A Prospective Study on Pattern of Adverse Drug Reactions Reported at Pharmacovigilance Centre of RIMS, Ranchi
Authors/Creators
- 1. Ex. Junior Resident, Department of Pharmacology, RIMS, Ranchi and President of Indian Medical Association (IMA), Ranchi, Jharkhand, India
- 2. Assistant Professor, Department of Pharmacology, Hi-Tech Medical College and Hospital, Rourkela, Odisha, India
- 3. Assistant Professor, Department of Pharmacology, Shri Ramkrishna Institute of Medical Sciences and Sanaka Hospital, Durgapur, West Bengal, India
Description
Background: Adverse drug reactions (ADR) are rated as fifth leading cause of death and accounts for approximately 5% of all hospital admissions. ADR monitoring plays a major role in pharmacotherapy, decision making in individual reports, regional, national and international programs. ADR monitoring can help to ensure that patients obtain safe and efficacious products. With the existing limited and inconsistent ADR data, more studies at institutional level can generate valid ADR information. Hence, this prospective study was designed to evaluate the pattern of ADRs in a tertiary care hospital. Methods: In our study all spontaneously reported ADRs were evaluated based on data collected from various clinical departments. Suspected drugs were coded according to WHO-anatomical therapeutic chemical classification. The organ system involvement for ADR was labeled as per WHO-ADR terminology. ADRs were also categorized into two types – augmented (A) and bizarre (B) as per Rawlins and Thompson classification. Causality Assessment was performed using WHO Uppsala Monitoring Centre (UMC) Causality Assessment Criteria. Severity of the identified ADRs was assessed using modified Hartwig’s criteria. The preventability of the reactions was assessed according to Schumock and Thornton’s criteria. Results: Out of all ADRs, 31.68% was type-A reactions while 68.32 % was type-B reactions. The commonly involved organ system was skin and appendages 56 (34.78%). The major causative drug class was antimicrobials (43.02%). The causality of most ADRs was “probable” (60.25%) followed by “possible” (34.78%). Most of the ADRs were moderate in nature (45.96%). Around 42.24% of the reported ADRs were definitely preventable. Conclusion: Adverse drug reaction is one of the leading cause of hospital based admissions. Practicing rational use of medicines and avoiding medication errors, a major fraction of ADRs can be prevented. Proper awareness among health care personnel and involvement of drug controlling authorities can minimize this grave situation.
Abstract (English)
Background: Adverse drug reactions (ADR) are rated as fifth leading cause of death and accounts for approximately 5% of all hospital admissions. ADR monitoring plays a major role in pharmacotherapy, decision making in individual reports, regional, national and international programs. ADR monitoring can help to ensure that patients obtain safe and efficacious products. With the existing limited and inconsistent ADR data, more studies at institutional level can generate valid ADR information. Hence, this prospective study was designed to evaluate the pattern of ADRs in a tertiary care hospital. Methods: In our study all spontaneously reported ADRs were evaluated based on data collected from various clinical departments. Suspected drugs were coded according to WHO-anatomical therapeutic chemical classification. The organ system involvement for ADR was labeled as per WHO-ADR terminology. ADRs were also categorized into two types – augmented (A) and bizarre (B) as per Rawlins and Thompson classification. Causality Assessment was performed using WHO Uppsala Monitoring Centre (UMC) Causality Assessment Criteria. Severity of the identified ADRs was assessed using modified Hartwig’s criteria. The preventability of the reactions was assessed according to Schumock and Thornton’s criteria. Results: Out of all ADRs, 31.68% was type-A reactions while 68.32 % was type-B reactions. The commonly involved organ system was skin and appendages 56 (34.78%). The major causative drug class was antimicrobials (43.02%). The causality of most ADRs was “probable” (60.25%) followed by “possible” (34.78%). Most of the ADRs were moderate in nature (45.96%). Around 42.24% of the reported ADRs were definitely preventable. Conclusion: Adverse drug reaction is one of the leading cause of hospital based admissions. Practicing rational use of medicines and avoiding medication errors, a major fraction of ADRs can be prevented. Proper awareness among health care personnel and involvement of drug controlling authorities can minimize this grave situation.
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Additional details
Dates
- Accepted
-
2023-06-25
Software
References
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