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Title Page
Site
Registered Address
Pharmacist-in-charge
Conducted on
Pharmacy Inspection Checklist
Registration Certificates
Is the current certificate of registration for the pharmacy available at the pharmacy and
is it displayed such that it is legible from the public pharmacy area?
Yes No
Is the current certificate of the supervising pharmacist available at the pharmacy and is
it displayed such that it is legible from the public pharmacy area?
Yes No
Storage of Medicinal Products
Are all prescription-only medicines, including veterinary prescription-only medicines
stored in the dispensary?
Yes No
Are all codeine containing non-prescription medicines and other schedule 5 controlled
drugs stored in the dispensary?
Yes No
Are all pharmacy only medicines stored behind the medicines counter?
Yes No
Are all other non-prescription medicines stored in an area of the pharmacy under the
control of the pharmacist?
Yes No
Does the pharmacy have a pharmaceutical grade fridge?
Yes No
Is the fridge clean and is food stored in a separate fridge?
Yes No
Are all medicines stored in the fridge in good condition?
Yes No
Is the fridge of an adequate capacity to permit the orderly storage of medicines?
Yes No
Is the fridge serviced annually?
Yes No
Is the maximum/minimum fridge temperature monitored, recorded and reviewed on a
daily basis as per the PSI Guidelines on the Sourcing, Storage and Disposal of Medicinal
Products within a Retail Pharmacy Business?
Yes No
Are all medicines stored in the pharmacy in date and is there an active documented
expiry date management system in place? The expiry dates of medicines may be
checked.
Yes No
Is the maximum/minimum temperature in the dispensary and any additional storage
areas monitored, recorded and reviewed on a daily basis as per the PSI Guidelines on
the Sourcing, Storage and Disposal of Medicinal Products within a Retail Pharmacy
Business?
Yes No
Are medicinal products only removed from their primary packaging in exceptional
circumstances? Have all stability implications been considered?
Yes No
Policies and Standard Operating Procedures
Select all implemented procedures for processes carried out in the pharmacy:
Sale & Sale &
Dispensing Sourcing Storage Expiry Supply of Supply of Manageme
of of Date Non- Non- of Controlle
Medicines Medicines Checking prescription prescription Drugs
of Codeine-
Medicinal containing
Products Medicines
Have all policies and procedures been approved by the Superintendent and Supervising
Pharmacist?
Yes No
Is there an implementation date for all procedures?
Yes No
Is there a review date for all procedures and is documentation relating to previous
reviews available?
Yes No
Are dated policy and procedure training records available for all staff for all relevant
procedures?
Yes No
Duty Register
Does the pharmacy have a duty register for the current year?
Yes No
Is there a pharmacist supervising the pharmacy for all hours of opening and is this
recorded in the duty register?
Yes No
Is the duty log being maintained correctly?
Yes No
Are all entries maintained contemporaneously, are they signed by the pharmacist and
do they include the pharmacists’ arrival and departure times?
Yes No
Does the supervising pharmacist work in the pharmacy for a significant proportion of
the opening hours?
Yes No
Is the duty register reviewed regularly to ensure all details are correct?
Yes No
Prescription Register/Daily Audit/Daily Dispensing Report
Is the prescription register/ daily dispensing report printed on a daily basis (within 24
hours)?
Yes No
Is the prescription register/ daily dispensing report dated and signed by the pharmacist?
Yes No
Is the prescription register/ daily dispensing report completed in the correct format in
accordance with the requirements of regulation 10 of the Medicinal Products
(Prescription and Control of Supply) Regulations 2003 (as amended)?
Yes No
Are emergency supplies recorded and if at the request of a patient is the reason for the
emergency supply recorded?
Yes No
Is the prescription register/ daily dispensing reports for the previous two years available
for review at the premises?
Yes No
Are all prescriptions for the previous two years available for review at the premises?
