Standards › ASF Health Standards v10 › Standard 17
Standard 17
Pharmacy
Pharmacy: prescriptions checked before dispensing, counselling, an accountable pharmacist, error recording, controlled medicines, storage, stock, recall and licensed sources.
Every prescription is checked for the medicine, the dose, the route, the frequency, the allergies, and interactions with other medicines before it is dispensed. The patient’s identity is confirmed before dispensing as set out in 1.1, which applies to every provider, and the prescription is complete as set out in the medicines safety rule. In a hospital pharmacy, the same item check is required.
Why it matters. A prescription that is wrong at the counter reaches the patient with no further check. Checking the medicine, dose, route and patient before dispensing is the last barrier before the patient takes it.
How the surveyor verifies this criterion
Sample. Review 10 checked prescriptions per month for the last 3 months, and the prescription check procedure in force.
1. Each prescription is checked for medicine, dose, route, frequency, allergies and interactions before dispensing.
Method. Check each sampled prescription for the check items recorded.
Evidence to show. Dispensing check record (HOS-FRM-009).
Pass when. Every sampled prescription has the full check recorded.
2. The patient’s identity is confirmed before dispensing.
Method. Check each record for the identity confirmation.
Evidence to show. Dispensing check record (HOS-FRM-009).
Pass when. Every sampled dispensing has identity confirmed.
3. The check is done by a second person where the rule requires it.
Method. Check each high-risk record for the second check.
Evidence to show. Dispensing policy (HOS-POL-002).
Pass when. Every high-risk dispensing has a second check recorded.
Immediate fail (any one means the criterion is not met)
- A prescription is dispensed with no check.
Documents
No documents yet.
E-learning
References
- World Health Organization (2014). High 5s Project: Standard Operating Protocol, Medication Reconciliation. Geneva: WHO Patient Safety.
- World Health Organization (2017). The third global patient safety challenge: tackling medication-related harm (Medication Without Harm). Geneva: WHO. https://www.who.int/publications/i/item/the-third-global-patient-safety-challenge-tackling-medication-related-harm
Each patient is given counselling on new medicines: how to take them, what to expect, and what to report. Counselling is recorded where the medicine is high-risk. Where the patient must manage their own medicines, understanding is checked as set out in the patient understanding rule.
Why it matters. A patient who gets a new medicine without understanding how to take it may take it wrongly, or stop it. Counselling on new medicines, given and checked, is what makes the treatment work.
How the surveyor verifies this criterion
Sample. Review the counselling records for 10 new medicines in the last 3 months.
1. Each new medicine is counselled on how to take it, what to expect and what to report.
Method. Check each record for the three elements.
Evidence to show. Counselling record (PHA-FRM-001).
Pass when. At least 95% of new medicines have all three elements recorded.
2. Understanding is checked with the patient.
Method. Check each record for the teach-back recorded.
Evidence to show. Counselling record (PHA-FRM-001).
Pass when. At least 90% of records show the understanding checked.
3. Counselling is recorded for each high-risk medicine.
Method. Check each high-risk medicine for the record.
Evidence to show. Counselling record (PHA-FRM-001).
Pass when. Every high-risk medicine has counselling recorded.
Immediate fail (any one means the criterion is not met)
- A new medicine is dispensed with no counselling.
Documents
E-learning
References
- World Health Organization (2017). The third global patient safety challenge: tackling medication-related harm (Medication Without Harm). Geneva: WHO. https://www.who.int/publications/i/item/the-third-global-patient-safety-challenge-tackling-medication-related-harm
A qualified pharmacist is accountable for the service at all times it is open, and the name of the accountable pharmacist is displayed. The accountable pharmacist is recorded on the rota, and the pharmacist’s qualification is verified as set out in the credential verification rule.
Why it matters. A pharmacy without a qualified pharmacist in charge has no one accountable for what is dispensed. Accountability must be named and present whenever the service is open.
How the surveyor verifies this criterion
Sample. Review the pharmacist rota against the opening hours for the last 3 months.
1. A qualified pharmacist is accountable for every session the service is open.
Method. Match each opening session to the rota.
Evidence to show. Pharmacist rota and cover register (PHA-REG-001).
Pass when. Every opening session has an accountable pharmacist recorded.
2. The accountable pharmacist’s name is displayed.
Method. Check the display in the service at the visit.
Evidence to show. Pharmacy accountability policy (PHA-POL-001).
Pass when. The name is displayed at the point of service.
3. The pharmacist’s qualification is verified.
Method. Check the verification record for each pharmacist on the rota.
Evidence to show. Pharmacist rota and cover register (PHA-REG-001).
Pass when. Every pharmacist on the rota has a verified qualification.
Immediate fail (any one means the criterion is not met)
- The pharmacy is open with no pharmacist on duty.
Documents
E-learning
References
- World Health Organization (2017). The third global patient safety challenge: tackling medication-related harm (Medication Without Harm). Geneva: WHO. https://www.who.int/publications/i/item/the-third-global-patient-safety-challenge-tackling-medication-related-harm
Dispensing errors and near misses are recorded and reviewed to change practice. Prescribing and administration errors are covered by the medicines safety rule, and serious incidents are investigated under the incident rule.
