Inspection Findings 2014

Introduction

Systems inspections are carried out under Section 67 of the Pharmacy Act 2007. These routine inspections are carried out by PSI inspectors, with the aim of providing assurance that the main systems, staff and structures are in place in all pharmacies in line with relevant legislative provisions and good pharmacy practice. These are unannounced inspections.

In 2014, 624 systems inspections were carried out by Authorised Officers (Inspectors) of the PSI.

During a systems inspection, PSI Inspectors examine the way in which medicines are supplied from the pharmacy to ensure a legitimate and safe basis for their supply. They also review of premises, workflow and the conditions existing for the storage and preparation of medicines, amongst other things.
This overview of the findings from systems inspections sets out key statistics under the following headings:

  1. Pharmacy premises and medicines storage
  2. The supply of prescription only medicines, including controlled drugs
  3. The management of controlled drugs in pharmacies
  4. Quality management systems
  5. Supply of medicines to patients in nursing homes/residential care settings

Reference to relevant resources are 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.

1. 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 separate and designated area, easily accessible to patients so that they may discuss their medicines therapy in private.

 Item Checked During Inspection
 % of Pharmacies
Meeting Compliance Standards

Patient Consultation Area
A patient consultation area was in place
 97
Dispensary
Dispensary was clean and/or well maintained
 87
Storerooms
Storerooms were clean and/or well maintained
 73
Bathrooms
Staff bathrooms were clean and/or well maintained
 76
Pharmaceutical Grade Fridge
Pharmaceutical grade fridges are in place for the storage of medicines in the pharmacy
 90
The medicines fridge is clean
 93
Maximum/minimum temperature records monitored and recorded on a daily basis in the:
Pharmacy fridge
Dispensary
Storage areas


60
48
54

Useful Resources

2. The Supply of Prescription Only Medicines, including Controlled Drugs

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 2496 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. 156 of the 2496 (6%) supplies checked were ‘emergency supplies'.
Of the items checked during inspection:

  • 92% of the prescriptions checked were in date and valid for the supply made;
  • 81% of the prescriptions reviewed were properly written.
    The majority of issues identified with regard to prescription writing related to the supply of schedule 2 controlled drugs. In particular, it was noted that:
    a.
    The quantity of medicines/dosage units to be supplied was not written in both words and figures, as required by legislation.
    b. The name and address of the patient was not handwritten on the prescription, as required by legislation.
  • 16% of the ‘emergency supplies’ reviewed (total = 156) were carried out in accordance with legislative requirements.
    84% of the ‘emergency supplies’ reviewed were not carried out in accordance with the necessary legislative requirements. A breakdown of these figures shows that:
    a..In 58.6% of these cases controlled drugs (Schedule 2, 3 or 4 controlled drugs) were supplied.
    b. In 13.6% 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.
    c. In 24.3% 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.
    d. In 3.5 % of cases, the pharmacist was not able to tell whether the medicine had been supplied at the request of a patient and/or a prescriber. In those cases the supply did not meet the requirements of either type of emergency supply. In each case either the quantity of medicines supplied to the patient exceeded the permitted quantity allowed for an emergency supply at the request of a patient or, the original prescription was not supplied to the pharmacy within 72 hours after the supply, as required if the supply was requested by a prescriber.

Useful resources:

3. Management of Controlled Drugs

The controlled drugs register is reviewed by PSI Inspectors to ensure that all receipts and supplies of schedule 2 controlled drugs are appropriately entered and accounted for. Stock checks are carried out during the inspection to verify that the quantity of stock specified in the controlled drugs register (i.e. the running stock balance) 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 drug safe.

 Item checked during inspection
 % of pharmacies
meeting compliance
standards

Controlled Drugs Register
Running stock balances were recorded in the Controlled Drugs Register
 94
Controlled drug stock checks were correct, i.e., the physical quantity of the controlled drug counted matched the balance in the controlled drugs register
 92
 No 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.
 94
Controlled Drugs Safe
All controlled drugs (schedule 2 and/or schedule 3) were stored in the controlled drugs safe.

 89

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4. 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 the relevant legislative requirements 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. In addition, Superintendent and Supervising Pharmacists should ensure that all pharmacy staff are following the approved SOPs for the pharmacy. 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 relevant legislative requirements 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 Staff Training in Pharmacy SOPs
Records show that pharmacy staff were trained in the use of the pharmacy's SOPs
 63
Error/incident logs
Records show that error/incident logs were being maintained at the pharmacy
 63
Record of Pharmacist on Duty
The duty register was properly maintained in respect of the particular dates checked.
 80

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5. Supply of Medicines to Patients in Nursing Homes/Residential Care Settings

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 their original prescriptions, which were reviewed by the pharmacist prior to supply. As part of the inspection, PSI Inspectors look 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 Home/Residential Care Settings
 76
Procedures
Written procedures are in place to govern the supply of medicines to patients in Nursing Homes/Residential Care Settings
 47
Medicines Use Reviews
Records show that medicines reviews are carried out
 41
Delivery Records
Delivery records were available for review at the pharmacy for supplies to patients in Nursing Homes/Residential Care Settings
 43

Useful resources:

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