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Background: Inappropriate over-the-counter supply of antibiotics in pharmacies for common infections is recognised as a source of antibiotic misuse that can worsen the global burden of antibiotic resistance. Objectives: To assess responses of community pharmacy staff to pseudo-patients presenting with symptoms of common infections and factors associated with such behaviour. Methods: A cross-sectional pseudo-patient study was conducted from Jan-Sept 2017 among 242 community pharmacies in Sri Lanka. Each pharmacy was visited by one trained pseudo-patient who pretended to have a relative with clinical symptoms of one of four randomly selected clinical scenarios of common infections (three viral infections: acute sore throat, common cold, acute diarrhoea) and a bacterial uncomplicated urinary tract infection. Pseudo-patients requested an unspecified medicine for their condition. Interactions between the attending pharmacy staff and the pseudo-patients were audio recorded (with prior permission). Interaction data were also entered into a data collection form immediately after each visit. Results: In 41% (99/242) of the interactions, an antibiotic was supplied illegally without a prescription. Of these, 66% (n = 65) were inappropriately given for the viral infections. Antibiotics were provided for 55% of the urinary tract infections, 50% of the acute diarrhoea, 42% of the sore throat and 15% of the common cold cases. Patient history was obtained in less than a quarter of the interactions. In 18% (44/242) of the interactions staff recommended the pseudo-patient to visit a physician, however, in 25% (11/44) of these interactions an antibiotic was still dispensed. Pharmacy staff advised the pseudo-patient on how to take (in 60% of the interactions where an antibiotic was supplied), when to take (47%) and when to stop (22%) the antibiotics supplied. Availability of a pharmacist reduced the likelihood of unlawful antibiotic supply (OR = 0.53, 95% CI: 0.31–0.89; P = 0.016) but not appropriate practice. Conclusions: Illegal and inappropriate dispensing of antibiotics was evident in the participating community pharmacies. This may be a public health threat to Sri Lanka and beyond. Strategies to improve the appropriate dispensing practice of antibiotics among community pharmacies should be considered seriously. Keywords: Antibiotic, Antibiotic resistance, Community pharmacy, Dispensing, Pharmacy staff, Sri Lanka, Pseudo-patient, Pharmacist, Pharmacy assistant, Inappropriate, Illegal * Correspondence: email@example.com The University of Sydney School of Pharmacy, Sydney, NSW, Australia Full list of author information is available at the end of the article © The Author(s). 2019 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Zawahir et al. Antimicrobial Resistance and Infection Control (2019) 8:60 Page 2 of 10 Background and often without a prescription. In Bangladesh, the public Medicines use is appropriate (rational and correct) when with a low income identified CPs as an important source of patients receive medicines appropriate to their clinical healthcare for all common health problems . As in most needs, in doses that meet their individual requirements, LMICs, CPs or drug stores are usually a patient’s first point for an adequate period of time, and at affordable prices of contact with the healthcare system for advice on com- . If any one of these conditions is not met, then it is mon ailments and other health problems . The main referred to as inappropriate (irrational or incorrect) use reasons for this include, but are not limited to, patients’ in- of the medicines. It has been estimated that worldwide ability to pay for both physician consultation fee and the more than half of medicines are prescribed, dispensed or prescribed medicine(s), limited time to visit a physician, sold inappropriately [2, 3]. and pharmacy specific factors, such as ease of access, long Inappropriate use of antibiotics is a global problem, par- opening hours, the ability to purchase medicines in small ticularly in the Asian region [4, 5]. It is common to see anti- quantities, credit facilities and personal familiarity and rela- biotics provided inappropriately for self-limiting viral tionship with the pharmacist [27–29]. Thepeopletophys- infections such as upper respiratory tract infections ician ratio in most of the LMICs is lower than the 2010 (URTIs) [5–8] and acute diarrhoea [6, 9], as well as bacter- WHO recommended ratio of 400:1 and couldalsobe ial infections including urinary tract infections (UTIs) [6, one of the factors for people visiting pharmacies as a