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Adverse drug reaction monitoring
The road to patient safety
Dr. Manjunath GNProf. 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 purchaseRapid approval
Clinical trial V/S clinical practiceSubject 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……….
The Problem of ADR
Risk factors of ADRDrug •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
How?...............
Good Pharmacovigilance Practice
Responsibility
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
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
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
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
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 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
“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
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
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 -1800-180-3024
