Assess the frequency and severity of adverse drug reactions due to errors in drug intake at a tertiary care hospital.
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Date
2015-09
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Abstract
Background: Drug-related problems are an important cause of morbidity and
mortality and a significant burden on healthcare resources. There are few studies to
account for errors in drug intake leading to adverse drug reactions (ADRs). This study
was pursued with the objective of determining the frequency and severity of the ADRs
resulting from erroneous drug intake, the expenses incurred in treating the same.
Methods: The study was a prospective, cross-sectional, observational study. The
study subjects were patients with ADRs due to errors in drug intake and from selfmedication.
All the information regarding the ADR were collected as per ADR
reporting form issued by Central Drugs Standard Control Organization. Causality
was assessed by both Naranjo and the WHO criteria for causality assessment. Direct
cost of all the medications, hospital charges (admission, bed charges, consultations
paid, treatment charges, investigations, and conveyance charges) were recorded to
find the financial burden due to error in drug intake.
Results: The study showed that nearly 30% of the ADRs were due to errors in drug
intake and the major contributing factor is self-modification either by discontinuation
or missed doses. Major drugs that are implicated in these ADRs were that of
metformin and insulins among anti-diabetic drugs and amlodipine and atenolol
among antihypertensives. These two groups contributed to 18 (62%) of the total
29 ADRs. Organ system commonly involved was central nervous system and that
was followed by musculoskeletal system. The average direct cost incurred in the
management of these ADRs was Rs. 5773 for non-serious adverse events (SAE’s)
and Rs. 11,400 for SAE’s.
Conclusion: Proper education about the importance of compliance and damaging
consequences of self-modification of drug dosage in patients who are on treatment
for chronic disorders like diabetes and hypertension will be an effective strategy to
prevent many of these ADRs.
Description
Keywords
Errors, Adverse drug reactions, Self-medication
Citation
Shivaprakash G, Ravi Praveen, Hadigal Sanjay, Pallavi L C. Assess the frequency and severity of adverse drug reactions due to errors in drug intake at a tertiary care hospital. International Journal of Basic & Clinical Pharmacology. 2015 Sep-Oct; 4(5): 931-935.