Complete safety data, especially for unexpected and serious adverse events, can only be captured through constant application of pharmacovigilance processes (preferably multi- country). It cannot be captured through clinical trials, which are typically conducted in an “artificial environment.” For example, selected patients are usually not taking any other medications, do not have concomitant infections, are taking the drug short term (during the duration of the trials only), are not children and not pregnant. Despite the obvious need for pharmacovigilance and existing regulations, very little is being done in this discipline in developing countries. Globally, only about 500,000 to 600,000 adverse event occurrences are captured. Developing countries, which represent more than two-thirds of the world population account for less than 5% of all ADR data.

The RaPID program, a consortium of the leading organizations in pharmacovigilance, can help develop a short and a long- term solution. The short-term solution could be implemented within 90 days, while the long-term solution, to build institutional capacity at the country level will take 3-5 years.

Our approach is to work with leading institutions from developed and developing world—this includes two WHO collaborating centers, the national regulatory authority of Switzerland, a pan-African health network and a leading academic and scientific research center in India. This consortium works directly with Ministries of Health, public health programs and public- private partnerships and product sponsors that develop and launch new drugs in developing countries.

Our work-flow includes the following steps:

• Assess and provide policy support for countries

• Design and establish country focused and disease focused pharmacovigilance systems

• Educate health professionals

• Gather adverse drug reaction data using health professionals.

• Enter data into a WHO approved and a globally recognized drug safety database

• Analyze data for causality

• Report findings to national regulatory agencies and international organizations

• Based on findings, provide recommendations for policy changes to WHO, Ministries of Health, PPP, and drug sponsors.

When implemented effectively, the information from pharmacovigilance allows for the intelligent, evidence-based use of medicines and has the potential for preventing many adverse reactions, thereby increasing effectiveness of national public health programs.