Safety Health Dictionary

An independent advisory committee – launched in 1971 in the United Kingdom – composed of doctors, pharmacists and other specialists. It advises the MEDICINES CONTROL AGENCY in the UK on the safety, e?cacy and pharmaceutical quality of MEDICINES for which licences are sought and also reviews reports of ADVERSE REACTIONS TO DRUGS, including spontaneous ‘Yellow Card’ reports from doctors or pharmacists who suspect that a patient has suffered an adverse reaction from a medicine. Its predecessor, the Committee for Safety of Drugs, was set up in 1963 in response to the THALIDOMIDE disaster.... committee on safety of medicines (csm)

The statutory body in Britain responsible for the health and safety of workers. The address of the HSE can be found in APPENDIX 7: STATUTORY ORGANISATIONS.... health and safety executive (hse)

The COMMITTEE ON SAFETY OF MEDICINES (CSM) has the function of scrutinising the e?cacy, quality and safety of new DRUGS before clinical trials and before marketing, as well as the surveillance of each drug after marketing so that adverse reactions are monitored and documented, and warnings issued as required. Early clinical trials of a drug can only be carried out after a clinical-trial certi?cate has been issued by the licensing authority.

The major defect in this system is the dif?culty in obtaining reports of adverse reactions. Evidence suggests that at most, about 10 per cent of such reactions are reported. One method of trying to obtain this information is the ‘yellow card’ system. It is so called because it is based on the distribution of yellow cards to all doctors, pharmacists and dentists, on which they are asked to report any adverse reaction happening to someone taking a drug, whether or not they think it is the cause. Alternatively the CSM has a Freephone line and on-line computer facilities (ADROIT) for practitioners to use. Even though the annual number of adverse reactions reported in this way has risen from around 5,000 in 1975 to more than 18,000, this is probably fewer than the number actually occurring.

Two further committees in this safety screen are the Joint Committee on Vaccination and Immunisation and the Adverse Reactions to Vaccines and Immunological Substances Committee.... safety of drugs

The Committee for safety of medicines was set up in 1963 after the thalidomide disaster. It is an advisory committee which examines drugs before clinical trials, before a product licence is granted, and when passed for marketing. A product cannot be tested in the human body without the company holding a clinical trial certificate. A product licence is renewable after five years. ... committee on safety of medicines

(HSE) (in Britain) a statutory body responsible for health and safety in the workplace (including factories, offices, and farms). See also COSHH.

HSE website: provides guidance on a wide range of health and safety topics... health and safety executive

(NPSA) formerly, a special health authority that led and coordinated work to improve all aspects of patient safety in England. The NPSA comprised three divisions: the National Reporting and Learning Service, the National Research Ethics Service, and the National Clinical Assessment Service. It closed in 2012, with its key functions transferred to *NHS England. In 2016 the same functions were transferred from NHS England to the newly formed *NHS Improvement.... national patient safety agency