2002 (BPCA) and the Pediatric Research Equity Act of 2003 (PREA), respectively. Under BCPA, the manufacturer takes the initiative in conducting pediatric studies and requests 6-month patent extensions from the FDA; however, this may not occur for drugs with limited market potential. PREA applies only to new molecular entities or new drugs, for which the FDA can require that the manufacturer conduct pediatric studies unless exceptions are granted. There is currently no regulation providing incentives for or requiring manufacturers to perform pediatric studies for the vast majority of drugs on the market in the generic forms used for pediatric patients.
Even for the small group of medications for which pediatric guidelines are available, a number of pitfalls exist at the prescribing, dispensing, administration, and monitoring stages that can result in medication errors and adverse drug events. Most adverse drug events for pediatric patients are a result of errors that occur at the prescribing stage, and they often involve incorrect dosing (IOM, 2000; Kaushal et al., 2001; Selbst et al., 2004; Chamberlain et al., 2004). Doses for pediatric patients must be calculated based on the patient’s weight and therefore must be determined specifically for each patient. But the calculations needed to develop the dosing are complicated, and errors are common (Selbst et al., 2004). Patient weight can be and often is obtained or recorded incorrectly (Selbst et al., 1999). Among the most serious dosing errors are 10-fold errors that occur when a decimal point is missing or misread. There have been several examples of children receiving 10 or 100 times the intended dose of a medication and dying as a result. In one case, a baby was given 15 milligrams of morphine instead of the intended 0.15 milligrams—a 100-fold difference in dosing (Goldstein, 2001).
Other dosing errors can occur if there is confusion between milligrams (mg) and micrograms (µg) or mg and milliliters (ml). Additionally, errors are common with combinations of products, for example, Tylenol with codeine; it may be unclear whether the dosage is for the Tylenol or the codeine. Finally, dosage errors may occur when a product is prepared in two different ways and the concentrations are different. For example, Tylenol comes in a syrup and a drop, but the concentrations differ.
The process of dispensing and administering medications for children, compared with that for adults, relies much more heavily on manual compounding of liquid medications and administration to patients who are unable to perform their own medication safety checks. This may well make the dispensing and administering of medications for children more prone to error. Additionally, errors can occur during the dispensing stage if drugs that look or sound alike are confused, for example, Zantac and Zyrtec or Tobrex and Tobradex. Additionally, the packaging of two medications may look alike, contributing to errors at the dispensing stage (Levine et al., 2001;