INTRODUCTION

In 1999, the Institute of Medicine published its landmark report "To Err is Human", which estimated that, in the United States, 44,000 to 98,000 deaths annually are due to medical errors, with 7,000 deaths attributable to medication errors.¹ Since this publication, interest in medication errors has increased dramatically.²-⁴ Two decades later, medication errors are still estimated to injure approximately 1.3 million people in the United States annually.⁵ In England, out of the estimated 237 million medication errors per year, 27.8% have the potential to cause moderate and severe harm.⁶ In France, the Enquête Nationale sur les Evénements Indésirables graves liés aux Soins (ENEIS) study revealed that 42% of serious adverse drug events are preventable.⁷ In response to this problem, the World Health Organization (WHO) launched in 2017 its "Global Patient Safety Challenge on Medication Safety- Medication Without Harm" aiming to reduce severe, avoidable medication-associated harm by 50% over the next five years, specifically by prioritizing and effectively managing "high-risk situations".⁸

Although medication errors constitute a major concern in different age groups, children are distinctively prone to this problem.⁹ Several factors heighten risk of medication errors in pediatrics, primordially the weight-based dosing that involves multiple calculations, in addition to the lack of appropriate pediatric formulations.⁹-¹¹ A recent systematic review conducted in pediatric intensive care units reported a median rate of medication errors at 14.6 per 100 medication orders, and between 6.4 and 9.1 per 1,000 patient-days.¹² In the community, medication errors involving children also occur frequently; reported data indicate an annual average of 63,358 young children in the United States experiencing medication errors, or one child every eight minutes.¹³ Moreover, pediatric patients are three times more likely than adults to experience potentially harmful medication errors.¹⁰

Patterns of medication errors in pediatrics are understudied in the hospital and community settings.¹⁴,¹⁵ Besides, using information from studies conducted on adults may be of limited value, since medication errors most likely differ between the two populations.¹⁶,¹⁷ Exploring specific patterns of medication errors in pediatrics compared with adults could enhance our understanding of this complex problem in pediatrics and inform targeted efforts to enhance patient safety.

In France, a national medication error reporting system, the French Medication Error Guichet, which is managed by the National Agency for Medicines and Health Products Safety, allows the collection of reported medication errors.¹⁸ Our study aimed to characterize the medication errors reported to the French Medication Error Guichet in pediatrics aged less than 18 years, and compare them with medication errors in adults, in each of the hospital and community settings.

METHODS

RESULTS

Between 2013 and 2017, 12,136 medication error reports were submitted to the French Medication Error Guichet. The flowchart of the reports is detailed in Figure 1. Among the 12,136 total medication error reports, 1,322 reports of medication error risk, and 2,593 reports involving geriatric population were not included. Concerning missing data, 1,340 reports with unknown error setting, and 2,163 reports with unknown age data were excluded. Finally, 4,718 reports on actual and potential medication errors in pediatrics and adults in the hospital and community settings were included in the analysis.

Figure 1.  Flowchart of the medication errors reported to the French Medication Error Guichet between 2013 and 2017ADR: adverse drug reaction; ME: medication error. 

DISCUSSION

We analyzed 4,718 medication errors reported to the national French Medication Error Guichet between 2013 and 2017. We comprehensively described medication errors in pediatrics, and identified pertaining specific patterns, in comparison with adults, in each of the hospital and community settings. We deepened our analyses with an exploration of medication errors with ADR, and serious ADR. Our findings generate important information for future error-prevention measures in pediatrics, and pave the way for interventional research targeting the needs of this population, with the ultimate goal of enhancing patient safety.

