Raffaella’s Literature Update

The following message is courtesy of Dr. Raffaella Ravinetto, Public Health Department, Institute of Tropical Medicine Antwerp, Belgium.

Dear Friends,

In the attached paper, Tharmalinga and colleagues share some interesting findings from the national regulatory authority in Sri Lanka. Doing secondary research on data routinely collected for regulatory oversight, the authors investigated the patterns of the medicines withheld and recalled by the regulator, in relation to the types of defects, their total numbers, therapeutic categories, pharmaceutical dosage forms, and stated country of manufacturer.

A total of 163 defects were identified in 143 defective medicines, among which the most common types of defects concerned contamination (= 59, 36.2%), stability (= 41, 25.2%), packaging and labelling (= 27, 16.6%) and active pharmaceutical ingredient (= 26, 15.9%). Out of 143 total defective medicines identified. Also very interesting, anti-infectives accounted for 41.9% of SF medicines, while parenteral preparations (44.0%) were found to be frequently defective.

Nearly 70% of the recalled and withheld medicines were of stated Indian origin.

I think there are some very interesting lessons here, that can inspire our future research and collaboration:

  • Regulators, national QC laboratories and Pharmacovigilance Programmes have a lot of routinely collected data. Secondary research on these routine data have the potential, like in this case, to share these lessons and to increase global evidence about substandard and falsified medicines
  • Some scholars and policy-makers tend to think of substandard medicines mainly in relation to the active pharmaceutical ingredient, and most medicines quality surveys are conducted with oral formulations. However, this paper reminds us that quality problems are much broader (contamination being a frequent and harmful one!) and that also injectables are widely concerned.

Have a nice reading,


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