Evaluation of Clinical Pharmacy Services and Drug Use in Renal Impairment.

NCT07241494 | Completed

• 1 other identifier: 18/12
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical pharmacy services aim to optimise medication use, enhance patient outcomes, and reduce the risk of drug-related harm through patient-centred pharmaceutical care. In hospital settings, clinical pharmacists collaborate with physicians and other healthcare professionals as part of a multidisciplinary team to identify, prevent, and resolve drug-related problems (DRPs). Pharmacist interventions are defined as any action initiated by a pharmacist that directly contributes to patient management or results in a modification of medication therapy. The clinical and economic benefits of such interventions have been widely recognised in various healthcare environments. This quasi-experimental study aims to investigate the impact of clinical pharmacy services on drug use and the management of DRPs in patients with renal impairment admitted to the general internal medicine ward. The study also evaluates the contribution of the clinical pharmacist to optimising the use of drugs that require renal dose adjustment. The study was conducted in a university hospital and included three consecutive patient groups: observation (control), education, and intervention. In the observation group, no pharmacist intervention was performed. In the education group, physicians received a structured educational presentation on renal dose adjustment for commonly prescribed medications. In the intervention group, the clinical pharmacist actively participated in daily ward rounds, identified and resolved DRPs, and provided recommendations to physicians. DRPs were classified using the Pharmaceutical Care Network Europe (PCNE) classification version 9.1. This study evaluates whether the integration of a clinical pharmacist into the healthcare team can improve the quality of pharmacotherapy, reduce DRPs-particularly those associated with renal dysfunction-and enhance patient safety and outcomes in hospitalised patients.

Conditions

Renal Impairments; Chronic Kidney Disease; Acute Kidney Disease; Medication Errors

Keywords

Renal impairment; drug-related problems (DRPs); clinical pharmacist; pharmaceutical care; Clinical Pharmacy Services; Medication Errors; Chronic Kidney Disease; Kidney Diseases

Outcome Measures

Primary Outcomes (1)

• Change in the number of drug-related problems (DRPs) per patient

  The total number of drug-related problems (DRPs) identified per patient, classified according to the Pharmaceutical Care Network Europe (PCNE) Classification System Version 9.1. This outcome measures the effect of clinical pharmacist-led educational and interventional activities on the identification and management of DRPs, with a specific focus on those associated with renal dysfunction.

  12 months

Secondary Outcomes (2)

• Percentage of drug-related problems (DRPs) associated with renal dysfunction

  12 months

• Acceptance rate of pharmacist recommendations by physicians

  12 months

Study Arms (3)

Observation Group (Control)

NO INTERVENTION

Patients with renal impairment hospitalised in the general internal medicine ward were monitored without any clinical pharmacist intervention. Prescriptions and drug use data were collected prospectively, and drug-related problems (DRPs) were identified retrospectively according to the Pharmaceutical Care Network Europe (PCNE) classification version 9.1. The results from this phase served as the baseline for comparison with subsequent groups.

Education Group

ACTIVE COMPARATOR

During this phase, physicians responsible for patient care received structured educational sessions delivered by the clinical pharmacist. The training focused on renal dose adjustment principles, identification of nephrotoxic drugs, and prevention of medication-related harm in patients with renal dysfunction. Patients admitted during this period were followed without direct pharmacist intervention. DRPs were identified and classified using the PCNE system to assess the indirect impact of education on prescribing behaviour.

Behavioral: Education for renal adjusments

Intervention Group

ACTIVE COMPARATOR

In this phase, the clinical pharmacist participated actively in daily ward rounds, performed comprehensive medication reviews, and identified drug-related problems (DRPs) using the Pharmaceutical Care Network Europe (PCNE) classification version 9.1. Interventions included recommendations for renal dose adjustments, correction of dosing errors, identification and prevention of drug-drug interactions, and optimisation of drug selection. The pharmacist communicated findings and recommendations directly to the treating physicians, and acceptance of interventions was documented.

Drug: Clinical Pharmacist-Led Pharmaceutical Care Service and Renal Dose Adjustment; Behavioral: Education for renal adjusments

Interventions

Clinical Pharmacist-Led Pharmaceutical Care Service and Renal Dose Adjustment DRUG

Clinical pharmacist-led interventions were implemented to optimise medication therapy and ensure patient safety among hospitalised patients with renal impairment. The interventions included several integrated pharmaceutical care activities conducted during daily ward rounds. The clinical pharmacist assessed renal function and adjusted medication doses according to up-to-date dosing guidelines and renal pharmacotherapy principles. In cases where inappropriate doses or dosing intervals were identified, corrective recommendations were communicated to the treating physicians to prevent under- or overdosing. The pharmacist also evaluated each patient's medication profile for potential drug-drug interactions and provided strategies to avoid clinically significant interactions. Drug selection was reviewed for indication, therapeutic appropriateness, and safety, with substitution or discontinuation proposed when necessary. In addition to these direct patient care activities, the clinical pharm

Also known as: Renal Dose Adjustment, Drug-Drug Interaction Management, Correction of Dosing Errors, Optimisation of Drug Selection, Educational Feedback to Physicians

Intervention Group

Education for renal adjusments BEHAVIORAL

The educational intervention consisted of regular training sessions delivered by the clinical pharmacist to physicians on renal dose adjustment principles, identification of nephrotoxic drugs, and prevention of drug-related problems in patients with renal impairment. The sessions aimed to improve physicians' knowledge and prescribing practices for medications requiring renal dose modification.

Education Group; Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hospitalised in the General Internal Medicine ward with an estimated glomerular filtration rate (eGFR) below 60 mL/min/1.73 m².
• Hospital stay of at least 48 hours.
• Receiving at least one medication that requires dose adjustment in renal impairment.
• Age 18 years or older.

You may not qualify if:

• eGFR value of 60 mL/min/1.73 m² or higher.
• Not receiving any medication that requires renal dose adjustment.
• Hospital stay shorter than 48 hours.
• Age under 18 years.
• Refusal or inability to provide informed consent.
• Lack of sufficient cognitive ability to participate in the study.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead
• Bezmialem Vakif University: collaborator

Study Sites (1)

Bezmialem Vakif University

Istanbul, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Muhammed Yunus BEKTAY, PHD

  Bezmialem Vakif University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: This study uses a prospective, quasi-experimental design consisting of three consecutive patient groups: observation (control), education, and intervention. The groups were not randomised but were included sequentially over time in the same hospital setting. In the observation group, no clinical pharmacist intervention was provided. In the education group, physicians received structured training on renal dose adjustments for commonly prescribed medications. In the intervention group, the clinical pharmacist actively participated in daily ward rounds, identified and resolved drug-related problems (DRPs), and provided recommendations to physicians. Comparisons among the three groups were made to evaluate the effect of clinical pharmacy services and educational interventions on the identification and management of DRPs in patients with renal impairment.

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 21, 2025
• Study Start: October 31, 2021
• Primary Completion: October 31, 2023
• Study Completion: May 31, 2024
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)