Standards › ASF Health Standards Version 11 › Standard 8
Standard 8
Medicines Safety
Medicines are managed safely, from look-alike and sound-alike medicines and prescription checks to high-alert medicines, storage, controlled medicines, reconciliation and error reporting. Pain criteria are in Standard 10 (Pain Management).
How to read the colours
Red: Must. Required in every setting. Criteria that protect life are always red.
Green: Medium. Required, adapted to what a humanitarian or transition setting can realistically do.
Yellow: Minimum. The lowest acceptable level in a humanitarian setting, where resources are very limited.
Each criterion is shown in three settings: Humanitarian settings, Transition and fragile, and Standard. In standard settings, every criterion is Must.
Every policy, SOP, form and course on this page is a draft to help you. Adapt it to your hospital, write your own, or upload your own documents. What the assessor checks is that the standard is met and that you can show how.
8.1Look-Alike, Sound-Alike Medications Are Specifically ManagedHumanitarian settings: MediumTransition and fragile: MustStandard: Must
Medicines with names or packaging that could be confused with another are listed for the facility’s own stock and managed with distinct safeguards: separated storage, distinct labelling or an independent check.
Why it matters. Two drugs that look or sound alike are a common cause of serious dispensing errors. A named list and distinct safeguards stop a mix-up before it reaches the patient.
Questions the surveyor asks
- Is there a named list of look-alike, sound-alike medicines for this facility’s own stock? General awareness of the risk is not the same as a list for what the facility holds.
- Are these medicines stored apart or distinctly labelled? Physical or visual separation, not reliance on staff memory alone.
- Is there an extra check step for these medicines? An additional safeguard is needed beyond general dispensing practice.
How the surveyor verifies this criterion
Sample. The list, the storage areas and the dispensing records for 20 dispensed items from the last 3 months.
1. List exists and is current
Method. Check the list against the current stock list.
Evidence to show. Look-alike and sound-alike medicines list (MNP-REG-001).
Pass when. Every stocked look-alike, sound-alike medicine is on the list, and the list is reviewed at least yearly.
2. Separation or labelling in place
Method. Walk through the storage areas and check labels.
Evidence to show. Look-alike and sound-alike medicines policy (MNP-POL-001).
Pass when. Every listed medicine is stored apart or carries a distinct label.
3. Extra check is recorded
Method. Check the dispensing records for listed medicines.
Evidence to show. Dispensing check record (HOS-FRM-009).
Pass when. The extra check is recorded for every listed medicine dispensed in the sample.
Good practice. The list is current, listed medicines are stored apart, and an extra check is recorded for each one.
Immediate fail (any one means the criterion is not met). No list exists for the facility’s own stock.
Partial because. The list exists but is not current, or the extra check is done but not recorded.
Staff, training and documents
Documents
- MNP-POL-001 Look-alike and sound-alike medicines
- MNP-REG-001 Look-alike and sound-alike medicines list
- HOS-FRM-009 Dispensing check record
E-learning
- Medication Safety: Operating SOP-MED-01 End to End (Must for pharmacy and nursing staff)
- Care & Treatment: Clinical Standards for Accreditation (Must for medical staff)
8.2Each Prescription Is Checked Before DispensingHumanitarian settings: MustTransition and fragile: MustStandard: Must
Every prescription is checked by a qualified pharmacist before it is dispensed, for dose, route, allergies, interactions and the patient’s identity, and the check is recorded.
Why it matters. Most dispensing errors are caught at the point of checking. A check that is skipped or not recorded gives no protection.
Questions the surveyor asks
- Is every prescription checked before it leaves the pharmacy? Urgent and downtime supplies included.
- Does the check cover dose, route, allergies and interactions? A quick look at the drug name alone misses most errors.
- Is the check recorded? An unrecorded check cannot be audited.
How the surveyor verifies this criterion
Sample. Twenty dispensing records from the last 3 months, including at least five out-of-hours or downtime supplies.
1. Each prescription is checked
Method. Check each sampled record for a pharmacist check.
Evidence to show. Dispensing check record (HOS-FRM-009).
Pass when. The check is recorded for every sampled prescription.
