Prescribing pattern and adverse drug reactions monitoring in patients with rheumatoid arthritis in a tertiary care hospital

Lakshmi Prabha M., Geetha Rani A., Meenakshi Balasubramanian, Ezhil Ramya J.


Background: Rheumatoid arthritis is a chronic inflammatory arthritis which requires lifelong treatment to prevent the damage to joints and to maintain day to day functioning of patients. All the drugs used in the treatment of rheumatoid arthritis show significant toxicity and hence it is very important that their use require regular monitoring for adverse reactions. The present study is designed to estimate the prescribing pattern and the occurrence of adverse drug reactions in patients with rheumatoid arthritis.

Methods: This prospective observational study was conducted from July 2014 to September 2014 in rheumatology outpatient department.75 patients who fulfilled the study criteria were observed for 3 months. Their prescriptions were collected and analysed. The CSDCO reporting forms were used for the collection of adverse drug reactions. Causality assessment was done by using WHO-UMC scoring system and severity assessment by modified Hartwig and Siegel scale.

Results: The study group consists of 85.6 % female. Majority of them were in age group 40-49 years. Average number of drugs per prescription was 4.97.Out of 75 patients, 57.33% were on single DMARD, and 33.33% required 2 DMARDs and 9.33% were prescribed 3 DMARDs. A total of 64 adverse drug reactions were reported out of which 29.6% was due to glucocorticoids, 25% was due to the use of NSAIDS and steroids. Chloroquine maculopathy occurred in 2 patients and elevated liver enzymes occurred in 6 patients due to methotrexate which necessitated DMARD withdrawal. Eight percent of the ADRs were severe.

Conclusions: Treatment of rheumatoid arthritis is based on DMARDs and glucocorticoids where it is difficult to prevent the occurrence of ADRs. Consistent monitoring of therapy is needed for early recognition of ADRs and prompt action.


Rheumatoid arthritis, Prescribing pattern, Adverse reactions

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Shah A, William CE. Rheumatoid arthritis. In: Longo, Fauci, Kasper, Hauser, Jameson and Localzo's Harrison's principles of internal medicine, Mc Graw Hill, New york, 18th edition; 2012:2:2738-2752.

Schuna A. A rheumatoid arthritis. In: Joseph DT, Michael PL, Robert TL, Gary YC, Gary MR, Barbara WG. Pharmacotherapy a pathophysiologic approach, Mc Graw Hill, New York, 7th edition; 2008:1505-1519.

Hellmann DB, Imboden JB. Rheumatological and immunological disorders. In: Papadakis MA, McPhee JS, Rabow MW. Current medical diagnosis and management, Mc Graw Hill, NewYork, 54th edition; 2015:816-821.

Amy Waserman. Diagnosis and management of rheumatoid arthritis american family physician. 2011;84(11):1245-52.

Smolen JS, Landewé R, Breedveld FC, Dougados M, Emery P, Gaujoux-Viala C, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs. Ann Rheum Dis. 2010;69(6):964-75.

Singh JA , Saag KG, Bridges L, Akl EA, Bannuru RR, Sullivan MC, et al. 2015 American college of rheumatology guideline for the treatment of rheumatoid arthritis care and research; 2015.

Furst DE, Ulrich RW, Prakash S. Non-steroidal antiinflammatory drugs, disease modifying antirheumatic drugs, non-opioid analgesics and drugs used in gout. In: Katzung BG, Masters SB, Anthony Trevor J's Basic and clinical pharmacology Mc Graw Hill, New York,12th edition; 635-659.

Chen SW. Rheumatic disorders. In: Koda-Kimble MA, Young LY, Alldredge BK, Corelli RL, Guglielmo JB, Kradjan WA, et al. Applied therapeutics: the clinical use of drugs. Lippincolt williams and wilkins, USA 9th Edition; 2009:43:1168-1208.

Brunton LL. ACTH adrenal steroids and pharmacology of adrenal cortex in Goodman and Gillman's Pharmacological basis of therapeutics Mc Graw Hill , USA, 12th edition; 2011:1127-1134.

Black RJ, Joseph RM, Brown B, Movahedi M, Lunt M, Dixon WG. Half of UK patients with rheumatoid arthritis are prescribed oral glucocorticoid therapy in primary care: a retrospective drug utilisation study. Arthritis research and therapy. 2015:17:375.

Chakravarty K, McDonald H, Pullar T, Taggart A, Chalmers R, Oliver S, et al. BSR/BHPR guideline for disease-modifying anti-rheumatic drug (DMARD) therapy in consultation with the British Association of Dermatologists Oxford university press; 2008.

The use of the WHO-UMC system for standardised case causality assessment. Available at http:// Accessed in February 2016.

Hartwig SC, Siegel J, Schneider PJ. Preventability and severity assessment in reporting adverse drug reactions. American Journal of Hospital Pharmacy. 1992;49:2229-31.

Gawde SR, Shetty YC, Merchant S, Kulkarni UJ, Nadkar MY. Drug utilization pattern and cost analysis study in rheumatoid arthritis patients-a cross sectional study in a tertiary care hospital Mumbai in British Journal of Pharmaceutical Research. 2013;3(1):37-45.

Shini VK, Aboobacker S, Pahuja S, Revikumar KG, Bhasi R. Pharmacoeconomic study of DMARDs in the management of rheumatoid arthritis. International Journal of Pharmaceutical Sciences Review and Research. 2010;5(3):148-542.