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Coartem®: Malaria diagnosis, treatment and patient benefit from community deployment

Source: TropIKA

Title of the session: Coartem®: Malaria diagnosis, treatment and patient benefit from community deployment

Date: 3rd November 2009

Agenda item: Symposium 15

Session theme: Treatment and prevention

Meeting room: Taifa/ Tin Tin

Chair(s): Prof. Oumar Gaye, University of Sheikh; Anta Diop, Dakar, Senegal

Presenters:

1. Dr. Hailemariam Lemma, Tigray, Health Bureau, Ethiopia
2. Abdunoor Mulokozi, Ifakara Health Insitute, Ifakara, Tanzania.
3. Christine Manyando, Institute of , Zambia
4. Lawrence Nwankwo, Ministry of Health and Eniviroment, Nigeria
5. Dr. Corine Karema, Malaria Coordinator, Rwanda

TropIKA rapporteur: Faith Apolot Okalebo, Elizabeth V. M. Kigondu

Major topics:

• 1. Community-based deployment of Coartem® in Ethiopia: Impact and implications for other rural regions of Africa
• 2. Pharmacovigilance in the ALIVEstudy-a model for safety monitoring in a resource-constrained environment
• 3. A prospective observational study of Coartem® in pregnancy
• 4. Optimising community-based use of Coartem®: Role Model Mothers: 5. Achieving effective home-based management of malaria

Keywords:

• Drug surveillance
• Home Based Malaria Management (HBMM)
• Role Model Mothers (RMM)
• Coartem®

Scope: Assessment of the safety, impact and effectiveness of treatment of malaria by community health workers (CHW)

REPORT ON ORIGINAL SESSION

Overview

This session was sponsored by Norvatis as evidenced by their strong marketing presence. The running theme was the safety and impact of distribution of Coartem® by Community Health Workers (CHWs). This strategy is promoted by WHO in order to improve access to care. Issues around safety, logistical problems, sustainability, scale up and retention of CHW and impact were explored. There were a total of 5 presentations by speakers who had received partial funding from Novartis. The speakers were drawn from Rwanda, Tanzania, Nigeria, Zambia and Ethiopia. The Tanzanian presentation was unique in that it was a case study of implementation of Post Marketing Surveillance in a home based management setting. Use of mobile telephone was reported to be an effective means of reporting and forwarding information on adverse drug reactions to the regulatory agency. Sound reporting was dependent on frequent retraining of the field workers. Two safety studies found the CHW distribution of Coartem is safe in adults and pregnant women. The Ethiopian study showed that CHW distribution of Coartem has had a positive impact by reducing malaria morbidity and mortality and utilization of formal health care facilities. It was a superior intervention to formal health care based provision of care. Challenges to CHW distribution of Coartem in Nigeria and to a lesser extent Rwanda included: poor storage conditions, erratic funding and inability to retain CHWs due to lack of adequate financial incentives. In Rwanda some of these problems had been overcome by innovative ways like forming cooperatives for CHW through which they could assess loans. This promoted retention. The audience was emphatic that Coartem was too expensive and this limited its access.

CONTEXT AND ISSUE

WHO advocates for home based management of malaria using ACT as a means of promoting access to antimalarials. Has this strategy had a positive impact in reducing morbidity and mortality? In this regard, how does it compare to delivery of ACT through formal health care facilities? Can Post marketing surveillance be effectively carried out in resource limited setting in which Coartem is primarily distributed by community health workers? What are the safety concerns and especially in pregnancy? What are the logistical problems in implementation of this intervention in Africa? Can RDT improve the cost effetctiveness of this intervention? This session attempted to answer these questions through presentations of studies done in 5 African countries.

Initiatives on the ground; experience/s derived

The impact of CHW distribution of was studied in Tigray in Ethiopia. This region is hypoendemic. Impact was measured comparing the morbidity, malaria related hospital admissions, mortality in two districts. In one district Coartem was distributed through formal health care system and in another it was distributed by Community health workers.

The safety of Coartem was studied by implementation of a unique post marketing survellience in which field workers and health workers were required to report adverse drug reactions to the national drug regulatory agency. The safety study in pregnancy carried in Zambia was an observational longitudinal study in which adverse drug reactions were looked for in women who had been treated with coartem.

The Rwandan and Nigerian speakers gave case studies on the logistical issues around distribution of Coartem by CHW in their respective countries.

Research Findings

1. In Rwanda and Ethiopia, CHW distribution has had a positive impact. It compares favorably to distribution in formal health care. In Rwanda there was a 60 % reduction in malaria morbidity between 2005 and 2008.

3. The Ethiopian study found that provision of malaria related services by CHW has a greater impact than provision of the same services by the formal health care system.

2. CHW worker delivery of services has improved access to care and 90 % of children are treated within 24 hours. Malaria related utilization of formal health care facilities has reduced.

