High risk medicines and systems
High risk medicines are medicines with an increased risk of causing significant patient harm or death if misused or used in error. It’s important health professionals have procedures in place to manage high risk medicines safely.
About high risk medicines
High risk medicines include medicines that have a very small safe dose range, can be dangerous if given the wrong way, or where mistakes in the medicines management system can lead to harm.
Mistakes don’t happen often with these medicines, but when they do, the consequences can be much worse.
Policy and categorisation of high risk medicines may vary between states, territories and healthcare settings so its important health organisations have their own systems and processes in place for these medicines.
Classification of high risk medicines
What counts as a high risk medicine can vary depending on the medicines and the types of patients treated.
In Australian hospitals, the acronym APINCHS is commonly used to help healthcare workers identify medicines that have a high potential to cause harm.
The APINCHS acronym stands for: Antimicrobials, Potassium and other electrolytes, Insulin, Narcotics (opioids) and other sedatives, Chemotherapeutic agents, Heparin and other anticoagulants, and Systems.
The APINCHS classification provides a framework to assist health professionals to identify high risk medicines.
APINCHS explained
| A | Antimicrobials |
|
|---|---|---|
| P | Potassium and other electrolytes |
|
| I | Insulin |
|
| N | Narcotics (opioids) and other sedatives |
|
| C | Chemotherapeutic agents |
|
| H | Heparin and other anticoagulants |
|
| S | Systems |
|
High Risk Medicines eLearning
The High Risk Medicines eLearning modules support health professionals to understand and manage high risk medicines.
The modules are available for health organisations with an approved workplace email domain. You can use the approved list of health service organisation email domains to check if your health organisation has access to the module, or you can contact the helpdesk to gain access.
Technical support and further information about the module is available on the High Risk Medicines Education website.
Resources and best practice recommendations
We have a range of information, resources and best practice recommendations for high risk medicines. These resources are created by a range of Australian and international organisations.
Antimicrobials
- Risk of confusion between non-lipid and lipid formulations of injectable amphotericin: UK National Patient Safety Agency
- SA Policy: Clinical Guideline. Aminoglycoside: recommendations for use, dosing and monitoring: SA Health
- Safer use of intravenous gentamicin for neonates: UK National Patient Safety Agency
Potassium and other electrolytes
- High Risk Medication Alert – Intravenous Potassium Chloride
- WA High Risk Medication Policy (includes use of IV potassium chloride): WA Department of Health
- NSW High-Risk Medicines Management Policy: NSW Ministry of Health (includes use of IV potassium chloride)
- Potassium solutions: IV administration of mis-selected concentrated potassium chloride: UK NHS Improvement
- Patient safety alert: Accidental overdose from intravenous potassium chloride concentrate solutions: UK NHS Improvement
- Safety strategies for potassium phosphates injection: ISMP Canada
- Reducing risk of harm from oral bowel cleansing solutions: UK NHS Improvement
- Potassium availability QUM indicator 6.1: Percentage of medication storage areas outside pharmacy where potassium ampoules are available
Best practice recommendation
Vials of concentrated forms of electrolytes (e.g. potassium chloride, potassium phosphate, magnesium sulfate, and sodium chloride greater than 0.9%) that require dilution before IV use are not available as ward or imprest stock and/or in automated dispensing cabinets on any patient care units (including in operating room/anaesthesia stock).
OR
Vials of concentrated electrolytes (e.g. 23.4% sodium chloride used to decrease intracranial pressure, potassium chloride used to stop the heart in cardiac surgery) are restricted to approved patient care units, stocked in limited quantities, segregated from other medicines in secure storage areas, and accompanied by protocols for use and other safeguards (e.g. warning labels).
Insulin
- Safer insulin prescribing - Fact sheet
- Safer insulin prescribing - Guidance for Australian pharmacists
- Safer insulin use - Fact sheet for consumers
- List of Medicines for Brand Consideration which specifies what medicines should be prescribed by brand in addition to active ingredient.
