Accessibility and potency of uterotonic drugs purchased by simulated clients in four districts in India

Abstract

BackgroundSurveillance 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.MethodsThe 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.ResultsIn 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.ConclusionPrivate 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.

Access to oxytocin and misoprostol for management of postpartum haemorrhage in Kenya, Uganda and Zambia: a cross-sectional assessment of availability, prices and affordability

“…[7][8][9] The quality, efficacy and safety of oxytocin and misoprostol have been widely studied. [10][11][12][13][14][15][16][17][18][19][20][21][22][23] Oxytocin is temperature sensitive and should therefore be stored under refrigeration at temperatures between 2°C and 8°C to prevent degradation expected at higher temperatures. 10 Degradation reduces potency and consequently the effectiveness of the medicine.…”

“…[11][12][13] Some studies on the quality of oxytocin found analysed samples to contain less active pharmaceutical ingredients than was claimed in the label, while some samples also failed sterility tests. [14][15][16] LMICs with low resources may also lack facilities required for adequate storage conditions for oxytocin to ensure integrity of the product, while they may also lack trained health workers for its administration. 17 Women living among displaced populations, in conflict areas, hard to reach areas, who deliver at home or with a traditional birth attendant seldom have access to a trained health worker.…”

Stability of misoprostol tablets collected in Malawi and Rwanda: Importance of intact primary packaging

“…This storage requirement can be challenging, especially in rural areas of low-and middle-income countries (LMICs) where infrastructure is poor and ambient temperatures are often high [8][9][10][11][12]. Indeed, several previous studies have shown that the quality of oxytocin, especially in LMICs, is often poor [3,[10][11][12][13][14][15][16][17].…”

Prevention of obstetric bleeding in high risk groups. Modern treatment tactics

“…Лекарственные средства из группы утеротонических препаратов играют важнейшую роль в акушерстве, в частности при осуществлении родоактивации и родовозбуждения, а также в ходе профилактики и лечения ПРК. Независимо от показаний при использовании утеротонических ЛС специалисты добиваются оптимального сочетания эффективности и безопасности их применения с учетом характеристик конкретных препаратов, их дозировок, способов введения, клинических показаний и противопоказаний к их применению, а также индивидуальных особенностей пациентки [25].…”

“…По мнению специалистов [12,13,25], в настоящее время отсутствие эффективных утеротонических препаратов является ключевым препятствием к существенному снижению материнской смертности в большинстве стран мира.…”