Int J Clin Pharm (2014) 36:604–614 DOI 10.1007/s11096-014-9944-7
RESEARCH ARTICLE
Provision of smoking cessation services in Australian community pharmacies: a simulated patient study Maya Saba • Jessica Diep • Renee Bittoun Bandana Saini
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Received: 14 November 2013 / Accepted: 31 March 2014 / Published online: 10 April 2014 Koninklijke Nederlandse Maatschappij ter bevordering der Pharmacie 2014
Abstract Background With the rising interest in expanding pharmacists’ role in smoking cessation, it is pertinent that community pharmacists be equipped with upto-date knowledge and competence to provide optimal therapeutic services that meet the demands of various presenting subsets of smokers. Objective To investigate and evaluate responses to requests of quitting smoking from ‘high risk’ smokers seeking assistance and treatment within the pharmacy venue. Setting Community pharmacies located within Sydney greater metropolitan area, New South Wales, Australia. Method A simulated patient methodology was utilised. Two scenarios were developed and enacted by two trained simulated patients in 100 randomly selected pharmacies. Scenario 1 involved a 28-yearold pregnant female who presents with a request for help in quitting smoking. Scenario 2 involved a 22-year-old female requesting a quit smoking product for her 55-year-old father who has cardiovascular problems. A standardised scoring key was designed to assess the performance of pharmacists during each encounter. Main outcome measure The primary outcome measure was the supply/non-supply
of nicotine replacement products and the corresponding provision of counselling and advice to facilitate smoking cessation. Results A product(s) was supplied in 42 % of the 100 encounters, while a product was adequately suggested pending doctor’s referral in 45 %. In 13 % of the cases, a product was not supplied based on inappropriate notions of nicotine replacement therapy not being safe in the presented scenario. Pharmacists performed better in dispensing scores (counselling about product use) as compared to pre-dispensing scores (eliciting patient history). ANOVA followed by regression analysis indicated that the estimated age and gender of the pharmacist/staff were significant predictors affecting total scores. Conclusion Whilst pharmacists’ counselling about smoking cessation aids seems satisfactory, further education is required to improve practice standards in terms of matching a patient’s history and smoking status to an appropriate product. Keywords Australia Counselling Nicotine replacement therapy Pharmacist Simulated patient Smoking cessation
Impact of findings on practice Electronic supplementary material The online version of this article (doi:10.1007/s11096-014-9944-7) contains supplementary material, which is available to authorized users. M. Saba (&) J. Diep B. Saini Faculty of Pharmacy, The University of Sydney, Pharmacy Building A15, Sydney, NSW 2006, Australia e-mail: [email protected] R. Bittoun Brain and Mind Research Institute, The University of Sydney, Pharmacy Building A15, Sydney, NSW 2006, Australia
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There are ‘gaps’ in pharmacists’ clinical history taking skills, awareness of current therapeutic evidence and confidence in recommending smoking cessation products. Further education and training are required to improve medical history taking skills and enhance pharmacists’ confidence of their perceived roles, both of which are essential for appropriate clinical decision-making and implementing evidence-based smoking cessation services.
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Introduction Smoking continues to be a leading preventable cause of mortality and morbidity globally [1]. Various strategies have been implemented by international health agencies [2], local governments [3] and healthcare professionals [4] to combat smoking. It is anticipated that in developed countries, where public health funds are being invested in such campaigns, smoking rates are declining [5]. Despite the decline, the prevalence of smoking continues to be a problem [6]. The profile of current smokers includes smokers who cannot quit unassisted or those have been unsuccessful in previous quit attempts, highly dependent smokers with a prospect of relapse and ‘vulnerable’ smokers with underlying medical conditions such as respiratory, cardiovascular and mental health diseases [7]. It is believed that those who are still smoking are possibly the ‘recalcitrant’ smokers who need specialised assistance to quit [7]. This recognition is underpinned by the World Health Organization’s International Classification of Diseases, where smoking is classified as a disease of dependence [8]. Contrary to previous clinical findings, current therapeutic evidence suggests that higher doses of nicotine replacement therapy (NRT) are more effective than lower doses, especially in highly dependent smokers. Additionally, the combination of more than one form of NRT has been proven to be significantly more effective as compared to single regimen approaches of NRT [9]. Current data also suggests that NRT can be administered to patients with stable cardiovascular conditions [10]. Whilst large randomised controlled trials are still required to evaluate smoking cessation during pregnancy, NRT is being recommended after failure of intense non-pharmacological measures, as the benefits of quitting outweigh the risks of continued smoking [11–13]. Community pharmacists can play an instrumental role in smoking cessation, especially since nicotine replacement products are available over-the-counter within pharmacies in most countries. Published systematic reviews, addressing smoking cessation programs in community pharmacy settings, demonstrate that trained community pharmacists, providing counselling and monitoring, can achieve improved smoking cessation rates [14–17]. In Australia, in 2011-12, the adult smoking rate was estimated to be 16.3 % [18]. This rate is much lower than several years ago, and quit attempt rates have been increasing [19]. It is believed, though, that a majority of smokers attempting to quit, are consistently underutilising NRT, in terms of both the recommended dosage and duration of therapy, and only a few smokers report receiving any support or advice [20, 21]. The pharmacy is a venue where many would seek assistance; yet again, service quality for smokers wishing to quit is unknown. In a previous Australian simulated patient study conducted in 2006, pharmacy-based smoking
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cessation interventions were found to be clinically suboptimal [22]. Moreover, the results of a recent clinical information needs analysis indicated ‘gaps’ in pharmacists’ practice of up-to-date smoking cessation services [23]. In light of the current therapeutic evidence, we anticipated that assessing community pharmacists’ awareness and confidence in providing smoking cessation services is crucial. This is of particular relevance to ‘high risk’ smokers, where smoking status confers additional risk, and it would be imperative for a health professional, presented with such smokers, to maximise the encounter and facilitate effective quit practices. Examples of commonly encountered ‘special needs’ smoker subgroups include pregnant women and patients with existing cardiovascular diseases (CVD) [24]. For instance, it is estimated that 14.5 % of Australian pregnant women and over 10 % of heart attack survivors are daily smokers [25, 26]. Current Australian guidelines suggest that pregnant women be offered intense support and proactive counselling for a trial period, after which NRT should be initiated, if the woman was unable to quit. In CVD patients, the optimal approach involves a combination of behavioural and pharmacotherapeutic interventions. However, in both scenarios, it is recommended that effective doses of pharmacotherapy be maintained and patients be monitored by a qualified healthcare professional [24]. Therefore, our study intended to explore the practice competence of community pharmacists in delivering effective smoking cessation interventions for these ‘higher risk’ patients.
Aim of the study The primary aim of this study was to investigate and evaluate pharmacy practice with respect to the supply of NRT and the provision of counselling in simulated pregnant and cardiovascular disease patients requesting help with quitting smoking.
Ethical approval This study was approved by the Human Research Ethics Committee at the University of Sydney, Australia (Project Number 2013/620).
