Introduction
Polypharmacy, which is the concomitant prescribing of multiple medications for patients, poses challenges for healthcare systems worldwide. Polypharmacy is driven by an ageing population, broader preventive treatments, and increasing comorbidities (the presence of multiple medical conditions) [
1‐
3].
Traditionally, numerical thresholds have been used to define polypharmacy, with thresholds ranging from two or more to 11 or more being reported in the literature [
4]. However, it is essential to note that more medications is not necessarily harmful in every instance. For example, in Payne et al.'s study, the risk of unplanned hospital admission for patients with comorbidities taking four to six medications was similar to those taking one to three (odds ratio 1.00; 95% confidence interval 0.88–1.14) [
5].
Polypharmacy can be appropriate when prescribing is evidence-based for patients with comorbidities [
1]. For instance, after a transient ischaemic attack or ischaemic stroke, combination treatment with multiple medications is often beneficial [
6]. However, polypharmacy becomes problematic when potentially inappropriate medications (PIMs) are prescribed, where the medication harm outweighs the benefits, if the medication is no longer indicated, or if adverse medication interactions and events occur [
1,
7].
Problematic polypharmacy is a particular concern for older adults due to their increased likelihood of accumulating comorbidities [
1], as well as age-related physiological changes that heighten their vulnerability to medication-related harm [
8]. Additionally, problematic polypharmacy can increase medication burden, impacting social and functional activities [
9].
Explicit criteria have been used to identify and measure problematic polypharmacy. Explicit criteria contain a catalogue of PIMs drawn from literature and expert consensus. Examples of such lists of PIMs that are important to avoid or which should be used cautiously in older adults due to their potential for adverse outcomes include the international Beers Criteria [
10] and STOPP/START Criteria [
11], as well as country-specific criteria such as the New Zealand Criteria, which list PIM indicators that New Zealand healthcare experts recommend for formal review [
12].
Another area of interest involves leveraging information technology to manage problematic polypharmacy. In 2023, Liu et al. introduced PolyScan, a tool to help clinicians identify older adults with polypharmacy and PIMs for intervention. PolyScan demonstrated strong performance, achieving 100% sensitivity, specificity, and positive and negative predictive values to screen for patients who require further review [
13].
While explicit criteria and PolyScan have been useful for identifying and measuring problematic polypharmacy, these approaches cannot tailor medication therapy to individual patient characteristics and preferences. The researchers in this study emphasised the necessity for an effective intervention for older adults with problematic polypharmacy, considering each patient’s unique treatment priorities. To meet this need, a novel pharmacist-led intervention was developed for primary healthcare. Its aims to optimise medication use and reduce PIMs for older adults with problematic polypharmacy. This intervention combines the PolyScan tool with pharmacist-led educational outreach and medication review.
Aim
In this study, the aim was to assess the preliminary feasibility of implementing the intervention within a general practice clinic. Specific components of the intervention procedures and processes were tested, and insights from patients and clinicians were gathered. The goal was to ascertain if a full-scale clinical trial of the intervention is warranted.
Ethics approval
The study adhered to the Declaration of Helsinki principles and received approval from the New Zealand Health and Disability Ethics Committees (reference number: 20/STH/238 date: 12/01/2021) and the New Zealand public health agency, Te Whatu Ora Te Pae Hauora o Ruahine o Tararua (reference number: 2021.01.021 date: 20/04/2021).
Discussion
Managing patients with comorbidities can be challenging due to the complexities of patient health and medication regimens, as well as the time constraints placed on clinicians. This study seeks to support clinicians through a preliminary feasibility assessment of an intervention designed to optimise medication use and reduce PIMs for older adults with polypharmacy.
The intervention procedures and processes met the study's assessment measures, with patient recruitment, retention, and adherence to the intervention protocol meeting the progression criteria for a full-scale intervention evaluation. Additionally, patients found the intervention easy to understand, did not find the intervention challenging to complete, and were satisfied with the LMQ-3. Respondents of the Attitudes Towards Collaboration Instruments for General Practitioners questionnaire also reported positive attitudes toward collaboration with the pharmacist.
Although the study met the preliminary feasibility assessment measures, it also identified valuable insights, which suggest design modifications are needed before a full-scale trial.
Effective patient recruitment remains a crucial challenge, and eligibility criteria should be expanded to include patients unable to provide independent informed consent. Obtaining consent from a welfare guardian or enduring power of attorney ensures that patients unable to provide independent informed consent are not excluded from an intervention that could benefit their health. Furthermore, the inclusion criteria for this study was set for patients taking 11 or more medications. Given the variation in numerical definitions of polypharmacy [
4], to expand the pool of eligible patients, it could be appropriate to lower the medication count required for inclusion in a future trial.
