Safety of drugs

In summary, federal regulation of the safety of drugs has had three major objectives ... 

On paper, the general case guidelines for the evaluation of the safety of drugs are... 

The ability of different drugs to differentially inhibit and/or induce individual cytochrome P-450 isoenzymes has become critical in assessing the potential safety of drug molecules. Table 18.7 presents an overview of some of what we have come... 

Drug Safety Evaluation has been written with the central objective of presenting an all-inclusive practical guide for those who are responsible for ensuring the safety of drugs and biologies to patients, health care providers, those involved in the manufacture of medicinal products, and all those who need to understand how the safety of these products is evaluated. 

Food and Drug Administration. FDA clears genetic test that advances personalized medicine. Test helps determine safety of drug therapy. Available at http //www.fda.gov/bbs/topics/ NEWS/2005/NEW01220.html. Accessed July 27, 2006. 

In the United Kingdom, the present yellow card system had its origins in 1965, when Witts, who was then a member of the Committee on Safety of Drugs (the precursor to the CSM), published a method for the collection of suspected adverse reactions to drugs. 

Despite reservations expressed by a number of these bodies, the Joint Subcommittee took the view that public opinion was unlikely to be content with anything short of Ministerial responsibility for verifying that adequate precautions had been taken to secure the safety of drugs, the more so because of the number and nature of new drugs. 

The Joint Subcommittee issued its Final Report on Safety of Drugs in March 1963, which states in paragraph 10 ... 

We think that a Committee on Safety of Drugs should be established with subcommittees to advise it on each of the three aspects, namely ... 

The three Health Ministers of the United Kingdom, in consultation with the medical and pharmaceutical professions and the ABPl, set up the Committee on Safety of Drugs (CSD) in June 1963. The three Health Ministers were the Secretary of State for Scotland, the Minister of Health and the Minister of Health and Social Services, Northern Ireland. 

Table 16.1 Membership of the Committee on Safety of Drugs and its Subcommittees (1963)...

The membership of the Committee on Safety of Drugs and its subcommittees changed further following the resignation of Sir Derrick Dunlop in May 1969, as a result of his appointment as the first Chairman of the Medicines Commission (MC), estabhshed under the Medicines Act 1968. 

Safety of Drugs Adverse Reactions Toxicity, Ciinicai Triai and Therapeutic Efficacy... 

During 1969-70, the nephropathic hazards of phenacetin again attracted much attention and the Committee made a seminal observation that has profoundly influenced our regulatory philosophy even today It is the safety of drugs in normal usage that is the Committee s concern, and because all drugs have their hazards when abused, particularly by over-dosage, the Committee has not considered that it should take special action in connection with phenacetin. ... 

In order to permit a smooth transition, the two committees (that on Safety of Drugs and that on Safety of Medicines) met simultaneously from Jime 1970 onwards, the CSD continuing to appraise products for clinical trials and... 

The Medicines Act, together with the associated EU legislation and EU and ICH guidelines, should ensure that the safety of drugs made to the highest quality, the acceptability of their risk/benefit ratio and the promotion of correct information to the prescribers and consumers are the dominant features of the controls that operate today. 

Ministry of Health, Scottish Home and Health Departments. Safety of Drugs. Final Report of the Joint Sub-Committee of the Standing Medical Advisory Committees. Her Majesty s Stationery Office, London, 1963. 

Chiidren Children less than 2 years of age because of the decreased margin of safety of drugs in this class in younger age groups. 

This is the way the methods for the scientific study of drugs in humans, the first theme of clinical pharmacology, were developed. The thalidomide disaster of 1961 stimulated the acceptance of the need for scientific evidence of efficacy and safety of drugs before they are marketed and promoted. Requiring this evidence by government agencies before approval for marketing then followed. 

---