Securing reproductive rights

Abstract

Your series on reproductive health and rights (Jan 3, pp 67, 75)1Graham W Hussein J The right to count.Lancet. 2004; 363: 67-68Summary Full Text Full Text PDF PubMed Scopus (18) Google Scholar, 2Davis V New and underused technologies to reduce maternal mortality.Lancet. 2004; 363: 75-76Summary Full Text Full Text PDF PubMed Google Scholar highlights the political, cultural, and industrial issues that hinder improvement of the sometimes inaccurate maternal death figures. Specific experiences and difficulties encountered when addressing this problem could be helpful for planning future interventions. The Health Ministry of Nicaragua started a countrywide programme for developing local therapeutic guidelines through an international external consultation. Post partum haemorrhage was chosen as the first health problem to be addressed. A pre-intervention study to describe perinatal-mother management at the Hospital Alemán-Nicaragüense (HAN) in Managua (October–November, 2000), showed extensive use of ergometrine during delivery. Evidence of the inefficiency of ergometrine in adverse climate conditions was discussed with HAN personnel and the national regulatory authorities. However, we encountered reluctance to change prescription behaviour based on non-controlled “personal good clinical experience” with ergometrine, and “lack of local data on pharmaceuticals of substandard quality”. Although previous studies had shown the instability of ergometrine in tropical climates,3Walker GJ Hogerzeil HV Potency of ergometrine in tropical countries.Lancet. 1988; 2: 393Abstract PubMed Scopus (36) Google Scholar, 4Hogerzeil HV Walker GJA De Goeje MJ Oxytocin more stable in tropical climates.BMJ. 1994; 308: 59PubMed Google Scholar a subsequent analysis of ergometrine quality was done by the National Laboratory for Quality Control (February, 2001). Samples of ampoules stored in several Nicaraguan drug warehouses were randomly selected. The analysis revealed a mean ergometrine content of 75·5% (USP acceptable range according to the US Pharmacopeia: 90–110%).5US Pharmacopoeia—USP XXV–National Formulary. US Pharmacopeial Convention, Rockville2002: 669-670Google Scholar With this locally generated evidence in hand, health-care professionals agreed to avoid ergo-metrine use in favour of oxytocin, a supply of which was granted by the drug regulatory authorities. Therapeutic guidelines were prepared, discussed, published, and disseminated (April, 2001). A post-intervention assessment was planned for October, 2001. From January to April, 2001, ergometrine consumption decreased, whereas that of oxytocin increased. Supply of ergometrine was stopped in April, 2001. Due to other commitments, the 6-month analysis was done in December, 2001, instead of October. Unexpectedly, a peak of ergometrine consumption reappeared in November, 2001, a period that was not to be included in the initial 6-month monitoring plan. This peak was attributed to a temporary lack of supply of oxytocin due to depletion of financial resources affecting the whole country. Likewise, these budgetary difficulties led to postponing follow-up consultation visits for the therapeutic guidelines project until November, 2002. At this time, the data were presented and discussed again with the HAN personnel and the health authorities. Removal of ergometrine from the National Basic Drug List was planned. Weaknesses in at least three steps of the therapeutic chain contributed to irrational drug use: regulation, marketing, and prescription. Information gap and failure to produce knowledge led to “ineffective” drug access. The real cost of this imbalance in terms of morbidity and mortality is difficult to evaluate, but it could be high. Selection of the most appropriate medicines for each environment on the basis of the best available evidence can contribute to the avoidance of these failures. We thank Nubia Blanco, Francisco J Álvarez (Laboratorio Nacional de Control de Calidad de Medicamentos, MINSA, Nicaragua). the health personnel of the Service of Obstetrics and Gynaecology of the Hospital Alemán Nicaragüense (Managua, Nicaragua) directed by Carla Cerrato, and the Centro de Información de Medicamentos (CIMED, MINSA, Nicaragua), at that time directed by Maritza Narváez.