This volume is a summary of material presented in the course given in the International School of Phannacology on "Drug Epidemiology and Post-Marketing Surveillance" between September 27 and October 8, 1990, at the "Ettore Majorana Center for Scientific Culture" in Erice, Sicily. The course, which was a NATO Advanced Study Institute, included lectures and workshops presented by experts in the new field of phannacoepidemiology. The material covered includes various approaches to spontaneous reporting of adverse drug reactions, including aggregate approaches, such as those used in France, and detailed analyses of individual reports, such as that done in The Netherlands and in Sweden. Also, included are studies using traditional epidemiology methods. In addition, modern pharmacoepidemiology makes considerable use of automated databases. As such, information is presented on their use as well. Phannacoepidemiology started in hospitals and some of the newest work in the field is returning to the hospital as a site for studies. Material on these topics was presented as well. Finally, selected new methodologic developments were outlined in specific examples presented that were of regulatory and commercial importance. This new field of phannacoepidemiology is exploding in interest internationally. Evidence of this is the increasing development of pharmacoepidemiology programs in industry, medical schools, pharmacy schools, and schools of public health. Also, there is a new International Society ofPhannacoepidemiology. Practitioners in this field tend to specialize in either analyses of spontaneous reporting or the use of formal epidemiologic techniques.

This volume is a summary of material presented in the course given in the International School of Phannacology on "Drug Epidemiology and Post-Marketing Surveillance" between September 27 and October 8, 1990, at the "Ettore Majorana Center for Scientific Culture" in Erice, Sicily. The course, which was a NATO Advanced Study Institute, included lectures and workshops presented by experts in the new field of phannacoepidemiology. The material covered includes various approaches to spontaneous reporting of adverse drug reactions, including aggregate approaches, such as those used in France, and detailed analyses of individual reports, such as that done in The Netherlands and in Sweden. Also, included are studies using traditional epidemiology methods. In addition, modern pharmacoepidemiology makes considerable use of automated databases. As such, information is presented on their use as well. Phannacoepidemiology started in hospitals and some of the newest work in the field is returning to the hospital as a site for studies. Material on these topics was presented as well. Finally, selected new methodologic developments were outlined in specific examples presented that were of regulatory and commercial importance. This new field of phannacoepidemiology is exploding in interest internationally. Evidence of this is the increasing development of pharmacoepidemiology programs in industry, medical schools, pharmacy schools, and schools of public health. Also, there is a new International Society ofPhannacoepidemiology. Practitioners in this field tend to specialize in either analyses of spontaneous reporting or the use of formal epidemiologic techniques.

December 13, 2002, the president of the United States announced that smallpox vaccination would be offered to some categories of civilians and administered to members of the military and government representatives in high-risk areas of the world. The events that precipitated that historic announcement included a series of terrorist attacks during the 1990s, which culminated in the catastrophic events of 2001. Although preparedness for deliberate attacks with biologic weapons was already the subject of much public health planning, meetings, and publications as the twentieth century neared its end, the events of 2001 led to a steep rise in bioterrorism-related government policies and funding, and in state and local preparedness activities, for example, in public health, health care, and the emergency response and public safety communities. The national smallpox vaccination program is but one of many efforts to improve readiness to respond to deliberate releases of biologic agents. The Institute of Medicine (IOM) Committee on Smallpox Vaccination Program Implementation was convened in October 2002 at the request of the Centers for Disease Control and Prevention (CDC), the federal agency charged with implementing the government's policy of providing smallpox vaccine first to public health and health care workers on response teams, then to all interested health care workers and other first responders, and finally to members of the general public who might insist on receiving the vaccine. The committee was charged with providing "advice to the CDC and the program investigators on selected aspects of the smallpox program implementation and evaluation." The committee met six times over 19 months and wrote a series of brief "letter" reports. The Smallpox Vaccination Program: Public Health in an Age of Terrorism constitutes the committee's seventh and final report, and the committee hopes that it will fulfill three purposes: 1) To serve as an archival document that brings together the six reports addressed to Julie Gerberding, director of CDC, and previously released on line and as short, unbound papers; 2) To serve as a historical document that summarizes milestones in the smallpox vaccination program, and; 3) To comment on the achievement of overall goals of the smallpox vaccination program (in accordance with the last item in the charge), including lessons learned from the program.