Although there is not a formal pharmacovigilance plan currently being implemented by the NMCP, Mozambique has been involved in drug safety and efficacy monitoring at both a national and international level since the early 2000s. This has included trials on the safety and immunogenicity of the RTS S/AS02A malaria vaccine in children aged one to four in 2003 (Macete et al., 2007) carried out in Manhiça.



 In 2011, following the roll-out of artemetherlumefantrine (AL) in 2009, the NMCP, in partnership with CISM, undertook its first drug efficacy study of AL in five sentinel sites. AL showed high cure rates and rapid resolution of parasitaemia, fever and gametocytemia in adults and children, and showed an excellent safety and tolerability profile (Makanga et al., 2011). At the time, this study was the largest data set assessing AL therapy for treatment of acute uncomplicated P. falciparum malaria. 

 

In 2015, the NMCP carried out a drug efficacy study in four drug-efficacy sentinel sites for AL (Gaza, Sofala, Tete and Cabo Delgado). The NMCP began bioassay studies in one district each – Maputo (Boane) and Mecufi (Cabo Delgado) in 2014. Both sites sprayed with deltamethirin and the insecticide was found to be effective after four months of application on all walls surfaces (grass, plastered and painted). 




The quality of spraying was found to be good on all types of walls in Boane, with the exception of four houses out of 10 in Mecufi where spraying was not consistent. These studies are continuing in 2015 with the addition of a new insecticide, DDT, in Boane and Metuge districts in Cabo Delgado with both deltamathrin and DDT.   

 

Routine (annual) insecticide resistance monitoring also began in 2014 at 21 sentinel sites studying four insecticides (DDT, lambacyhalothrin, deltamethrin and bendiocarb). In 2015 one other insecticide was added (perimiphos-methyl) and tested in six sentinel sites (Nampula city, Chimoio city, Xai-Xai city, Boane, Magude and Maputo). Sentinel sites for resistance monitoring are selected by the NMCP according to the National Strategic Plan (2012-2016) criteria: 

 

From 2015, the entomology department will select sites based on a number of criteria, such as funding, location of insectaries and where IRS should be carried out (in line with the revised vector control strategy).  

 

 Monitoring malaria control  Data used to inform malaria control in Mozambique comes from three main sources: (i) routine health information, which gathers data from the public health system and may be complemented by other types of official data such as socio-demographic information; (ii) largescale household (DHS, MICS, MIS); and (iii) operational research and intervention studies.  The analyses presented here are based largely on data from cross-sectional household surveys and are described in detail in Section 6 - Overview of technical methods. Here we briefly describe the routine health information system and sentinel sites, and give examples of data generated through operational research.  

 

 Routine health information system  Mozambique’s health management information systems (HMIS) include a variety of populationbased and health facility-based data sources. The health facility-related data sources are public health surveillance, health services data and health system monitoring data. The HMIS is comprised of multiple systems.


 The majority of these are paper-based individual level data collection (in a health register or patient file) at the service level; aggregate facility data are reported monthly through the national data flow, meaning individual patient data are sent from health facility to district level where data are aggregated and sent to the provincial level, before being again aggregated and sent to the national level. A key tool of the HMIS is the aggregate data reporting system, which is the conduit for data flow for the majority of programme data from facility to district to province to central level. 


Following that, Mozambique developed its own approach and a software package called the módulo básico, a routine HMIS that includes surveillance and disease notification, and has since experienced success with implementation throughout Mozambique. Paper-based reports with aggregated data from peripheral health units are entered into a computer database at district level, and then electronically aggregated reports are transmitted mostly by flash drive or CD to the provincial level, aggregated there and then transmitted onward to the central level. 

 

An assessment of HMIS data quality in Sofala by Gimmbel et al (2011) found that HMIS data are both reliable and consistent, supporting their use in primary health care programme monitoring and evaluation. However, an earlier study, when analysing the quality of routine data for malaria control, revealed primary data to be of poor quality and not meeting the needs of malaria control management (Chilundo et al., 2004). With a lack of malaria sentinel sites and data limitations through the HMIS, the NMCP is still heavily dependent on national representation household survey data for planning and management of malaria.  

 

Efforts to improve capacity include staff training, rationalisation of the forms used at health facility and district level, as well as the (ongoing) development of the new HMIS (SIS-MA in Portuguese). This is a full information M&E system based on the DHIS2 platform and other software, which will enhance the quality of data and reporting. The intention is to enhance the efficiency of programme implementation. No major issues have been revealed during fieldtesting, which took place with the direct participation of the MISAU and pilot districts.