Retail Pharmacies Business Guide
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All 38 Documented Cases
TGA Enforcement Action & License Revocation Risk
Business closure/license revocation = 100% revenue loss (unquantified in sources; typical community pharmacy revenue AUD 500k-2M+ annually at risk); estimated enforcement investigation cost: AUD 5,000-15,000 in compliance remediation and legal feesPharmacies must document risk assessments, ingredient sourcing, RTPM records, and preparation protocols per updated PBA Guidelines (51+ changes as of 1 October 2024). Failure to maintain compliant documentation exposes the practice to TGA enforcement action, including license revocation under the Therapeutic Goods Act 1989 and state-based pharmacy legislation. License revocation or suspension results in immediate cessation of all compounding services and potential business closure.
Excessive Compliance Labor & Rework Due to October 2024 Guideline Expansion
Training cost: 5-10 hours per staff member × AUD 30-50/hour × average 3-5 staff members = AUD 450-2,500 per pharmacy; SOP redesign and audit labor: 20-40 hours × AUD 60-80/hour = AUD 1,200-3,200; total estimated one-time remediation cost: AUD 2,000-6,000 per pharmacy; ongoing monthly compliance overhead increase: AUD 300-800/month (additional record-keeping, verification, supervisor review)On 1 October 2024, the Pharmacy Board of Australia released revised Guidelines on Compounding of Medicines with 51+ key changes, including expanded risk assessment requirements, enhanced ingredient sourcing documentation, and stricter RTPM record-keeping. Pharmacies using manual processes (Excel, paper logs) must: (1) conduct staff retraining on new requirements (5-10 hours per staff member); (2) redesign SOP documentation templates to align with new guidance; (3) audit historical batch records for compliance gaps and perform rework/documentation remediation. This is unplanned cost with no corresponding revenue increase.
Manual Documentation Bottleneck & Service Capacity Loss
Estimated 15-30 hours/month of pharmacist time at AUD 50-80/hour (fully-loaded cost) = AUD 750-2,400/month per FTE = AUD 9,000-28,800/year per pharmacist; 2-5% revenue leakage due to lost/delayed scripts during manual documentation bottlenecks = AUD 10,000-50,000/year for typical community pharmacy (estimated AUD 1-2M annual turnover)Pharmacists performing compounding must: (1) conduct and document risk assessments before batch preparation; (2) maintain real-time prescription monitoring (RTPM) records; (3) document ingredient compliance and sourcing; (4) prepare comprehensive batch records and labeling; (5) verify SOP compliance. These tasks are typically performed manually in Excel/paper logs, consuming 2-4 hours per 10-20 compounded medicines. With PBA Guidelines updated October 1, 2024, documentation requirements expanded, increasing manual workload without corresponding staffing increases. Result: Pharmacists experience task backlog, patient queues form, and customers exit to buy from competitors or receive slower service, eroding market share.
Unbilled or Delayed Medication Management Services
AUD 2,000–8,000 per pharmacy annually (unclaimed QUM base payments: AUD 125/quarter + AUD 12.50 per bed; unclaimed DMMR: AUD 180.65 per eligible patient annually; follow-up services: AUD 56.33–28.16 per service)Retail pharmacies deliver Residential Medication Management Reviews (RMMR), Quality Use of Medicines (QUM) services, and Domiciliary Medication Management Reviews (DMMR) but fail to claim within required timeframes. QUM services must be claimed quarterly in arrears by month-end deadline. DMMR (Item 900, AUD $180.65) limited to once per 12 months—overbilling risks denial. Manual ledgers create deadline drift.