Medication-related harm is thought to contribute to around 250,000 hospital admissions each year in Australia. The estimated annual cost of this is $1.4 billion.

Improving medication safety was the focus of a major global drive headed by the World Health Organization. This challenge aims to reduce medication errors by 50% over the five years to 2025. The Australian Government made a commitment to participate in the challenge, with the national response developed by the Australian Commission on Safety and Quality in Health Care (ACSQHC).

Reducing harm from high-risk medications was one of the main goals of this challenge.

What are high-risk medications?

A high-risk medication is one that has a higher risk of causing significant patient harm or death if used in error. They include medications with a narrow therapeutic index and those that present a high risk when administered via the wrong route. A narrow therapeutic index means that the difference between the dose required to achieve the desired effect and the dose likely to achieve toxic effects is small. Therefore, any errors that cause even minor changes in the plasma level are likely to be significant.

While the incidence of errors with high-risk medications is not necessarily higher than other medicines, the consequences of errors can be much more severe. For example, errors involving the administration of vincristine intrathecally instead of intravenously have an 85% fatality rate. Of the patients who survive this particular medication error, devastating neurological effects occur, including quadriplegia and persistent vegetative state.

There is no standardised list of high-risk medications in Australia, and the assigning of risk may vary between hospitals. However, the APINCH acronym can assist healthcare professionals to identify medication groups known to be associated with a higher risk of medication-related harm. An ‘S’ was later added to the original acronym. This represents ‘systems’ which includes other evidence-based practices known to improve safety, such as independent-double checks.

According to the Institute for Safe Medication Practices (ISMP), independent double checks can detect up to 95% of medication errors before they reach the patient. The independent nature of the double-check appears to be a critical element in the process. Studies demonstrate that mandated checks are often not independent, as healthcare professionals typically share information with the person performing the check which can lead to confirmation bias. These “primed” checks have not been shown to reduce medication errors.

  Example medications
A Antimicrobials Aminoglycosides
Vancomycin
Amphotericin (liposomal)
P Potassium and other electrolytes Injections of concentrated  electrolytes e.g.  potassium, magnesium, calcium, hypertonic sodium chloride
I Insulin All insulins
N Narcotics and other sedatives Hydromorphone, oxycodone, morphine, fentanyl, alfentanil, remifentanil, and analgesic patches
Benzodiazepines
Thiopentone, propofol and other short-term anaesthetics
C Chemotherapeutic agents Vincristine, methotrexate, etoposide, azathioprine
Oral chemotherapy
H Heparin and other anticoagulants Warfarin, enoxaparin, heparin
Direct oral anticoagulants (DOACs): dabigatran, rivaroxaban, apixaban
S Systems Medication safety systems such as independent double checks, safe administration of liquid medications using oral syringes, standardised order sets and medication charts etc.

The APINCHS acronym includes many routinely used medications, highlighting the need for constant vigilance. While this acronym does not cover every medication that could be considered high-risk, it is a useful tool and may be used by facilities to develop their own list of high-risk medications. This may further assist in the identification of potential risks and facilitate the implementation of risk-reduction strategies.

How can risks be minimised?

According to Standard 4 of the National Safety and Quality Health Service (NSQHS) Standards, health services must identify high-risk medications used and take appropriate action to ensure they are used appropriately. Actions to minimise risk should address every stage of medication use, from storage through to prescribing, dispensing and finally, administration to the patient.

A single strategy is rarely sufficient to achieve significant improvements in medication safety. Therefore, a layered approach is required. Strategies that could be used to improve the safety of high-risk medicines in the hospital environment include:

  • Monitor and analyse incident reports and logs;
  • Monitor occurrence and reporting of adverse drug reactions;
  • Monitor published literature from medication safety and patient safety organisations;
  • Assess local situations regarding alerts, advisories and reports;
  • Conduct risk assessments and audits;
  • Staff education;
  • Automation;
  • Implementation of forcing functions (i.e. prevent something from happening until certain conditions are met);
  • Implementation of fail-safes (i.e. prevent malfunction or unintentional operation by reverting back to a predetermined safe state if a failure occurs); and
  • Limiting access or use (e.g. restrict access to certain medications, require special conditions for administration of a particular medication).

The ISMP ranks risk-mitigation strategies in their Hierarchy of Effectiveness. According to this hierarchy, the least effective strategies are education and rules/policies; the most effective strategies are automation, forcing functions and constraints.

The removal of potent high-risk medications from certain clinical areas is an example of a highly effective strategy. For example, the use and storage of concentrated potassium ampoules in patient care areas is a well-documented root cause of fatal errors. A simple strategy for reducing the risk associated with this product has been to remove it from general patient care areas and replace it with pre-mixed solutions. For critical areas where high concentrations of potassium are required, a risk assessment should be completed before it is decided to keep the ampoules as ward stock. If the ampoules are kept, they must be stored separately and be readily identifiable from preparations with similar packaging.

Clear therapeutic guidelines should also be developed for the safe use of high-risk medications such as potassium within a facility. Points that could be considered include:

  • Use oral potassium instead of IV where clinically appropriate;
  • IV potassium chloride orders should always be written in millimoles;
  • Encourage the use of standardised pre-mixed solutions;
  • Define the maximum allowable concentration of an IV solution;
  • Define the maximum hourly rate and daily limits; and
  • Specify the recommended infusion rate, infusion pump requirements, and patient

Contributing factors

There are many additional factors that may increase the risk of medication-related harm in an individual, including:

  • Advanced age;
  • Renal impairment;
  • Presence of chronic disease and comorbidities;
  • Higher complexity of the patient’s medication regimen; and
  • The use of multiple

Polypharmacy is a noteworthy contributor to risk, with each additional medication exponentially increasing the risk of medication-related harm. Studies show that the risk of harm is 13% for the administration of two medications, yet jumps to 82% when seven or more medications are administered.

Summary

High-risk medications present a significant risk to patient safety. Not only are errors associated with these medications more likely to result in serious patient harm, but the medicines are also commonly used in the clinical setting. Reducing errors with this diverse range of medications requires a collaborative approach among healthcare professionals, as the most effective risk management tools target multiple points in the medication use process.

The ACSQHC has recently published a status report to evaluate the impact of programs implemented in relation to the WHO challenge. A summary of Australia’s progress towards reaching the WHO Global Patient Safety Challenge goals can be found on the ACSQHC website.

 

References:

  1. Australian Commission on Safety and Quality in Health High Risk Medication Alert – Intravenous Potassium Chloride. Sydney: ACSQHC; 2019.
  2. Australian Commission on Safety and Quality in Health High Risk Medication Alert – Vincristine. Sydney: ACSQHC; 2017.
  3. Australian Commission on Safety and Quality in Health Care. Status report Medication without harm – WHO Global Patient Safety Challenge. Australia’s response. Sydney: ACSQHC; 2024.
  4. Institute for Safe Medication Independent double checks: worth the effort if used judiciously and properly. Pennsylvania: ISMP; 2019.
  5. Lim R, Kalisch Ellett LM, Semple S, Roughead The Extent of Medication-Related Hospital Admissions in Australia: A Review from 1988 to 2021. Drug Safety 2022; 45: 249-57.
  6. Pharmaceutical Society of Australia. Medicine Safety: Take Care. Canberra: PSA; 2019.
  7. Westbrook JI, Li L, Raban MZ, Woods A, Koyama AK, Baysari MT, et al. Associations between double-checking and medication administration errors: a direct observational study of paediatric inpatients. BMJ Qual Safe. 2021; 30:320-330.
  8. Wiley Preventing errors with high-risk medications. Drug Topics 2019; 1633(8).

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