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Steve Brooke - One of the best experts on this subject based on the ideXlab platform.
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Accessibility and potency of Uterotonic drugs purchased by simulated clients in four districts in India
BMC pregnancy and childbirth, 2014Co-Authors: Cynthia Stanton, Deepak Nitya Nand, Alissa Koski, Ellie Mirzabagi, Steve Brooke, Breanne Grady, Luke C. MullanyAbstract: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. 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. 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. 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.
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Uterotonic drug quality an assessment of the potency of injectable Uterotonic drugs purchased by simulated clients in three districts in ghana
BMJ Open, 2012Co-Authors: Cynthia Stanton, Alissa Koski, Ellie Mirzabagi, Breanne Grady, Patience Cofie, Steve BrookeAbstract:Objectives Given use of Uterotonics for postpartum haemorrhage and other obstetric indications, the importance of potent Uterotonics is indisputable. This study evaluated access to and potency of injectable Uterotonics in Ghana. Design Study design involved research assistants simulating clients to purchase oxytocin and ergometrine from different sources. Drug potency was measured via chemical assay by the Ghana Food and Drugs Board. Setting The study was conducted in three contrasting districts in Ghana. Outcome measure The per cent of active pharmaceutical ingredient was measured to assess the quality of oxytocin and ergometrine. Results 69 formal points of sale were visited, from which 55 ergometrine ampoules and 46 oxytocin ampoules were purchased. None of the ergometrine ampoules were within British Pharmacopoeia specification for active ingredient, none were expired and one showed 0% active ingredient, suggestive of a counterfeit drug. Among oxytocin ampoules purchased, only 11 (26%) were within British Pharmacopoeia specification for active ingredient and two (4%) were expired. The median percentages of active ingredients were 64% and 50% for oxytocin and ergometrine, respectively. Conclusions The quality of injectable Uterotonics in three contrasting districts in Ghana is a serious problem. Restrictions regarding the sale of unregistered drugs, and of registered drugs from unlicensed shops, are inadequately enforced. These problems likely exist elsewhere but are not assessed, as postmarketing drug quality surveillance is generally restricted to well-funded disease-specific programmes relying on antiretroviral, antimalarial and antibiotic drugs. Maternal health programmes must adopt and fund the same approach to drug quality as is standard in programmes addressing infectious disease.
Cynthia Stanton - One of the best experts on this subject based on the ideXlab platform.
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Accessibility and potency of Uterotonic drugs purchased by simulated clients in four districts in India
BMC pregnancy and childbirth, 2014Co-Authors: Cynthia Stanton, Deepak Nitya Nand, Alissa Koski, Ellie Mirzabagi, Steve Brooke, Breanne Grady, Luke C. MullanyAbstract: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. 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. 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. 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.
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direct observation of Uterotonic drug use at public health facility based deliveries in four districts in india
International Journal of Gynecology & Obstetrics, 2014Co-Authors: Cynthia Stanton, Alissa Koski, Luke C. Mullany, Nitya Nand Deepak, Ashalata Mallapur, Geetanjali Katageri, Ellie MirzabagiAbstract:Abstract Objective To describe intrapartum Uterotonic drug use and related behaviors in public health facility-based deliveries and to describe drug storage conditions in associated pharmacies. Methods A descriptive study was conducted between August and November 2011 to document practices related to Uterotonic administration and storage based on direct observation of deliveries at public health facilities in four Indian districts (n = 97, n = 89, n = 91, and n = 89) with contrasting maternal health and socioeconomic indicators. Results Uterotonic drug use before and after delivery was common among the 366 study participants. Labor augmentation rates ranged from 53.5%–93.0% of deliveries across districts, with many receiving multiple Uterotonics and administration via intramuscular injection or intravenous push. Uterotonic use following delivery ranged from 78.6%–99.1% across districts, with correct use of Uterotonics for postpartum hemorrhage prevention varying from 6.0%–8.8% in Uttar Pradesh and 41.2%–76.4% in Karnataka. Active management of the third stage of labor following Indian guidelines was less than 10% in all districts. Storage of Uterotonics at room temperature was common. Conclusion Given that labor augmentation is nearly routine and at odds with Indian guideline recommendations, rigorous research is needed to assess maternal and fetal outcomes of current versus guidelines-based practice. Active management of the third stage of labor as per Indian guidelines was minimal.
