The Indian Practitioner

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

Pattern and Frequency of Spontaneously Reported Suspected ADRs in Admitted Patients at a Tertiary Care Hospital of Central India: A Pharmacovigilance Study


Affiliations
1 Associate Professor, Department of Pharmacology, S.S. Medical College, Rewa, Madhya Pradesh, India
2 Assistant Professor, Department of Physiology, S.S. Medical College, Rewa, Madhya Pradesh, India
3 AYUSH Medical Officer, Department of Ayush, Medical Officer, PHC, Devtalab, Rewa, Madhya Pradesh, India
4 Department of Pharmacology, S.S. Medical College, Rewa, Madhya Pradesh, India
5 Professor & Head, Department of Pharmacology, S.S. Medical College, Rewa, Madhya Pradesh, India
6 3rd year PG Resident, Department of Pharmacology, S.S. Medical College, Rewa, Madhya Pradesh, India
     

   Subscribe/Renew Journal


Background: ADRs constitute an enormous burden for society and it is one of the leading causes of death. ADRs are poorly and inadequately reported and up to 57% of ADRs are unrecognized by attending physicians.

Aims & Objectives: The aim of this study is to assess the frequency, clinical pattern and spectrum of suspected ADRs in admitted patients.

Material & Methods: This study was conducted, in a multidisciplinary tertiary care hospital, in which a total of 54 cases with suspected ADRs were enrolled. Data was collected by a researcher through telephonic conversation by healthcare professionals from the admitted patients of hospital in CDSCO - ADR reporting form. The data were analyzed by Microsoft word - excel version 2007. All the multiple responses were presented in terms of numbers and percentage.

Results: In the present study, maximum patients (31.48%) belonged to 26-40 years age group, of these maximum patients (35.18%) belonged to lower middle socioeconomic status. Majority of patients (68.51%) were residents of rural areas. Skin & mucous membranes and gastrointestinal system were most frequently (37.18%) involved organ systems; most frequent ADR (17.58%) was skin rashes, followed by pruritus (13.56%). Majority (56.78%) of suspected ADRs were associated with antimicrobials. Among antimicrobials, ceftriaxone + sulbactam is associated with majority (34.51%) of suspected ADRs.

Conclusion: ADR monitoring is the key component of effective drug regulation systems, clinical practice and public health programmes. Hospital based ADR monitoring and reporting programmes aim to identify and quantify the risks associated with the use of the drugs.


Keywords

Pharmacovigilance Program of India, PvPI, Adverse Drug Event, Adverse Drug Reaction, Central Drugs Standard Control Organization, CDSCO.
Subscription Login to verify subscription
User
Notifications
Font Size


  • Rehan HS, Chopra D, Kakkar A. Physician’s guide to pharmacovigilance: Terminology and causality assessment. European Journal of Internal Medicine. 2009;20:3-8.

  • Mohanta GP, Manna PK. Textbook of Pharmacovigilance concept and practice.1st ed. Hyderabad: Pharma Med Press; 2016.

  • Kumar A, Khan H. Signal detection and their assessment in Pharmacovigilance. Open Pharmaceutical Sciences Journal. 2015;2:66-73.

  • World Health Organization. Requirements for adverse reaction reporting. Geneva, Switzerland: 1975.

  • Vrabie M, Marinescu V. Polypharmacy in bipolar disorder-a focus on drug-drug interaction. Revista Romana de Psihiatrie. 2011;13:128‒133.

  • Fracas A, Bojita M. Adverse drug reaction in clinical practice: a causality assessment of a case of drug-induced pancreatitis. J Gastrointestin Liver Dis. 2009;18(3):353-58.

  • Padmaja U, Adhikari P, Pereira P. A prospective analysis of adverse drug reaction in a south Indian hospital. Online J Health Allied Scs. 2009;8(3):12.

  • Sriram S, Ghasemi A, Ramaswamy R, Devi M, Balasuramanian R, Ravi TK, Sabzghabaee AM. Prevalence of adverse drug reaction at a private tertiary care hospital in south India. JRMS. 2011;16(1):16-25.

  • Sajin G. Joseph, Dinesh K. Badyal. Spontaneous Adverse Drug Reaction Monitoring in a Tertiary Care Hospital in Northern India. JK Science. 2016;18 (2):103-106.