To enhance patient-pharmacist understanding and relationship building, a preliminary meeting should be arranged between the patient and the pharmacist to discuss the intervention and the patient's health. Additionally, it should be acknowledged that this intervention was not intended to and cannot replace opportunities to develop New Zealand indigenous Māori-led initiatives, such as Hikaka et al.'s medication intervention for Kaumatua (Māori elders) [
27]. However, to ensure the quality of the intervention for Kaumatua, adopting Lacey et al.’s 'Hui Process' as a framework for the preliminary meeting and subsequent consultations could facilitate relationship building and ensure cultural safety [
28].
Pharmacists delivering the intervention should receive training in consultation skills to support a patient-centred approach during the medication review. A future pharmacist training package may incorporate Wolters et al.’s patient-centred communication model [
29] and Grimes and Barnett et al.'s consultation skills programme for improving communication, consultation, and health coaching skills [
30].
Although patients expressed satisfaction with the LMQ-3, the PROM questionnaire lacks some essential information required to function as an outcome measure in a future clinical trial. A PROM selected for future use should provide data on sensitivity to change, minimal clinically important differences, and baseline score estimates. There is a lack of relevant data in the literature for the LMQ-3.
The 8-week follow-up period should be reconsidered, as some pharmacist recommendations were not yet implemented by general practitioners who reviewed patients on a 3-monthly prescription cycle. A longer follow-up period would allow practitioners more time to consider the pharmacist's recommendations and identify beneficial or hazardous effects that may only become evident long after the intervention [
31,
32].
The time allocated for each medication review should be extended to 60 min. However, it is important to consider the implications of this increased time allocation for healthcare stakeholders and funders, as it may require additional resources and impact capacity. Nevertheless, it is worth noting that the medication review in this intervention was comprehensive and involved patients with complex medication regimens. Therefore, each review required more time than a standard consultation addressing a medical concern. Research has also established that investing time in a comprehensive medication review can lead to time and cost savings elsewhere by preventing adverse drug events, improving the quality of medication processes, and freeing up clinicians for other tasks [
33‐
35].
Internationally, a variety of interventions have been developed to address problematic polypharmacy among older adults. In a Cochrane Review, 38 studies of relevant interventions were identified [
36]. Among these, Basager et al. assessed a prescribing appropriateness criteria-set during medication reviews for older Australian adults taking five or more medications [
37]. Campins et al. evaluated a medication assessment programme for community-dwelling older adults taking eight or more medications in Spain [
38]. Muth et al. examined a complex intervention to improve medication appropriateness for older adults taking five or more medications in Germany [
39].
Despite international efforts, no single intervention has been definitively proven to be the most effective. Additionally, many studies lack detailed information on intervention development and implementation, which is crucial for enhancing their efficacy and replicability across different settings [
36]. This study contributes to the existing literature of interventions developed to address problematic polypharmacy in older adults. The study intervention is unique in its utilisation of PolyScan to identify older adults with polypharmacy and PIMs. The study also stands out from many existing studies with its systematic approach to intervention development and implementation.
A key strength of this study was the careful and deliberate method used to evaluate the intervention. The study employed clear measures to assess intervention procedures and processes, including quantitative and qualitative assessment measures and progression criteria. The study also had several constraints. Firstly, all patients received the intervention to test specific procedures and processes. As a result, aspects of the full-scale intervention, such as the recruitment of the control group, randomisation process, and allocation concealment, were beyond the scope of this study. Secondly, the study had a small sample size and a short follow-up period. However, the study was not designed to identify statistically significant long-term findings. Thirdly, the pharmacist and clinic were not blinded to the intervention, which could have influenced clinician behaviour and reported outcomes. Lastly, while established methods were used to analyse qualitative data, the interviewer's involvement in the intervention's development could have biased feedback. An independent interviewer might have reduced bias, but was not feasible due to budget and logistic constraints.
There is recognition that pharmacist-led interventions in primary care can have a positive impact on patient outcomes by reducing medication-related adverse effects, medication errors, and hospital admissions [
40‐
42]. Through close collaboration with other healthcare professionals, pharmacists can contribute to improving patient safety and the quality of care provided by clinics [
43]. Therefore, for general practice clinics seeking to enhance their services and improve patient outcomes, integrating pharmacists into their teams through this intervention is a promising initiative that warrants further evaluation.
For researchers, this study exemplifies the use of the Medical Research Council's best practice framework for developing and evaluating interventions [
14]. Despite the framework's availability since 2008, limited interventions for older adults with polypharmacy have referenced it in their development [
36]. Future research on similar interventions may benefit from adopting this framework to ensure that interventions are replicable, practical, and implementable across different settings.
Lastly, this study underscores the importance of feasibility testing intervention procedures and processes. Despite its necessity, research suggests that feasibility evaluations are often overlooked [
44]. Researchers may consider using the mixed-method approach employed in this study to design similar feasibility studies in future research.
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