A Cross-Sectional Investigation of the Quality of Selected Medicines for Noncommunicable Diseases in Private Community Drug Outlets in Cambodia during 2011–2013

Abstract

Although the issue of substandard and falsified medicines is quite well known, most research has focused on medicines used to treat communicable diseases, and relatively little research has been carried out on the quality of medicines for noncommunicable diseases (NCDs). This study was designed to assess the quality of seven widely used medicines for NCDs in Cambodia during 2011-2013. Medicines were collected from private community drug outlets in Phnom Penh (urban area), by stratified random sampling and in Battambang, Kandal, Kampong Speu, and Takeo (rural areas) by convenience sampling. Samples were subsequently analyzed by visual inspection, authenticity investigation, and pharmacopoeial analysis by high-performance liquid chromatography. Various discrepancies were observed in visual inspection of packages and medicines. Of 372 tablet/capsule samples from 64 manufacturers in 16 countries, the manufacturers confirmed 107 (28.8%) as authentic; the authenticity of other samples could not be verified. Three hundred sixty-four (97.8%) samples were registered in Cambodia. Among all samples, 23.4% (95% CI 19.2-28.0) were noncompliant in one or more of the quality tests: 12.9% (95% CI 9.7-16.7) contained an amount of active pharmaceutical ingredient outside the permitted range, including some showing extreme deviations, 14% (95% CI 10.6-17.9) failed because of content variation, and 10.8% (95% CI 7.8-14.4) failed to meet pharmacopoeial reference ranges in dissolution tests. Pharmaceutical quality appeared to be unrelated to storage conditions. Although no sample was obviously falsified, there is a high prevalence of substandard medicines for NCDs in Cambodia, indicating the need for focused regulatory action, including collaborative initiatives with manufacturers.

A Comprehensive Analysis of Select Medicines Collected from Private Drug Outlets of Dhaka City, Bangladesh in a Simple Random Survey

“…The results presented in this study demonstrate that 5.3% samples (95% CI, 0.021-0.086) were non-compliant (including all tested samples but excluding the falsi ed samples). The poor dissolution rates of the samples were a persistent problem, an observation which had previously been reported in our studies [56,57,60,61]. As an essential indicator of bioavailability and drug quality, the dissolution test has not been given as much attention as it deserves [58,62,63].…”

Clarification of the internal structure and factors of poor dissolution of substandard roxithromycin tablets by near-infrared chemical imaging

“…However, the presence of SFMs poses significant risks to individuals, such as lost treatment opportunities, treatment failures, and they could even be life-threatening ( Rahman et al, 2018 ). We have also reported that poor quality antibiotics have been detected in the common pharmaceutical market in a LMIC ( Yoshida et al, 2014 , Islam et al, 2017 , Khan et al, 2013 , Rahman et al, 2019 ). Although most medicines were of good quality, some of these have been intentionally falsified, while others have been unintentionally degraded.…”

Patient safety and public health concerns: poor dissolution rate of pioglitazone tablets obtained from China, Myanmar and internet sites

“…3 ), were all of foreign origin, which may suggest that medicines can enter the country through unauthorized channels. The authenticity of the products and legitimacy of the manufacturers remained unclear due to the poor responses to our questionnaire (Supplemental Files S1 and S2 ) from both manufacturers and medicine regulatory authorities (Table 3 ), as observed previously [ 17 , 38 , 39 ]. A possible explanation of the low response in the former case might be that manufacturers are already aware that their products are of low quality.…”