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Journal ArticleDOI

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

TL;DR: Assessment of acceptability of oral solid medicines in older ambulatory patients with and without dysphagia found that 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.
About: This article is published in International Journal of Pharmaceutics.The article was published on 2016-10-30 and is currently open access. It has received 71 citations till now. The article focuses on the topics: Dysphagia & Population.

Summary (2 min read)

1. Introduction

  • 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 .
  • For older patients who cannot swallow tablets, the availability of these formulations could be beneficial.

2.2 Administration of the Sydney Swallow Questionnaire (SSQ)

  • The SSQ is a validated questinnarie and composed of 17 questions assessing oral and pharyngeal swallowing function with responses entered onto a 101 mm visual analog scale except for question 12 (R. C. Dwivedi et al., 2010; K. L. Wallace et al., 2000) .
  • The SSQ was administered to the participants during an interview which took place in the private consultation room in the pharmacy.
  • The participant placed a mark on the horizontal line of the visual analog scale.
  • The first millimeter of the line was disregarded and a score of 0-100 was calculated by measuring the distance from the center of the mark to the first millimeter of the line for each question.
  • The maximum possible total score for the SSQ was 1700, with higher score indicating greater severity of swallowing dysfunction.

2.3 Pilot of the Medicines Acceptability Questionnaire (MAQ)

  • The content/face validity of the MAQ was assessed by two experts in the field acting as respondents.
  • Cronbach's alpha test was conducted to evaluate the level of reliability and internal consistency using the Statistical Package of the Social Sciences (SPSS) version 22.0 (IBM Corp., Armonk, NY, USA).
  • Cronbach's alpha scores of 0.7 or above were deemed as acceptable according to Nunnally and Bernstein (J. Nunnally and L. Bernstein, 1994) .
  • The MAQ was administered to the participants during the interview together with the SSQ.
  • The interviews were conducted by two of the authors (AG and JB).

2.4 Data analysis

  • Data analysis was performed using the Statistical Package of the Social Sciences (SPSS) version 22.0 (IBM Corp., Armonk, NY, USA).
  • The results are reported as mean ± standard deviation (SD).
  • Spearman's nonparametric correlation was used to identify the presence of significant correlations between total SSQ score and age of participants or number of solid oral medicines taken daily.
  • The Mann-Whitney U test was conducted to assess links between gender of participants and total SSQ score, and comparing the means of participants' selfperceived health status between the dysphagia and non-dysphagia group.
  • Chi-Square test was conducted to evaluate the relationship between dysphagic status of the participant and difficulty in swallowing tablets and capsules.

3.1 Validation of the Medicines Acceptability Questionnaire (MAQ)

  • 3 Ability to swallow tablets and capsules in patients with and without dysphagia by the MAQ A total of 12 (7.8%) participants experienced ongoing difficulties in swallowing tablets and capsules according to the results from the MAQ.
  • Figure 1 shows percentage of participants who has chosen the size and shape of tablets that were perceived as starting to cause difficulty in swallowing.
  • The majority of participants with dysphagia found that tablets of sizes 11 mm and 13 mm might started to cause difficulties in swallowing; the percentages of participants selecting 11 mm or 13 mm were 52.9%, 52.9%, 58.8% and 64.7% for flat round, arched round, oblong and oval tablets respectively.
  • Similar results were observed regarding difficulties in swallowing capsules of different sizes in participants with and without dysphagia .
  • In participants with dysphagia, over a third (35%) selected size #00 as that which started to cause problems in swallowing; however, around 30% of these participants also considered size #2 to be difficult to swallow.

3.4 Acceptability of alternative solid oral dosage forms

  • A low proportion of participants had had experience of using the alternative solid oral dosage forms, except for dispersible/effervescent tablets which were referenced mainly to soluble paracetamol and dispersible aspirin tablets as examples (Table 3 ).
  • The acceptability scores of different oral solid dosage forms are shown in Figure 3 .
  • Participants described the good/bad points they considered for each formulation as listed in Table 4 .

