DOI: http://dx.doi.org/10.18203/2319-2003.ijbcp20204093

Safety reporting study of nonsteroidal anti-inflammatory drugs in a tertiary care teaching hospital, SIMS, Uttar Pradesh

Saborni Dey, Harsh Kumar, Anand Kumar Shukla

Abstract


Background: The nonsteroidal anti-inflammatory drugs (NSAIDs) are among the most frequently used drugs to treat pain and inflammation. Although NSAIDs are having enormous clinical use, but are not devoid of adverse drug reactions (ADRs) as peptic ulcer, gastritis, renal, neurological reactions etc. So, this pilot study is intended to assess the incidence and pattern of ADRs of the NSAIDs in a tertiary care teaching hospital.

Methods: Total 600 Orthopaedic out-patients of SIMS, Hapur were enrolled in the study to observe the risk of ADRs due to NSAIDs. All the ADRs were further analysed in relation to age, sex, types of drug and its pattern etc. The causality was analysed by using Naranjo’s Algorithm and severity was analysed by using the Hartwing and Siegel scale.

Results: Out of the 600 patients with NSAID therapy, 35 patients (5.83%) experienced total 10 types of ADRs. The adverse drug reactions observed by the patients were gastric symptoms, headache, urticaria, oedema etc. The most frequently observed ADR was gastritis. With all the prescribed drugs Tab Diclofenac sodium accounted for 57.14% and Paracetamol for 11.42% of all the ADRs. According to Naranjo’s Algorithm 62.87% ADRs were possible’ and 37.14% were of probable type and ADRs were mostly mild in severity.

Conclusion: In this study, incidence of adverse reactions to nonsteroidal anti-inflammatory drugs was 5.83 and the most common implicated drug for the ADRs were Diclofenac sodium. Most of the adverse effects were mild and tolerable.


Keywords


Adverse drug reactions, Nonsteroidal anti-inflammatory drugs, Pharmacovigilance

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References


The Uppsala Monitoring Centre. Definitions: glossary of terms in pharmacovigilance, http :// www, who-umc. org/ graphics/ 27400. Pdf. Accessed 12 February 2020.

Pincus T, Swearingen C, Cunmine P, Callahaw LP. Preference for nonsteroidal anti-inflammatory drugs versus acetaminophen and concomitant use of both types of drugs in patients with osteoarthritis. J Rheumatd. 2000;27:1020-27.

Mcquaid KR. Drugs used in the treatment of gastrointestinal diseases. In: Katzung BG, editor. Basic and Clinical Pharmacology. 10th ed. McGraw Hill; 2007:1009-19.

Naranjo CA, Busto U, Sellers EM, Sandor P, Ruisl, Roberts EA. A method for estimating the probability of adverse reactions. Clin Pharmacol Ther. 1981;30:239-45.

Hartwig SC, Siegel J, Schneider PJ. Preventability and severity assessment in reporting adverse drug reactions. Am J Hosp Pharm. 1992;49:2229-32.

Shahani S, Nerlekar S. Adverse drug reactions in dermatology and a growing need for pharmacovigilance. J Pharmacovig Drug Saf. 2009;6:35-7.

Gor AP, Saksena M. Adverse drug reactions of non-steroidal anti-inflammatory drugs in orthopaedic patients. J Pharmaco Pharmacother. 2011;2(1):26-9.

Venkatachalam S, Bhat R. ADR monitoring of NSAIDs among the in-patients of the orthopedic ward in a tertiary care centre: A prospective observations study. J Clin. Diag Research. 2012;6(1):42-6.

Mannesse CK, Derkx FH, Ridder MA, Man in 't Veld AJ, Van der Cammen TJ. Contribution of adverse drug reactions to hospital admission of older patients. Age ageing. 2000;29(1):35-9.

Hajjar ER, Hanlon JT, Artz MB, Lindblad CI, Pieper CF, Sloane RJ et al. Adverse drug reaction risk factors in older outpatients. AMJ Geriatr. Pharmacother. 2003;1(2):82-9.

Egger T, Dormann H, Ahne G, Runge U, Neubert A, Criegee- Rieck M. Identification of adverse drug reactions in geriatric in-patients by using a computerized drug database. J drugs aging. 2003;20:769-76.

Balinska-Miskiewicz W, Boznanski A, Liebhart J, Malolepszy J, Grabowski M, et al. Description of adverse drug reactions in multispeciality hospital and monitoring pharmacovigilance. Adv Clin Exp Med. 2006;15:81-3.

Mujahid M, Sharma M, Aqil M, Iqbal D, Kapur P. Drug utilization and adverse drug reaction monitoring in NSAID users in South Delhi. Int J of Res in Pharmacy and Chemistry. 2012;2(1):103-8.

Dhikav V, Singh S, Anand KS. Newer nonsteroidal anti-inflammatory drugs: A review of their therapeutic potential and adverse drug reactions. J IND Acad Commun Med. 2002;3:332-8.

Boelsterli UA. Diclofenac induced liver injury: A paradigm of idiosyncratic drug toxicity. Toxicol Appl Pharmacol. 2003;192:307-22.

Sulleyman H, Cardirci E, Albayrak A, Hallici Z. Nimesulide is a selective COX-2 inhibitory, atypical non-steroidal anti-inflammatory drug. Curr Med Chem. 2008;15:278-83.

Sriram S, Ghasemi A, Ramasamy R, Devi M, Balasubramanian R. Prevalance of ADRs at private tertiary care hospital in South India. J Res Med Sci. 2011;16(1):16-25.