first 10]. Inappropriate prescribing of antibiotics is observed in point of contact with a healthcare professional. many developing countries  and though most of the Therefore, community pharmacists, being the first URTIsare viralinfections, there appears to be a high healthcare professional most people in LMICs approach prevalence of antibiotic prescriptions provided for viral for medical advice, such as common viral infections, are URTIs in developing and transitional countries, ranging in the best position to help people with appropriate use of from about 40 to 75% and for acute diarrhoea from about medicines. Pharmacists have the antibiotics knowledge ne- 20 to 55% . A recent country-specific analysis reported cessary to ensure rational use of antibiotics  and can a high rate of antibiotic use for viral URTIs in public pri- contribute to reducing ABR in the community. They can mary care facilities in South East Asian countries, including also contribute to the appropriate and safe use of antibi- Bangladesh (59% of viral URTIs were being treated with an- otics by providing advice to patients on antibiotics supply tibiotics); Bhutan (34%); Korea (65%); Rajasthan, India for prescription. In addition, pharmacists can play an im- (94%); Karnataka, India (70%); Indonesia (72%); Maldives portant role in managing common infections by providing (43%); Myanmar (87%); Sri Lanka (70%); Thailand (43%) appropriate over-the-counter (OTC) medicines and and EastTimor (55%). non-pharmacological treatments, and referring patients to Self-medication with antibiotics is also a major contribu- a medical practitioner, when necessary. tory factor to inappropriate use of antibiotics in the com- However in many LMICs, community pharmacists munity . The emergence and spread of antibiotic are selling antibiotics inappropriately for self-limiting resistance (ABR), especially the appearance of multidrug- viral URTIs [32–35], acute diarrhoea [32, 35, 36]and resistant bacterial strains which are highly resistant to uncomplicated UTIs [32, 34]. Concerns have been many antibiotic classes, has raised a major global public raised about such inappropriate antibiotic dispensing health concern  and has been linked to the inappropri- practice due to profit aspirations, low quality of prac- ate use of antibiotics [15–17]. ABR is also associated with tice, insufficient drug sellers’ knowledge and training increased morbidity, mortality and treatment costs [18, 19] [28, 35, 37, 38]. Whilst anecdotally, there is evidence and the greatest burden occurs in low and middle-income for supply of antibiotics without a prescription in Sri countries (LMICs) . If no actions are taken, it has been Lanka, there is very little empirical research on the estimated that antimicrobial resistance will lead to 10 mil- provision of antibiotics in Sri Lankan community lion deaths by 2050, and a loss of US$100 trillion of the pharmacies. Therefore, this study aimed to determine world economic output [20–22]. community pharmacy staff ’s (pharmacist or any other A systematic review of nine surveys conducted in the staff who attended to the pseudo-patient) responses Asian region, found that self-medication with when a pseudo-patient presented with symptoms of non-prescription antimicrobials among the general public common infections and possible factors associated was 58% (7761 out of 13,366 of weighted cases) . Stud- with such behaviour. ies have found that the main source of antibiotics used for self-medication is community pharmacies (CPs) [6, 16, 23, Methods 24]. In China, Ye et al. reported that about 80% of the pub- Study design lic purchased antibiotics without a prescription from CPs This pseudo-patient study was part of a larger study for self-medication . In LMICs, the preferred method conducted among Sri Lankan CPs from January to Sep- for purchasing medicines is through private pharmacies tember 2017. There were two arms to this study; one of Zawahir et al. Antimicrobial Resistance and Infection Control (2019) 8:60 Page 3 of 10 which involved pseudo-patients’ direct antibiotic product informed consent, did not participate in the pseudo- requests (DPR) from 242 CPs throughout Sri Lanka . patient visits. Each of the participating pharmacies was The current findings were from the second arm, which in- visited by a pseudo-patient and a research assistant. volved pseudo-patient visits to the same 242 pharmacies While the pseudo-patient interacted with the pharmacy but presenting with the clinical symptoms of one of four staff, the accompanying research assistant observed scenarios of common infections (symptoms-based re- and covertly audio recorded