Methods Study design A simulated patient (SP) method was utilised to determine how community pharmacists respond to a patient’s request for assistance with quitting smoking. The SP method, also
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known as pseudo-patron, pseudo-patient or mystery shopper method, involves a trained individual going into a pharmacy and enacting a particular scenario by requesting help from pharmacy staff, while being indiscernible from genuine patients [27]. This method has been extensively employed in Australian [28–31] and international [32–36] studies, evaluating various aspects of customer care provided by pharmacists throughout daily practice. Sample size Given that the primary aim of this study was to assess whether pharmacists provided NRT in 2 scenarios where NRT supply was the most appropriate action, we used this criteria to calculate our sample size. In the previous simulated patient study cited earlier [22], 10 % of the pharmacists did not supply a product. Estimating that this proportion may be 2.5 times higher in our case, i.e. in complicated pregnancy and cardiovascular scenarios, and using a power of 80 % and a 2-sided significance level of 5 %, sample size calculation indicated the enactment of 33 presentations per scenario. Accordingly, 50 pharmacies
were recruited for enacting each scenario, resulting in a total of 100 pharmacies being recruited in this study. Selection of pharmacies A list of 1,160 pharmacies was obtained from an Australian local business directory. The list was restricted to community pharmacies located within Sydney greater metropolitan area, New South Wales. A random sample of 150 pharmacies (100 ? 50 spare) was generated from the obtained list using the ‘RAND’ function in Microsoft Excel. The first 50 pharmacies were randomly allocated for scenario 1 and the second 50 for scenario 2. When a pharmacy could not be located or was no longer in business, it was replaced by a nearby chosen pharmacy from the spare 50 pharmacies within the subset (first 25 pharmacies for scenario 1 and second 25 for scenario 2). Simulated patient scenarios Two SP scenarios were employed and enacted by two different researchers. Both simulated patients received
Table 1 Simulated patient scenarios Details of SP encounter
General information
Key prompts
SP entering pharmacy and approaching dispensary
28-year-old femalea
Pregnant*
15-20 cigarettes/day for over 10 years
SP requesting to speak to pharmacist
First cigarette within half an hour of waking up with coffee
Aware of dangers of smoking on foetus and determined to quit
Scenario 1
SP tells pharmacist: ‘‘I want to buy a product for quitting smoking’’
Stress as the major smoking trigger
Tried quitting 2 years ago with first pregnancy without success
Smokes more during first hours of day
No treatments sought before
Smokes even when sick
No medical conditions/allergies/breastfeeding Taking prenatal vitamins and folic acid tablets daily
Scenario 2 SP entering pharmacy and approaching dispensary
55-year-old maleb
SP requesting to speak to pharmacist
First cigarette upon waking up straight away (before breakfast and coffee)
SP tells pharmacist: ‘‘I want to buy a product for quitting smoking’’
20-25 cigarettes/day for over 30 years
Driving as the major smoking trigger (works as company driver) Smokes more during first hours of day Smokes even when sick
Recent heart problems* (atherosclerosis, described in lay language as blocked arteries in the heart) Convinced to quit following doctor’s suggestion and family pressure Tried quitting few years ago upon being diagnosed with hypertension Nicotine gums previously tried, as suggested by doctor, without any success Medical history of hypertension No allergies Taking Aspirin, blood pressure and hyperlipidemia tablets daily
SP simulated patient a
The 28-year-old female was represented by simulated patient 1, who enacted scenario 1
b
The 55-year-old male represents the father of 22-year-old simulated patient 2, who enacted scenario 2
* It should be noted that pregnancy and the history of cardiovascular disease were not made obvious to the pharmacist. The SPs provided this information upon the pharmacist’s questioning or in cases when the pharmacist proceeded with counselling/dispensing without asking about medical history/reasons for quitting
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sufficient training in simulation methodology by senior experienced academics within the institution, before enacting the corresponding scenarios. Scenario 1 involved a 28-year-old female (author 1), in the initial weeks of pregnancy, who presented at the pharmacy, requesting assistance with smoking cessation. Scenario 2 involved a 22-year-old female (author 2) requesting a ‘quit smoking’ product for her 55-year-old father who has cardiovascular problems and about whom she was quite worried. Table 1 describes the SP scenarios in depth. In both scenarios, the SP requested to speak with the pharmacist; however, in situations when the pharmacist was not available or could not be accessed and a pharmacy staff member offered assistance instead, the same scenario was applicable and the information in Table 1 was provided in response to the staff’s directed questions. If not proactively suggested by the pharmacist, the SP in both scenarios was to enquire about the use of various nicotine replacement products. Simulated patient protocol A standardised data collection form was completed by the SP immediately after leaving the pharmacy to minimise the risk of recall bias. Besides integrating the scoring key, the data collection form allowed the SP to document visible/ obvious demographic information about the pharmacy busyness (based on number of customers), quality service accreditation (through display of the Quality Care in Pharmacy Program (QCPP) symbol), pharmacy type (banner/chain or independent) and the gender and estimated age of the pharmacist. The simulated patients accompanied each other during 8 (4 per scenario) pharmacy visits (8 %) to ensure consistency and validation of the simulation protocol and data recording process. Since immediate feedback to participants was not provided, the encounters were not audio recorded. All visits were conducted during opening hours of the pharmacies, mainly between 9am and 4 pm during August and September 2013, and were timed according to geographical closeness. Visited pharmacies were not advised of the research study. To ensure non-biased encounters and minimise the risk of social desirability bias, the protocol of this study did not require obtaining the previous consent of participants; this justification underpinned the ethical approval of the protocol [37]. Scoring criteria Pharmacists’ performance was scored along a comprehensive scale of outcomes, ranging from their ability to ask pertinent questions about the patient’s history and level of dependence (pre-clinical actions), to recommending an
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appropriate product and providing counselling (clinical actions). Figure 1 summarises the scoring key utilised to assess pharmacists’ performance. Both pre-clinical and clinical action scores were based on the Pharmaceutical Society of Australia’s standards for pharmacists’ provision of non-prescription medicines [38] and a previously developed scoring system for assessing community pharmacists’ counselling skills [39]. Assessment of level of dependence score was based on the two most commonly used items of the Fagerstro¨m Test for Nicotine Dependence [40]. In the presented cases, NRT provision was an appropriate action given the SPs’ high risk profile and nonsuccess with previous pharmacological and non-pharmacological methods. However, pharmacists, who at least highlighted the use of NRT but referred the patient to a doctor for further monitoring instead of supplying a product, were allocated a score for appropriate clinical actions. It was considered that such pharmacists demonstrated professionalism in requiring a ‘second medical opinion’, rather than erring when not confident. When a product was supplied, the dispensing score was dependent on the adequacy of the dispensing protocol and the counselling provided. Data analysis Collected data was analysed using SPSS version 21.0 (IBM, Armonk, NY, USA). For analysis purposes, the 2 scenarios were treated separately. Demographic data and scoring outcomes were analysed using descriptive statistics. Independent sample t-tests were utilised to compare performance scores between scenarios. With all statistical assumptions being met, one-way ANOVA was performed to assess the effect of various pharmacy and pharmacist demographic predictors on performance scores. Where required, post hoc analyses were adjusted for multiple comparisons using Tukey’s method. Additionally, given that the basic assumptions and the ‘rule of thumb’ sample size assumptions (n = 50) for regression were met [41], multiple linear regression models for each scenario were developed to explore the effects of significant predictors on obtained scoring outcomes.
Results A total of 100 community pharmacies were visited. Table 2 summarises the general demographic characteristics of visited pharmacies/pharmacists. Despite requesting to speak with the pharmacist, 4 % of the encounters were handled by a pharmacy staff member. Most pharmacies (87 %) did not have a dedicated labelled area/aisle for smoking cessation products.
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608 Fig. 1 Scoring key utilised for assessing pharmacists’ performance
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I. Pre-Clinical Actions for Smoking Cessation – Score A+B (/9) A. Eliciting Patient History – Score (/7) 1 mark each for asking about: 1. Product user? 2. Duration of smoking? 3. Reasons/factors behind deciding to quit?
B. Determining Patient Dependence Level – Score (/2) 1 mark each for asking about: 1. Number of cigarettes/day? 2. Time to first cigarette?
4. Medications/products tried in previous quit attempts? Efficacy? 5. Medical conditions/pregnancy/ breastfeeding? 6. Allerg ies? 7. Current medications?