- Sub-cutaneous insulin chart
- High concentration insulin products Safety Notice: NSW Health
- Insulin errors: ISMP Canada
- The adult patient’s passport to safer use of insulin: UK NHS Improvement
- Safer administration of insulin: UK NHS Improvement
- Medication Errors with the Dosing of Insulin: Problems across the Continuum: Pennsylvania Patient Safety Authority
- Insulin Measures Worksheet: Pennsylvania Patient Safety Authority
Best practice recommendation
Sliding scale insulin is not used to treat patients with hyperglycaemia. Regular antihyperglycaemic therapy is prescribed to treat diabetics, with supplemental insulin only added to treat hyperglycaemia as necessary in accordance with established protocols.
Narcotics and other sedatives
- HYDROmorphone (High-risk medicine): Changes to Dilaudid injectable preparations Safety Alert: NSW Health
- Oxycodone Safety Notice: NSW Health
- Safe use of midazolam Safety Notice: NSW Health
- HYDROmorphone (High-risk medicine) Safety Alert: NSW Health
- Safe storage of accountable medicines Safety Information: NSW Health
- Opioids: Resources for use of opioids for the treatment of pain: SA Health
- Fentanyl skin patches – Safe use Safety Notice: NSW Health
- Fentanyl skin patches: NSW Therapeutic Advisory Group
- Fentanyl skin patches: US Institute for Safe Medication Practices
- Fentanyl skin patches: ISMP Canada
- Fentanyl patch fatalities linked to “bystander apathy”. We ALL have a role in prevention! Institute for Safe Medication Practices (ISMP)
- Advancing opioid safety for children in hospital: Institute for Safe Medication Practices (ISMP) Canada
- Risks with high dose morphine and diamorphine injections: UK NHS Improvement
- Reducing errors with opioid dosing: UK NHS Improvement
- Reducing risk of overdose with midazolam injection in adults: UK NHS Improvement
Best practice recommendations
Antidotes for moderate sedation and PCA/other IV infusion to treat pain and accompanying guidelines for emergency use are readily available near the point of use.
Neuromuscular blocking agents are not available as ward or imprest stock and/or in automated dispensing cabinets (except in operating room/anesthesia stock).
OR
If available in critical care units and/or the ED, neuromuscular blocking agents are sequestered from other ward or imprest stock medications (including those stocked in automated dispensing cabinets) and labelled with auxiliary warnings to clearly identify the drugs as respiratory paralysing agents that require mechanical ventilation when used.
The types of patient-controlled analgesia (PCA) pumps used in the hospital are limited to two or less to maximise competence with their use.
Monitoring practice tools
- Documentation pain intensity QUM indicator 4.1: Percentage of postoperative patients whose pain intensity is documented using an appropriate validated assessment tool.
- Written pain management planQUsM indicator 4.2: Percentage of postoperative patients that are given a written pain management plan at discharge and a copy is communicated to the primary care clinician.
- Sedatives at discharge QUM indicator 5.7: Percentage of patients receiving sedatives at discharge that were not taking them at admission.
Chemotherapeutic agents
- High Risk Medication Alert – Vincristine
- Safe Use of Vincristine Safety Alert: NSW Ministry of Health
- Methotrexate – Improving compliance with oral methotrexate guidelines and safety alert: UK NHS Improvement
- Preventative guidance: Wrong route administration of chemotherapy: UK NHS Improvement
- Dispensing vincristine: Best Practice #1: Targeted Medication Safety Best Practices for Hospitals: ISMP
- Oral chemotherapy – Analysis of incidents: ISMP Canada Safety Bulletin
- Methotrexate: inadvertent daily administration: ISMP Canada
- Fluorouracil RCA analysis – ISMP Canada
Best practice recommendations
Prescribers include the mg/m2 dose or area under the curve dose or mg/kg dose with all chemotherapy drug orders. Parameters are periodically reviewed (on at least a weekly basis) for prolonged hospital admissions, as current weight/Body Surface Area (BSA) may differ from admission measurements.
