Research Journal of Pharmacy and Technology

Open Access Open Access  Restricted Access Subscription Access
Open Access Open Access Open Access  Restricted Access Restricted Access Subscription Access

A Prospective Observational Study on Adverse Drug Reactions in General Medicine Department of a Tertiary Care Teaching Hospital


Affiliations
1 Department of Pharmacy Practice, NITTE (Deemed to be University), Mangaluru- 575018 Karnataka, India
2 Department of General Medicine, NITTE (Deemed to be University), Mangaluru- 575018 Karnataka, India
3 Department of Pharmacology, NITTE (Deemed to be University), Mangaluru- 575018 Karnataka, India
     

   Subscribe/Renew Journal


Present study was carried out to estimate the incidence of ADRs reported in general medicine department, to evaluate the causality, severity and preventability of ADRs caused by any drugs. A prospective observational study was carried out for a period of 8 months. Patients admitted during the study period were included as per the study criteria and monitored for ADRs. The clinical system, spectrum of ADRs noted and assessment of ADRs was done by causality, preventability and severity. The different scales are applied for assessment of causality, severity and preventability. Data was analysed by using descriptive statistics. A total number of 270 patients were included. 55 ADRs were observed in 52 patients. Higher incidence of suspected ADRs were exhibited with the age group of 61-70 years. The hospital stay extended for more than nine days in 32 (61.5%) patients who experienced ADR. The causality assessment by WHO Probability Scale, showed that out of 55 ADRs, majority were probable 38 (69.09%), whereas 11 (22%) reactions were possible and 6 (10.91%) reactions were certain. Based on Naranjo’s scale, 29 (52.73%) reactions were probable and 26 (47.27%) reactions were possible. Majority of 29 (53%) reactions were moderate in severity. Proper monitoring of adverse reactions is useful to minimize the incidence of ADRs and prevent further occurrence of the same. The regular monitoring of ADRs can reduce the morbidity and can improve the patients compliance which in turn can produce better therapeutic outcome.

Keywords

Adverse Drug Reaction, Causality, Severity, Preventability, Naranjo’s Scale.
Subscription Login to verify subscription
User
Notifications
Font Size


  • The Importance of Pharmacovigilance-Safety Monitoring of medicinal products. World Health Organisation. 2002.

  • WHO- International drug monitoring the role of national centres. Tech Rep Ser WHO 1972, no 498. https://www.whoumc.org/media/2680/who-technical-report498.pdf. Last accessed on 10 Dec 2016.

  • Asscher AW, Parr GD, Whitmarsh VB. Towards the safer use of medicines Br Med J. 1995; 311: 1003-1005.

  • Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. The lancet. 2000 Oct 7; 356(9237):12559.

  • Schatz S, Weber R. Adverse drug reactions. Pharmacy Practice. 2015 Aug 24; 1:1.

  • Flores R. Epidemiology of ADRs in Internal Medicine, HCC. Journal of Life Sciences. 2016; 10:54-7.

  • Roden DM. Principles of clinical pharmacology. In: Kasper DL, Hauser SL, Jameson JL, Fauci AS, Longo DL, Loscalzo J, editors. Harrison’s Principles of Internal Medicine. 19 th edition. Newyork: MC Graw Hill Education; 2015.P.43-44.

  • Rawlins MD, Thomas SH. Mechanism of adverse drug reaction. In: Davies DM, Ferner RE, Glanville H, editors. Davies’s Text book of adverse drug reaction. 5th edition. UK: Chapman and Hall medical; 1998.P.40-41.

  • Tangiisuran B, Scutt G, Stevenson J et al. Development and validation of a risk model for predicting adverse drug reactions in older people during hospital. Stay: Brighton Adverse Drug Reactions Risk (BADRI) Model. PLOS One. 2014; 9:e111254.

  • Suke SG, Kosta P, Negi H. Role of pharmacovigilance in India: An overview. Online journal of public health informatics. 2015; 7(2).

  • World Health Organization Uppsala Monitoring Centre (WHO-UMC) causility assessment system.

  • Naranjo CA, Busto U Sellars EM, Sandor P, Ruiz i, Roberts EA, Janecek E. Method for estimating the probability of adverse drug reactions. ClinPharmacolTher. 1981; 30:239-245.

  • Hartwig SC, Seigel J and Schneider PJ. Preventability and severity assessment in reporting adverse drug reactions. Am J Hosp Pharm 1992; 49:2229-2232.

  • Shrivastava M, Uchit G, Chakravarti A, Joshi G, Mahatme M, Chaudhari H. Adverse drug reactions reported in Indira Gandhi government medical college and hospital, Nagpur. J Assoc Physicians India. 2011 May; 59:296-9.

  • Adhikari A Bhattacharjee N, Bhattacharya S, Indu R, Ray M. Evaluation of Frequency Adverse Drug Reactions in Tertiary Care Hospital of Kolkata. J Young Pharm. 2017; 9(3):311-314.

  • Asawari R, Atmaram P, Madhu P. Clinical Pattern and Severity of Cutaneous Adverse Drug Reactions. Int J Pharm Pharm Sci.2013; 5(2): 612-616.

