DOI: http://dx.doi.org/10.18203/2319-2003.ijbcp20161564

Evaluation of prescribing pattern and adverse effects of fixed dose combination of non-steroidal anti-inflammatory drugs

Alpa Pragnesh Gor, B. K. Shah

Abstract


Background: The use of fixed does combination of drugs is a major controversial health related issue. The non-steroidal anti-inflammatory drugs (NSAIDs) is one of the most frequently use drugs in population. The present study was undertaken to observe the pattern of use fixed dose combinations of NSAIDs and its adverse effects.

Methods: The study was approved by the institutional ethics committee. Randomly selected patients irrespective of age and sex, who were on NSAIDs from the indoor and outdoor patients of paediatric, medicine and orthopaedic departments, were included in the study. Patients with history of administration of NSAIDs in last 30 days kidney, liver, acid-peptic disease, pregnancy and lactation were excluded from the study. WHO causality assessment scale was used for adverse reactions occurred due to fixed dose combinations (FDCs) of NSAIDs. The preventability, severity of the adverse drug reactions (ADRs) was evaluated.

Results: Total one thousand participants were included in the study, among them 112 had received analgesic FDCs.  Diclofenac+paracetamol and ibuprofen+paracetamol were the highest used in the study. Maximum combinations were found in the age group 41-60 years, the second highest (37 combinations) were in age group of 19-40 years.  Fourty-two ADRs were due to the use of FDCs of NSAIDS. It was found that nimesulide+paracetamol was culprit in causing ADRs in 60 percent and diclofenec+paracetamol was in 40 percent of the participants. GI related adverse reaction observed in 28 participants. It was found that eighty percent of the adverse reaction was possible in nature. Most of the ADRs were mild in nature.  It was evident that majority of ADRs were definitely preventable.

Conclusions: There is a wide use of analgesic FDCs which should be discouraged.


Keywords


FDCs, NSAIDs, ADR

Full Text:

PDF

References


Chandler S, Gautam, Saha L. Fixed dose drug combinations (FDCs): rational or irrational: a view point. British Journal of Clinical Pharmacology. 2008;65:795-6.

19th WHO Model List of Essential Medicines (April 2015). Available at http:// www.who.int/ medicines/ publications/ essential medicines/ eml2015_8-may-15.pdf. Accessed on 10 October2015.

Department of pharmaceuticals. Available at http:// pharmaceuticals.gov.in/ pdf/ nlem.pdf. Accessed on 10 October 2015.

Raut S, Dhone P, Pise N, Verma R, Gupta RK. Current pattern of use of irrational fixed dose combinations: a prescription audit study. Research Journal of Pharmaceutical, Biological and Chemical Sciences. 2012;3(4):617-22.

Mcgettigan P, Roderick P, Mahajan R, Kadam A, Pollock AM. Use of fixed dose combination (FDC) drugs in india: central regulatory approval and sales of FDCs containing non-steroidal anti- inflammatory drugs (NSAIDs), metformin, or psychotropic drugs. PLoS Med. 2015;12(5):e1001826.

The use of the WHO-UMC system for standardised case causality assessment. Available at http://who-umc.org/ graphics/ 24734. pdf. Accessed on 10 October 2015.

Schumock GT, Thornton JP. Focusing on the preventability of adverse drug reactions. Hosp Pharm. 1992;27:538.

8.http://edusanjalpharmacology.blogspot.in/2012/12/severity-assessment-of-adrs.html ( accessed on oct 10, 2015)

Tripathi SA, Shah R, Sharma DC. Analgesic activity of fixed dose combinations of paracetamol with diclofenac sodium and paracetamol with tramadol on different pain models in healthy volunteers a randomized double blind crossover study. J Anaesthesiol Clin Pharmacol. 2012;28:465-9.

Kastury N, Singh S, Ansari KU. An audit of prescription for rational use of fixed dose drug combinations. Indian J Pharmacol. 1999;31:367-9.

Chopra D, Rehan HS, Mehra P, Kakkar AK. A randomized, double-blind, placebo-controlled study comparing the efficacy and safety of paracetamol, serratiopeptidase, ibuprofen and betamethasone using the dental impaction pain model. Int J Oral Maxillofac Surg. 2009;38:350-5.

Gupta P, Sachdev HPS. Safety of oral use of nimesulide in children: systematic review of randomized controlled trials. Indian Pediatrics. 2003;40:518-31.

Shah SA, Nerukar RP. Evaluation of prescribing trends and rationality of use of oral proteolytic enzymes. Ind J Pharmacol. 2013;45:309-10.

Gor AP, Kharod NM .Nimesulide induced gastritis in a 10 year old child - a case report. Int J Curr Pharm Res. 2011;3(2):163-4.

Saha K. Use of nimesulide in Indian children must be stopped. British Med J. 2003;326(7391):713.

Legal Requirements for the sale and purchase of drug products containing pseudoephedrine, ephedrine, and phenylpropanolamine. Available at http:// www.fda.gov/ drugs/ drugsafety/ informationbydrugclass/ ucm150767.htm. Accessed on 10 October 2015.

FDA issues public health warning on phenylpropanolamine.www.fda.gov/drugs/drugsafety/informationbydrugclass/ucm150763.htm. Accessed on 10 October 2015.

Amitava S. Indian market’s fixation with fixed dose combinations (editorial). Rational Drug Bulletin. 2002;12:1.

Tripathi KD. Drugs and fixed dose combinations banned in India. in: Essentials Of Medical Pharmacology, 5th edition. New Delhi, India. Jaypee Brothers;2004:847-848.

Duggin GG. Combination analgesic-induced kidney disease: the Australian experience. Am J Kidney Dis. 1996;28(1):39-47.