Clinical Practice Guidelines for Vaccine Management in Ambulatory Care: a Systematic Review Following the AGREE II Approach

Abstract

Breaches in the cooling chain with exposure of vaccines to temperatures outside the target range of +2°C to +8°C may reduce their efficacy and impair immune responses. Following the Appraisal of Guidelines for Research and Evaluation (AGREE II) approach, this review assesses the quality and content of international clinical practice guidelines on vaccine management. The results were used to derive recommendations for the vaccine management in ambulatory care in Germany. Based on a systematic search and screening process with predefined criteria, the selected guidelines were rated by three reviewers using the AGREE II domains: scope and purpose, stake-holder involvement, rigor of development, clarity of presentation, applicability, and editorial independence. The content of the guidelines was retrieved and summarized according to five predefined categories: cold chain, responsibilities, equipment, storage, and monitoring. The review was registered in PROSPERO (CRD42021270524). A total of nine clinical practice guidelines were selected for evaluation. The sum score of the documents varied between 17% to 89% of the maximum possible score. All guidelines included recommendations in the five content categories but differed in detail. The key recommendations were: a) continuous cold chain required; b)≥2 trained, responsible staff members; c) storage in original wrappings; d) appropriate, preferably purpose-built refrigerator with two-point thermometer or data logger; e) routinely implemented monitoring processes including daily temperature recording. A public monitoring system was recommended in some guidelines. Our systematic review identified key information for vaccine storage and management to support the future development of German recommendations for vaccine storage.