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

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...

Descripción completa

Detalles Bibliográficos
Autores principales: 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9703323/
https://www.ncbi.nlm.nih.gov/pubmed/36427901
http://dx.doi.org/10.1136/bmjgh-2022-009762
_version_ 1784839818247667712
author 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
author_facet 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
author_sort Dewi, Aksari
collection PubMed
description 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.
format Online
Article
Text
id pubmed-9703323
institution National Center for Biotechnology Information
language English
publishDate 2022
publisher BMJ Publishing Group
record_format MEDLINE/PubMed
spelling pubmed-97033232022-11-29 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 BMJ Glob Health Original Research 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. BMJ Publishing Group 2022-11-25 /pmc/articles/PMC9703323/ /pubmed/36427901 http://dx.doi.org/10.1136/bmjgh-2022-009762 Text en © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Original Research
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
A study of the quality of cardiovascular and diabetes medicines in Malang District, Indonesia, using exposure-based sampling
title A study of the quality of cardiovascular and diabetes medicines in Malang District, Indonesia, using exposure-based sampling
title_full A study of the quality of cardiovascular and diabetes medicines in Malang District, Indonesia, using exposure-based sampling
title_fullStr A study of the quality of cardiovascular and diabetes medicines in Malang District, Indonesia, using exposure-based sampling
title_full_unstemmed A study of the quality of cardiovascular and diabetes medicines in Malang District, Indonesia, using exposure-based sampling
title_short A study of the quality of cardiovascular and diabetes medicines in Malang District, Indonesia, using exposure-based sampling
title_sort study of the quality of cardiovascular and diabetes medicines in malang district, indonesia, using exposure-based sampling
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9703323/
https://www.ncbi.nlm.nih.gov/pubmed/36427901
http://dx.doi.org/10.1136/bmjgh-2022-009762
work_keys_str_mv AT dewiaksari astudyofthequalityofcardiovascularanddiabetesmedicinesinmalangdistrictindonesiausingexposurebasedsampling
AT patelanushka astudyofthequalityofcardiovascularanddiabetesmedicinesinmalangdistrictindonesiausingexposurebasedsampling
AT palagyianna astudyofthequalityofcardiovascularanddiabetesmedicinesinmalangdistrictindonesiausingexposurebasedsampling
AT praveendevarsetty astudyofthequalityofcardiovascularanddiabetesmedicinesinmalangdistrictindonesiausingexposurebasedsampling
AT ihsanbachtiarrifaipratita astudyofthequalityofcardiovascularanddiabetesmedicinesinmalangdistrictindonesiausingexposurebasedsampling
AT hariadiniayuklawuningtyas astudyofthequalityofcardiovascularanddiabetesmedicinesinmalangdistrictindonesiausingexposurebasedsampling
AT lyrawatidiana astudyofthequalityofcardiovascularanddiabetesmedicinesinmalangdistrictindonesiausingexposurebasedsampling
AT sujarwotosujarwoto astudyofthequalityofcardiovascularanddiabetesmedicinesinmalangdistrictindonesiausingexposurebasedsampling
AT maharaniasri astudyofthequalityofcardiovascularanddiabetesmedicinesinmalangdistrictindonesiausingexposurebasedsampling
AT tampubolongindo astudyofthequalityofcardiovascularanddiabetesmedicinesinmalangdistrictindonesiausingexposurebasedsampling
AT janstephen astudyofthequalityofcardiovascularanddiabetesmedicinesinmalangdistrictindonesiausingexposurebasedsampling
AT pisanielizabeth astudyofthequalityofcardiovascularanddiabetesmedicinesinmalangdistrictindonesiausingexposurebasedsampling
AT dewiaksari studyofthequalityofcardiovascularanddiabetesmedicinesinmalangdistrictindonesiausingexposurebasedsampling
AT patelanushka studyofthequalityofcardiovascularanddiabetesmedicinesinmalangdistrictindonesiausingexposurebasedsampling
AT palagyianna studyofthequalityofcardiovascularanddiabetesmedicinesinmalangdistrictindonesiausingexposurebasedsampling
AT praveendevarsetty studyofthequalityofcardiovascularanddiabetesmedicinesinmalangdistrictindonesiausingexposurebasedsampling
AT ihsanbachtiarrifaipratita studyofthequalityofcardiovascularanddiabetesmedicinesinmalangdistrictindonesiausingexposurebasedsampling
AT hariadiniayuklawuningtyas studyofthequalityofcardiovascularanddiabetesmedicinesinmalangdistrictindonesiausingexposurebasedsampling
AT lyrawatidiana studyofthequalityofcardiovascularanddiabetesmedicinesinmalangdistrictindonesiausingexposurebasedsampling
AT sujarwotosujarwoto studyofthequalityofcardiovascularanddiabetesmedicinesinmalangdistrictindonesiausingexposurebasedsampling
AT maharaniasri studyofthequalityofcardiovascularanddiabetesmedicinesinmalangdistrictindonesiausingexposurebasedsampling
AT tampubolongindo studyofthequalityofcardiovascularanddiabetesmedicinesinmalangdistrictindonesiausingexposurebasedsampling
AT janstephen studyofthequalityofcardiovascularanddiabetesmedicinesinmalangdistrictindonesiausingexposurebasedsampling
AT pisanielizabeth studyofthequalityofcardiovascularanddiabetesmedicinesinmalangdistrictindonesiausingexposurebasedsampling