The period from mid 1980s marked an increasing interest in antimalarial drug resistance among biomedical researchers in Tanzania. Thus, several small-scale clinical trials were conducted by researchers from the NIMR in collaboration with local and foreign universities, funded by bilateral agencies such as SDC, DANIDA, USAID, DFID and multilateral agencies including WHO, UNDP and UNICEF. Findings from each of such studies gave evidence that CQ was increasingly facing resistance and treatment failures.
Spread of drug resistance and recommended level to prompt policy change
The need for changing the policy came from accumulated evidence and increasing debates on increasing trend of P. falciparum resistance to CQ, that has been observed in different parts of the country [
21‐
26] since the mid-1950s (also see Table
1 & Figure
1), through to 1970s [
27] and the last two decades [
4,
28]. The Minister of Health, Hon. Anna Abdallah, informed the Parliament of the United Republic of Tanzania during the 2002–2003 budgetary session that her Ministry's decision to suspend CQ as the first-line drug was based on sound evidence pointing to the high cure-rate failure of about 60% while the SP cure rate was 85–90% and was more cost-effective than other antimalarials [
27]. While WHO recommends policy change to an alternative drug when the treatment failure reached 25%, evidence from different sentinel sites in the country indicated that up to the time of policy change, CQ treatment failure rate [
6] had already reached 52% (ranging 28–72%), 9.5% for SP (ranging 6–32%), and other drugs such as amodiaquine (AQ) and quinine was less than 4.6% (ranging 3.5% – 6%). The increasing numbers of malaria morbidity and mortality in the country, from year to year, was associated by local and foreign researchers with the increasing trend of parasite resistance to CQ. Concern was, therefore, raised about the need to review and improve the national malaria treatment policy guidelines. Another important reason for the increased enthusiasm for policy change towards the end of 1990s is that some countries such as Kenya, Botswana, Malawi and South Africa had already revised their national drug policy guidelines whereby SP had replaced CQ as the first-line drug [
6].
Table 1
Trends in antimalarial drug resistance in Tanzania, 1950s–1990s
Early 1950s | A dose of 2.5 mg/kg is still efficacious (grace period) |
Mid-1970s | Owing to slow increase in resistance, the therapeutic dose was gradually increased to the maximum safe level of 25 mg/kg (alert period) |
Late 1980s | Resistance to the maximum dose began to reach levels of significant public health importance (alert period) |
Mid-1990s | WHO recommended drug policy action if resistance (total treatment failure) reaches 25% (change period) |
Late 1990s | Tanzania established sentinel sites in nine regions to monitor resistance by standard methods |
Sentinel sites for antimalarial drug resistance monitoring
In 1997, the MoH of Tanzania through its NMCP, in collaboration with EANMAT, decided to select nine areas in different parts of the country to act as sentinel sites for monitoring antimalarial drug resistance. These sites were selected on a number of criteria, including areas with different socio-economic characteristics and accessibility to antimalarial drug sources and varying malaria endemicity and drug resistance patterns. This was followed by the NMCP with support from WHO and other donors to commission a number of studies from research institutions like NIMR and IHRDC, university teaching hospitals, and other institutions to monitor drug resistance and report findings to the Government for consideration. From their inception, the sentinel sites have provided an environment for producing evidence based on which the National Task Force on Antimalarial Drug Policy and EANMAT developed a policy-brief summary to feedback to the national policy makers, who were finally convinced of the widespread CQ resistance and clinical treatment failures throughout the country, which had never happened previously.
The National Task Force on Antimalarial Drug Policy
The National Task Force on Antimalarial Drug Policy was formulated in May 1999 as a sub-committee of the National Malaria Advisory Committee (NMAC) in consultation with the EANMAT and WHO country office in Dar Es Salaam. This body is comprised of interdisciplinary professionals, some of them from the MoH acting as key policy decision-makers (including the Director of Preventive Services, NIMR's Director General, Muhimbili National Hospital, the National Pharmacy Board, Integrated Management of Childhood Illnesses (IMCI) and the Medical Stores Department). WHO Country office also has been participating in several activities of the Task Force and the NMAC and in providing the necessary and feasible technical and material assistance.
