Adverse reactions Good Clinical Practice

Good clinical practice (GCP) guidelines are published and should be adhered to. Normal precautions should be applied to protect the safety and health of test subjects throughout the trial, with provision for emergency treatment and effective treatment against possible adverse reactions. 

A type A adverse drug reaction is a possibility if a patient is given a higher than recommended dose for any particular route of administration due to practitioner error. In order to avoid this it is good clinical practice for drug dosages to be checked by another member of staff prior to administration. Where this is not possible, or impracticable, extreme care must be taken to ensure that a patient receives the right dose of the correct medicine by the route intended. 

In the last 15 years there has been increasing emphasis on the use of high-quality evidence in therapeutic practice, principally as obtained from large, randomized clinical trials and from systematic reviews of the results of many such trials. However, while it has been possible to obtain useful information about the beneficial effects of interventions in this way, evidence about harms, including adverse drug reactions, has been more difficult to obtain. Even trials that yield good estimates of benefits are poor at providing evidence about harms for several reasons ... 

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