II. Clinical Actions for Smoking Cessation – Score C+D (/9) C. Pharmacological Plan – Score (/6) Product(s) Dispensed Nicotine Replacement Product(s) dispensed
(6 marks)
No Product(s) Dispensed Product(s) suggested (Pending doctor’s referral or non pharmacologic measures)
(6 marks)
Product not safe in presented scenario
D. Non-Pharmacological Plan – Score (/3) 1 mark each for providing: 1. Lifestyle/behavioural advice
2. Follow-up monitoring
3. Supporting material (written information, quitline resources, etc.) (0 marks)
1 mark each for providing: 1. Adequate product? 2. Exact dose? 3. When to take dose? 4. Duration of therapy? 5. Instructions for use? 6. Adverse effects and smoking with NRT not contraindicated?
III. Total Performance Score – Score I+II (/18)
A single product was supplied in only 36 % of the visits (16 % in scenario 1 and 56 % in scenario 2), while a combination was dispensed in 6 % of the cases (2 % in scenario 1 and 10 % in scenario 2). A product was suggested, yet not supplied, pending doctor’s referral in 45 % of the encounters (60 % in scenario 1 and 30 % in scenario 2), even though NRT supply would have been appropriate. In 13 % of the visits though, a product was not supplied based on the inappropriate advice of NRT being not safe in the corresponding scenario (22 % in scenario 1 and 4 % scenario 2). Several interesting outcomes were also noted. For instance, most pharmacists (90 %) provided life-style advice and follow-up monitoring, while the provision of supporting material was more common in the cardiovascular scenario. Twenty-seven percent of the pharmacists
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advised the SP that NRT patches could be purchased through subsidised pricing via the Pharmaceutical Benefits Scheme with a medical prescription rather than purchasing them over-the-counter at the time of the encounter. Electronic cigarettes, acupuncture and hypnotherapy were also recommended by a few pharmacists as successful smoking cessation techniques. Surprisingly, one pharmacy staff member (not a pharmacist) pointed out that smoking could be continued throughout pregnancy, if going ‘cold turkey’ was hard, and that delivering a low-birth weight baby was the only adverse effect incurred. Table 3 presents mean total scores calculated and compares them between scenarios. Results indicated that pharmacists in both scenarios performed better in clinical actions as compared to pre-clinical actions. Additionally, the patient with CVD problems was better handled than the
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Table 2 General demographic data of visited pharmacies/pharmacists Demographics
Proportion
Overall proportion (n = 100)
Scenario 1 (n = 50)
Scenario 2 (n = 50)
Independent
27
27
54
Chain/banner
23
23
46
43
33
76
7
17
24
SEIFA scoresc Low (1–4)
14
9
23
Medium (5–7)
12
12
24
High (8–10)
24
29
53
Pharmacy typea
QCPP accreditation
b
Visible sign Non-visible sign
Estimated dispensary loadd Busy ([5)
3
5
8
Moderate (3–5)
20
9
29
Slow (1–2)
18
16
34
Quiet (nil)
9
20
29
46
50
96
4
0
4
Individual handling enquiry Pharmacist Pharmacy staff Pharmacist/staff estimated agee Graduate-34 years
28
24
52
35–50 years
18
21
39
4
5
9
Female
26
31
57
Male
24
19
43
[50 years Pharmacist/staff gender
Presence of labelled smoking cessation area Yes
5
8
13
No
45
42
87
QCPP Quality Care Pharmacy Program, SEIFA Socioeconomic Indexes for Areas a
Chain pharmacies operate like franchises with pharmacies operating under the same name. Banner pharmacies belong to a group but may have different names and policies. Both types are usually larger than independent pharmacies b Quality Care Pharmacy Program (QCPP) is a quality assurance program implemented by the Pharmacy Guild of Australia that provides support and guidance on professional health services and pharmacy business operations c
Socioeconomic Indexes for Areas (SEIFA 2011) is a product developed by the Australian Bureau of Statistics that ranks areas in Australia based on relative socioeconomic advantage and disadvantage. Higher scores correspond to more affluent areas
d
Dispensary load was determined by the number of customers, sitting and standing, waiting in the dispensary area
e
The age of the individual handling the enquiry was documented by the simulated patient through visual estimation
pregnant patient. Figure 2 illustrates the scoring along specific items for both scenarios. Table 4 and Table 1 of ESM outline the scores with respect to potential demographic predictors. In scenario 1 (pregnancy), ANOVA results indicated that the total performance score was significantly affected by QCPP sign visibility and having a male pharmacist handling the smoking cessation request. Pharmacists aged less than 35 years elicited patient history better as compared to older pharmacists, and male pharmacists/staff handled product dispensing better than
females. Similarly, in scenario 2 (CVD), estimated age was a potential predictor affecting the total performance score, with younger pharmacists performing better. In the multiple regression analysis, summarised in Table 2 of ESM and based on the significant associations presented in Table 4 and in Table 1 of ESM, age appeared as a significant predictor of preclinical scores, in scenario 1 (pregnancy), with younger pharmacists/staff achieving better results. Gender was also a significant variable affecting total performance scores in this scenario, with males performing better than females.
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Table 3 Total scores obtained for both scenarios
CI confidence interval Italic values correspond to statistically significant differences in scores between scenarios based on p value \0.05 using independent sample t tests
a
Mean total score (95 % CI)
Scenario 1
Scenario 2
Significance (p value)
Pre-clinical actions score (/9)
3.34 (2.85–3.83)
4.20 (3.60–4.80)
0.03
Eliciting patient history (/7)
2.12 (1.75–2.49)
2.86 (2.37–3.35)
0.02
Determining dependence level (/2)
1.22 (1.04–1.40)
1.34 (1.16–1.52)
0.35
5.91 (5.18–6.64)
6.54 (5.93–7.15)
0.19
4.51 (3.81–5.21)
4.64 (4.10–5.18)
0.77
Clinical actions score (/9) Pharmacological plan (/6) Non-pharmacological plan (/3) Total performance score (/18)
1.40 (1.19–1.61)
1.90 (1.64–2.17)
0.004
9.25 (8.21–10.29)
10.74 (9.74–11.70)
0.04
(Pre-clinical ? clinical actions scores)
b Pre-Clinical Actions – Determining Dependence Level
Pre-Clinical Actions – Eliciting History
50
50 45 40 Proportion 35 30 Asked 25 20 15 10 5 0
45 40 Proportion Asked 35 30 25
Scenario 1 (n=50)
Scenario 1 (n=50)
20
Scenario 2 (n=50)
Scenario 2 (n=50)
15 10 5 0 Number of Cigarettes/Day?
c 50 45 40 Proportion 35 Asked 30 25 20 15 10 5
d
Clinical Actions – Product(s) Supply
50 45 40 35 Proportion Provided 30 25 20 15 10 Scenario 1 (n=9) 5 Scenario 2 (n=33) 0
Time to First Cigarette?
Clinical Actions – Non-Pharmacological Measures
Scenario 1 (n=50) Scenario 2 (n=50)
0
Fig. 2 Proportions of individual items of various scoring outcomes
Discussion This study represents the first simulated patient study assessing community pharmacists’ response to requests for smoking cessation assistance by patients at high risk of adverse outcomes from smoking. The simulation was fabricated to depict highly dependent smokers, in whom previous attempts to quit
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with either non-pharmacological or pharmacological measures were unsuccessful. In both cases, NRT use, under medical supervision, would have been the most appropriate evidence-based action [24]. However, over half of the pharmacists failed to provide an appropriate product. Over 4 in 10 pharmacists also suggested that a product was appropriate, though they directed the patient to the doctor.
