Voluntary reporting of adverse

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. 

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... 

One of the most important aspects of the UK regulatory system is the scheme provided by the voluntary reporting of adverse reactions to a marketed drug. As most serious ADRs are rare events, they are unlikely to be detected in early clinical trials. The problem is essentially one of numbers, as relatively small numbers of patients are exposed to a new drug before it is released on to the market. Marketing may, therefore, be the first adequate safety trial. The main functions of the adverse reactions reporting system are ... 

Griffin JP, Weber JCP Voluntary systems of adverse reaction reporting. Part I. Adv Drug React Ac Pois Rev 1985 4 213-30. 

The United States is not the only country concerned about the safety of ephedra. Health Canada, the Canadian health regulatory agency, requested a voluntary recall of products containing both natural and chemical ephedra in 2002, because it received 60 reports of adverse events related to ephedra use. 

Griffin and Weber, Voluntary Systems of Adverse Reaction Reporting. ... 

MedWatch. URL http //www.fda.gov/medwatch/index.html. The FDA s MedWatch Web site outlines procedures for voluntary reporting of serious adverse events or product problems by consumers and healthcare practitioners. It also includes... 

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. 

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