Establishing and clinically estimating a risk factor for an adverse reaction to a given drug or class of drugs (e.g. NSAIDs in patients with rheumatoid arthritis) can be useful in a clinical trial for a novel drug but is usually not sufficient to support a marketing authorization. Traditional methods of assigning risk include the use of a severity factor for the disease, a history of previous reactions to that drug or that class of drugs, and an aggregation of evidence from different sources (e.g. a history of previous reactions, pharmacokinetic factors, and severity of the disease in such patients). This type of risk assessment is therefore called “picture-based” risk assessment and has been successfully applied in many cases, but not all. For example, a clinical trial of a drug for the treatment of AIDS may require an assessment of the risk of developing rifampicin-related hepatotoxicity, but the treatment does not involve the use of rifampicin at all. In such situations, an alternative form of risk assessment, called “signature-based” risk assessment, is required. In a signature-based approach, the risk is estimated based on the combination of a high-dose exposure to the drug with a specific phenotype, e.g. untreated HIV-1 infection if treatment is to be with tenofovir, and rifampin in such patients. A history of previous reactions to the drug or a phenotype, e.g. rifampicin-induced hepatotoxicity in patients receiving tenofovir, is not required.
Collection of data on anaphylaxis in different regions of the world provides insights into the epidemiology of the condition, generates hypotheses regarding triggers, and promotes education of health care providers regarding appropriate management for anaphylaxis.
The International Programme on Chemical Safety (IPCS) is a joint initiative of the World Health Organization (WHO) and the United Nations Environment Programme (UNEP). Its mission is to provide timely, clear, and scientifically reliable information on the safety of chemicals and chemical products (CPS). The IPCS program assists employers, consumers, users, and non-governmental organizations (NGOs) in the use of CPS. d2c66b5586