Evidence map›Paper›PMID 31516106›Full record

ArticleThe American journal of tropical medicine and hygiene2019

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

Mohammad Sofiqur Rahman, Naoko Yoshida, Hirohito Tsuboi, Uy Sokchamroeun, Tep Keila, Tey Sovannarith, Heng Bun Kiet, Eav Dararath, Yoshio Akimoto, Tsuyoshi Tanimoto and 1 more

Abstract read
In one paragraph

Article in The American journal of tropical medicine and hygiene, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 1 synthesis or guideline pooled it.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Mohammad Sofiqur RahmanMedi-Quality Security Institute, Kanazawa University, Kanazawa, Japan.
Naoko YoshidaDepartment of Clinical Pharmacy and Healthcare Sciences, Kanazawa University, Kanazawa, Japan.
Hirohito TsuboiDepartment of Clinical Pharmacy and Healthcare Sciences, Kanazawa University, Kanazawa, Japan.
Uy SokchamroeunNational Health Product Quality Control Center, Ministry of Health, Phnom Penh, Cambodia.
Tep KeilaNational Health Product Quality Control Center, Ministry of Health, Phnom Penh, Cambodia.
Tey SovannarithNational Health Product Quality Control Center, Ministry of Health, Phnom Penh, Cambodia.
Heng Bun KietDepartment of Drugs and Food, Ministry of Health, Phnom Penh, Cambodia.
Eav DararathDepartment of Drugs and Food, Ministry of Health, Phnom Penh, Cambodia.
Yoshio AkimotoMedi-Quality Security Institute, Kanazawa University, Kanazawa, Japan.
Tsuyoshi TanimotoPharmaceutical and Medical Device Regulatory Science Society of Japan, Osaka, Japan.
Kazuko KimuraMedi-Quality Security Institute, Kanazawa University, Kanazawa, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

Pharmaceutical PreparationsPharmaciesQuality ControlCambodiaCommerceCounterfeit DrugsCross-Sectional StudiesDrug ContaminationDrug PackagingHumansNoncommunicable DiseasesCounterfeit DrugsPharmaceutical Preparations

Identifiers

PMID31516106
PMCPMC6838583

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.