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Vol 276 No 7394 p380
1 April 2006

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Compliance is a complex matter

By Nina Barnett and Derek Taylor

Nina Barnett is a pharmacist in aged care from London and Derek Taylor is chairman of the UKCPA care of the elderly group, from Liverpool

Good compliance with prescribed medication is essential if the therapeutic benefit of medicines is to be optimised. It is influenced by many factors, including the patient's physical state, eg, dexterity, sight and ability to swallow, and mental function, eg, cognition, motivation and understanding of complex medication regimens. If a potential concordance problem has been identified, a full assessment of the person’s ability to comply is required to determine the optimal solution. This can include simplifying medication regimens, providing tick charts, large-print labels, medicine reminder charts and easily removable caps. Multi-compartment compliance aids (MCAs) are another option; consideration of the stability of the medicines in these devices must be taken into account.

Implementing the process of assessment is difficult. A number of assessment tools to aid patient concordance have been developed both nationally and locally, but none is widely used. The single assessment process, which is part of the National Service Framework for Older People (2001), now includes four medication-related questions in the overview assessment, undertaken by health or social care professionals. This is intended to trigger a referral to appropriately trained pharmacy staff so that issues, including compliance, can be addressed. However, this system is still developing in many areas and referral to pharmacy staff seldom occurs at present.

People with disabilities may require help with medication compliance, under the Disability Discrimination Act 1995. This act places a legal obligation on all pharmacists to ensure that people with a long-term (lasting more than one year) physical or mental impairment, which has a substantial and long-term adverse effect on their ability to carry out day-to-day activities, have access to help and support with their medicines.

The new NHS “Community pharmacy contractual framework” also defines support for people with disabilities as an essential service. It states that pharmacies must use an agreed tool to assess those patients who have a disability and who request assistance with managing their medicines. Support may be offered at level 1 (ie, legible labelling, repackaging of solid dosage forms, reminder charts, medicine administration records) or level 2 (medicines supplied in an MCA). However, the assigned assessment tool is lengthy and has not been validated, leading to some NHS trusts developing their own tools.

The NHS Primary Care Contracting organisation published “Support for people with disabilities” in response to the Disability Discrimination Act 1995. A template was produced to allow structured, formal assessment of an individual’s ability to comply with their prescribed medication. However, the length of this assessment has meant that it is not widely used. Currently, most patients receiving compliance aids have not had a structured and documented assessment.

As an intervention, one could argue that MCAs can be a valuable solution for some patients. They allow health and social care professionals to feel that compliance issues have been addressed, despite there being little evidence to support their use.

There are obvious benefits with the use of MCAs. They can act as a visual prompt for patients and carers to take or administer a medicine. However, the MCA only demonstrates to a carer that a medicine has been removed. It presents no proof that the medicine has been taken. If a patient is to use the device unaided, health and social care professionals need to be confident that the patient is able to access the device, considering issues such as physical and mental impairment, as discussed previously.

There is often great pressure for clinicians to supply MCAs as compliance aids. This is because in some areas formal carers are only permitted to administer medicines from an MCA, despite the fact that care agencies have a statutory requirement for training on medicines administration. There is no requirement to ensure the regular supply of refilled or new devices, despite the obvious risks of not doing so, and not all pharmacies provide this service.

Many MCAs are not washable and can therefore become contaminated with repeated use. In addition, not all forms of medicines are suitable for inclusion in an MCA, eg, liquids, non-oral and those for occasional use.

For those health professionals providing direct care to the patient, a list of medicines contained in the compliance aid with instructions is essential, because the repackaged medicines cannot be identified. There is also a practical issue for pharmacists supporting MCA use, in terms of the risks associated with errors in secondary dispensing.

The use of an MCA must not be seen as a panacea to all compliance problems. It can remove the important link between patients and their medicines and can become an unidentifiable jumble of tablets to the patient.

The suitability of particular medicines to be included in an MCA has always been of concern to pharmacists. Church and Smith added much information to this subject in their recent article (PJ, 21 January, pp75–81 PDF (60K)). However, there is often a significant professional dilemma over the decision to exclude those dosage forms that may not be stable in the MCA against the desire to include as many of the medicines as possible. After all, if the patient has been correctly assessed as needing an MCA, is he or she not less likely to comply with any medicines that have been supplied outside the device?

Those lists that provide stability data regarding the inclusion of particular medicines in an MCA highlight the need for more research in this subject. It is clear that many pharmaceutical companies have taken a legal stance by suggesting their medicines must be not be included in an MCA where no data are available. Although there are some dosage forms that have been demonstrated not to be physically suitable for inclusion, pharmacists may be concerned by more general issues of stability, such as hygroscopicity. Considering the limited shelf-life of filled MCAs (often four weeks or less), to what degree are hygroscopic tablets likely to degrade? Those pharmacists who can remember the days of 1,000-tablet dispensing packs may recall supplying dispersible aspirin tablets from pots without desiccants. It was encouraging that Church and Smith stated that joint research has been initiated with their regional quality assurance department into the stability of certain medicines in MCAs. The need for a more comprehensive national stability database is pressing and pharmaceutical companies should be encouraged to contribute to this database.

In summary, the assessment of a person’s compliance needs with regard to medicines is a complex process that should be undertaken using a structured assessment tool. There is a wide range of support that can be given to patients to help with their medicines regimens. Pharmacists are legally and professionally responsible for this support.

The use of an MCA, while only one possible solution to these issues, can prove a useful compliance aid in particular patients. Although we support the need for more stability research, we would encourage pharmacists to take a holistic approach to the compliance needs of patients.

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