Transcript Reporting of Adverse Drug Reactions: a study among Clinicians

Reporting of Adverse Drug Reactions:
a study among Clinicians
Lisha Jenny John, Mohamed Arifulla, Jenny
Cheriathu and Jayadevan Sreedharan
Journal of Applied Pharmaceutical Science 2012
By:
Mohammed Almoslem
Ibrahim Asiri
Introduction
• Adverse drug reaction
– A reaction which is noxious and unintended and
which occurs at doses normally used in humans
for prevention, diagnosis or therapy of disease, or
for the modification of physiological functions
(WHO, 2000).
Introduction
• Pharmacovigilance
– It is the science and activities relating to the
detection, assessment, understanding and
prevention of adverse drug effects or any other
drug-related problem (WHO, 2000).
Introduction
• Serious ADR
– An adverse drug reaction that requires
hospitalization, prolongs hospitalization, is
permanently disabling, or results in death of the
patient (Lazarou et al., 1998).
Methods
• Study propose
– The aim of the study is to investigate knowledge,
practice and factors affecting ADR reporting
among clinicians.
• Study design
– Cross sectional study carried out among 55
doctors during study period.
– Hospital in United Arab Emirates, Ajman
Methods
• Sample procedure
– 110 doctors were working in the institute
– 50% (55 doctors) were randomly recruited
– 76% was the response rate (42 questionnaire)
Methods
• Research tool
– Self-administered questionnaire
• Demographics
• Knowledge of ADR reporting
• Attitude to report
• Factor affecting reporting
• Open-ended and close ended questions
• Pilot study to randomly selected doctors
Methods
• Statistical analysis
– SPSS program
– Chi-square test
– Significance: P value <0.05
Results
• Demographics
– Response rate 76% (42/55)
– 50% male and the mean age of 36±8
– Multiethnic population (Egyptian and Indian)
– 22 clinicians were specialized (52.4%)
– 41/42 had come across ADRs in their clinical
practice included serious ADRs
– 16.7% noticed serious ADRs in their patient on a
monthly basis
Results
• Demographics
– The most frequent ADRs noticed are drug induced
rashes, and diarrhea.
– The commonly implicated drugs are antibiotics
and analgesics
– The observed serous ADRs are Steven Johnson’s
syndrome and anaphylaxis
Steven Johnson’s syndrome
Anaphylaxis
Results
• Knowledge of ADR reporting
– ADR that have to be reported
• 97.6% for serious
• 95% unusual
• 88% new drugs and new reactions to existing drugs
Results
• Knowledge of ADR reporting
– Who can report ADR
• 97.6% clinicians
• 81% nurses and pharmacists
• 42.9 patients
Results
• Knowledge of ADR reporting
– The awareness about pharmacovigilance centre
• Only 19 (45.2%) aware of its existence
• Only 6 had reported ADRs to pharmcovigilance centre
• Only 28 (66.7%) felt ADR reporting was necessary
Results
• Attitudes towards ADR reporting
– 13 (31%) reporting is professional obligation
– 24 (57%) reporting should be compulsory
– 13 (31%) reporting is voluntary process
Results
• Factors encouraging reporting of ADRs
Results
• Factors discouraging reporting of ADRs
Results
• Measures to improve ADR reporting
Results
• Education and training on ADRs
– Only 3 had received training on how to report ADR
and all had received training from India.
– 97.6% of the clinicians were willing to be trained
in reporting of ADRs.
Conclusion
• It is desirable to initiate workshops and
training programs on ADR reporting to
overcome the underreporting
• ADR reporting should be considered as an
integral part of the clinical activities by the
health care providers.
Thank You