2. The check covers the key items
Method. Check the record against the dose, route, allergy and interaction fields.
Evidence to show. Pharmacy dispensing policy (HOS-POL-002).
Pass when. All four items are recorded in every sampled record.
3. Counselling is given
Method. Check the counselling record for each sampled patient.
Evidence to show. Counselling record (PHA-FRM-001).
Pass when. Counselling is recorded for every sampled patient.
Good practice. Every prescription checked and recorded, with all key items covered and counselling recorded.
Immediate fail (any one means the criterion is not met). Medicines are dispensed with no pharmacist check at all.
Partial because. The check is done but not recorded, or the key items are not covered.
Staff, training and documents
Documents
- HOS-POL-002 Pharmacy dispensing policy
- HOS-FRM-009 Dispensing check record
- PHA-FRM-001 Counselling record
E-learning
- Medication Safety: Operating SOP-MED-01 End to End (Must for pharmacy staff)
8.3High-Alert Medicines Are Double-Checked Before GivingHumanitarian settings: MediumTransition and fragile: MustStandard: Must
High-alert medicines, such as insulin, concentrated potassium, anticoagulants and opioids, are double-checked by a second qualified person before they are given, and the check is recorded.
Why it matters. A small error with a high-alert medicine can cause serious harm quickly. A second check catches what one person misses.
Questions the surveyor asks
- Is there a list of high-alert medicines used in the facility? The list must match what is actually stocked and given.
- Is a second qualified person involved in each check? The same person checking their own work does not count.
- Is the check recorded? A check that is not written down cannot be audited.
How the surveyor verifies this criterion
Sample. Twenty administrations of high-alert medicines from the last 3 months, and the high-alert medicines list.
1. List exists
Method. Check the list against the medicines stocked and given.
Evidence to show. High-alert medicines (HOS-SOP-006).
Pass when. Every high-alert medicine given in the sample is on the list.
2. Second check happens
Method. Check each sampled administration for a second signature.
Evidence to show. Ward medicine administration checks (WRD-SOP-002).
Pass when. A second qualified person checks at least 18 of the 20 sampled administrations.
3. Check is recorded
Method. Check the administration chart for each sampled dose.
Evidence to show. High-alert medicines on every ward (ONC-SOP-006).
Pass when. The second check is recorded for every sampled administration.
Good practice. A list of high-alert medicines is kept, and each one is double-checked and recorded.
Immediate fail (any one means the criterion is not met). High-alert medicines are given without any second check.
Partial because. The second check is done but not recorded, or only some of the list is covered.
Staff, training and documents
Documents
- HOS-SOP-006 High-alert medicines
- ONC-SOP-006 High-alert medicines on every ward
- WRD-SOP-002 Ward medicine administration checks
E-learning
- Medication Safety: Operating SOP-MED-01 End to End (Must for nursing staff)
8.4Medicines Are Stored Securely and at the Right TemperatureHumanitarian settings: MediumTransition and fragile: MustStandard: Must
Medicines are kept in secure storage, at the temperature the manufacturer specifies, with temperature checked and recorded, and out-of-date stock removed.
Why it matters. Medicines that are stored too warm, too cold, or without security lose their effect or are misused. Regular checking catches the problem early.
Questions the surveyor asks
- Is storage secure and locked? Access is limited to authorised staff.
- Is the temperature checked and recorded every day? A recorded range is needed, not an occasional spot check.
- Is out-of-date stock removed? Expired medicines are quarantined and removed, not left on the shelf.
How the surveyor verifies this criterion
Sample. Storage areas and the temperature records for the last 30 days, plus the stock and expiry register.
1. Secure storage
Method. Inspect the storage area and the key log.
Evidence to show. Medicine storage and temperature control (HOS-SOP-005).
Pass when. Storage is locked, and access is limited to named staff.
2. Temperature recorded daily
Method. Check the temperature log for the last 30 days.
Evidence to show. Medicine storage and temperature monitoring (PHM-SOP-001).
Pass when. Temperature is recorded every working day, and out-of-range readings are acted on.
3. Stock is in date
Method. Check the stock and expiry register against the shelves.
Evidence to show. Stock management, shortages and expiry (PHA-SOP-002).
