Background
The decision to establish the Drug Stability Programme followed a comprehensive literature review of published evidence on drug stability of antimicrobial agents.
Undertaken by the UK OPAT Initiative, the review* demonstrated a total absence of published data in the field compliant with the standards stipulated in the Yellow Covered Document.
Open and invited requests to a range of organisations, commercial and non commercial, for access to primary stability data yielded no results.
The demonstrated need for stability data, particularly to inform practice in Outpatient Parenteral Antimicrobial Therapy, led to the decision to establish this independent programme as a service to the community.
*Accepted for poster presentation, ECCMID 2016.
Purpose and Objectives
The drug stability testing programme exists to provide evidence on the stability of agents and devices used in infection management practice, particularly those used in Outpatient Parenteral Antimicrobial Therapy (OPAT) services.
The programme will provide an expanding repository of open access data on drug and device stability compliant with UK NHS standards as provided by the yellow Covered Document. For the first time healthcare professionals will be able to reference open access stability data reports to aid decision making, inform practice and offer opportunities to improve patient safety and patient outcomes, especially within the OPAT arena. The programme objectives are central to the charitable objective of the British Society for Antimicrobial Chemotherapy which is “To support the acquisition and dissemination of knowledge in the field of antimicrobial chemotherapy”
Partners and Providers
Working collaboratively to serve the community
Stability testing will be undertaken by a quality assured provider, appointed following an open competitive tender process. The provider appointed for the period 2016-2018 is BioPharma Stability Testing Laboratory (BSTL), a dedicated testing laboratory supplying services to pharmaceutical & home healthcare companies and with over 35 years of expertise in parenteral drug stability testing.
Commissioning Studies
Organisations can commission a stability study for their agent / device through the Drug Stability Programme. Commissioned studies will be undertaken by the programme’s chosen provider and will lead to open access publication of peer review data.
The benefits of commissioning a study are:
- Opportunity to get medicines/devices tested to Yellow Covered Document standards
- Full methodology and results will be accessible to all NHS organisations free-of-charge
- Opportunity to open markets currently limited due to the high standard of testing required by the NHS
- Data on each medicine that has been tested in two elastomeric devices plus syringe and infusion bags across a range of storage conditions
- Journal peer review publication and website availability
- Highly competitive pricing model
Studies can be commissioned by:
- Pharmaceutical companies
- Device manufacturers
- Diagnostic companies
- NHS organisations
- Private healthcare / homecare organisations
- There will be capacity to fund up to 4 studies per annum so early enquiries are advisable.
To discuss commissioning a study, and for further information on costs and timescale, please contact Felicity Drummond at OPAT@bsac.org.uk. The aim of the project is to obtain where possible positive stability data in appropriate medical devices enabling OPAT teams to adhere to the principles of antimicrobial stewardship in both OPAT and in-patient settings.
The outcomes of the stability tests undertaken will not be a simple pass or fail. On identifying a compound with sub-optimal stability our teams of experts will endeavour to understand the mechanism for degradation leading to lack of stability. Due to the nature of antimicrobial agents many are unstable compounds with pH playing a key role in the speed of degradation. Stability can frequently be improved by maintaining the compounded solutions pH within fixed parameters. This is achieved by the addition of small quantities of commercially available buffers, compounds that maintain the pH of a solution within certain boundaries. Following identification of appropriate buffer, additional stability testing will be completed in appropriate administration devices. It is envisaged that this method of testing will to optimise the medicines, doses, regimens and durations available to OPAT teams. Organisations commissioning studies will, in most instances, receive advice and peer review publication on how to prepare and ensure stability of their agent.