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Medication safety for children with medical complexity

Posted: Oct 20, 2020

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Principal author(s)

Kathleen Huth, Patricia Vandecruys, Julia Orkin, Hema Patel; Canadian Paediatric Society, Community Paediatrics Committee

Paediatr Child Health 2020 25(7):473. (Abstract).

Abstract

Due to advances in medical care and innovations in health technology, many children with life-limiting conditions are now living longer. These children are often referred to as ‘children with medical complexity (CMC)’, and they are characterized by chronic conditions, increased health care utilization, and technology dependence. Their complexity of care and inherent fragility lead to higher risk for medication errors, both in-community and in-hospital. High rates of care fragmentation, miscommunication, and polypharmacy in CMC increase opportunities for error, particularly as children transition between health care settings and practitioners. Data on the factors contributing to higher risk of medication errors in this population and how they can be effectively addressed are lacking. This practice point provides clinical guidance for health care professionals to ensure medication safety when caring for CMC, with focus on practical strategies for outpatient and inpatient care.

Keywords: Adverse drug events; Children with medical complexity; Medication; Safety

Background

Medication errors are common in children [1]. As preventable events, they may involve incorrect ordering, dispensing, or administration (Table 1) [2]. Failures in the multi-stage process of delivering medication can cause significant harm to patients [3][4]. While medication errors in hospitalized children most commonly involve incorrect dosing, the main source of reported errors in the outpatient setting is incorrect administration by a caregiver [7][8].

Children with medical complexity (CMC) are defined by chronic conditions, increased health care utilization, and technology dependence [9][10]. CMC are at higher risk for medication errors and preventable adverse drug events (ADEs), particularly during care transitions [11][12]. Fragmented care, with multiple medications prescribed by practitioners in multiple settings, may increase opportunity for error. A Canadian cohort of hospitalized CMC identified a median of six medications for each patient, with care provided by a median of 13 outpatient physicians across six subspecialties [13].

Guidelines to improve medication safety are limited. Most studies of medication errors and interventions focus on inpatient settings, whereas errors occur in all care settings—in the home, in the community or at school, and in ambulatory clinics [14]. Practitioners must be able to identify and mitigate risk for medication errors in high-risk patients in all settings.

Table 1. Types of medication errors
Wrong medication
Wrong dose prescribed or administered
Wrong concentration or preparation error
Wrong duration or frequency
Drug-drug interaction
Known allergy to medication
Omitted or duplicated medication
Medication order not discontinued
Adapted from references [2][15]

Factors that contribute to risk of medication errors in CMC

In all children, weight-based dosing and diverse drug formulations contribute to risk for medication error, as does the lack of evidence regarding optimal dosing, safety, and efficacy specific to the paediatric population [15]-[19].

In CMC, risk for medication error is compounded by several factors (Table 2). Polypharmacy, or the use of multiple medications concurrently to treat one or more medical conditions, is a strong risk factor for ADEs [20]-[22]. Use of four or more prescribed drugs has been associated with important discrepancies in hospital admission medication orders [23]. As the number of medications increases, so does opportunity for ordering and administration errors as well as drug interactions [2]. Lack of standardization in medication doses, preparations, and labelling contributes to this risk. Parents often report medications in terms of volume, not dose. They may be unaware that concentrations vary and may change even with a simple prescription renewal. Adding to this issue, many liquid medication labels specify the volume to be administered, not the actual dose.

CMC often have multiple prescribers with varying, sometimes conflicting care goals. Suboptimal communication between prescribers compounds the dangers of ADEs. Multiple caregivers are often involved in medication administration at school or in separate parental homes, which can increase opportunity for miscommunication and error.

Complex regimens involving multiple medications scheduled concomitantly also increase opportunities for error. Medications may be prescribed to CMC to manage challenging symptoms despite limited evidence for their indication, or despite multi-system side effects. Complementary alternative medicine is used more frequently by patients with chronic conditions, increasing the likelihood of interactions among prescription medication and over-the-counter products [24]. CMC may also be more susceptible to adverse effects in the settings of comorbid malabsorption, or renal or hepatic impairment.

