About CERTs
Annual Report Year 3
CERTs Progress
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University of North Carolina at Chapel Hill—
“Small” Errors: Improving Drug Safety for Children
The UNC CERTs is devoted to improving the use of therapeutics in the pediatric population (neonates, infants, toddlers, children and adolescents). Thus, the UNC CERTs couples broad attention to practical improvements with a targeted emphasis on mainstream problems in therapeutics. The UNC CERTs distills these focal points into strategies for improving outcomes from the use of drugs and devices in the pediatric population.
Key projects:
- Development of evidence-based tools to assess pain in pediatric patients for earlier and more effective therapeutic intervention
- Assessment of the skeletal effects of vitamin D and calcium supplementation in children with cystic fibrosis
- Design and testing of toolkits for the more accurate diagnosis and more effective treatment of attention deficit hyperactivity disorder (ADHD)
The University of North Carolina CERTs is targeting safer drug use in a particularly vulnerable population—children. In keeping with its mission of improving the use of therapeutics in the pediatric population, UNC CERTs is tackling the prevalence of medication errors while treating children, a poorly understood problem.
“My office set up a structured system for evaluating ADHD patients, using the tools in the UNC CERTs toolkit. This helped us standardize the way ADHD is approached and diagnosed. It's just a better way to practice medicine.”
—New York pediatrician
Inpatient adverse drug events among pediatric patients have not been adequately assessed. Children present unique challenges when ordering, dispensing, and monitoring medications. Potential adverse drug event (ADE) rates for children can be three times higher than for adult patients.
Because so few clinical trials involve pediatric subjects, dosing for children has largely been done through calculations based on weight, as much by tradition as by empirical evidence. The more calculations required to prescribe and administer a medicine, the greater the potential for error. Medicines often must be diluted by pharmacists for use by pediatric patients, presenting another opportunity for mistakes.
As age decreases, vulnerability increases. Very young children are not able to warn care providers about potential mistakes with medication. Infants, especially newborns, are particularly subject to injury from even the smallest dosing error with particular drugs. But many differences between adults and children in susceptibility to ADEs are not as clearly understood.
To get a better picture of the rates and character of adverse drug events in young patients, UNC illustrated one of the chief strengths of the CERTs program, its partnerships with a diverse array of institutions. Enlisting the aid of the United States Pharmacopeial (USP) Convention Inc., UNC set out to get a detailed picture of medication errors in relation to the continuum of pediatric care (where medication errors are most likely to occur, where interventions will be most effective) as well as which therapies are most susceptible to misuse.
USP is a not-for-profit organization that has promoted public health by establishing standards of quality for medicines and other therapies. These standards are published in the federally recognized United States Pharmacopeia and National Formulary (USP-NF).
USP offered an innovative and powerful way for UNC to track medication errors in its pediatric patients. MedMARx™ is a Web-based system for entering and tracking mistakes made when prescribing, documenting, and administering medications. Participants can enter anonymous patient information, including age, and a host of relevant details on the particular medication error. These include the level of injury done to the patient, if any, and the stage at which the error occurred, allowing healthcare providers to pinpoint where quality improvement should be aimed.
Because MedMARx is anonymous, anyone using the system can access it to find drug errors similar to ones happening at his or her institution. A flexible and powerful search function helps find only those instances that pertain to a physician's or hospital's particular interests.
This potent feature was the key to a revealing and dramatic UNC CERTs success. Co-principal investigators Drs. William H. Campbell and William L. Roper and their team analyzed over 2000 pediatric inpatient records among the more than 70,000 currently in the MedMARx database.
Their findings revealed good news and bad. The majority of errors were cases in which the misused medication reached the patient but did not cause harm. Most of the mistakes, about 52%, occurred at the administration phase, where errors of omission or an improper dose or quantity were the most commonly reported types.
- Most commonly misused, according to the UNC team, were:
- IV fluids, e.g. dextrose/sodium chloride solution
- Gentamicin, a common antibiotic used against group B streptococci and E. coli
- Total parenteral nutrition, i.e., nutrient fluids delivered intravenously or subcutaneously, which is primarily a concern in premature infants
- Cefotaxime, another common antibiotic
Overall, the analysis supported previous studies that suggested pediatric populations are more vulnerable to adverse drug events. The results have led to the drafting of an addition to the USP recommendations, Error Avoidance Recommendations for Pediatric and Neonatal Medicine Use. This is currently under review and should be published soon.
UNC CERTs efforts to protect children from ADEs continue. Adding to the wealth of information from the MedMARx system, UNC researchers are also analyzing errors in pediatric patients submitted to the USP Medical Error Reporting Program. The aggregate data from both of these systems will be compared with data on adult patients to further refine the big picture of adverse drug events in children.
Dr. William Campbell, co-principal investigator of the UNC CERTS, along with Dr. Brian Strom, principal investigator for the University of Pennsylvania CERTs, were named to a new subcommittee of the FDA in December 2001. The Drug Safety and Risk Management Subcommittee will advise the FDA on safety issues in the evaluation of new therapies and new uses for existing therapies.
“A goal of the CERTs is to optimize the balance of the risks and benefits of medical products,” says Dr. Rob Califf, director of the CERTs Coordinating Center. “Having CERTs Steering Committee members on this subcommittee is a logical extension of this mission. As the FDA moves more vigorously to implement programs of risk management, I expect that this committee will play an important role in giving both general and specific advice to the FDA.”