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Uterotonic drug quality an assessment of the potency of injectable Uterotonic drugs purchased by simulated clients in three districts in ghana
BMJ Open, 2012Co-Authors: Cynthia Stanton, Alissa Koski, Ellie Mirzabagi, Breanne Grady, Patience Cofie, Steve BrookeAbstract:Objectives Given use of Uterotonics for postpartum haemorrhage and other obstetric indications, the importance of potent Uterotonics is indisputable. This study evaluated access to and potency of injectable Uterotonics in Ghana. Design Study design involved research assistants simulating clients to purchase oxytocin and ergometrine from different sources. Drug potency was measured via chemical assay by the Ghana Food and Drugs Board. Setting The study was conducted in three contrasting districts in Ghana. Outcome measure The per cent of active pharmaceutical ingredient was measured to assess the quality of oxytocin and ergometrine. Results 69 formal points of sale were visited, from which 55 ergometrine ampoules and 46 oxytocin ampoules were purchased. None of the ergometrine ampoules were within British Pharmacopoeia specification for active ingredient, none were expired and one showed 0% active ingredient, suggestive of a counterfeit drug. Among oxytocin ampoules purchased, only 11 (26%) were within British Pharmacopoeia specification for active ingredient and two (4%) were expired. The median percentages of active ingredients were 64% and 50% for oxytocin and ergometrine, respectively. Conclusions The quality of injectable Uterotonics in three contrasting districts in Ghana is a serious problem. Restrictions regarding the sale of unregistered drugs, and of registered drugs from unlicensed shops, are inadequately enforced. These problems likely exist elsewhere but are not assessed, as postmarketing drug quality surveillance is generally restricted to well-funded disease-specific programmes relying on antiretroviral, antimalarial and antibiotic drugs. Maternal health programmes must adopt and fund the same approach to drug quality as is standard in programmes addressing infectious disease.
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Uterotonic use at home births in low income countries a literature review
International Journal of Gynecology & Obstetrics, 2010Co-Authors: Dawn Flandermeyer, Cynthia Stanton, Deborah ArmbrusterAbstract:Abstract Objectives This literature review compiles data on rates of use, indications, types of provider, mode of administration, and dose of Uterotonics used for home births in low-income countries, and identifies gaps meriting further research. Methods Published and unpublished English language articles from 1995 through 2008 pertaining to home use of Uterotonics were identified via electronic searches of medical and social science databases. In addition, bibliographies of articles were examined for eligible studies. Data were abstracted and analyzed by the objectives outlined for this review. Results Twenty-three articles met the inclusion/exclusion criteria. Use rates of Uterotonics at home births ranged widely from 1% to 69%, with the large majority of observations from South Asia. Descriptive studies suggest that home use of Uterotonics before delivery of the baby are predominantly administered by nonprofessionals to accelerate labor, and are not perceived as unsafe. Conclusions To achieve maximum benefit and minimal harm, programs that increase access to Uterotonics for postpartum hemorrhage prevention must take into account existing practices among pregnant women. Further research regarding access to Uterotonics and intervention studies for provider behavior change regarding Uterotonic use is warranted.
Luke C. Mullany - One of the best experts on this subject based on the ideXlab platform.
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an exploration of village level Uterotonic practices in fenerive est madagascar
BMC Pregnancy and Childbirth, 2016Co-Authors: L J Collins, Luke C. Mullany, Kristin Mmari, Christian W Gruber, Rachel FaveroAbstract:Pharmaceutical Uterotonics are effective for preventing postpartum hemorrhage and complications related to unsafe abortion. In Madagascar, however, traditional birth attendants (Matrones) commonly administer medicinal teas for Uterotonic purposes. Little is known about Matrone practices and how they might coincide with efforts to increase Uterotonic coverage. The aims of this study were to: 1) identify indications for presumed Uterotonic plant use by Matrones, 2) explore Uterotonic practices at the village level, and 3) describe the response of health practitioners to village-level Uterotonic practices. Twelve in-depth interviews with health practitioners, Matrones and community agents were conducted in local dialect. All interviews were audio-recorded, transcribed, and translated into English for analysis using Atlas.ti. Medicinal plant specimens were also collected and analyzed for the presence of Uterotonic peptides. While Matrones reported to offer specific teas for Uterotonic purposes, health practitioners discussed providing emergency care for women with complications associated with use of specific teas. Complications included retained placenta, hypertonic uterus, hemorrhage and sepsis. Chemical analysis indicated the presence of cysteine-rich peptides in the Dantoroa/Denturus plant used in some Matrones’ teas. The presence of Uterotonic peptides in one plant used by Matrones may indicate that Matrones intend to administer Uterotonics for safer childbirth. This finding, combined with practitioner reports of complications related to some medicinal teas, points to a need for availability of an evidence-based Uterotonic at the village level, namely, misoprostol pills or oxytocin in the form of uniject.
