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 AlmoslemIbrahim 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 syndromeAnaphylaxis

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