On 23
rd July 1999, the Task Force developed a three-page summary, drawing on evidence from clinical trials in the sentinel sites. This information was supplemented with a review of national health management information (HMIS) records, as a research policy-brief to highlight to national policy-makers the trend in antimalarial drug resistance, the status of malaria-related morbidity and mortality, and provide immediate suggestions for short and long term intervention towards effective and sustainable malaria control in the country [
10]. The evidence presented in such a brief document was exactly the same as it appeared in the technical research report by Abdulla
et al [
6] warning of the increase of resistance to chloroquine. On that ground, it was recommended that SP should be adopted as the first-line drug in the interim period, while efforts to find the most suitable alternative were underway. It was recommended that the decision to change the policy should be interim because of the increasing evidence on high SP resistance in various parts such as Muheza and Kilombero districts [
7]. By that time, neighbouring countries like Malawi and Kenya, as well as South Africa and Botswana had already switched to SP as their first-line drug in 1992 and 1996 respectively [
4,
24], while records on SP resistance in Malawi indicating to have had remained below 10% over the past six years [
6].
Consensus building
Researchers and members of the Task Force recognized that numerous and sometimes conflicting evidence had been presented by researchers through technical research reports and/or presentations at scientific conferences and publications in peer reviewed journals. The issue of how to reconcile the evidence and deliver a common, simple and clear message to policy-makers was raised. The solution proposed was to organize stakeholder workshops to identify, discuss and synthesize the most pertinent research and health facility-based information concerning malaria treatment and the way forward. The NMCP in liaison with the NMAC, national Drug Policy Task Force and WHO Country office organized malaria workshops and meetings with departmental heads and directors within the MoH and other partner institutions such as the pharmaceutical industry, bednet manufacturing industries, research institutions such as NIMR, IHRDC and academic institutions such as the MUCHS, St. Augustine University Teaching Hospital – Bugando and KCMC, and intervention projects such as Tanzania Essential Health Interventions Project (TEHIP) and the Adult Morbidity and Mortality Project (AMMP). One of the latest workshops held was the one of May 1999 in Bagamoyo in Tanzania supported by the WHO Roll Back Malaria (RBM) Programme. Based on the presentations made by several participants during the workshops, the discussion focused on developing a common way of understanding the trend of drug resistance and the pros and cons of whether to maintain the status quo with CQ as the first-line drug or to switch to alternative drugs like SP, AQ, chlorproguanil-dapsone (Lapdap) or others.
Despite the intense discussion about alternative drug regimens, there was a common appreciation that CQ treatment failure rates at different levels and in different drug monitoring sentinel sites were alarming enough to justify the need for change. The remaining question that was left for Parliament to answer in liaison with the MoH and other partners (e.g. NMCP, NMAC, Drug Policy Task Force) was whether to replace CQ either with SP as a single first-line therapy or in combination with other regimens. RBM, through its representative in East Africa, expressed readiness to support technically and materially where necessary and feasible to facilitate any government policy change decision. As one of the respondents argued, this was a very important message to the country policy-makers because of the budget implications of such a change.
The actual policy change process and current perceptions of the change
After the national Task Force on antimalarial drug policy had presented its policy brief, a series of newspapers and some private radio stations began to inform the public that CQ was no longer a recommended drug for malaria treatment and that the Government was considering replacing it with a new drug. This information caused public concern and debates erupted in different parts of the country about the rationality for the change. Those involved were the general public, the research community, traders, the pharmaceutical industry, and health-care providers in the public and private health facilities. To maintain public confidence, the Minister of Health gave out a press release that indicated the Government stand concerning the treatment guidelines to be followed while strategies were underway to make an appropriate decision. Nobody was assured of the time of the actual policy change and which type of new treatment guideline would be recommended, as a senior health manager remarked while interviewed in this study:
"It was not clear when the policy would have changed, as sometimes information that was coming out in the press releases last year was controversial. There is a time when the Minister for Health seemed to criticize the information that came out in one of the local newspapers that CQ was no longer effective, and advised the public to remain patient until his ministry gets sufficient evidence. On the other hand, researchers continued to disseminate information indicating high levels of resistance and suggesting for finding out a more suitable drug".
