Medications are the principal tools doctors use to maintain health, reverse illness, and extend patients’ survival, hopefully with good quality of life. Yet medications may also cause serious illness and fail to have the desired effect if they are used improperly. Medications may be extraordinarily expensive, and the cost to individual patients, to hospitals, and to our health system has become almost prohibitive. Thus, the proper use of medications and prescribing of medications is critically important.
PRINCIPLES OF RATIONAL THERAPEUTICS
“It’s not likely to be harmful” is no justification for trying something without demonstrated efficacy for the patient’s problem, unless the intervention is in the setting of a clinical trial or the patient is informed of off-label use without evidence of benefit.
Before any medication is ordered in a hospital or prescribed for an outpatient, the prescriber needs to consider the (1) efficacy, (2) safety, and (3) cost of the medication, in that order of importance. Without efficacy for the condition being treated, no medication should be given. There is a risk of toxicity with virtually all medications, so there must be a consideration of risk and benefit before starting or continuing medications.
The quality of medical studies supporting the use of medications varies widely. In recent years, the quality of data has been graded by the groups reviewing the literature and making recommendations, such as the Chest guidelines for anticoagulation (Table 9-1). These grading systems consider the methodologies of the studies as well as the strength of the results.
TABLE 9-1Strength of Recommendations Grading System ||Download (.pdf) TABLE 9-1 Strength of Recommendations Grading System
|Grade of Recommendation ||Benefits vs Risks and Burdens ||Methodological Strength of Supporting Evidence ||Implications |
|Strong recommendation, high-quality evidence (1A) ||Benefits clearly outweigh risk and burdens or vice versa ||Consistent evidence from randomized controlled trials without important limitations or exceptionally strong evidence form observational studies. ||Recommendation can apply to most patients in certain circumstances. Further research is very unlikely to change our confidence in the estimate of effect. |
|Strong recommendation, moderate-quality evidence (1B) ||Benefits clearly outweigh risk and burdens or vice versa ||Evidence from randomized controlled trials with important limitations (inconsistent results, methodological flaws, indirect or imprecise) or very strong evidence from observational studies. ||Recommendation can apply to most patients in certain circumstances. Higher-quality research may well have an important impact on our confidence in the estimate of effect and may change the estimate. |
|Strong recommendation, low or very low-quality evidence (1C) ||Benefits clearly outweigh risk and burdens or vice versa ||Evidence for at least one critical outcome from observational studies, case series, or randomized controlled trials, with serious flaws or indirect evidence. ||Recommendation can apply to most patients in certain circumstances. Higher-quality research is likely to have an important ...|