Table 2. Factors contributing to risk of medication errors in CMC
Polypharmacy
Multiple prescribers at multiple sites of care delivery may use multiple pharmacies
Multiple caregivers administering medications in school and at home
Frequent transitions between health care settings
Frequent changes in medications and doses in response to fluctuating clinical status
Different formulations and routes of delivery
No standardized concentrations of liquid preparations of medications
Uncommon medications, or medications used for an off-label indication
Challenges with medication administration (i.e., via gastrostomy or jejunostomy tube)
Interactions among medications with differing pharmacokinetics and side effect profiles
Potential renal or hepatic impairment (i.e., from an underlying chronic condition or other medications)
Burden on caregivers to manage complex medication regimens

Interventions with potential to improve medication safety

While there is minimal paediatric-specific evidence to support the recommendation of strategies to promote medication safety, the following guidelines offer practical approaches for practitioners caring for CMC.

Engaging and empowering caregivers

Recent studies that involved families as partners in error surveillance identified preventable adverse events that were not otherwise reported [25][26]. In one study, most “near-misses” reported by parents were related to medications [26]. With caregivers serving as a constant across care transitions, building capacity and a culture that supports identification of medication concerns is crucial for preventing errors. Data is lacking on optimal strategies for practitioners wishing to educate and empower caregivers to understand their child’s medication regimen and flag concerns. The ‘teach-back’ method involves asking a patient or caregiver to explain information that has just been shared, in their own words, so as to check understanding, then offering opportunities to clarify and check again [27][28]. This tool has been used effectively to reinforce patient education for a variety of health topics [29], and may be one approach to ensuring that caregivers of CMC can reliably describe and demonstrate correct medication dosing and administration. Emphasizing the central role of caregivers in maximizing medication safety may encourage their engagement in preventing and reporting medication errors [30]. Strategies for empowering caregivers to support medication safety may include the following:

  • Discuss the incidence and risk factors for medication errors to increase caregiver awareness of the potential for harm.
  • Help families maintain a current and detailed medication list (including dose, concentration, volume, and route of administration) and ensure that it is readily accessible for appointments, emergency department visits, and admissions to hospital.
  • Educate caregivers on the difference between the dose (i.e., total milligrams) and concentration (i.e., milligrams per millilitre) of medications, so they are prepared to identify the dose when different dilutions are available in different care settings.
  • Inform caregivers that the dilution of liquid medications is not standardized and may change with prescription renewal.
  • Discuss medication indications, potential side effects, potential interactions, and plan reassessment with caregivers. Engage them in teach-back to ensure understanding.
  • Explore ways to optimize medication safety at home, perhaps by minimizing the number of caregivers responsible for administering medications, documenting administration on a central record, routinely checking equipment (including dosing tools), and ensuring the safety for other children in the home by safe medication storage and disposal methods.
  • Encourage caregivers to ask questions of prescribing clinicians and pharmacists when instructions are unclear or inconsistent with their understanding of dosage or administration.
  • Support caregivers in bringing their concerns to the attention of prescribing clinicians, such as suspected medication allergies, intolerances, or adverse drug events.

Optimizing interdisciplinary team communication

Failure to communicate is the leading root cause of sentinel events, including medication errors [31]. Improving communication among patients and families, physicians, nurses, and pharmacists can prevent medication errors [5][7]. For CMC, this strategy is particularly relevant. Interventions may involve standardized, accessible documentation of medications, with shared understanding of indications and plans for reassessment. Adhering to best practices for prescribing, such as avoiding abbreviations, specifying dose per kilogram in addition to the total dose, and using generic names, can prevent miscommunication [17]. Engaging outpatient practitioners during discharge planning may prevent miscommunication regarding medication changes during care transitions [32][33]. A ‘medical home’ model of care, with explicit identification of a primary provider, has been shown to reduce care fragmentation and medical errors for CMC, and supports medication safety by maintaining a current, accessible medication list [34]. A shared repository that ensures appropriate security and privacy of personal health information, and access to care plans via a shared electronic health record, can facilitate team communication about medication regimens. Education and training on medication errors for the interdisciplinary team— including families—builds shared understanding both of risks and strategies to prevent error [35].

Medication reconciliation during transitions in care

Medication reconciliation is a systematic process of reviewing all medications currently taken by the patient—including name, dose, route, and frequency—verified through more than one information source (i.e., caregiver interview and electronic medical record, medication vials, or community pharmacy list) [36]. There is strong evidence that this process identifies medication discrepancies [27][37][38] and that it may reduce 30-day readmissions [39]. Accreditation Canada requires medication reconciliation to be performed for patients during all care transitions as standard practice [40]. However, the benefits of reconciliation are limited and may not capture administration errors [11][14]. Also, medication reconciliation is specific to one point in time and thus may not capture the high frequency of medication changes in CMC. Regular review of each medication, to ensure active indication (or that it can be safely discontinued), appropriate dose (considering weight-based dosing changes or conditions that may impair metabolism), and absence of adverse effects, is a key aspect of care planning for CMC [41].

