Assessment of drug prescription patterns and drug-drug interactions in chronic liver disease patients: a prospective observational study

INTRODUCTION

Chronic liver disease (CLD) is a progressive condition with significant global morbidity and mortality, affecting approximately 800 million individuals worldwide. Due to the presence of comorbidities and the need for multiple medications, CLD patients are frequently exposed to polypharmacy, increasing the risk of potential drug-drug interactions (pDDIs). These interactions can worsen liver function, compromise treatment outcomes, and heighten the risk of adverse drug reactions. Understanding prescription trends and identifying clinically significant pDDIs is crucial for optimizing pharmacotherapy and ensuring patient safety in this high-risk population.

Objective of the Study

To analyze the prescription patterns of the drugs in patients with chronic liver disease and to assess potential drug-drug interactions in patients with chronic liver disease.

Methodology

A prospective observational study that will be conducted over eight months at the Department of General Medicine, Justice K.S. Hegde Charitable Hospital, Mangaluru. A total of approximately 160 CLD patients aged 18 years and above, prescribed two or more medications, will be included using purposive sampling. The study focuses on patients aged 18 and older who have been diagnosed with chronic liver disease (CLD) and are prescribed two or more medications. Demographic information will be collected, including age, gender, alcohol use history, medical history, clinical history, laboratory findings, and details about the medications using a structured data collection form. The medications will be assessed for potential drug-drug interactions (DDIs) using a standard interaction checker (e.g., UpToDate) and classified according to their severity as mild, moderate, or severe. The severity of liver disease will be evaluated using the Child-Pugh scoring system, which categorizes patients into Classes A, B, or C.

Inclusion Criteria:

• Patients aged 18 years and above

• Patient diagnosed with CLD, with or without comorbidities

• Patients prescribed with two drugs

Exclusion Criteria:

• Pregnant and lactating women

• Patient with incomplete medical records

• Patients with psychiatric, terminal, or cognitive illness

Statistical Analysis

Qualitative analysis data will be expressed as frequency and percentage. Quantitative variable will be expressed as mean ±SD or median (IQR). Chi square/fisher exact test will be used to find the association between categorical variables. SPSS software version 29.0 will be used for statistical analysis. P value <0.05 will be considered statistically significant.

Outcome Measures

The study will reveal the most frequently prescribed medications for patient CLD, highlighting any trends or preferences among healthcare providers. The study will provide a detailed analysis of potential drug- drug interactions that may occur in patients with Chronic liver Disease, emphasizing the risks and implications for patient safety.