Adverse Drug Reaction Terms
Definition of Terms and Minimum Requirements for their Use: Respiratory and Skin Disorders
Provides concise definitions for twenty-six terms frequently used when reporting respiratory and skin disorders that may be caused by adverse reactions to drugs. Addressed to drug regulatory authorities and the drug safety units of pharmaceutical companies, the book responds to the problems created when spontaneous reports of adverse drug reactions use imprecise, incorrect, or inconsistent terms. With these problems in mind, the book sets out precise definitions of terms, and minimum requirements for their use, for the most important respiratory and skin disorders that may be caused by drugs. The book is part of an on-going project to develop an internationally agreed terminology for the designation, reporting, validation and coding, of adverse drug reactions, giving priority to the most severe disorders that may be caused by drugs.
The book has two parts. The first gives recommended terms, definitions, and minimum requirements for their use for eighteen respiratory disorders, moving from asphyxia and asthma to respiratory arrest, depression, and paralysis. Each recommended term is accompanied by a brief explanation, a clear definition, and a statement of basic requirements, which should be met whenever the term is used to designate and report an adverse drug reaction. Where relevant, information also includes the clinical tests or findings needed to support diagnosis of the disorder. Similar information is provided in the second part, which defines and characterizes eight of the most important cutaneous eruptions that may be caused by drugs.