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:
- Pharmacy premises and medicines storage
- The supply of prescription only medicines, including controlled drugs
- The management of controlled drugs in pharmacies
- Quality management systems
- 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:
- 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.
- 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:
- In 54.5% of these cases controlled drugs (Schedule 2, 3 or 4 controlled drugs) were supplied.
- 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.
- 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.
- 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 |
Useful resources:
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