This document provides a high-risk medication reference list for pediatric patients (Table 1), which was developed taking into account the medications used in children featured in the high-risk medication reference lists for hospitals and chronic patients of the Recommendations for the Safe Use of High-Risk Medications document8 as well as specific lists for pediatric patients compiled through the review of the literature.10–15

This list should be used as a reference by health care organizations to produce their own high-risk medication lists for the pediatric population, which they will use for developing, prioritizing and implementing preventive measures (see Section II).

The WHO and patient safety organizations emphasize the need for health care organizations to develop and implement programs to improve high-risk medication safety aimed at reducing errors at every stage of the medication use process.3,8,16–25 These programs must be an organizational priority and be supported and led at the institutional level in order to convey their importance to the entire organization.

The organization’s high-risk medication management program should be strengthened and expanded by taking into account the specific safety concerns associated with the pediatric population. This requires the engagement of pediatricians, pharmacists and other professionals involved in the care of this population, whose role is to develop initiatives that specifically target pediatric patients to be integrated in the general safety practices implemented by the organization and to ensure their implementation in clinical practice.

The measures that organizations need to take to develop a program to reduce errors involving high-risk medications are:

• 1

  Develop an organization-specific list of high-risk medications to prioritize in the implementation of safety practices

An organization-specific high-risk medication list for pediatric patients should be developed using the general high-risk medication list presented in the previous section as a reference and taking into consideration the characteristics of the pediatric population served. The list should include, at a minimum, the following medications which are deemed high priority for all patient groups, including both adult and pediatric patients:

• -

  Anticoagulants, insulins, opioids, neuromuscular blockers, IV potassium, oral methotrexate (non-oncologic use) and cytostatic drugs (unless they are not used at the facility).

In addition, the following should be included specifically for pediatric patients:

• -

  IV adrenergic agonists, aminoglycosides and vancomycin, medications used for moderate and minimal sedation, parenteral nutrition and IV paracetamol.

Additional medications from the general reference list may be included, taking into account the most serious incidents recorded in the specific organization or identified in medication and patient safety publications. A key consideration is that the list should not be too long to ensure the feasibility of implementing the necessary safety practices in the organizations, as a list in itself is of little value if the health care staff is unaware of its existence or is not accompanied by effective risk-reduction strategies.16

• 2

  Select and implement multiple safety practices at the various stages of the medication use process for each therapeutic class or specific medication included in the health care organization’s high-risk list

Each organization must select and implement multiple general and specific safety practices (see section III) for each and every stage of the medication use process, aimed at reducing the incidence of errors associated with the use of medications included in its high-risk list. It is important to keep in mind that a single risk-reduction practice rarely suffices to prevent all possible incidents involving a high-risk medication.

The following recommendations should be taken into account in selecting safety practices for implementation:

• -

  Safety practices should be implemented at every stage of the medication process (procurement, storage, prescribing, reviewing, dispensing, preparation, administration, monitoring, patient and caregiver education and care transitions) with engagement of all professionals involved.

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  The “hierarchy of effectiveness” of error prevention practices should be taken into consideration (Fig. 1).26 It is recommended to prioritize highly effective practices, such as those involving automation and/or the use of technology, constraints or computerized alerts, or moderately effective ones, such as standardization and simplification. These should be combined with less effective practices requiring health care professionals to adhere to rules, protocols or procedures to avoid errors or those that may rely on memorization.26,27 It is important to note that improvement is more likely with the implementation of few but highly effective practices aimed at preventing the most frequent errors involving each high-risk medication compared to the implementation of a large number of less-effective practices.

  
  

  Fig. 1.

  Hierarchy of effectiveness of medication error prevention practices26 (reproduced with the approval of ISMP-Canada).

  The most effective practices are those involving systemic changes and that do not rely on memory, attention or human behavior, although their implementation is usually more complex. Medium-leverage practices reduce the probability of errors occurring. They are relatively quick and easy to implement, but they need constant reinforcement and updating. The least effective measures are those that are person-based. They are quicker and easier to implement, but they must be accompanied by other measures to achieve a safe system.
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  Ensure that error prevention does not rely solely on low-effectiveness practices, such as labeling the drawers or boxes containing high-risk medications or disseminating the organization high-risk medication list or information on these medications.

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  Limit the use of double-checking to specific critical points in the medication process and certain high-risk medications (e.g., chemotherapy or opioid infusions).

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  Consider the root causes and factors that increase the likelihood of errors in pediatric patients. For instance, given that errors in pediatric patients frequently result from the need to perform calculations to adjust the dose based on age and/or body weight, or to manipulate commercial presentations by splitting or diluting due to the unavailability of pediatric formulations, specific safe practices aimed at detecting and reducing errors at these critical steps should be selected.

