History of Pharmacovigilance
Introduction
Pharmacovigilance is the science and activities related to detecting, assessing, understanding, and preventing adverse effects or any other drug-related problems associated with pharmaceutical products. The history of pharmacovigilance spans several decades and has evolved in response to various drug-related incidents and concerns. Here is an overview of its key milestones:
1. Thalidomide tragedy (late 1950s - early 1960s): Thalidomide was a drug prescribed to pregnant women to alleviate morning sickness. However, it led to severe birth defects in thousands of babies. This incident highlighted the need for systematic monitoring of drug safety and effectiveness.
2. Kefauver-Harris Amendment (1962): The thalidomide disaster prompted the United States Congress to pass the Kefauver-Harris Amendment, which required drug manufacturers to prove the efficacy and safety of their products before they could be approved for marketing.
3. World Health Organization (WHO) Uppsala Monitoring Centre (UMC) (1978): The WHO established the UMC in Uppsala, Sweden, as a center to collect and evaluate reports of adverse drug reactions (ADRs) from various countries. This marked a significant step towards international collaboration in pharmacovigilance.
4. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) (1990s): The ICH brought together regulatory authorities and the pharmaceutical industry to develop guidelines for the conduct of clinical trials and safety reporting, including guidelines for pharmacovigilance practices.
5. European Medicines Agency (EMA) (1995): The EMA, formerly known as the European Agency for the Evaluation of Medicinal Products (EMEA), was established to coordinate the evaluation and supervision of medicinal products in the European Union (EU). Pharmacovigilance became an integral part of the agency's activities.
6. Food and Drug Administration Modernization Act (FDAMA) (1997): This act expanded the authority of the U.S. Food and Drug Administration (FDA) to monitor post-marketing drug safety, including the establishment of the MedWatch program for reporting ADRs.
7. Adverse Event Reporting System (AERS) (2001): The FDA launched AERS, a computerized database that stores and analyzes reports of adverse events and medication errors submitted to the agency.
8. Good Pharmacovigilance Practices (GVP) (2012): The European Union introduced GVP guidelines to harmonize and standardize pharmacovigilance practices across member states.
9. Pharmacovigilance in Developing Countries: Over the years, the importance of pharmacovigilance has also grown in developing countries, and efforts have been made to strengthen their pharmacovigilance systems to ensure patient safety.
Pharmacovigilance continues to evolve with advances in technology and international cooperation, aiming to improve drug safety monitoring and ensure the benefits of medicines outweigh the risks. It plays a crucial role in safeguarding public health and promoting the rational use of medicines worldwide.
