Intensive care in low-income countries--a critical need.

n engl j med 367;21 nejm.org november 22, 2012 1974 to strengthen the planning of the postauthorization phase and reduce preventable harm. Once a product is on the market, new safety signals may emerge. Spontaneous reports of adverse reactions can be used to identify patterns of drug–drug and drug–disease interactions that were not apparent before authorization. Collection of data from all possible sources should be optimized, since adverse reactions in elderly populations are generally underreported. The risk-management plan for a drug — based on its risk profile — should be designed to fill knowledge gaps, and targeted measures should be used to minimize risk. Regulators must ensure that the development and evaluation of drugs take into account global demographic changes, so that safe and effective drugs reach the patients who ultimately use them.