Also, according to several respondents, the policy change was not in the interests of the pharmaceutical manufacturers and traders, who had built up large stocks of CQ and had profited much from its familiarity among most of their client populations. Drug supply companies had already invested in small vans to deliver CQ with a banner 'CHLOROQUINE' on their sides.
Medical practitioners and biomedical researchers considered it was too early to change the policy. One of the reasons stated was that many people still believed that CQ was effective despite variations between different areas and that SP resistance was reported to be on the increase. Some high-ranking government officers at parliamentary and ministerial levels identified themselves as being among those who were still using CQ effectively. Detractors also relied on a few incidences of patients who had had side effects with other antimalarial drugs and also pointed paucity of information available regarding SP resistance. This fact is similar to one found in the report by Abdulla
et al [
6] warning that:
"Anecdotal evidence indicates that many health professionals are unaware of the extent of resistance to CQ and do not perceive an urgent need for change".
It was also expressed that the decision to change the policy was a very sensitive issue considering the financial implications of the change, both to the government and to the users of the drugs on one hand, and the lack of expertise to manage the change and the uncertainty of treatment outcomes in the use of the new drug.
The Government's official announcement of the policy change came out of the media in 2000, although the actual implementation officially started on 1
st August 2001. Before this Government policy-decision was passed, approval by the national parliament was sought through the speech by the Minister of Health by then to the Parliament while presenting his ministry's annual budget [
6]. Scientific facts played a prominent role, as the Minister pointed out that based on the routine health facility-based morbidity and mortality statistics on malaria and biomedical research evidence, the MoH was convinced that it was high time for the government to replace CQ with a more cost-effective first-line drug that obviously could alter the existing treatment regimen as a whole. The agenda for change was presented based on a summary report by the mentioned Drug Policy Task Force, supplemented by collective information from HMIS records submitted to the MoH, drawn from all regions and policy-research related workshop/conference proceedings, describing the malaria situation.
A similar speech was the one presented by the new Minister of Health, this time Hon. Anna Abdallah during the 2002–2003 Budget Session for her ministry [
27] in 2002. With these two speeches, the members of the Parliament (MPs) were convinced of the need for change, albeit the decision to switch would be interim, given that more clinical and cost-effectiveness studies were ongoing in some sentinel sites to establish more evidence regarding the most appropriate treatment option. This was justified by the presence of the 5-year Interdisciplinary Monitoring Programme for Antimalarial Drugs in Tanzania (IMPACT-Tz) whose initiation involved the MoH as a key stakeholder. The IMPACT-Tz project is a collaborative venture between the U.S Centres for Disease Control (CDC), IHRDC, NIMR, LSHTM, AMMP, TEHIP, MUCHS, WHO and district health authorities [
27,
30].
All the respondents in this study expressed the need for continued research on alternative drug regimens that are cost-effective if used in real situations, and to publish systematically organized policy-briefs to keep policy-makers and national programme managers informed of the malaria treatment situation and its socio-economic consequences. It was clarified that each research project should consider the presentation of concise policy feedback report by arranging to meet directly, where possible, with policy-makers and programme managers to present their findings and recommendations and share discussions with them whereby various questions can be answered on the spot and reaching agreement on the way forward. It was emphasised that the policy reports should be in the simplest possible language rather than using too technical scientific jargons which would discourage most of the non-technical scientific readers among whom are some policy-makers, planners and programme managers.