Why it matters. Dispensing errors happen in every pharmacy. The ones that reach the patient are the ones nobody recorded. Recording errors and near misses, and reviewing them, is how the service gets safer.
How the surveyor verifies this criterion
Sample. Review the error and near-miss log for the last 12 months, with the review and changes made.
1. Each dispensing error and near miss is recorded.
Method. Compare the log with the errors reported in the period.
Evidence to show. Dispensing error and near-miss log (PHA-REG-002).
Pass when. No error or near miss is missing from the log.
2. Each entry is reviewed and a change is made to practice.
Method. Check each entry for the review and the change.
Evidence to show. Dispensing error and near-miss log (PHA-REG-002).
Pass when. Every entry has a review and a change recorded.
3. Serious incidents are investigated and reported.
Method. Check each serious incident for the investigation record.
Evidence to show. Incident reporting policy (INC-POL-001).
Pass when. Every serious incident is investigated and recorded.
Immediate fail (any one means the criterion is not met)
- An error is corrected at the counter with no record.
Documents
E-learning
References
- World Health Organization (2017). The third global patient safety challenge: tackling medication-related harm (Medication Without Harm). Geneva: WHO. https://www.who.int/publications/i/item/the-third-global-patient-safety-challenge-tackling-medication-related-harm
- World Health Organization (2021). Global Patient Safety Action Plan 2021–2030: Towards Eliminating Avoidable Harm in Health Care. Geneva: WHO. https://www.who.int/publications-detail-redirect/9789240032705
Controlled medicines are dispensed under WHO guidance on controlled medicines, with each supply recorded and reconciled.
Why it matters. Controlled medicines are open to misuse and diversion. Dispensing them under the rules, with a record of every item, is the only way to show each one reached a legitimate patient.
How the surveyor verifies this criterion
Sample. Review the controlled medicines register for the last 3 months, reconciled with stock.
1. Each controlled medicine supply is recorded with the prescriber confirmed.
Method. Check each supply for the record and the prescriber confirmation.
Evidence to show. Controlled drugs register (HOS-REG-001).
Pass when. Every supply is recorded with the prescriber confirmed.
2. The register is reconciled with stock.
Method. Reconcile the register with the stock count at the visit.
Evidence to show. Controlled medicines register (PHM-FRM-002).
Pass when. The register matches the stock count.
3. Each supply is recorded at the time it is made.
Method. Check the time recorded against the time of supply.
Evidence to show. Controlled medicines register (PHM-FRM-002).
Pass when. At least 95% of supplies are recorded at the time.
Immediate fail (any one means the criterion is not met)
- A controlled medicine is given with no record.
Documents
No documents yet.
E-learning
- Medication Safety: Operating SOP-MED-01 End to End (T-08)
- Prescribing & Controlled Substance Management (TM-05)
References
- World Health Organization. Ensuring balance in national policies on controlled substances: guidance for governments. Geneva: WHO; 2011.
Medicines are stored securely, at the right temperature, and are kept separate from items that should not mix.
Why it matters. Medicines lose their effect or become unsafe if stored wrongly. Secure, correct storage, checked and recorded, keeps the stock safe to dispense.
How the surveyor verifies this criterion
Sample. Review the storage conditions list and the daily temperature record for the last 30 days, and walk through the storage areas.
1. Medicines are stored securely and at the correct temperature.
Method. Check the temperature record against the range set for each medicine.
Evidence to show. Fridge temperature log (PHM-FRM-001).
Pass when. Every reading is within the set range, or the out-of-range action is recorded.
2. Medicines that should not mix are kept separate.
Method. Walk through the storage and check the separation.
Evidence to show. Storage conditions list (PHM-SOP-001).
Pass when. Every area keeps the separation rule.
3. Temperature is recorded daily.
Method. Check the log for a reading on each day.
Evidence to show. Fridge temperature log (PHM-FRM-001).
Pass when. Every day in the period has a reading recorded.
Immediate fail (any one means the criterion is not met)
- A fridge medicine is left at room temperature.
Documents
No documents yet.
E-learning
References
- World Health Organization. Good storage and distribution practices for medicines, WHO Technical Report Series No. 957, Annex 5. Geneva: WHO; 2010.
Stock is managed to avoid shortages and wastage, with a defined process for shortages, substitution and recall.
Why it matters. Running out of a medicine harms patients, and holding too much wastes money and leads to expiry. A managed stock, with a defined process for ordering, prevents both.
How the surveyor verifies this criterion
Sample. Review the stock and expiry register for the last 3 months, and the stock management process.
1. Stock is counted and expiry checked each month.
Method. Check the register for a count and expiry check each month.
Evidence to show. Stock and expiry register (PHA-REG-004).
Pass when. Every month has a count and an expiry check recorded.
2. A shortage or substitution follows the defined process.
Method. Check each recorded shortage for the process followed.
Evidence to show. Stock and expiry register (PHA-REG-004).
Pass when. Every shortage has the process and the approval recorded.
