia. Available at: http://www.psa.org.au/supp orting-practice/professional-practice-standards/phar macist-only-medicines-s3-protocols/. Accessed 18. 04.11. 15. Watson MC, Norris P, Granas AG. A systematic review of the use of simulated patients and pharmacy practice research. Int J Pharm Pract 2006; 14:83–93. 16. Professional Practice Standards. 4th ed, 2010, Pharmaceutical Society of Australia. Available at: http://www.psa.org.au/supporting-practice/professio nal-practice-standards/. Accessed 15.07.11. 17. Standards for the Supply by Pharmacists of the Emergency Contraception Pill, Pharmacy Council of New Zealand, 2011. Available at: http://www. pharmacycouncil.org.nz/cms_show_download.php? id¼214/. Accessed 14.11.11. 18. Hattingh L, Forrester K, Smith N, Searle J. Pharmacy practice developments: the potential impact on pharmacists’ legal liability. J Law Med 2007;14: 297–402.
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19. Low J, Hattingh H, Forrester K. Australian Pharmacy Law and Practice. Sydney, Australia: Elsevier; 2010. 148. 20. Queddeng K, Chaar B, Williams K. Emergency contraception in Australian community pharmacies: a simulated patient study. Contraception 2011;83: 176–182. 21. Anderson C, Bissell P. Using semi covert research to evaluate an emergency hormonal contraception service. Pharm World Sci 2004;26:102–106. 22. Weiss M, Booth A, Jones B, Ramjeet S, Wong E. Use of simulated patients to assess the clinical and communication skills of community pharmacists. Pharm World Sci 2010;32:353–361. 23. Cohen M, Brown T, Cockerill R, Dunn S. 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. 24. Black KI, Mercer CH, Kubba A, Wellings K. Provision of emergency contraception: a pilot study comparing access through pharmacies and clinical settings. Contraception 2008;77:181–185. 25. 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;57:2367–2378. 26. French AC, Kaunitz AM. Pharmacy access to emergency hormonal contraception in Jacksonville, FL: a secret shopper survey. Contraception 2007;75:126– 130. 27. Nelson AL, Jaime CM. Accuracy of information given by Los Angeles County pharmacies about emergency contraceptives to sham patient in need. Contraception 2009;79:206–210. 28. Bennett W, Petraitis C, D’Anella A, Marcella S. Pharmacists’ knowledge and the difficulty of obtaining emergency contraception. Contraception 2003;68: 261–267. 29. Hussainy SY, Stewart K, Chapman CB, et al. Provision of the emergency contraceptive pill without prescription: attitudes and practices of pharmacists in Australia. Contraception 2011;83:159–166. 30. Adair JG. The Hawthorne effect: a reconsideration of the methodological artifact. J Appl Psychol 1984;69: 334–345.
Research Briefs
Requests for emergency contraception in community pharmacy: An evaluation of services provided to mystery patients Samantha J. Higgins, M.Pharm., B.PharmaceutSc.a, H. Laetitia Hattingh, Ph.D., M.Pharm., B.Pharm., G.C.AppLaw., A.A.C.P.A.a,b,* a
School of Pharmacy, Griffith University, Queensland 4222, Australia School of Pharmacy, Curtin University, Perth, WA 6845, Australia
b
Abstract Background: Requests for supply of the emergency contraceptive pill (ECP) through community pharmacies require consideration of a range of factors and the application of professional judgment. Pharmacists should therefore be able to follow a structured reasoning process. Objectives: The research involved an assessment of history taking and counseling by pharmacy staff through mystery patient emergency contraception product requests. Methods: Two challenging ECP request case scenarios were developed with assessment tools. Mystery patients were trained to present the scenarios to pharmacies. A project information package and expression of interest form was posted to 135 pharmacies in the Gold Coast, Australia; 23 (17%) pharmacies agreed to participate. Results: Pharmacy staff was exposed to 1 of 2 scenarios during December 2010. Staff interactions were recorded, analyzed, and rated to evaluate the management of ECP requests. The results identified practice gaps among pharmacy staff with respect to information gathering and the provision of advice. Conclusion: Ongoing training is required to enhance the skills, competence, and confidence of pharmacy staff in managing complicated requests for nonprescription medicines, such as the ECP. The impact of time pressures and financial burdens on the provision of pharmaceutical services needs to be acknowledged. Ó 2013 Elsevier Inc. All rights reserved. Keywords: Pharmacy services; Emergency contraception; History taking; Counseling
Introduction Requests for the supply of the emergency contraceptive pill (ECP) through Australian community pharmacies require consideration of a range
of factors and the application of professional judgment. Pharmacists need to obtain relevant clinical information to be able to make informed decisions about the therapeutic appropriateness.
