- Email: [email protected]
Securing reproductive rights
CORRESPONDENCE
COMMENTARY
CORRESPONDENCE e-mail submissions to [email protected]
Securing reproductive rights Sir—Your series on reproductive health and rights (Jan 3, pp 67, 75)1,2 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,3,4 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%).5 With this locally generated evidence in hand, health-care professionals agreed to avoid ergometrine 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.
*Albert Figueras, Edgar Narváez, Cristina Aguilera, Joan-Ramon Laporte *Fundació Institut Català de Farmacologia, Departament de Farmacologia, Terapèutica i Toxicologia, Universitat Autònoma de Barcelona, Hospital Vall d’Hebron, E-08035–Barcelona, Spain (e-mail: [email protected])
1 2
Graham W, Hussein J. The right to count. Lancet 2004; 363: 67–68. Davis V. New and underused technologies to reduce maternal mortality. Lancet 2004; 363: 75–76.
3
4
5
Walker GJ, Hogerzeil HV. Potency of ergometrine in tropical countries. Lancet 1988; 2: 393. Hogerzeil HV, Walker GJA, De Goeje MJ. Oxytocin more stable in tropical climates. BMJ 1994; 308: 59. US Pharmacopoeia—USP XXV–National Formulary. Rockville: US Pharmacopeial Convention, 2002: 669–70.
Sir—We congratulate you on bringing maternal mortality into the public debate again (Jan 3). That an estimated 500 000 women die every year from pregnancy-related complications is one of the most shameful statistics of modern times. Although many aspects of maternal mortality are highly complex, there are two simple changes that could slash maternal mortality rates overnight. Both, however, have been suppressed for political reasons. The first is the worldwide introduction of the cheap, stable, orally active prostaglandin misoprostol. Prostaglandins cause the uterus to contract and are essential in obstetric practice, with uses ranging from labour induction and treatment of post-partum haemorrhage to missed and incomplete abortion. For the common problems of severe pre-eclampsia and post-partum haemorrhage, they are life-saving. For most of these indications, the alternatives to misoprostol are either ineffective or prohibitively expensive. Misoprostol has huge potential, but the manufacturer has refused to support its use for reproductive health indications for fear of the anti-abortion lobby. Its development has therefore relied on individual enthusiasts who have worked tirelessly over the past decade to establish safe and effective doses (see http://www.misoprostol.org, accessed Feb 5, 2004). Recognising its massive potential for saving women’s lives, governments have recently introduced misoprostol into South Africa, Ghana, and Uganda. It remains unlicensed in all other African countries, and neither misoprostol nor any alternative prostaglandin is listed on the WHO essential drugs list. Why is the international community silent on this issue? Where is the global initiative to make the most important life-saving drug in women’s health care
THE LANCET • Vol 363 • March 20, 2004 • www.thelancet.com
For personal use. Only reproduce with permission from The Lancet.
989
COMMENTARY
CORRESPONDENCE e-mail submissions to [email protected]
Securing reproductive rights Sir—Your series on reproductive health and rights (Jan 3, pp 67, 75)1,2 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,3,4 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%).5 With this locally generated evidence in hand, health-care professionals agreed to avoid ergometrine 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.
*Albert Figueras, Edgar Narváez, Cristina Aguilera, Joan-Ramon Laporte *Fundació Institut Català de Farmacologia, Departament de Farmacologia, Terapèutica i Toxicologia, Universitat Autònoma de Barcelona, Hospital Vall d’Hebron, E-08035–Barcelona, Spain (e-mail: [email protected])
1 2
Graham W, Hussein J. The right to count. Lancet 2004; 363: 67–68. Davis V. New and underused technologies to reduce maternal mortality. Lancet 2004; 363: 75–76.
3
4
5
Walker GJ, Hogerzeil HV. Potency of ergometrine in tropical countries. Lancet 1988; 2: 393. Hogerzeil HV, Walker GJA, De Goeje MJ. Oxytocin more stable in tropical climates. BMJ 1994; 308: 59. US Pharmacopoeia—USP XXV–National Formulary. Rockville: US Pharmacopeial Convention, 2002: 669–70.
Sir—We congratulate you on bringing maternal mortality into the public debate again (Jan 3). That an estimated 500 000 women die every year from pregnancy-related complications is one of the most shameful statistics of modern times. Although many aspects of maternal mortality are highly complex, there are two simple changes that could slash maternal mortality rates overnight. Both, however, have been suppressed for political reasons. The first is the worldwide introduction of the cheap, stable, orally active prostaglandin misoprostol. Prostaglandins cause the uterus to contract and are essential in obstetric practice, with uses ranging from labour induction and treatment of post-partum haemorrhage to missed and incomplete abortion. For the common problems of severe pre-eclampsia and post-partum haemorrhage, they are life-saving. For most of these indications, the alternatives to misoprostol are either ineffective or prohibitively expensive. Misoprostol has huge potential, but the manufacturer has refused to support its use for reproductive health indications for fear of the anti-abortion lobby. Its development has therefore relied on individual enthusiasts who have worked tirelessly over the past decade to establish safe and effective doses (see http://www.misoprostol.org, accessed Feb 5, 2004). Recognising its massive potential for saving women’s lives, governments have recently introduced misoprostol into South Africa, Ghana, and Uganda. It remains unlicensed in all other African countries, and neither misoprostol nor any alternative prostaglandin is listed on the WHO essential drugs list. Why is the international community silent on this issue? Where is the global initiative to make the most important life-saving drug in women’s health care
THE LANCET • Vol 363 • March 20, 2004 • www.thelancet.com
For personal use. Only reproduce with permission from The Lancet.
989