Pharmacovigilance - continued
The effect of globalization on pharmacovigilance
In the 1980s and 1990s, as trade barriers dropped and international research and development exploded, the global trade in pharmaceutical products increased dramatically, bringing with it a pressing need to harmonize drug regulations among trading partners. In 1990, the International Conference on Harmonization (ICH) initiative was started with seventeen member nations. Since then, the harmonization movement has gone global with more than sixty member countries, and is now working on expanding its activities into non-ICH countries. But harmonizing pharmacovigilance and drug safety guidelines can be problematic in today’s world. While many countries have clear regulations and efficient national and pharmacovigilance centers, many others do not, making true globalization of drug safety a challenge for drug developers and clinical researchers.
Yet the pressure to harmonize pharmacovigilance and drug safety is intense–and likely to increase significantly. In today’s world, where pharmaceutical companies have clinical sites in multiple nations, issues of drug safety assume global significance. In addition, consumerism, free trade and communication across borders, an
d increasing use of the Internet have resulted in changes in access to, and information on, all medicines. These changes have given rise to new concerns such as illegal sale and acquisition of medicines and drugs over the Internet, increasing self-medication practices, widespread manufacture and distribution of counterfeit medicines, increasing use of traditional medicines outside the confines of the traditional culture of use, and increasing use of traditional medicines and herbal medicines with other medicines with the potential for adverse interactions. To date however, there is no internationally agreed-upon plan to manage a multi-nation drug safety crisis.
In the case of herbal and non-traditional medicines, these substances are often omitted from the monitoring programs of regulatory authorities. Only about 70 countries have any type of regulation in place for herbal medicines. According to WHO, there are many examples of herbal and over the counter medicines that have been adulterated, diluted, tampered-with or even contaminated with chemicals. It is WHO’s position that these medications should be brought under regulation and subject to drug safety and pharmacovigilance activities. Recently the FDA passed a new ruling for dietary supplements called the Dietary Supplement and Nonprescription Drug Consumer Protection Act HR 3546. It requires mandatory reporting of serious adverse events for dietary supplements and over the counter drugs, and will become law in December 2007.