DI-010 A systematic literature review of antimicrobial stability data in elastomeric devices

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Outpatient parenteral antimicrobial therapy (OPAT) is an established approach to patient care, the benefits of which are clinical, financial and preferred place of care for patients. In order to maximise these benefits ‘once daily’ antimicrobials should be used. Antimicrobial stewardship principles state that, where possible, narrow spectrum, organism specific agents should be used for infection management. Commercially available narrow spectrum agents frequently require administration 2, 3 or more times each day. A dilemma for OPAT services arises therefore to either: (1) use once daily broad spectrum antimicrobials going against stewardship principles; (2) administer narrow spectrum agents as a continuous infusion via a portable medical device.


Medicines administration via a portable device requires appropriate stability data. The Yellow Covered Document (YCD) stipulates the minimum dataset for assessment of stability. To facilitate OPAT services to adhere to stewardship requirements and access stability data for narrow spectrum agents, a comprehensive literature review was undertaken. This review assessed the published antimicrobial stability literature available and its compliance with the dataset required by the YCD.

Material and methods

Searches were conducted in Medline, EMBASE, Global Health, International Pharmaceutical Abstracts and Biomedical Research Database in April 2014 and November 2015.


420 records were identified, 299 of which were excluded following title and abstract review. Full text review of 121 citations identified no papers that met the dataset requirements of the YCD.


Access to stability data in administration devices is a barrier to service expansion within the antimicrobial stewardship agenda. This review found no published studies that fully complied with YCD standards for shelf-life extension.

References and/or acknowledgements

The Yellow Covered Document:

References and/or acknowledgements

A Standard Protocol for Deriving and Assessment of Stability- Part 1. Third Edition, 2015. NHS Pharmaceutical Quality Assurance Committee.

References and/or acknowledgements

Conflict of interest:

References and/or acknowledgements

Corporate sponsored research or other substantive relationships: MG and TH serve on the BSAC UK OPAT Initiative Steering Group receiving reimbursement of travel expenses only from the BSAC for attending and speaking at OPAT related events. MG reports attending advisory boards for Merck, Pfizer, Gilead and receiving educational travel and speaker grants from Merck and Astellas Pharmaceuticals/Sanofi, respectively. MS has attended an advisory board for Baxter. TH has received support to attend conferences from Sanofi, Astellas and Novartis and attended advisory board for Cubist, Astra Zeneca, MSD, Novartis and Ferring Pharmaceuticals Ltd.

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