Voluntary reporting of adverse reactions

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. 

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. 

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 ... 

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... 

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

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

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. 

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 ... 

The health care professional, pharmaceutical manufacturer and regulator all share a common interest in the development and use of drugs that are effective and have an acceptable level of undesirable effects. Medwatch and similar programs are important tools for detection of adverse events effects. However, they are limited by the reUance on voluntary reporting as an individual health care professional is not required by law to report adverse drug reactions to the FDA [4]. 

The ramifications of the thalidomide tragedy were many-fold but the key lesson for the development of pharmacovigilance was that active systems for detecting hazards are needed. Within a few years this had been taken forward with the introduction of voluntary (or spontaneous ) schemes for reporting of suspected adverse drug reactions (ADRs). These have stood the test of time as an alerting mechanism or early warning system and wiU be covered in more detail in Chapter 3. 

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