4. Discussion

  • A range of medicine formulations have been made available for patients who find it difficult to swallow tablets and capsules.
  • The acceptability of these formulations in targeted patient groups is often unclear.
  • Studies have reported that increasing age is associated with increased severity and prevalence of dysphagia in elderly populations (G. Holland et al., 2011; K. Kawashima et al., 2004) .
  • Szcaesniak et al. studied SSQ score in a non-dysphagic population and found that there was no significant correlation between age and SSQ score (M. M. Szczesniak et al., 2014) .

5. 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 conventional tablets and capsules will likely to assist in medication administration and management in patient with dysphagia and might lead to better adherence.

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Citations
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Journal ArticleDOI
TL;DR: The development of drug-loaded nanofibers containing nifedipine and atorvastatin calcium can be a potential buccal delivery system for geriatric patients' convenience.
Abstract: Geriatric patients are more likely to suffer from multiple chronic diseases that require using several drugs, which are commonly ingested. However, to enhance geriatric patients’ convenience, the electrospun nanofiber system was previously proven to be a successful alternative for the existing oral dosage forms, i.e., tablets and capsules. These nanofibers prepared either as single- or multi-layered fibers could hold at least one active compound in each layer. They might also be fabricated as ultra-disintegrated fibrous films for oral cavity administration, i.e., buccal or sublingual, to improve the bioavailability and intake of the administered drugs. Therefore, in this work, a combination of nifedipine and atorvastatin calcium, which are frequently prescribed for hypertension and hyperlipidemia patients, respectively, was prepared in a coaxial electrospinning system for buccal administration. Scanning electron microscopy image showed the successful preparation of smooth, non-beaded, and non-porous surfaces of the drug-loaded nanofibers with an average fiber diameter of 968 ± 198 nm. In contrast, transmission electron microscopy distinguished the inner and outer layers of those nanofibers. The disintegration of the drug-loaded nanofibers was ≤12 s, allowing the rapid release of nifedipine and atorvastatin calcium to 61% and 47%, respectively, after 10 min, while a complete drug release was achieved after 120 min. In vitro, a drug permeation study using Franz diffusion showed that the permeation of both drugs from the core–shell nanofibers was enhanced significantly (p < 0.05) compared to the drugs in a solution form. In conclusion, the development of drug-loaded nanofibers containing nifedipine and atorvastatin calcium can be a potential buccal delivery system.

15 citations

Journal ArticleDOI
TL;DR: This novel drug delivery system offers a patient-centric solution to the long-standing challenge of administering sustained release medicines to patients with dysphagia and can potentially be used for paediatric patients.

13 citations

Journal ArticleDOI
TL;DR: A literature review was conducted in order to identify the availability of patient centric coating materials claiming to shorten esophageal transit times and improve the overall SODF swallowing experience for older patients.
Abstract: Oral drug administration provided as solid oral dosage forms (SODF) remains the major route of drug therapy in primary and secondary care. There is clear evidence for a growing number of clinically relevant swallowing issues (e.g., dysphagia) in the older patient population, especially when considering the multimorbid, frail, and polymedicated patients. Swallowing impairments have a negative impact on SODF administration, which leads to poor adherence and inappropriate alterations (e.g., crushing, splitting). Different strategies have been proposed over the years in order to enhance the swallowing experience with SODF, by using conventional administration techniques or applying swallowing aids and devices. Nevertheless, new formulation designs must be considered by implementing a patient centric approach in order to efficiently improve SODF administration by older patient populations. Together with appropriate SODF size reductions, innovative film coating materials that can be applied to SODF and provide swallowing safety and efficacy with little effort being required by the patients are still needed. With that in mind, a literature review was conducted in order to identify the availability of patient centric coating materials claiming to shorten esophageal transit times and improve the overall SODF swallowing experience for older patients. The majority of coating technologies were identified in patent applications, and they mainly included well-known water soluble polymers that are commonly applied into pharmaceutical coatings. Nevertheless, scientific evidence demonstrating the benefits of given SODF coating materials in the concerned patient populations are still very limited. Consequently, the availability for safe, effective, and clinically proven solutions to address the increasing prevalence of swallowing issues in the older patient population is still limited.

