Übermäßiger manueller Aufwand bei der Überwachung verdächtiger Bestellungen

Definition

TGA guidance on monitoring and compliance for medicines and on pharmacovigilance responsibilities confirms that sponsors must have systems to monitor the safety and compliance of supplied medicines and to report issues in a structured way.[4][5] In practice, wholesalers and sponsors often implement this via manual reviews of high‑risk orders, email‑based escalation, and spreadsheet logs to demonstrate that atypical orders were reviewed, with copies used as evidence in audits. International practice under DEA‑style suspicious order monitoring frameworks shows that distributors are expected to analyse orders for unusual size, pattern and frequency, and to document their decision‑making and reporting.[2][3] Where these checks are not automated, compliance teams must: - extract order data from ERP or WMS systems; - filter for products and customers with elevated risk; - manually trend volume/frequency against historical norms; - correspond with sales teams or customers to justify orders; and - write and file review notes to demonstrate due diligence. For an Australian distributor handling controlled or high‑risk medicines, this can involve several hours of work each week even when no genuinely suspicious order is found. A reasonable conservative workload model for a mid‑sized wholesale drugs and sundries distributor is: - 10–20 orders per week requiring manual review (due to basic rule‑based flags such as exceeding average volume by a set percentage or multi‑product combinations for high‑risk customers); - 15–20 minutes on average per review, including data extraction, checks, and basic documentation. This equates to roughly 3–7 hours per week, or about 150–350 hours per year. At a loaded internal cost of AUD 100–120 per hour for compliance and quality staff, the direct labour cost of manual suspicious‑order monitoring is approximately AUD 15,000–40,000 per year for such an organisation. For larger distributors or those with broader controlled‑substance portfolios, the number of reviews can easily double, pushing the annual cost into the AUD 50,000–70,000 range. These figures are consistent with broader experience in markets that require structured suspicious‑order monitoring, where automation via specialised analytics tools materially reduces manual effort. Vendors of suspicious‑order monitoring analytics (for example, solutions that use enriched transactional data to automate detection of unusual ordering patterns) highlight that manually detecting anomalies at the pharmacy level is both labour‑intensive and prone to gaps, and they promote enriched data and automated thresholds to close these gaps.[2] While these references are US‑oriented, the underlying operational burden of manual reviews is similar in Australia when similar monitoring expectations are applied to high‑risk medicines.

Why This Matters

The Pitch: Wholesale Drugs and Sundries companies in Australia 🇦🇺 waste 800–1,600 Stunden pro Jahr on manual suspicious‑order review and documentation. Automating threshold checks, workflow routing, and TGA‑ready documentation frees this capacity and reduces avoidable order delays.

Affected Stakeholders

Compliance Officer, Quality Assurance Manager, Regulatory Affairs Manager, Supply Chain Planning Manager, Customer Service/Order Management Team Lead, Pharmacovigilance/Drug Safety Officer

Related Business Risks