Use of standardised patients to assess antibiotic dispensing for tuberculosis by pharmacies in urban India: a cross-sectional study.
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ABSTRACT: Background
India's total antibiotic use is the highest of any country. Patients often receive prescription-only drugs directly from pharmacies. Here we aimed to assess the medical advice and drug dispensing practices of pharmacies for standardised patients with presumed and confirmed tuberculosis in India.Methods
In this cross-sectional study in the three Indian cities Delhi, Mumbai, and Patna, we developed two standardised patient cases: first, a patient presenting with 2-3 weeks of pulmonary tuberculosis symptoms (Case 1); and second, a patient with microbiologically confirmed pulmonary tuberculosis (Case 2). Standardised patients were scheduled to present each case once to sampled pharmacies. We defined ideal management for both cases a priori as referral to a health-care provider without dispensing antibiotics or steroids or both.Findings
Between April 1, 2014, and Nov 29, 2015, we sampled 622 pharmacies in Delhi, Mumbai, and Patna. Standardised patients completed 1200 (96%) of 1244 interactions. We recorded ideal management (defined as referrals without the use of antibiotics or steroids) in 80 (13%) of 599 Case 1 interactions (95% CI 11-16) and 372 (62%) of 601 Case 2 interactions (95% CI 58-66). Antibiotic use was significantly lower in Case 2 interactions (98 [16%] of 601, 95% CI 13-19) than in Case 1 (221 [37%] of 599, 95% CI 33-41). First-line anti-tuberculosis drugs were not dispensed in any city. The differences in antibiotic or steroid use and number of medicines dispensed between Case 1 and Case 2 were almost entirely attributable to the difference in referral behaviour.Interpretation
Only some urban Indian pharmacies correctly managed patients with presumed tuberculosis, but most correctly managed a case of confirmed tuberculosis. No pharmacy dispensed anti-tuberculosis drugs for either case. Absence of a confirmed diagnosis is a key driver of antibiotic misuse and could inform antimicrobial stewardship interventions.Funding
Grand Challenges Canada, Bill & Melinda Gates Foundation, Knowledge for Change Program, and World Bank Development Research Group.
SUBMITTER: Satyanarayana S
PROVIDER: S-EPMC5067371 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:As the first point of care for many healthcare seekers, private pharmacies play an important role in tuberculosis (TB) care. However, previous studies in India have showed that private pharmacies commonly dispense symptomatic treatments and broad-spectrum antibiotics over-the-counter (OTC), rather than referring patients for TB testing. Such inappropriate management by pharmacies can delaye TB diagnosis. We assessed medical advice and OTC drug dispensing practices of pharmacists for standardized patients presenting with classic symptoms of pulmonary TB (case 1) and for those with sputum smear positive pulmonary TB (case 2), and examined how practices have changed over time in an urban Indian site. We examined how and whether private pharmacies improved practices for TB in 2019 compared to a baseline study conducted in 2015 in the city of Patna, using the same survey sampling techniques and study staff. The proportion of patient-pharmacist interactions that resulted in correct or ideal management, as well as the proportion of interactions resulting in antibiotic, quinolone, and corticosteroid are presented, with standard errors clustered at the provider level. To assess the difference in case management and the use of drugs across the two cases by round, a difference in difference (DiD) model was employed. A total of 936 SP interactions were completed over both rounds of survey. Our results indicate that across both rounds of data collection, 331 of 936 (35%; 95% CI: 32-38%) of interactions were correctly managed. At baseline, 215 of 500 (43%; 95% CI: 39-47%) of interactions were correctly managed whereas 116 of 436 (27%; 95% CI: 23-31%) were correctly managed in the second round of data collection. Ideal management, where in addition to a referral, patients were not prescribed any potentially harmful medications, was seen in 275 of 936 (29%; 95% CI: 27-32%) of interactions overall, with 194 of 500 (39%; 95% CI: 35-43%) of interactions at baseline and 81 of 436 (19%; 95% CI: 15-22%) in round 2. No private pharmacy dispensed anti-TB medications without a prescription. On average, the difference in correct case management between case 1 vs. case 2 dropped by 20 percent points from baseline to the second round of data collection. Similarly, ideal case management decreased by 26 percentage points between rounds. This is in contrast with the dispensation of medicines, which had the opposite effect between rounds; the difference in dispensation of quinolones between case 1 and case 2 increased by 14 percentage points, as did corticosteroids by 9 percentage points, antibiotics by 25 percentage points and medicines generally by 30 percentage points. Our standardised patient study provides valuable insights into how private pharmacies in an Indian city changed their management of patients with TB symptoms or with confirmed TB over a 5-year period. We saw that overall, private pharmacy performance has weakened over time. However, no OTC dispensation of anti-TB medications occurred in either survey round. As the first point of contact for many care seekers, continued and sustained efforts to engage with Indian private pharmacies should be prioritized.
