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 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.

Direct observation of uterotonic drug use at public health facility-based deliveries in four districts in India.

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.

Knowledge, attitudes, and practices related to uterotonic drugs during childbirth in Karnataka, India: a qualitative research study.

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.

Uterotonic use during childbirth in Uttar Pradesh: accounts from community members and health providers.

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.

Uterotonic drug quality: an assessment of the potency of injectable uterotonic drugs purchased by simulated clients in three districts in Ghana.

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.