From Product-Quality Complaints to Patient-Safety Triage: A Structured Narrative Review and Proposed PRCS-TRACE Framework

Product-quality complaints are usually handled as pharmaceutical quality-system events, yet defects in sterility, potency, identity, packaging, labelling, storage, distribution or delivery-device function may affect medication use, treatment continuity and patient outcomes. This structured narrative review examines product-quality complaints (PQCs) as a patient-safety interface linking pharmaceutical quality systems, pharmacovigilance, medication-error prevention, recall action and pharmacoepidemiology. Existing pharmacovigilance, quality-management and recall systems address different components of this pathway, but no integrated framework was identified in the sources reviewed that specifies how product-quality complaints should be linked to exposure evidence and patient outcomes. Sources were identified through targeted PubMed searches and purposive retrieval of official regulatory, pharmacovigilance and public-health documents up to 5 June 2026; the review was not registered and included no quantitative synthesis. The sources identified concentrate on regulatory architecture, sentinel contamination events and shortage-associated harms; routine complaints are studied comparatively little, and no source identified reported the complaint-to-defect-to-exposure-to-outcome cascade with a complaint-level denominator. We propose the term patient-relevant complaint status (PRCS) for a complaint warranting patient-safety triage because the reported defect could plausibly affect exposure, sterility, potency, identity, delivery, medication use or treatment continuity, together with a TRACE workflow, a six-level clinical-consequence classification and separately graded certainty for defect confirmation, patient exposure and outcome attribution. These tools are proposed, unvalidated and hypothesis-generating; they do not convert complaints into adverse reactions, recalls into causality or spontaneous reports into incidence. Their intended role is to structure patient-safety triage, batch-aware linkage, exposure reconstruction, clinical follow-up and proportionate mitigation while causal attribution remains incomplete; this role requires prospective validation before routine implementation.