A study of the quality of cardiovascular and diabetes medicines in Malang District, Indonesia, using exposure-based sampling

Dewi, Aksari; Patel, Anushka; Palagyi, Anna; Praveen, Devarsetty; Ihsan, Bachtiar Rifai Pratita; Hariadini, Ayuk Lawuningtyas; Lyrawati, Diana; Sujarwoto, Sujarwoto; Maharani, Asri; Tampubolon, Gindo; Jan, Stephen; Pisani, Elizabeth

doi:10.1136/bmjgh-2022-009762

Cited by 7 publications

(10 citation statements)

References 19 publications

(40 reference statements)

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“…21 The study methods are reported in detail elsewhere, according to MEDQUARG guidelines. 22 The MEDQUARG checklist is available in the study archive. 23 Briefly, we designed an exposure-based sample frame.…”

Section: Methodsmentioning

confidence: 99%

Variation in price of cardiovascular and diabetes medicine in Indonesia, and relationship with quality: a mixed methods study in East Java

Pisani

Dewi

Palagyi

et al. 2022

Preprint

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Lower-middle income Indonesia, the world's fourth most populous country, has struggled to contain costs in its mandatory, single-payer public health insurance system since the system's inception in 2014. Public procurement policies radically reduced prices of most medicines in public facilities and the wider market. However, professional associations and the press have questioned the quality of these low-cost, unbranded generic medicines. We collected 204 samples of 4 cardiovascular and 1 antidiabetic medicine from health facilities and retail outlets in East Java. We collected amlodipine, captopril, furosemide, simvastatin and glibenclamide, sampling to reflect patients' likelihood of exposure to specific brands and outlets. We recorded sales prices and maximum retail prices, and tested medicines for dissolution and percent of labelled content, using high-performance liquid chromatography. We conducted in-depth interviews with supply chain actors. All samples, including those provided free in public facilities, met quality specifications. Most manufacturers make both branded and unbranded medicines. Retail prices varied widely. The median ratio of price to the lowest price for an equivalent product was 5.1, and a few brands sold for over 100 times the minimum price. Prices also varied between outlets for identical products, as retail pharmacies set prices to maximize profit. Since very low-cost medicines were universally available and of good quality, we believe richer patients who chose to buy branded products effectively protected medicine quality for poorer patients in Indonesia, because manufacturers cross-subsidize between branded and unbranded versions of the same medicine.

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Section: Methodsmentioning

confidence: 99%

Variation in price of cardiovascular and diabetes medicine in Indonesia, and relationship with quality: a mixed methods study in East Java

Pisani

Dewi

Palagyi

et al. 2022

Preprint

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“…No amlodipine sample failed assay or dissolution testing, a result consistent with findings in an earlier study of cardiovascular and diabetic medicines conducted in just one district of Indonesia. 18 At the other extreme, one in five of the 75 samples of amoxicillin dry syrup contained below the permitted amount of active ingredient. Failure on both assay and dissolution were also high for cefixime, at 7.7% and 14.4% respectively.…”

Section: Discussionmentioning

confidence: 99%

“…At least two studies have attempted to account for these variations in market share, the first, in DRC Congo, by weighting prevalence by distributor sales volume, 17 and the second, in Indonesia, in its sampling design 18 . In Congo, researchers found that poor quality products had smaller distribution, so the overall prevalence of substandard medicines was lower than raw prevalence estimates would suggest.…”

Section: Introductionmentioning

confidence: 99%

A randomised survey of the quality of antibiotics and other essential medicines in Indonesia, with volume-adjusted estimates of the prevalence of substandard medicines