11 citations

Journal ArticleDOI
11 Oct 2018
TL;DR: Patient and gastroenterologist perception of patient preference for different oral drug formulations is triggered by the same attributes but with inverse importance, and to improve adherence, patients should be involved in the choice of the treatment formulation.
Abstract: Background Pharmaceutical treatment prescribed according to patient preference for a formulation may have a positive impact on adherence to treatment and consequently on treatment outcomes. Aim This study aimed at understanding patient preference for pharmaceutical formulations and attributes that trigger patient preference and physician perception of patient preference. Methods Between August and September 2017, gastroenterologists and patients with mild to moderate ulcerative colitis from France, Germany, Spain, and the UK participated in an online survey. The investigation was exploratory in nature, and descriptive results are presented. Results Patient (n = 380) preference appears to be driven by the appearance (format, shape, size, and color - 44%), number of units per administration (39%), and number of administrations per day (17%). Gastroenterologist (n = 159) preference is instead driven by the number of administrations per day (55%), number of units per day (26%), and tablet size (19%). Overall, 254 (67%) patients preferred a tablet formulation, 111 (29%) preferred granules, and 15 (4%) other formulations. According to gastroenterologist perception of patient preference, only 49% of patients prefer tablets, 38% prefer granules, and 13% have no preference. After switching from granules to tablets, 25% patients expressed negative feelings for granules. However, after switching from tablets to granules, 44% of patients still have positive perceptions of tablets. Among patients receiving tablets (n = 255), 18 (7%) perceived their treatment to be not at all effective versus 16 (13%) patients receiving granules (n = 125). A similar proportion of patients in the two groups perceived their treatment as extremely effective (48 vs. 46%, respectively). Conclusions Patients generally prefer tablets. Patient and gastroenterologist perception of patient preference for different oral drug formulations is triggered by the same attributes but with inverse importance. To improve adherence, patients should be involved in the choice of the treatment formulation.

11 citations

Journal ArticleDOI
TL;DR: The core formulation of minitablets was found to show similarity in dissolution profile with marketed formulation and hence was further carried forward for functional coating over it and modified Plackett Burman Design was applied for studying important factors.
Abstract: The present work aims at studying process parameters affecting coating of minitablets (3 mm in diameter) through Wurster coating process. Minitablets of Naproxen with high drug loading were manufac...

11 citations

References
More filters
Journal ArticleDOI
TL;DR: The study supports the use of five or more medications in the current definition of polypharmacy to estimate the medication-related adverse effects for frailty, disability, mortality, and falls.

852 citations


"Acceptability of oral solid medicin..." refers background in this paper

  • ...Almost half of participants took 5 or more solid oral medicines daily, which qualifies as polypharmacy by definition of some published studies (D. Gnjidic et al., 2012; U. JuniusWalker et al., 2007; D. Koper et al., 2013)....

    [...]

Journal ArticleDOI
TL;DR: After matching for age and sex, there were significant differences in the competence scores, history of stroke, and perceived ill health status observed between the group with dysphagia and the group without dysphagIA.
Abstract: The objective of this cross-sectional study was to determine the prevalence of dysphagia among elderly persons living at home in a community using a questionnaire for dysphagia screening. As the reliability of the questionnaire had not yet been confirmed in an epidemiological study, it was also verified. The relationship between dysphagia and the level of daily living competence was also clarified. The subjects consisted of 1313 elderly persons 65 years and older (575 males and 738 females) living at home in a community. The questionnaire included questions concerning the individual's past history of stroke, and questions for dysphagia screening, competence scoring, and perceived ill health. The reliability of the questionnaire was confirmed after calculating the Cronbach's alpha coefficient to be 0.83. The results of a factor analysis showed that the cumulative contribution rate was 61.8%. The prevalence rate of dysphagia was 13.8%. After matching for age and sex, there were significant differences in the competence scores, history of stroke, and perceived ill health status observed between the group with dysphagia and the group without dysphagia.

256 citations


"Acceptability of oral solid medicin..." refers background or result in this paper

  • ...Studies have reported that increasing age is associated with increased severity and prevalence of dysphagia in elderly populations (G. Holland et al., 2011; K. Kawashima et al., 2004)....