Pass when. No expired medicine is on the shelves, and expired stock is recorded as removed.
Good practice. Secure storage, daily temperature records, and expired stock removed and recorded.
Immediate fail (any one means the criterion is not met). Medicines are kept unlocked and with no temperature records at all.
Partial because. Temperature is recorded but not on every day, or expiry checks are done but not recorded.
Staff, training and documents
Documents
- HOS-SOP-005 Medicine storage and temperature control
- PHM-SOP-001 Medicine storage and temperature monitoring
- PHA-SOP-002 Stock management, shortages and expiry
E-learning
- Medication Safety: Operating SOP-MED-01 End to End (Must for pharmacy and nursing staff)
- Medication Safety & Storage in Guest Facilities (Must for guest and day-care facilities)
8.5Controlled Medicines Are Recorded and CountedHumanitarian settings: MustTransition and fragile: MustStandard: Must
Controlled medicines are recorded in a register, counted at each handover, and signed by two people. Prescribing of opioids is reviewed, and any discrepancy is investigated.
Why it matters. Controlled medicines are high-risk for misuse and diversion. A register and a double count are the simplest way to detect a loss.
Questions the surveyor asks
- Is there a register for all controlled medicines? Every receipt, supply and administration is recorded.
- Is each count double-signed? Two people count, and both sign.
- Are discrepancies investigated? A difference between the register and the stock is an incident, not a note.
How the surveyor verifies this criterion
Sample. The controlled medicines register and count sheets for the last 3 months, and the opioid prescribing reviews.
1. Register is complete
Method. Check the register against the stock and the prescriptions.
Evidence to show. Controlled drugs register (HOS-REG-001).
Pass when. Every entry is complete, and the balance matches the stock.
2. Counts are double-signed
Method. Check the count sheets for two signatures at each handover.
Evidence to show. Controlled medicines register (PHM-FRM-002).
Pass when. Every sampled count is signed by two people.
3. Opioid prescribing is reviewed
Method. Check the review records for sampled opioid prescriptions.
Evidence to show. Opioid prescribing review and diversion monitoring (MNP-SOP-001).
Pass when. Each sampled opioid prescription has a review record.
Good practice. A complete register, double-signed counts at each handover, and reviewed opioid prescriptions.
Immediate fail (any one means the criterion is not met). A controlled medicine is missing and not reported.
Partial because. The register is kept but not complete, or counts are done by one person.
Staff, training and documents
Documents
- HOS-REG-001 Controlled drugs register
- PHM-FRM-002 Controlled medicines register
- MNP-SOP-001 Opioid prescribing review and diversion monitoring
- MNP-FRM-001 Opioid prescribing review record
E-learning
- Prescribing & Controlled Substance Management (Must for prescribers and pharmacy staff)
8.6Medicines Are Reconciled at Admission, Transfer and DischargeHumanitarian settings: MediumTransition and fragile: MustStandard: Must
The medicines a patient takes are compared at admission, transfer and discharge with the medicines prescribed. Differences are resolved with the prescriber and recorded.
Why it matters. Medicines are often lost or duplicated at a transition of care. A reconciliation at each point stops errors from being carried into the next setting.
Questions the surveyor asks
- Is a reconciliation done at admission? The home medicines are listed, not assumed.
- Is a reconciliation done at transfer and discharge? Each handover is a risk point.
- Are differences resolved and recorded? A difference left unresolved is an error waiting to happen.
How the surveyor verifies this criterion
Sample. Ten admission, ten transfer and ten discharge records from the last 3 months.
1. Admission reconciliation
Method. Check each admission record for a home medicines list.
Evidence to show. Medicines reconciliation (HOS-SOP-007).
Pass when. A reconciled list is recorded in at least 9 of 10 admissions.
2. Transfer and discharge reconciliation
Method. Check each transfer and discharge record against the prescribed list.
Evidence to show. Medicine reconciliation at admission, transfer and discharge (LTC-SOP-002).
Pass when. A reconciled list is recorded in at least 9 of 10 records for each.
3. Differences resolved
Method. Check each recorded difference for a resolution.
Evidence to show. Medicines management policy (HOS-POL-001).