| S-EPMC10218738 | biostudies-literature
Project description:BackgroundIn India, men are more likely than women to have active tuberculosis but are less likely to be diagnosed and notified to national tuberculosis programmes. We used data from standardised patient visits to assess whether these gender differences occur because of provider practice.MethodsWe sent standardised patients (people recruited from local populations and trained to portray a scripted medical condition to health-care providers) to present four tuberculosis case scenarios to private health-care providers in the cities of Mumbai and Patna. Sampling and weighting allowed for city representative interpretation. Because standardised patients were assigned to providers by a field team blinded to this study, we did balance and placebo regression tests to confirm standardised patients were assigned by gender as good as randomly. Then, by use of linear and logistic regression, we assessed correct case management, our primary outcome, and other dimensions of care by standardised patient gender.FindingsBetween Nov 21, 2014, and Aug 21, 2015, 2602 clinical interactions at 1203 private facilities were completed by 24 standardised patients (16 men, eight women). We found standardised patients were assigned to providers as good as randomly. We found no differences in correct management by patient gender (odds ratio 1·05; 95% CI 0·76-1·45; p=0·77) and no differences across gender within any case scenario, setting, provider gender, or provider qualification.InterpretationSystematic differences in quality of care are unlikely to be a cause of the observed under-representation of men in tuberculosis notifications in the private sector in urban India.FundingGrand Challenges Canada, Bill & Melinda Gates Foundation, World Bank Knowledge for Change Program.
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| S-EPMC6488076 | biostudies-literature
Project description:BackgroundExisting studies of the quality of tuberculosis care have relied on recall-based patient surveys, questionnaire surveys of knowledge, and prescription or medical record analysis, and the results mostly show the health-care provider's knowledge rather than actual practice. No study has used standardised patients to assess clinical practice. Therefore we aimed to assess quality of care for tuberculosis using such patients.MethodsWe did a pilot, cross-sectional validation study of a convenience sample of consenting private health-care providers in low-income and middle-income areas of Delhi, India. We recruited standardised patients in apparently good health from the local community to present four cases (two of presumed tuberculosis and one each of confirmed tuberculosis and suspected multidrug-resistant tuberculosis) to a randomly allocated health-care provider. The key objective was to validate the standardised-patient method using three criteria: negligible risk and ability to avoid adverse events for providers and standardised patients, low detection rates of standardised patients by providers, and data accuracy across standardised patients and audio verification of standardised-patient recall. We also used medical vignettes to assess providers' knowledge of presumed tuberculosis. Correct case management was benchmarked using Standards for Tuberculosis Care in India (STCI).FindingsBetween Feb 2, and March 28, 2014, we recruited and trained 17 standardised patients who had 250 interactions with 100 health-care providers, 29 of whom were qualified in allopathic medicine (ie, they had a Bachelor of Medicine & Surgery [MBBS] degree), 40 of whom practised alternative medicine, and 31 of whom were informal health-care providers with few or no qualifications. The interactions took place between April 1, and April 23, 2014. The proportion of detected standardised patients was low (11 [5%] detected out of 232 interactions among providers who completed the follow-up survey), and standardised patients' recall correlated highly with audio recordings (r=0·63 [95% CI 0·53-0·79]), with no safety concerns reported. The mean consultation length was 6 min (95% CI 5·5-6·6) with a mean of 6·18 (5·72-6·64) questions or examinations completed, representing 35% (33-38) of essential checklist items. Across all cases, only 52 (21% [16-26]) of 250 were correctly managed. Correct management was higher among MBBS-qualified doctors than other types of health-care provider (adjusted odds ratio 2·41 [95% CI 1·17-4·93]; p=0·0166). Of the 69 providers who completed the vignette, knowledge in the vignettes was more consistent with STCI than their actual clinical practice-eg, 50 (73%) ordered a chest radiograph or sputum test during the vignette compared with seven (10%) during the standardised-patient interaction; OR 0·04 (95% CI 0·02-0·11); p<0·0001.InterpretationStandardised patients can be successfully implemented to assess tuberculosis care. Our data suggest a big gap between private provider knowledge and practice. Additional work is needed to substantiate our pilot data, understand the know-do gap in provider behaviour, and to identify the best approach to measure and improve the quality of tuberculosis care in India.FundingGrand Challenges Canada, the Bill & Melinda Gates Foundation, Knowledge for Change Program, and the World Bank Development Research Group.
