A new guideline on medication management for patients with swallowing difficulties highlights the implications of medication alteration, as Dr David John Wright explains

  • The optimisation of pharmaceutical care in patients with swallowing difficulties is a responsibility of all members of the healthcare team
  • All patients should be questioned to determine whether they have difficulty in taking tablets or capsules
  • Where dysphagia is identified and the oral route is still suitable, a liquid medicine with an appropriate consistency should be prescribed
  • Where dysphagia is identified and either the oral route is unsuitable or is suitable but no suitable liquid formulations are available, alternative formulations should be explored
  • Where tablet crushing or capsule opening is the only option, advice should be sought from a pharmacist and/or the Medicines Information Centre regarding the clinical consequences of such actions
  • All actions regarding the selection of medicines, formulations, and selected administration technique should be fully documented

 

  • This working party guideline was developed during a one-day meeting
  • The development of this guidance was supported by an educational grant from Rosemont Pharmaceuticals Ltd
  • The content of the working party guideline and this article is independent of and not influenced by the commercial sponsorship
 

In 2005, results from a survey of patients presenting with swallowing difficulties in a community pharmacy showed that almost 60% of patients resorted to crushing tablets or opening capsules to enable them to take their medication.1

In 2002, similar research in care homes for the elderly identified that alteration of solid oral dosage forms by carers was common practice, and this was usually for prescribed medication.2 All medicines that carers reported crushing were available in alternative formulations. Furthermore, a number of the medicines that were reported as being crushed were in formulations that should not be altered (e.g. modified-release, enteric coated, etc).

Patients and carers are not the most suitable people to make judgements independently on how to administer medication and, consequently, it is important that the prescribers and other healthcare professionals do not unwittingly place them in this situation.

In Autumn 2006, a working party comprising a general practitioner, community pharmacist, speech and language therapist, barrister, coroner, senior lecturer in pharmacy, and lecturer in healthcare law was set up to develop national guidance to enable healthcare professionals to provide high quality pharmaceutical care to patients with swallowing difficulties. The aim was to provide a simple user-friendly document containing practical and common sense guidance. The recommendations made by the working party group are summarised in this article.

This guidance was published in October 2006,3 and full and summary versions can be downloaded from www.eguidelines.co.uk/dysphagia/

Identification of patients with swallowing difficulties

The working party group generally felt that healthcare professionals tend to assume that most patients can swallow tablets or capsules without actually asking them. Furthermore, patients who cannot take tablets or capsules for psychological reasons, may be unwilling to voice this to their doctor, and can resort to formulation manipulation.

All patients should, therefore, be asked by their GP whether they have difficulty swallowing medication before a prescription for a solid oral dose formulation is written. The situations where signs and symptoms may indicate swallowing difficulties are listed in Box 1.

Specialist assessment (e.g. gastroenterology, speech and language therapy) may be required for patients with any clinical condition that may require them to take liquid nutritional supplements or receive medicines via enteral feed tubes. The guideline contains a management algorithm to aid healthcare professionals who deal with medication management (Figure 1).

Doctors are in a good position to identify whether a patient has swallowing difficulties; however, some onus should be placed on carers to inform prescribers of the problem. Also, the recent introduction of 'medicines use reviews' (MURs) in community pharmacies provides another opportunity for such symptoms to be identified and recorded.5

Box 1: Signs and symptoms indicative of swallowing difficulties4

  • Difficult or painful chewing or swallowing
  • Dry mouth (xerostomia)
  • Difficulty controlling food or liquid in the mouth
  • Coughing/choking before, during, or after swallowing
  • Hoarse/wet voice quality
  • Feeling of obstruction (e.g. globus sensation)
  • Unexplained weight loss
  • Regurgitation of undigested food
  • Recurrent chest infections (resulting from aspiration)
 

Figure 1: Algorithm for the medication management of adults with swallowing difficulties

Figure 1

Management of patients with swallowing difficulties

When dysphagia is identified, the prescriber needs to ascertain the cause and appropriate treatment strategies. In parallel with this process, the continuing administration of the patient's long-term medication will require careful consideration.

The presence of short-term dysphagia, and subsequent increased risk of choking or aspiration in some instances, may also change the risk:benefit ratio of some medicines and result in their temporary discontinuation. However, the general practitioner may not be able to identify whether dysphagia will be long term or short term and, therefore, may start the algorithm in Figure 1 at 'Is the oral route appropriate?'.

Once an ongoing need for the medicine is accepted, a suitable liquid formulation should be identified, providing the patency of the oral route has been established.

By definition, unlicensed products cannot be marketed, and so the availability of some liquid preparations might not be immediately obvious to many healthcare professionals. In this case, a pharmacist should be consulted as they will either be aware of any unlicensed products or will be able to contact the manufacturer of such medicines on the enquiring healthcare professional's behalf.