    [...]

  • ...This also broadly agrees with or is slightly lower than other published data on prevalence of dysphagia in older primary care patients (B. R. Bloem et al., 1990; P. H. Chen et al., 2009; K. Kawashima et al., 2004)....

    [...]

Journal ArticleDOI
TL;DR: The results clearly demonstrate that the prevalence of a wide range of eating-related problems far exceeds accepted estimates of dysphagia alone and support a multidisciplinary approach to mealtime interventions for the institutionalized elderly.
Abstract: A mealtime screening tool was administered to 349 residents of a home for the aged to determine the prevalence of mealtime difficulties including, but not limited to, dysphagia. Mealtime difficulties, as assessed during a single meal observation of each resident, were documented in 87% of these individuals. Though 68% exhibited signs of dysphagia, 46% had poor oral intake, 35% had positioning problems, and 40% exhibited challenging behaviors. An increased prevalence of mealtime difficulties was related to both the presence and degree of cognitive impairment. Oral intake was best among residents with severe cognitive impairment, many of whom received partial to total feeding assistance. In contrast, poor oral intake was associated with mild-moderate cognitive impairment, pointing to a need for more aggressive intervention with this group. The results clearly demonstrate that the prevalence of a wide range of eating-related problems far exceeds accepted estimates of dysphagia alone and support a multidisciplinary approach to mealtime interventions for the institutionalized elderly. Additionally, the magnitude of problems identified has implications for both resource and staff-training requirements in long-term care facilities.

253 citations


"Acceptability of oral solid medicin..." refers background in this paper

  • ...Swallowing difficulties (dysphagia) are 58 common in older people which affect their ability to take oral medicines, especially tablets 59 and capsules (C. M. Steele et al., 1997; I. Strachan and M. Greener, 2005)....

    [...]

Journal ArticleDOI
TL;DR: Applied to patients with neuromyogenic dysphagia, the 17-question inventory shows strong test-retest reliability over 2 weeks as well as face, content, and construct validity.

215 citations


"Acceptability of oral solid medicin..." refers methods in this paper

  • ...…Sydney Swallow Questionnaire (SSQ) 107 The SSQ is a validated questinnarie and composed of 17 questions assessing oral and 108 pharyngeal swallowing function with responses entered onto a 101 mm visual analog scale 109 except for question 12 (R. C. Dwivedi et al., 2010; K. L. Wallace et al., 2000)....

    [...]

Journal ArticleDOI
TL;DR: This older general practice population in Germany is among the top pharmaceutical user group of European study samples and GPs should be aware that low subjective health and medication disagreement are independent predictors of polypharmacy.
Abstract: Background Older people consume an increasing amount of medication. Polypharmacy is associated with an elevated risk of adverse health outcomes resulting in hospitalizations and sometimes death. Objectives To describe the prevalence of prescribed and over-the-counter (OTC) medications among older general practice patients living in the community. To determine predictors of polypharmacy (five or more prescribed drugs) from a variety of patient- and doctor-related factors. Methods Sixty-seven randomly selected practices in two areas of Germany and 466 of their older patients (70+ years) were recruited for a geriatric assessment study. A cross-sectional analysis of health problems, GPs' awareness and their interventions was conducted. In this post hoc analysis, we assessed the medication use as reported by older patients and compared it with doctors' perceived medication regimens for their respective patients. The detailed assessment of patients' health and well-being enabled us to explore a variety of predictors of polypharmacy using logistic regression analysis with forward selection. Results Study participants consumed an average of 3.7 prescribed medicines and an additional 1.4 OTC drugs. In all, 26.7% of patients used five and more chronically prescribed drugs. A set of five determinants predicted polypharmacy best: breathlessness, hypertension, dependency on instrumental activities of daily living, low subjective health and medication disagreement between doctors and patients. Conclusion This older general practice population in Germany is among the top pharmaceutical user group of European study samples. Apart from disease-specific determinants, GPs should be aware that low subjective health and medication disagreement are independent predictors of polypharmacy.

203 citations