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Accessibility and potency of Uterotonic drugs purchased by simulated clients in four districts in India
BMC pregnancy and childbirth, 2014Co-Authors: Cynthia Stanton, Deepak Nitya Nand, Alissa Koski, Ellie Mirzabagi, Steve Brooke, Breanne Grady, Luke C. MullanyAbstract: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. 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. 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. 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.
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direct observation of Uterotonic drug use at public health facility based deliveries in four districts in india
International Journal of Gynecology & Obstetrics, 2014Co-Authors: Cynthia Stanton, Alissa Koski, Luke C. Mullany, Nitya Nand Deepak, Ashalata Mallapur, Geetanjali Katageri, Ellie MirzabagiAbstract:Abstract Objective To describe intrapartum Uterotonic drug use and related behaviors in public health facility-based deliveries and to describe drug storage conditions in associated pharmacies. Methods A descriptive study was conducted between August and November 2011 to document practices related to Uterotonic administration and storage based on direct observation of deliveries at public health facilities in four Indian districts (n = 97, n = 89, n = 91, and n = 89) with contrasting maternal health and socioeconomic indicators. Results Uterotonic drug use before and after delivery was common among the 366 study participants. Labor augmentation rates ranged from 53.5%–93.0% of deliveries across districts, with many receiving multiple Uterotonics and administration via intramuscular injection or intravenous push. Uterotonic use following delivery ranged from 78.6%–99.1% across districts, with correct use of Uterotonics for postpartum hemorrhage prevention varying from 6.0%–8.8% in Uttar Pradesh and 41.2%–76.4% in Karnataka. Active management of the third stage of labor following Indian guidelines was less than 10% in all districts. Storage of Uterotonics at room temperature was common. Conclusion Given that labor augmentation is nearly routine and at odds with Indian guideline recommendations, rigorous research is needed to assess maternal and fetal outcomes of current versus guidelines-based practice. Active management of the third stage of labor as per Indian guidelines was minimal.
Alissa Koski - One of the best experts on this subject based on the ideXlab platform.
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Accessibility and potency of Uterotonic drugs purchased by simulated clients in four districts in India
BMC pregnancy and childbirth, 2014Co-Authors: Cynthia Stanton, Deepak Nitya Nand, Alissa Koski, Ellie Mirzabagi, Steve Brooke, Breanne Grady, Luke C. MullanyAbstract: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. 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. 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. 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.
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direct observation of Uterotonic drug use at public health facility based deliveries in four districts in india
International Journal of Gynecology & Obstetrics, 2014Co-Authors: Cynthia Stanton, Alissa Koski, Luke C. Mullany, Nitya Nand Deepak, Ashalata Mallapur, Geetanjali Katageri, Ellie MirzabagiAbstract:Abstract Objective To describe intrapartum Uterotonic drug use and related behaviors in public health facility-based deliveries and to describe drug storage conditions in associated pharmacies. Methods A descriptive study was conducted between August and November 2011 to document practices related to Uterotonic administration and storage based on direct observation of deliveries at public health facilities in four Indian districts (n = 97, n = 89, n = 91, and n = 89) with contrasting maternal health and socioeconomic indicators. Results Uterotonic drug use before and after delivery was common among the 366 study participants. Labor augmentation rates ranged from 53.5%–93.0% of deliveries across districts, with many receiving multiple Uterotonics and administration via intramuscular injection or intravenous push. Uterotonic use following delivery ranged from 78.6%–99.1% across districts, with correct use of Uterotonics for postpartum hemorrhage prevention varying from 6.0%–8.8% in Uttar Pradesh and 41.2%–76.4% in Karnataka. Active management of the third stage of labor following Indian guidelines was less than 10% in all districts. Storage of Uterotonics at room temperature was common. Conclusion Given that labor augmentation is nearly routine and at odds with Indian guideline recommendations, rigorous research is needed to assess maternal and fetal outcomes of current versus guidelines-based practice. Active management of the third stage of labor as per Indian guidelines was minimal.