It is important to emphasize that each center must define and adapt these safety practices according to its available processes, workflows, and technologies, and that it must carry out strategic reflection and planning with a view to both the functional and structural evolution of the organization.

• 3

  Include practices promoting active involvement of patients, family members and caregivers in the safe use of high-risk medications

Patients, parents and/or caregivers should be educated and informed about any prescribed high-risk medications and the possible errors and adverse effects that may occur. They should also be encouraged to take an active role in treatment and to ask any questions they may have about the medication. Special emphasis should be placed on the importance of proper storage to prevent accidental poisoning or misuse of these medications.

They should also be provided with written information and materials to help ensure safe use, in easily understandable language. To this end, it is recommended that original documents be used, preferably documents that are also available in electronic format and can not only be downloaded directly but also be integrated into electronic support, management, monitoring and educational resources. The recommendations document includes the information leaflet 10 Tips for Safely Administering Medication to Children, developed specifically for parents and family members.9

• 4

  Disseminate the high-risk medication risk and established safety practices and train health care professionals

All professionals involved in the use of medicines should be informed of the list of high-risk medications and error-reduction practices. The following actions, among others, are recommended to this end:

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  Designate specific staff to coordinate all the activities related to safety programs in pediatric care settings with the support and recognition of the management of the facility.

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  Organize informational sessions or trainings to discuss the reasons for selecting the medications, medication errors and the harm to patients that could be prevented, as well as the importance of implementing each risk-reduction practice.

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  Include a practical component in educational interventions, for instance, simulation-based learning, to train clinicians and care teams on the use of high-risk medications and early response to adverse drug events.

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  Create incentives for reporting incidents involving high-risk medications, including medication errors and adverse drug reactions (for instance, by including them among the objectives and targets of the departments or units) so as to promote a safety culture among the health care staff.

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  Promote multidisciplinary analysis of incidents occurring at the center and provide feedback on these incidents at regular intervals for learning purposes, including the measures adopted by the center.

• 5

  Monitor the implementation of safety practices and evaluate their effectiveness

Health care organizations must establish medication process and outcome indicators to monitor the implementation and to evaluate the effectiveness of established safety practices. Evaluations should be conducted at regular intervals to measure and analyze outcomes with the Risk Management Committee, the Pharmacy and Therapeutics Committee, and the center’s management team.

In this regard, it is advisable to monitor the actions undertaken at the center through periodic analysis of reported incidents.

Finally, it should be noted that safety management in healthcare centers must be a dynamic process. Therefore, organizations should regularly review and update their list of high-risk medications and established safe practices, taking into account the causes of errors involving these medications at their own facility, their healthcare activity, and published strategies for improving the use of high-risk medications.

The document presents a series of general safety practices applicable to all high-risk medications (Table 2).3,4,8,20,22,28–39 These practices target each of the stages of the medication use process, from medication selection and procurement, through medication storage, prescribing, transcribing and reviewing, preparation, administration and monitoring to care transitions and patient and caregiver education. Although they focus on the safe use of high-risk medications in pediatric patients, many of them are also applicable to any type of medication or patient.

Fig. 2.

Recommended symbols to identify high-risk medications.

In addition to these recommendations, the full version of the document describes the most frequent errors and specific safety practices for the following high-risk therapeutic classes or medications: IV adrenergic agonists, aminoglycosides, oral anticoagulants, heparin and other parenteral anticoagulants, neuromuscular blockers, insulin, medications for minimal and moderate sedation, parenteral nutrition, opioids, methotrexate (non-oncologic use), IV paracetamol, IV potassium and vancomycin. Due to length constraints, we were unable to summarize this information in the present article, so we recommend consulting the full version of the document.9

Health care centers should implement specific pediatric practices combined with general practices to improve safety, bearing in mind the criteria presented in Section II and the characteristics of the patients and care settings of the center. In pediatric care in particular, it is important to consider that certain subsets of patients, such as neonates, patients with complex chronic conditions, oncological patients and obese patients, and certain care settings, such as emergency departments, intensive care units, day hospitals, and hospital-at-home units, call for special considerations that are key to ensuring safe medication use.

In conclusion, safety in the use of high-risk medications in pediatric care is a crucial challenge that requires a comprehensive and multidisciplinary approach adapted to the specific characteristics of this vulnerable population. The development of programs for high-risk medication safety in health care organizations, with implementation of effective safety strategies at every stage of the medication process and promoting the education of health care professionals, patients and caregivers, is an essential step toward reducing medication errors and their adverse consequences. To succeed, this joint effort requires institutional commitment and ongoing evaluation of implemented interventions, thereby ensuring sustained improvement in pediatric patient safety and enhancing the safety culture of health care organizations.