Multi-compartment compliance aids: do you need to review what you do?
Did you know?
- For many medicines, removing doses from original packaging and placing them in a multi-compartment compliance aid (MCA) will be outside the terms of the marketing authorisation (ie, unlicensed use). Removal from packaging, therefore, transfers responsibility for stability from the manufacturer to the prescriber and pharmacist.
- Generic omeprazole is reported to be hygroscopic and unsuitable for MCAs but Losec capsules are stable for 14 days at room temperature and up to 75 per cent relative humidity.
- Carbamazepinetablets have been reported to lose a third of their efficacy if exposed to atmospheric moisture — tablets harden, resulting in poor dissolutionand absorption.
- MCAs that are sealed blisters may offer a better barrier to water vapour and gases than those based on a series of compartments with sliding lids. Blisters should be sealed as soon as possible after filling.
- Drug release from modified-release tablets can be affected by humidity.
- Puttingalendronate in an MCA may result in it being swallowed like any other tablet, instead of at least 30 minutes before breakfast or any other medicine.
- Putting capsules and tablets in the same compartment can result in hydrolysis of susceptible drugs due to the high water content of gelatin capsule shells (soft or hard).
- Mixing capsules with modified-release tablets poses a risk of changing the release characteristics of those tablets.
- Inclusionof hard and soft gelatin capsules together in a compartment should be avoided because water exchange can result in capsule brittleness, softening or distortion.
- If a Controlled Drug is put into an MCAwith other medicines, the whole unit must be stored in the CD cabinet before the prescription is collected.
- In general, medicines placed in unsealed MCAs are given a seven-day expiry date compared with eight weeks for medicines placed in sealed MCAs.
- Legislation requires patient information leaflets to be supplied with medicines in MCAs.
The take-home message from our professional body on the subject of multi-compartment compliance aids (MCAs) is that they should not be the automatic default option for patients who have adherence problems.
“Over the years, use of MCAs has become all too common. We find ourselves in a situation where people who don’t need them are having them imposed,” Wing Tang, the Royal Pharmaceutical Society’s senior professional support pharmacist, told The Journal.
But is there really a need for change? According to the RPS guidance, there is little evidence of the benefit of MCAs but it would be fair to say that there is also little evidence of the benefit of alternative compliance interventions.
The argument for change, however, seems cogent. Mr Tang explains that, first of all, using MCAs presents extra risk. Repackaging medicines into them introduces an extra step in dispensing where error can occur. It can lead to problems in identifying medicines and can cause confusion, particulary if different systems of administration are required because not all medicines fit into the MCA. Repackaging may also have a detrimental effect on the stability — and therefore efficacy — of medicines (see later).
Secondly, he says:“With medicines we have positive evidence to support their safety and efficacy before we use them. Generally it would always be better to have positive evidence for doing something rather than waiting for evidence of benefit or harm to emerge.” Added to this, is the cost perspective: should funds be spent on MCAs when there is little good evidence for them?
Another issue to throw into the mix is a concern that use of these systems deskills carers. Moreover, some believe it is detrimental to patient engagement in that medicines taking becomes a “robotic” task requiring little understanding of what each medicine is for and leading to loss of knowledge and patient autonomy.
To be absolutely clear, the RPS is not saying that MCAs have no place in patient care. Doubtless, they do help some patients. What it is saying is that MCAs are not the only option (see Panel 1 for others) and, most importantly, that patients should be properly assessed for suitability. In terms of good practice, that might involve pharmacists asking if a patient has been properly assessed when next they are presented with a new request for MCA dispensing. Or it might mean asking for current MCA patients to have their needs reviewed.
Panel 1: medication compliance strategies
Support for patients to take their medicines includes:
- Medication reviews to avoid unnecessary polypharmacy
- Simplifying medication regimens
- Effective patient counselling and education
- Reminder charts
- Medicines administration record charts
- Labels with large print or pictograms
- Information sheets
- Reminder alarms
- IT solutions, such as phone apps and telemedicine
- Wing-capped bottles
- Blister popping devices or pill presses
- Multi-compartment compliance aids
What patient assessment means
A sticking point is that there is no national multidisciplinary assessment tool that has been evaluated. Nevertheless, Mr Tang points out that there are several tools that may be used (see Resources). Relevant patient factors commonly considered by these tools include:
- Medical history
- Visual and hearing impairment
- Literacy and language problems, including health literacy
- Beliefs and choices
The RPS has produced criteria for such tools and important questions to ask include:
- Does the assessment involve the patient or carer in decision-making?
- Does the assessment involve a pharmacist with knowledge of pharmaceutics and medicines stability as well as clinical expertise?
- Has all the underpinning information been considered (eg, patient characteristics, whether adherence is intentional or not, alternative options, medicines stability, any agreed plan for medication, benefits versus risks of supplying in an MCA, quality of communication between the prescriber, pharmacy and patient)?
- Has equality and disability discrimination legislation been considered?