Yes No
Controlled Drugs (CD) Register, Inventory & Safe
Does the pharmacy have a Controlled Drugs register?
Yes No
Is the CD register completed in accordance with legislation and instructions, i.e. is a
dedicated page provided for each product, are all required details entered, are the
details entered in chronological order within 24 hours of supply and are errors corrected
by marginal/ footnotes etc.?
Yes No
Is there evidence of the pharmacist routinely reviewing and checking stock balances?
Yes No
Are all CD registers for the last two years available for review?
Yes No
Where controlled drugs have been removed from the active balance and destroyed is
there documentation relating to the witnessed destruction of controlled drugs available
for review?
Yes No
Do the quantities of CDs recorded in the register match the quantities located in the CD
safe?
Yes No
Is there a lockable safe for the storage of medicines (schedule 2 and 3 controlled drugs)
in place in the dispensary?
Yes No
Is the CD safe secured (bolted to a solid wall/ floor) in accordance with regulations?
Yes No
Has the CD safe been certified by the Gardaí and is the certificate available for review at
the pharmacy?
Yes No
Does the CD safe have sufficient capacity to permit the orderly storage of all schedule 2
and 3 controlled drugs?
Yes No
Are all schedule 2 and 3 controlled drugs stored in the CD safe? Is the CD safe reserved
solely for the storage of medicines?
Yes No
Are expired/ patient returned controlled drugs stored in a designated part of the CD
safe and appropriately labelled?
Yes No
Prescriptions
Are the original prescriptions available for review?
Yes No
Are they valid and in date (dispensed within 14 days of the date on the prescription and
not dispensed prior to the date on the prescription)?
Yes No
Do they meet the handwriting requirements for controlled drugs?
Yes No
Have they been entered correctly into the CD register (CD2 only) and prescription
register?
Yes No
Have they been endorsed with the date of dispensing and the word 'dispensed'/
quantity dispensed?
Yes No
Are the original prescriptions available for review?
Yes No
Are they valid and in date (dispensed within 6 months of the date on the prescription)?
Yes No
Are they correctly written? Have they been entered correctly into the prescription
register?
Yes No
Have they been endorsed with the date of dispensing and the word 'dispensed'/
quantity dispensed?
Yes No
Premises
Is the premises self-contained?
Yes No
Has the PSI/Garda Security Assessment been completed and are there adequate
security arrangements in place, e.g. alarm, shutters, CCTV, panic buttons, as applicable?
Have any/all recommendations made by the crime prevention officer been
implemented?
Yes No
Is the external and the internal premises in a good state of repair and decoration, and
are all fixtures and fittings of an acceptable standard?
Yes No
Are all storage areas in the premises in a good state of repair and decoration, and are all
fixtures and fittings of an acceptable standard?
Yes No
Are all entrances to the premises well maintained, clear and accessible?
Yes No
Is the trading name of the pharmacy displayed at all entrances to the premises?
Yes No
Dispensary - Is the dispensary area easily identifiable by signage?
Yes No
Does the layout enable the pharmacist to both maintain patient confidentiality and
exercise supervision of the sale and supply of medicinal products in the dispensary, at
the medicines counter and while in the patient consultation area?
Yes No
Is a dispensing bench with a smooth impervious & washable surface and adequate
space for expected volume of activity in place?
Yes No
Is there a dedicated dispensary sink with access to hot and cold (potable) water?
Yes No
Are dedicated areas for preparing Extemporaneous Products/ Monitored Dosage
Systems in place (if applicable)? 12.12 Is adequate lighting/ ventilation provided in the
dispensary?
Yes No
Does the location of the medicines counter restrict access to pharmacy only medicinal
products?
Yes No
Is access to the dispensary/ non-prescription medicines area and all areas where
medicines or confidential records are stored restricted to authorised personnel?
Yes No
Is a suitable waiting area provided for patients?
