DOI: http://dx.doi.org/10.18203/2319-2003.ijbcp20212077

A pharmacovigilance study in patients of chronic non-infective respiratory diseases attending outpatient department of pulmonary medicine in a tertiary care teaching hospital

Sanket S. Gaidhane, Akash A. Khobragade, Abhijeet Joshi, Monisha S. Chavan, Likith H. V., Akshay A. Chaware

Abstract


Background: Adverse drug reactions (ADR) are the known dangers of any medicinal therapy. They are not only responsible for increasing the mortality and morbidity but also for multiplying the health care expenditure. It is important to monitor the adverse effects of the drugs in the patients on treatment for chronic non-infective respiratory diseases attending OPD of pulmonary medicine in a tertiary care teaching hospital

Methods: The study was single-centric, non-randomized and observational hospital-based study which was carried out for a period of 1 and a half years in JJ Hospital. The patients who were included in the study suffered from either of the 4 diseases-Chronic obstructive pulmonary disease (COPD), asthma, bronchiectasis or interstitial lung diseases (ILD). Data were analyzed by using Microsoft excel sheet. Based on the outcome of modified Hartwig and Siegel severity assessment scale, ADRs were grouped into various severity categories.

Results: One hundred and thirty-two number of ADRs were seen in 69 out of 352 patients (19.6 %) of the study population. The occurrence of ADR was found slightly higher in males i.e., 53.62% as compared to females i.e., 46.38%. The patients who were on treatment for ILD showed highest percentage of ADRs i.e., 57.89% which is followed by bronchiectasis (17.39%), COPD (16.17%) and lastly asthma (10.26%). The ADRs belonging to GIT system were highest in number i.e., 80. The most frequently occurring ADR in the study was palpitation which occurred in 14 cases i.e., 20.29%. Out of 132 ADRs observed, 96 i.e., 72.73% belonged to the mild category and 36 ADRs i.e., 27.27% belonged to the moderate category. Not a single severe ADR was found in the study.

Conclusions: It was found that 19.6% of the patient population suffered from ADRs, which is a considerable number. It is essential that health care professionals should support ADR monitoring process for the safety of the medicinal product. Proper implementation of ADR monitoring will help to reduce the harmful effects by early detection of drug safety problems in patients, assessing the risk-benefit in an individual and the population, improving the selection, rational use of drugs through the provision of timely warning to healthcare professionals.


Keywords


ADR, COPD, Asthma, Bronchiectasis, ILD, Modified Hartwig and Siegel severity assessment scale

Full Text:

PDF

References


Burney P, Jarvis D, Perez-Padilla R. The global burden of chronic respiratory disease in adults. Int J Tuberculosis Lung Dis. 2015;19(1):10-20.

Khan A, Adil MS, Nematullah K, Ihtisham S, Aamer K .ASC assessment of adverse drug reaction in PD of a TCHJBCP. 2015;6(3):84-8.

Tyagi N, Gulati K, Vijayan VK, Ray A. A study to monitor adverse drug reactions in patients of chronic obstructive pulmonary disease: Focus on theophylline. Indian j chest dis allied sci. 2008;50(2):199.

Geneva: World Health organization. Requirements for adverse drug reaction reporting. 1975;1039-109.

Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: A meta-analysis of prospective studies. JAMA. 1998;279:1200-5.

Ohta K, Fukuchi Y, Grouse L, Mizutani R, Rabe KF, Rennard SI et al. A prospective clinical study of theophylline safety in 3810 elderly with asthma or COPD. Respir Med. 2004;98:1016-24.

Shamna M, Dilip C, Ajmal M, Linu PM, Shinu C, Jafer CP. A prospective study on Adverse Drug Reactions of antibiotics in a tertiary care hospital. Yahiya Mohammed b. Saudi Pharmaceutical J. 2013;12:30-3.

Petrova G, Stoimenova A, Dimitrova M, Kamusheva M, Petrova D, Georgiev O. Assessment of the expectancy, seriousness and severity of adverse drug reactions reported for chronic obstructive pulmonary disease therapy. SAGE open medicine. 2017;5:205031.

Oltmanns U, Kahn N, Palmowski K, Träger A, Wenz H, Heussel C et al. Pirfenidone in Idiopathic Pulmonary Fibrosis: Real-Life Experience from a German Tertiary Referral Center for Interstitial Lung Diseases. Respiration. 2014;88(3):199-207.

Jamali AN, Aqil M, Alam MS, Pillai KK, Kapur P. A pharmacovigilance study on patients of bronchial asthma in a teaching hospital. J Pharm Bioallied Sci. 2010;2(4):333-6.

Bhosale U, Jaiswal S, Yegnanarayan R, Godbole G. A pharmacovigilance study of antiasthmatic agents in patients of bronchial asthma at a tertiary care hospital. J Clin Exp Res. 2013;1(2):26.

Jiang C, Huang H, Liu J, Wang Y, Lu Z, Xu Z. Adverse Events of Pirfenidone for the Treatment of Pulmonary Fibrosis: A Meta-Analysis of Randomized Controlled Trials. PLoS ONE. 2012;7(10):e47024.

Hartwig SC, Siegel J, Schneider PJ. Preventability and severity assessment in reporting adverse drug reactions. Am J Heal Pharm. 1992;49(9):2229-32.