- All > Medicine Access and Rational Use > Supply Management
- All > Quality and Safety: Medicines > Quality Assurance
(1988; 1 page)
SIR,-Post-partum haemorrhage is a major cause of direct maternal death, causing around 33% of such deaths where maternal mortality is high/ 21 % in countries with lower rates and 8% in England and Wales. An estimated 125 000 women, mainly living in developing countries, die every year from this cause. Parenteral ergometrine is an invaluable drug in the treatment and prevention of excessive uterine bleeding following obstetric delivery.
We have received reports from obstetricians and others working in developing countries about the occasional ineffectiveness of ergometrine. Information on the stability and storage of parenteral ergometrine notes that it should be stored at a temperature not exceeding 8 degrees Celsius and be protected from light. These requirements are either not known by most people involved in drug supply in tropical countries or are not followed.
We collected 24 samples from twenty peripheral health facilities in Bangladesh, Democratic Yemen, and Zimbabwe. None had been kept in a refrigerator. 5 had passed the manufacturer’s expiry date by up to 12 months. Only 9 (37%) conformed to the USP and BP with potencies between 450-550 pg/ml. 8 (33%) had potencies of 400-449 Ilg/ml (80-89%). 7 (29%) had potencies of 20% or less, 5 of these 7 specimens were from one manufacturer, presented in unstained glass vials, and between 12 and 14 months had elapsed since manufacture. Similar findings come from a Sudanese- Swedish study on the deterioration of drugs during transport and storage (N. Stjornstrom, National Board of Health and Welfare, Sweden).
There appears to be a significant problem with the potency of injectable ergometrine stored at ambient temperatures in tropical countries. Ergometrine vials must be stored in a refrigerator, as vaccines are. If that is not possible we recommend that ergometrine be used within one year of manufacture.