Pisani,

Rahmawati,

Mulatsari

et al. 2023

Preprint

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IntroductionMost substandard and falsified medicines are at best not optimally effective, and at worst fatal. While the World Health Organisation and others warn they are a major threat to public health in low and middle income countries, little is known about their true prevalence. Authors of meta-analyses universally warn that survey data are not generalisable, because of unrepresentative study designs and variations in medicines included; tests performed; reference standards and pharmacopeia used; and definitions used when translating multiple quality parameters into a single pass/fail measure.We hypothesised that weighting for sales volume of different products and brands would increase accuracy of estimates of medicine quality.Methods and FindingsWe collected samples of allopurinol, amlodipine, cefixime and dexamethasone, as well as amoxicillin in 2 formulations in seven districts across Indonesia, the world’s fourth most populous country. Outlets, including retail pharmacies, over the counter medicine shops, public and private hospitals, primary health centres, doctors and nurses were randomised. We also sampled from the internet. Retail samples were collected by mystery shoppers, other samples overtly.We tested 1274 samples for identity and assay, and all relevant samples for dissolution and uniformity of content, using USP reference standards and monographs. Samples that failed any laboratory test were considered out of specification. We calculated prevalence per product and brand, and weighted the results by the sales volume of each product, using sales data from IQVIA and the national public procurement system.The weighted prevalence of out-of-specification products was 4.9%, 40.3% lower than the raw estimate (8.2%). Antibiotics were more likely to be substandard (weighted prevalence 6.8 vs 3.1; raw prevalence 13.6 vs 4.9, p<0.000). There was no relationship between quality and any of the following: price; branded status; public procurement status; outlet type. Our estimate compared with the Indonesian medicine regulator’s estimate of 4.0%, calculated based on unweighted analysis of 13,539 samples of a wider variety of medicines, collected overtly nation-wide.ConclusionsWhere data are available, weighting survey results by sales volume is a cost-effective way of improving the accuracy of estimates of out-of-specification medicines measured in field surveys.

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“…This study was nested in a larger study of the quality of cardiovascular medicines in Malang District, involving the collection of medicine distribution and price data, and in-depth interviews with individuals with either direct experience, or knowledge of, the landscape relating to CVD medicines in Malang, including funding, pricing, procurement, distribution, prescription, dispensing and record-keeping [17]. Potential participants were approached by e-mail outlining details of the study and requesting their participation; those who agreed to participate provided verbal or written consent, including for the recording of interviews.…”

Section: Participant Recruitment and Consentmentioning

confidence: 99%

Continuity of CVD treatment during the COVID-19 pandemic: evidence from East Java, Indonesia

Dewi

Pisani

Ihsan

et al. 2023

J of Pharm Policy and Pract

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Background In Indonesia, the world's fourth most populous country, cardiovascular diseases (CVDs) are a leading cause of death and disability. Government efforts to reduce the burden of CVD include a community-based prevention and early detection programme, and the provision of medicines to prevent cardiovascular events. Disruptions to medicine supply chains, service provision, and movement during the COVID-19 pandemic potentially threatened the continuity of these efforts. We investigated the distribution and dispensing of common CVD medicines in Malang district, East Java, before the pandemic and early in its course. Methods From January to October 2020, we collected monthly data on stock levels, sales or dispensing volumes, and price for five common CVD medicines (amlodipine, captopril, furosemide, glibenclamide and simvastatin), from a public and a private distributor, and from public health facilities (n = 4) and private pharmacies (n = 2). We further complied monthly data on patient numbers in two primary health centres. We tracked changes in stocks held and volumes dispensed by medicine type and sector, comparing the three months before the local COVID-19 response was mobilised with the subsequent seven months. We conducted interviews with pharmacists (n = 12), community health workers (n = 2) and a supply chain logistics manager to investigate the reasons for observed changes, and to learn details of any impacts or mitigation measures. Results The pandemic affected demand more than supply, causing medicine stocks to rise. Restricted service provision, lock-down measures and fear of infection contributed to a sharp drop in patient numbers and dispensing volumes in the public sector. Meanwhile private sector sales, especially of lower-priced CVD medicines, rose. Community health workers attributed some poor health outcomes to interruption in regular patient check-ups; this interruption was aggravated by formal mitigation policies. Conclusions Fears that COVID-19 would interrupt medicine availability were unfounded in East Java. Public sector patients may have compensated for reduced service access by switching to private pharmacies. Mitigation policies that ignored administrative procedures were not effective.

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A study of the quality of cardiovascular and diabetes medicines in Malang District, Indonesia, using exposure-based sampling

Cited by 7 publications

References 19 publications

Variation in price of cardiovascular and diabetes medicine in Indonesia, and relationship with quality: a mixed methods study in East Java

Variation in price of cardiovascular and diabetes medicine in Indonesia, and relationship with quality: a mixed methods study in East Java

A randomised survey of the quality of antibiotics and other essential medicines in Indonesia, with volume-adjusted estimates of the prevalence of substandard medicines

Continuity of CVD treatment during the COVID-19 pandemic: evidence from East Java, Indonesia

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