Usage of Medicines in Compliance Aids

The information that UKMI provides about the stability of drugs in medicines compliance aids (MCAs) is intended for use by healthcare professionals

For any enquiries about this information please email Tiffany Barrett or Trevor Beswick at SWMI@uhbristol.nhs.uk

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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 (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: SWMI@uhbristol.nhs.uk

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