Inspection Findings 2013

The PSI carries out inspections of pharmacies under Section 67 of the Pharmacy Act 2007 to ensure, in the public interest, the safe supply of medicines and the promotion of the highest standards in pharmacy practice.

In 2013, 388 regular/systems inspections were carried out by the PSI. Systems inspections are unannounced inspections of pharmacies by Authorised Officers (Inspectors) of the PSI. These inspections examine the way in which medicines, including prescription only medicines and controlled drugs are supplied from the pharmacy to ensure a legitimate and safe basis for their supply. These inspections also review premises, workflow and the conditions existing for the storage and preparation of medicines, as well as the governance and quality systems of a pharmacy.

An overview of the findings and key statistics for those inspections in 2013 are provided below. These are based on an analysis of the findings from 387 inspections, which were carried out in 2013. Relevant resources are also provided to assist pharmacists, pharmacy owners and pharmacy staff in meeting the standards of compliance expected under the Pharmacy Act 2007, including inspection checklists that are available both for regular/systems inspections and for new pharmacy openings.

These findings were made available in two parts through the PSI newsletter in June and August 2014.

PART ONE

Part one of this overview provides the key statistics regarding the supply of medicines to patients in nursing homes and/or residential care settings, quality management systems, and pharmacy premises and medicines storage.

1. Supply of Medicines to Patients in Nursing Homes/Residential Care Settings[1]

The sale and supply of medicines to patients in nursing homes or residential care settings are examined to verify that medicines are safely supplied in accordance with original prescriptions, which were reviewed by the pharmacist prior to supply. This review looks at procedures and records governing the supply of medicines, the use of prescriptions, patient counselling and medication use reviews to ensure that patients in nursing homes or residential care facilities receive the same level of professional care as those patients who present in person at a pharmacy.

Item checked during inspection	% of pharmacies meeting compliance standards
Use of Original Prescriptions Pharmacists confirmed that original prescriptions are always present and reviewed in the pharmacy before medicines are dispensed to patients in Nursing Homes/Residential Care Settings	71%
Procedures Written procedures are in place to govern the supply of medicines to patients in Nursing Homes/Residential Care Settings	61%
Medicines Use Reviews Records show that medicines reviews are carried out	53%
Delivery Records Delivery records were available for review at the pharmacy for supplies to patients in Nursing Homes/Residential Care Settings	57%

Useful resources:

2. Quality Management Systems

The quality management system is the overall system in place at the pharmacy to ensure that the pharmacy operates in a manner which is safe for patients and the public and is in accordance with legislation and best practice.

Standard Operating Procedures (SOPs) are a key part of the quality management system at the pharmacy. SOPs are documents which describe each process in the pharmacy in detail. Superintendent and Supervising Pharmacists should approve each of the SOPs for a pharmacy, ensure that all relevant staff are trained on SOPs relevant to their work and also that the SOPs are reviewed periodically to make sure they are up to date with best practice. The quality management system should also address how the pharmacy identifies and minimises risk through the reporting of errors and incidents, and the implementation of corrective actions. It is important that the quality management system is documented in order to demonstrate how the pharmacy operates in compliance with the law and best practice.

In conducting their review of the quality management system at the pharmacy, inspectors will ask to see a number of documents including SOPs, error and incident management systems and pharmacist staffing records which together demonstrate the quality management system in process.

Item checked during inspection	% of pharmacies meeting compliance standards
Evidence of Training in Pharmacy SOPs Records show that pharmacy staff were trained in the pharmacy’s SOPs	60%
Error/incident logs Records show that error/incident logs were being maintained at the pharmacy	62%
Record of Pharmacist on Duty The duty register was properly maintained in respect of the particular dates checked.	78%

Useful resources:

Inspectors’ Advice on Standard Operating Procedures (SOPs) is available on the PSI website (Dec 2013)
Regulation of Retail Pharmacy Businesses Regulations 2008

3. Pharmacy Premises and Medicines Storage

Pharmacy premises are reviewed to verify that there is a safe and effective working environment for the storage, preparation and sale and supply of medicines. The premises are checked to ensure that they are in good repair, clean and orderly. The public pharmacy area, the dispensary, storerooms and the staff sanitary facilities are reviewed as part of this check. Storage arrangements for fridge medicines, dispensary medicines and expiry date checking systems are reviewed to make sure that medicines are stored in accordance with the requirements of their marketing authorisations. The patient consultation area is also reviewed to ensure that it is a private, designated area, easily accessible to patients so that they may discuss their medicines therapy in confidence.

