Dr David Wright revisits the consensus guideline for patients with swallowing difficulties and explains why the correct formulation is as important as the medicine
Dysphagia is a physical impairment of the swallowing process, and in 2005–2006 it was the primary diagnosis for 24,754 patients admitted to UK hospitals, accounting for 63,204 bed days.1 Oesophageal cancer should always be excluded before looking for other causes of dysphagia. Stroke and Parkinson's disease are also major causes. One study showed 64–90% of acute stroke patients experience dysphagia,2 with 8% going on to develop persistent swallowing difficulties.3 Furthermore, 30% of patients with Parkinson's disease4 and 100% of patients with motor neurone disease5 report symptoms of dysphagia. In an ageing UK population, incidence of dysphagia, which is mainly associated with age-related conditions, can be expected to increase.
About the consensus guideline
In addition to treating the cause of the dysphagia and managing the patient's fluid and nutrient requirements, the prescriber is usually also faced with having to prescribe pharmacotherapy. Evidence suggested that patients with dysphagia were frequently prescribed tablets and capsules and that carers often resorted to crushing or opening (formulation tampering) prior to administration.6 Recognising that the oral route is usually the most convenient for the patient, and might, therefore, result in better compliance, the Consensus guideline on the medication management of adults with swallowing difficulties, published in 2006, was developed by an expert team to standardise the approach to managing medicine administration in patients with dysphagia, as well as for those patients who have a psychological aversion to swallowing tablets.7
Guidelines are usually concise to ensure ease of use and consequently recommendations are frequently made with little explanation. The aim of this article is to review the guideline 2-years on, consider in depth some of the recommendations made, and focus on new information that is available.
Prescriber awareness of dysphagia
The main message of the consensus guideline is to ensure that prescribers are always aware of dysphagia when prescribing. Although the primary responsibility for identifying problems with taking tablets and capsules lies with the prescriber, the role of the community pharmacist when undertaking medicine use reviews, and that of carers when administering medicines, is also highlighted.
Communication at the secondary care–primary care interface was not considered within the guideline but has recently been identified as one area for improvement when managing patients with dysphagia.8 Discharge notes often fail to mention the symptom of dysphagia and consequently GPs may authorise prescriptions to continue treatment started in hospital without considering the appropriateness of the formulation. For instance, a patient with tuberculosis and dysphagia was discharged from hospital into a care home and prescribed long-term antibiotics only to be re-admitted within a couple of weeks due to lack of therapeutic response. On investigation it was found that the hospital had been preparing the medicines in liquid form for the patient and this information had been omitted from the discharge notes. The GP had prescribed capsules for the patient that had been opened and administered in food and hot drinks to mask the flavour. It was believed that tampering with the medicine and mixing it with hot food and drinks had rendered it ineffective, as subsequent prescribing of liquid formulations of the same medicines achieved the desired response (pers. comm.).
This example illustrates the importance of noting the condition of dysphagia on all written forms of communication between primary and secondary care. The GP should notify the hospital when a patient experiencing difficulties swallowing medicines is admitted, and if his or her prescription is required in a particular format. When receiving patients back into primary care with conditions associated with swallowing difficulties, such as stroke and Parkinson's disease, the GP should confirm the presence or absence of dysphagia before authorising the new prescription.
Identifying the most suitable formulation
By making prescribers more aware of dysphagia, the aim is to ensure that the most appropriate formulation is prescribed for each patient. The algorithm devised by the guideline development group to aid prescribers in making this decision is shown in Figure 1 (see below). It can be seen that wherever the oral route was deemed appropriate and patients were unwilling or unable to take tablets and capsules and the problem was likely to be long term, a liquid or dispersible medicine was always preferential to recommending formulation tampering. This may seem surprising considering the extra cost associated with the acquisition of liquid medicines, however the panel decided that the benefits of liquid medicines outweighed the risks of formulation tampering.