  • John LJ, Arifulla M, Cheriathu J, Sreedharan J. Reporting of adverse drug reactions: A study among Clinicians. J App Pharmaceut Sci. 2012;2(6):135-9.

  • Daulat MP, Abhishake VJ, Singh P, Raj B. A prospective study of adverse drug reactions in a tertiary care teaching hospital. International Journal of Basic & Clinical Pharmacology. 2018;7(10):1965-69.

  • Jose J, Rao PG. Pattern of adverse drug reaction notified by spontaneous reporting in Indian tertiary care teaching hospital. Pharmacol Res. 2006;54: 226-233.

  • Mandavi SD, D’Cruz S, Sachdev A, Tiwari P. Adverse drug reactions & their risk factors among Indian ambulatory elderly patients. Indian J Med Res. 2012;136:404–410.

  • Gupta R, Sheik A, Strachan D, Anderson HR. Increasing hospital admission for systemic allergies disorders in England: analysis of national admission data. Br Med J. 2003; 327(7424):1142-3.

  • Chawla S, Kalra BS, Dharmshaktu P, Sahni P. Adverse drug reaction monitoring in a tertiary care teaching hospital. J PharmacolPharmacother. 2011;2(3):196-8.

  • Pandey V, Singh A, Singh P, Bhupendra R, Dubey V. Adverse drug reaction monitoring and assessment of causality in intensive care unit, in the department of medicine at a tertiary care hospital of Central India. EJPMR. 2018;5(12):290-294.

  • Solunke RR, Dharmadhikari SC, Jaju JB, Parekar S, Gurung A. Pharmacovigilance Study of Antiretroviral Drugs in Tertiary Care Hospital- A Prospective Study. JMSCR. 2018;6(8):1048-1059.

  • Singh H, Dulhani N, Tiwari P, Singh P, Sinha T. A prospective, observational cohort study to elicit adverse effects of antiretroviral agents in a remote resourcerestricted tribal population of Chhattisgarh. Indian J Pharmacol. 2009; 41 (9): 224-6.

  • Camargo AL, Cardoso Ferreira MB, Heineck I. Adverse drug reactions: A cohort study in internal medicine units at a university hospital. Eur J Clin Pharmacol. 2006;62:143–149.

  • Kumar N, Shekar C, Kumar P, Kundu AS. Kuppuswamy’s Socio-economic status scale-updating for 2007. Indian Journal of pediatrics. 2007;74:1131-1132.

  • Chatterjee S, Ghosh AP, Barbhuiya J, Dey SK. Adverse cutaneous drug reactions: A one year survey at a dermatology outpatient clinic of a tertiary care hospital. Indian J Pharmacology. 2006;38:429-431.

  • Kathiria JM, Sattigere BM, Desai PM, Patel SP. A study of adverse drug reactions in patients admitted to intensive care unit of a tertiary care teaching rural hospital. Int J Pharm Pharm Sci. 2013;5(1):160-163.

  • Murphy BM and FrigoLC. Development, Implementation and results of a successful multidisciplinary adverse drug reaction reporting program in a University Teaching Hospital. 1993;28:1199-1204.

  • Prosser TR, Kamysz PL. Multidisciplinary adverse drug reaction surveillance programme. Am J Hosp Pharm. 1990;47:1334-1339.

  • Arulmani R, Rajendran SD, Suresh B. Adverse drug reaction monitoring in a secondary care hospital in South India. Br J ClinPharmacol. 2008;65(2):210–216.

  • Wester K, Jonnson AK, Spigset O, Druid H, Hagg S. Incidence of fatal adverse drug reactions: a population based study. Br J Clin Pharmacol. 2007;65(4):573-579.

  • Gor AP, Desai SV. Adverse drug reaction in the inpatients of Medicine Department of a rural tertiary care teaching hospital and influence of pharmacovigilance in reporting ADR. Indian J Pharmacol. 2008;40(1):37-40.

  • Vora MB, Trivedi HR, Shah BK, Tripathi CB. Adverse drug reaction in inpatient of internal medicine wards at a tertiary care hospital: a prospective cohort study. J Pharmacol Pharmacother. 2011;2 (1):21-25.

  • Harsha R. A prospective study of adverse drug reactions in outpatients and inpatients of medicine department in a tertiary care hospital, Kempegowda institute of medical sciences. Int J Basic Clin Pharmacol. 2015;4(3):515-521.