the interaction during the quests- SBRs) including, acute sore throat (adult female), visits. Each pseudo-patient requested an unspecified common cold (four year-old child), acute diarrhoea (adult medicine for the treatment of the symptoms of one of male) and UTI (adult female). The DPR and SBR visits four randomly selected clinical scenarios of common were conducted randomly within a time interval of infections (acute sore throat, common cold, acute diar- approximately two to six weeks apart. rhoea (possible viral infections), and a bacterial un- The pseudo-patient approach can be considered as a ro- complicated UTI). Three levels of requests were made bust methodological tool for pharmacy practice research, by the pseudo-patient to obtain an antibiotic. The first especially as the knowledge of being observed can lead to level of request consisted of requesting an unspecified behavioural change [40, 41]. Despite its own methodo- medicine to alleviate the reported symptoms of the logical disadvantages, in general, the pseudo-patient common infection. If an antibiotic was not given, the method increases the validity of the study design and ac- pseudo-patient used the second level of the request; curacy of the findings compared to other self-reported “Can’t you give me something stronger?” If the phar- qualitative or quantitative surveys mainly because of the macy staff did not provide an antibiotic, the absence of social-desirability bias [42, 43]. pseudo-patient openly stated, “I would like an anti- biotic,” which was considered as the third level of re- Sample size calculation and sampling quest. If the pharmacy staff asked any questions related The sample size for this study was derived from a previ- to reported symptoms, pseudo-patients were trained to ous phase: a self-reported cross-sectional country survey answer according to the pre-determined scenarios. conducted among CP staff in Sri Lanka. The survey In addition, advice provided by pharmacy staff and the sample size (n = 369) was calculated based on the results availability of a pharmacist during the visit were noted. of a previous pilot study (Zawahir S, Amarasinghe M, The availability of a pharmacist was confirmed as follows, Hassali MA, Lekamwasam S: Knowledge, attitudes and a research assistant observed the pharmacy licence dis- practices related to antibiotic use among community played in the pharmacy with a photograph of the pharma- and hospital pharmacists in district galle, Sri Lanka, cist. If the photo displayed did not match the attending Preparation) and the sample size calculation has been pharmacy staff or there was no photo displayed, then the detailed in a previous publication . A total of 267 pseudo-patient asked “Can I talk to your pharmacist, (72%) pharmacies agreed to participate in the please?” The availability of the pharmacist was then based self-reported survey and all agreed to be approached to on the response to this question. In Sri Lanka, the licence obtain consent for pseudo-patient visits and audio re- issued by the National Medicine Regulatory Authority to cordings of the visits. However, 243 pharmacies agreed run a community pharmacy should be displayed in the to participate in the pseudo-patient visits and eventually pharmacy with the photo of a pharmacist who owns the 242 visits were made as one pharmacy went out of the pharmacy or is employed . business during the study. A total of 204 agreed to an Although as part of the visit the pseudo-patient did audio recording of the interaction during the visit. not ask why an antibiotic was not provided, any reason stated spontaneously by the pharmacy staff was captured Clinical scenarios and data collection from the audio-recording and reported accordingly. The scenarios were developed based on previously pub- Immediately after each visit, the pseudo-patient and lished literature [32, 44]. The scenarios and expected visit research assistant completed the data collection sheet outcomes are detailed in Table 1. The pseudo-patients (Table 2) together while listening to the audio record- with the symptoms of viral infections were expected to be ing. The questions in the data collection sheet were appropriately advised and provided with suitable OTC based on WWHAM (Who for, What symptoms, How medicines (if necessary) and the pseudo-patients with un- long, Any medicine tried, other Medication taken)  complicated UTI symptoms were expected to be referred and What-Stop-Go protocols. to a physician. Thirty-two pseudo-patients were involved in the Data analysis visits. They were either recent pharmacy graduates or Descriptive statistics such as frequencies (%) were