Liquid medicines consist of more than just the drug and its solvent, as manufacturers spend a considerable amount of time ensuring the reliability of dosing and maximising patient acceptability in order to improve compliance. There are several general characteristics of liquid medicines:
- potencies are designed to result in a 5 ml dosage (maximal for both measurement and swallowing)
- ingredients and flavours are included to mask the taste of the drug
- suspending agents ensure even distribution of the drug within each dose
- solvents are chosen to maximise drug stability—a number of liquid formulations available contain no water at all and this is due to the instability of the drug. The existence of a liquid formulation of a drug provides no guarantee of the stability of a crushed tablet in water
- liquid medicine manufacturers also consider the texture of their medicine, acknowledging that thicker more ‘gloopy’ formulations are often better for swallowing as there is a reduced likelihood of aspiration.
|Figure 1: Algorithm for the medication management of adults with swallowing difficulties|
Tampering with drugs
The consensus guideline clearly states that formulations designed to modify or alter release of a drug should not be tampered with because this may effect the efficacy of the drug. Similarly, concerns for the person administering opened capsules or crushed tablets advise that cytotoxic and hormonal products should not be crushed.
One important aspect frequently overlooked by prescribers when recommending that tablets be crushed or capsules opened is the taste of the resultant mixture when added to water or food. Compressing a tablet or placing powder or granules in a gelatine capsule minimises the amount of drug that makes contact with the surface of the tongue and therefore renders it more palatable. In circumstances where the taste of the formulation is still unpleasant, manufacturers often resort to film or sugar coating. Quinine sulphate and ibuprofen are both good examples of unpalatable drugs that are available with a sugar coating. One patient recently remarked that ‘one of the worst parts of being on a high dependency unit was receiving my tablets crushed up. I often wished the doctors had had to take it themselves as they may have thought a bit more carefully about it.’
In addition to the benefits to the patient of using a liquid formulation, issues surrounding litigation also need to be considered. Prescribing a licensed liquid medicine is associated with significantly lower risk to the prescriber than recommending formulation tampering, which may result in an unlicensed medicine being administered to the patient.7
As stated within the consensus guideline, the recommendation to tamper with a formulation should always be fully documented together with the rationale behind the decision, thereby minimising the likelihood of a successful litigation claim.
Recent interviews undertaken at the University of East Anglia with patients who had dysphagia identified that these patients were still receiving medicines in inappropriate formulations, were unwilling to question the prescriber, and so were forced to make their own decision as to how best to administer their medicines (pers.comm.). This research confirms the need for advice, such as that provided by the consensus guideline, and the difficulties associated with implementation. Prescribing inappropriate formulations can result in unsafe tampering or even worse, complete non-compliance. The most important message from this guideline therefore confirms the need for all prescribers to ask patients whether they have any difficulties swallowing their medicines and, when this is identified, to prescribe the most appropriate formulations.
- HESonline: Hospital Episode Statistics. Primary Diagnosis: 3 Character 2005–06. www.hesonline.nhs.uk/Ease/servlet/ContentServer?siteID=1937&categoryID=203 December 2006 (accessed 4th August, 2008).
- Mann G, Hankey G, Cameron D. Swallowing function after stroke: prognosis and prognostic factors at 6 months. Stroke 1999; 30 (4): 744–748.
- Smithard D, O’Neill P, England R et al. The natural history of dysphagia following a stroke. Dysphagia 1997; 12 (4): 188–193.
- Kurihara K, Kita K, Hirayama K, Hara T. Dysphagia in Parkinson disease. Rinsho Shinkeigaku 1993; 33 (2): 150–154.
- Kuhlemeier K. Epidemiology and dysphagia. Dysphagia 1994; 9 (4): 209–217.
- Wright D. Medication administration in nursing homes. Nursing Standard 2002; 16 (42): 33–38.
- Wright D, Chapman N, Foundling-Miah M et al. Consensus guideline on the medication management of adults with swallowing difficulties. Berkhamsted: MGP Ltd, October 2006.
- Kelly J, D’Cruz G, Wright D. A qualitative study of the problems surrounding medicine administration to patients with dysphagia. Dysphagia 2008 (published online: 8 August 2008). G