Regulatory Compliance Pharmacy Checklist Template
Regulatory Compliance Pharmacy Checklist Template
This checklist supports you in making a high standard of regulatory compliance at your company. It includes all necessary information just as a quality program, the standard of premises, and much more.
Regulatory Compliance Pharmacy Checklist Template
This checklist supports you in making a high standard of regulatory compliance at your company. It includes all necessary information just as a quality program, the standard of premises, and much more.
Related categories
Preview of the template
Audit
Current Reference Works on Hand (either hard copy or electronic copy)
APF ( Some States also have compulsory equipment requirements in terms of scales, measures, glass slabs etc)
AMH
Therapeutic Guidelines (Complete set), ETG or equivalent
Source of Current Australian Product Information and Consumer Medicine Information
(MIMS Annual with MIMS Abbreviated, e-MIMS or AusDI Advanced)
Drug Interactions reference (updated at least quarterly) (AusID Advanced, Drug Interaction Facts, Drug Interaction Analysis and Management, eMIMS Drug Alert Interactions, Micromedex, Stockleys Drug Interactions Online or Lexi-Interact Online)
Pediatric Reference (from an Australian source including a teaching hospital)
Evidence-based reference work on complimentary and alternative medicines
(Herbs and Natural Supplements, Herbal Medicines, eMIMS or AusID Advanced)
Electronic Access to current publications (as required by the Pharmacy Board of Australia)
(Office Consolidation or copies of the legislation controlling the practice of pharmacy)
Quality Program
Is the pharmacy certified under the Pharmacy Guild of Australia's Quality Care Program
Date of program completion
Date of expiry
Standard of Premesis
Dispensary not less than 9m squared
Hygienic Condition
Adequate Ventilation
Adequate Lighting (what is the standard for this type of work)
Temperature Control of Therapeutic goods and health care products (room temp
Safe, secure and hygienic storage of therapeutic goods and health care products
Safe and secure storage of confidential and sensitive information. Appropriate disposal of confidential information
Supervision from dispensary for all scheduled medicines
Premises registration certificate
Adequate shelving for Schedule 4 poisons
(Has a balance check of S8's been performed in the last 4 weeks? Random audit should be performed of record keeping and balances of fast moving items. Is the process used to deal with incorrect stock balances in the S8 register appropriate and in line with regulations?)
Barcode scanner
Adequate counselling area showing consideration for patient privacy
Non-PBS Approved pharmacies only – adequate signage explaining consequences of not obtaining medicine as a pharmaceutical benefit
DAA packing – adequate space, adequate storage of patient medication; process - final check must always be checked by a pharmacist and a procedure in place for medication changes and there should be records kept of date of filling, initals of person filling, initials of the person checking and initals of the person handing out the pack
Record keeping for compounded and re-packaged items - is it appropriate?
(Use of and filing of appropriate Batch sheets or compounding recording book.
Prescription Dispensed
Prescriptions Monday AM
Number of Pharmacists Monday AM
Prescriptions Monday PM
Number of Pharmacists Monday PM
Prescriptions Tuesday AM
Number of Pharmacists Tuesday AM
Prescriptions Tuesday PM
Number of Pharmacists Tuesday PM
Prescriptions Wednesday AM
Number of Pharmacists Wednesday AM
Prescriptions Wednesday PM
Number of Pharmacists Wednesday PM
Prescriptions Thursday AM
Number of Pharmacists Thursday AM
Prescriptions Thursday PM
Number of Pharmacists Thursday PM
Prescriptions Friday AM
Number of Pharmacists Friday AM
Prescriptions Friday PM
Number of Pharmacists Friday PM
Pharmacy Access
Can the pharmacy be accessed directly from within the premises of a supermarket?
Matters for further discussion
CPI
Follow - up required?
Primary health care
(eg.smoking cessation, community lectures, participation in medicines week, etc.)
Follow - up required?
