17. January 2010 by harshit.

pharmakon-a drug or medicine
vigilans-watchful or careful

• The monitoring, detection, evaluation and responding to drug safety hazards in humans during pre’marketing development and post-marketing (Shakir and Lezton 2002)
• WHO: The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem (Edwards 2002)

Ÿ  Safety monitoring and evaluation throughout whole life-cycle of a productŸ   Encompasses non-clinical, clinical, post-marketing safety dataŸ  Evaluation requires a holistic approachŸ  Signals detected during development do not necessarily kill the productWhy pharmacovigilance?

• Limited value of animal experiments in predicting human safety
• Clinical trials are limited in time and number of patients; are ‘artificial’. Patients are selected (adults, no other drugs, no other diseases). Not representative of real-life use.
• Rare or delayed serious reactions are likely to remain unnoticed
• Ethical Requirements
• Legal Requirements
• Assess risk benefit

Functions of pharmacovigilance
(WHO Guidelines, 2000)

• Detection and study of adverse reactions
• Measurement of risk
• Measurement of effectiveness
• Benefit & harm evaluation
• Dissemination of information, education

Ø    Early warning Ø    Rational and safe use of medicines CORPORATE PHARMACOVIGILANCE- SCOPE

• Identify common and rare side effects
• Assess risk benefit Processing and regulatory submission of SAEs
• Processing and regulatory submission of SAEs
• Communications of SAEs reported
• Causality assessment of SAEs reported in any part of world
• Monitoring compliance of SAE processing and reporting
• Generation of PSURs

Rationale for pharmacovigilanceInformation obtained prior to first marketing is inadequate to cover all aspects of drug safety:

•     tests in animals are insufficiently predictive of human safety,
•     in clinical trials patients are selected and limited in number,
•     conditions of use in trials differ from those in clinical practice,
•     duration of trials is limited
•     Information about rare but serious adverse reactions, chronic toxicity, use in special groups (such as children, the elderly or pregnant women) or drug interactions is often not available.
• Prevents Disasters
• Builds up customer confidence
• Ensures Compliance and retention
• Builds brand image

Pharmacovigilance is needed in every country, because there are differences between countries in the occurrence of adverse drug reactions because of differences in:

•   drug production
•   distribution and use (e.g. indications, dose, availability)
•   genetics, diet, traditions of the people
•   pharmaceutical quality and composition (excipients) of locally produced pharmaceutical products
•   the use of non-orthodox drugs (e.g. herbal remedies) which may pose special toxicological problems, when used alone or in combination with other drugs.   

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17. January 2010 by harshit.

Clinical trial methodology that allows trial design modifications to be made after patients has been enrolled in a study, without compromising the scientific method and integrity of data.

It also Empowers sponsor to response to data collected during the Trial like Modifying sample size, dropping a treatment arm, balancing Treatment assignments using adaptive randomization or simply stopping a study early for success or failure.

Patients randomized to treatment arms based on the response to treatment of previous patients. Real-time safety & efficacy data incorporated into randomization strategy and Play-the-winner: Assignment of patients to treatment arms that resulted in fewer adverse events or better efficacy

Advantages:

Cost reduction: Stopping unsuccessful trials earlier, identifying successful trials sooner, dropping unnecessary treatment arms or     determining effective dose regimes faster

Reduction in lead time between phases, especially II and III:

Reduced time to market

Improved patient safety

Reduced exposure to unsuccessful treatment arms    

Increased access to effective treatment arms

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