Pooja Maharjan

and 5 more

Background There is evidence to suggest that many medicines commonly used for pregnant women for the management of hypertensive disorders of pregnancy are poor quality. Objective To review the available studies systematically reporting medicine quality, routinely used in the prevention and management of hypertensive disorders of pregnancy. Search strategy We searched five electronic databases- Ovid MEDLINE, EMBASE, CINAHL, ProQuest and Cochrane Library, without year or language limitations. Selection criteria Studies reporting on quality parameters of nine medicines - magnesium sulphate, aspirin, calcium supplements, amlodipine, nifedipine, methyldopa, enalapril, hydralazine and labetalol, using any valid laboratory methods. Data collection and analysis Two reviewers independently screened the studies, extracted data and assessed the quality. Results were reported narratively by type of medicine. Main results Of 5669 citations screened, 33 studies from 27 countries were included. Five quality studies on magnesium sulphate- two (Nigeria and USA) found substandard medicine due to failing API specification and contaminants, respectively. Another study from Nigeria and a multi-country study (10 lower-middle- and low-income countries) found poor-quality due to failing the pH criteria. Seven of eight studies evaluating aspirin found quality issues, including degraded medicines in five studies (Brazil, USA, Yugoslavia and Pakistan). Five studies of calcium supplements found quality issues, particularly heavy metal contamination. Of 15 antihypertensives quality studies, 12 found substandard medicines and one study identified counterfeit medicines. Conclusion We identified multiple findings of poor quality across all types of medicines used in hypertensive disorders of pregnancy, raising concerns regarding their safety and effectiveness.

Peter Lambert

and 8 more

Objective: To investigate the compatibility of oxytocin and tranexamic acid injection products when mixed for the purpose of co-administration by intravenous infusion. Population or Sample: Oxytocin and tranexamic acid were collected from hospitals taking part in a multicentre postpartum haemorrhage treatment (E-MOTIVE) trial in Kenya, Nigeria, Tanzania, and South Africa. Methods: The compatibility of two sentinel products of oxytocin injection and tranexamic acid injection in 200mL infusion bags of both 0.9%w/v saline and Ringer’s Lactate was assessed. We analysed all tranexamic acid -oxytocin combinations, and each evaluation was conducted for up to 6hrs. Subsequently, the compatibility of multiple tranexamic acid products with reference oxytocins products when mixed in 0.9%w/v saline over a period of 1 hour was investigated. Results: We found a significant interaction between certain oxytocin and tranexamic acid products after mixing them in vitro and observing for 1 hour. The interaction substantially impacted oxytocin content leading to reduction in concentration (14.8% - 29.0%) immediately on mixing (t=0 minutes). In some combinations, the concentration continued to decline throughout the stability assessment period. Oxytocin loss was observed in 7 out of 22 (32%) combinations tested. Conclusions: In a clinical setting, mixing oxytocin and tranexamic acid may result in an underdosing of oxytocin, compromising care in an emergency life-threatening situation. The mixing of oxytocin and tranexamic acid injection products for co-administration with IV infusion fluids should be avoided until the exact nature of the interaction and its implications are understood.