Good decision making need not always be based on the results of randomized controlled trials for two reasons: (1) such results are not always available, and (2) other forms of knowledge may be definitive. For example, few drug products used for neonatal and pediatric patients have been tested in randomized controlled trials in these populations. When a drug exists that has been tested in the adult population, pediatricians must use their medical expertise and overall knowledge of therapeutics to make decisions regarding the “off-label” use of the drug to meet the needs of their patients (see Box 2-4).

Moreover, all illnesses do not require drug therapy. The need for a drug should be evaluated and weighed against alternative treatments to avoid overuse or inappropriate uses of medications (IOM, 2001). For instance, antibiotics are contraindicated for treating the common cold or a viral infection but are often requested and prescribed nonetheless, thus contributing to problems of antibiotic resistance. As another example, certain drugs, particularly antidepressants, analgesics, and muscle relaxants, are commonly and inappropriately prescribed for elderly patients, contributing to adverse drug events that necessitate health care services, physician contact, hospitalization, and emergency department visits (Golden et al., 1999; Hanlon et al., 2000a,b; Fick et al., 2004; Fialova et al., 2005).

When the decision is made to select a medication, care is necessary to screen the drug regimen for potential drug–drug and drug–food interactions; age- or gender-related metabolic or pharmacologic considerations; incidence and severity of side effects; tolerance effects over time; relationship to placebo effects; and comparability to other, nonmedication-related treatments (Nies, 2001). Poor decision making can result in prescribing that fails to help the patient or causes harm. Even if the correct decisions are made in determining the medication regimen, poor communication of prescription orders in any format (written, oral, electronic) can lead to serious adverse drug events (Cohen, 2000; USP, 2004).

A number of studies have cited prescribing as a principal source of overall medication errors, estimating incidence rates of 18.9 to 58.4 percent (Bates et al., 1995; Lesar et al., 1997; Gurwitz et al., 2000; USP, 2004). The numerous types of prescribing errors identified in the literature include the following (Lesar et al., 1990):

  • Failure to alter drug therapy in patients with impaired renal or hepatic function.

  • Failure to notice a patient’s history of allergy to the prescribed drug class or missing critical information about a patient’s known drug allergies.

  • Use of the wrong drug name (e.g., sound-alike or look-alike names), wrong dosage form (e.g., intramuscular versus intravenous injection), or

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