Jyothi Bhat

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Pharmacovigilance- An Experience of the
Peripheral Centre, Bangalore

• By
• Jyothi Bhat
• IInd Year M. Pharm
• Dept. of Pharmacy Practice
• Al-Ameen College of Pharmacy

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INTRODUCTION

• Pharmacovigilance is the detection,
• assessment and prevention of adverse drug
• reactions in humans.
• Indian Scenario
• 3.7 of patients in hospital
• 0.7 of admissions
• 1.8 fatal
• Cost Rs 187-2820, mean Rs 690 per ADE

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• Pharmacovigilance - Major Aims

• Early detection of unknown safety
• problems
• Identification of risk factors
• Quantifying risks
• Preventing patients from being affected
• unnecessarily

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ADVERSE DRUG REACTION (ADR)

• A response to a drug which is noxious and
• unintended, and which occurs at doses
• normally used in man for the prophylaxis,
• diagnosis, or therapy of disease, or for the
• modifications of physiological function.

ADVERSE DRUG EVENT (ADE)
Medical occurrence temporally associated with
the use of a medicinal product, but not
necessarily causally related
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OBJECTIVE OF THE STUDY

• To create awareness among the healthcare
  professionals about pharmacovigilance
• To monitor the adverse events of drugs reported
  to the department and to assess the causality
• To contribute to the assessment of safety, risk
  and effectiveness of medicines

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METHODOLOGY

• Awareness was created among the clinicians of all
  the departments by giving a talk at the
  clinicians meet
• ADE forms were distributed to major wards
• Clinical Pharmacist collects the reports
• Outpatients are also referred in case of a
  suspected ADE
• Clinical Pharmacist collects the case and
  medication history of the patient
• ADE is scrutinized and suggestions sent to
  physician
• Causality assessment carried out as per the
  Naranjo and WHO Scales
• Alert Cards prepared and issued to patients

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• STUDY CENTRE
• Victoria Hospital St. Marthas Hospital
• STUDY PERIOD
• Jan 2006-Sep 2006
• STUDY
• Study involved a total of 114 ADEs

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• RESULTS

Demographic Profile of the ADEs
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Age Group of Patients
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Class of Drugs
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The Organ System Affected
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Type of Skin Reaction
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The Reporting Department
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Naranjo Rating
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• WHO Rating

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CONCLUSION

• We have been successful in creating awareness
  about pharmacovigilance among the doctors in the
  hospitals
• The culture of reporting which was non-existent
  was initiated by the department
• The department got 114 suspected ADE in a period
  of 7 months, which was consolidated and reported
  to the heads of the respective department for
  their information.

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• REFERENCES

• Meylers Side Effects of Drugs 2000
• AHFS Drug Information
• Current Index of Medical Specialities (CIMS)
  July-Oct 2006
• Pharmacist Handbook
• Micromedex Healthcare Series Vol. 129

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• Sharma VK, Sethuraman G, et.al. Cutaneous adverse
  drug reactions clinical pattern and causative
  agents-a 6 year series from Chandigarh.
• General Policy Topics. WHO Drug Information
  199711(1)

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Thank You