M PHARM SEMINARONPOST MARKETING SURVILLANCE

SIKSHA‘O’ANUSANDHAN UNIVERSITY BHUBANESWARNAME- GAYATREE UTTARKABAT

M PHARM 2nd SEMESTERREG. NO- 1361655001

DATE-2.4.2014

SUB: QUALITY ASSURANCE OF PHARMACETICALS-II

INTRODUCTION:

Post marketing surveillance refers to any means of obtaining information about a product after it has been approved for public use.

Section 505(0)(3) authorizes FDA to require certain post marketing studies and clinical trials for prescription drugs approved under section 505(b) and biological product approved under section 351.

WHY WE NEED PMS:

To assess a known serious risk related to the use of the drug

To assess signals of serious risk related to the use of the drug

To identify an unexpected serious risk when available data indicates the potential for a serious risk

Risk of drug- drug/food interaction

Long term effects

SOURCES OF PMS INFORMATION

The following may be considered as sources of information;

Expert user groups

Customer surveys

Customer complaints and warranty claims

Post CE-market clinical trials.

Literature reviews

The media.

METHODS OF SURVEILLANCE:

Thus, four types of studies are generally used to identify drugs effects:

1. Controlled clinical trials,

2. Spontaneous or voluntary recording

3. Cohort studies

4. Case control studies

CONTROLLED CLINICAL TRIALS:

To minimize bias through such method as randomization

Directly monitor patients for the duration of studies.

For evaluating a drug’s efficacy and safety.

They are often costly.

SPONTANEOUS REPORTING:

A communication from an individual (e.g: health care professional, consumer) to a company or regulatory authority .

This describes a suspected adverse event(S)

But the actual incidence of adverse drug reaction can not be determined through spontaneous reporting.

COHORT STUDIES:

Studies follow a defined group of patient for a period of time.

Patient are not randomly assigned

Case control studies identify patient with the adverse effects to be studied, and compare them with the sample drawn from the same cohort that gave rise to cases.

CASE CONTROL STUDIES:

MANUFACTURER PMS SYSTEM:

These are some of the type of knowledge and feed back which can achieved from a PMS system.

Detection of some manufacturing problems.

Product quality improvement.

Conformation (or otherwise) of risk analysis.

Knowledge of long term performance/reliability and /or chronic complication.

Knowledge of performance in different user population.

Feedback on indication of use.

Feedback on instruction for use.

Feedback on use with other devices.

Feedback on customer satisfaction.

Feedback on continuing market viability.

SOP FOR POST-MARKETING SURVEILLANCE1. Procedures related to drug use-results surveys

2. Procedures related to post-marketing clinical studies

3. Standards related to in-house inspections

4. Procedures related to the outsourcing of duties in post-marketing surveys, etc.

5. Procedures related to the preservation of records involving duties in post-marketing surveys, etc.

6. Any other procedures necessary for appropriate and smooth implementation of post-marketing surveys, etc

FAERS(FDA ADVERSE EVENT

REPORTING SYSTEM ) Detection of events not seen in clinical trials

Includes broad patient population: children, pregnant women, elderly.

Identification of trends, possible other clinical emerging, safety concern risk factors

> 7 million reports since 1969

Nearly 1 million new reports in 2012

CONCLUSION:

Post marketing surveillance is defined broadly as any information-gathering activity that is performed after product approval.

Post marketing surveillance (PMS) is the practice of monitoring the safety of a pharmaceutical drug which is on the market.

Vaccines and other medical products have risk that may include rare serious adverse events not detected.

Post marketing surveillance uses a number of approaches to monitor the safety of licensed drugs, including spontaneous reporting databases, prescription event monitoring patient registries and record linkage between health database.

REFERENCES:

1. FOOD AND DRUGS ADMINISTRATION, ‘‘Supplementary reports to contracts and grants committee on Medicaid”, from the division of Drugs Experience, BUREAU OF DRUGS,1982, 10-32.

2. Introduction to Postmarketing Drug Safety Surveillance: LT Andrew Fine, Pharm.D., BCPS

3. Pharmaceutical Regulations in Japan: chapter-4