Please note – the information on individual drugs and their stability in medicines compliance aids is being updated in 2019.
The information that UKMI provides about the stability of drugs in medicines compliance aids (MCAs) is intended for use by healthcare professionals
About UKMI MCA stability information
Manufacturers of medicines have robust data on the stability of their products when stored in their original packaging. There is very little reliable data available on the stability of medicines after they are removed from their original packaging and stored under different conditions.
What UKMI MCA stability information does – it makes recommendations on the suitability of solid dose forms for transfer from the manufacturers’ original packaging to multi-compartment compliance aids (MCAs). These recommendations are based on
- physico-chemical stability and characteristics of the medicine and its formulation(s)
- advice, where available, from manufacturers
- data, where available, on storage in MCAs
Most entries are based on a lead brand. Some, but not all, generic products are included. Some medicines are not included at all. For example there are very few oral chemotherapy agents included as it is widely accepted that these medicines are unsuitable for use in a MCA. Similarly some dose forms are generally not included for similar reasons e.g. effervescent, dispersible tablets.
The recommendations should be used alongside the guidance from the Royal Pharmaceutical Society document :Improving Patient Outcomes The better use of multi-compartment compliance aids (RPS MCA 2013) which is fully endorsed by the UKMi executive.
What UKMI MCA stability information does not do – it does not endorse the routine use of MCAs. For some patients, there may not be an alternative way to achieve safe medicine administration and the use of MCAs is likely to continue. However, in line with RPS guidance (RPS MCA 2013), the use of original packs and appropriate pharmaceutical support is the preferred option.
Your own professional judgement is required – UKMI offers general advice. We have not attempted to produce advice for the various types of MCA e.g. heat or cold sealed, patient self-filled, pharmacy packed etc. Users should use the recommendations to make a professional, clinical decision about the appropriateness of transferring their patient’s medicines to a specific MCA in the context of other issues such as
- relevant organisational policies and procedures,
- the patient’s characteristics,
- the complexity of the dose regime (e.g. irregular dosing or dose titrations),
- storage and transport considerations,
- measures to mitigate against factors that may affect stability e.g. heat and light.
Decisions to transfer a specific product to a MCA may vary depending on the above factors.
You should read the document attached below (“Covering Information for UKMI MCA stability information”) before using UKMI MCA stability information in practice, the document covers two areas –
- Developing a dataset for MCA stability information – this is a brief explanation of the sources used to compile the stability information for each drug and the process UKMI followed. There are also links to guidance issued by the relevant national professional organisations
- UKMI MCA stability information descriptors – this explains the standardised recommendations and risk mitigation suggestions
We welcome feedback. All feedback should be emailed to: South West Medicines Information