Int J Clin Pharm (2014) 36:604–614 Table 4 Analysis of variances results for total scores and possible predictors—Scenario 1
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Predictors
Mean score (95 % CI) Total pre-clinical actions score (/9)
Total clinical actions score (/9)
Total performance score (/18)
Independent
2.93 (2.38 to 3.48)
5.61 (4.56 to 6.67)
8.54 (7.17 to 9.91)
Chain/banner
3.83 (2.98 to 4.68)
6.26 (5.19 to 7.33)
10.09 (8.46 to 11.71)
Pharmacy type
Visibility of QCPP sign Visible
3.51 (2.98 to 4.04)
6.15 (5.41 to 6.89)
9.66 (8.61 to 10.71)
Non-visible
2.29 (1.10 to 3.56)
4.43 (1.37 to 7.49)
7.62 (2.73 to 10.70)
SEIFA scores Low
2.57 (2.03 to 3.11)
5.43 (3.94 to 6.92)
8.00 (6.25 to 9.75)
Medium
3.17 (1.66 to 4.67)
5.83 (4.04 to 7.63)
9.00 (6.25 to 11.75)
High
3.88 (3.21 to 4.54)
6.23 (5.17 to 7.29)
10.11 (8.61 to 11.60)
Busy
4.33 (-4.30 to 13.06)
6.00 (-2.61 to 14.61)
1.33 (-6.21 to 26.87)
Moderate
3.80 (3.03 to 4.57)
5.75 (4.47 to 7.04)
9.55 (7.79 to 11.31)
Slow
3.22 (2.47 to 3.98)
6.03 (4.99 to 7.07)
9.25 (7.83 to 10.67)
Quiet
2.22 (1.30 to 3.15)
6.00 (3.54 to 8.46)
8.22 (4.99 to 11.46)
Pharmacy busyness
Pharmacist/staff estimated age
CI confidence interval, QCPP Quality Care Pharmacy Program, SEIFA Socioeconomic Indexes for Areas Bold values in the table correspond to significant differences in scores across predictors based on p \ 0.05 using one way ANOVA
Graduate-34 years
3.64 (2.95 to 4.34)
6.21 (5.28 to 7.15)
9.85 (8.44 to 11.27)
35–50 years
3.28 (2.52 to 4.04
5.41 (4.00 to 6.83)
8.69 (6.84 to 10.55)
[50 years
1.50 (-0.09 to 3.09)
6.00 (1.69 to 10.31)
7.50 (2.55 to 12.45)
Pharmacist/staff gender Female
3.00 (2.26 to 3.74)
5.04 (3.87 to 6.21)
8.04 (6.45 to 9.63)
Male Presence of labelled smoking cessation area
3.71 (3.06 to 4.36)
6.85 (6.09 to 7.62)
10.56 (9.36 to 11.77)
Yes
3.40 (0.54 to 6.26)
5.60 (0.91 to 10.30)
9.00 (1.81 to 16.19)
No
3.33 (2.83 to 3.84)
5.94 (5.21 to 6.68)
9.27 (8.25 to 10.31)
The results highlight that many pharmacists lack the confidence in recommending NRT in such scenarios, preferring to defer clinical decision-making to their medical counterparts. Nevertheless, when a product was supplied, the counselling provided about product usage and the ongoing support offered were adequate. This research provides a clear insight into key areas for future improvement in pharmacybased practice of providing smoking cessation services. Given the availability of NRT over-the-counter in community pharmacies, competence in providing effective smoking cessation strategies should be an important area for pharmacists and pharmacy staff, both from public health and therapeutic perspectives. Areas for improvement and future training requirements should include better clinical history taking skills, improved awareness of current therapeutic evidence and enhanced confidence in recommending smoking cessation strategies/products for ‘high risk’ patients with pre-existing medical conditions. It was apparent that pharmacists were poorer at eliciting clinical/medical history as compared to dispensing a product. While many pharmacists probed for nicotine
dependence levels, few enquired about allergies, pregnancy, underlying conditions or current medications. These findings also substantiate the results of other simulated patient studies performed in different areas, all of which point towards pharmacists’ weaknesses in assessing patients’ medical history [29–31, 42]. Despite many studies suggesting that the professional practice paradigm needs to shift from products to services [43], it appears that ‘product supply’ is still a ‘comfort zone’ for many practitioners. Research demonstrates that pharmacists are better at service provision when dealing with direct product requests, as opposed to responding to patient symptoms [44]. However, eliciting clinical/medical history is a crucial element in therapeutic decision making and a key patient safety goal in various healthcare settings, including the ‘‘National Competency Standards Framework for Pharmacists in Australia’’ and ‘‘The Joint Commission’’ in the United States [45, 46]. Efforts should, thus, be directed to enhance pharmacists’ skills in this clinical area. Pharmacists’ confidence in dispensing a smoking cessation aid was another area of concern, particularly in the
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pregnancy scenario, where 60 % suggested referral to a physician rather than supplying a product; this represents a lost healthcare opportunity in converting a high risk smoker to an abstinent one. Lack of confidence may be attributed either to lack of training or lack of experience in applying clinical knowledge in new situations [47]. In a recent Australian needs analysis study, which aimed at exploring pharmacists’ knowledge about current smoking cessation practice, 80 % of pharmacists were aware of the safety of NRT in pregnancy [23]. However, it appears that this knowledge is not being successfully translated into practice. Another possible reason behind why community pharmacists may refer patients to physicians could be the reluctance of bypassing inter-professional boundaries, particularly in patients with conditions that require careful adjustment of therapy and ongoing scrutiny for possible adverse effects, as was the case in this study [48, 49]. With increased clinical decision making roles, such as the prescribing roles in place for appropriately qualified pharmacists in the United Kingdom [50], being able to make therapeutic decisions and liaising with medical colleagues with respect to situations such as pregnancy and existing disease conditions is important. Another issue may be pharmacists’ heavy reliance on standard medical databases, where nicotine products are listed as pregnancy ‘category D’, i.e. suspected to cause an increased incidence of human foetal malformations or irreversible damage. Hence, highly specialised skills are required to recognise what these categories actually imply and to understand that NRT could potentially lower the nicotine dose delivered to the foetus, as the nicotine plasma concentration achieved following NRT is much lower than that after cigarettes [51]. Clearly, this represents an area for undergraduate pharmacy training as well as continuing professional education. Age was shown to have a significant effect on performance, with younger pharmacists scoring better in eliciting medical history. This could be attributed to the recency of training/education rather than age itself. Data on the effect of age on pharmacists’ performance is conflicting. In some studies, younger pharmacists performed better [29, 52], while in others, older pharmacists with more experience achieved better results [53]. Furthermore, an unexpected predictor was the gender of the pharmacist, with males obtaining higher scores in the pregnancy scenario. It should be noted that this study, like other simulated patient studies, assesses for particular behaviours and, thus, represents an idealisation of practice. Therefore, results should be interpreted with caution in real life practice, where pharmacists may be limited in context of the demands, patients and situations that they may encounter. Whilst pharmacists’ performance in the pregnancy scenario was somewhat disappointing, we should acknowledge that
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there are no clear cut guidelines for the provision of NRT to pregnant women covered by professional training. It is also well-known that pharmacists’ prescribing activities are rule-abiding, and this should be accounted for when judging performance. Other limitations include the fact that the considered scenarios were highly specific, and results, thus, may not be generalisable to other scenarios presented in Australian community pharmacies. Only pharmacies located within the designated geographical location were visited. Additionally, the scoring criteria were based on Australian standards and adapted from previous studies. Even though a standardised data collection form was employed and immediate recording of data (within 10 min) was considered, the risk of recall bias cannot be completely eliminated. Pharmacy/pharmacist demographics were also observed and estimated rather than actually obtained.
Conclusion Community pharmacists’ overall skills in providing smoking cessation services were somewhat inadequate. Further education and training are required to improve clinical/medical history taking skills and enhance pharmacists’ confidence of their perceived roles, both of which are essential for appropriate clinical decision-making. Whilst current evidence confirms that pharmacists can play a role in improving abstinence outcomes when delivering specialised services, handling of complex situations in chance encounters with current smokers could be significantly improved. Acknowledgments Funding
None.
None.
