Objective To quantify antibiotics sales without a prescription and to explore provision of patient assessment and medicine information related to antibiotics requested with or without a prescription in Surabaya community pharmacies.
Methods Scenarios of specific product requests (ciprofloxacin tablets and tetracycline capsules) and a request of amoxicillin dry syrups based on a new prescription were presented by simulated patients to 105 purposively selected pharmacies. Data were recorded by simulated patients after their purchase of each product. They documented the questions asked in patient assessment, the content of information given, recommendations provided and pharmacy workers’ characteristics.
Results Antibiotics requested without a prescription were sold in 80 (91%) pharmacies. Information related to ciprofloxacin tablets and tetracycline capsules was only provided when requested by the simulated patient in 69% and 68% of pharmacies for the two scenarios, respectively. Very few pharmacies assessed patients. Medicine information on indication, dosing, duration and direction for use was provided more frequently in all cases. Medicine information was more likely to be given when a new prescription of amoxicillin dry syrups being presented. Overall, the majority of sampled pharmacies responded antibiotics requests inappropriately.
Conclusion Inappropriate responses to antibiotic requests with or without a prescription remain an issue in Indonesia with pharmacy workers often failing to adequately assess patients. The illegality of delivering antibiotics without a prescription is of a considerable concern. Therefore, strategies to control antibiotics dispensing in community pharmacies should be seriously considered.
Objectif: Quantifier les ventes d’antibiotiques sans prescription et analyser les données sur l’évaluation du patient et l’information sur les médicaments liée aux demandes d’antibiotiques avec ou sans prescription dans les pharmacies communautaires à Surabaya.
Méthodes: Des scénarios de demandes spécifiques de produits (comprimés de ciprofloxacine et gélules de tétracycline) et demandes de sirop sec d’amoxicilline, ont été présentés par des patients fictifs à 105 pharmacies sélectionnées dans ce but. Les données ont été enregistrées par les patients fictifs après l’achat de chaque produit. Ils ont noté les questions posées dans l’évaluation du patient, le contenu des informations fournies, les recommandations fournies et les caractéristiques du personnel des pharmacies.
Résultats: Des antibiotiques demandés sans prescription ont été vendus dans 80 (91%) pharmacies. Les informations relatives aux comprimés de ciprofloxacine et aux gélules de tétracycline ont été fournies uniquement à la demande du patient fictif dans 69% et 68% des pharmacies pour les deux scénarios, respectivement. Très peu de pharmacies ont évalué les patients. Les informations sur l’indication et le dosage du médicament, la durée et les recommandations pour l’usage ont été fournies plus souvent dans tous les cas. Les informations sur les médicaments étaient plus susceptibles d’être données lors de la présentation d’une prescription pour sirop sec d’amoxicilline. Dans l’ensemble, la majorité des pharmacies échantillonnées ont répondu de façon inappropriée aux demandes d’antibiotiques.
Conclusion: Les réponses inappropriées aux demandes d’antibiotiques avec ou sans prescription demeurent un problème en Indonésie avec une évaluation souvent non adéquate des patients par le personnel des pharmacies. La délivrance illégale des antibiotiques sans ordonnance est une préoccupation importante. Par conséquent, des stratégies de contrôle de la délivrance dans les pharmacies communautaires devraient être sérieusement envisagées.
Objetivo: Cuantificar las ventas de antibióticos sin prescripción y explorar el suministro de valoración del paciente y la información médica relacionada con los antibióticos demandados con y sin prescripción en las farmacias comunitarias de Surabaya.
Métodos: Se presentaron escenarios de pedidos de productos específicos (comprimidos de ciprofloxacina y cápsulas de tetraciclina) y un pedido de jarabe de amoxicilina en polvo para reconstituir basándose en una nueva prescripción a pacientes simulados en 105 farmacias escogidas para este propósito. Los datos fueron recogidos por los pacientes simulados tras haber comprado cada producto. Documentaron las preguntas hechas durante la valoración del paciente, el contenido de la información dada y las características de los trabajadores de la farmacia.
