Pediatric patients are disproportionately affected by improper and wrong-dose errors in perioperative settings.
Data from the report showed that the three most common types of errors were prescribing, omission, and improper dose/quantity [wrong dose]. The leading causes of errors were performance deficit, procedure/protocol not followed, and communication. Among the most commonly involved agents in errors were antimicrobials and central nervous system drugs. For errors associated with harm, central nervous system agents were the most common.
What really stands out, however, is the impact these errors have had on pediatric patients. For example, in the operating room setting, of 3,773 cases, 7.3% of the errors resulted in harmful outcomes-pediatric 16.7%, adult 11.3%, and geriatric 10%.
"Whenever we have looked at pediatric data as a subset, we have seen higher harm rates than we see in general data," said Diane Cousins, R.Ph., VP, Center for the Advancement of Patient Safety at USP. Cousins went on to say that there is a correlation between the high percentage of wrong-dose errors and the lack of clinical trials that result in labeling and dosing standards for pediatric patients. The result, according to Cousins: Pediatric doses are manipulated enough to create errors.
The FDA's pediatric exclusivity provision gives drug companies an incentive to conduct pediatric clinical trials. When studies are conducted as requested by the FDA, the drug company will receive an additional six months of marketing exclusivity for products that have existing exclusivity or patent protection. And the "Pediatric Rule" allows the FDA to require pediatric clinical trials if a drug is expected to be widely used in children or represents a significant medical advantage over previously approved products.
In 2006, 120 pediatric products were studied. The FDA concluded that many of the studies have raised more issues. Long-term safety and effects on growth, learning, and behavior continue to be understudied, and neonates remain mostly unstudied regarding the safety and efficacy of the therapies being used to treat them.
What's the take-home message for healthcare practitioners and health-system administrators? Expand the pharmacy department's role in perioperative care by having dedicated staff pharmacists in the medication use process, including medication reconciliation and standardizing or limiting the products routinely available. "We feel that kind of involvement and oversight would really be helpful, especially for wrong-dose errors that we see so often with pediatric patients," said Cousins. She hopes that the USP report will help administrators see why there is a need for pharmacy involvement.
Patient safety experts said that while the USP report is worrisome, the high percentage of pediatric med errors is nothing new. "Dosing for pediatric patients has always been a major problem both in the acute care setting and outside the hospital," said Michael Cohen, president of the Institute for Safe Medication Practices (ISMP).
Cohen went on to say that often there is confusion between ml and mg as well as between drops and ml. He said that sometimes the errors originate in the pharmacy with the original labeling. A pharmacist, for instance, could be thinking drops but typing ml. In that scenario, it wouldn't be difficult for someone who is reading that pharmacy label to make a mistake.
In addition to utilizing pharmacists in perioperative settings, USP also recommends that hospitals develop checklists that are accurately completed prior to patients leaving the area, in order to minimize the loss of information through handoffs. It is also recommended that they develop strategies to ensure that medications-in particular, antimicrobial agents-are administered at the correct time.