Both in hospital and community settings, frequently reported in pediatrics were wrong dose errors, and those involving antibacterials for systemic use. Specifically, these two characteristics were more likely to be associated with reported medication errors in pediatrics compared with adults. Our findings reiterate the dominance of dosing errors in the pediatric population. For instance, using data from national reporting systems, dosing errors were the most encountered types, accounting for 47.7% of errors in the hospital setting in Denmark, and 62.5% of errors in the community in Ireland.¹⁶,²³ Medication dosing in pediatrics bears a high risk of error, due to the complicated drug doses calculations based on patient's age, weight, or body surface area, the increased need for drug dilutions and manipulations subsequent to the lack of pediatric formulations, and the presence of multiple dosing devices used for delivering medications at home, possibly leading to confusion.⁹,¹¹,²⁴,²⁵ Although these errors are a long-standing problem in pediatrics, the literature does not provide to-date conclusive evidence on effective interventions in this regards.²⁶,²⁷ In the hospital setting, computerized physician order entry, unit dose dispensing systems, and educational/risk management programs are suggested to reduce dosing errors.²⁶ For example, through a recent systematic review of the literature, Gates et al. found that dosing errors were less prevalent in hospitals with computerized physician order entry, but without evidence that this result represented a causal relationship.²⁷ In the community setting, through a randomized controlled trial, Yin et al. showed that providing parents with dosing tools more closely matched to prescribed dose volumes, pictographic instructions, and milliliter-only units on labels and tools are promising strategies for reducing pediatric dosing errors.²⁸ There is a pressing need for research employing robust controlled designs to assess the true impact of different interventions on dosing errors and associated harm to patients.

The involvement of antibacterials for systemic use in pediatric medication errors is also commonly reported elsewhere, with proportions reaching 27.2% in the hospital setting and 17% in the community.¹⁶,²³ Antibiotics are extensively used in pediatrics, and subject to overtreatment through pressure from parents on clinicians to prescribe them.²⁹,³⁰ These factors potentially explain the common involvement of antibacterials in reported medication errors. A French study using a national reimbursement claims database showed that half (49%) the children received antibacterials for systemic use.³¹ An opportunity may exist in decreasing unnecessary exposure to antibacterials, and the medication errors that occur with their use.

In our analysis, administration stage topped the reported medication errors in adult and pediatric populations, in both settings. The common citation of administration errors is probably because they are the most visible and closest to the patient.³² Specifically, our findings in pediatrics are supported by other studies. Through a systematic review of the literature, Miller et al. found administration error occurrence between 72 and 75 in every 100 reported medication errors.³³ Recent estimates also highlight this issue, whereby administration errors accounted between 42.5% and 54% of pediatric medication errors.¹⁴,¹⁵ Of interest, Kaushal et al. found that harmful errors occurred most commonly at the drug administration stage by parents.³⁴ Interventional studies in hospital medication administration errors explored barcode medicine administration, electronic prescribing, education and training, use of smart pumps, and standard concentration.³⁵ However, evidence is not conclusive regarding their impact or effects on reducing errors.³⁵ In the community, all caregivers including parents, extended family members, and school nurses should be adequately trained on how to appropriately administer the medication to children.³⁶

In the hospital setting, our findings of analgesics, and blood substitutes and perfusion solutions being frequently reported in medication errors in pediatrics are in line with the literature.²³,³⁷ For instance, in the national study by Rishoej et al., both of these drug classes were commonly involved in reported medication errors, with respective proportions of 13% and 6%.²³ Of interest, our comparison with reported medication errors in adults indicates that errors involving analgesics, and blood substitutes and perfusion solutions related more to pediatrics. Through an observational study, Jimenez et al. also found that pediatrics had higher medication errors related to electrolytes and total parenteral nutrition compared with adults (19.9% vs. 8.3%).¹⁴ Accordingly, prevention strategies targeting analgesics, and blood substitutes and perfusion solutions may considerably enhance pediatric patient safety, especially that these classes encompass high-alert medications in pediatrics, such as opioids, and parenteral nutrition.³⁸ Within this scope, we identified that blood substitutes and perfusion solutions related more to reported medication errors with serious ADR in pediatrics. For instance, one of the described serious ADRs was electrolyte disorders such as hyperkalemia or hyperglycemia resulting from errors with solutions for parenteral nutrition (data not shown).

