Safe drugs defined

If the drug proves safe and effective, phase III trials are initiated. (In the context of clinical trials, safe and effective are rarely used in the absolute sense. Safe generally refers to a favourable risk beneht ratio, i.e. the benefits should outweigh any associated risk. A drug is rarely 100 per cent effective in all patients. Thus, an acceptable level of efficacy must be defined, ideally prior to trial commencement. Depending upon the trial context, efficacy could be defined as prevention of death/prolonging of life by a specific time-frame. It could also be defined as alleviation of disease symptoms or enhancement of the quality of life of sufferers (often difficult parameters to measure objectively). An acceptable incidence of efficacy should also be defined (particularly for phase II and III trials), e.g. the drug should be efficacious in, say, 25 per cent of all patients. If the observed incidence is below the minimal acceptable level, then clinical trials are normally terminated. 

The FDA defines OTC drugs as safe and effective for use by the general public without a doctor s prescription. 

At the same time the FDA was attempting to deal with DES residues, the agency also recognized the fundamental strangeness of the no residue requirement. In effect, it said that if a carcinogenic animal drug could not be detected in food, the food was to be considered safe. This is odd, because it defines safety in terms of the capabilities of analytical chemistry. It is not only odd, it makes no sense whatsoever. Our ability to detect chemicals in the environment bears no relationship whatsoever to the health risks they pose. 

It is insufficient to define the MAP simply in terms of the drug works and seems to be safe. The acceptable benefit risk ratio will depend greatly on the seriousness of the target disease and the availability of other treatments. 

Regarding the sale and supply, the natural tendency of medicinal products approved in the United Kingdom was a pharmacy sale under the supervision of a pharmacist, unless restrictions were relaxed or tightened. Legislation had already existed in the United States (Durham-Humphrey Amendment of 1951) that defined the kinds of drugs that could not be safely used without medical supervision and restricted... 

As enacted in 1938, the FD C Act defined a new drug as any drug that was not generally recognised as safe. Section 505 of the 1938 Act provided that an NDA must be submitted for every new drug, and authorised FDA to permit an NDA to become effective or to disapprove it, but not affirmatively to approve an NDA. If FDA took no action within 60 days after the filing of an NDA, the NDA automatically became effective and the drug could lawfully be marketed. 

While the safe upper limit of QT is not defined, it is suggested that the interval not be permitted to exceed 0.52 seconds during treatment. If dose reduction does not eliminate the excessive prolongation, stop the drug. If concomitant diuretics are needed, consider low doses and the addition or primary use of a potassium-sparing diuretic and monitor serum potassium. 

In many states, it is illegal to drive with any detectable amount of controlled substance in blood. Other states define drugged driving as driving when the driver is incapable of driving safely... 

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