* Corresponding author. Tel.: þ61 8 9266 7376; fax: þ61 8 9266 2769. E-mail address: [email protected] (H.L. Hattingh). 1551-7411/$ - see front matter Ó 2013 Elsevier Inc. All rights reserved. doi:10.1016/j.sapharm.2012.03.004
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Legal requirements need to be considered, and ethical reasoning may be necessary.1-4 The ECP Postinor-2Ò (levonorgestrel; Schering, Alexandria, New South Wales, Australia) was down-scheduled in Australia in 2004 from a prescription (Schedule 4) to a pharmacist-only (Schedule 3) medicine.5 The down-scheduling followed an international trend of making the ECP more readily available. It is currently available as a nonprescription medicine in approximately 60 countries.6 Pharmacy availability of the ECP has not lead to increased or inappropriate use, an increase in unprotected sex, or a decrease in the use of more reliable methods of contraception.7-10 International studies have indicated that nonprescription availability of the ECP enables women to receive the ECP within 24 hours of unprotected sexual intercourse.7,11,12 However, a recent Australian telephone survey of a random sample of 632 women aged between 16 and 35 years indicated that less than half of the participants were aware of it being available without a prescription.13 The ECP supply process is more complex than the supply of most other nonprescription products because it involves specific sensitive and personal information to be gathered and detailed advice to be provided. Australian pharmacists are not required to undergo specific ECP training or credentialing to supply the ECP. However, the Pharmaceutical Society of Australia (PSA) developed an ECP supply protocol to assist
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pharmacists with ECP requests. This protocol provides a structured framework for complying with professional pharmacist duties.14 The aim of this research was to review the quality of services provided by community pharmacy staff associated with requests for the ECP.
Methods The research involved an assessment of history taking and counseling by pharmacy staff to mystery patients through product request scenarios for emergency contraception.15 Ethics approval was granted by the Griffith University Human Research Ethics Committee. Case scenarios Two case scenarios (Table 1) with essential criteria were developed in collaboration with a focus group of 7 pharmacy practice academics. The case scenarios reflected ECP requests that required particular focus on history taking and patient education. Assessment tools were developed for each scenario considering essential criteria, the ECP protocol, professional practice standards and guidelines, and Queensland legislation.1,14,16 Pharmacy recruitment The Gold Coast, a city with a population of approximately 500,000 people in Southeast
Table 1 Mystery patient scenarios Scenario 1 involved an 18-year-old male presenting to the pharmacy requesting the morning-after pill, seeking extra contraception for future use for his young girlfriend. On questioning, he described the circumstances requiring the medication “just in case,” being that the pair were traveling to a remote destination on a camping trip the following day and would not have reasonable access to a pharmacy or doctor’s surgery on the off chance that their usual method of contraception (barrier method) failed. The essential criteria for scenario 1 included to Determine the nature of request and relationship Determine the age of the female patient and attempt to confirm identity Identify that third-party supply is not appropriate Provide continuum of caredreferral to doctor or alternative options to obtain supply Provide the patient with adequate privacy and ensure confidentiality Scenario 2 involved a 30-year-old female presenting to the pharmacy requesting the morning-after pill. She required the medication as a result of a suspected sexual assault. She had gone out for a few drinks the previous evening with friends but blacked out soon after her first drink. She described having no knowledge of events after blacking out and was worried that her drink was spiked and that something might have happened. Essential criteria for scenario 2 required pharmacists to Determine the possibility of sexual assault Provide referral to a doctor and/or the police and/or a sexual health clinic Provide adequate counseling about the medication considering the patient’s lack of knowledge with first-time use Provide the patient with adequate privacy and ensure confidentiality Eliminate the presence of known preexisting contraindications to ECP
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Queensland, Australia, was targeted for participant recruitment, representing a variety of community pharmacy business models. A project information package and expression of interest form was posted to 135 pharmacies, requesting pharmacists to participate in the research by returning the signed consent form. The information package disclosed that a mystery patient would visit the pharmacy to request a nonprescription medication in a specified time period; however, details about the specific product were omitted. Pharmacies also were contacted by telephone 1 week after initial distribution of the information package to encourage participation. Twenty-three pharmacies (17% of 135) agreed to participate. Based on location, these pharmacies were divided into north (11) and south (12) groups and assigned a mystery patient scenario. Mystery patient visits Two mystery patients were selected from a pool of candidates based on their physical characteristics and expertise (Table 2). They had to memorize and act their scenarios in a pharmacy setting and recall relevant information for data collection purposes. Both mystery patients received extensive training in preparation for their being able to assess pharmacy staff interactions. Training also involved going through potential pharmacy staff responses and doing role plays. The scenario 1 and 2 visits were spread 1 week apart; all visits for a specific scenario were conducted on 1 day to maintain the integrity of scenario details. The research team accompanied the mystery patients but remained concealed throughout the pharmacy interactions. The mystery patients provided detailed feedback to the researchers immediately after each interaction, and these details were recorded onto the assessment tool. After the visits, letters were sent to all participating pharmacies about visit details to enable editing of dispensing software to reflect the pseudoscenario.
