Voluntary reporting schemes

Department of Environment Food and Rural Affairs, 2006. UK Voluntary Reporting Scheme for Engineered Nanoscale Materials. Defra, London. 

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 ... 

Voluntary adverse reactions reporting system the yellow card scheme ... 

This report sets out the future objectives of the Vinyl 2010 - Voluntary Commitment of the PVC Industry. Principles and actions covering the period 2000-2010 apply to the following PVC manufacture, Additives-plasticisers and stabilisers waste management social progress and dialogue management, monitoring and financial scheme. 

EMS in line with Dow s stated commitment to Responsible Care the corporate headquarters were visited in March 1999 as part of the voluntary management verification system. The CER refers to the main points raised in the audit report, which is also available on the internet. Dow participates in similar schemes in Canada and Australia. In Europe auditing is part of ISO 14001 and the EM AS requirements. No figures are presented concerning the number of sites audited or certified. 

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. 

Spontaneous ADR reporting is conceptually simple. Reports are submitted on a voluntary basis and information from them is entered onto a database which is screened regularly for signals. The main elements of a scheme which are essential to its success may be summarised as follows ... 

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