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The impact of thermal stability of oxytocin on access, and the importance of setting proper product specifications

Concerns are frequently raised about the challenge of maintaining the effectiveness of oxytocin for postpartum hemorrhage (PPH) prevention in tropical settings when refrigerated storage conditions cannot be assured.1 The reason for concern is that when oxytocin is exposed to high temperatures for extended periods of time, the effective dose can drop below the prescribed industry standard of 90%–110% of the label claim before its expiry date. In the present report, we raise two questions arising from this situation. First, are the current standards and specifications for the storage and shelf life of oxytocin clinically relevant and aligned with a public health interest in ensuring access to efficacious and safe treatment? Second, if the current standards and specifications are not clinically relevant, is access to a vital medicine needed to save lives being hindered? Oxytocin has a rated shelf life of 3 years when maintained at 2–8°C. Hogerzeil et al.2 have documented that when oxytocin is stored at a continuous temperature of 30°C, its potency falls by 14% after 1 year. The temperaturerelated degradation of oxytocin shows firstorder kinetics (a constant fractional decrease in potency over time).3 Therefore, projected over 3 years, the expected fall in potency at this temperature would be approximately 36%. For a continuous temperature of 40°C, Hogerzeil et al.2 documented a 6% loss of potency over 1 month. After 1 year, this means a 50% decrease in potency. The actual temperatures to which the product is exposed in realworld clinical use—even in the tropics—are not this extreme. For example, the mean annual temperature is 25°C in Delhi (India) and 27°C in Abuja (Nigeria). Nonetheless, deviations from refrigerated conditions can result in the product falling below the industry standard potency before its expiry date. The operative question is whether oxytocin’s effectiveness and clinical benefit is significantly reduced when the assay indicates a fall below the current industry standard of 90%–110%. Evidence of oxytocin’s effectiveness for reducing the risk of PPH is summarized in a Cochrane review by Westhoff et al.4 Across the five trials retained—comparing oxytocin with no uterotonic, with blood loss of more than 500 mL as an endpoint—there was no discernable difference in clinical effectiveness between oxytocin doses of 5 and 10 IU (Table 1). There have been no headtohead dosefinding studies, so there is insufficient evidence from these trials to determine definitively whether there is a difference in effectiveness by dose (5 vs 10 IU). Nevertheless, the available evidence indicates that with routine use at a dose of 10 IU (as recommended by WHO10), even a 50% loss of potency (delivering an effective dose of 5 IU) might not compromise clinical benefit. Degradation has implications not only for effectiveness but also for safety. For many drugs, it can result in toxic secondary products.