NDA worried about faulty antimalarial dosage given to children

KAMPALA- The National Drug Authority (NDA) has asked Ministry of Health to investigate the dosage of antimalarial drugs being prescribed for children.

Dr Helen Ndagije, the Director of Product Safety at NDA said some of the cases of adverse drug reactions of artemether/lumefantrine reported, later turned out to be cases of over dose based on age and children’s weight.

“For children, the ministry [of health] should investigate if the way medicine is being prescribed is not bringing harm to the children because in a small spot check, we found that there are some medicines, according to the children’s age and weight, that was beyond what they should take,” Dr Ndagije said on Friday during the third annual pharmacovigilance stakeholders meeting in Kampala.

Dr Ndagije said: “When we checked manufacturer’s specifications for that particular case, the dose had been doubled and it was slightly higher.”

She said that this could expose children to side effects since there are some cases where children are given antimalarial drugs when they do not have malaria.

Dr Ndagije said sometimes children are given medicine without checking their age and weight yet these are crucial factors.
However, the permanent secretary at the Ministry of Health, Dr Diana Atwine, said that pharmacovigilance is the role of NDA.
“The role of doing pharmacovigilance is done by NDA. If it is a practising issue, our councils would investigate depending on the complaint,” Dr Atwine said.

Individual Case Safety Report reported in quarter two indicates that the most reported incidents occurred in the age group of 45-64 years, followed by the elderly with children and infants manifesting the least reported incidents of overdose.

To engage the public on the quality of medicines, NDA launched a mobile application that can be used by patients and the public to report safety issues.

Patients can now report safety issues of their medicines to NDA following the establishment of the Med Safety Mobile App that will enable the public to report the side effects of drugs.

According to NDA, drugs help to treat many ailments and are a key part of the medical care system, but can cause adverse effects, as well, because of their toxic nature.
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