An annual retrospective analysis of adverse drug reactions reported at adverse drug reaction monitoring center, Nalgonda

Background: Adverse drug reactions (ADR) are rated as fifth leading cause of death and accounts for approximately 5% of all hospital admissions. Under reporting of ADR from healthcare professional is considered as the contributing factor for increased morbidity and mortality. India has taken well appreciated step to launch Pharmacovigilance Programme of India (PvPI) to safeguard heath care of Indian population. This study looks into the detailed analysis of ADR reported to adverse drug reaction monitoring centre (AMC), Government Medical College, Trivandrum to assess its pattern, causality, severity and seriousness of ADR. Primary objectives of this study are the pattern of adverse drug reactions reported to ADR monitoring centre (AMC) and secondary objective is to assess causality, severity.Methods: A record based descriptive study was conducted in the ADR monitoring centre of government medical college, Trivandrum, Kerala from September 1st 2016 to February 2017(6 months). The data were collected from the all reported case records/ ADR report form of CDSCO. The details of the various adverse drug reactions were identified and analysed to find the pattern of adverse drug reactions including distribution of age, gender, causal drug group, system organ class. Also, an attempt is made to do causality assessment using WHO UMC scale and severity by using Heart wig Seigel Scale.Results: Out of 320 ADR cases, majority of reports were due to cutaneous manifestations. Most common ADRs were erythema, induration, and rash, itching. Females were 56% and males were 44%. Majority cases were of adult age group. Causality 91.88% were probably related, 75.6% were mild reaction. 25% of cases were serious. 77.5% were recovered. Antibacterial implicated 25(7.8%) followed by anti-epileptics 24 (7.5%) ADR.Conclusions: The pattern of adverse drug reactions reported to this AMC is comparable to the studies done in other parts of country. A strong need for streamlining of ADR monitoring system and reporting reemphasized by this study, which will promote the ADR reporting in healthcare professionals.

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Adverse drug reaction monitoring—cost and benefit considerations. Part I: frequency of adverse drug reactions causing hospital admissions

Pharmacoepidemiology and Drug Safety ◽

10.1002/(sici)1099-1557(199710)6:3+<s71::aid-pds282>3.3.co;2-9 ◽

1997 ◽

Vol 6 (S3) ◽

pp. S71-S77 ◽

Cited By ~ 53

Author(s):

N. Muehlberger ◽

S. Schneeweiss ◽

J. Hasford

Keyword(s):

Adverse Drug Reaction ◽

Drug Reaction ◽

Adverse Drug Reactions ◽

Hospital Admissions ◽

Reaction Monitoring ◽

Drug Reactions ◽

Monitoring Cost ◽

Adverse Drug Reaction Monitoring ◽

Cost And Benefit

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Post-Marketing Surveillance as an Instrument of Adverse Drug Reaction Monitoring

Adverse Reactions to Non-Steroidal Anti-Inflammatory Drugs: Clinical Pharmacoepidemiology ◽

10.1007/978-3-0348-5722-2_3 ◽

1992 ◽

pp. 33-40

Author(s):

H. Kewitz

Keyword(s):

Adverse Drug Reaction ◽

Drug Reaction ◽

Reaction Monitoring ◽

Adverse Drug Reaction Monitoring ◽

Post Marketing Surveillance ◽

Post Marketing

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Knowledge, attitude and practice toward adverse drug reaction reporting among practicing clinicians at a tertiary care hospital

International Journal of Basic & Clinical Pharmacology ◽

10.18203/2319-2003.ijbcp20171090 ◽

2017 ◽

Vol 6 (4) ◽

pp. 845

Author(s):

Toshan L. Todar ◽

Manju Agrawal ◽

Rajesh Hishikar ◽

Anuja Jha ◽

Basant Maheshwari ◽

...

Keyword(s):

Adverse Drug Reaction ◽

Drug Reaction ◽

Tertiary Care ◽

Reaction Monitoring ◽

Adverse Drug Reaction Monitoring ◽

Medical College ◽

Monitoring Centre ◽

Adr Reporting ◽

Attitude And Practice ◽

Knowledge Attitude And Practice

Background: Pharmacovigilance has evolved as an important tool for dealing with Adverse Drug Reactions (ADRs) both in pre-marketing and post-marketing scenario. Underreporting of ADRs at our Adverse drug reaction Monitoring Centre (AMC) led us to conduct this study to assess Knowledge, Attitude and Practice (KAP) of the practicing clinicians at our tertiary care Pt. J.N.M. Medical College associated Dr. B.R.A.M. Hospital, Raipur, Chhattisgarh, India, towards ADRs reporting.Methods: This was a cross-sectional study using pretested questionnaires consisting of 29 questions related to KAP of the practicing clinicians at Pt. J.N.M. Medical College associated Dr. B.R.A.M. Hospital, Raipur towards ADRs reporting. The percentage of responders for each question was calculated. All statistical analysis was performed in Microsoft Office Excel 2007.Results: Out of 135 questionnaires distributed only 100 were considered for analysis, so the overall response rate was 74.07%. We calculated the result from the 100 responders. Overall 77% responders were aware of existence of ADR monitoring system in India, while only 40% were aware of its existence at their hospital. Only 8% responders had reported ADRs to the National Pharmacovigilance Centre and 10% to the Adverse drug reaction Monitoring Centre (AMC) at their hospital. Lack of knowledge about where, how and whom to report ADRs, lack of time, inability to decide what to report (known or unknown ADRs) and unavailability of ADR reporting form were the important factors discouraging them reporting ADRs.Conclusions: Creating awareness regarding ADR reporting through CMEs among practicing clinicians and early sensitization at medical undergraduate level for medical students may improve the current ADR reporting rate.

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