1. 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

2. 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).

3. 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).

4. 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).

5. Methods Study propose Study design
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

6. Methods Sample procedure 110 doctors were working in the institute
50% (55 doctors) were randomly recruited
76% was the response rate (42 questionnaire)

7. 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

8. Methods Statistical analysis SPSS program Chi-square test
Significance: P value <0.05

9. 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

10. 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

11. Steven Johnson’s syndrome
Anaphylaxis

12. 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

13. Results Knowledge of ADR reporting Who can report ADR 97.6% clinicians
81% nurses and pharmacists
42.9 patients

14. 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

15. Results Attitudes towards ADR reporting
13 (31%) reporting is professional obligation
24 (57%) reporting should be compulsory
13 (31%) reporting is voluntary process

16. Results
Factors encouraging reporting of ADRs

17. Results
Factors discouraging reporting of ADRs

18. Results
Measures to improve ADR reporting

19. 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.

20. 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.

21. Thank You