Cargando…
Accessibility and potency of uterotonic drugs purchased by simulated clients in four districts in India
BACKGROUND: Surveillance of drug quality for antibiotics, antiretrovirals, antimalarials and vaccines is better established than surveillance for maternal health drugs in low-income countries, particularly uterotonic drugs for the prevention and treatment of postpartum hemorrhage. The objectives of...
Autores principales: | , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2014
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4240854/ https://www.ncbi.nlm.nih.gov/pubmed/25392131 http://dx.doi.org/10.1186/s12884-014-0386-y |
_version_ | 1782345783752785920 |
---|---|
author | Stanton, Cynthia Nand, Deepak Nitya Koski, Alissa Mirzabagi, Ellie Brooke, Steve Grady, Breanne Mullany, Luke C |
author_facet | Stanton, Cynthia Nand, Deepak Nitya Koski, Alissa Mirzabagi, Ellie Brooke, Steve Grady, Breanne Mullany, Luke C |
author_sort | Stanton, Cynthia |
collection | PubMed |
description | BACKGROUND: Surveillance of drug quality for antibiotics, antiretrovirals, antimalarials and vaccines is better established than surveillance for maternal health drugs in low-income countries, particularly uterotonic drugs for the prevention and treatment of postpartum hemorrhage. The objectives of this study are to: assess private sector accessibility of four drugs used for uterotonic purposes (oxytocin, methylergometrine, misoprostol, valethamate bromide); and to assess potency of oxytocin and methylergometrine ampoules purchased by simulated clients. METHODS: The study was conducted in Hassan and Bagalkot districts in Karnataka state and Agra and Gorakhpur districts in Uttar Pradesh state. A sample of 877 private pharmacies was selected (using a stratified, systematic sampling with random start), among which 847 were successfully visited. The target sample size for assessment of accessibility was 50 pharmacies per drug, per district. The target sample size for potency assessment was 100 purchases each of oxytocin and methylergometrine across all districts. Successful drug purchases varied by state. RESULTS: In Agra and Gorakhpur, 90%-100% of visits for each of the drugs resulted in a purchase. In Bagalkot and Hassan, only 29%-52% of visits for each drug resulted in a purchase. Regarding potency, the percent of active pharmaceutical ingredient was assessed using United States Pharmacopeia monograph #33 for both drugs; 193 and 188 ampoules of oxytocin and methylergometrine, respectively, were assessed. The percent of oxytocin ampoules outside manufacturer specification ranged from 33%-40% in Karnataka and from 22%-50% in Uttar Pradesh. In Bagalkot and Hassan, 96% and 100% of the methylergometrine ampoules were outside manufacturer specification, respectively. In Agra and Gorakhpur, 54% and 44% were outside manufacturer specification, respectively. CONCLUSION: Private sector accessibility of uterotonic drugs in study districts in Karnataka warrants attention. Most importantly, interventions to assure quality oxytocin and particularly methylergometrine are needed in study districts in both states. |
format | Online Article Text |
id | pubmed-4240854 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2014 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-42408542014-11-23 Accessibility and potency of uterotonic drugs purchased by simulated clients in four districts in India Stanton, Cynthia Nand, Deepak Nitya Koski, Alissa Mirzabagi, Ellie Brooke, Steve Grady, Breanne Mullany, Luke C BMC Pregnancy Childbirth Research Article BACKGROUND: Surveillance of drug quality for antibiotics, antiretrovirals, antimalarials and vaccines is better established than surveillance for maternal health drugs in low-income countries, particularly uterotonic drugs for the prevention and treatment of postpartum hemorrhage. The objectives of this study are to: assess private sector accessibility of four drugs used for uterotonic purposes (oxytocin, methylergometrine, misoprostol, valethamate bromide); and to assess potency of oxytocin and methylergometrine ampoules purchased by simulated clients. METHODS: The study was conducted in Hassan and Bagalkot districts in Karnataka state and Agra and Gorakhpur districts in Uttar Pradesh state. A sample of 877 private pharmacies was selected (using a stratified, systematic sampling with random start), among which 847 were successfully visited. The target sample size for assessment of accessibility was 50 pharmacies per drug, per district. The target sample size for potency assessment was 100 purchases each of oxytocin and methylergometrine across all districts. Successful drug purchases varied by state. RESULTS: In Agra and Gorakhpur, 90%-100% of visits for each of the drugs resulted in a purchase. In Bagalkot and Hassan, only 29%-52% of visits for each drug resulted in a purchase. Regarding potency, the percent of active pharmaceutical ingredient was assessed using United States Pharmacopeia monograph #33 for both drugs; 193 and 188 ampoules of oxytocin and methylergometrine, respectively, were assessed. The percent of oxytocin ampoules outside manufacturer specification ranged from 33%-40% in Karnataka and from 22%-50% in Uttar Pradesh. In Bagalkot and Hassan, 96% and 100% of the methylergometrine ampoules were outside manufacturer specification, respectively. In Agra and Gorakhpur, 54% and 44% were outside manufacturer specification, respectively. CONCLUSION: Private sector accessibility of uterotonic drugs in study districts in Karnataka warrants attention. Most importantly, interventions to assure quality oxytocin and particularly methylergometrine are needed in study districts in both states. BioMed Central 2014-11-13 /pmc/articles/PMC4240854/ /pubmed/25392131 http://dx.doi.org/10.1186/s12884-014-0386-y Text en © Stanton et al.; licensee BioMed Central Ltd. 2014 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Research Article Stanton, Cynthia Nand, Deepak Nitya Koski, Alissa Mirzabagi, Ellie Brooke, Steve Grady, Breanne Mullany, Luke C Accessibility and potency of uterotonic drugs purchased by simulated clients in four districts in India |
title | Accessibility and potency of uterotonic drugs purchased by simulated clients in four districts in India |
title_full | Accessibility and potency of uterotonic drugs purchased by simulated clients in four districts in India |
title_fullStr | Accessibility and potency of uterotonic drugs purchased by simulated clients in four districts in India |
title_full_unstemmed | Accessibility and potency of uterotonic drugs purchased by simulated clients in four districts in India |
title_short | Accessibility and potency of uterotonic drugs purchased by simulated clients in four districts in India |
title_sort | accessibility and potency of uterotonic drugs purchased by simulated clients in four districts in india |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4240854/ https://www.ncbi.nlm.nih.gov/pubmed/25392131 http://dx.doi.org/10.1186/s12884-014-0386-y |
work_keys_str_mv | AT stantoncynthia accessibilityandpotencyofuterotonicdrugspurchasedbysimulatedclientsinfourdistrictsinindia AT nanddeepaknitya accessibilityandpotencyofuterotonicdrugspurchasedbysimulatedclientsinfourdistrictsinindia AT koskialissa accessibilityandpotencyofuterotonicdrugspurchasedbysimulatedclientsinfourdistrictsinindia AT mirzabagiellie accessibilityandpotencyofuterotonicdrugspurchasedbysimulatedclientsinfourdistrictsinindia AT brookesteve accessibilityandpotencyofuterotonicdrugspurchasedbysimulatedclientsinfourdistrictsinindia AT gradybreanne accessibilityandpotencyofuterotonicdrugspurchasedbysimulatedclientsinfourdistrictsinindia AT mullanylukec accessibilityandpotencyofuterotonicdrugspurchasedbysimulatedclientsinfourdistrictsinindia |