  • Sriram S, Ghasemi A, Ramasamy R, Devi M, Balasubramanian R, Ravi TK et al. Prevalence of Adverse drug reactions at a private tertiary care hospital in south in india. J Res Med Sci. 2011; 16(1):16-25.

  • Lokesh Kumar. Pharmacovigilance/Reporting Adverse Drug Reactions: An approach to enhance health surveillance and extending market share by minimizing the chances of drug withdrawals. Int J Pharm Pharm Sci. 2015; 7(9): 1-7.

  • Prasad Rv, Pasha MAM, Fatima A, Deepalatha C. A demographic study on gender related differences in adverse drug reactions of a tertiary care teaching hospital. Int J Community Med Public Health. 2017 Jul; 4(7):2344-2347.

  • Khurshid F, Aqil M, Alam MS, Kapur P, Pillai KK. Monitoring of adverse drug reactions associated with antihypertensive medicines at a university teaching hospital in New Delhi. Daru. 2012 Sep 1; 20(9):1.

  • Singh H, Dulhani N, Kumar BN, Singh P, Tewari P, Nayak K. A Pharmacovigillance Study in Medicine of Tertiary Care Hospital in a Chhattisgarh (Jagdalpur), India. J Young Pharm. 2010; 2(1):95-100.

  • Vora MB, Trivedi HR, Shah BK, Tripathi CB. Adverse drug reactions in inpatients of internal medicine wards at a tertiary care hospital: A prospective cohort study. Journal of pharmacology and pharmacotherapeutics. 2011 Jan; 2(1):21.

  • Davies EC, Green CF, Taylor S, Williamson PR et al. Adverse Drug Reactions in Hospital In-patients: A prospective Analysis of 3695 Patient- Episodes. PloS one February 2009; 4(2) 4439:1-7.

  • Shareef J, Vincen M, Shastry CS. A Prospective Study On Adverse Drug Reactions In A Tertiary Care Teaching Hospital. Am. J. PharmTech Res. 2013; 3(6):508-517.

  • Prajapati K, Desai M, Shah S, Panchal J, Kapadia J, Dikshit R. An analysis of serious adverse drug reactions at a tertiary care teaching hospital. PerspectClin Res 2016; 7:181-186.

  • Ramakrishnaiah H, Krishnaiah V, Pundarikaksha HP, Ramakrishna VB. A prospective study on adverse drug reactions in outpatients and inpatients of medicine department in a tertiary care hospital. Int J Basic ClinPharmacol. 2015 Jun; 4(3):515-521.


Abstract Views: 232

PDF Views: 0




  • A Prospective Observational Study on Adverse Drug Reactions in General Medicine Department of a Tertiary Care Teaching Hospital

Abstract Views: 232  |  PDF Views: 0

Authors

N. M. Rayees
Department of Pharmacy Practice, NITTE (Deemed to be University), Mangaluru- 575018 Karnataka, India
Sampath Kumar
Department of General Medicine, NITTE (Deemed to be University), Mangaluru- 575018 Karnataka, India
K. C. Bharath Raj
Department of Pharmacy Practice, NITTE (Deemed to be University), Mangaluru- 575018 Karnataka, India
K. S. Rajesh
Department of Pharmacy Practice, NITTE (Deemed to be University), Mangaluru- 575018 Karnataka, India
Juno J. Joel
Department of Pharmacy Practice, NITTE (Deemed to be University), Mangaluru- 575018 Karnataka, India
K. Prasanna Shama
Department of Pharmacology, NITTE (Deemed to be University), Mangaluru- 575018 Karnataka, India
M. P. Gururaja
Department of Pharmacology, NITTE (Deemed to be University), Mangaluru- 575018 Karnataka, India
U. P. Nandakumar
Department of Pharmacy Practice, NITTE (Deemed to be University), Mangaluru- 575018 Karnataka, India

Abstract


Present study was carried out to estimate the incidence of ADRs reported in general medicine department, to evaluate the causality, severity and preventability of ADRs caused by any drugs. A prospective observational study was carried out for a period of 8 months. Patients admitted during the study period were included as per the study criteria and monitored for ADRs. The clinical system, spectrum of ADRs noted and assessment of ADRs was done by causality, preventability and severity. The different scales are applied for assessment of causality, severity and preventability. Data was analysed by using descriptive statistics. A total number of 270 patients were included. 55 ADRs were observed in 52 patients. Higher incidence of suspected ADRs were exhibited with the age group of 61-70 years. The hospital stay extended for more than nine days in 32 (61.5%) patients who experienced ADR. The causality assessment by WHO Probability Scale, showed that out of 55 ADRs, majority were probable 38 (69.09%), whereas 11 (22%) reactions were possible and 6 (10.91%) reactions were certain. Based on Naranjo’s scale, 29 (52.73%) reactions were probable and 26 (47.27%) reactions were possible. Majority of 29 (53%) reactions were moderate in severity. Proper monitoring of adverse reactions is useful to minimize the incidence of ADRs and prevent further occurrence of the same. The regular monitoring of ADRs can reduce the morbidity and can improve the patients compliance which in turn can produce better therapeutic outcome.

Keywords


Adverse Drug Reaction, Causality, Severity, Preventability, Naranjo’s Scale.

References