Malaria due to P. falciparum is the number one cause of morbidity and mortality in Uganda where it is highly endemic in 95% of the country. The use of efficacious and effective antimalarial medicines is one of the key strategies for malaria control. Until 2000, Chloroquine (CQ) was the first-line drug for treatment of uncomplicated malaria in Uganda. Due to progressive resistance to CQ and to a combination of CQ with Sulfadoxine-Pyrimethamine, Uganda in 2004 adopted the use of ACTs as first-line drug for treating uncomplicated malaria. A review of the drug policy change process and postimplementation reports highlight the importance of managing the policy change process, generating evidence for policy decisions and availability of adequate and predictable funding for effective policy roll-out. These and other lessons learnt can be used to guide countries that are considering anti-malarial drug change in future. 1. Introduction Malaria is the number one cause of morbidity and mortality in Uganda. It is highly endemic in 95% of the country, and the remaining 5% of the country is prone to malaria epidemics [1]. Over 95% of the malaria cases are due to plasmodium falciparum. Effective malaria case management, using efficacious and effective antimalarial medicines, is one of the recommended strategies for malaria control [2]. Until 2000, Chloroquine (CQ) was the first-line medicine for treatment of uncomplicated malaria in Uganda, and Sulfadoxine/Pyrimethamine (SP) or Amodiaquine (AQ) was the 2nd-line medicine while Quinine (Qn) was the reserve medicine. For severe malaria, Qn was the recommended medicine initially given intravenously until the patient is conscious and able to take medicines orally [3]. However, in the late 1990s, parasite resistance to CQ, at varying levels in the 8 East African Network for Monitoring Antimalarial Treatment (EANMAT) sentinel sites located in different parts of the country, was documented. By 2000, the parasitological resistance to CQ had increased significantly, ranging from <5% to >50% in different sites, and clinical failure following CQ treatment in Uganda had increased to about 38% [4], exceeding the WHO recommended threshold of clinical failure of 25%, beyond which policy change is recommended in the shortest time possible [5]. Uganda embarked on a malaria treatment policy change process as shown in Figure 1. After several technical discussions and considerations, the first-line antimalarial medicine for uncomplicated malaria was changed from CQ only, and a new interim policy with a combination of CQ and
References
[1]
P. E. Okello, W. Van Bortel, A. M. Byaruhanga et al., “Variation in malaria transmission intensity in seven sites throughout Uganda,” American Journal of Tropical Medicine and Hygiene, vol. 75, no. 2, pp. 219–225, 2006.
[2]
Roll Back Malaria Partnership, “Global Malaria Action Plan,” 2008, http://www.rollbackmalaria.org/gmap/0-5.html.
[3]
Ministry of Health, “Uganda Malaria Control Policy,” 2000.
[4]
M. R. Kamya, N. N. Bakyaita, A. O. Talisuna, W. M. Were, and S. G. Staedke, “Increasing antimalarial drug resistance in Uganda and revision of the national drug policy,” Tropical Medicine and International Health, vol. 7, no. 12, pp. 1031–1041, 2002.
[5]
World Health Organization, Regional Office for Africa, Brazzaville, “Framework for Developing, Implementing, and Updating Antimalaria Treatment Policy: A Guide for Country Malaria Control Programmes,” 2003, http://afrolib.afro.who.int/documents/2003/english/framedrugp.pdf.
[6]
World Health Organization, “Global report on antimalarial drug efficacy and drug resistance: 2000–2010,” 2010, http://www.searo.who.int/LinkFiles/Malaria_antimalarial_drug_efficacy10.pdf.
[7]
A. O. Talisuna, A. Nalunkuma-Kazibwe, N. Bakyaita et al., “Efficacy of sulphadoxine-pyrimethamine alone or combined with amodiaquine or chloroquine for the treatment of uncomplicated falciparum malaria in Ugandan children,” Tropical Medicine and International Health, vol. 9, no. 2, pp. 222–229, 2004.
[8]
N. Bakyaita, G. Dorsey, A. Yeka et al., “Sulfadoxine-pyrimethamine plus chloroquine or amodiaquine for uncomplicated falciparum malaria: a randomized, multisite trial to guide national policy in Uganda,” American Journal of Tropical Medicine and Hygiene, vol. 72, no. 5, pp. 573–580, 2005.
[9]
S. G. Staedke, A. Mpimbaza, M. R. Kamya, B. K. Nzarubara, G. Dorsey, and P. J. Rosenthal, “Combination treatments for uncomplicated falciparum malaria in Kampala, Uganda: randomised clinical trial,” The Lancet, vol. 364, no. 9449, pp. 1950–1957, 2004.