pharmacy students from two public universities. The used to describe the data. Pearson’s chi-square test research assistants who were involved in obtaining and binary logistic regression analysis were performed Zawahir et al. Antimicrobial Resistance and Infection Control (2019) 8:60 Page 4 of 10 Table 1 Detailed scenarios with rationale and expected outcome Case Reported symptoms Additional information (If requested) Rationale Expected outcome 1 Pseudo-patient’s sister (25 years old) 1. No known allergies. URTIs are common self- No antibiotic should be is having difficulty swallowing; it is 2. No concurrent medicine. limiting viral infections for dispensed. painful when swallowing. She has a 3. No co-morbidities. which antibiotics are widely The pseudo-patient should be slight fever too. She has had 4. Gargled with salt water prescribed in Sri Lanka . advised to gargle with salt symptoms for past three days. but didn’t help much. water; provide an OTC Requested some medicine to relieve 5. Not tried any medicine. antipyretic e.g. paracetamol, for her symptoms. 6. No cough. the fever. Advice on proper 7. No headache. dose. The pseudo-patient 8. Not visited a physician. should be advised to see the 9. Not pregnant. physician if symptoms continue 10. Not breast feeding. for more than a week or get worse. 2 The antibiotic is for pseudo-patient’s 1. No known allergies. URTIs are common No antibiotic should be niece (4 years old). She has been 2. No concurrent medicine. self-limiting viral infections dispensed. suffering from a productive cough, 3. No co-morbidities. for which antibiotics are The pseudo-patient should be runny nose (clear mucus), slight fever, 4. Tried chlorpheniramine widely prescribed in Sri advised to use paracetamol for occasional sneezing and some loss of maleate and paracetamol. Lanka . fever. Advice on proper dose. appetite. The symptoms started three 5. No difficulties in breathing. Advice to see the physician if days ago. Requested medicine to 6. No sore throat. symptoms continue for more relieve the condition. 7. Clear nasal discharge. than a week, or they get worse 8. No headache. (in particular fever and aches). 9. 1–2 coughs per hour. 10. Not visited a physician. 11. Brings up a little phlegm when she coughs. 12. The cough is not worse at night. 3 The antibiotic is for pseudo-patient’s 1. No known allergies. Acute respiratory infections, No antibiotic should be younger brother (20 years old) who is 2. No concurrent medicine. diarrhoea, and neonatal dispensed. having acute loose bowel motion for 3. No co-morbidities. infections remain major Advice to take Oral rehydration the past two days (watery diarrhoea). 4. Tried diphenoxylate problems particularly solution. He has to go to toilet almost every hydrochloride, it has in children in South Asian Proper Oral rehydration solution 3–4 h. The pseudo-patient requested helped a little but still countries . preparation method should be some medicine to alleviate the has watery diarrhoea discussed. reported symptoms. and going to toilet Hygiene advice should be provided every 3–4h. such as hand washing. 5. Taking oral rehydration The pseudo-patient should be solution as well. advised to see a physician, if the 6. No vomiting. diarrhoea continues for a week or 7. No mucus or blood in stools. gets worse. 8. No abdominal pain. 9. No appetite. 10. Not visited a physician. 11. No fever. 12. Currently, no family member is having similar symptoms. 4 The antibiotic request is for pseudo- 1. No known allergies. Approximately 50% of No antibiotic should be dispensed. patient herself. Reported symptoms 2. No concurrent medicine. women are treated for UTIs The pseudo-patient should be are discomfort on urination with a 3. No comorbidities. with antibiotics at some advised to see a physician. burning sensation and the need to 4. Not tried anything. point in their lifetime . urinate more frequently. She has 5. Low grade fever. been drinking more water than usual 6. No back pain. to alleviate the symptoms. She also 7. No genital ulcer. has a slight fever. The symptoms 8. She is not pregnant/not started two days ago. expecting to be pregnant Requested some medicine to cure in near future. the reported symptoms. 9. Not visited a physician. 