| S-EPMC4633317 | biostudies-literature
Project description:Worldwide, antimicrobial resistance is increasing rapidly and is associated with misuse of antimicrobials. The HATUA study (a broader 3-country study) investigated the antibiotic dispensing practices of pharmaceutical providers to clients, particularly the propensity to dispense without prescription. A cross-sectional study using a 'mystery client' method was conducted in 1148 community pharmacies and accredited drugs dispensing outlets (ADDO) in Mwanza (n = 612), Mbeya (n = 304) and Kilimanjaro (n = 232) in Tanzania. Mystery clients asked directly for amoxicillin, had no prescription to present, did not discuss symptoms unless asked [when asked reported UTI-like symptoms] and attempted to buy a half course. Dispensing of amoxicillin without prescription was common [88.2, 95%CI 86.3-89.9%], across all three regions. Furthermore, the majority of outlets sold a half course of amoxicillin without prescription: Mwanza (98%), Mbeya (99%) and Kilimanjaro (98%). Generally, most providers in all three regions dispensed amoxicillin on demand, without asking the client any questions, with significant variations among regions [p-value = 0.003]. In Mbeya and Kilimanjaro, providers in ADDOs were more likely to do this than those in pharmacies but no difference was observed in Mwanza. While the Tanzanian government has laws, regulations and guidelines that prohibit antibiotic dispensing without prescription, our study suggests non-compliance by drug providers. Enforcement, surveillance, and the provision of continuing education on dispensing practices is recommended, particularly for ADDO providers.
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Project description:ObjectivesPrivate pharmacies are widely established in most low/middle-income countries (LMICs) including Nepal, and are often considered as a patient's first point of contact for seeking healthcare. The aim of this study was to investigate the pattern of antibiotic dispensing in private pharmacies through exit interviews with patients to review their medication information.Design and settingCross-sectional study. Data collection was carried out in 60 days at 33 randomly selected private pharmacies in the Rupandehi district of Nepal.ParticipantsPatients attending private pharmacies (n=1537).Main outcome measureThe pattern of antibiotic prescribing and dispensing was investigated using WHO's core prescribing indicator, 'the percentage of patients prescribed an antibiotic'. Frequency distributions were presented based on patients' characteristics, sources of antibiotic, registration status of pharmacies and education of the pharmacist or drug retailer, and disease or condition. ?2 tests and regression analysis were applied to explore factors associated with the pattern of antibiotic dispensing.ResultsOf patients attending private pharmacies, the proportion receiving at least one antibiotic (38.4%) was above the WHO recommended value (20.0%-26.8%). The most commonly dispensed antibiotics were cefixime (16.9%) and the third-generation cephalosporins (38.0%) class. High dispensing rates of antibiotics for selected conditions (eg, respiratory infections, diarrhoeal cases) appeared contrary to international recommendations. The percentage of antibiotic dispensed was highest for patients who obtained their medicines from unlicensed pharmacies (59.1%). Young people were more likely to receive antibiotics than other age groups.ConclusionsThe antibiotic dispensing pattern from private pharmacies in Nepal was high compared with WHO guidelines, suggesting initiatives to reduce inappropriate use of antibiotics should be implemented. The findings of this study may be generalisable to other LMICs in order to assist in developing policies and guidelines to promote more appropriate dispensing and prescribing practices of antibiotics and limit the spread of antibiotic resistance.
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Project description:Community pharmacies are the main channel of antibiotics distribution. We aimed to analyze the dispensing of non-prescribed antibiotics and knowledge of pharmacy staff. We conducted a cross-sectional study in Punjab, Pakistan between December 2017 and March 2018. A self-administered, structured, pretested, and validated bilingual questionnaire was used, and we used chi-square tests in the statistical analysis. A total of 573 (91.7%) pharmacy retailers responded to the survey; 44.0% were aged 31-40 years and all were men. Approximately 81.5% of participants declared that dispensing non-prescribed antibiotics is a common practice in community pharmacies, and 51.1% considered themselves to be authorized to dispense these drugs; 69.3% believed this a contributing factor to antimicrobial resistance. Most (79.1%) respondents believed that this practice promotes irrational antibiotics use, and half (52.2%) considered antimicrobial resistance to be a public health issue. Only 34.5% of respondents reported recommending that patients consult with a doctor prior to using antibiotics, and 61.8% perceived that their dispensing practices reduce patients' economic burden. Approximately 44.9% of pharmacy retailers stated that they have proper knowledge about antibiotics use. Nitroimidazole was the main class of antibiotic dispensed without a prescription. Dispensing of injectable and broad-spectrum antibiotics can be potential threat for infection cure. Poor knowledge of staff is associated with dispensing of non-prescribed antibiotics. This inappropriate practice must be addressed immediately.