Item checked during inspection	% of pharmacies meeting compliance standards
Patient Consultation Area A Patient consultation area was in place	95%
Dispensary Dispensary was clean and/or well maintained	80%
Storerooms Storerooms were clean and/or well maintained	64%
Bathrooms Staff bathrooms were clean and/or well maintained	77%
Pharmaceutical grade fridge Pharmaceutical grade fridges are in place for the storage of medicines in the pharmacy	85%
The medicines fridge is clean	92%
Maximum/minimum temperature records monitored and recorded on a daily basis in the: - Pharmacy fridge - Dispensary - Storage Areas	66% 50% 54%

Useful resources:

Inspectors’ Advice on Storage Conditions available on the PSI website (Feb 2014).
PSI Guidelines on Sourcing, Storage and Disposal of medicinal products within a retail pharmacy business
PSI Guidelines on Patient Consultation Areas

PART TWO

Part two of this overview provides the key statistics[2] regarding the supply of prescription only medicines and the management of controlled drugs in pharmacies.

4. The Supply of Prescription Only Medicines

Prescriptions are examined to ensure there is a legitimate and valid basis for the safe supply of prescription only medicines (POM), including controlled drugs (CD). PSI Inspectors normally select four supplies and ask to see the prescriptions used to authorise these supplies during a routine systems inspection. A total of 1548 supplies were selected for review. 50% of these supplies related to the supply of controlled drugs.

In certain emergency circumstances, prescription only medicines can be supplied at the request of a patient and/or a prescriber subject to specific safeguards being adhered to. It should be noted that controlled drugs can never be supplied without a prescription or using the ‘emergency supply’ exemption referred to in legislation. 96 of the 1548 (6.2%) supplies checked were ‘emergency supplies'.

Of the items checked during inspection:

92% (1424 of 1548) of the prescriptions checked were in date and valid
85% (1315 of 1548) of the prescriptions reviewed were properly written
15% (232 of 1548) of the prescriptions checked were not properly written. The majority of these prescriptions related to the supply of schedule 2 controlled drugs. In particular, it was noted that:
• The quantity of medicines/dosage units to be supplied was not written in both words and figures, as required by legislation.
• The name and address of the patient was not handwritten on the prescription, as required by legislation.
26% (25 of 96) of the ‘emergency supplies’ reviewed were carried out in accordance with legislative requirements
74% (71 of 96) of the ‘emergency supplies’ reviewed were not carried out in accordance with the necessary legislative requirements. A breakdown of these figures shows that:
• In 49.3% (47 of 96) of these cases[3] controlled drugs were supplied.
• In 38% (37 of 96) of these cases the quantity of medicines supplied to the patient exceeded the permitted quantity allowed in respect of an emergency supply carried out at the request of a patient.
• In 11.3% (11 of 96) of cases where the supply was requested by a prescriber, the original prescription was not supplied to the pharmacy within 72 hours after the supply, as required.
• Other 1.4% (1 of 96).

Useful resources:

The Medicinal Products (Prescription and Control of Supply Regulations) 2003 (as amended)
Inspectors' Advice on Emergency Supply available on the PSI website (May 2012)

5. Management of Controlled Drugs

The controlled drugs register is reviewed to ensure that all receipts and supplies of schedule 2 controlled drugs are legitimately accounted for. Stock checks are carried out during the inspection to verify that the quantity of stock specified in the controlled drugs register corresponds with the physical quantity of the controlled drug in the safe. PSI Inspectors review the balances for three controlled drugs preparations during each inspection.

PSI Inspectors also check to make sure that schedule 2 and 3 controlled drugs are securely stored in a locked controlled drugs safe.

Item checked during inspection	% of pharmacies meeting compliance standards
Controlled Drugs Register Running stock balances were recorded in the Controlled Drugs Register	90%
Controlled drug stock checks were correct i.e. the physical quantity of the controlled drug counted matched the balance in the controlled drugs register	91%
In 6% (23 of 387) of cases omissions were identified in the Controlled Drugs Register. In these cases supplies to patients were not recorded in the register and/or controlled drugs received from wholesalers were not recorded in the register.
Controlled Drugs Safe All controlled drugs (schedule 2 and/or schedule 3) were stored in the controlled drugs safe	92%

Useful resources:

[1] 115 of the 387 Retail Pharmacy Businesses inspected supplied patients in Nursing Homes/Residential Care Settings.

[2]

These findings relate to the specific aspects of the pharmacy's systems assessed on the date of the inspection.
[3] 89% of the supplies relate to the supply of schedule 3 or schedule 4 controlled drugs.