Conflicts of interest The authors have no conflicts of interest to declare.
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RESEARCH ARTICLE
Provision of smoking cessation services in Australian community pharmacies: a simulated patient study Maya Saba • Jessica Diep • Renee Bittoun Bandana Saini
•
Received: 14 November 2013 / Accepted: 31 March 2014 / Published online: 10 April 2014 Koninklijke Nederlandse Maatschappij ter bevordering der Pharmacie 2014
Abstract Background With the rising interest in expanding pharmacists’ role in smoking cessation, it is pertinent that community pharmacists be equipped with upto-date knowledge and competence to provide optimal therapeutic services that meet the demands of various presenting subsets of smokers. Objective To investigate and evaluate responses to requests of quitting smoking from ‘high risk’ smokers seeking assistance and treatment within the pharmacy venue. Setting Community pharmacies located within Sydney greater metropolitan area, New South Wales, Australia. Method A simulated patient methodology was utilised. Two scenarios were developed and enacted by two trained simulated patients in 100 randomly selected pharmacies. Scenario 1 involved a 28-yearold pregnant female who presents with a request for help in quitting smoking. Scenario 2 involved a 22-year-old female requesting a quit smoking product for her 55-year-old father who has cardiovascular problems. A standardised scoring key was designed to assess the performance of pharmacists during each encounter. Main outcome measure The primary outcome measure was the supply/non-supply
of nicotine replacement products and the corresponding provision of counselling and advice to facilitate smoking cessation. Results A product(s) was supplied in 42 % of the 100 encounters, while a product was adequately suggested pending doctor’s referral in 45 %. In 13 % of the cases, a product was not supplied based on inappropriate notions of nicotine replacement therapy not being safe in the presented scenario. Pharmacists performed better in dispensing scores (counselling about product use) as compared to pre-dispensing scores (eliciting patient history). ANOVA followed by regression analysis indicated that the estimated age and gender of the pharmacist/staff were significant predictors affecting total scores. Conclusion Whilst pharmacists’ counselling about smoking cessation aids seems satisfactory, further education is required to improve practice standards in terms of matching a patient’s history and smoking status to an appropriate product. Keywords Australia Counselling Nicotine replacement therapy Pharmacist Simulated patient Smoking cessation
Impact of findings on practice Electronic supplementary material The online version of this article (doi:10.1007/s11096-014-9944-7) contains supplementary material, which is available to authorized users. M. Saba (&) J. Diep B. Saini Faculty of Pharmacy, The University of Sydney, Pharmacy Building A15, Sydney, NSW 2006, Australia e-mail: [email protected] R. Bittoun Brain and Mind Research Institute, The University of Sydney, Pharmacy Building A15, Sydney, NSW 2006, Australia
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There are ‘gaps’ in pharmacists’ clinical history taking skills, awareness of current therapeutic evidence and confidence in recommending smoking cessation products. Further education and training are required to improve medical history taking skills and enhance pharmacists’ confidence of their perceived roles, both of which are essential for appropriate clinical decision-making and implementing evidence-based smoking cessation services.
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Introduction Smoking continues to be a leading preventable cause of mortality and morbidity globally [1]. Various strategies have been implemented by international health agencies [2], local governments [3] and healthcare professionals [4] to combat smoking. It is anticipated that in developed countries, where public health funds are being invested in such campaigns, smoking rates are declining [5]. Despite the decline, the prevalence of smoking continues to be a problem [6]. The profile of current smokers includes smokers who cannot quit unassisted or those have been unsuccessful in previous quit attempts, highly dependent smokers with a prospect of relapse and ‘vulnerable’ smokers with underlying medical conditions such as respiratory, cardiovascular and mental health diseases [7]. It is believed that those who are still smoking are possibly the ‘recalcitrant’ smokers who need specialised assistance to quit [7]. This recognition is underpinned by the World Health Organization’s International Classification of Diseases, where smoking is classified as a disease of dependence [8]. Contrary to previous clinical findings, current therapeutic evidence suggests that higher doses of nicotine replacement therapy (NRT) are more effective than lower doses, especially in highly dependent smokers. Additionally, the combination of more than one form of NRT has been proven to be significantly more effective as compared to single regimen approaches of NRT [9]. Current data also suggests that NRT can be administered to patients with stable cardiovascular conditions [10]. Whilst large randomised controlled trials are still required to evaluate smoking cessation during pregnancy, NRT is being recommended after failure of intense non-pharmacological measures, as the benefits of quitting outweigh the risks of continued smoking [11–13]. Community pharmacists can play an instrumental role in smoking cessation, especially since nicotine replacement products are available over-the-counter within pharmacies in most countries. Published systematic reviews, addressing smoking cessation programs in community pharmacy settings, demonstrate that trained community pharmacists, providing counselling and monitoring, can achieve improved smoking cessation rates [14–17]. In Australia, in 2011-12, the adult smoking rate was estimated to be 16.3 % [18]. This rate is much lower than several years ago, and quit attempt rates have been increasing [19]. It is believed, though, that a majority of smokers attempting to quit, are consistently underutilising NRT, in terms of both the recommended dosage and duration of therapy, and only a few smokers report receiving any support or advice [20, 21]. The pharmacy is a venue where many would seek assistance; yet again, service quality for smokers wishing to quit is unknown. In a previous Australian simulated patient study conducted in 2006, pharmacy-based smoking
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cessation interventions were found to be clinically suboptimal [22]. Moreover, the results of a recent clinical information needs analysis indicated ‘gaps’ in pharmacists’ practice of up-to-date smoking cessation services [23]. In light of the current therapeutic evidence, we anticipated that assessing community pharmacists’ awareness and confidence in providing smoking cessation services is crucial. This is of particular relevance to ‘high risk’ smokers, where smoking status confers additional risk, and it would be imperative for a health professional, presented with such smokers, to maximise the encounter and facilitate effective quit practices. Examples of commonly encountered ‘special needs’ smoker subgroups include pregnant women and patients with existing cardiovascular diseases (CVD) [24]. For instance, it is estimated that 14.5 % of Australian pregnant women and over 10 % of heart attack survivors are daily smokers [25, 26]. Current Australian guidelines suggest that pregnant women be offered intense support and proactive counselling for a trial period, after which NRT should be initiated, if the woman was unable to quit. In CVD patients, the optimal approach involves a combination of behavioural and pharmacotherapeutic interventions. However, in both scenarios, it is recommended that effective doses of pharmacotherapy be maintained and patients be monitored by a qualified healthcare professional [24]. Therefore, our study intended to explore the practice competence of community pharmacists in delivering effective smoking cessation interventions for these ‘higher risk’ patients.
Aim of the study The primary aim of this study was to investigate and evaluate pharmacy practice with respect to the supply of NRT and the provision of counselling in simulated pregnant and cardiovascular disease patients requesting help with quitting smoking.
Ethical approval This study was approved by the Human Research Ethics Committee at the University of Sydney, Australia (Project Number 2013/620).
