An-Najah Staff

The primary aims of this study were to investigate the attitude of the Palestinian public to patient package insert (PPI) and to evaluate the practical and legal issues of PPI in Palestine. Three hundred and seventy one (371) patients were verbally interviewed using a yes or no questionnaire that examine their attitude toward the information presented in (PPI). More than half of the patients (51.7%) said that they read the (PPI), but either find it vague or raise their fears and concerns. A second group of patients (44.5%) said that they do not read the (PPI). A third group (3.8%) said that they do not find or do not know about the PPI. This study emphasizes the need for a pharmacy legislation regarding PPI design and language, introduction of electronic pharmacy labeling and finally better patient-pharmacist communication to educate patients about over-thecounter (OTC) and prescription only medications (POM).

Background and Objective: 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.
Method: 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.
Results: 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.
Conclusion: 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. Key words: patient package insert, evaluation, Palestine, drug information.

Background and Objective: 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. Method: 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. Results: 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. Conclusion: 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. Key words: patient package insert, evaluation, Palestine, drug information.

Background and Objective: 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.
Method: 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.
Results: 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.
Conclusion: 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.