3. Expired stock is removed promptly.
Method. Check each expiry entry for the date of removal.
Evidence to show. Stock and expiry register (PHA-REG-004).
Pass when. Every expired item is removed and recorded.
Immediate fail (any one means the criterion is not met)
- A common medicine is out of stock with no process followed.
Documents
E-learning
References
- World Health Organization (2017). The third global patient safety challenge: tackling medication-related harm (Medication Without Harm). Geneva: WHO. https://www.who.int/publications/i/item/the-third-global-patient-safety-challenge-tackling-medication-related-harm
A recall can be carried out within a set time, with the patients affected identified and contacted, and recalled stock removed from storage at once.
Why it matters. When a medicine is recalled, the pharmacy must find and stop every affected item, and reach every patient who received it, within a set time. A recall that is slow can harm many patients.
How the surveyor verifies this criterion
Sample. Review the recall test record for the last 12 months, and the recall procedure with its time limit.
1. A recall is carried out within the set time.
Method. Check each recall for the time taken against the limit.
Evidence to show. Recall test record (PHA-FRM-002).
Pass when. Every recall is completed within the set time.
2. Each patient affected is identified and contacted.
Method. Check each recall for the patients identified and contacted.
Evidence to show. Recall test record (PHA-FRM-002).
Pass when. At least 95% of affected patients are contacted.
3. Recalled stock is removed from storage at once.
Method. Check each recall for the time the stock was removed.
Evidence to show. Recall test record (PHA-FRM-002).
Pass when. Every recalled item is removed at once.
Immediate fail (any one means the criterion is not met)
- A recalled medicine is still on the shelf a week later.
Documents
E-learning
References
- World Health Organization. Good storage and distribution practices for medicines, WHO Technical Report Series No. 957, Annex 5. Geneva: WHO; 2010.
Medicines are bought only from suppliers licensed to supply them. Each supplier’s licence is checked and recorded before the first order. A medicine whose origin cannot be shown is quarantined and is not dispensed. This protects patients against falsified or unregistered products.
Why it matters. Medicines bought from unlicensed suppliers may be fake, degraded or unsafe. Buying only from licensed sources, and recording the source of each batch, protects patients and the pharmacy.
How the surveyor verifies this criterion
Sample. Review the list of licensed suppliers, and the batch source record for the last 3 months.
1. Each supplier’s licence is checked and recorded before the first order.
Method. Check each supplier for the licence record before its first order.
Evidence to show. Supplier review record (PRC-FRM-001).
Pass when. Every supplier has a licence recorded before its first order.
2. Each supplier’s licence is rechecked at its expiry.
Method. Check the licence expiry dates against the recheck records.
Evidence to show. Licensed supplier and batch source register (PHA-REG-003).
Pass when. Every licence is rechecked before or at its expiry.
3. A batch whose source cannot be shown is quarantined.
Method. Check each batch for its source and any quarantine record.
Evidence to show. Licensed supplier and batch source register (PHA-REG-003).
Pass when. Every batch without a shown source is quarantined.
Immediate fail (any one means the criterion is not met)
- A medicine is bought from an unlicensed seller.
Documents
E-learning
References
- World Health Organization. Substandard and falsified medical products. Fact sheet. Geneva: WHO.
Medicines are stored at the correct temperature and checked on a schedule. Controlled drugs are secure and counted. Expired stock is removed promptly.
Why it matters. Ambulatory clinics often store medicines and vaccines in a fridge or cupboard nobody checks. A wrong temperature or an unlocked controlled drug is a silent risk that only a record can show.
How the surveyor verifies this criterion
Sample. Review the temperature log and the controlled-drug register for the last 3 months, and check the storage area.
1. Medicines are stored at the correct temperature and checked on a schedule.
Method. Check the temperature log for the schedule and the range.
Evidence to show. Fridge temperature log (PHM-FRM-001).
Pass when. Every scheduled reading is recorded and in range, or the action is recorded.
2. Controlled drugs are secure and counted.
Method. Check the register against the count and the storage security.
Evidence to show. Controlled medicines register (PHM-FRM-002).
Pass when. Every count matches the register.
3. Expired stock is removed promptly.
Method. Check the stock at the visit for expired items.
Evidence to show. Stock and expiry register (PHA-REG-004).
Pass when. No expired item is in use or stock.
Immediate fail (any one means the criterion is not met)
- No temperature record is kept; controlled drugs are kept unlocked; expired vaccines are found in use.
Documents
No documents yet.
E-learning
References
- World Health Organization. Good storage and distribution practices for medicines, WHO Technical Report Series No. 957, Annex 5. Geneva: WHO; 2010.
- World Health Organization. Ensuring balance in national policies on controlled substances: guidance for governments. Geneva: WHO; 2011.
Additional resources: guidelines in the GMJ library
These guidelines are held in the GMJ guideline library (news.gmj.ge). WHO and PAHO are the issuing bodies; MSF guidelines are marked MSF.
- Digital transformation handbook for reporting substandard and falsified medical products · WHO · criteria: Whole standard
Digital reporting systems for substandard and falsified medicines, for regulators and health ministries.
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