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Uterotonic use during childbirth in uttar pradesh accounts from community members and health providers
Midwifery, 2013Co-Authors: Ellie Mirzabagi, Alissa Koski, Nitya Nand Deepak, Vandana TripathiAbstract:Abstract Objective this qualitative study aimed to document provider and community practices regarding Uterotonic use during labour and delivery in Uttar Pradesh, India, as well as the knowledge, attitudes, and values that underlie such use. Methods, setting, and participants a total of 140 in-depth interviews were conducted between May and July 2011 in Agra and Gorakhpur districts, with clinicians, nurses, recently delivered women, mothers-in-law with at least one grandchild, traditional birth attendants, unlicensed village doctors, and pharmacist assistants at chemical shops. Findings interviews reveal that injectable Uterotonic use for the purposes of labour augmentation is widespread in both clinical and community settings. However, use of Uterotonics for postpartum haemorrhage prevention and treatment appears to be relatively limited and was rarely discussed by respondents. Key beliefs underlying Uterotonic use were identified, including high valuation of labour pain, rapid delivery, and biomedical intervention, particularly administration of medicines. Other factors promoting the use of Uterotonics for labour augmentation included lack of knowledge about adverse effects, provider beliefs that prolonged labour poses risks to the baby, community perceptions that modern women are less able to have spontaneous delivery, and financial incentives for Uterotonic administration. Conclusions and implications major challenges to overcome in minimising Uterotonic misuse include entrenched use for labour augmentation in both institutional and community deliveries, perceptions of injectable Uterotonics as curative agents symbolic of biomedical care, and the widespread availability of these drugs. The findings demonstrate a need for programmes that reduce inappropriate use of Uterotonics, promote appropriate use for postpartum haemorrhage prevention and treatment, and ensure adherence to evidence-based guidelines.
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knowledge attitudes and practices related to Uterotonic drugs during childbirth in karnataka india a qualitative research study
PLOS ONE, 2013Co-Authors: Nitya Nand Deepak, Alissa Koski, Ellie Mirzabagi, Vandana TripathiAbstract:Background and Objectives India has the highest annual number of maternal deaths of any country. As obstetric hemorrhage is the leading cause of maternal death in India, numerous efforts are under way to promote access to skilled attendance at birth and emergency obstetric care. Current initiatives also seek to increase access to active management of the third stage of labor for postpartum hemorrhage prevention, particularly through administration of an Uterotonic after delivery. However, prior research suggests widespread inappropriate use of Uterotonics at facilities and in communities–for example, without adequate monitoring or referral support for complications. This qualitative study aimed to document health providers’ and community members’ current knowledge, attitudes, and practices regarding Uterotonic use during labor and delivery in India’s Karnataka state. Methods 140 in-depth interviews were conducted from June to August 2011 in Bagalkot and Hassan districts with physicians, nurses, recently delivered women, mothers-in-law, traditional birth attendants (dais), unlicensed village doctors, and chemists (pharmacists). Results Many respondents reported use of Uterotonics, particularly oxytocin, for labor augmentation in both facility-based and home-based deliveries. The study also identified contextual factors that promote inappropriate Uterotonic use, including high value placed on pain during labor; perceived pressure to provide or receive Uterotonics early in labor and delivery, perhaps leading to administration of Uterotonics despite awareness of risks; and lack of consistent and correct knowledge regarding safe storage, dosing, and administration of oxytocin. Conclusions These findings have significant implications for public health programs in a context of widespread and potentially increasing availability of Uterotonics. Among other responses, efforts are needed to improve communication between community members and providers regarding Uterotonic use during labor and delivery and to target training and other interventions to address identified gaps in knowledge and ensure that providers and pharmacists have up-to-date information regarding proper usage of Uterotonic drugs.