3. Coartem use in the 2nd and 3rd trimesters of pregnancy is safe.

5. The post marketing surveillance program found that Coartem is generally safe. This is still ongoing.

6. Post Marketing surveillance in resource limited settings is feasible. There was greater reporting of adverse drug reactions by the informal sector as opposed to the formal health care system. This was attributed to use of phones as well as field workers trained to identify and report potential adverse reactions.

7. Coartem is safe for use in pregnancy and frequency of adverse drug reactions is low as shown by studies in Zambia and Tanzania.

Lessons learned

1. Innovation is key to overcoming obstacles in CHW delivery of Coartem. Examples innovations critical in overcoming logistic problems included:
2. Provision of Health care workers with safety boxes for safe disposal used swabs after use of RDT in Ethiopia.
3. In Rwanda, provision of CHW with boxes for storage has helped improve storage conditions. Studies show that maintains the stability of drugs stored in the box.
4. Rwanda has negotiated with Novartis to develop packaging that enables providers to select appropriate doses for different age groups.
5. In Tanzania, the mobile phone was found to be a useful means of conveying information on adverse drug reactions to health workers and to the National Drug Authority.
6. Issues of sustainability should be critically addressed

Issues raised, obstacles, difficulties

Sustainability of the program is a problem as highlighted by the Nigerian experience where there was a delay in the program implementation due to lack of donor funding.

CHW were difficult to retain due to lack of payment. This was reported by the speaker from Nigeria and a member of the audience from Malawi. However this problem was not experienced in Rwanda and Ethiopia. In these countries financial incentives were provided through cooperative societies to which the CHW were requested to join or by exemption from paying certain taxes. In addition CHW were allowed to raise revenue from the sale of Coartem. A member of the audience from Uganda said CHW were retained in his country by giving each CHW a bicycle and non-financial incentives such as social recognition.

Other logistical challenges included: poor storage of coartem by CHW in Nigeria; erratic drug supply in Nigeria; overstocking of Coartem in Rwanda that led to expiry of drugs. In Nigeria there was initially lack of community ownership.

There was a feeling that the private sector has not been sufficiently engaged in providing coartem.

Future plans

1. To scale up CHW distribution of Coartem in a number of African studies.
2. In Nigeria, there are plants to carry out advocacy at government level so that government can have a budget to fund home based management of malaria that includes paying CHW salary.
3. Post marketing survelliance in Tanzania is an ongoing activity

FINDINGS AND CONCLUSIONS

From formal presentations

Public health Implications

1. The sustainability of CHW distribution is critically dependent sustainable funding by donors and African governments especially in the Nigerian context.
2. In a small scale intervention, RDT has been hygienically been done by CHW and has the potential in increase the cost effectiveness of home based management of malaria.

Policy Impact

The presentations have significant policy implications since they provide evidence of the effectiveness of distribution of Coartem by CHW. This intervention may be scaled up in many African countries. The logistical problems pointed out can be used by planners to design interventions to ensure the success of the intervention.

It was obvious from the input of the audience that different African countries have much to learn from each other.

Translational Research Impact

From the discussions it was clear that translational research need to be done on mechanisms to retain CHWs by provision of incentives.

The safety study carried out in Zambia showed that contrary to recommendations, Coartem is inadvertently given to mothers in the first trimester of pregnancy. However not serious adverse reactions were observed in this group. This points to the need for more safety studies on the use of Coartem in the first trimester of pregnancy.

Main points of agreement

The audience was in agreement that CHW need financial and non-financial incentives in order to sustain the intervention.

It was agreed that CHW should have basic level of literacy, should be respected within their communities as well as demonstrate positive deviant behavior.

Main points of divergence

The main concern by the audience is that Coartem still remains inaccessible to the general population since in many countries adults still have to pay for Coartem. Coartem is expensive for many people.

It is very useful to note that a member of the audience from Malawi reported that home based management of malaria failed in her country because of lack of a spirit of volunteerism. Consequently the Government’s response was the institution of an Essential Health care package in which every village has a Village Health Care Clinic. The clinic is manned by Government paid Health Surveillance Assistants who have a job description similar to that of a community health worker. The operations of the Village Health Clinics are overseen by a Village Health committee. This model of health care is interesting could be considered in some African countries.

There were also concerns that CHW could abuse their positions by selling the drugs and overprescribing to generate more revenue. Though this has not been observed in Ethiopia, Rwanda and Nigeria, the potential for abuse of office still remains.

Recommendations

1. Increase incentive for community health funders.
2. Issues around sustainability and quality service deliver should be explored.

Personal observations from rapporteur

The selection of speakers was excellent because each covered different aspects of the intervention. The discussion from the audience was lively and their contributions raised very critical issues and concerns. Novartis should be congratulated for going an extra mile to facilitate the session. It was obvious that careful thought had been given to selection of the venue and the general organization of the session which was a cut above other sessions attended by the rapporteur within the MIMS conference.

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