Short summary

The study focus on multimorbidity and polypharmacy in geriatric patients, where medicine needs to be adjusted according to renal function to prevent e.g. side effects or lack of treatment effect. Clinical pharmacists are trained in reviewing a patient's medication critically, but the potential benefits of their interventions on renal risk medication in Danish hospital setting are unknown.

Rationale

Geriatric patients are characterized by age-associated declines in physiologic reserve and function across multiorgan systems, leading to increased vulnerability for adverse health outcomes. Furthermore, multimorbidity and polypharmacy are frequent in geriatric patients.

Approximately 20% of the most frequently used medications in Danish hospitals needs to be adjusted according to renal function. If not adjusted, there is an increased risk of side effects that could harm frail patients in particular or a potential lack of effect of some treatments.

Another characteristic of geriatric, multimorbid and polypharmacy patients are the lack of evidence based recommendations for pharmacologic treatments. As clinical trials often exclude elderly or patients with comorbidities, there are no evidence for how to treat this emerging group of patients pharmacologicallyii. Instead, clinicians must take into account multiple factors such as treatment goals, risks, life expectancy, economy, patient ability as well as patient needs and wishes.

As an example, the NHS Scotland published the Polypharmacy Guidance Realistic Prescribing, which aims to provide guidance on preventing inappropriate polypharmacy at every stage of the patient journey in a patient centered manner.

Clinical pharmacists are trained in reviewing a patient's medication list as a whole and to identify inappropriate drug combinations and drug formulations and focusing on economy, patients preferences and pill burden that will affect patient compliance. However, taking these considerations into account may also result in deviation from clinical drug recommendations in e.g. SPCs or evidence based guidelines to reach a medication list realistic for the geriatric patient.

The aim of this study is to investigate recommendations made by clinical pharmacists while conducting medication reviews at the University Hospital Sønderjylland to frail patients with impaired renal function. The recommendations are based on a developed tool containing a list of medicine that requires a dose adjustment according to renal function, and the applicability of the developed tool in practice will be explored in details.

Description of the cohort

Clinical pharmacists (CP) from the Hospital Pharmacy at the University Hospital Sønderjylland will be invited to participate in the study. Before initiating the clinical part of the project, CPs will in April 2023 be invited to attend a 4-hour tailored brush up session on medication treatment of patients with impaired kidney function. Furthermore, they will be introduced to the project and on how to use the tool actively during their medication reviews. During established clinical work on wards with frail, elderly (>65 years) patients with impaired renal function the CP will collect data when performing medication reviews on patients with prescription on one or more drugs from the renal risk drug tool. Impaired renal function is in the current study defined as follows: - CKD is defined as kidney damage or glomerular filtration rate (GFR) <60 mL/min/1.73 m2 for 90 days or more, irrespective of cause. - AKI is diagnosed by an absolute increase in sCr, at least 0.3 mg/dL (26.5 μmol/L) within 48 hours or by a 50% increase in sCr from baseline within 7 days or measured (If data within 7 days is not available, 90 days will be used instead). Patients with AKI will be excluded from the study. If the patient can collaborate, and the attending physician wishes so, an interview will be performed when the CP conducts the medication review. The interview with the patient will also include information on the consequences of impaired renal function on medication treatment. A minimum of 25 patients are expected to be included in the project. Recommendations of medication treatment will if possible be discussed with the physician, but only recommendations related to impaired renal function will be documented as a part of the project. Furthermore, the applicability of the tool will be evaluated by the CP's after 1) each medication review, and 2) after the project is terminated (see section "Evaluation from CPs").

Data and biological material

Data will be collected from the electronic patient record system and entered into the Research Electronic Data Capture system (REDCap) and include:

- Datacollector ID and Ward type

- CPR-number (anonymized after finalized data collection)

- Patient's age, gender

- Admission date

- Kidney function (most recent result and range for the past 3-5 lab results)

- Number of prescriptions (total)

- Number of renal risk drug (from tool)

- Number of recommendations (total)

- Number of recommendations in renal risk drugs (from tool)

For each renal risk drug (tool), the following data are registered:

- the active pharmaceutical ingredients (API) and formulation

- strength and dose

- indication

- recommendation according to tool

CP intervention recommend to the attending physician

- Date of recommendation provided to physician

- Text description of pharmacists' consideration before making the recommendations

- Discrepancy between pharmacists recommendations and recommendation of renal lists

- Adjustment of medication treatment according to current renal function (cessation, pausing, dose adjustment or substitution)

After the CP recommendation, the CP will follow up 24 hours and later during the admission on the outcome of the intervention during the hospital stay.

- Renal function (documentation of whether the renal function was impaired during any time of the admission - and whether normal renal function was established before discharge)

- Physician action (if any)

- Physician feedback (if any)

- Actual or estimated clinical outcome including readmissions and mortality (if any)

- Creatinine lab results after ≥24 h (if any)

- Adjustment of medication treatment according to current renal function before discharge (cessation, pausing, dose adjustment or substitution)

Evaluation from CPs

Participation in the study and the usefulness of the developed tool will be assessed among participating CPs. The evaluation contain two parts:

CP evaluation after each medication review Reflective questions will be answered by the CP after each medication review. The question will be related to the applicability of the tool in practice, the CP's (qualitative) reflections concerning the provided recommendations and optimizing comments in that regard. CP evaluation after the project has been finalized.

A survey containing 25 questions will be sent to the participating CP. The organization of the quality project, collaboration with the medical doctor, and potential suggestion to optimize the tool and its recommendations will be evaluated.

Collaborating researchers and departments

Geriatric department, Sygehus Sønderjylland

Publications associated with the project

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