POST MARKETING SURVEILLANCE

AnoopInder Kaur

Drugs

“Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of

disease" and “Articles (other than food) intended to affect the

structure or any function of the body of man or other animals"

Drugs

• Recognized by an official pharmacopoeia or formulary.

• Use in the diagnosis, cure, mitigation, treatment, or prevention of disease.

• Affect the structure or any function of the body

Drug development- Why?

•Lifestyle changes•Environment

•Resistance in microbes•Co infections

Clinical trials

Practice helping certify a new drug molecule as safe and efficacious for human use before reaching the market.

Phases of CT

Restrictions of phases

• Small population• Lesser indications• Concomitant medicines• Stringent Inclusion Criteria

Why PMS?

• Safety assurance• Adverse effects• Available to General Population• Wider range of patients conditions• Potential of chronic use

Objectives

• Collect more information on benefits, risks and optimal use.• Evaluate doses or schedules • Demonstrate wider use• Provide data on other patient populations or states of disease• Document the use of the drug over longer periods of time• Focus on pharmacoeconomic • Identify “patient” use issues that could slow or impede the sale

of the product

Types

Active:

• Structured plan eliciting tolerability and safety data

Passive

• Spontaneous reporting

Periodic Safety Update Reports- submitted every 6 months for 2 years of approval

Advantages

• Safety- off label use, concomitantly used drugs, vulnerable population, long duration use, differences in prescription.

• Recognise rarest ADRs• Increased severity, frequency of known ADRs• New use• No sample size restrictions• Drug-Drug/Food Interactions

Criticism

• Patients bear expenses.• Pseudo scientific excuse.• Luring doctors.• Unethically performed.• No claim, insurance to patients.

ADR Reporting Systems

• MedWatch: US• Yellow Card: UK• Health Canada: Canada• European Medicine Agency: Europe• CDSCO (PVP): India

Regulations

• CFR Title 21 Part 310.305: Records and reports concerning adverse drug experiences on marketed prescription drugs for human use without approved new drug applications.

• CFR Title 21 Part 312.32: IND Safety Reporting.• CFR Title 21 Part 314.80: Post marketing reporting of adverse drug

experiences.• Dietary Supplements: Voluntary Reporting• CFR Title 21 Part 355: Over The Counter Drugs

PMS In India

• Pharmacovigilance programme in 2010 by CDSCO.

• PV Centres all over.• Regular reporting.• ̴�179 ADR centres till 2014

Distribution of ADR reports based of types of senders

PvP Performance Report 2014-2015

Top Ten Drugs Reported to cause ADRs

PvP Performance Report 2014-2015

Wherever the ART OF MEDICINE is loved, there also is love of HUMANITY

Hippocrates