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Adverse drug reaction
monitoring
The road to patient safety
Dr. Manjunath GN
Prof. and Head of Pharmacology
SSMC, TUMKUR
1
Presentation goal
To raise awareness about
How can we help improve patient safety
through effective reporting of ADRs
Detection
Assessment
Understand
Prevention
What is ADR monitoring / pharmacovigilance?
Why???
Why pharmacovigilance?
Self medication Drug promotion
Use of drugs outside
the confines
Largest producer
Online purchaseRa...
Clinical trial V/S clinical practice
Subject RCT Clinical practice
 Number of patients
Dozens, hundreds, rarely
thousands...
The Problem of ADR
Risk factors of ADR
Drug
•Non selective and nonspecific
•Narrow therapeutic range
•Lipophilic
Patient
•Comorbid conditions...
How?...............
Good Pharmacovigilance Practice
Responsibility
What to report ?
• New drugs
• Established drugs
– All serious reactions-well recognized
– All reactions to vaccines
– Rea...
Where and how to report ?
• Nearest ADR
monitoring centers
(Department of
pharmacology)
• Pharmacovigilance
center
• Regio...
Methods of causality assessment
• WHO assessment scale
• Naranjo’s scale
• European ABO system
• Karch and Lasagna’s scale...
Naranjo’s scale Yes No Don’t
know
1 Are there previous conclusion reports on this reaction? +1 0 0
2 Did the adverse event...
Who???
Why it has to be reported???
Creation of a signal
Regulatory action
• Summary of Product Characteristics (SPC) –
information to HCP on how to use the medicinal
product safe...
“Gatifloxacin formulation for systemic use in
human by any route including oral and
injectable”.
GSR NO. 218(E) Dated 16.0...
Reasons not to report
• Uncertain association
• Too trivial to report
• Too well known to report
• Unaware- of the need to...
Take home message
Report the ADR Promptly
Its time to join hands &
Share a common goal to deliver safe drugs
to our patients 
????????
For further information:
Central Drugs Standard Control Organization
http://www.cdsco.nic.in/
Help line -1800-180...
Pharmacovigilance orientation
Pharmacovigilance orientation
Pharmacovigilance orientation
Pharmacovigilance orientation
Pharmacovigilance orientation
Pharmacovigilance orientation
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Adverse drug reaction reporting - road to safety

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Pharmacovigilance orientation

  1. 1. Adverse drug reaction monitoring The road to patient safety Dr. Manjunath GN Prof. and Head of Pharmacology SSMC, TUMKUR 1
  2. 2. Presentation goal To raise awareness about How can we help improve patient safety through effective reporting of ADRs
  3. 3. Detection Assessment Understand Prevention What is ADR monitoring / pharmacovigilance?
  4. 4. Why???
  5. 5. Why pharmacovigilance? Self medication Drug promotion Use of drugs outside the confines Largest producer Online purchaseRapid approval
  6. 6. Clinical trial V/S clinical practice Subject RCT Clinical practice  Number of patients Dozens, hundreds, rarely thousands Thousands to millions  Length of time Days to weeks Days to years  Population Pregnant, children, the elderly are excluded Potentially, all the population  Other treatments They are avoided Possibly, more than one  Dose Fixed (generally) Variable (generally)  Conditions Rigorous follow up; more information Flexible follow up; patient less informed Premarketing studies- Reveal most common and acute untoward effect, BUT……….
  7. 7. The Problem of ADR
  8. 8. Risk factors of ADR Drug •Non selective and nonspecific •Narrow therapeutic range •Lipophilic Patient •Comorbid conditions •Disease of end organs •Age, women •Genetic and ethnic variability •Compliance Prescription •Wrong selection of drug, drug combination, dose, route, duration
  9. 9. How?............... Good Pharmacovigilance Practice
  10. 10. Responsibility
  11. 11. What to report ? • New drugs • Established drugs – All serious reactions-well recognized – All reactions to vaccines – Reactions to blood products – Unexpected high frequency of a known adverse reaction – All reactions to pregnant & lactating women including new born
  12. 12. Where and how to report ? • Nearest ADR monitoring centers (Department of pharmacology) • Pharmacovigilance center • Regional centers • Online submission • App on mobile Help line – 1800-180-3024
  13. 13. Methods of causality assessment • WHO assessment scale • Naranjo’s scale • European ABO system • Karch and Lasagna’s scale • Kramer scale • Bayesian network • Yale logarithm • Spanish imputation system
  14. 14. Naranjo’s scale Yes No Don’t know 1 Are there previous conclusion reports on this reaction? +1 0 0 2 Did the adverse event appear after the suspect drug was administered? +2 -1 0 3 Did the AR improve when the drug was discontinued or a specific antagonist was administered? +1 0 0 4 Did the AR reappear when drug was readministered? +2 -1 0 5 Are there alternate causes [other than the drug] that could solely have caused the reaction? -1 +2 0 6 Did the reaction reappear when a placebo was given? -1 +1 0 7 Was the drug detected in the blood [or other fluids] in a concentration known to be toxic? +1 0 0 8 Was the reaction more severe when the dose was increased, or less severe when the dose was decreased? +1 0 0 9 Did the patient have a similar reaction to the same or similar drugs in any previous exposure? +1 0 0 10 Was the adverse event confirmed by objective evidence? +1 0 0 > 9 = definite, 5-8 = probable, 1-4 = possible, 0 = unlikely
  15. 15. Who???
  16. 16. Why it has to be reported???
  17. 17. Creation of a signal
  18. 18. Regulatory action • Summary of Product Characteristics (SPC) – information to HCP on how to use the medicinal product safely and effectively • Patient Information Leaflets (PIL) – modified • Changes in classification: – – From Over the counter to Prescription only Medicine – – From renewable prescription to non-renewable – Special medical prescription – Restricted prescription • Marketing Authorization withdrawal • Batch recall based on clustering of ADRs
  19. 19. “Gatifloxacin formulation for systemic use in human by any route including oral and injectable”. GSR NO. 218(E) Dated 16.03.2011 Nimesulide formulations for human use in children below 12 years of age. GSR NO. 82(E) Dated10.02.2011
  20. 20. Reasons not to report • Uncertain association • Too trivial to report • Too well known to report • Unaware- of the need to report ADR's • Not enough time • Non availability of ADR forms • Too bureaucratic • Legal issues • Lack of feed back
  21. 21. Take home message
  22. 22. Report the ADR Promptly Its time to join hands & Share a common goal to deliver safe drugs to our patients 
  23. 23. ???????? For further information: Central Drugs Standard Control Organization http://www.cdsco.nic.in/ Help line -1800-180-3024
  • kedarbandekar

    Jul. 31, 2021
  • sudhambbs2010

    Aug. 8, 2018

Adverse drug reaction reporting - road to safety

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