10. Last time had the same problem about 12 months ago OTC- Over the counter; URTIs- Upper respiratory tract infections; UTIs- Urinary tract infections using independent predictors (availability of pharma- supply without a prescription for reported common cist, gender, geographical area of the pharmacy, type infections. The P value of < 0.05 was considered as of scenario presented and type of pharmacy) to evalu- statistically significant. SPSS version 24 was used for ate the possible factors associated with antibiotic all the analyses. Zawahir et al. Antimicrobial Resistance and Infection Control (2019) 8:60 Page 5 of 10 Table 2 Information included in the data collection sheet 242), semi-government pharmacies (7%; 17/242) and pharmacies in private hospitals (4.1%; 10/242). The clin- Data collected ical scenario of uncomplicated UTI of adult female was 1 Geographical location of the pharmacy presented to 62 CPs and the other three scenarios - 2 Details of attending pharmacy staff acute sore throat (adult), common cold (four-year-old 4 Requested a prescription child) and acute diarrhoea (adult), were presented 4 Whether antibiotic dispensed equally among 180 pharmacies. 5 Antibiotic dispensing detail (level of request, type, dose and Overall, in 41% (99/242) of instances, antibiotics were frequency) sold illegally without a prescription in response to the 6 WWHAMM questions pseudo-patients reported clinical symptoms (Table 3). The Who is the medicine for? adults’ pseudo-patient scenarios of acute sore throat, acute What are the symptoms? How long have you had the symptoms? diarrhoea, and uncomplicated UTI accounted for the What action has already been taken? highest proportions of illegal antibiotic sales (49%; 90/ Are you taking any other medicine? 182), whereas pharmacy staff were more reluctant to sell Have other medical and lifestyle history taken? (specific to the scenario) antibiotics without a prescription when pseudo-patients presented with the symptoms of the common cold for a 7 Other medical and lifestyle history inquired by pharmacy staff Age, gender, Allergies, Environmental exposure, Suspected adverse child (15%; 9/60). The adult common infection scenar- drug reaction and any other related to specific scenario ios were significantly more likely to receive antibiotics 8 Patient advice on dispensing compared to the paediatric one, χ (1, N =242) = Including how much to take, how to take, when to take, how 22.15, P < 0.001). In two-thirds of the instances antibi- often to take and when to stop. otics were sold inappropriately for underlying viral 9 Recommendations including provision of OTC medicine and infections (65/99) including acute sore throat, com- referrals to a physician moncoldand acutediarrhoea.Inthe majority of in- stances an antibiotic was sold upon the 1st or 2nd level of request (73%; 72/99) without the pseudo-pa- Results tient requesting an antibiotic by name, and the rest A total of 242 pharmacies were visited by the pseudo-pa- were supplied on the 3rd level of request (Fig. 1). tients. The types of pharmacies which agreed to the About half of the visited pharmacies were observed to pseudo-patient visits included, private chain pharmacies have a pharmacist on duty. In about two-thirds of the (45%; 109/242), private single pharmacies (43.8%; 106/ instances (61%; 60/99) antibiotics were sold by a Table 3 Antibiotic sale without a prescription based on reported clinical case All cases Pseudo-patient case presented, frequency (%) Overall Sore throat Common cold Diarrhoea UTI n = 242 n =60 n =60 n =60 n =62 1st level of request 39 (16) 11 (18) 1 (2) 9 (15) 18 (29) (Can I get some medicine to alleviate the symptoms) 2nd level of request (Can I get 33 (14) 7 (12) 6 (10) 11 (18) 9 (15) something stronger) 3rd level of request 27 (11) 8 (13) 2 (3) 10 (17) 7 (11) (I would like an antibiotic) Antibiotic dispensed (all degree) 99 (41) 26 (43) 9 (15) 30 (50) 34 (55) Antibiotic not dispensed 143 (59) 34 (57) 51 (85) 30 (50) 28 (45) Antibiotics dispensed cases n =99 n =26 n =9 n =29 n =34 Ciprofloxacin 29 (30) 1 (4) Nil 2 (7) 26 (76) Metronidazole 23 (23) Nil Nil 23 (79) Nil Erythromycin 19 (20) 17 (65) Nil 2 (7) Nil Amoxicillin 9 (9) 1 (4) 8 (89) Nil Nil Azithromycin 8 (8) 7 (27) Nil 1 (3) Nil Norfloxacin 5 (5) Nil Nil Nil 5 (15) Other antibiotics 7 (4) Nil 1 (11) 1 (3) 3 (9) Zawahir et al. Antimicrobial Resistance and Infection Control (2019) 8:60 Page 6 of 10 pharmacy staff member other than a qualified when selling an antibiotic for a childbearing-aged female pharmacist. Though availability of a pharmacist sig- pseudo-patient presenting with symptoms of UTI (Table 4). nificantly reduced the likelihood of antibiotics supply None of the pseudo-patients with diarrhoea were ques- without a prescription (OR = 0.53, 95% CI: 0.31 to tioned about important symptoms, such as, the presence of 0.89; P = 0.016), that was not impacted on antibiotic blood in stool, fever, prolonged episodes of watery stools, or supply between viral and bacterial infections (OR = significant complications of diarrhoea such as dehydration 1.02, 95% CI: 0.41 to 2.53; P =0.972). and vomiting. The median interaction time between the Overall, only a few pharmacy staff asked the pseudo-patients who received an antibiotic and pharmacy pseudo-patients about concurrent medical conditions (10%; staff was 2 min (IQR = 1–3min). 