In line with the literature, wrong route and wrong technique error types were not commonly reported in pediatric and adult medication errors in hospital setting.²³,³²,³⁹,⁴⁰ Importantly, our findings suggest that these error types were more likely to be associated with reported medication errors with serious ADR in pediatrics compared with adults. Data from the Finnish Poison Information Centre indicate that incorrect route of administration error type occurred mainly in hospitals.⁴⁰ This type resulted in the most serious medication errors.⁴⁰ Children under 10 years of age were particularly exposed to this error type.⁴⁰

In the community setting, vaccines were the drug class most frequently involved in reported errors in pediatrics. Common involvement of vaccines in pediatric medication errors was also reported elsewhere.¹⁵ This comes parallel to the substantial exposure to vaccinations throughout early childhood, and the complex vaccination schedule.⁴¹ Using data from the United Kingdom National Reporting and Learning System, the study of Rees et al. conducted to characterize the pediatric safety incidents occurring in family practice, found that vaccine-related incidents were the most frequently described, with wrong time, wrong dose, and wrong vaccine error types, being the most frequently reported. These vaccination incidents resulted in harm in 70.6% of cases.⁴² Vaccines are nonemergency drugs given in specific, controlled circumstances, and pertaining error types are associated with predictable vaccine-related human factors challenges; the targeting of which presents a valuable opportunity to prevent errors.¹⁵,⁴¹

This study adds evidence that medication errors involving analgesics are commonly reported in pediatrics in the community.¹³,¹⁶,⁴³ Nevertheless, our analysis showed that these agents were less likely to be associated with reported medication errors in pediatrics compared with adults. In contrast, although psycholeptics were infrequently reported in community pediatric medication errors, as shown elsewhere, our study found that they related more to reported medication errors with serious ADR in pediatrics compared with adults.¹³ Based on the National Poison Data System in the United States from 2000 to 2012, Kamboj et al. found that atypical antipsychotics- a group of psycholeptics were associated with 32.1% of medication errors among children aged 6 to 19 years, compared with 20.6% among adults aged 20 years or above.⁴⁴ Our results thus join the emerging literature in suggesting a pediatric-specific pattern concerning medication errors involving psycholeptics. Finding effective targeted strategies for reducing pertaining medication errors and associated harm is crucial.

Noteworthy, we report a discordance with the former literature concerning medication errors involving cough and cold preparations. While this drug class was previously commonly involved in medication errors in children in the community, it was not identified as such in our analysis.¹³,¹⁶,⁴³ Smith et al., in their study spanning 2002-2012, showed a sharp decline in both the frequency and rate of errors involving cough and cold preparations from 2005 through 2012.¹³ Decline in pertaining errors could be related to the decreased use of these agents, which might be attributed to the recommendation against the use of over-the-counter cough and cold preparations among young children.⁴⁵ Indeed, recent evidence did not identify these agents in reported medication errors in pediatrics.¹⁵

In the community, wrong technique error type was not frequently reported in pediatrics; yet, our comparative analysis showed that this error type is pediatric-specific, relating more to reported medication errors, as well as medication errors with ADR in this population. This may be explained by the increased need for drug manipulation in pediatric care that is mainly driven by the lack of commercially-available, age-appropriate formulations.¹¹,²⁴ Other reasons include parents misunderstanding medication preparation instructions, or altering the technique for administration from the physician instructions due to the lack of proper equipment, or because the recommended technique did not work at home.⁴⁶,⁴⁷ Suggested actions include interventions to enhance carers' understanding of administration techniques through proper and precise instructions, having appropriate equipment at home, in addition to routine provider inquiry about problems in daily medication use.⁴⁷,⁴⁸

Finally, as medication errors were reported throughout the medication use process in both settings, involvement of all actors along the continuum of care is crucial to ensure patient safety.

CONCLUSIONS

Pediatrics are not little adults; they require particular attention in medication use. Our study characterized medication errors in pediatrics, and identified specific medication error patterns in this population, compared with adults. Drug classes particularly implicated in pediatric medication errors included antibacterials for systemic use, analgesics, blood substitutes and perfusion solutions, vaccines, and psycholeptics. Other error-prone areas involved primarily the administration stage; in addition to wrong dose, wrong technique, and wrong route types. Our results hold important implications for health professionals, caregivers, manufacturers, and policy makers, as well as researchers with respect to focused measures to enhance pediatric medication safety.