Author Archives: Evelyne Mbeiza

Meeting to disseminate guidelines for submission of periodic safety update report and any other reports that may be relevant to determine the safety efficacy and quality of a drug

Reference is made to the National Drug Policy and Authority (Pharmacovigilance) Regulations, 2014. Market Authorization Holders (MAH) are required to have an appropriate system for pharmacovigilance and risk management in place in order to assure responsibility and liability with regards to the safety, efficacy and quality of their products on the Ugandan market. NDA has…

The National Drug Quality control laboratory of NDA extends its ISO/IEC 17025 accreditation to Glove testing.

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ISO/IEC 17025 is the global quality standard for testing and calibration laboratories and forms the basis for accreditation. The NDA laboratory that is now ISO/IEC 17025 accredited has demonstrated that they are technically proficient and able to produce precise and accurate test results. The NDQCL has been assessed by ANAB for its ability to produce…

Risk of hypersensitivity reaction in infants and children following administration of Nevirapine

This communication is to remind you about the risk of hypersensitivity reaction in infants and children receiving Nevirapine which may have fatal outcomes. The National Pharmacovigilance Centre has received cases of preventable death as a result of septicaemia which was secondary to Nevirapine hypersensitivity. When children develop rash due to Nevirapine hypersensitivity and the care…

Increased risk of ototoxicity following concomitant administration of Gentamicin and Furosemide

Dear Healthcare provider, This communication is to remind you about the increased risk of ototoxicity following concomitant administration of gentamicin and furosemide. Nephrotoxicity and ototoxicity are the most important side effects of aminoglycosides for example Gentamicin. Furosemide is a loop diuretic which is documented to cause hearing loss in some patients especially at a high…

Previously unidentified potential risk of visual color distortions with Pregabalin

Pregabalin is a gama aminobutyric acid (GABA) analogue used in the treatment of pain due to nerve injury, fibromyalgia, epilepsy, and anxiety disorders. Pregabalin is registered in Uganda, and known to be prescribed in the management of neuropathic pain and anxiety disorders. Case series reviewed from the WHO global database of individual case safety reports…

Risk of Abortion and birth defects with fluconazole

Fluconazole is used in the treatment and prevention of specified fungal infections in adults and children. Management of opportunistic fungal infections among HIV infected mothers, and the inherent increased risk of fungal infections during pregnancy may call for Fluconazole use. Review of current literature has shown evidence to suggest an increased risk of spontaneous abortion…