Article: Causality assessment of adverse drug reaction in Pulmonology Department of a Tertiary Care Hospital

Background: Adverse drug reaction (ADR) is considered to be the sixth leading cause of death. The incidence rate estimates approximately 2% of hospital admissions are due to ADRs.

Objective: To monitor ADRs in Pulmonology department of a tertiary care hospital patient with pulmonary diseases in an inpatient department of pulmonology.

Materials And Methods: A prospective, single centered, observational and open labeled study was carried out in Princess Esra Hospital. The patient population was broadly divided into four categories based on diagnosis - chronic obstructive pulmonary disease, Infections, Asthma and Others. Suspected ADRs were reported, analyzed, and causality assessment was carried out using Naranjo's algorithm scale.

Results: A total of 302 patients were observed, of which 98 patients experienced ADRs, which accounted for 32.23% of the incidence and totally 160 ADEs were observed. Adult Patients were found to have higher incidence (32.09%) while the incidence rate was slightly greater in geriatric patients (32.39%). The highest incidence of ADEs were found in others group (78.57%). Majority of ADRs were suspected to be due to theophylline (19.39%). Gastrointestinal system (38.75%) was the most common organ system affected due to ADRs. Drug was withdrawn in 12 patients, and specific treatment was administered to 32 patients in view of clinical status. Specific treatment for the management of suspected reaction was administered in 32.65% of ADR reports.

Conclusion: A relatively high incidence of adverse drug events (32.2%) have been recorded which shows that not only Geriatric patients, but also adults are more susceptible to adverse drug effects. A number of drugs in combination were used, and ADEs often get multiplied. Careful therapeutic monitoring and dose individualization is necessary.

Citing Articles

Exploration and Evaluation of Adverse Drug Reactions Documented in a Tertiary-Care Hospital in Chennai: An In-Depth Retrospective Observational Study.

Selva P, Durairajan S Cureus. 2024; 16(5):e60977.

PMID: 38915954 PMC: 11194127. DOI: 10.7759/cureus.60977.

Incidence, preventability, and causality of adverse drug reactions at a university hospital emergency department.

Kauppila M, Backman J, Niemi M, Lapatto-Reiniluoto O Eur J Clin Pharmacol. 2020; 77(4):643-650.

PMID: 33188450 PMC: 7935812. DOI: 10.1007/s00228-020-03043-3.

An assessment of reported adverse drug reactions in a Tertiary Care Hospital in South India: A retrospective cross-sectional study.

Gupta S, Kumar K Int J Pharm Investig. 2018; 7(4):193-197.

PMID: 29692979 PMC: 5903024. DOI: 10.4103/jphi.JPHI_81_17.

Improving the assessment of adverse drug reactions using the Naranjo Algorithm in daily practice: The Japan Adverse Drug Events Study.

Murayama H, Sakuma M, Takahashi Y, Morimoto T Pharmacol Res Perspect. 2018; 6(1).

PMID: 29417762 PMC: 5817823. DOI: 10.1002/prp2.373.

Assessment of the expectancy, seriousness and severity of adverse drug reactions reported for chronic obstructive pulmonary disease therapy.

Petrova G, Stoimenova A, Dimitrova M, Kamusheva M, Petrova D, Georgiev O SAGE Open Med. 2017; 5:2050312117690404.

PMID: 28228952 PMC: 5308439. DOI: 10.1177/2050312117690404.

References

1.

Moore N, Lecointre D, Noblet C, Mabille M . Frequency and cost of serious adverse drug reactions in a department of general medicine. Br J Clin Pharmacol. 1998; 45(3):301-8. PMC: 1873369. DOI: 10.1046/j.1365-2125.1998.00667.x. View

2.

Granowitz E, Brown R . Antibiotic adverse reactions and drug interactions. Crit Care Clin. 2008; 24(2):421-42, xi. DOI: 10.1016/j.ccc.2007.12.011. View

3.

Ohta K, Fukuchi Y, Grouse L, Mizutani R, Rabe K, Rennard S . A prospective clinical study of theophylline safety in 3810 elderly with asthma or COPD. Respir Med. 2004; 98(10):1016-24. DOI: 10.1016/j.rmed.2004.02.020. View

4.

Yee D, Valiquette C, Pelletier M, Parisien I, Rocher I, Menzies D . Incidence of serious side effects from first-line antituberculosis drugs among patients treated for active tuberculosis. Am J Respir Crit Care Med. 2003; 167(11):1472-7. DOI: 10.1164/rccm.200206-626OC. View

5.

Lazarou J, Pomeranz B, Corey P . Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA. 1998; 279(15):1200-5. DOI: 10.1001/jama.279.15.1200. View

6.

Gallelli L, Ferreri G, Colosimo M, Pirritano D, Guadagnino L, Pelaia G . Adverse drug reactions to antibiotics observed in two pulmonology divisions of catanzaro, Italy: a six-year retrospective study. Pharmacol Res. 2002; 46(5):395-400. DOI: 10.1016/s1043661802002104. View

7.

Nebeker J, Barach P, Samore M . Clarifying adverse drug events: a clinician's guide to terminology, documentation, and reporting. Ann Intern Med. 2004; 140(10):795-801. DOI: 10.7326/0003-4819-140-10-200405180-00009. View

8.

Newnham D . Asthma medications and their potential adverse effects in the elderly: recommendations for prescribing. Drug Saf. 2001; 24(14):1065-80. DOI: 10.2165/00002018-200124140-00005. View

9.

Shamna M, Dilip C, Ajmal M, Linu Mohan P, Shinu C, Jafer C . A prospective study on Adverse Drug Reactions of antibiotics in a tertiary care hospital. Saudi Pharm J. 2014; 22(4):303-8. PMC: 4142362. DOI: 10.1016/j.jsps.2013.06.004. View

10.

Gholami K, Kamali E, Hajiabdolbaghi M, Shalviri G . Evaluation of anti-tuberculosis induced adverse reactions in hospitalized patients. Pharm Pract (Granada). 2014; 4(3):134-8. PMC: 4156846. View

11.

Edwards I, Aronson J . Adverse drug reactions: definitions, diagnosis, and management. Lancet. 2000; 356(9237):1255-9. DOI: 10.1016/S0140-6736(00)02799-9. View

Causality Assessment of Adverse Drug Reaction in Pulmonology Department of a Tertiary Care Hospital