Abstract
Polypharmacy and comorbidities makes the patients with Chronic Obstructive Pulmonary Disease (COPD) highly susceptible to adverse drug reactions (ADRs). ADRs are associated with considerable morbidity, mortality, high direct and indirect medical costs. This study was undertaken to map out the ADR profile of COPD patients in the inpatient setting. The pattern, frequency, risk factors and causality of ADRs were assessed. The study was a cross sectional survey conducted among inpatients with COPD in a tertiary care hospital in Kerala. ADRs were monitored based on daily questioning for symptoms. Descriptive statistics was used for data analysis. 71% of the patients developed ADRs. Theophylline was the most frequently prescribed drug. Highest proportion of ADRs were due to Systemic Corticosteroids. Overall, the commonest ADR was dyspepsia, however Causality assessment showed that hyperglycemia due to systemic steroids was the most frequent ADR for which a causality could be suggested. Physicians should be especially vigilant about hyperglycemia associated with systemic use of steroids. Presence of comorbidities were not associated with increased prevalence of ADRs; but there was a higher prevalence among males which was statistically significant.
Keywords-ADR, ADR monitoring, COPD, Pharmacovigilance, Polypharmacy.
References
1. Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2017. Available from: http://goldcopd.org. Accessed on 14/3/2017.
2. The burden of COPD by WHO. Available at http://www.who.int/respiratory/copd/burden/en. Accessed on 14/3/2017.
3. Global burden of disease. Institute for Health Metrics and Evaluation. Available at http://www.healthdata.org/results/country-profiles.India.
4. Jose J, Rao PG. Pattern of adverse drug reactions notified by spontaneous reporting in an Indian tertiary care teaching hospital. Pharmacol Res. 2006 Sep; 54(3):226-33. DOI:10.1016/j.phrs.2006.05.003.
5. PharmacovigilanceProgramme of India- Indian Pharmacopoeia Commission. PVPI toolkit. Available from http://ipc.nic.in/writereaddata/linkimagess/PDF%20PV%20Toolkit-1898248681.pdf. Accessed on 16/3/2017.
6. World Health Organization- Uppsala Monitoring Centre causality assessment. Available from http://www.who.int/medicines/areas/quality_safety/safety_efficacy/WHO causality _ assessment.pdf. Accessed on 16/3/2017.
7. WHO definition of ADR. Available from http://www.who.int/medicines/areas/quality_safety/safety_efficacy/.../definitions.pdf. Accessed on16/3/2017.
8. K.D Tripati. Drugs for Cough and Bronchial Asthma. In: KD Tripati, Ed: Essentials of Medical Pharmacology. Sixth edition. Jaypee brothers limited 2008: 195-209.
9. Peter J. Barnes. Pulmonary pharmacology. In: Laurence L Brunton, Ed: Goodman and Gillman’s The Pharmacological basis of Therapeutics. Twelfth edition. McGraw-Hill 2011: 717-735.
10. N. Tyagi, K. Gulati, V.K. Vijayan and A. Ray. A Study to Monitor Adverse Drug Reactions in Patients of Chronic Obstructive Pulmonary Disease: Focus on Theophylline. Indian J of Chest Diseases & Allied Sciences 2008; 50:199-203.
11. Conn HO, Poynard T. Corticosteroids and peptic ulcer: Metaanalysis of adverse events during steroid therapy. J Intern Med 1994 Dec; 236(6):619-32.
12. Lieberman P, Patterson R, Kunske R. Complications of long-term steroid therapy for asthma. J Allergy ClinImmunol1972 Jun; 49(6):329-36.
13. Ramankutty V, Joseph A, Soman CR. High prevalence of type 2 diabetes in an urban settlement in Kerala, India. Ethn Health 1999 Nov; 4(4):231-9. DOI: 10.1080/13557859998010.
Corresponding Author
Sangeetha Purushothaman
*Assistant Professor, Department of Pharmacology
Travancore Medical College, Thattamala P.O,
Kollam, Kerala - 691020, India
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.
DOI: https://dx.doi.org/10.18535/jmscr/v5i4.28