Similarly, the pharmacist would be able to comment on the comparable bioavailability of the liquid product compared with the tablets as, in a few circumstances, a dosage alteration may be required.

Unfortunately, unlicensed medicines do not always appear in practice computer systems and this may result in a need to produce hand-written prescriptions. Apart from this physical barrier, there is also the psychological barrier associated with the prescribing of unlicensed medicines.

When the healthcare professional is prescribing an unlicensed liquid medication in exchange for a licensed tablet or capsule, the prescriber is not changing their diagnosis or choice of therapy. The change is in the formulation and, therefore, the main concern is the quality of the product that the patient receives and this is largely determined by the supplier.

Where suitable liquid formulations are not available, alternative routes of administration, should be considered such as:

  • transdermal
  • parenteral/injectable
  • buccal
  • rectal
  • intranasal
  • sublingual.

In the rare circumstances that a licensed liquid medicine, unlicensed formulation, or alternative formulation is not available, the working party agreed that as a last resort, and only after consultation with a pharmacist or the Medicines Information Centre, it may be appropriate to recommend that tablets are crushed or capsules opened.

This, however, has both legal (see Box 2) and clinical consequences. Again, a pharmacist would be the most appropriate healthcare professional to discuss the potential effects of formulation manipulation with.

If this is not possible, and no medicine with a similar indication can be identified as having a suitable alternative route of administration, then discontinuation may be enforced.

Box 2: Legal implications of altering a solid-dose formulation

  • To protect patients, the law imposes a duty on healthcare professionals to give the:6
  Right medicine to the
Right patient at the
Right time in the
Right dose and in the
Right formulation.

Breaching this duty is negligence and causing harm would give the patient a right to compensation.7 Administration of a medicine by altering a solid-dose formulation, such as by crushing a tablet or opening a capsule, is an unlicensed use. If harm occurs then liability would arise.8 To protect the patient, before crushing a tablet, a healthcare professional must consider whether:

  • alternative products such as liquid preparations are available
  • the patient knows of any risks and consents to the tablet being crushed9
  • the decision to alter the formulation is evidence-based and safe.10
   
Box 2 — written by Richard Griffith, Lecturer in Healthcare Law, University of Wales, and member of the guideline development group

Communication is key

The legal experts within the working party commented repeatedly on the need for careful documentation of all considerations and actions. This is particularly important if an unlicensed action is to be authorised, and also when patients are being discharged from secondary into primary care. Inadequate or unnecessarily brief discharge letters can result in the formulation not being stated, and patients with swallowing difficulties being unwittingly prescribed solid-dose formulations.

Summary

The working party believed that the ability to swallow tablets and capsules should never be assumed by any member of the primary healthcare team. Where patients are identified as not able or willing to swallow solid oral dosage forms, in most instances the prescription of liquid formulation with appropriate consistency will be the most logical solution. The local pharmacist or the Medicines Information Centre should be contacted to help with identifying suitable alternative formulations where they are not immediately apparent, or when formulation tampering is the only available course of action.

This consensus guideline protects healthcare professionals by showing that they have discharged their duty of care.

Following the guideline will assist you in making a logical, evidenced-based decision about when to alter a solid dose formulation or recommend the use of alternative preparations, such as liquid medicines, for patients with swallowing difficulties.

Acknowledgements

Nigel Chapman — HM Coroner for Nottinghamshire

Mathias Foundling-Miah — Consultant Pharmacist and Barrister at Law, Nottingham

Ralph Greenwall — Senior Pharmacist, Bradford PCT

Anne Guyon — Lecturer in Speech and Language Therapy, UEA

Honor Merriman — GP and CPD tutor, Oxford

The working party members have received honoraria from Rosemont Pharmaceuticals Ltd in recognition of their time spent developing the guideline.

 

  1. Strachan I, Greener M. Medication-related swallowing difficulties may be more common than we realise. Pharmacy in Practice 2005; 15 (10): 411–414
  2. Wright D. Medication administration in nursing homes. Nursing Standard 2002; 16 (42): 33–38.
  3. Consensus guideline on the medication management of adults with swallowing difficulties. Berkhamsted: MGP Ltd, October 2006.
  4. National Institute for Health and Care Excellence. Clinical guideline 32: Nutrition support in adults. London: NICE, 2006.
  5. NatPaCT. Community Pharmacy: Frequently Asked Questions. Leeds: NHS Modernisation Agency, 2005.
  6. Griffith R. Managing medicines for residents with swallowing problems. Nursing and Residential Care 2006; 8 (5): 229–232.
  7. Prendergast v Sam and Dee (1989) 1 Med LR 36.
  8. The Product Liability Directive (85/374/EEC).
  9. Chester v Afshar (2002) EWCA 724.
  10. Bolitho v City & Hackney HA (1997) 3 WLR. 1151.G