Voluntary reporting

In addition to the CIR process the cosmetic industry has instituted a second, important, self-regulatory procedure the voluntary reporting of adverse reactions, which is intended to provide data on the type and incidence of adverse reactions noted by consumers or by their medical advisors. This reporting procedure creates early awareness of problems handled outside hospital emergency facilities or centers for acute poisoning. 

Nuclear Plant Reliability Data System Nuclear Engineering data from all U.S. NPP (currently 91 plants) failure data describing 44,000 events Voluntary reporting of engineering information and failures for selected systems and components as defined in a reportable scope manual 64. 

DATA BOUNDARY Voluntary reporting of engineering information and failures for selected systems and components as defined in a reportable scope manual... 

For VOLUNTARY reporting of adverse events and product problems... 

Appendix A contains a MedWatch form, which is used by health care professionals for voluntary reporting of adverse reactions and problems with tiie drag product. Is also contains advice about voluntary reporting. This form is a part of tiie FDA medical products reporting program. 

MedWatch A centralised MedWatch programme is provided to encourage the voluntary reporting of adverse drug reaction(s) by the medical profession. 

Form FDA 3500 Voluntary reporting of adverse events (reactions, failures, malfunctions) with drugs or devices by medical personnel... 

One of the most important aspects of the UK regulatory system is the scheme that provides for the voluntary reporting of adverse reactions to a marketed drug. Since most serious ADRs are rare... 

Gamble, D.E., and Peterson, L.G. (1986) Trazodone overdose four years of experience from voluntary reports. / Clin Psychiatry 47 544-546. 

Since 1992, the Food and Drug Administration has received nearly 30,000 reports of medication errors. These are voluntary reports, so the number of medication errors that actually occur is thought to be much higher. There is no typical medication error, and health professionals, patients, and their families are all involved. Some examples ... 

See Praesel, 967 S.W.2d at 392. (Holding the reporting statute in Texas is a voluntary reporting mechanism and failure to report the condition is not negligence per se. The recording statutes control no actual conduct that leads to harm, and imposing liability for failure to report would expose physicians to an overly broad civil liability.)... 

In response to voluntary reports from physicians to the FDA or the manufacturer, the FDA has issued warnings, made label changes, required manufacturers to conduct postmarketing studies, and ordered product withdrawals that have ultimately prevented patient deaths and suffering. 

Because of RAP s special interest in CCR near misses, it was decided to create a reference datalmse for CCR near miss reports a comparison with later voluntary reports regarding the CCR task environment could then be... 

Two informal analyses show that this level of voluntary reporting is probably adequate to get a proper insight into the RAP-incident root causes ... 

Detection usually on the basis of voluntary reporting by employees ... 

Voluntary reports are usually made by the person who detects the error. In many organizations, individuals are afraid to report errors, because there is fear that they might be associated with disciplinary actions. An anonymous reporting program may promote better error reporting. 

Most hospitals collect internal medication error data through a voluntary reporting mechanism. This system is used as the backbone of error reporting because it requires minimal resources for data collection and is supported by organizational risk management programs. Voluntary reporting is presumed to underreport total errors. It is widely believed that... 

Voluntary reporting. Doctors, nurses and pharmacists are supplied with cards on which to record suspected adverse reaction to drugs. In the UK, this is called the Yellow Card system and the Committee on Safety of Medicines collates the results and advises the government s Medicines Control Agency. It is recommended that for ... 

One of the key self-regulatory procedures in the cosmetic industry is the voluntary reporting process of adverse reactions. The program is intended to provide data on the type and frequency of adverse reactions reported by consumers or by their medical advisors to the industry. It is an important means of detecting problems that are not treated in hospital emergency rooms (i.e., documented in the National Electronic Injury Surveillance System, NEISS) or do not reach poison control centers. 

FDA investigations, which eventually identified natural latex/natural rubber (NLNR) allergy as an emerging public health concern, were started in response to voluntary reports submitted by physicians, nurses, and technologists (5). The first reports described deaths that... 

The organization and preliminary results of an intensified voluntary reporting system for rheumatologists in the UK... 

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