DDA - register and entering out and storage - minimum specifications dependon the number of doses stored. Sending in of DDA scripts by 7th day of the month
Follow - up required?
Workloads
Follow - up required?
Medicine/buprenorphine substitution program
Follow - up required?
CAL’s
Follow - up required?
Sale and supply of psuedoephidrine - project stop
Follow - up required?
Storage of schedule 3 medication
Follow - up required?
Dispensing scripts from faxed copies. Scanned copies. Duplicates, phone orders - what is the site policy and does a script follow within 24 hours
Follow - up required?
Practising certificates for each pharmacist working at the site
Follow - up required?
Display of pharmacy owners names and PIC/Pharmacist on duty
Follow - up required?
Alarm system and is it monitored
Follow - up required?
Cold Chain testing
Follow - up required?
All staff knows where to access and have read the HPS Pharmacies Operations Manual.
Follow - up required?
You have a current copy of the Professional Practices Standards and all pharmacists have reviewed the standards & completed the check sheet. This document can be found in the accreditation folder located on the Q drive or on the intranet
Follow - up required?
All equipment has been calibrated
Follow - up required?
Your evidence folder is up to date and includes all templates, checklists and documentation that the auditor will require. (Please refer to evidence checklist). This is available in your site’s QCPP accreditation folder.
Follow - up required?
Every phone has a Bomb Threat checklist next to it. This document can be located in the accreditation folder on the Q drive or on the intranet.
Follow - up required?
Your site has a current copy of the Customer Service Statement displayed. This document is available in the operations manual but may need to be adjusted for your site.
Follow - up required?
If you counsel patients you have the What Stop Go poster displayed in your professional services area and your professional services area is clearly separated from your front dispensary area. A copy of the What Stop Go poster can be obtained in the accreditation folder in the Q drive or on the intranet.
Follow - up required?
You have the safe lifting/manual handling poster displayed in the pharmacy for all staff members who may be required to lift or transport heavy objects. This document is available in the accreditation folder located on the Q drive or on the intranet.
Follow - up required?
All dispensary stock has been checked for expiry dates, and all expired stock removed. Any short dated stock is clearly marked and located at the front of the shelves to ensure that purchasing staff monitor the expiry date.
Follow - up required?
All staff members are in full HPS uniform and have personal identification tags. If new identification tags or uniforms are required, you will need to liaise with HR.
Follow - up required?
All Cytotoxic medication has a PURPLE cyto sticker on the barcode
Follow - up required?
All fridges have been checked and no food or drink is stored in any vaccines fridges
Follow - up required?
The pharmacy is clean, neat and tidy and complies with all OHS standards and regulations. Your regulations are located in your QCPP manual.
Follow - up required?
When was the last site meeting + view agenda
Follow - up required?
Return of unwanted medication procedure
Follow - up required?
Practice professional indemnity insurance
Follow - up required?
Lease for premises
Follow - up required?
Contract Service Level
Hours of clinical service in line with contract
FTE allocation in line with contract
Service fees as per contract - are all aspects of service being charged
Mark up as per contract
Are reporting deadlines being met
Key KPIs being met
Have all variations to contract been documented
Customer service/communications.
When was the manager's last meeting with Hospital management - GM and DON. What is their process for handling Incidents/corrective actions?
What is their process for handling Incidents/corrective actions?
Operational Processes
My Patient process is being followed
Is the script owing process best practice?
Are PPIs provided?
Has the PPI target been achieved?
Are medscheck being provided?
Is the Medscheck target being achieved?
Is the PBS claim closed on the last day of the month?
Other observed processes
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This template, developed by Lumiform employees, serves as a starting point for businesses using the Lumiform platform and is intended as a hypothetical example only. It does not replace professional advice. Companies should consult qualified professionals to assess the suitability and legality of using this template in their specific workplace or jurisdiction. Lumiform is not liable for any errors or omissions in this template or for any actions taken based on its content.