Pharmacovigilance orientation

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