Inspection Findings 2015

Introduction

The purpose of the PSI’s statutory inspection function is to provide public assurance of safe standards of pharmacy practice in the State, to promote good and safe practice within retail pharmacy businesses and ensure compliance with legislative requirements, guidelines, best practice requirements and the Code of Conduct for Pharmacists. The PSI inspects retail pharmacy businesses to assess compliance with the Pharmacy Act 2007, together with other pharmacy and medicines legislation in the interests of the health and safety of the public.

PSI Authorised Officers (inspectors) carry out different types of inspections, and in 2015 conducted 382 pharmacy inspections, as follows:

  • One hundred and twelve (112) inspections were carried out under Section 19 of the Pharmacy Act 2007 (registration-related inspections),
  • One hundred and forty-four (144) systems inspections were carried out under Section 67 of the Act, and
  • One hundred and twenty-six (126) other inspections carried out under Section 67 of the Act. These include re-inspections and targeted inspections to check specific areas of practice, for example the provision of flu vaccination services.

The statistical data below is based on the inspection findings of the 144 systems inspections only.

Routine systems inspections are carried out by PSI inspectors, with the aim of providing assurance that the systems, staff and structures are in place in all pharmacies in line with relevant legislative provisions and good pharmacy practice. These are unannounced inspections.

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 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
 99
Dispensary
Dispensary was clean and/or well maintained
 76
Storerooms
Storerooms were clean and/or well maintained
 63
Bathrooms
Staff bathrooms were clean and/or well maintained
 74
Pharmaceutical Grade Fridge
Pharmaceutical grade fridges are in place for the storage of medicines in the pharmacy
 98
The medicines fridge is clean
 95
Maximum/minimum temperature records monitored and recorded on a daily basis in the:
Pharmacy fridge
Dispensary
Storage areas


75
61

58

 

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 576 supplies were selected for review. Approximately 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. 35 of the 576 (6%) supplies checked were ‘emergency supplies'.

Of the items checked during inspection:

  • 91% of the prescriptions checked were in date and valid for the supply made.
  • 80% 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:

  1. The quantity of medicines/dosage units to be supplied was not written in both words and figures, as required by legislation.
  2. The name and address of the patient was not handwritten on the prescription, as required by legislation.
  • 6% of the ‘emergency supplies’ reviewed (total = 35) were carried out in accordance with legislative requirements.
  • 94% of the ‘emergency supplies’ reviewed were not carried out in accordance with the necessary legislative requirements. A breakdown of these figures shows that:
  1. In 54.5% of these cases controlled drugs (Schedule 2, 3 or 4 controlled drugs) were supplied.
  2. In 27.3% 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. 
  3. In 12.1% 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. 
  4. In 6.1% 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
 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
 88
 No omissions were identified in the Controlled Drugs Register.
 95
Controlled Drugs Safe
All controlled drugs (schedule 2 and/or schedule 3) were stored in the controlled drugs safe.

 89

Useful resources:

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
 67
Error/incident logs
Records show that error/incident logs were being maintained at the pharmacy
 65
Record of Pharmacist on Duty
The duty register was properly maintained in respect of the particular dates checked.
75

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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, medication use reviews and delivery records 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.

39 pharmacies of the 144 inspected during 2015 supplied to patients in Nursing Homes/Residential Care Settings.

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
 90
Procedures
Written procedures are in place to govern the supply of medicines to patients in Nursing Homes/Residential Care Settings
 74
Medicines Use Reviews
Records show that medicines reviews are carried out
33
Delivery Records
Delivery records were available for review at the pharmacy for supplies to patients in Nursing Homes/Residential Care Settings
 54

Useful resources:

Relevant Legislation

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