Elsevier

Ambulatory Pediatrics

Volume 7, Issue 5, September 2007, Pages 383-389
Ambulatory Pediatrics

Safety and Preventive Care
Adverse Drug Events in Pediatric Outpatients

https://doi.org/10.1016/j.ambp.2007.05.005Get rights and content

Objective

To determine rates and types of adverse drug events (ADEs) in the pediatric ambulatory setting.

Methods

A prospective cohort study at 6 office practices in the greater Boston area was conducted over 2-month periods. Duplicate prescription review, telephone surveys 10 days and 2 months after visit, and chart reviews were done. A 2-physician panel classified the severity, preventability, and ability to ameliorate (ie, if the severity or duration of the side effect could have been mitigated by improved communication) ADEs.

Results

We identified 57 preventable ADEs (rate 3%; 95% confidence intervals [CI], 3%–4%) and 226 nonpreventable ADEs (rate 13%; 95% CI, 11%–15%) in the medical care of 1788 patients. Of the ADEs, 152 (54%) were able to be ameliorated. None of the preventable ADEs were life threatening, although 8 (14%) were serious. Forty (70%) of the preventable ADEs were related to parent drug administration. Improved communication between health care providers and parents and improved communication between pharmacists and parents, whether in the office or in the pharmacy, were judged to be the prevention strategies with greatest potential.

Conclusions

Patient harm from medication use was common in the pediatric ambulatory setting. Errors in home medication administration resulted in the majority of preventable ADEs. Approximately one fifth of ADEs were potentially preventable and many more were potentially able to be ameliorated. Rates of ADEs due to errors are comparable in children and adults despite less medication utilization in children.

Section snippets

Methods

We performed a prospective cohort study of patients under age 21 from 6 office practices. Data collection methodologies included duplicate prescription review, 2 surveys, and chart review. All data were reviewed for medication errors, including those with the potential for harm (near misses) and those that actually caused harm (preventable ADEs). In addition, data were reviewed for harm from medications that were not associated with an error (nonpreventable ADEs). All ADEs were further

Rates of Prescriptions and Survey Responses

During the study period, 21 209 visits were made by 13 919 patients, of whom 3838 (28%) received a prescription (Figure 1). Of these, 1007 (26%) patients were excluded. Of the remaining 2831 patients, 328 (12%) opted out of the study and 1788 (63%) completed the initial survey, with office practice response rates ranging from 58% to 78%. The second survey was completed by 1239 (69%) of these 1788 patients.

Parents most commonly were the survey respondents (1715 [96%]), followed by legal

Discussion

We found that ADEs were common in the pediatric ambulatory setting, occurring in about 16% of children treated. This result is particularly surprising given the simpler medication regimens in pediatric outpatients compared with pediatric inpatients and adult outpatients. Of the ADEs, 1 in 5 were judged to be preventable, and just over half were able to be ameliorated. Most were of relatively low severity. Of note, errors resulting in ADEs occurred most commonly at the stage of drug

Acknowledgments

We thank the 6 office practices, their pediatric health care providers, and their patients for participating in this study. This study was supported by a grant from The Agency for Health Care Research and Quality, Rockville, Md. (Grant #5 P01 HS11534-04).

References (19)

  • R. Kaushal et al.

    Pediatric medication errors: what do we know? What gaps remain?

    Ambul Pediatr

    (2004)
  • H.A. McPhillips et al.

    Potential medication dosing errors in outpatient pediatrics

    J Pediatr

    (2005)
  • Institute of Medicine. To Err Is Human. Building a Safer Health System. Kohn LT, Corrigan JM, Donaldson MS, eds....
  • T.A. Brennan et al.

    Incidence of adverse events and negligence in hospitalized patients. Results of the Harvard Medical Practice Study I

    N Engl J Med

    (1991)
  • L.L. Leape et al.

    The nature of adverse events in hospitalized patients. Results of the Harvard Medical Practice Study II

    N Engl J Med

    (1991)
  • E.J. Thomas et al.

    Incidence and types of adverse events and negligent care in Utah and Colorado

    Med Care

    (2000)
  • D.W. Bates et al.

    Incidence of adverse drug events and potential adverse drug events. Implications for prevention. ADE Prevention Study Group

    JAMA

    (1995)
  • R. Kaushal et al.

    Medication errors and adverse drug events in pediatric inpatients

    JAMA

    (2001)
  • T.K. Gandhi et al.

    Adverse drug events in ambulatory care

    N Engl J Med

    (2003)
There are more references available in the full text version of this article.

Cited by (112)

  • Making Polypharmacy Safer for Children with Medical Complexity

    2023, Journal of Pediatrics
    Citation Excerpt :

    An adverse drug event is defined as “Any harm experienced by a patient as a result of exposure to a medication.” An adverse drug event can happen as a direct result of the medication itself, like oversedation by a central nervous system agent or through a drug interaction with another medication, and most commonly manifests as a dermatologic, gastrointestinal, or respiratory symptom.7,11,16 Or an adverse drug event could happen as a consequence of administration, like a mismeasured dose or improperly prepared liquid medication, which has been associated with undertreated symptoms among CMC, like seizures or pain.12

  • Development and stability of an oral suspension of procarbazine in pediatrics

    2019, Journal of Drug Delivery Science and Technology
View all citing articles on Scopus
View full text