Standard operating procedure (SOP) · ONC-SOP-006 · Version 0.1 · Draft for local review
Supports: 51.7
At a glance
- Every ward uses the same defined list of high-alert medicines, which is kept up to date and displayed.
- Each high-alert medicine has a second independent check before it is given, and that check is recorded.
- Concentrated electrolytes and insulin are stored separately from general stock, with clear labels.
- Chemotherapy checks follow ONC-SOP-002 and ONC-FRM-002.
- Stop and check if: a high-alert medicine is found with no label, no second check, or stored with general stock.
1. Purpose
To make sure that medicines with a high risk of serious harm when used in error are given with extra safeguards on every ward, and that these safeguards are recorded (51.7).
2. Scope
| Item | Coverage |
|---|---|
| Applies to | All prescribers, pharmacists, nurses and any staff who store, prepare or give medicines in the facility |
| Locations | Every ward, clinic and treatment area, including theatres, emergency and day units |
| Medicines | The high-alert list in Section 6 and any medicine added to it by the medicines committee |
3. Definitions
| Term | Meaning in this SOP |
|---|---|
| High-alert medicine | A medicine that has a high risk of causing significant harm when used in error, as defined by the facility's list, which is based on the ISMP list of high-alert medications |
| Independent double check | A second registered professional checks the prescription, the drug, the dose, the route and the rate from the source documents, without the first person's input, and signs the record |
| Concentrated electrolyte | A preparation of potassium, sodium or magnesium that must be diluted before use, and is not given undiluted |
4. Background
High-alert medicines cause a disproportionate share of serious medication harm. The risk is greatest when a medicine is confused with another, when a concentrated form is given undiluted, when a dose is calculated wrongly, or when a medicine is taken from general stock by mistake.
5. Responsibilities
| Role | Responsibility |
|---|---|
| Medicines committee | Maintains the list, approves additions and removals, and reviews incidents each quarter |
| Pharmacist | Advises on storage, labelling and checks, and verifies prescriptions where the SOP requires it |
| Ward manager | Makes sure the list is displayed, storage is separated, and checks are carried out and audited |
| Prescriber | Writes a complete prescription with the indication, dose, route and rate, and includes a weight-based calculation where needed |
| Nurse preparing or giving | Carries out the independent double check, and records it before giving the medicine |
6. The high-alert list
The list below is the minimum set for every ward. The medicines committee may add to it, and must record the date of each change.
| Group | Examples |
|---|---|
| Anticoagulants | Heparin infusions, low molecular weight heparin at treatment dose, warfarin when used with an infusion |
| Insulin | All insulins, including insulin infusions |
| Opioids | Morphine, diamorphine, fentanyl and other opioids given by infusion or by patient-controlled analgesia |
| Concentrated electrolytes | Concentrated potassium chloride, concentrated potassium phosphate, concentrated sodium chloride above 0.9 percent, magnesium sulphate for infusion |
| Chemotherapy and cytotoxic drugs | All cytotoxic drugs, following ONC-SOP-002 and ONC-FRM-002 |
| Neuromuscular blocking agents | Suxamethonium, rocuronium, vecuronium and others |
| Antiseizure medicines given intravenously | Phenytoin, sodium valproate and others, when given by infusion |
| Sedatives given by infusion | Midazolam and propofol infusions |
7. Storage
- Store concentrated electrolytes and insulin in a separate, labelled area or cupboard, not in general stock.
- Label each high-alert medicine with a red 'high-alert' sticker or equivalent, and display the ward's list in the medicines room.
- Dilute concentrated electrolytes in pharmacy where possible. On the ward, keep only the diluted form in stock.
- Check the storage area against the list at each stock check, and record the result.
8. Safety and checks
- Prescribe the high-alert medicine with the indication, dose, route, rate and maximum dose written in full.
- Prepare the medicine, then complete the independent double check with a second registered professional before it is given.
- Check the label, dose, rate and concentration against the prescription, and sign the record for both checks.
- Give the medicine only after both checks are recorded. If the checker disagrees, stop and contact the prescriber and pharmacist.
An independent double check is not a signature on the first person's work. The second checker must recalculate the dose from the source and confirm it separately.
9. Decision points
| Situation | Action |
|---|---|
| A high-alert medicine has no second check | Do not give. Carry out the check now, and report if it was given without one |
| A medicine not on the list is high-alert in practice | Raise it with the pharmacist, who refers it to the medicines committee |
| Concentrated electrolyte found on the ward undiluted | Remove from the ward, inform the pharmacist and ward manager, and record the event |
| Prescriber not available for an urgent high-alert medicine | Follow the facility's urgent prescribing route, and record the verbal order with the second check |
10. Escalation
- Medicine given without a check, or a near miss: report under INC-SOP-001 within 24 hours.
- Repeated checks not done by a team: the ward manager and the pharmacy lead review the team's practice the same week.
- Medicines committee to review any incident involving a high-alert medicine within 30 days.
11. Monitoring
The pharmacy team audits 20 high-alert administrations each month across the wards, and checks storage monthly. Results go to the medicines committee each quarter.
| Measure | Target |
|---|---|
| High-alert medicines with a recorded independent double check | 100 percent |
| Concentrated electrolytes and insulin stored separately from general stock | 100 percent |
| Lists displayed and current on each ward | 100 percent |
12. Records
- Prescription with the indication and calculation.
- Independent double check record, signed by both staff.
- Stock and storage check records.
- Incident reports.
13. Training
All staff who prescribe, prepare or give high-alert medicines complete training on the list, the double-check process and storage at induction and every year, with a practical assessment.
14. Related documents
| Code | Document |
|---|---|
| ONC-SOP-002 | Chemotherapy independent two-person check |
| ONC-FRM-002 | Chemotherapy two-person check record |
| ONC-SOP-001 | Cytotoxic drug safe handling |
| NEO-SOP-002 | Weight-based medicine dosing for neonates and infants |
| INC-SOP-001 | Root cause analysis of serious incidents |
15. Evidence
This SOP is based on the reference sources listed below and on the requirement of criterion 51.7 of the ASF standards. The list must be checked against the current ISMP list and the facility's formulary at each review.
E-learning for this document
- No course linked yet. Request a high-alert medicines course from the academy (see the Standard 51 request list).
References
- Institute for Safe Medication Practices (ISMP). List of High-Alert Medications in Acute Care Settings. Current edition.
- The Joint Commission. National Patient Safety Goal NPSG.03.06.01 on medication safety. Current edition.
- Facility medicines formulary and high-alert list (to be inserted by the unit at adoption).
Change history
| Version | Date | Change |
|---|---|---|
| 0.1 | 2026-10-26 | First draft for review. Not yet approved by the ASF Expert Committee. |
Related standard