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Uterotonic drug quality an assessment of the potency of injectable Uterotonic drugs purchased by simulated clients in three districts in ghana
BMJ Open, 2012Co-Authors: Cynthia Stanton, Alissa Koski, Ellie Mirzabagi, Breanne Grady, Patience Cofie, Steve BrookeAbstract:Objectives Given use of Uterotonics for postpartum haemorrhage and other obstetric indications, the importance of potent Uterotonics is indisputable. This study evaluated access to and potency of injectable Uterotonics in Ghana. Design Study design involved research assistants simulating clients to purchase oxytocin and ergometrine from different sources. Drug potency was measured via chemical assay by the Ghana Food and Drugs Board. Setting The study was conducted in three contrasting districts in Ghana. Outcome measure The per cent of active pharmaceutical ingredient was measured to assess the quality of oxytocin and ergometrine. Results 69 formal points of sale were visited, from which 55 ergometrine ampoules and 46 oxytocin ampoules were purchased. None of the ergometrine ampoules were within British Pharmacopoeia specification for active ingredient, none were expired and one showed 0% active ingredient, suggestive of a counterfeit drug. Among oxytocin ampoules purchased, only 11 (26%) were within British Pharmacopoeia specification for active ingredient and two (4%) were expired. The median percentages of active ingredients were 64% and 50% for oxytocin and ergometrine, respectively. Conclusions The quality of injectable Uterotonics in three contrasting districts in Ghana is a serious problem. Restrictions regarding the sale of unregistered drugs, and of registered drugs from unlicensed shops, are inadequately enforced. These problems likely exist elsewhere but are not assessed, as postmarketing drug quality surveillance is generally restricted to well-funded disease-specific programmes relying on antiretroviral, antimalarial and antibiotic drugs. Maternal health programmes must adopt and fund the same approach to drug quality as is standard in programmes addressing infectious disease.
Ellie Mirzabagi - One of the best experts on this subject based on the ideXlab platform.
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Accessibility and potency of Uterotonic drugs purchased by simulated clients in four districts in India
BMC pregnancy and childbirth, 2014Co-Authors: Cynthia Stanton, Deepak Nitya Nand, Alissa Koski, Ellie Mirzabagi, Steve Brooke, Breanne Grady, Luke C. MullanyAbstract: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. 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. 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. 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.
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direct observation of Uterotonic drug use at public health facility based deliveries in four districts in india
International Journal of Gynecology & Obstetrics, 2014Co-Authors: Cynthia Stanton, Alissa Koski, Luke C. Mullany, Nitya Nand Deepak, Ashalata Mallapur, Geetanjali Katageri, Ellie MirzabagiAbstract:Abstract Objective To describe intrapartum Uterotonic drug use and related behaviors in public health facility-based deliveries and to describe drug storage conditions in associated pharmacies. Methods A descriptive study was conducted between August and November 2011 to document practices related to Uterotonic administration and storage based on direct observation of deliveries at public health facilities in four Indian districts (n = 97, n = 89, n = 91, and n = 89) with contrasting maternal health and socioeconomic indicators. Results Uterotonic drug use before and after delivery was common among the 366 study participants. Labor augmentation rates ranged from 53.5%–93.0% of deliveries across districts, with many receiving multiple Uterotonics and administration via intramuscular injection or intravenous push. Uterotonic use following delivery ranged from 78.6%–99.1% across districts, with correct use of Uterotonics for postpartum hemorrhage prevention varying from 6.0%–8.8% in Uttar Pradesh and 41.2%–76.4% in Karnataka. Active management of the third stage of labor following Indian guidelines was less than 10% in all districts. Storage of Uterotonics at room temperature was common. Conclusion Given that labor augmentation is nearly routine and at odds with Indian guideline recommendations, rigorous research is needed to assess maternal and fetal outcomes of current versus guidelines-based practice. Active management of the third stage of labor as per Indian guidelines was minimal.
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Uterotonic use during childbirth in uttar pradesh accounts from community members and health providers
Midwifery, 2013Co-Authors: Ellie Mirzabagi, Alissa Koski, Nitya Nand Deepak, Vandana TripathiAbstract:Abstract Objective this qualitative study aimed to document provider and community practices regarding Uterotonic use during labour and delivery in Uttar Pradesh, India, as well as the knowledge, attitudes, and values that underlie such use. Methods, setting, and participants a total of 140 in-depth interviews were conducted between May and July 2011 in Agra and Gorakhpur districts, with clinicians, nurses, recently delivered women, mothers-in-law with at least one grandchild, traditional birth attendants, unlicensed village doctors, and pharmacist assistants at chemical shops. Findings interviews reveal that injectable Uterotonic use for the purposes of labour augmentation is widespread in both clinical and community settings. However, use of Uterotonics for postpartum haemorrhage prevention and treatment appears to be relatively limited and was rarely discussed by respondents. Key beliefs underlying Uterotonic use were identified, including high valuation of labour pain, rapid delivery, and biomedical intervention, particularly administration of medicines. Other factors promoting the use of Uterotonics for labour augmentation included lack of knowledge about adverse effects, provider beliefs that prolonged labour poses risks to the baby, community perceptions that modern women are less able to have spontaneous delivery, and financial incentives for Uterotonic administration. Conclusions and implications major challenges to overcome in minimising Uterotonic misuse include entrenched use for labour augmentation in both institutional and community deliveries, perceptions of injectable Uterotonics as curative agents symbolic of biomedical care, and the widespread availability of these drugs. The findings demonstrate a need for programmes that reduce inappropriate use of Uterotonics, promote appropriate use for postpartum haemorrhage prevention and treatment, and ensure adherence to evidence-based guidelines.
