Oral dosage form modifications for older adults: a mixed methods investigation

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McGillicuddy, Aoife
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University College Cork
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Introduction: Oral dosage forms (ODFs), particularly solid ODFs, are the most popular and most commonly prescribed of all medication formulations. Older adults are the highest consumers of prescription medication. However, age-related pharmacokinetic, pharmacodynamic and physiological changes can complicate the administration of oral medicines to older adults and may result in these ODFs being modified (e.g. tablets crushed or split, or capsules opened) in order to facilitate administration of the appropriate dose or to overcome swallowing difficulties. These modifications may impact on the safety and/or efficacy of the medication, which could have clinical consequences for patients. In addition, many of these modifications represent an off-licence use of the medication, which has subsequent legal implications for healthcare professionals. Despite guidelines advocating that the modification of ODFs should be avoided, it appears to be common practice. Therefore, there is a need to gain a greater understanding of ODF modifications for older adults. Aim: The overall aim of this research was to investigate ODF modifications for older adults in an Irish setting and to gain an understanding of the factors influencing this practice. Methods: A mixed methods approach, using both quantitative and qualitative research methods, was used. Initially, a quantitative systematic review was conducted to identify the available evidence on the prevalence of difficulty swallowing ODFs and the modification of ODFs to overcome swallowing difficulties amongst the older cohort. Secondly, a qualitative systematic review was undertaken to determine the knowledge, attitudes and beliefs of patients, healthcare professionals and carers about ODF modifications. The findings of these reviews served to guide the generation of research questions for the empirical, primary research studies. A retrospective audit of drug charts in one aged care facility (ACF) in Ireland was completed to provide preliminary data on ODF modifications in an Irish setting. Following this, a qualitative, semi-structured interview study was conducted with nurses working in acute and long-term care settings, to elucidate their knowledge, attitudes and beliefs about ODF modification and administration for older adults. Based on the findings of these studies, a direct observation of medication administration to older adults in five ACFs was conducted to provide more in-depth information on ODF modifications. Finally, the views and experiences of community-dwelling older adults and their carers around ODF modifications were explored using qualitative, semi-structured interviews. Results: The quantitative systematic review highlighted the paucity of studies investigating ODF modifications, with only three studies describing modifications in care settings, which when combined with the limitations of the data collection methods used, demonstrated the requirement for further research investigating this issue. The qualitative systematic review provided useful insights into the factors that influence the knowledge, attitudes and beliefs of healthcare professionals and patients about ODF modifications; highlighting that (i) the variability of individual patient’s requirements, (ii) poor communication practices and (iii) lack of knowledge about modifications, when combined with (iv) the complex healthcare environment, complicate decision-making regarding ODF modification. Results from the retrospective audit emphasised that modifications were commonly required to ensure patients’ needs could be met, particularly for fractional dosing. Whilst there was a lack of evidence-based information to support decision making around modifications, in many cases no suitable alternatives were available. This was echoed in the nurse interview study, with modifications seen to be a routine and necessary occurrence in older patient care. The nurses’ role as patient advocate however, helps to optimise formulation suitability within current limitations. The direct observation study once again demonstrated the ubiquity of ODF modifications, providing detailed insights into ODF modification practices in an Irish setting but also highlighting the challenges encountered when administering oral medicines to older adults. Finally, the challenges encountered in the community-setting were elucidated, and there is a clear need for greater engagement with the issue of ODF suitability for community-dwelling older adults. Conclusions: This thesis has made a significant contribution to understanding ODF modifications for older adults. It is clear that ODFs are not meeting the needs of the older cohort. Modifications are common and necessary, due to age-related changes combined with limitations of currently available formulations. This thesis has provided important information about current practices, but has also highlighted the complex factors that give rise to the need to modify ODFs for older adults. There is a need to prioritise engaging with this issue in order to optimise ODF suitability for older adults. This will necessitate input from a wide variety of key stakeholders, including healthcare professionals, industry and regulatory bodies, as well as patients and carers. The findings of this thesis provide direction and important insights that will guide this process.
Oral dosage form modifications , Older adults , Mixed Methods
McGillicuddy, A. 2018. Oral dosage form modifications for older adults: a mixed methods investigation. PhD Thesis, University College Cork.