BACKGROUND: 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.
METHODS: 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).
RESULTS: 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.
CONCLUSIONS: Our systematic review identified key information for vaccine storage and management to support the future development of German recommendations for vaccine storage.
UNASSIGNED: Unterbrechungen der Impfstoffkühlkette mit Temperaturen außerhalb des Zielbereichs von+2°C bis+8°C können die Wirksamkeit von Impfstoffen verringern und die Immunantwort beeinträchtigen. Die Einhaltung von Standards zum Impfstoffmanagement ist daher essentiell, doch sind für Deutschland bisher keine Leitlinien dazu formuliert. Dieser Review vergleicht die Qualität und die Inhalte internationaler Leitlinien und Empfehlungen zum Impfstoffmanagement mit Hilfe des AGREE II Instruments (Appraisal of Guidelines for Research and Evaluation). Aus den Ergebnissen werden Empfehlungen für das Impfstoffmanagement in der ambulanten Versorgung in Deutschland abgeleitet.
METHODS: Ausgehend von einer systematischen Recherche wurden internationale Leitlinien und Empfehlungen zum Impfstoffmanagement durch drei Reviewer anhand der AGREE II-Domänen bewertet. Die Domänen waren: Geltungsbereich und Zweck, Beteiligung von Interessengruppen, Genauigkeit der Leitlinienentwicklung, Klarheit der Gestaltung, Anwendbarkeit und Redaktionelle Unabhängigkeit. Die inhaltlichen Empfehlungen der Leitlinien wurden nach den fünf Kernthemen Kühlkette, Ausrüstung, Personal und Personalqualifikation, Lagerung und Monitoring analysiert. Das Studiendesign wurde in PROSPERO (CRD42021270524) registriert.
UNASSIGNED: Insgesamt wurden neun Leitlinien und Empfehlungen bewertet. Die Gesamtpunktzahl der einzelnen Publikationen variierte zwischen 17% und 89% der maximal möglichen Punktzahl. Alle Leitlinien enthielten Empfehlungen zu den fünf Kernthemen, unterschieden sich jedoch in der Detailtiefe. Die wichtigsten Empfehlungen lauteten: a) durchgehende Kühlkette erforderlich; b)≥2 geschulte Verantwortliche pro Einrichtung; c) Lagerung in der Originalverpackung; d) geeigneter Kühlschrank, vorzugsweise Spezialkühlschrank, mit Min-Max-Thermometer oder Datenlogger; e) routinemäßiges Monitoring des Impfkühlschranks mit täglicher Temperaturaufzeichnung. Ein öffentliches Überwachungssystem wird in einigen Leitlinien empfohlen.
UNASSIGNED: Unsere systematische Übersichtsarbeit identifizierte Schlüsselinformationen für die Lagerung und das Management von Impfstoffen, um die zukünftige Entwicklung deutscher Empfehlungen zur Impfstofflagerung anzuregen und zu unterstützen.

Sick newborns in neonatal units who are unable to breastfeed are fed expressed breast milk. In Sri Lanka, most mothers stay in hospital throughout baby\'s stay to provide this milk freshly. In other countries mothers go home, express breast milk at home and bring it to hospital. There are concerns about the safety of transported expressed milk if used in a tropical middle-income country. The aim of this paper is to compare and contrast advice offered by different hospitals and organizations on how to express, store and transport breast milk safely.
We assessed guidelines used by hospital staff of the four Level 3 neonatal units in Melbourne, Australia, National Health Service UK, guidelines and training manuals of the Human Milk Banking Association of North America, the World Health Organization and an information leaflet from Family Health Bureau, Sri Lanka. Information on breast milk expression, storage and transport provided by the guidelines were tabulated under seven topics: general information; container for milk collection; hand expression; using a pump for expression; storage; thawing / warming; and transport of expressed breast milk. The AGREE II tool was used to assess the guidelines written for hospital staff.
There was considerable agreement on most recommendations provided by these sources, but no single source covered all topics in full. Most recommend hand expression as the initial method for expressing of breast milk, followed by breast pump use, except the Sri Lankan recommendations which strongly discourages the use of breast pumps. Durations of storage under various conditions are generally similar in the different recommendations. Most guidelines recommend a \'cool box\' or container with ice or freezer packs for transportation of milk.
A single document containing recommendations on all aspects of expressing, storing and transporting breast milk should be available for each unit, with the same basic information for mothers and the healthcare staff and further technical details for staff if required. The Sri Lankan recommendations need to be updated based on current worldwide practices and further studies are needed to establish a safe method of transport of expressed breast milk in Sri Lanka.

OBJECTIVE: Vaccines and other pharmaceuticals are essential medical supplies that require continuous storage at specific temperatures to maintain viability. Power outages can lead to a break in the cold chain, resulting in the degradation of essential medicines.
CONCLUSIONS: After a power outage, the stability of vaccines and other medicines can be difficult to ascertain. Many public health guidelines therefore recommend discarding potentially compromised pharmaceuticals unless the cold chain can be guaranteed-a costly endeavour. There are government guidelines aimed at minimizing exposure to high temperatures in the event of a power outage; however, the usefulness of these guidelines is uncertain.
CONCLUSIONS: The actual cost of vaccine and pharmaceutical loss due to a break in the cold chain is poorly studied and requires further research. Additional recommendations regarding the stability of specific medicines would also be a valuable resource.

This commentary compares Centers for Disease Control (CDC) guidelines for vaccine storage with international cold chain standards. Problems related to the use of domestic refrigerators in clinical settings are discussed. Optimal vaccine refrigerator design characteristics are summarized. The adoption of World Health Organization storage recommendations is advised.

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