Pass when. Every difference is resolved and recorded with the prescriber.
Good practice. Reconciled lists at admission, transfer and discharge, with every difference resolved.
Immediate fail (any one means the criterion is not met). A discharge is made with no medicines list at all.
Partial because. Reconciliation is done at admission but not at discharge, or differences are not recorded.
Staff, training and documents
Documents
- HOS-SOP-007 Medicines reconciliation
- LTC-SOP-002 Medicine reconciliation at admission, transfer and discharge
- HOS-POL-001 Medicines management policy
E-learning
- Medication Safety: Operating SOP-MED-01 End to End (Must for nursing and prescribing staff)
8.7Medication Errors Are Reported and ReviewedHumanitarian settings: MediumTransition and fragile: MustStandard: Must
Every dispensing error, near miss and medication error is reported in a log, reviewed each month, and used to change practice.
Why it matters. Errors that are not reported cannot be learned from. A simple log and a monthly review turn each near miss into a system fix.
Questions the surveyor asks
- Is there a log of errors and near misses? Near misses count, not only harm.
- Is the log reviewed each month? A log that is never read is not a review.
- Does the review lead to a change? Evidence of a change is the proof of learning.
How the surveyor verifies this criterion
Sample. The error log for the last 6 months and the monthly review minutes.
1. Log is kept
Method. Check the error log for entries over the last 6 months.
Evidence to show. Dispensing error and near-miss log (PHA-REG-002).
Pass when. Entries are recorded with date, medicine and outcome.
2. Review each month
Method. Check the review minutes for the last 6 months.
Evidence to show. Medicines management policy (HOS-POL-001).
Pass when. A review is recorded in at least 5 of the 6 months.
3. Change is made
Method. Check the review minutes for a recorded change to practice.
Evidence to show. Dispensing error and near-miss log (PHA-REG-002).
Pass when. At least one recorded change to practice follows from a review.
Good practice. A complete log, a monthly review, and a recorded change to practice.
Immediate fail (any one means the criterion is not met). Errors are not recorded at all.
Partial because. The log is kept but not reviewed, or reviews are not followed by change.
Staff, training and documents
Documents
- PHA-REG-002 Dispensing error and near-miss log
- HOS-POL-001 Medicines management policy
E-learning
- Medication Safety: Operating SOP-MED-01 End to End (Must for all staff who handle medicines)
- Incident Reporting, Just Culture and Open Disclosure (Must for all staff)
Who is responsible for Standard 8
Each criterion names the positions responsible for it. Every position links to its own terms of reference.
| Criterion | Responsible | Supports |
|---|---|---|
| 8.1 Look-Alike, Sound-Alike Medications Are Specifically Managed | Chief pharmacist Pharmacist (dispensing) |
Pharmacy technician Registered nurse |
| 8.2 Each Prescription Is Checked Before Dispensing | Pharmacist (dispensing) Clinical pharmacist |
Physician (general) Pharmacy technician |
| 8.3 High-Alert Medicines Are Double-Checked Before Giving | Registered nurse | Physician (general) Pharmacist (dispensing) |
| 8.4 Medicines Are Stored Securely and at the Right Temperature | Pharmacy technician | Chief pharmacist Registered nurse |
| 8.5 Controlled Medicines Are Recorded and Counted | Chief pharmacist | Pharmacist (dispensing) Physician (general) |
| 8.6 Medicines Are Reconciled at Admission, Transfer and Discharge | Physician (general) Clinical pharmacist |
Registered nurse |
| 8.7 Medication Errors Are Reported and Reviewed | Chief pharmacist | Registered nurse Pharmacist (dispensing) |
Role details: reporting, supervision and training
Training shown is the general recommendation. Role-specific training is set in the next improvement round.