25/242), any action that has already been taken (8%; 20/242) The most common antibiotic sold to pseudo-patients and concurrent medicines used (1.7%; 4/242). In 18% (44/ with sore throat was erythromycin (65%; 17/26), amoxicil- 242) of the instances, pseudo-patients were recommended lin for common cold (89%; 8/9), metronidazole for acute to see a physician. However, in about a quarter of them diarrhoea (79%; 23/29) and ciprofloxacin for female UTI (25%; 11/44) an antibiotic was still provided. Only a quarter cases (77%; 26/34) (Table 3). of the pseudo-patients with UTI (24%; 15/62) were advised In 143 pharmacies, the staff did not provide an anti- to see a physician (Table 4). biotic to the pseudo-patient. The primary reason for In about one-third of the pharmacies (36%; 36/99) where not supplying an antibiotic was the absence of a pre- an antibiotic was sold, the pseudo-patients were further scription from a physician (100/143; 70%). None of the questioned about their symptoms or concurrent medical pharmacy staff discussed the reported symptoms with conditions. The questions related to action that has already the pseudo-patient. They did not discuss issues such as been taken (12%; 12/99), drug allergies (10%; 10/99), and severity of the current health condition, possible aeti- concurrent medicines used (2%; 2/99). About half of the ology of the infection, risk of emergence of ABR if an pseudo-patients were advised on how and how often to antibiotic is inappropriately supplied for a viral infec- take the provided antibiotic, and about a quarter of them tion and risk of supplying an antibiotic for a possible were advised on when to stop taking the antibiotic. Avail- bacterial infection (UTI) without being diagnosed by a ability of a pharmacist in the pharmacy had no impact on physician. Instead, they simply denied giving an anti- patient counselling. In none of the pharmacies did staff biotic with or without stating a reason. The median inquire about the pregnancy status of the pseudo-patients interaction time between the pseudo-patient who did Fig. 1 Levels of antibiotic requests and dispensing. Level 1 request – Requesting an unspecified medicine to alleviate the reported symptoms of the common infection. Level 2 request –“Can’t you give me something stronger?”. Level 3 request –“I would like an antibiotic” Zawahir et al. Antimicrobial Resistance and Infection Control (2019) 8:60 Page 7 of 10 Table 4 Patient history taking, counselling and recommendation Frequency (%) Overall Sore throat Common cold Diarrhoea UTI n = 242 n =60 n =60 n =60 n =62 Asked about other symptoms 25 (10) 7 (12) 11 (18) 6 (10) 2 (2) Action has been taken 20 (8) 5 (8) 9 (15) 4 (7) 2 (3) Taking any other medicine 4 (1.7) 2 (3) 1 (2) 0 1 (2) Recommended to see a 44 (18) 6 (10) 14 (23) 9 (15) 15 (24) physician Antibiotic dispensed cases, frequency (%) Questions asked about; n =99 n =26 n =9 n =30 n =34 Other symptoms/ comorbidities 36 (36) 10 (38) 6 (67) 14 (47) 6 (18) (Yes) Action already taken 12 (12) 3 (11) 3 (33) 4 (13) 2 (6) Other medicine taking 2 (2) 1 (4) 0 0 1 (3) Pregnancy status 0 N/A N/A N/A 0 Drug allergies 10 (10) 5 (19) 0 2 (7) 3 (9) Patient counselling/ advice; Recommended to see a 10 (10) 2 (8) 0 5 (17) 3 (9) physician How to take 59 (60) 16 (62) 3 (33) 16 (53) 24 (71) How often to take 47 (47) 10 (38) 3 (33) 13 (43) 21 (62) When to stop taking 22 (22) 4 (15) 0 7 (23) 11 (32) N/A Not applicable not receive an antibiotic and pharmacy staff was also 2 pseudo-patients in 61% of the interactions . The major min (IQR = 1–3min). reason for the prevailing situation with regard to unlawful antibiotic supply among community pharmacies in Sri Discussion Lanka may be poor regulation of antibiotics supply in the To the best of our knowledge, this is one of the first two country and this has been discussed in the DPR arm of the pseudo-patient studies conducted in Sri Lanka, including study . A similar poor regulation of medication-dis- all different types of community pharmacies throughout pensing policies has also accounted for variable rates of the country, to evaluate pharmacy staff’s behaviour when non-prescription antibiotic sales in other parts of the presented with symptoms of common infections. world [16, 27, 32, 40, 48]. Despite Sri Lankan laws explicitly prohibiting the sup- This study also revealed