Comparative analysis of patient package inserts of local and imported anti-infective agents in Palestine

ABSTRACT

The patient package insert is an important source of drug information. The aim of this study was to evaluate and compare the PPI of the anti-infective agents manufactured in Palestine with the imported equivalents. The selection criteria generated 15 different anti-infective agents available as 36 locally manufactured products and 15 imported equivalents. The design of the patient package insert was evaluated in terms of the number of words used in eight main headings and the presence or absence of certain information regarding nine statements. Inserts of locally manufactured products have significantly fewer words than those of imported products with respect to warnings, dosage and administration, and side effects. The most significant difference was found in the warnings. Moreover, differences were found between inserts of local and imported products in terms of the presence of the nine informative statements. Locally manufactured products did not mention inactive ingredients, clinical pharmacology or date of last revision, but all of them provided information on the use of the drug during pregnancy and lactation and on the duration of therapy. However, in general they provided less information than the imported equivalents. Palestinian authorities and local manufacturers should implement appropriate measures to regulate the quality and quantity of information in the patient package insert of locally produced anti-infective agents. PPI improvement will better direct health practices to the benefit of the patients