Skip Navigation

Safety

monitoring safety of ACTs

For more recent information about the Pharmacovigillance partnership between the ACT Consortium and The Global Health Network, please visit globalpharmacovigilance.tghn.org.

 

 

How can we assess the safety of antimalarials? from ACT Consortium on Vimeo.

 

Phase II and III clinical trials are aimed at identifying common adverse effects of drugs in carefully selected patients, but their sample size means that they are not suitable for identifying rare but potentially serious adverse effects or defining safety in high risk populations.

Setting up and maintaining systems capable of collecting and collating data on adverse events will be challenging in most countries, but particularly so in Africa where it is anticipated the bulk of antimalarials will be used, and where the potentially most vulnerable populations reside.

During the lifetime of the ACT Consortium, there was a particular concern about efficacy and safety in those co-infected with HIV/AIDs, who constitute a significant proportion of those requiring ACTs. There were similar concerns about safety of antimalarials in infants and the malnourished.

Research questions addressed by the consortium

  • How can existing networks and trials best be utilised to collect data on adverse events? This will include setting up an antimalarial adverse event database 
  • What is the frequency within the target population of adverse effects occurring with the different antimalarial combinations?
  • What is the comparative tolerability of the different ACTs?
  • What factors (e.g. age group, co-morbidity, repeated administration) predispose patients to developing adverse drug reactions?
  • Are there any signals of new or unreported adverse events occurring with the ACTs or other new combination antimalarials? 
  • Are ACTs equally safe and efficacious in HIV-positive individuals, and are there clinically significant drug interactions between ACTs and antiretrovirals?

 

Learn about our projects and resources on assessing the safety of ACTs or download a summary of our research findings.