Surveillance, definition

Case Definitions for Infectious Conditions Under Public Health Surveillance." Morbidity and... 

Centers for Disease Control and Prevention. "Case Definitions for Infectious Conditions Under Public Health Surveillance." Morbidity and Mortality Weekly Report 46 (RR-10) (1997). 

Centers for Disease Control and Prevention 1993 Revised Classification System for HIV Infection in Adults and AIDS Surveillance Case Definition... 

How many people would have to get smallpox before it is considered an outbreak One suspected case of smallpox is considered a public health emergency. Smallpox surveillance in the United States includes detecting a suspected case or cases, making a definitive diagnosis with rapid laboratory confirmation at CDC, and preventing further smallpox transmission. A suspected smallpox case should be reported immediately by telephone to state or local health officials. They should immediately obtain advice regarding isolation of the patient or patients, and on laboratory specimen collection. State or local health officials should notify CDC immediately at (404) 639-2184 or (404) 639-0385 if a suspected case of smallpox is reported. 

Phase IV. Studies or trials conducted after a medicine is marketed to provide additional details about the medicine s efficacy or safety profile. Different formulations, dosages, durations of treatment, medicine interactions, and other medicine comparisons may be evaluated. New age groups, races, and other types of patients can be studied. Detection and definition of previously unknown or inadequately quantified adverse reactions and related risk factors are an important aspect of many Phase IV studies. If a marketed medicine is to be evaluated for another (i.e., new) indication, then those clinical trials are considered Phase II clinical trials. The term postmarketing surveillance is frequently used to describe those clinical studies in Phase IV (i.e., the period following marketing) that are primarily observational or nonexperimental in nature, to distinguish them from well-controlled Phase IV clinical trials or marketing studies. 

Because ARMS is a form of passive surveillance that is based on spontaneous reports, it has a number of limitations. Most importantly, it cannot establish a definitive, causal relationship between the ingestion of an incriminated substance and the occurrence of symptoms. Since people are exposed daily to a myriad of food ingredients, it is inherently difficult to attribute an adverse event to a specific food substance. Moreover, symptoms reported are often vague or general in nature. Other confounders, which were discussed by Bradstock et al. (1986), include ... 

Phase III Extended large-scale trials to obtain additional evidence of efficacy and safety, and definition of adverse effects. Humans exposed several hundred to several thousand Phase IV Post-marketing surveillance occurs after the chnical trials programme is complete. It is used to collect adverse event data from a large patient population. Humans exposed 10 000+... 

Recent initiatives by global organizations such as ISO (International Organization for Standardization, www.iso.org) and ICH (International Conference on Harmonization, www.ich.org) are attempting to bring consistency in concept and standardization in definition to the QMS. In 2004, the Pharmaceutical Inspection Co-Operation Scheme (PIC/S, www.picscheme.org) issued its recommendation on Quality System Requirements for Pharmaceutical Inspectorates. The U.S. Food and Drug Administration (FDA) initiated inspection surveillance approaches based upon QMS organization and is another source of definition and interpretation. 

A review of the published literature (28 eyes in 25 patients) has shown that in all cases there were other associated risk factors, so that a definitive conclusion about a causal relation cannot be reached (30). Nevertheless, latanoprost should be used with caution in patients with risk factors for cystoid macular edema and special surveillance is necessary. 

Marketing authorization holders are required to develop written procedures for the surveillance, receipt, evaluation, and reporting of postmarketing ADEs to the FDA. The definitions of postmarketing adverse experiences and unexpected adverse experiences are as follows (66) ... 

Centers for Disease Control and Prevention (2003b). Syndrome definitions for diseases associated with critical bioterrorism-associated agents. Retrieved March 10,2006, from http //www. bt.cdc.gov/surveillance/syndromedef/... 

CBCNews (2003). The econoniicimpact of SARS. Retrieved March 27, 2007 from the CBC Web site http //www.cbc.ca/news/ background/sars/economi cimpact.html Centers for Disease Control and Prevention (CDC). (2003a). Questions and answers about monkeypox. Retrieved March 27,2007 from http //www.cdc.gov/ncidod/monkeypox/qa.htm Centers for Disease Control and Prevention. (2003b). Revised U.S. surveillance case definition for severe acute respiratory syndrome (SARS) and update on SARS cases—United States and worldwide, December 2003. Morbidity Mortality Weekly Report, 52(49), 1202-1206. 

Terms and definitions used in surveillance programs of adverse events and adverse ejfects after immunization... 

Definitions are fundamental to the establishment of any functioning surveillance system. There must be different definitions for monitoring and evaluation. An... 

The term medical surveillance is vague, but commonly utilized. There is no generally accepted definition of medical surveillance. Medical surveillance involves performing an observational study of either an individual or a population and includes collection, collation, analysis, and dissemination of data. The data acquired varies, and may be on exposures, disease, injury, death, and/or disability. There are numerous examples of medical surveillance with vastly different models. For example, the United States has formed the Army Medical Surveillance Activity (AMSA). Its main functions are to analyze, interpret, and disseminate information regarding the status, trends, and determinants of the health and fitness of America s Army and to identify and evaluate obstacles to medical readiness. AMSA is the central epidemiological resource for the Army. 

---