Computerized order entry and decision support tools

Computerized physician order entry (CPOE) has been shown to reduce prescription errors in both inpatient and outpatient settings [35][42]-[44], and has been recommended as a strategy to ensure medication safety [18][45][46]. Decision support tools may include dosing calculators, standard order sets, drug interaction and allergy alerts, and evidence-based treatment recommendations [47]. These tools are variably effective, however, with limited evidence for improving outcomes [46]-[48]. Benefit is limited by the risk of “alarm fatigue”— desensitization when clinicians are exposed to multiple alarms—as well as by over-reliance on computerized cues [47][48].

Pharmacist-led interventions

The role of the pharmacist in preventing medication errors extends beyond medication reconciliation [5][35][49][50] to advising practitioners on appropriate indications and dosing, advising families on medication administration, and flagging drug interactions, particularly in patients with polypharmacy. CMC benefit from coordinated care [51], which may involve designating a central pharmacy to minimize opportunity for miscommunication and error. Pharmacist involvement during care transitions has been shown to reduce readmissions and emergency department visits for patients with complex medication regimens [52]. Pharmacist roles may include individualized patient counselling in both outpatient and inpatient settings, collaboration with the interdisciplinary team on clinical rounds, and post-discharge follow-up calls for high-risk patients [49][52].

Medication organization tools may be beneficial, such as prefilled and dated medication “dosettes” or “push packs”, calendar checklists, or cell phone applications with medication reminders. Standardizing concentrations of compounded medications, labelling, and dosing tools could help prevent dosing errors for medications not available in a suspension formulation [8]. By ensuring standardized documentation of the medication dose, along with volume and concentration, pharmacists can double-check prescriptions. Pharmacists can also prepare a printed list of all medications and a medication calendar. These tools are most helpful when all medications are filled at one location [53].

Summary

Because of their inherent complexity and frequent use of health care services, CMC are at high risk for medication error [10]. Reducing scope for error for CMC requires multi-faceted approaches targeting all stages of medication use, from prescribing to preparation, administration, and monitoring. All of the interventions reviewed here support collaborative efforts that ensure medication safety both in hospital and in the community.

  1. Consider all CMC to be at high risk for medication errors, and educate caregivers concerning risks.
  2. Assist the patient and family members to maintain a complete, current list of medications that is readily accessible to all members of the child’s health care team.
  3. Empower patients and families to be partners in ensuring medication safety, through clear communication.
  4. Minimize the number of prescribers whenever possible, with medication changes centralized through a single pharmacy.
  5. Regularly reassess indication and dosing for each medication, and discontinue medications that are no longer needed.
  6. Simplify the daily drug regimen as much as possible. Consider number of medications, number of doses, timing of doses, and route of administration.
  7. Assess drug interactions when a new medication is added to the child’s regimen, using the assistance of a pharmacist and clinical decision support tools.
  8. Perform medication reconciliation and allergy verification for all children during transitions in care. Guidance at discharge should include any changes to the medication regimen, including the practitioner responsible for drug monitoring and reassessment.
  9. During hospitalizations, all CMC should be evaluated by a pharmacist skilled in medication safety practices.
  10. Communicate with the child’s school or other community care centres to ensure that medications are being administered as needed in these settings.

Acknowledgements

This practice point has been reviewed by the Hospital Paediatrics Section Executive, and the Acute Care and Drug Therapy and Hazardous Substances Committees of the Canadian Paediatric Society.

CANADIAN PAEDIATRIC SOCIETY COMMUNITY PAEDIATRICS COMMITTEE
Members: Tara Chobotuk MD, Carl Cummings MD (past Chair), Michael Hill MD, Audrey Lafontaine MD, Alisa Lipson MD, Marianne McKenna MD (Board Representative), Julia Orkin MD (Chair), Larry Pancer MD (past member)
Liaison: Peter Wong MD, CPS Community Paediatrics Section
Principal authors: Kathleen Huth MD, Patricia Vandecruys B.Pharm, MSc, Julia Orkin MD, Hema Patel MD

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Disclaimer: The recommendations in this position statement do not indicate an exclusive course of treatment or procedure to be followed. Variations, taking into account individual circumstances, may be appropriate. Internet addresses are current at time of publication.

Last updated: Feb 8, 2024

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