  • Shamna M, Dilip C, Ajmal M, Linu Mohan P, Shinu C, Jafer CP, Mohammed Y. A prospective study on Adverse Drug Reactions of antibiotics in a tertiary care hospital. Saudi Pharmaceutical Journal. 2014;22:303–308.

  • Marques J, Ribeiro-Vaz I, Pereira AC, Polõnia J. A survey of spontaneous reporting of adverse drug reactions in 10 years of activity in a pharmacovigilance centre in Portugal. Int J Pharm Pract. 2014;22:275–282.

  • Vijendra R, Pundarikaksha HP, Gopal MG, Girish K, Vasundara K, Jyothi R. A prospective study of cutaneous adverse drug reaction in a tertiary care hospital. National journal of basic medical sciences. 2013;3(1):44-51.

  • Khurshid F, Aqil M, Alam MS, Kapur P, Pillai KK. Monitoring of adverse drug reaction associated with antihypertensive medicines at a university teaching hospital in New Delhi. J Phar Sci. 2012;34:1-6.

  • Aqil M, Imam F, Hussain A, Alam MS, Kapur P, Pillai KK. A pharmacovigilance study for monitoring adverse drug reactions with antihypertensive agents at a south Delhi hospital. Int J Pharm Pract. 2006;14:311-3.

  • Biston P, Melot C, Degaute JP, Clement D, Quoidbach A. Prolonged antihypertensive effect of amlodipine: a prospective double-blind randomized study. Blood Press. 1999;8:43-48.


Abstract Views: 184

PDF Views: 0




  • Pattern and Frequency of Spontaneously Reported Suspected ADRs in Admitted Patients at a Tertiary Care Hospital of Central India: A Pharmacovigilance Study

Abstract Views: 184  |  PDF Views: 0

Authors

Prabhakar Singh
Associate Professor, Department of Pharmacology, S.S. Medical College, Rewa, Madhya Pradesh, India
Amita Singh
Assistant Professor, Department of Physiology, S.S. Medical College, Rewa, Madhya Pradesh, India
Arpita Singh
AYUSH Medical Officer, Department of Ayush, Medical Officer, PHC, Devtalab, Rewa, Madhya Pradesh, India
Vivek Pandey
Department of Pharmacology, S.S. Medical College, Rewa, Madhya Pradesh, India
Bhupendra Raj
Professor & Head, Department of Pharmacology, S.S. Medical College, Rewa, Madhya Pradesh, India
Ankita Dixit
3<sup>rd</sup> year PG Resident, Department of Pharmacology, S.S. Medical College, Rewa, Madhya Pradesh, India

Abstract


Background: ADRs constitute an enormous burden for society and it is one of the leading causes of death. ADRs are poorly and inadequately reported and up to 57% of ADRs are unrecognized by attending physicians.

Aims & Objectives: The aim of this study is to assess the frequency, clinical pattern and spectrum of suspected ADRs in admitted patients.

Material & Methods: This study was conducted, in a multidisciplinary tertiary care hospital, in which a total of 54 cases with suspected ADRs were enrolled. Data was collected by a researcher through telephonic conversation by healthcare professionals from the admitted patients of hospital in CDSCO - ADR reporting form. The data were analyzed by Microsoft word - excel version 2007. All the multiple responses were presented in terms of numbers and percentage.

Results: In the present study, maximum patients (31.48%) belonged to 26-40 years age group, of these maximum patients (35.18%) belonged to lower middle socioeconomic status. Majority of patients (68.51%) were residents of rural areas. Skin & mucous membranes and gastrointestinal system were most frequently (37.18%) involved organ systems; most frequent ADR (17.58%) was skin rashes, followed by pruritus (13.56%). Majority (56.78%) of suspected ADRs were associated with antimicrobials. Among antimicrobials, ceftriaxone + sulbactam is associated with majority (34.51%) of suspected ADRs.

Conclusion: ADR monitoring is the key component of effective drug regulation systems, clinical practice and public health programmes. Hospital based ADR monitoring and reporting programmes aim to identify and quantify the risks associated with the use of the drugs.


Keywords


Pharmacovigilance Program of India, PvPI, Adverse Drug Event, Adverse Drug Reaction, Central Drugs Standard Control Organization, CDSCO.

References