The types of patient for whom MCAs may be considered as an appropriate option are those with physical impairment but no carers (formal or informal) and those with cognitive impairment but who have carers.
MCAs would generally be unsuitable for patients who are physically and cognitively able, those who are cognitively impaired and have no carers, and those who are physically impaired but have carers, the RPS guidance says.
If, following a proper assessment, an MCA is considered of benefit, the next thing to be considered is whether or not repackaging medicines into an MCA will affect their efficacy. A medicines stability assessment for each medicine to be placed in the MCA should be performed and, ideally, documented.
For some products, published stability data may be available from the manufacturer but, more often than not, this is limited. However, the following are generally considered unsuitable for inclusion in MCAs:
- Effervescent or dispersible tablets
- Dosage forms intended for buccal or sublingual administration
- Cytotoxic drugs
- Products that require refrigeration
- Dosage forms that will not fit into a compartment
- Medicines to be taken “as directed” or prn
- Medicines, such as warfarin, where the dose is likely to vary
- Medicines that need to be taken in a specific way (eg, before of after food)
In the absence of data, there are also a number of general clues that may help pharmacists come to a reasonable opinion about a product, says Colin Cable, the RPS pharmaceutical science information adviser.
These are to do with knowing about how a particular tablet or capsule has been packaged by its manufacturer. According to the RPS guidance, useful questions to ask are:
- Is the tablet packaged in a foil strip? (For example, Arthrotec; this is a relatively expensive form of packaging and indicates sensitivity to moisture.)
- Are there desiccants present in the packaging? (eg, Ikorel and Madopar)
- Is the tablet packed in a glass container? (Again, relatively expensive and reserved for products that require additional protection.)
- Are the original blister packs darkly coloured rather than clear or white? (For example, Adalat; signals light sensitivity.)
- How are the tablets coated? (Generally, sugar-coated tablets provide a better moisture barrier than film-coated tablets, although some film coatings can provide good protection too.)
- Does the chemical structure of the drug render it more prone to degradation? (For example, hydrolysis of esters, such as aspirin, may occur.)
Mr Tang points out: “If a pharmacist is not able to do stability assessment, who else is?” However, the RPS guidance recognises that stability assessment may not always be possible. Advice is that, where published data do not exist and a stability assessment has not been conducted, the medicine should be considered at risk of being unstable within the MCA.
An additional source of information on physico-chemical stability is UK Medicines Information. The network has been working on a searchable, open-access database to be used alongside the RPS guidance, Trevor Beswick, director at South West Medicines Information and Training, told The Journal. The database is currently being piloted and is expected to be launched in early autumn.
It should be noted that even where a stability assessment concludes that it is undesirable to place a medicine in an MCA, pharmacists must use their professional judgement as part of an assessment of the benefits and risks for individual patients in deciding if the medicine should be supplied in the aid, Mr Tang adds.
Other good practice points
The provision of MCAs should be supported with other measures. Panel 2 suggests advice to offer patients and the key points Panel summarises the practical questions to ask.
Panel 2: Advice for MCA patients and their carers
- These compliance aids are unlikely to be child-resistant and should be kept out of reach of children.
- They should also be stored in a cool, dry place, out of direct sunlight.
- Don’t try to make any changes to the contents of the compliance aid. Let your pharmacy know if your prescriber changes your medicines or doses.
- If the medicines in an aid are spilt or have moved compartments, don’t put them back. Return them to the pharmacy so that arrangements can be made for resupply.
- Return any compliance aids containing medicines that have not been taken to the pharmacy for proper disposal.
- Supplying medicines in compliance aids is more complex than dispensing a normal prescription. Obtain prescriptions in good time so that any queries can be sorted out and the medicines dispensed with the care they need.
- A sample of currently used patient assessment tools and further resources is available on an RPS webpage dedicated to better use of MCAs.
- A CPD article on the Disability Discrimination Act is available on PJ Online. It gives examples of patient problems and reasonable adjustments to medicines supply that can be made.
- Further details of the UKMi database will appear in The Journal when it is launched.
Key points to consider
- Have the patient’s needs been properly assessed?
- Are the medicines suitable for inclusion in an MCA?
- Has the MCA been filled with minimal risk of microbial or cross contamination (eg, medicines not handled with bare hands and any reusable parts cleaned thoroughly)?
- Is the MCA adequately labelled? Could the patient (or carer) easily identify each tablet? Has all necessary information been included?
- If the patient has a carer, has he or she been adequately trained, including on giving medicines not suitable for MCAs? What if there are several agency carers?
- How frequently are MCAs to be supplied? Is there a balance between the labour of dispensing one week at a time and the potential waste if more than a week’s worth is dispensed but an item is changed and the entire contents need to be thrown away?
- What are the risks of making multiple MCA packs available?
- Is there a plan for follow-up and regular review?
- What records will be kept and how?
- How will your system be audited?
Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2013.11123667
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