A pharmacist verifies that the mg/m2 dose, or area under the curve dose, listed with a chemotherapy order is correct, and documents (eg. with initials or electronically) a double check of the prescriber’s calculated dose (or it is performed electronically) before preparing and dispensing the medicine.
Nurses permanently document (e.g. with initials or electronically) an independent double check of the prescriber’s calculated dose for chemotherapy before administering the medicine.
The base solution and all additives (including the drug, dose, volume drawn into each syringe, diluents, actual drug containers) for chemotherapy admixtures or compounded oral solutions are independently double checked by a pharmacist or a nurse (even if initially prepared by a pharmacist) and documented (e.g. with initials or electronically) before they are added to the final product.
Heparin and other anticoagulants
- National Anticoagulant Incident Analysis report. Describes and quantifies incidents that have involved anticoagulants. Incidents have been captured from healthcare settings (primarily hospitals) in states and territories across Australia.
- Non-vitamin K antagonist oral anticoagulant (NOAC) Guidelines: Clinical Excellence Commission (CEC) 2016
- Newer oral anticoagulants (update) Safety Notice: NSW Health
- Warfarin (revised) Safety Notice: NSW Health
- New oral anticoagulants Safety Notice: NSW Health
- Unfractionated Heparin: ISMP Canada
- Heparin-induced thrombocytopenia: ISMP Canada
- Actions that can make anticoagulant therapy safer: UK National Patient Safety Agency
- Appropriate anti-coagulant use: ISMP Canada
- Preventing error relating to commonly used anticoagulants: The Joint Commission
Systems
- Inadvertent wrong route injection: Identification of Post-Injection Syndrome Olanzapine Pamoate Long Acting Injection Safety Notice: NSW Health
- Wrong route errors with oral medication Safety Notice: NSW Health
- Correct identification of medication and solutions for epidural anaesthesia and analgesia Safety Notice: NSW Health
- Promoting safer measurement and administration of liquid medicines via oral and other enteral routes: UK NHS Improvement
- Lowering the risk of medication errors: Independent double checks for patient controlled analgesia: ISMP Canada
- High alert drugs and infusion pumps: Extra precautions required: ISMP Canada
Best practice recommendations
Specially designed oral syringes, which cannot be connected to IV tubing, are used for dispensing/administering oral liquid solutions.
General infusion pumps with smart pump technology are in use with full functionality employed to intercept and prevent wrong dose/wrong infusion rate errors due to misprogramming the pump, miscalculation, or an inaccurately prescribed dose or infusion rate.
Only one type of epidural infusion pump is used and is different from general infusion devices used in the organisation.
If bar-coding at the point-of-care is used for medication administration, an interdisciplinary team reviews metrics from the system, including the percent of medicines with a readable barcode, scanning compliance rates, and bypassed or acknowledged alerts, and any barriers associated with using the technology are addressed to maximise the safe use of the system.
Additional resources
- Medicine shortages and discontinuations
- Fact sheet: Strategies to support safe use of clonazepam oral liquid
- Preventing harm from phenol in medical imaging
- Neural connector devices to reduce misconnection errors - Guidelines for implementation in Australia
- National Anticoagulant Incident Analysis report
- Clinical Excellence Commission (CEC) Medication safety and Quality: High-risk medicines
- NSW Therapeutic Advisory Group (NSW TAG) High Risk Medicines Protocols and Guidelines
- Government of South Australia, SA Health High risk medicines
- Government of Western Australia, Department of Health High risk medications policy
- Western Australia Therapeutic Advisory Group (WATAG) High-risk Drugs
- Department of Health Therapeutic Goods Administration
- Institute for Safe Medication Practices (ISMP) ISMP High-Alert Medications
- Institute for Safe Medication Practices (ISMP)
- Institute for Safe Medication Practice Canada
- NHS England medication safety resources