Methods Study design A simulated patient (SP) method was utilised to determine how community pharmacists respond to a patient’s request for assistance with quitting smoking. The SP method, also
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known as pseudo-patron, pseudo-patient or mystery shopper method, involves a trained individual going into a pharmacy and enacting a particular scenario by requesting help from pharmacy staff, while being indiscernible from genuine patients [27]. This method has been extensively employed in Australian [28–31] and international [32–36] studies, evaluating various aspects of customer care provided by pharmacists throughout daily practice. Sample size Given that the primary aim of this study was to assess whether pharmacists provided NRT in 2 scenarios where NRT supply was the most appropriate action, we used this criteria to calculate our sample size. In the previous simulated patient study cited earlier [22], 10 % of the pharmacists did not supply a product. Estimating that this proportion may be 2.5 times higher in our case, i.e. in complicated pregnancy and cardiovascular scenarios, and using a power of 80 % and a 2-sided significance level of 5 %, sample size calculation indicated the enactment of 33 presentations per scenario. Accordingly, 50 pharmacies
were recruited for enacting each scenario, resulting in a total of 100 pharmacies being recruited in this study. Selection of pharmacies A list of 1,160 pharmacies was obtained from an Australian local business directory. The list was restricted to community pharmacies located within Sydney greater metropolitan area, New South Wales. A random sample of 150 pharmacies (100 ? 50 spare) was generated from the obtained list using the ‘RAND’ function in Microsoft Excel. The first 50 pharmacies were randomly allocated for scenario 1 and the second 50 for scenario 2. When a pharmacy could not be located or was no longer in business, it was replaced by a nearby chosen pharmacy from the spare 50 pharmacies within the subset (first 25 pharmacies for scenario 1 and second 25 for scenario 2). Simulated patient scenarios Two SP scenarios were employed and enacted by two different researchers. Both simulated patients received
Table 1 Simulated patient scenarios Details of SP encounter
General information
Key prompts
SP entering pharmacy and approaching dispensary
28-year-old femalea
Pregnant*
15-20 cigarettes/day for over 10 years
SP requesting to speak to pharmacist
First cigarette within half an hour of waking up with coffee
Aware of dangers of smoking on foetus and determined to quit
Scenario 1
SP tells pharmacist: ‘‘I want to buy a product for quitting smoking’’
Stress as the major smoking trigger
Tried quitting 2 years ago with first pregnancy without success
Smokes more during first hours of day
No treatments sought before
Smokes even when sick
No medical conditions/allergies/breastfeeding Taking prenatal vitamins and folic acid tablets daily
Scenario 2 SP entering pharmacy and approaching dispensary
55-year-old maleb
SP requesting to speak to pharmacist
First cigarette upon waking up straight away (before breakfast and coffee)
SP tells pharmacist: ‘‘I want to buy a product for quitting smoking’’
20-25 cigarettes/day for over 30 years
Driving as the major smoking trigger (works as company driver) Smokes more during first hours of day Smokes even when sick
Recent heart problems* (atherosclerosis, described in lay language as blocked arteries in the heart) Convinced to quit following doctor’s suggestion and family pressure Tried quitting few years ago upon being diagnosed with hypertension Nicotine gums previously tried, as suggested by doctor, without any success Medical history of hypertension No allergies Taking Aspirin, blood pressure and hyperlipidemia tablets daily
SP simulated patient a
The 28-year-old female was represented by simulated patient 1, who enacted scenario 1
b
The 55-year-old male represents the father of 22-year-old simulated patient 2, who enacted scenario 2
* It should be noted that pregnancy and the history of cardiovascular disease were not made obvious to the pharmacist. The SPs provided this information upon the pharmacist’s questioning or in cases when the pharmacist proceeded with counselling/dispensing without asking about medical history/reasons for quitting
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sufficient training in simulation methodology by senior experienced academics within the institution, before enacting the corresponding scenarios. Scenario 1 involved a 28-year-old female (author 1), in the initial weeks of pregnancy, who presented at the pharmacy, requesting assistance with smoking cessation. Scenario 2 involved a 22-year-old female (author 2) requesting a ‘quit smoking’ product for her 55-year-old father who has cardiovascular problems and about whom she was quite worried. Table 1 describes the SP scenarios in depth. In both scenarios, the SP requested to speak with the pharmacist; however, in situations when the pharmacist was not available or could not be accessed and a pharmacy staff member offered assistance instead, the same scenario was applicable and the information in Table 1 was provided in response to the staff’s directed questions. If not proactively suggested by the pharmacist, the SP in both scenarios was to enquire about the use of various nicotine replacement products. Simulated patient protocol A standardised data collection form was completed by the SP immediately after leaving the pharmacy to minimise the risk of recall bias. Besides integrating the scoring key, the data collection form allowed the SP to document visible/ obvious demographic information about the pharmacy busyness (based on number of customers), quality service accreditation (through display of the Quality Care in Pharmacy Program (QCPP) symbol), pharmacy type (banner/chain or independent) and the gender and estimated age of the pharmacist. The simulated patients accompanied each other during 8 (4 per scenario) pharmacy visits (8 %) to ensure consistency and validation of the simulation protocol and data recording process. Since immediate feedback to participants was not provided, the encounters were not audio recorded. All visits were conducted during opening hours of the pharmacies, mainly between 9am and 4 pm during August and September 2013, and were timed according to geographical closeness. Visited pharmacies were not advised of the research study. To ensure non-biased encounters and minimise the risk of social desirability bias, the protocol of this study did not require obtaining the previous consent of participants; this justification underpinned the ethical approval of the protocol [37]. Scoring criteria Pharmacists’ performance was scored along a comprehensive scale of outcomes, ranging from their ability to ask pertinent questions about the patient’s history and level of dependence (pre-clinical actions), to recommending an
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appropriate product and providing counselling (clinical actions). Figure 1 summarises the scoring key utilised to assess pharmacists’ performance. Both pre-clinical and clinical action scores were based on the Pharmaceutical Society of Australia’s standards for pharmacists’ provision of non-prescription medicines [38] and a previously developed scoring system for assessing community pharmacists’ counselling skills [39]. Assessment of level of dependence score was based on the two most commonly used items of the Fagerstro¨m Test for Nicotine Dependence [40]. In the presented cases, NRT provision was an appropriate action given the SPs’ high risk profile and nonsuccess with previous pharmacological and non-pharmacological methods. However, pharmacists, who at least highlighted the use of NRT but referred the patient to a doctor for further monitoring instead of supplying a product, were allocated a score for appropriate clinical actions. It was considered that such pharmacists demonstrated professionalism in requiring a ‘second medical opinion’, rather than erring when not confident. When a product was supplied, the dispensing score was dependent on the adequacy of the dispensing protocol and the counselling provided. Data analysis Collected data was analysed using SPSS version 21.0 (IBM, Armonk, NY, USA). For analysis purposes, the 2 scenarios were treated separately. Demographic data and scoring outcomes were analysed using descriptive statistics. Independent sample t-tests were utilised to compare performance scores between scenarios. With all statistical assumptions being met, one-way ANOVA was performed to assess the effect of various pharmacy and pharmacist demographic predictors on performance scores. Where required, post hoc analyses were adjusted for multiple comparisons using Tukey’s method. Additionally, given that the basic assumptions and the ‘rule of thumb’ sample size assumptions (n = 50) for regression were met [41], multiple linear regression models for each scenario were developed to explore the effects of significant predictors on obtained scoring outcomes.
Results A total of 100 community pharmacies were visited. Table 2 summarises the general demographic characteristics of visited pharmacies/pharmacists. Despite requesting to speak with the pharmacist, 4 % of the encounters were handled by a pharmacy staff member. Most pharmacies (87 %) did not have a dedicated labelled area/aisle for smoking cessation products.
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608 Fig. 1 Scoring key utilised for assessing pharmacists’ performance
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I. Pre-Clinical Actions for Smoking Cessation – Score A+B (/9) A. Eliciting Patient History – Score (/7) 1 mark each for asking about: 1. Product user? 2. Duration of smoking? 3. Reasons/factors behind deciding to quit?
B. Determining Patient Dependence Level – Score (/2) 1 mark each for asking about: 1. Number of cigarettes/day? 2. Time to first cigarette?
4. Medications/products tried in previous quit attempts? Efficacy? 5. Medical conditions/pregnancy/ breastfeeding? 6. Allerg ies? 7. Current medications?