Resultados: Los antibióticos pedidos sin prescripción fueron vendidos en 80 (91%) de las farmacias. La información relacionada con los comprimidos de ciprofloxacina y las cápsulas de tetraciclina solo se dio cuando la pidieron los pacientes simulados en 69% y 68% de las farmacias de los dos escenarios, respectivamente. Muy pocas farmacias realizaron la valoración del paciente. La información de la medicación relacionada con indicación, dosis, duración y dirección de uso era dada, en todos los casos, con una mayor frecuencia. La información sobre la medicación era dada más a menudo cuando se presentaba una prescripción para un jarabe de amoxicilina en polvo para reconstituir. En general, la mayoría de las farmacias muestreadas respondieron de forma inadecuada al pedido de antibióticos.
Conclusión: Las respuestas inapropiadas frente al pedido de antibióticos con y sin prescripción, continúa siendo un problema en Indonesia en donde los trabajadores de la farmacia no responden adecuadamente a la hora de asesorar a los pacientes. La venta ilegal de antibióticos sin prescripción es una gran preocupación, por lo que deberían considerarse seriamente estrategias que controlen la dispensación de antibióticos en farmacias comunitarias.
Antibiotics are usually used in the management of infectious diseases. Irrational and inappropriate use of antibiotics has been a worldwide problem for many years. In some developing countries, factors such as lack of laboratory services, poor medicine quality, and improper dosing and duration of therapy due to financial difficulty have contributed to the problem (Sarkar & Gould 2006). Indonesia as a developing country is no exception with its frequent, epidemics of infectious diseases and lack of resources to adequately ensure the quality use of antibiotics.
Determinants of imprudent uses of antibiotics vary, including irrational prescribing, unnecessary or inappropriate usage and the availability of antibiotics over-the-counter (Radyowijati & Haak 2003). In Indonesia, antibiotics have been frequently dispensed without prescription in pharmacies, drug stores, and even many roadside stalls (Hadi et al. 2010). It is, however, unclear whether these sales are accompanied with the delivery of complete and correct information to purchasers.
This study, therefore, aimed to quantify antibiotics sales without a prescription in Surabaya community pharmacies, to investigate pharmacy staff’s response to antibiotic requests with or without a prescription in terms of identifying their patients and providing medicine information.
Research design and sample size
The study was conducted from July to August 2010 after receiving approval from the institution’s Research Ethics Committee. A simulated patient method was considered well suited to investigate counselling practices in the natural environment. The researchers developed scenarios, designed data forms and recruited observers who acted as patients at the time they entered the sampled pharmacies.
After obtaining a list of 631 community pharmacies in Surabaya from the Health Agency, the sample size was calculated by assuming an average counselling rate of 50% within 10% of the point estimate. Approximately 84 pharmacies were required to obtain 2-sided 95% confidence interval with the finite population. To anticipate a number of pharmacies that were no longer in business, an additional 21 pharmacies were selected. Next, 105 pharmacies were purposively sampled where the pharmacist was considered present in the pharmacy business hours (Faturrohmah et al. 2009).
Three scenarios were designed to assess ability of pharmacy staff to respond to antibiotics requests and provide appropriate information. Each pharmacy was visited by three observers for each of the three scenarios. Two scenarios were for specific product requests, i.e. the purchase of ciprofloxacin (10 tablets) and tetracycline (2 capsules), while the other scenario was based on a new prescription for amoxicillin dry syrups, written by a doctor. Detailed rationale and desired outcomes for the three scenarios are presented in Table 1.