inappropriate supply of antibi- ply of any antibiotic without a prescription, regardless of otics in response to reported symptoms of common in- the patient’s medical condition or symptoms, this study fections of viral aetiology. As the pseudo-patient clinical found that antibiotics were not only commonly provided scenarios were representing possible viral infections without a prescription (illegal) for common infections, (acute sore throat, common cold and acute diarrhoea) but also inappropriately for viral infections. The antibi- and a probable bacterial infection (uncomplicated UTI), otics were supplied without even being specifically re- the expected behaviour of the staff for the reported quested by the pseudo-patients. In addition, pharmacy scenarios was to effectively obtain relevant medical and staff failed to adequately inquire about the presenting lifestyle-related history, advise the pseudo-patient symptoms, give correct advice or offer alternative OTC appropriately, provide an OTC medicine or products. However, the overall supply was lower when non-pharmacological treatment (as necessary, for viral the presenting common infection was that of a child’s, infections) or refer them to a physician (in the case of and when a pharmacist was present. UTI). Despite this fact about two thirds of staff who gave The current results showed that unlawful antibiotic sup- out an antibiotic, had supplied them inappropriately for ply was high (41%) and this finding was supported by DPR viral infections. The potential reasons for such behaviour pseudo-patient visit findings from the same pharmacies, of community pharmacy staff have been discussed in a where antibiotics were provided without a prescription to recent self-reported national survey conducted among Zawahir et al. Antimicrobial Resistance and Infection Control (2019) 8:60 Page 8 of 10 community pharmacy staff in Sri Lanka which mainly vulnerable paediatric patients or their lack of clinical com- highlighted staff ’s inadequate clinical experience and petency in dealing with such patients, or perhaps both. As knowledge about antibiotics (Zawahir S, Lekamwasam S, none of the staff determined the cause of the infection and Aslani P: A cross-sectional national survey of commu- failed to educate the pseudo-patient appropriately whether nity pharmacy staff: knowledge and antibiotic provision, an antibiotic was needed or not, also supports the argu- submitted). Similar behaviour has also been observed in ment above about limited clinical training and therefore many other LMICs [16, 32, 35, 49]. A pseudo-patient knowledge of staff. study conducted in Riyadh, Saudi Arabia found that irre- Further, only about half of the pseudo-patients who spective of the aetiology of the infections, antibiotics obtained antibiotics, received any form of counselling or were freely dispensed without a prescription for all the advice. Counselling patients on “when to stop taking an- presented clinical symptoms of sore throat, acute sinus- tibiotics” does not appear to be part of the current itis, otitis media, acute bronchitis, diarrhoea and UTI process of providing antibiotics in Sri Lankan pharma- . Ayele at el., found that community pharmacy staff cies. A similar inadequate patient history taking and lack in Northwest Ethiopia dispensed antibiotics inappropri- of patient counselling was also observed in the DPR arm ately for self-limiting acute diarrhoea and URTIs . Il- of the pseudo-patient study . This is not only a prob- legal and inappropriate supply of antibiotics in lem in Sri Lanka. Other studies from LMICs have also pharmacies will not only promote ABR but also be asso- highlighted similar issues [38, 50]. Pharmacy staff ’s be- ciated with significant adverse events including drug side liefs about the usefulness of counselling, time con- effects, high medical costs, and complications of infec- straints, absence of any patient counselling guidelines in tions leading to longer hospital stays and possible emer- Sri Lanka and/or lack of privacy in community pharma- gence of multi drug resistance. cies and limited clinical knowledge, may have contrib- When comparing the findings of the DPR arm of the uted to the poor counselling observed. This provides an study  to the current SBR study findings, it can be seen important opportunity for continued professional devel- that a large proportion of the pharmacies supplied antibi- opment of Sri Lanka pharmacy staff. otics illegally, on both occasions when visited by the Although it was revealed that the presence of a pharma- pseudo-patient. This demonstrates that, potentially, the cist in the pharmacy may have been