The primary source of information for patients regarding the medicine is patients information leaflet (PIL). The main aim of the study is to evaluate the errors and incomplete information in PIL sold with marketed medicines in Pakistan.
For the present study, 11 different classes of oral medicines of different multinational and national pharmaceutical industries were purchased from different pharmacies. The present study has been revealed incomplete information related to medicines in PILs. 9 out of 11 PILs have 48.84% (n= 63) major while minor errors were 51.16% (n= 66).
The major errors were included incomplete information of indications, adverse drug effects, drug mechanism, dosage errors, drug-drug and drug-food interactions, precautions and warning, pharmacokinetic profile and pregnancy and lactation. Whereas, omission of structural formula, molecular weight, chemical names, laboratory tests, clinical trials data, font size, and less use of national language (urdu) have been observed as minor errors.
It has been concluded that majority of PILs sold with marketed medicines were not up to the mark and met the regulatory requirements. In countries like Pakistan, mainly pharmaceutical industries have not called attention on information of marketed drugs medicines proved a shocking situation regarding the negligence of health matter in Pakistan.
Key words: Patients information leaflet; errors; incomplete information; pharmacovigilance
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