[10]
Ministry of Health, Uganda, “National policy on malaria treatment 2005,” 2005, http://www.health.go.ug/mcp/NationalPolicyonMalariaTreatment(07_03_06).pdf.
[11]
World Health Organization, “Position of WHO's Roll Back Malaria Department on malaria treatment policy,” 2003, http://www.who.int/malaria/publications/atoz/who_apt_position.pdf.
[12]
A. Attaran, K. I. Barnes, C. Curtis et al., “WHO, the Global Fund, and medical malpractice in malaria treatment,” The Lancet, vol. 363, no. 9404, pp. 237–240, 2004.
[13]
C. Fogg, F. Bajunirwe, P. Piola et al., “Adherence to a six-dose regimen of artemether-lumefantrine for treatment of uncomplicated Plasmodium falciparum malaria in Uganda,” American Journal of Tropical Medicine and Hygiene, vol. 71, no. 5, pp. 525–530, 2004.
[14]
S. G. Staedke, M. R. Kamya, G. Dorsey et al., “Amodiaquine, sulfadoxine/pyrimethamine, and combination therapy for treatment of uncomplicated falciparum malaria in Kampala, Uganda: a randomised trial,” The Lancet, vol. 358, no. 9279, pp. 368–374, 2001.
[15]
G. Dorsey, D. Njama, M. R. Kamya et al., “Sulfadoxine/pyrimethamine alone or with amodiaquine or artesunate for treatment of uncomplicated malaria: a longitudinal randomised trial,” The Lancet, vol. 360, no. 9350, pp. 2031–2038, 2002.
[16]
S. Ogwang, M. Engl, M. Vigl, H. Kollaritsch, G. Wiedermann, and W. H. Wernsdorfer, “Clinical and parasitological response of Plasmodium falciparum to chloroquine and sulfadoxine/pyrimethamine in rural Uganda,” Wiener Klinische Wochenschrift, vol. 115, no. 3, pp. 45–49, 2003.
[17]
R. Ndyomugyenyi, P. Magnussen, and S. Clarke, “The efficacy of chloroquine, sulfadoxine-pyrimethamine and a combination of both for the treatment of uncomplicated Plasmodium falciparum malaria in an area of low transmission in western Uganda,” Tropical Medicine and International Health, vol. 9, no. 1, pp. 47–52, 2004.
[18]
A. F. Gasasira, G. Dorsey, B. Nzarubara et al., “Comparative efficacy of aminoquinoline-antifolate combinations for the treatment of uncomplicated falciparum malaria in Kampala, Uganda,” American Journal of Tropical Medicine and Hygiene, vol. 68, no. 2, pp. 127–132, 2003.
[19]
F. Checchi, P. Piola, C. Kosack et al., “Antimalarial efficacy of sulfadoxine-pyrimethamine, amodiaquine and a combination of chloroquine plus sulfadoxine-pyrimethamine in Bundi Bugyo, western Uganda,” Tropical Medicine and International Health, vol. 9, no. 4, pp. 445–450, 2004.
[20]
A. Yeka, K. Banek, N. Bakyaita, et al., “Artemesinin versus nonartemesinin combination therapy for uncomplicated malaria: randomized clinical trials from four sites in Uganda,” PLoS Medicine, vol. 2, no. 7, pp. 654–662, 2005.
[21]
National Drug Authority, Uganda, “Human drug register for January 2011,” 2011, http://www.nda.or.ug/docs/Human_list.pdf.
[22]
WHO; Promoting quality of medicines programme (PQM)—USAID, “Quality of antimalarials in Sub Saharan Africa,” 2010.
[23]
F. K. Kato, “The malaria treatment policy change process in Uganda,” 2006.
[24]
National Malaria Control Programme, Ministry of Health, Uganda Malaria Research Centre, and Malaria Consortium, “Assessing the availability of the first and second line antimalarials in selected health facilities in Uganda,” 2007.
[25]
National Malaria Control Programme, “Analysis of malaria attendances according to AL dosage age groups,” 2007.
[26]
D. Zurovac, J. Tibendarana, J. Nankabirwa, J. Ssekitooleko, A. Talisuna, and J. B. Rwakimari, “Evaluation of outpatient malaria case-management under artemether-lumefantrine treatment policy in Uganda,” 2007.
[27]
L. Kapiriri and D. K. Martin, “The Global Fund Secretariat's suspension of funding to Uganda: how could this have been avoided?” Bulletin of the World Health Organization, vol. 84, no. 7, pp. 576–580, 2006.
[28]
Ministry of Health, “Annual health sector performance reports for the financial year 2006/07,” 2007.
[29]
J. A. Mulligan, R. Mandike, N. Palmer et al., “The costs of changing national policy: lessons from malaria treatment policy guidelines in Tanzania,” Tropical Medicine and International Health, vol. 11, no. 4, pp. 452–461, 2006.