associated with a same reasons explain the provision of antibiotics without a lower likelihood of antibiotic supply without a prescrip- prescription, whether the pseudo-patient requests an anti- tion, the presence of the pharmacists did not impact the biotic by name  or presents with symptoms of a com- counselling received by the pseudo-patient nor result in mon infection which the pharmacy staff believe can be an appropriate response to the reported symptoms of treated by an antibiotic. Therefore, there is substantial common infections. Therefore, this supports the argu- room for practice improvement, both in increasing clinical ment above about limited clinical training and the know- knowledge as well as enforcing the legal requirements sur- ledge of staff. It is also evident from the literature that rounding antibiotics supply. However, the current study un-qualified pharmacy staff or pharmacists with poor clin- found that the proportion of community pharmacies pro- ical knowledge may be contributing to inappropriate anti- viding an antibiotic without a prescription was 20% less biotic supply [39, 51]. when there was a SBR compared to a DPR. This difference The inappropriate provision of antibiotics and inad- may be due to several reasons. The observed higher preva- equate counselling provided to pseudo-patients observed lence of antibiotic supply during DPR may be due to the in this study challenges the goal of appropriate use of staff’s false perception that when the patient is requesting antibiotics in communities, and can contribute to global an antibiotic by a specific product name, the patient has antibiotic misuse . In turn, this can have a serious knowledge about it or has had previous experience in public health threat through contributing to antibiotic using it. They may therefore feel more confident in provid- resistance at individual and population levels . ing an antibiotic. In the case of SBR, the pseudo-patient Therefore, the prevailing situation related to illegal and was required to describe the symptoms to the pharmacy inappropriate antibiotic supply in Sri Lanka is not only staff, which may have initiated more discussion and an in- challenging to the public health of the country, but has creased effort from the staff to appropriately diagnose and global consequences . provide treatment options other than an antibiotic. Fur- thermore, the staff may have felt that the pseudo-patient had not tried any products in the past, and so they may Limitations have been less confident in providing an antibiotic. Although repeated training and rehearsals were made to The observed low proportion of antibiotic supply (15%) ensure consistency between pseudo-patients and to in- for the reported paediatric scenario is a positive sign. This crease the internal validity of the data collected, it is still could be due to either pharmacy staff’s concern about possible that some interpersonal differences among Zawahir et al. Antimicrobial Resistance and Infection Control (2019) 8:60 Page 9 of 10 pseudo-patients may have impacted the behaviour of the was anonymised, and all data were kept confidential, including personal identifiers complied with local data protection legislations. pharmacy staff. This approach may also have limited ex- ternal validity, since in normal circumstances the Consent for publication pharmacist would probably have much more informa- Not applicable. tion about the client. A real patient has the tendency to Competing interests communicate freely about his/her pathology, therefore, The authors declare that they have no competing interests. the outcomes measured by this method may vary from real situations . Furthermore, self-selection of the Publisher’sNote study participants may have impacted the study findings. Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. Conclusions Author details The University of Sydney School of Pharmacy, Sydney, NSW, Australia. It is evident from this study that antibiotics are given out Population Health Research Centre, Department of Medicine, Faculty of from pharmacies illegally without a prescription and clinic- Medicine, University of Ruhuna, Galle, Sri Lanka. ally inappropriately. Presence of a pharmacist in the phar- Received: 9 January 2019 Accepted: 19 March 2019 macy may have reduced the illegal supply but it did not appear to impact appropriate practice. Immediate action is sought from all stakeholders in- References 1. WHO. How to develop and implement a national drug policy. Geneva: cluding healthcare professionals, local policy makers as World Health Organization; 2001. 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