Yes No
Does the premises have a separate, designated, conveniently located private patient
consultation area, which is directly accessible from the public area of the pharmacy?
Yes No
Does the patient consultation area comply with the PSI's Guidelines on Patient
Consultation Areas, in terms of size, wheelchair accessibility, signage, provision of a
table/ worktop & three chairs?
Yes No
If the seasonal influenza vaccination service is provided in the pharmacy does the
patient consultation area meet the requirements of the PSI's Guidelines?
Yes No
Is there a clean and well maintained staff toilet with wash hand basin and a staff break
area provided at the premises?
Yes No
Are all areas of the premises where medicines or records are stored included in the floor
plan of the registered premises submitted to the PSI?
Yes No
Is housekeeping in all areas of the pharmacy maintained at an acceptable standard?
Yes No
Miscellaneous
Are Extemporaneous Medicinal Products offered?
Yes No
Are there procedures in place for preparing extemporaneous products?
Yes No
Are detailed records of products prepared maintained?
Yes No
Is all required equipment available in the pharmacy?
Yes No
Is all equipment clean and appropriately calibrated?
Yes No
Is the pharmacy in a Residential Care Setting?
Yes No
Are there procedures in place which address the management of the supply of
medication to<br>patients in residential care homes?
Yes No
Are records of the patient consent, medicines delivery, pharmacist visits, patient
counseling, and interdisciplinary medicine therapy review available for review for all
patients in residential care settings?
Yes No
Are Veterinary Medicinal Products available and Veterinary Prescriptions made?
Yes No
Are veterinary medicinal products stored in a designated area(s) of the pharmacy?
Yes No
Are prescription medicines, prescription only exempt medicines, pharmacy only
medicines, licensed merchant medicines, companion animal remedies and veterinary
medicines requiring refrigeration stored appropriately?
Yes No
Does the pharmacy have a veterinary register?
Yes No
Are records of all incoming and outgoing veterinary medicines (VPOM, VPOM (E), PS and
LM) recorded in the veterinary register in accordance with legislative requirements?
Yes No
Are veterinary prescriptions available, correctly written, and up-to-date (dispensed
within one year of the date on the prescription)?
Yes No
Have they been entered correctly into the veterinary register and endorsed with the
date of dispensing and signed by the pharmacist?
Yes No
Are all records (register and prescriptions) for the last five years available for review at
the premises?
Yes No
Does the pharmacy have all required equipment such as general equipment, a
computer, with pharmacy email and internet access, electronic dispensing system and
drug interaction software, dispensing equipment, dispensing containers, child-resistant
containers (CRCs), disposable plastic cups, and extemporaneous equipment?
Yes No
Does the pharmacy have appropriate reference books such as Martindale or other
complete drug reference, current BNF & current BNF for children, current Stockley’s and
drug interaction software, access to relevant current PSI guidelines, and additional
references if additional services are provided, e.g. veterinary reference, if providing
veterinary services?
Yes No
Does the pharmacy have a medicinal product waste bin and a designated storage area
for the bin?
Yes No
Is all waste and patient returned medication stored in a designated area of the
pharmacy segregated from active stock pending timely processing?
Yes No
Is evidence of waste collections by an authorised waste management company
available?
Yes No
Does the pharmacy have a methylated spirits register and license (if applicable) and is
there a designated area for the storage of methylated sprits?
Yes No
Does the pharmacy have a poisons register (if applicable) and are poisons stored in an
appropriate designated area of the pharmacy?
Yes No
Does the pharmacy have a shredder for confidential paper waste?
Yes No
Is the pharmacy registered with the Data Protection Commissioner and is a policy which
covers all electronic and manual records in place?
Yes No
Does the pharmacy have a confidentiality policy in place for all staff?
Yes No
Completion
Additional Comments
Pharmacist-in-charge Name & Signature
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solutions. The templates are intended to be used as hypothetical examples only and should not be used as a substitute for professional advice.
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