Voluntary reporting system development: 1: information

Medication Errors Reporting System. This system was developed by the Institute for Safe Medication Practice (ISMP) in 1975 and is a voluntary medication error reporting system. The system receives reports from frontline practitioners and shares its information with the pharmaceutical companies and the FDA, and is managed by U.S. Pharmacopoeia (USP). 

To Err Is Human spawned legislation at the state level that requires the development of voluntary and mandatory reporting systems, with legal protections (Prager, 2000). To date, twenty states have legislated the implementation of mandatory reporting systems the National Academy of State Health Policy writes informative reports on patient safety initiatives that are under way at the state level. 

Food and Drug Administration (FDA) Surveillance System. This was developed and is managed by the FDA. As part of this system, all adverse events reports concerning medical products after their formal approval are submitted to the FDA. In the case of medical devices, the device manufacturers report information on items such as deaths, serious injuries, and malfunctions. Furthermore, the device user facilities such as hospitals and nursing homes are required to report deaths to both the FDA and manufacturers and also serious injuries to device manufacturers. In regard to drug-related adverse events, reporting is mandatory for all manufacturers, but it is voluntary for physicians, consumers, and so on [2]. 

Med Marx System. This Internet-based system is established for hospitals to report medication errors anonymously on a voluntary basis. The system was developed by the USP in 1998 and the information contained in the system is not shared with the FDA. 

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