Table 1. Detailed scenarios and rationale for designing the scenarios
|Scenario 1: |
Product request for ciprofloxacin 10 tablets 500 mg
|The medicine was for observer herself (22 years old) who had discomfort on urination with a burning sensation and the need to urinate more frequent. The symptoms had occurred for 24 hours and she had taken more glass of water than usual to alleviate the symptoms.||Based on findings of our previous study (Sukorini et al. 2009), it was hypothesized that ciprofloxacin tablets can easily be obtained without a prescription.||Refusal to dispense, then referring to see a doctor|
|Scenario 2: |
Product request for 2 capsules tetracycline 250 mg (using a brand name Super Tetra®)
|The medicine was for observer’s friend (22 years old) who had infected wounds on his right leg for 3 days. He had used medicated bandages but water may aggravate the wound.||Tetracycline capsules (under a brand name Super Tetra®) had been widely used in the past for relieving wound by pouring it after releasing the powder from capsule shells. Although the manufacturer has reformulated it become soft-capsules consisting of liquid medicine, the illegal dispensing by community pharmacies are still unknown. ||Refusal to dispense, then referring to see a doctor or offering topical antibiotics under Pharmacist-only-Medicine groups|
|Scenario 3: |
A prescription for amoxicillin dry syrups 125 mg per 5 ml (A medicine that should be reconstituted to make suspension dosage form before taking it)
|The medicine prescribed was for observer’s niece/nephew (5 years old) who suffered from productive cough, rainy nose, fever and lost of appetite. The symptoms occurred for 2 days and accompanied by nausea. The patient had taken cough medicine, decongestants and antipyretics a day before visiting the doctor.||The appropriate information provided by community pharmacy staff regarding the use of suspension medicine for paediatric patients is unknown.||Providing information on both duration and direction for use and keeping the prescription sheets for documentation in each pharmacy|
Six final year pharmacy students were recruited as simulated patients (observers). They were trained on the scenarios to be used, the use of data collection forms and were assessed for their interpersonal skills as simulated patients. Training in completing data forms was undertaken to assure inter-rater reliability among observers. Prior to pharmacy visits, the observers rehearsed with the researchers to obtain standardization of the simulated requests.
The observers were instructed to answer questions briefly and give no further information unless asked. Relevant information was provided if the pharmacy staff asked using open-ended questions. Otherwise, they were only allowed to answer ‘yes’ or ‘no’. However, if no counselling was initially offered in two scenarios for specific product requests, the observers were instructed to ask in a standardized manner for the appropriateness of product related to the cases. In the scenario of a new prescription, if the medicine prescribed was not available, the observers were instructed to leave the pharmacy without asking any questions.
Data collection and rating system
Pharmacy visits were conducted during business hours. Soon after each visit, each observer completed a data form outside the pharmacy. The documentation included space to record the questions asked in patient assessment, the content of information given, the recommendation provided and the characteristics of pharmacy staff. In the data forms, pharmacy staff with a pharmacist qualification was categorized as ‘pharmacist’. Before leaving the pharmacy in each visit, the observers were instructed to ask whether the person they talked to was the pharmacist and to estimate the age of the staff member who served them.
All data were coded and entered into the Statistical Package for Social Sciences (spss 17.0). Frequency distributions were compiled and examined for responses to all questions. Chi-squared analysis was used to compare the proportions of each variable among different scenarios.
As 17 pharmacies on the sampled list were no longer in business, a total of 88 pharmacies were visited for each scenario, accounting for 264 visits for all scenarios. The availability of the medicines and pharmacy staff characteristics are displayed in Table 2.
Table 2. Distribution of availability of medicines and pharmacy characteristics on the three scenarios
|Availability of medicines|
| Available as requested||80/88 (91)||80/88 (91)||74/88 (84)|
| Available with substitution||1/88 (1)*||4/88 (4)†||–|
| Not available||7/88 (8)||4/88 (4)||14/88 (16)|
|Refusal to dispense||0/88 (0)||0/88 (0)||–|
|Referral to see a physician||5/88 (6%)||0/88 (0)||NA|
|Pharmacy staff characteristics|
| Pharmacist||17/88 (19)||12/88 (14)||14/74 (19)|
| Female||74/88 (84)||72/88 (82)||60/74 (81)|
| Age||21–40||76/88 (86)||64/88 (73)||61/74 (84)|
|41–60||12/88 (14)||24/88 (27)||12/74 (15)|
It can be seen from Table 3 that limited data from patients were collected by pharmacy staff in the two scenarios for purchase of antibiotics without prescription. In Scenario 3, no information on patient allergies was collected.