II. Clinical Actions for Smoking Cessation – Score C+D (/9) C. Pharmacological Plan – Score (/6) Product(s) Dispensed Nicotine Replacement Product(s) dispensed
(6 marks)
No Product(s) Dispensed Product(s) suggested (Pending doctor’s referral or non pharmacologic measures)
(6 marks)
Product not safe in presented scenario
D. Non-Pharmacological Plan – Score (/3) 1 mark each for providing: 1. Lifestyle/behavioural advice
2. Follow-up monitoring
3. Supporting material (written information, quitline resources, etc.) (0 marks)
1 mark each for providing: 1. Adequate product? 2. Exact dose? 3. When to take dose? 4. Duration of therapy? 5. Instructions for use? 6. Adverse effects and smoking with NRT not contraindicated?
III. Total Performance Score – Score I+II (/18)
A single product was supplied in only 36 % of the visits (16 % in scenario 1 and 56 % in scenario 2), while a combination was dispensed in 6 % of the cases (2 % in scenario 1 and 10 % in scenario 2). A product was suggested, yet not supplied, pending doctor’s referral in 45 % of the encounters (60 % in scenario 1 and 30 % in scenario 2), even though NRT supply would have been appropriate. In 13 % of the visits though, a product was not supplied based on the inappropriate advice of NRT being not safe in the corresponding scenario (22 % in scenario 1 and 4 % scenario 2). Several interesting outcomes were also noted. For instance, most pharmacists (90 %) provided life-style advice and follow-up monitoring, while the provision of supporting material was more common in the cardiovascular scenario. Twenty-seven percent of the pharmacists
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advised the SP that NRT patches could be purchased through subsidised pricing via the Pharmaceutical Benefits Scheme with a medical prescription rather than purchasing them over-the-counter at the time of the encounter. Electronic cigarettes, acupuncture and hypnotherapy were also recommended by a few pharmacists as successful smoking cessation techniques. Surprisingly, one pharmacy staff member (not a pharmacist) pointed out that smoking could be continued throughout pregnancy, if going ‘cold turkey’ was hard, and that delivering a low-birth weight baby was the only adverse effect incurred. Table 3 presents mean total scores calculated and compares them between scenarios. Results indicated that pharmacists in both scenarios performed better in clinical actions as compared to pre-clinical actions. Additionally, the patient with CVD problems was better handled than the
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Table 2 General demographic data of visited pharmacies/pharmacists Demographics
Proportion
Overall proportion (n = 100)
Scenario 1 (n = 50)
Scenario 2 (n = 50)
Independent
27
27
54
Chain/banner
23
23
46
43
33
76
7
17
24
SEIFA scoresc Low (1–4)
14
9
23
Medium (5–7)
12
12
24
High (8–10)
24
29
53
Pharmacy typea
QCPP accreditation
b
Visible sign Non-visible sign
Estimated dispensary loadd Busy ([5)
3
5
8
Moderate (3–5)
20
9
29
Slow (1–2)
18
16
34
Quiet (nil)
9
20
29
46
50
96
4
0
4
Individual handling enquiry Pharmacist Pharmacy staff Pharmacist/staff estimated agee Graduate-34 years
28
24
52
35–50 years
18
21
39
4
5
9
Female
26
31
57
Male
24
19
43
[50 years Pharmacist/staff gender
Presence of labelled smoking cessation area Yes
5
8
13
No
45
42
87
QCPP Quality Care Pharmacy Program, SEIFA Socioeconomic Indexes for Areas a
Chain pharmacies operate like franchises with pharmacies operating under the same name. Banner pharmacies belong to a group but may have different names and policies. Both types are usually larger than independent pharmacies b Quality Care Pharmacy Program (QCPP) is a quality assurance program implemented by the Pharmacy Guild of Australia that provides support and guidance on professional health services and pharmacy business operations c
Socioeconomic Indexes for Areas (SEIFA 2011) is a product developed by the Australian Bureau of Statistics that ranks areas in Australia based on relative socioeconomic advantage and disadvantage. Higher scores correspond to more affluent areas
d
Dispensary load was determined by the number of customers, sitting and standing, waiting in the dispensary area
e
The age of the individual handling the enquiry was documented by the simulated patient through visual estimation
pregnant patient. Figure 2 illustrates the scoring along specific items for both scenarios. Table 4 and Table 1 of ESM outline the scores with respect to potential demographic predictors. In scenario 1 (pregnancy), ANOVA results indicated that the total performance score was significantly affected by QCPP sign visibility and having a male pharmacist handling the smoking cessation request. Pharmacists aged less than 35 years elicited patient history better as compared to older pharmacists, and male pharmacists/staff handled product dispensing better than
females. Similarly, in scenario 2 (CVD), estimated age was a potential predictor affecting the total performance score, with younger pharmacists performing better. In the multiple regression analysis, summarised in Table 2 of ESM and based on the significant associations presented in Table 4 and in Table 1 of ESM, age appeared as a significant predictor of preclinical scores, in scenario 1 (pregnancy), with younger pharmacists/staff achieving better results. Gender was also a significant variable affecting total performance scores in this scenario, with males performing better than females.
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Table 3 Total scores obtained for both scenarios
CI confidence interval Italic values correspond to statistically significant differences in scores between scenarios based on p value \0.05 using independent sample t tests
a
Mean total score (95 % CI)
Scenario 1
Scenario 2
Significance (p value)
Pre-clinical actions score (/9)
3.34 (2.85–3.83)
4.20 (3.60–4.80)
0.03
Eliciting patient history (/7)
2.12 (1.75–2.49)
2.86 (2.37–3.35)
0.02
Determining dependence level (/2)
1.22 (1.04–1.40)
1.34 (1.16–1.52)
0.35
5.91 (5.18–6.64)
6.54 (5.93–7.15)
0.19
4.51 (3.81–5.21)
4.64 (4.10–5.18)
0.77
Clinical actions score (/9) Pharmacological plan (/6) Non-pharmacological plan (/3) Total performance score (/18)
1.40 (1.19–1.61)
1.90 (1.64–2.17)
0.004
9.25 (8.21–10.29)
10.74 (9.74–11.70)
0.04
(Pre-clinical ? clinical actions scores)
b Pre-Clinical Actions – Determining Dependence Level
Pre-Clinical Actions – Eliciting History
50
50 45 40 Proportion 35 30 Asked 25 20 15 10 5 0
45 40 Proportion Asked 35 30 25
Scenario 1 (n=50)
Scenario 1 (n=50)
20
Scenario 2 (n=50)
Scenario 2 (n=50)
15 10 5 0 Number of Cigarettes/Day?
c 50 45 40 Proportion 35 Asked 30 25 20 15 10 5
d
Clinical Actions – Product(s) Supply
50 45 40 35 Proportion Provided 30 25 20 15 10 Scenario 1 (n=9) 5 Scenario 2 (n=33) 0
Time to First Cigarette?
Clinical Actions – Non-Pharmacological Measures
Scenario 1 (n=50) Scenario 2 (n=50)
0
Fig. 2 Proportions of individual items of various scoring outcomes
Discussion This study represents the first simulated patient study assessing community pharmacists’ response to requests for smoking cessation assistance by patients at high risk of adverse outcomes from smoking. The simulation was fabricated to depict highly dependent smokers, in whom previous attempts to quit
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with either non-pharmacological or pharmacological measures were unsuccessful. In both cases, NRT use, under medical supervision, would have been the most appropriate evidence-based action [24]. However, over half of the pharmacists failed to provide an appropriate product. Over 4 in 10 pharmacists also suggested that a product was appropriate, though they directed the patient to the doctor.