Data analysis The assessment tools collected information on receiving the request, establishing the patient’s need, appropriateness of therapy, referral or supply, and provision of education. Each category comprised detailed tick box criteria that were completed by the researchers immediately after the pharmacy visits, based on the mystery patient’s recollection of the interaction. The performances in each of the categories were subsequently graded based on the proportion of the tick box criteria that were satisfied: participants addressing R90% of the criteria were deemed to have provided comprehensive services; those addressing approximately 50% were deemed as providing a moderate level of service; and a poor level of service was assigned to participants addressing limited criteria. Performance also was assessed for impact on the patient’s outcome. This process involved a revision of the cumulative performance with particular attention given to criteria that were not addressed.
Results Information gathering This process involved the fundamentals of history taking and included determining the intended user of the ECP, indication for use, current medication, medical and allergy history, history of ECP use, and scenario-specific essential criteria. Five of the 12 scenario 1 pharmacies determined the intended ECP user, whereas 8 of the 11 scenario 2 pharmacies determined the intended user, with the remaining 3 pharmacies assuming that the ECP was for the presenting customer. Five scenario 1 pharmacies determined the relationship of the mystery patient with the intended user, but none of the 12 pharmacies determined the age of the male mystery patient. Staff at 3 pharmacies determined previous ECP use history. According to overall ratings of scenario 1 pharmacies, 2 pharmacies obtained
Table 2 Mystery patient characteristics Mystery patient 1 was an 18-year-old male university student with previous experience as a pseudopatient in the assessment of pharmacy students’ counseling skills Mystery patient 2 was a female in her early 30s with extensive experience as a midwife, an understanding of medicines, patient history taking, and counseling on health interventions
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a moderate history, whereas the remaining 10 pharmacies obtained no or poor history. Ten scenario 1 pharmacies refused to supply the ECP. All 11 scenario 2 pharmacies supplied the ECP to the patient. The overall assessment of the pharmacies showed that staff at 6 pharmacies obtained a comprehensive history, 1 pharmacy obtained a moderate history, and 4 obtained poor patient histories. Information commonly not collected included allergy, breastfeeding status, and details about the patient’s menstrual cycle. Staff at 8 pharmacies used ECP questionnaires for data collection. Six pharmacies determined the mystery patient’s reason for ECP request, thus indicating that 5 pharmacies supplied ECP without detailed information about the scenario. Overall, scenario 2 pharmacies performed better in data collection than did scenario 1 pharmacies.
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3 pharmacies provided comprehensive patient counseling, 4 pharmacies provided moderate counseling, and the remaining 4 pharmacies provided poor counseling. Information about the risk of ectopic pregnancy, the need to be tested for sexually transmitted infections, and the need for medical follow-up were commonly omitted during counseling, and only 1 pharmacist used a Consumer Medicine Information leaflet in the counseling process. Staff at 6 of the pharmacies determined that the ECP request was a result of suspected sexual assault (essential criteria), and 5 offered a referral to the police or another health professional. Overall, scenario 2 pharmacies performed better in the provision of counseling when compared with scenario 1 pharmacies.
