Causality assessment of adverse drug reaction reported in patients treated with arthritis in a tertiary care hospital: A prospective study

Abstract

Background: Rheumatoid arthritis (RA) is an autoimmune chronic inflammatory condition, initially affecting smaller joints but slowly progressing to involve larger joints. Osteoarthritis (OA) is a degenerative disease affecting mainly large joints. Pain, stiffness, and loss of mobility are the cardinal features of OA. Treatment goals of RA are pain relief, slowing the progression of joint inflammation and prevention of joint disability or deformity, whereas those of OA are immediate relief of symptoms and improving joint function. Non-steroidal anti-inflammatory drugs (NSAIDS) and disease-modifying anti-rheumatic drugs (DMARDS) are used to treat above conditions. Long treatment is associated with development of ADR. The present study aimed to evaluate the prevalence of ADR patients treating for arthritis. Aims and Objectives: The objective of the study was as follows: (i) To assess the prevalence of use of drugs and drug classes in RA and OA; (ii) to assess the prevalence of adverse events (ADE) of prescribed drugs; and (iii) causality assessment of ADE. Materials and Methods: This study was an observational study of ADE of drug prescribed among 100 arthritis patients in a tertiary care teaching hospital, India. Patients diagnosed with RA or OA with or without comorbidities were enrolled in the study based on inclusion and exclusion criteria. Causality assessment severity was assessed from Hartwig and colleagues’ criteria and preventable ADE was defined by Schumock and Thornton’s criteria. Results: Out of 100 arthritis cases, the prevalence of OA was more than RA. OA was more commonly seen in males and RA in females. Arthritis was more prevalent in the age group of 36–65 years. NSAIDs were the first-choice drug in arthritis. Among NSAIDS, diclofenac was the commonly used drug for monotherapy in OA and methotrexate was commonly used in RA. Sixty-eight ADEs were detected in 51 patients. The prevalence of ADE was 35.7%. Thirty out of 68 ADEs (44.1%) were preventable. NSAIDS and DMARDS resulted in ADEs by 23 (29.6%) and 24 (34.8%) events, respectively. Common affected organs were cutaneous manifestations, gastrointestinal tract, and eyes which accounted for 20 (29.4%), 18 (26.5%), and 8 events (11.6%), respectively. Continuation of the suspected drug was noted in 42 ADEs (61.8%), classified as severity level 1 and 2a-b, and 43 ADEs (63.2%) were completely or partially resolved during the study period. Conclusion: ADEs are common in RA and OA patients with the prevalence of 35.7%. ADEs should be monitored properly and reported to prevent irrational use of drugs.