Table 3. Distribution of medicine information provided on the three scenarios
| Who the medicine is for?||2 (2)||2 (2)||23 (31)||-|
| What are the symptoms?||2 (2)||7 (8)||4 (5)||-|
| How long have the symptoms been present?||2 (2)||1 (1)||1 (1)||-|
| Action taken?||1 (1)||1 (1)||1 (1)||-|
| Is the patient taken any other medicines?||-||-||1 (1)||-|
| Are there any allergies to any medicines?||-||-||-||-|
| Information given|
| Without being asked||2 (2)||7 (8)||56 (76)||–|
| On demand||61 (69)||60 (68)||–||–|
| None*||18 (21)||18 (21)||18 (24)||–|
| Not Applicable†||7 (8)||3 (3)||–||–|
| Medicine information|
| What the medicine is for?||57 (65)||40 (46)||35 (47)||<0.01‡|
| How much to take the medicine?||31 (35)||60 (68)||52 (70)||<0.001‡§|
| How long to take the medicine?||18 (21)||5 (6)||32 (43)||<0.01‡§, <0.001¶|
| What the direction for use is?||31 (35)||58 (66)||52 (70)||<0.001‡§|
| What the side effects are?||1 (1)||–||–||–|
| What the precautions/ interactions/contra-indications are?||1 (1)||–||–||–|
| What the risks of the medicine are, if not taken?||2 (2)||–||1 (1)||–|
| How to store the medicine?||–||–||10 (14)||–|
Table 3 shows that only 2% of pharmacies presented with Scenario 1 and 8% of pharmacies presented with Scenario 2 offered medicine information immediately without being asked by the observers. Information was only provided on demand in more than two-thirds of the two cases.
Table 3 also presents eight items of medicine information provided by pharmacy staff for each scenario. In Scenario 1, of the 57 pharmacy workers, who provided information on indication, 24 (42%) stated that the medicine was an antibiotic and 11 (19%) explained that the medicine was for infection. Approximately 56% (n = 32) of pharmacy staff specified that ciprofloxacin can be used to treat urinary tract disorders. Detailed information on duration to take the medicine varied among the pharmacies. Thirteen of eighteen pharmacy staff said that patients should complete the course of therapy for the ten tablets requested. In terms of information on directions for use, most staff (17/31, 55%) instructed the patient to take the medicine three times a day, while the remaining 45% explained that the medicine should be taken twice a day. Additionally, several pharmacy workers recommended that the observers take a more appropriate medicine for the relief of their symptoms, i.e. pipemidic acid tablets (n = 4), phenazopyridine hydrocloride tablets (n = 3), amoxicillin tablets (n = 1), cefadroxil tablets (n = 1), and furosemide tablets (n = 1).
Similar to Scenario 1, information on indication, dosing, duration, and direction for use the medicine was mostly given to observers who requested tetracyline capsules. With regard to information on indication, 12% staff (5/40) explained that the medicine was an antibiotic and 37 staff (92%) added that the medicine was for relieving wounds. Of 58 pharmacy staff, who provided information on directions for use, 34 (59%) stated that the medicine can be poured into the wound and the remainder (41%) clarified that the medicine can only be taken orally.
In Scenario 3, 70% pharmacy staff who gave information on dosing and directions for use instructed the observers to take one teaspoonful of the medicine three times a day. In addition, staff in two pharmacies suggested that the medicine should be taken every 8 h per day. Information on completion of therapy was given by 32 staff (43%), in which 20 of them added that leftover antibiotics should not be kept 7 days after being reconstituted. Moreover, of the 74 pharmacies, 44 (60%) provided a medicine label, giving information as written on the prescription that the medicine should be taken three times daily, 17 of them included information that the patient should take a full course.
In this scenario, 31 pharmacies (42%) provided information on both duration and direction for use. Of these pharmacies, 12 (39%) not only dispensed the medicines but also returned prescription sheets to the observers, accounting for 19 pharmacies (26%) that provided appropriate responses.
Comparison of scenarios
Table 3 also presents a comparison among the three scenarios in terms of rates of provision of medicine information. There were differences among the three scenarios with regard to provision of medicine information on indication, dosing, duration and direction for use. A higher proportion of pharmacies responded appropriately for Scenario 3 (26%) than Scenario 2 (4%) and 1 (0%) (P < 0.001) and for Scenario 2 (4%) than 1 (0%) (P < 0.05).
The results of this study showed that antibiotics can easily be obtained without a prescription in Surabaya community pharmacies. Interestingly, almost all antibiotics requested without a prescription were dispensed by pharmacy staff without an initial assessment as to the appropriateness of the request. Medicine information was not offered spontaneously on delivery of the antibiotics without prescriptions, but only when it was specifically requested. The information, however, was likely to be given if antibiotics were purchased with a prescription. Whether requested with or without a prescription, the type of medicine information provided was limited to indication, dosing, duration and directions for use.