[30]
E. M. Malik, T. A. Mohamed, K. A. Elmardi et al., “From chloroquine to artemisinin-based combination therapy: the Sudanese experience,” Malaria Journal, vol. 5, article no. 65, 2006.
[31]
R. Shretta, J. Omumbo, B. Rapuoda, and R. W. Snow, “Using evidence to change antimalarial drug policy in Kenya,” Tropical Medicine and International Health, vol. 5, no. 11, pp. 755–764, 2000.
[32]
P. Ringwald, T. Sukwa, L. K. Basco et al., “Monitoring of drug-resistant malaria in Africa,” The Lancet, vol. 360, no. 9336, pp. 875–876, 2002.
[33]
A. W. Holly, D. Durrheim, and R. Shretta, “The process of changing national malaria treatment policy: lessons from country-level studies,” Health Policy and Planning, vol. 19, no. 6, pp. 356–370, 2004.
[34]
G. M. Mubyazi and M. A. Gonzalez-Block, “Research influence on antimalarial drug policy change in Tanzania: case study of replacing chloroquine with sulfadoxine-pyrimethamine as the first-line drug,” Malaria Journal, vol. 4, article number 51, 2005.
[35]
H. A. Williams, D. Durrheim, and R. Shretta, “The process of changing national malaria treatment policy: lessons from country-level studies,” Health Policy and Planning, vol. 19, no. 6, pp. 356–370, 2004.
[36]
M. Jowett, N. Miller, and N. Mnzava, “Malaria expenditure analysis. Tanzania case study. Report prepared for DFID-EA (Tanzania) and the Roll Back Malaria Initiative,” International Programme, Centre for Health Economics, University of York, York, UK, 2000.
[37]
C. A. Goodman, P. G. Coleman, and A. J. Mills, “Changing the first line drug for malaria treatment—Cost-effectiveness analysis with highly uncertain inter-temporal trade-offs,” Health Economics, vol. 10, no. 8, pp. 731–749, 2001.
[38]
W. K. Asenso-Okyere and J. A. Dzator, “Household cost of seeking malaria care. A retrospective study of two districts in Ghana,” Social Science and Medicine, vol. 45, no. 5, pp. 659–667, 1997.
[39]
J. O. Nabyonga, F. Ssengooba, and S. Okuonzi, “Can donor aid for health be effective in a poor country? Assessment of prerequisites for aid effectiveness in Uganda,” The Pan African Medical Journal, vol. 3, p. 9, 2009.
[40]
N. Oomman and M. Bernstein, Following the Funding for HIV/AIDS: A Comparative Analysis of the Funding Practices of PEPFAR, the Global Fund and World Bank MAP in Mozambique, Uganda and Zambia, Center for Global Development, Washington, Wash, USA, 2007.
[41]
Kaiser Daily HIV/AIDS report, “HIV/AIDS/global financial crisis could harm HIV/AIDS funding,” Piot says, 2008, http://www.global healthreporting.org/article.asp?DR_ID=55258.
[42]
S. A. Okuonzi and J. Macrae, “Whose policy is it anyway? International and national influences on health policy development in Uganda,” Health Policy and Planning, vol. 10, no. 2, pp. 122–132, 1995.
[43]
S. Abdulla, C. Goodman, P. Coleman, G. Mubyazi, N. Kikumbih, and T. Okorosobo, “The Costs, Effects and Cost-Effectiveness of Changing the First-Line Drug for the Treatment of Malaria in Tanzania,” Health Economics and Financing Programme (HEFP), LSHTM. Working Paper No. 01/00, 2000 http://www.dfid.gov.uk/r4d/PDF/Outputs/HealthEcFin_KP/WP01_00.pdf.
[44]
J. A. Mulligan, R. Mandike, N. Palmer et al., “The costs of changing national policy: lessons from malaria treatment policy guidelines in Tanzania,” Tropical Medicine and International Health, vol. 11, no. 4, pp. 452–461, 2006.
[45]
Uganda Bureau of Statistics, “National household Survey report,” 2005.
[46]
B. Wasunna, D. Zurovac, C. A. Goodman, and R. W. Snow, “Why don't health workers prescribe ACT? A qualitative study of factors affecting the prescription of artemether-lumefantrine,” Malaria Journal, vol. 7, article no. 29, 2008.
[47]
B. B. Kangwana, J. Njogu, B. Wasunna et al., “Short report: malaria drug shortages in kenya: a major failure to provide access to effective treatment,” American Journal of Tropical Medicine and Hygiene, vol. 80, no. 5, pp. 737–738, 2009.