Discussion Provision of advice Provision of advice involved giving of relevant medication information including details of dose, adverse effects, advice on management, risks of therapy, follow-up advice, written information, and essential criteria for the specific scenarios. Essential criteria for scenario 1 included information on long-term options for contraception (eg, the combined oral contraceptive pill), education on alternative contraceptive methods, and if not supplying the ECP some information on alternatives to nonprescription ECP (eg, obtaining a prescription from a doctor). The essential criteria for scenario 2 involved referral to the police to report suspected sexual assault and/or a referral to a sexual health clinic or doctor for support, testing of sexually transmittable infections and to follow-up on the drink-spiking claim. The ECP was supplied by only 2 scenario 1 pharmacies. Seven interactions involved a pharmacist in some capacity, whereas the remaining 5 interactions only involved pharmacy support staff. Four pharmacies provided moderate patient counseling, 2 of which supplied the ECP, and the staff at the remaining 8 pharmacies provided no counseling. Staff at 5 of the 10 pharmacies that refused supply advised the mystery patient to either return with or send the female requiring the ECP, whereas the remaining 5 pharmacies did not offer follow-up advice or an alternative to obtaining supply. Most scenario 2 pharmacies (10/11) involved pharmacists in the counseling process. The staff at
The pharmacy interactions were used to evaluate the management of ECP requests by pharmacists and pharmacy staff. The analyzed data provided valuable insight into pharmacy practice and suggested that there were specific identifiable service gaps among pharmacists and pharmacy staff. However, the impact of time pressures and financial burdens on the provision of pharmaceutical services needs to be acknowledged. In terms of history taking, none of the scenario 1 pharmacies and only 6 of the scenario 2 pharmacies obtained a complete patient history. These findings support national and international research, prompting consideration of credentialing pharmacists in the supply of the ECP17 and highlighting the need for specific pharmacist and pharmacy staff training in history taking. The scenario 2 pharmacies rated better than the scenario 1 pharmacies in terms of overall history taking. This outcome was somewhat expected because of the high rate of refusal to supply ECP for scenario 1 (10 of the 12 pharmacies refused to supply). The support staff from 5 of these pharmacies did not involve a pharmacist in their decision-making process. Although the outcome did not involve supply, the mystery patient should have been counseled about alternative options and ongoing management. Additionally, supplying to a third party is a legislative gray area and requires pharmacists’ input and judgment regarding appropriateness of supply, depending on the specific circumstances.18,19 The PSA standards and protocols covering nonprescription medicines
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indeed indicate that pharmacists are responsible for the safe and judicious use of nonprescription medicines.14,16 Patient education is a pivotal pharmacist role to promote the quality use of medicines. The PSA standards specify that pharmacists should work with consumers to provide tailored verbal and written information to ensure that consumers have sufficient knowledge and understanding of their medicines and therapeutic devices to facilitate safe and effective use.16 The counseling required with ECP supply is indeed more detailed than most other nonprescription products.14 However, the majority of both scenario 1 and 2 pharmacies did not provide comprehensive counseling. The results confirm previous research that highlighted pharmacists’ ECP counseling needed to improve 12,20-23 and that patients received better quality information when attending a clinical service.24-28 However, studies have highlighted that some female patients are uncomfortable with pharmacists providing detailed ECP counseling.11,13,25 In contrast, a study of pharmacists’ perceptions of their role when supplying the ECP indicated that they viewed it part of their role to counsel about future contraception and sexually transmitted infections.29 Nevertheless, most pharmacists in this study did not provide detailed counseling. Study limitations There is limited ability to generalize the results to all community pharmacies because the participants represented a relatively small sample of community pharmacy staff and the geographical area was limited. Pharmacies were visited only once, and circumstantial factors occurring on the particular day or time will have impacted on the services provided. A limitation of the mystery patient approach is that staff at the participating pharmacies could have expected the mystery patient visit and this could have influenced their behavior, the so-called Hawthorne effect.30 This effect was minimized through providing limited information during recruitment and conducting all of a specific scenario visits on the same business day. Additionally, although both mystery patients were trained and had experience, there was no mechanism undertaken to assess or ensure interrater reliability between them. The recording performance relied on the mystery patients’ recollection of interactions. To
minimize this limitation, the assessment tool was completed immediately after the interactions to maximize recall.
