The inability or refusal to take medication and in particular to swallow tablets and capsules is a significant concern and one that must be managed by all care homes.
The risks are poor compliance or overdose, both of which can lead to deterioration in health and even hospitalisation. However, seemingly simple solutions such as crushing or mixing tablets with water can lead a care home down the complex and legally onerous path of medicines manipulation – and result in a poor outcome for the resident. Sharon Griffiths, Managing Director of the Association of Pharmaceutical Specials Manufacturers (APSM), explains more.
In a recent incident, an 83-year-old woman had been discharged from hospital to a care home following a chest infection. The patient had difficulty swallowing food and after a few days the doctor noted that her condition was deteriorating and was concerned that she may need to be re-hospitalised. On discussion with the nursing sister and care assistants, it was discovered that the patient was unable to swallow tablets or capsules and although they had tried opening the capsule, the patient refused to take them as tablets.
The doctor noted that the anti-arrhythmia drug was a slow release formulation and should not be dispensed in single dose by opening a capsule. Further it was a critical drug so could not be withheld. An unlicensed special liquid preparation was ordered and prepared so that the medication would need to be given via a nasogastric tube. No licensed preparation was available in this situation.
This case study clearly highlights a typical care home situation and the risks of medicines manipulation. Firstly, unless it is clearly marked on the directions of use, only a qualified pharmacist or pharmacologist can advise on whether or not capsules or tablets can be crushed, mixed with liquids or taken with foods. There is good reason for this. Crushing tablets and opening capsules can often alter the pharmacological nature of the drug with potentially wide-reaching consequences. These range from unacceptable taste or reduced availability of the active ingredient – leading to risk of non-treatment – as the case in this instance – to the potential of inadvertent overdose and subsequent adverse events from consuming the large bolus dose of a slow-release capsule.
Secondly, any attempt to manipulate a medicine from the way it was prescribed – including the simple act of crushing a tablet and mixing it with water to make it easier to swallow – changes its status from a licensed pharmaceutical to an off-label use. This effectively transfers the legal responsibility for patient safety from the original prescriber to the administrator, in this instance the nurse at the care home. This responsibility includes making the patient aware of the risks and obtaining consent, or if they are unable to then the reason why it should be documented.
So what is the solution? In the first instance, assessment of the patient is essential to understand the reason for their refusal to swallow tablets and how their individual medication needs can be met. For example, aspiration of liquid into the lungs can be a significant risk with dysphagia so for these patients providing a liquid medication would not be advised. This will normally be carried out by an SLT who will advise the best consistency – it may not be a simple choice of solid or a liquid.
A doctor can then prescribe a formulation to meet the patient’s specific need. If a licensed medicine is not available, or is not suitable to be crushed or opened, the doctor will prescribe an unlicensed medicine or ‘Special’, which is formulated specifically to meet the needs of the patient. In doing so, the prescriber takes responsibility for the safety and efficacy and the pharmacist will work closely with a licensed Specials manufacturer to ensure the accuracy and quality of the formulation. The prescription is then reimbursed in the normal way through the NHS.
The supply and manufacture of unlicensed medicines in the UK is well-established and well-regulated and exists exactly for patients such as those in care homes whose complex needs require a solution to be tailored to them.
For the care home this means peace-of-mind, that their residents are compliant with their medication, the risks are minimised and that the legal responsibilities of the care home are not compromised.