In this study, more than 90% of community pharmacies sold antibiotics without prescription. This is in stark contrast to findings of a Zimbabwean study using simulated clients to assess pharmacy staff performance (Nyazema et al. 2007) which reported a low prevalence of sales of antibiotics without prescription. The study thus demonstrated good adherence of Zimbabwean pharmacy staff, especially of the pharmacist, to their regulations surrounding the supply of antibiotics. In Indonesia, oral antibiotics, including ciprofloxacin tablets and tetracycline capsules are categorized as Prescription-only-Medicines. Hence, requests for both antibiotics without a prescription are prohibited (Indonesian Government 2009). Our study, therefore, showed that pharmacy staff in Surabaya failed to obey the regulations.
Our findings are, however, in line with some simulated patient studies conducted in the last 10 years (Wachter et al. 1999; Llor & Cots 2009). Wachter et al. (1999) found that 38% of Nepali pharmacies sold antibiotics for dysuria cases, while Llor and Cots (2009) observed that the sales of antibiotics when presenting urinary tract infection occurred in almost 80% of Spanish pharmacies. Llor and Cots (2009) also reported that the percentage of the antibiotics sales for that case was the highest compared to the sales for sore throat (35%) and acute bronchitis (17%). Similarly, the sales of antibiotics without prescription were reported by up to 87% of Vietnamese respondents (Duong et al. 1997).
Despite high illegal sales of antibiotics, Llor and Cots (2009) noted that the pharmacists examined their patients by asking about other symptoms (69%) and possible drug allergies (17%). In the Wachter et al. (1999) study, although no questions regarding allergies were asked in all cases, the majority of drug dispensers collected data related to the presented symptoms, such as frequency, duration, and other accompanying symptoms. In contrast, in the scenarios we presented involving antibiotics requests without a prescription, assessment of patients was insufficient to determine the appropriateness of requested medicines. Only few pharmacies asked about the patient, their symptoms, duration and action taken. It should also be noted that the questions were asked only when the simulated patients asked whether such medicine was appropriate. In other words, patient assessment was only on demand, after providing the requested product. This phenomenon might indicate that pharmacy staff are more focused on the sales of their products than the safety and efficacy of the medicines to their patients.
In Scenario 3, an interesting finding of our study was that 22% of pharmacies returned the prescription to the observers after dispensing antibiotics. This concords with the results of our previous study using scenarios of a new prescription for ciprofloxacin tablets and a new prescription for chloramphenicol eye ointments (Sukorini et al. 2009). This may confirm that antibiotics are available as over-the-counter medicines in Surabaya community pharmacies. Further research is needed to explore the rationale for this trend.
In terms of medicine information provided for the three scenarios, information on indication, dosing, duration and directions for use were more likely to be given than on side effects, precautions/interactions/contraindications, the risks of not taking the medicine, and storage. There were, however, 14% of pharmacies providing information on storage of amoxicillin dry syrups after being reconstituted. This dosage form may be the reason for pharmacy workers to deliver such information.
Of the three scenarios, the scenario of amoxicillin dry syrup accounted for highest rates of information on dosing, duration and directions. Similar to our previous study (Sukorini et al. 2009), information on dosing and directions for use in response to a prescription for ciprofloxacin tablets was provided by more than 75% of pharmacies. A request of antibiotics based on prescription orders might be a reasonable explanation for this trend. In addition, comparing Scenarios 1 and 2, information on indication was more frequently given in Scenario 1, while information on dosing and directions for use was mostly provided in Scenario 2. The differences might be due to differences in the leading questions that were asked for the two scenarios. In Scenario 1, if no information was initially given, the observers asked whether the medicine was appropriate for patient’s condition. Meanwhile, the leading question for Scenario 2 was whether the medicine can be poured to the wound.
Looking at pharmacy staff’s responses when giving information on directions for use of tetracycline capsules, up to 59% delivered incorrect information by stating that the medicine was for topical treatment. Interestingly, as the medicine had been reformulated from hard-capsules to soft-capsules that no longer consisted of powders, it is clear that the majority of pharmacy workers lacked product knowledge. In a review article, Radyowijati and Haak (2003) showed that lay people usually believe that all pharmacy workers are knowledgeable. If this is the case, it is worrying if the medicine information provided was inaccurate. A pharmacy that is recognized as a place where people can get reliable medicine information may become a threat to public health.