Conclusion Community pharmacy staff may not be sufficiently prepared for challenging ECP requests. Ongoing training is required to enhance the skills, competence, and confidence of pharmacy staff in managing complicated requests for nonprescription medicines, such as the ECP.29,30 More studies could enable development of training tools and support mechanisms to address identified practice shortcomings. Acknowledgments This project was supported by a Griffith Health Institute grant. The authors gratefully acknowledge the support from the 2 mystery patients, the input from the 7 focus group members, and the willingness of the 23 community pharmacies to participate. References 1. Health (Drugs and Poisons) Regulation 1996 (Qld), Office of the Queensland Parliamentary Counsel. Available at: http://www.legislation.qld.gov.au/LEGISLTN/ CURRENT/H/HealDrAPoR96.pdf/. Accessed 23.07.11. 2. Wisewoulds Lawyers correspondence to Pharmaceutical Defence Limited. The parameters of reporting a minor’s request to dispense MAP. 2005; July 26. 3. Position Statement: Ethical Issues in Declining to Supply. Canberra: Pharmaceutical Society of Australia; 2003. 4. Cooper RJ, Bissell P, Wingfield J. Ethical, religious and factual beliefs about the supply of emergency hormonal, contraception by UK community pharmacists. J Fam Plann Reprod Health Care 2008;34: 47–50. 5. Edited Minutes of National Drugs and Poisons Scheduling Committee Meeting 39-October 2003, Available at: http://www.tga.gov.au/ndpsc/record/ rr200310c.pdf/. Accessed 07.07.11. 6. International Consortium for Emergency Contraception. Available at: http://www.cecinfo.org/. Accessed 15.07.11. 7. Killick S, Irving G. A national study examining the effect of making emergency hormonal contraception available without prescription. Hum Reprod 2004;19: 553–557. 8. Fontes E, Guerreiro J, Costa T, Miranda A. Pattern of use of emergency oral contraception among Portuguese women. Pharm World Sci 2010;32:496–502.
Higgins & Hattingh / Research in Social and Administrative Pharmacy 9 (2013) 114–119 9. Harper CC, Weiss DC, Speidel JJ, Raine-Bennett T. Over-the-counter access to emergency contraception for teens. Contraception 2008;77:230–233. 10. Marston C, Meltzer H, Majeed A. Impact on contraceptive practice of making emergency hormonal contraception available over the counter in Great Britain: repeated cross sectional surveys. BMJ 2005;331:271–275. 11. Anderson C, Blenkinsopp A. Community pharmacy supply of emergency hormonal contraception: a structured literature review of international evidence. Hum Reprod 2006;21:272–284. 12. Gainer E, Blum J, Toverud E-L, et al. Bringing emergency contraception over the counter: experiences of nonprescription users in France, Norway, Sweden and Portugal. Contraception 2003;68: 117–124. 13. Hobbs MK, Taft AJ, Amir LH, et al. Pharmacy access to the emergency contraceptive pill: a national survey of a random sample of Australian women. Contraception 2011;83:151–158. 14. Direct Product Request Protocol. Supply of Levonorgestrel as a Pharmacist Only Medicine for Emergency Contraception (EC). 2008, Pharmaceutical Society of Australia. Available at: http://www.psa.org.au/supp orting-practice/professional-practice-standards/phar macist-only-medicines-s3-protocols/. Accessed 18. 04.11. 15. Watson MC, Norris P, Granas AG. A systematic review of the use of simulated patients and pharmacy practice research. Int J Pharm Pract 2006; 14:83–93. 16. Professional Practice Standards. 4th ed, 2010, Pharmaceutical Society of Australia. Available at: http://www.psa.org.au/supporting-practice/professio nal-practice-standards/. Accessed 15.07.11. 17. Standards for the Supply by Pharmacists of the Emergency Contraception Pill, Pharmacy Council of New Zealand, 2011. Available at: http://www. pharmacycouncil.org.nz/cms_show_download.php? id¼214/. Accessed 14.11.11. 18. Hattingh L, Forrester K, Smith N, Searle J. Pharmacy practice developments: the potential impact on pharmacists’ legal liability. J Law Med 2007;14: 297–402.
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