| S-EPMC8143445 | biostudies-literature
Project description:BackgroundIndia has the highest burden of tuberculosis (TB). Although most patients with TB in India seek care from the private sector, there is limited evidence on quality of TB care or its correlates. Following our validation study on the standardized patient (SP) method for TB, we utilized SPs to examine quality of adult TB care among health providers with different qualifications in 2 Indian cities.Methods and findingsDuring 2014-2017, pilot programs engaged the private health sector to improve TB management in Mumbai and Patna. Nested within these projects, to obtain representative, baseline measures of quality of TB care at the city level, we recruited 24 adults to be SPs. They were trained to portray 4 TB "case scenarios" representing various stages of disease and diagnostic progression. Between November 2014 and August 2015, the SPs visited representatively sampled private providers stratified by qualification: (1) allopathic providers with Bachelor of Medicine, Bachelor of Surgery (MBBS) degrees or higher and (2) non-MBBS providers with alternative medicine, minimal, or no qualifications. Our main outcome was case-specific correct management benchmarked against the Standards for TB Care in India (STCI). Using ANOVA, we assessed variation in correct management and quality outcomes across (a) cities, (b) qualifications, and (c) case scenarios. Additionally, 2 micro-experiments identified sources of variation: first, quality in the presence of diagnostic test results certainty and second, provider consistency for different patients presenting the same case. A total of 2,652 SP-provider interactions across 1,203 health facilities were analyzed. Based on our sampling strategy and after removing 50 micro-experiment interactions, 2,602 interactions were weighted for city-representative interpretation. After weighting, the 473 Patna providers receiving SPs represent 3,179 eligible providers in Patna; in Mumbai, the 730 providers represent 7,115 eligible providers. Correct management was observed in 959 out of 2,602 interactions (37%; 35% weighted; 95% CI 32%-37%), primarily from referrals and ordering chest X-rays (CXRs). Unnecessary medicines were given to nearly all SPs, and antibiotic use was common. Anti-TB drugs were prescribed in 118 interactions (4.5%; 5% weighted), of which 45 were given in the case in which such treatment is considered correct management. MBBS and more qualified providers had higher odds of correctly managing cases than non-MBBS providers (odds ratio [OR] 2.80; 95% CI 2.05-3.82; p < 0.0001). Mumbai non-MBBS providers had higher odds of correct management than non-MBBS in Patna (OR 1.79; 95% CI 1.06-3.03), and MBBS providers' quality of care did not vary between cities (OR 1.15; 95% CI 0.79-1.68; p = 0.4642). In the micro-experiments, improving diagnostic certainty had a positive effect on correct management but not across all quality dimensions. Also, providers delivered idiosyncratically consistent care, repeating all observed actions, including mistakes, approximately 75% of the time. The SP method has limitations: it cannot account for patient mix or care-management practices reflecting more than one patient-provider interaction.ConclusionsQuality of TB care is suboptimal and variable in urban India's private health sector. Addressing this is critical for India's plans to end TB by 2025. For the first time, we have rich measures on representative levels of care quality from 2 cities, which can inform private-sector TB interventions and quality-improvement efforts.
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Project description:BackgroundThe initiation of anti-tuberculosis treatment (ATT) based on results of WHO-approved microbiological diagnostics is an important marker of quality tuberculosis (TB) care. Evidence suggests that other diagnostic processes leading to treatment initiation may be preferred in high TB incidence settings. This study examines whether private providers start anti-TB therapy on the basis of chest radiography (CXR) and clinical examinations.MethodsThis study uses the standardized patient (SP) methodology to generate accurate and unbiased estimates of private sector, primary care provider practice when a patient presents a standardized TB case scenario with an abnormal CXR. Using multivariate log-binomial and linear regressions with standard errors clustered at the provider level, we analyzed 795 SP visits conducted over three data collection waves from 2014 to 2020 in two Indian cities. Data were inverse-probability-weighted based on the study sampling strategy, resulting in city-wave-representative results.FindingsAmongst SPs who presented to a provider with an abnormal CXR, 25% (95% CI: 21-28%) visits resulted in ideal management, defined as the provider prescribing a microbiological test and not offering a concurrent prescription for a corticosteroid or antibiotic (including anti-TB medications). In contrast, 23% (95% CI: 19-26%) of 795 visits were prescribed anti-TB medications. Of 795 visits, 13% (95% CI: 10-16%) resulted in anti-TB treatment prescriptions/dispensation and an order for confirmatory microbiological testing.InterpretationOne in five SPs presenting with abnormal CXR were prescribed ATT by private providers. This study contributes novel insights to empiric treatment prevalence based on CXR abnormality. Further work is needed to understand how providers make trade-offs between existing diagnostic practices, new technologies, profits, clinical outcomes, and the market dynamics with laboratories.FundingThis study was funded by the Bill & Melinda Gates Foundation (grant OPP1091843), and the Knowledge for Change Program at The World Bank.
| S-EPMC10306035 | biostudies-literature
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