It is also worth noting that the remainder (41%) who recommended the patient to take tetracycline capsules orally only delivered two capsules as requested. There was no indication that antibiotics should be taken in a full course of therapy. When a scenario of ciprofloxacin tablets was presented, the majority stated about completion of therapy. Of those who provided information on the direction for use, 55% advised to take the medicine three times daily while the rest stated that it should be taken twice a day. The inappropriate information supplied by pharmacy workers, which did not conform to principles of appropriate antibiotic use (Niederman 2005), may contribute to increases of antimicrobial resistance, including improper dosing and potential non-compliance with the regimen.
In the two scenarios of antibiotics requests without prescription, OTC supply was inappropriate and the requests should have triggered a recommendation to see a doctor. However, such advice was only given by few pharmacy staff in response to a request of ciprofloxacin tablets. Other advice related to this scenario was an offer to substitute ciprofloxacin tablets with other medicines, including other antibiotics. Indeed, it may contribute to antimicrobial resistance due to unnecessary antibiotics usage (Niederman 2005).
With regard to a request of tetracycline capsules, no advice to see a physician was given. However, as the request was considered improper, a number of pharmacy staff suggested substituting tetracycline capsules with a combination of bacitracin zinc and neomycin sulphate. This response might be considered appropriate as topical antibiotics may be substituted under Pharmacist-only-Medicine groups, referring to the regulation (Department of Health 1990, 1993). Although both active ingredients have been found to lower uncomplicated wound infection rates (Davis et al. 2005), appropriate information of topical antibiotics usage should always be provided.
Of general concern is the apparent lack of accurate prescribing, dispensing and use of antibiotics. Many strategies have been implemented to help control of antimicrobial resistance. Clinicians, for example, have been encouraged to change their prescribing behaviour (Hooton & Levy 2001; Harbarth & Samore 2005; Sarkar & Gould 2006). Health care regulation and policies are also crucial to restrict antibiotics use, especially to limit the use for self-medication. Other strategies included developing educational programs or campaigns for prescribing practice, designing public information campaigns, screening and improved surveillance, and immunization (Harbarth & Samore 2005; Foucault & Brouqui 2006).
A community intervention has been implemented among Latino adults to reduce public demand on antibiotics for self-medication (Mainous et al. 2009). Educational messages including patient education pamphlets and public service advertisements were tailored and circulated through community sites, newspapers and radio in the intervention community, but not in the control community. The results, however, were unsatisfactory as there was no improvement in public attitudes despite the intervention. The authors suggested that public education alone without regulations was inadequate. However, no strategies have directly targeted illegal and inappropriate antibiotics sales through pharmacies. Providing pharmacy staff training might be a potential approach to improve community pharmacy services in responding antibiotic requests.
As mentioned above, a pharmacy is a healthcare setting where public expects to obtain reliable health and medicine information. Of all pharmacy workers, the pharmacist is the most qualified to provide such advice. Hence, the pharmacist should play a significant role in the provision of antibiotics by undertaking appropriate assessment and delivering accurate information on the correct use of these medicines. In this current study, although we purposively sampled pharmacies with the intention of examining the ability of pharmacist to give accurate information, the provision of information delivered by pharmacist only occurred in less than 20% of pharmacies. Although data on pharmacy staff’s qualifications were based on self report of respondents’, which was the limitation of this study, the failure of many pharmacists in Surabaya community pharmacies to meet their patients, provide sufficient information and ensure the safe, effective and efficacy of medicine is a source of further concern.
The findings demonstrate that the sale of antibiotics for self-medication continues in Indonesia without any effort from pharmacy workers to examine the appropriateness of requests for these medicines. Almost all pharmacies responded inappropriately for antibiotic requests without a prescription, and a minority provided proper responses for prescribed antibiotics. Information on indication, dosing, duration and direction for use was more likely to be given than the other information. The rates of provision of information, however, were higher for prescribed antibiotics than OTC antibiotics. It is also disturbing that almost all information was provided only when requested. Therefore, we should recognize the urgent need to control antibiotics dispensing in community pharmacies and implement strategies to improve pharmacists’ practice in the supply of and counselling for antibiotics.