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knowledge attitudes and practices related to Uterotonic drugs during childbirth in karnataka india a qualitative research study
PLOS ONE, 2013Co-Authors: Nitya Nand Deepak, Alissa Koski, Ellie Mirzabagi, Vandana TripathiAbstract:Background and Objectives India has the highest annual number of maternal deaths of any country. As obstetric hemorrhage is the leading cause of maternal death in India, numerous efforts are under way to promote access to skilled attendance at birth and emergency obstetric care. Current initiatives also seek to increase access to active management of the third stage of labor for postpartum hemorrhage prevention, particularly through administration of an Uterotonic after delivery. However, prior research suggests widespread inappropriate use of Uterotonics at facilities and in communities–for example, without adequate monitoring or referral support for complications. This qualitative study aimed to document health providers’ and community members’ current knowledge, attitudes, and practices regarding Uterotonic use during labor and delivery in India’s Karnataka state. Methods 140 in-depth interviews were conducted from June to August 2011 in Bagalkot and Hassan districts with physicians, nurses, recently delivered women, mothers-in-law, traditional birth attendants (dais), unlicensed village doctors, and chemists (pharmacists). Results Many respondents reported use of Uterotonics, particularly oxytocin, for labor augmentation in both facility-based and home-based deliveries. The study also identified contextual factors that promote inappropriate Uterotonic use, including high value placed on pain during labor; perceived pressure to provide or receive Uterotonics early in labor and delivery, perhaps leading to administration of Uterotonics despite awareness of risks; and lack of consistent and correct knowledge regarding safe storage, dosing, and administration of oxytocin. Conclusions These findings have significant implications for public health programs in a context of widespread and potentially increasing availability of Uterotonics. Among other responses, efforts are needed to improve communication between community members and providers regarding Uterotonic use during labor and delivery and to target training and other interventions to address identified gaps in knowledge and ensure that providers and pharmacists have up-to-date information regarding proper usage of Uterotonic drugs.
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Uterotonic drug quality an assessment of the potency of injectable Uterotonic drugs purchased by simulated clients in three districts in ghana
BMJ Open, 2012Co-Authors: Cynthia Stanton, Alissa Koski, Ellie Mirzabagi, Breanne Grady, Patience Cofie, Steve BrookeAbstract:Objectives Given use of Uterotonics for postpartum haemorrhage and other obstetric indications, the importance of potent Uterotonics is indisputable. This study evaluated access to and potency of injectable Uterotonics in Ghana. Design Study design involved research assistants simulating clients to purchase oxytocin and ergometrine from different sources. Drug potency was measured via chemical assay by the Ghana Food and Drugs Board. Setting The study was conducted in three contrasting districts in Ghana. Outcome measure The per cent of active pharmaceutical ingredient was measured to assess the quality of oxytocin and ergometrine. Results 69 formal points of sale were visited, from which 55 ergometrine ampoules and 46 oxytocin ampoules were purchased. None of the ergometrine ampoules were within British Pharmacopoeia specification for active ingredient, none were expired and one showed 0% active ingredient, suggestive of a counterfeit drug. Among oxytocin ampoules purchased, only 11 (26%) were within British Pharmacopoeia specification for active ingredient and two (4%) were expired. The median percentages of active ingredients were 64% and 50% for oxytocin and ergometrine, respectively. Conclusions The quality of injectable Uterotonics in three contrasting districts in Ghana is a serious problem. Restrictions regarding the sale of unregistered drugs, and of registered drugs from unlicensed shops, are inadequately enforced. These problems likely exist elsewhere but are not assessed, as postmarketing drug quality surveillance is generally restricted to well-funded disease-specific programmes relying on antiretroviral, antimalarial and antibiotic drugs. Maternal health programmes must adopt and fund the same approach to drug quality as is standard in programmes addressing infectious disease.
