The results of 29 ergometrine samples from Gambia/ Malawi, Sudan and Zimbabwe (Table 2) confirm the picture from earlier field studies from Bangladesh, Yemen and Zimbabwe5 in which only 9/24 (37%) samples complied with the USP/BP levels of active ingredient at 90-110% of the stated content. In the present series only 6/25 (24%) samples comply to USP/BP limits.
The combined data of both series therefore refer to 49 unexpired samples from 34 different facilities in 6 countries. Of these, only 15 (31%) complied with USP/BP limits; 12 (24%) had an 80-89% level of active ingredient, and as much as 15 (31%) samples had less than 60% potency.
These data indicate that there is a real field problem with the potency of ergometrine injection at the level of the end-user. The fact that over 70% of all non-expired samples do not comply to USP/BP standards strongly suggests that there is a stability problem.
Informal observations from the Royal Dutch Association for the Advancement of Pharmacy of the Netherlands suggests that the problem is not limited to developing countries. For example, one of four samples of locally formulated ergometrine injection taken from different large hospital pharmacies in the Netherlands did not comply to USP/BP standards, with a level of active ingredient of 84% of the stated amount37. Further study seems justified.
The 15 (31%) unexpired ergometrine samples in the two studies with potencies less than 60% were taken from five developing countries and concerned six different manufacturers. This shows that some products are of very bad quality at the level of the end-user, and that the problem is a real and not an academic one.
With oxytocin injection there seems to be less of a problem, but field data are too few to draw definitive conclusions (see Annex 2). One of the 6 samples from Zimbabwe was expired. Of the remaining 5 samples one was within the pharmacopoeial limits, and the other four were over the limit of 110%. There seems to be a pattern in which the products contain over 140% of the stated amount one year after manufacture, decreasing to 104-123% after about two years. If this overdose would be intentional this practice is not recommended. However, the results should be interpreted with caution as the official analysis method of oxytocin is still a biological method on rat uterus, which is prone to inaccuracy.