Table 2.
Overview of the cohort event monitoring (CEM) programmes
| Ghana (WHO) | Ghana (AMFm) | Kenya | Nigeria (pilot) | Nigeria (scale-up) | Zimbabwe | |
|---|---|---|---|---|---|---|
| Agency responsible for CEM Programme | Food and Drugs Authority Ghana | Food and Drugs Authority Ghana | PPB | NAFDAC | NAFDAC | MCAZ |
| Programme name | WHO CEM | AMFm CEM | CEM for AL | Pilot CEM on patients treated for malaria with ACTs | Scale-up CEM on patients treated for malaria with ACTs | Cohort Event Monitoring of artemisinin combination therapies |
| Monitored medicines | All antimalaria medicines | AA, AL | AL | AL, AAa | AL, AAa | AL |
| Rationale for CEM study | Assess safety and quality of anti-malaria medicines as a result of a high number of ADR reports received for anti-malarials | Assess safety and quality of AMFm anti-malarials due to change in malaria treatment policy | Change in treatment policy to use of new antimalaria medicines, widespread use of the new medicine, safety of monitored medicine not known | Change in malaria treatment policy to ACTs. Inadequate information on safety of ACTs among populations in Nigeria | Change in malaria treatment policy to use of ACTs. Inadequate information on safety of ACTs among populations in Nigeria. Inadequate information on safety profile of ACTs obtained from the pilot | To understand safety and effectiveness of AL combination therapy introduced for the treatment of uncomplicated malaria in Zimbabwe following WHO guideline in 2006 |
| Cohort size, target/actual | 10,000/7320 | 10,000/5949 | 3000/3238 | 3000/3010 | 10,000/10,260 | 10,000/6800 |
| Monitoring sites, total no. (% urban distribution) | 5 (100) | 4 (100) | 8 (60) | 6 (100) | 18 (100) | 84 (30) |
| Type of sites | Public sector tertiary and secondary level hospitals | Public sector tertiary and secondary level hospitals | Public sector secondary and primary level hospitals | Public sector tertiary, secondary and primary level hospitals | Same as pilot with the inclusion of private sector community pharmacies | Public sector secondary and primary level hospitals and private sector community pharmacies |
| Staff required for monitoring, total no. and type of staff | 50 Doctors, pharmacists, nurses, dispensing technologists |
51 Doctors, pharmacists, nurses, pharmacy assistants |
63 Doctors, nurses, pharmacists, clinical assistants, clerical staff and lab personnel |
41 Doctors, nurses, pharmacists, clinical assistants, Lab technician, clerical assistants |
103 Doctors, nurses, pharmacists, clinical assistants, Lab technician, clerical assistants |
444 Doctors, nurses, pharmacists, clinical assistants, clerical staff, rural and environmental health workers (follow up of patients) |
| Approximate budget in US$ | 95,000 | 108,000 | 76,000 | 50,000 | 146,000 | 200,000 |
| Approximate actual cost in US$ | 108,000 | 120,000 | 124,000 | 80,000 | 221,000 | 250,000 |
| Sources of funding including commodities | WHO, FDA | Global Fund, Malaria control programme, FDA | EU, PPB, Malaria control | WHO, NAFDAC, Malaria control, SFH, YGC | Global Fund, Malaria control, NAFDAC, WHO, Sanofi Aventis | Global Fund, UNICEF, MCAZ |
AA artesunate-amodiaquine, ACTs artemisinin combination therapies, AL artemether-lumefantrine, AMFm Affordable Medicines Facility for malaria, EU European Union, FDA Food and Drug Administration, MCAZ Medicines Control Authority of Zimbabwe, NAFDAC National Agency for Food and Drug Administration and Control, PPB Pharmacy and Poisons Board, SFH Society for Family Health, WHO World Health Organization, YGC Yakubu Gowon Centre
aA co-packaged formulation of AA (Arsuamoon®) was used in the pilot while a fixed-dose combination with reduced strength of amodiaquine (Winthrop ASAQ®) was used in the scale up