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Pharmacovigilance in developing countries (part I): importance and challenges
Shaimaa Elshafie1,2, Iman Zaghloul3, Anne Marie Roberti4
1National Organization for Drug Control and Research, Cairo, Egypt. shaimaaelshafie83@gmail.com.
The thalidomide disaster spurred pharmacovigilance, but developing nations lag in drug safety monitoring. This article explores the barriers hindering robust pharmacovigilance systems in these critical regions.
Area of Science:
- Pharmacovigilance and Global Drug Safety
- Public Health Policy in Developing Nations
Background:
- The thalidomide disaster catalyzed pharmacovigilance development in developed countries.
- Drug safety monitoring systems are underdeveloped in many developing countries.
- There is a growing need for post-marketing drug surveillance in developing nations.
Purpose of the Study:
- To analyze the obstacles to establishing effective pharmacovigilance systems in developing countries.
- To highlight the importance of drug safety monitoring in resource-limited settings.
Main Methods:
- Literature review and analysis of existing pharmacovigilance frameworks.
- Examination of challenges specific to developing country contexts.
Main Results:
- Identified key barriers including resource limitations, lack of trained personnel, and inadequate regulatory frameworks.
- Highlighted the disparity in pharmacovigilance infrastructure between developed and developing nations.
Conclusions:
- Addressing the identified barriers is crucial for improving drug safety in developing countries.
- Strengthening pharmacovigilance is essential for protecting public health globally.
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