| Role | Reports to | Supervises | Recommended training |
|---|---|---|---|
| Chief pharmacist | Hospital director | Clinical pharmacists; pharmacists; pharmacy technicians | Facility induction; medication safety (general recommendation) |
| Clinical pharmacist | Chief pharmacist | None | Facility induction; medication safety (general recommendation) |
| Pharmacist (dispensing) | Chief pharmacist | Pharmacy technicians; pharmacy assistants | Facility induction; medication safety (general recommendation) |
| Pharmacy technician | Pharmacist (dispensing) | None | Facility induction; medication safety (general recommendation) |
| Pharmacy assistant | Pharmacist (dispensing) | None | Facility induction; medication safety (general recommendation) |
| Registered nurse | Head of nursing (per ward) | None | Facility induction; medication safety (general recommendation) |
| Physician (general) | Head of department (per specialty) | Resident physician / house officer | Facility induction; medication safety (general recommendation) |
| Resident physician / house officer | Physician (general) | None | Facility induction; medication safety (general recommendation) |
Questions and answers
The criterion text is the authority. These answers summarise it.
Who does Standard 8 apply to?
Every facility that prescribes, stores, dispenses or gives medicines, including outpatient, day-care and home-based services. Scale the criteria to the medicines the facility handles.
What do the colours mean for this standard?
Red (Must) is required in every setting. Green (Medium) is required, adapted to what a humanitarian or transition setting can realistically do. Yellow (Minimum) is the lowest acceptable level in a humanitarian setting. In standard settings, every criterion is Must.
Must look-alike and sound-alike medicines be on a named list?
Yes. Under 8.1 the facility keeps a specific list for the medicines it stocks, with distinct safeguards for each one.
Must every prescription be checked before dispensing?
Yes. Under 8.2 a qualified pharmacist checks each prescription before it leaves the pharmacy, and the check is recorded.
Must high-alert medicines be double-checked?
Under 8.3 a second qualified person checks the dose and the patient before a high-alert medicine is given. In a humanitarian setting, a documented alternative safeguard may be used where a second person is not available.
Must controlled medicines be counted?
Yes. Under 8.5 controlled medicines are recorded in a register and counted at each handover, with a double signature.
Must a patient’s medicines be reconciled on admission and discharge?
Yes. Under 8.6 the medicines a patient takes are compared at admission, transfer and discharge, and the differences are resolved and recorded.
Do I have to use the documents on this page?
No. The policies, SOPs, forms and registers are drafts to help you. Adapt them to your pharmacy and wards, write your own, or upload your own. What the assessor checks is that the criterion is met and that you can show how.
Guidelines for this standard
9 guidelines are held in the GMJ Guidelines Library and listed here. Each link opens the full guideline on news.gmj.ge. The complete library, grouped by standard, is at Guidelines.
- Medication Without Harm – Global Patient Safety Challenge on Medication Safety (World Health Organization)
- WHO Guideline on Balanced National Controlled Medicines Policies to Ensure Medical Access and Safety (World Health Organization)
- Good Storage and Distribution Practices for Medical Products (TRS 1025, Annex 7) (World Health Organization)
- Safe management of pharmaceutical waste from health care facilities: global best practices (World Health Organization)
- Safety Monitoring of Medicinal Products (World Health Organization)
- The selection and use of essential medicines, 2025: AWaRe (Access, Watch, Reserve) classification of antibiotics (World Health Organization)
- Model List of Essential Medicines, 24th list (World Health Organization)
- Global Patient Safety Action Plan 2021–2030: Towards Eliminating Avoidable Harm in Health Care (World Health Organization)
- WHO Nine Patient Safety Solutions (World Health Organization)
Also relevant to this standard:
- Medicines optimisation: the safe and effective use of medicines to enable the best possible outcomes (National Institute for Health and Care Excellence (UK))
- Clinical Practice Guideline for Prescribing Opioids for Pain — United States, 2022 (Centers for Disease Control and Prevention (US))
References
- World Health Organization (2017). Medication Without Harm: Global Patient Safety Challenge on Medication Safety. Geneva: WHO.
- World Health Organization (2014). Good storage and distribution practices for medical products (TRS 1025, Annex 7). Geneva: WHO.
- World Health Organization (2017). WHO Guideline on Balanced National Controlled Medicines Policies to Ensure Medical Access and Safety. Geneva: WHO.
- World Health Organization (2021). Global Patient Safety Action Plan 2021–2030. Geneva: WHO.
- World Health Organization. WHO Nine Patient Safety Solutions (2007). Geneva: WHO.