This audit assesses drug allergy documentation quality in a paper-based hospital, implying urgent need for improvement strategies.
Background/Objectives: Accurate drug allergy documentation is essential for patient safety; however, documentation quality remains poor worldwide. In resource-limited settings that rely on paper records, allergy information may become fragmented across multiple forms, and evidence on concordance between paper-based documentation systems is limited. This audit assessed concordance between clinical notes and drug Kardex records, and completeness of drug allergy documentation entries, in a manual hospital system. Methods: This retrospective clinical audit, reported in accordance with SQUIRE 2.0 guidelines, examined 88 randomly selected patient records from 525 consecutive admissions to a general medicine ward in Pakistan during June–July 2024, retrospectively reviewed in August 2024. The audit assessed allergy status documentation in clinical notes and the drug Kardex, evaluated completeness against five internationally recommended elements (drug name, reaction description, severity, date, and treatment), and measured inter-system concordance using McNemar’s test and Cohen’s kappa. Results: Drug allergy status was documented in 25.0% of clinical notes (95% CI: 16.5–35.4%) versus 94.3% of drug Kardex records (95% CI: 87.2–98.1%), representing a 69.3 percentage-point gap (McNemar χ2 = 59.06, p < 0.001). Inter-system agreement was poor (κ = 0.0079; 95% CI: −0.046 to 0.062), with an overall concordance of 28.4%. Discordant pairs showed that undocumented allergy status was far more likely in clinical notes than in the drug Kardex (OR = 62.00). Kardex-only documentation occurred in 62 of 88 patients (70.5%). Among nine patients with documented allergy history in at least one source, none met the five-element completeness standards (0%; 95% CI: 0.0–33.6%). Recorded entries were generic statements such as “drug allergy” or “allergic to antibiotics” without clinically actionable details. Conclusions: Drug allergy documentation showed two major quality failures: poor concordance between parallel paper records and lack of actionable detail in recorded entries. The two systems functioned independently rather than as complementary safety checks, with allergy information often present in the drug Kardex but absent from clinical notes. This Kardex-only failure mode may be a practical target for quality improvement through structured five-element templates, prompts for clinicians to review the drug Kardex, and interdisciplinary allergy-reconciliation workflows. These strategies require prospective evaluation in this setting.
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Obeidat et al. (2026) studied this question.
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