Int J Clin Pharm (2014) 36:604–614 Table 4 Analysis of variances results for total scores and possible predictors—Scenario 1
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Predictors
Mean score (95 % CI) Total pre-clinical actions score (/9)
Total clinical actions score (/9)
Total performance score (/18)
Independent
2.93 (2.38 to 3.48)
5.61 (4.56 to 6.67)
8.54 (7.17 to 9.91)
Chain/banner
3.83 (2.98 to 4.68)
6.26 (5.19 to 7.33)
10.09 (8.46 to 11.71)
Pharmacy type
Visibility of QCPP sign Visible
3.51 (2.98 to 4.04)
6.15 (5.41 to 6.89)
9.66 (8.61 to 10.71)
Non-visible
2.29 (1.10 to 3.56)
4.43 (1.37 to 7.49)
7.62 (2.73 to 10.70)
SEIFA scores Low
2.57 (2.03 to 3.11)
5.43 (3.94 to 6.92)
8.00 (6.25 to 9.75)
Medium
3.17 (1.66 to 4.67)
5.83 (4.04 to 7.63)
9.00 (6.25 to 11.75)
High
3.88 (3.21 to 4.54)
6.23 (5.17 to 7.29)
10.11 (8.61 to 11.60)
Busy
4.33 (-4.30 to 13.06)
6.00 (-2.61 to 14.61)
1.33 (-6.21 to 26.87)
Moderate
3.80 (3.03 to 4.57)
5.75 (4.47 to 7.04)
9.55 (7.79 to 11.31)
Slow
3.22 (2.47 to 3.98)
6.03 (4.99 to 7.07)
9.25 (7.83 to 10.67)
Quiet
2.22 (1.30 to 3.15)
6.00 (3.54 to 8.46)
8.22 (4.99 to 11.46)
Pharmacy busyness
Pharmacist/staff estimated age
CI confidence interval, QCPP Quality Care Pharmacy Program, SEIFA Socioeconomic Indexes for Areas Bold values in the table correspond to significant differences in scores across predictors based on p \ 0.05 using one way ANOVA
Graduate-34 years
3.64 (2.95 to 4.34)
6.21 (5.28 to 7.15)
9.85 (8.44 to 11.27)
35–50 years
3.28 (2.52 to 4.04
5.41 (4.00 to 6.83)
8.69 (6.84 to 10.55)
[50 years
1.50 (-0.09 to 3.09)
6.00 (1.69 to 10.31)
7.50 (2.55 to 12.45)
Pharmacist/staff gender Female
3.00 (2.26 to 3.74)
5.04 (3.87 to 6.21)
8.04 (6.45 to 9.63)
Male Presence of labelled smoking cessation area
3.71 (3.06 to 4.36)
6.85 (6.09 to 7.62)
10.56 (9.36 to 11.77)
Yes
3.40 (0.54 to 6.26)
5.60 (0.91 to 10.30)
9.00 (1.81 to 16.19)
No
3.33 (2.83 to 3.84)
5.94 (5.21 to 6.68)
9.27 (8.25 to 10.31)
The results highlight that many pharmacists lack the confidence in recommending NRT in such scenarios, preferring to defer clinical decision-making to their medical counterparts. Nevertheless, when a product was supplied, the counselling provided about product usage and the ongoing support offered were adequate. This research provides a clear insight into key areas for future improvement in pharmacybased practice of providing smoking cessation services. Given the availability of NRT over-the-counter in community pharmacies, competence in providing effective smoking cessation strategies should be an important area for pharmacists and pharmacy staff, both from public health and therapeutic perspectives. Areas for improvement and future training requirements should include better clinical history taking skills, improved awareness of current therapeutic evidence and enhanced confidence in recommending smoking cessation strategies/products for ‘high risk’ patients with pre-existing medical conditions. It was apparent that pharmacists were poorer at eliciting clinical/medical history as compared to dispensing a product. While many pharmacists probed for nicotine
dependence levels, few enquired about allergies, pregnancy, underlying conditions or current medications. These findings also substantiate the results of other simulated patient studies performed in different areas, all of which point towards pharmacists’ weaknesses in assessing patients’ medical history [29–31, 42]. Despite many studies suggesting that the professional practice paradigm needs to shift from products to services [43], it appears that ‘product supply’ is still a ‘comfort zone’ for many practitioners. Research demonstrates that pharmacists are better at service provision when dealing with direct product requests, as opposed to responding to patient symptoms [44]. However, eliciting clinical/medical history is a crucial element in therapeutic decision making and a key patient safety goal in various healthcare settings, including the ‘‘National Competency Standards Framework for Pharmacists in Australia’’ and ‘‘The Joint Commission’’ in the United States [45, 46]. Efforts should, thus, be directed to enhance pharmacists’ skills in this clinical area. Pharmacists’ confidence in dispensing a smoking cessation aid was another area of concern, particularly in the
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pregnancy scenario, where 60 % suggested referral to a physician rather than supplying a product; this represents a lost healthcare opportunity in converting a high risk smoker to an abstinent one. Lack of confidence may be attributed either to lack of training or lack of experience in applying clinical knowledge in new situations [47]. In a recent Australian needs analysis study, which aimed at exploring pharmacists’ knowledge about current smoking cessation practice, 80 % of pharmacists were aware of the safety of NRT in pregnancy [23]. However, it appears that this knowledge is not being successfully translated into practice. Another possible reason behind why community pharmacists may refer patients to physicians could be the reluctance of bypassing inter-professional boundaries, particularly in patients with conditions that require careful adjustment of therapy and ongoing scrutiny for possible adverse effects, as was the case in this study [48, 49]. With increased clinical decision making roles, such as the prescribing roles in place for appropriately qualified pharmacists in the United Kingdom [50], being able to make therapeutic decisions and liaising with medical colleagues with respect to situations such as pregnancy and existing disease conditions is important. Another issue may be pharmacists’ heavy reliance on standard medical databases, where nicotine products are listed as pregnancy ‘category D’, i.e. suspected to cause an increased incidence of human foetal malformations or irreversible damage. Hence, highly specialised skills are required to recognise what these categories actually imply and to understand that NRT could potentially lower the nicotine dose delivered to the foetus, as the nicotine plasma concentration achieved following NRT is much lower than that after cigarettes [51]. Clearly, this represents an area for undergraduate pharmacy training as well as continuing professional education. Age was shown to have a significant effect on performance, with younger pharmacists scoring better in eliciting medical history. This could be attributed to the recency of training/education rather than age itself. Data on the effect of age on pharmacists’ performance is conflicting. In some studies, younger pharmacists performed better [29, 52], while in others, older pharmacists with more experience achieved better results [53]. Furthermore, an unexpected predictor was the gender of the pharmacist, with males obtaining higher scores in the pregnancy scenario. It should be noted that this study, like other simulated patient studies, assesses for particular behaviours and, thus, represents an idealisation of practice. Therefore, results should be interpreted with caution in real life practice, where pharmacists may be limited in context of the demands, patients and situations that they may encounter. Whilst pharmacists’ performance in the pregnancy scenario was somewhat disappointing, we should acknowledge that
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there are no clear cut guidelines for the provision of NRT to pregnant women covered by professional training. It is also well-known that pharmacists’ prescribing activities are rule-abiding, and this should be accounted for when judging performance. Other limitations include the fact that the considered scenarios were highly specific, and results, thus, may not be generalisable to other scenarios presented in Australian community pharmacies. Only pharmacies located within the designated geographical location were visited. Additionally, the scoring criteria were based on Australian standards and adapted from previous studies. Even though a standardised data collection form was employed and immediate recording of data (within 10 min) was considered, the risk of recall bias cannot be completely eliminated. Pharmacy/pharmacist demographics were also observed and estimated rather than actually obtained.
Conclusion Community pharmacists’ overall skills in providing smoking cessation services were somewhat inadequate. Further education and training are required to improve clinical/medical history taking skills and enhance pharmacists’ confidence of their perceived roles, both of which are essential for appropriate clinical decision-making. Whilst current evidence confirms that pharmacists can play a role in improving abstinence outcomes when delivering specialised services, handling of complex situations in chance encounters with current smokers could be significantly improved. Acknowledgments Funding
None.
None.
Conflicts of interest The authors have no conflicts of interest to declare.
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