E-DRUG: Study of CVD medicine quality in Indonesia
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Many e-druggers will be aware of the recalls of paracetamol syrup and paediatric formulations of other medicines in Indonesia. While investigations continue, the evidence linking the use of non-pharmaceutical grade inactive ingredients in these products to acute kidney failure, which has caused at least 178 deaths (mostly in children) is strong. Doctors treating children with kidney failure did not suspect that medicines may be at fault, and no reports were made through the national pharmacovigilance system.
After WHO issued an alert related to contamination of children's cough syrups in Gambia on October 5th, the Indonesian medicine regulator BPOM launched a proactive investigation of paediatric syrups. By October 20th they had identified a number of medicines and brands that were potentially contaminated with EG/DEG and initiated a nation-wide recall, while requiring quarantining of other brands pending further investigation.
Meanwhile the Ministry of Health alerted health personnel, and made treatment widely available. Despite this rapid and apparently effective action (no new deaths from acute kidney failure have been reported since the recall) families of victims have nevertheless initiated a class action lawsuit against BPOM and the Ministry of Health, as well as a number of pharmaceutical companies.
Against this backdrop, we draw to your attention a recently published study of the quality of cardiovascular and diabetes medicines in East Java, Indonesia, conducted by Aksari Dewi and colleagues. The study used an innovative sampling strategy that reflected patient exposure (the likelihood that a patient in the study area would take a specific brand acquired from a specific outlet).
The abstract is below, and the full, open-access article can be accessed at:
https://gh.bmj.com/content/7/11/e009762
Abstract
Background
The WHO has warned that substandard and falsified medicines threaten health, especially in low and middle-income countries (LMICs). However, the magnitude of that threat for many medicines in different regions is not well described, and high-quality studies remain rare. Recent reviews of studies of cardiovascular and diabetes medicine quality recorded that 15.4% of cardiovascular and 6.8% of diabetes samples failed at least one quality test. Review authors warn that study quality was mixed. Because they did not record medicine volume, no study reflected the risk posed to patients.
Methods and findings
We investigated the quality of five medicines for cardiovascular disease and diabetes in Malang district, East Java, Indonesia. Our sample frame, based on dispensing volumes by outlet and price category, included sampling from public and private providers and pharmacies and reflected the potential risk posed to patients. The content of active ingredient was determined by high-performance liquid chromatography and compared with the labelled content. Dissolution testing was also performed.
We collected a total of 204 samples: amlodipine (88); captopril (22); furosemide (21); glibenclamide (21) and simvastatin (52), comprising 83 different brands/products. All were manufactured in Indonesia, and all samples met specifications for both assay and dissolution. None was suspected of being falsified.
Conclusions
While we cannot conclude that the prevalence of poor-quality medicines in Malang district is zero, our sampling method, which reflects likely exposure to specific brands and outlets, suggests that the risk to patients is very low; certainly nothing like the rates found in recent reviews of surveys in LMICs. Our study demonstrates the feasibility of sampling medicines based on likely exposure to specific products and underlines the dangers of extrapolating results across countries.
The sample-level data for this study, with brand and corporate identities masked in accordance with the requirements of the ethics review boards, are available at: https://doi.org/10.7910/DVN/EBQYUB File 07.
Elizabeth Pisani
Co-Principal Investigator
STARMeds Team
(Systematic Tracking of At-Risk Medications)
Indonesia
Elizabeth Pisani <pisani@ternyata.org>