Acceptability of oral solid medicines in older adults with and without dysphagia: A nested pilot validation questionnaire based observational study

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Abstract

Older patients (aged 65 years and over) are the major consumers of medicines and many barriers affect their ability in taking medicines orally, especially swallowing difficulties. Moreover, the characteristics of differing medicine formulations might have an impact on their acceptability in older patients. The aims of this study were to validate a Medicines Acceptability Questionnaire (MAQ) and to assess acceptability of oral solid medicines in older ambulatory patients with and without dysphagia. One hundred and fifty six older patients attending community pharmacies were recruited and attended face to face interviews. Two questionnaires were administered during the interviews, the validated Sydney Swallow Questionnaire (SSQ) assessing oral and pharyngeal swallowing function and the newly developed MAQ evaluating patient acceptability of oral solid medicines. Seventeen (11%) participants displayed symptoms compatible with swallowing difficulties identified by the SSQ. Participants with swallowing difficulties were considered themselves more likely to have problems in swallowing tablets and capsules of large sizes (11 mm and 13 mm tablets and size #00 capsules) compared to participants without dysphagia. Dispersible/effervescent tablets and orally disintegrating tablets were considered to be the most acceptable in this cohort, followed by mini-tablets. Chewable tablets and granules were the least favoured. Consistently higher acceptability scores were seen in the dysphagic population than in the non-dysphagic population for all of the dosage forms that were easier to swallow than tablets and capsules. The development of these formulations will assist in medication taking in older patients with dysphagia and potentially their adherence to drug treatments.

Graphical abstract

Percentage of participants selecting the tablet size and shape that started to cause difficulty in swallowing.

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Introduction

Patient acceptability to a pharmaceutical dosage form is critical to ensure adherence and therapeutic outcomes, especially in children and older people (Liu et al., 2014). Acceptability has previously been defined as “an overall ability of the patient and caregiver (defined as ‘user’) to use a medicinal product as intended (or authorised)” (Kozarewicz, 2014). The European Medicines Agency has required the assessment of patient acceptability to be an integrated part of paediatric medicinal product development (EMA, 2013; Kozarewicz, 2014). However, acceptability of medicines in older adults has been largely overlooked. Older patients (aged 65 years and over) account for 50% of the medicine prescriptions in the UK (Rajaei-Dehkordi and McPherson, 1997). The oral route remains the most preferred mode for medicine administration; however, there are barriers for older patients to take medications orally (Liu et al., 2014). Swallowing difficulties (dysphagia) are common in older people which affect their ability to take oral medicines, especially tablets and capsules (Steele et al., 1997, Strachan and Greener, 2005). Consequently, medicines are often modified such as crushing tablets or capsules opened to assist administration to older patients (Kelly and Wright, 2009, Wright, 2002). This leads to unlicensed used of medicines and can potentially cause ineffective use or toxicity of the medicine (Stegemann et al., 2012).

Characteristics of a pharmaceutical dosage form, such as the size, shape, and surface texture of a tablet, have an impact on how easily a solid oral medicine can be swallowed and pass through the pharynx and oesophagus (Channer and Virjee, 1985, Evans and Roberts, 1981, Hey et al., 1982, Overgaard et al., 2001). Previous knowledge on these effects has been demonstrated in healthy young subjects; however, this remains unclear in older people especially those with existing swallowing difficulties. The type of formulation might be another factor affecting the ability and willingness of older patients to take their medicines. A number of solid oral dosage forms that are “easier to swallow” than tablets and capsules have been made available in recent years including orally disintegrating tablets (ODTs), dispersible tablets, mini-tablets and multi-particulates (granules). As most of these formulations are designed and developed for paediatric use, acceptability of some of these dosage forms in children has been reported (Cohen et al., 2005, Motte et al., 2005, Nasrin et al., 2005). For older patients who cannot swallow tablets, the availability of these formulations could be beneficial. The use of dispersible/effervescent tablets and ODTs has been demonstrated in older patients (Bayer et al., 1988, Nelson et al., 2006). Especially, ODTs have been proven to be easier to swallow than conventional tablets for patients with dysphagia (Carnaby-Mann and Crary, 2005). However, evidence in the acceptability of these solid dosage forms in older patients is still sparse. This research is a pilot study where a Medicines Acceptability Questionnaire (MAQ) was initially developed and validated before assessing the acceptability of a range of solid oral medicine dosage forms in older ambulatory patients attending community pharmacies and investigating the association between patient acceptability and the presence of swallowing difficulties.

Section snippets

Study population and setting

The study was approved by the Ethics Committee of University of Hertfordshire (LMS/SF/UH/00081) and was conducted at community pharmacies in the South East England area in the UK during October to November 2014. A convenient sample of pharmacies were recruited to participate in the study. The pharmacist in charge in each pharmacy was informed the purpose of the study and approached consecutive patients attending the pharmacy during week-day (Monday–Friday) opening hours who were eligible for

Validation of the Medicines Acceptability Questionnaire (MAQ)

The content/face validity of the MAQ was established by experts. Any items where questions were raised were modified and the revised versions were tested again until there were no further questions. The total Cronbach’s alpha score was calculated as 0.940 and scores after eliminating any items from the questionnaire were in the range of 0.928–0.945, indicating good reliability and internal consistency of the questions.

Participant demographics and the Sydney Swallow Questionnaire (SSQ) scores

Fifteen pharmacies were approached and of these 10 (including both

Discussion

A range of medicine formulations have been made available for patients who find it difficult to swallow tablets and capsules. However, the acceptability of these formulations in targeted patient groups is often unclear. This pilot study is the first attempt to evaluate the acceptability of a range of solid oral dosage forms in older patients with and without dysphagia, using the newly developed Medicines Acceptability Questionnaire (MAQ). The content validity and reliability of the MAQ was

Conclusions

A significant proportion of older patients attending community pharmacies have symptoms compatible with dysphagia. These patients are more likely to have difficulties in swallowing tablets and capsules compared to those with no dysphagia. Healthcare professionals should identify patients with high risk of having problems swallowing their medicines and assist in selecting most appropriate medicine dosage forms. The development and availability of alternative oral formulations other than

Acknowledgements

The authors would like to thank the kind supply of capsule shells from Capsugel (Morristown, New Jersey, USA).

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