PSUR

Slide 1: 

PSUR DR.s.Gunasakaran,MD Principal Investigator

Need for PSUR… : 

Need for PSUR…

Surveillance of Marketed drugs : 

Surveillance of Marketed drugs

WHY PSURs…? : 

WHY PSURs…?

General principles : 

General principles

General scope of information : 

All clinical and non-clinical safety data ADRs not AE Spontaneous reports : unless specified : ADRs Clinical Study and Literature cases : Not related to drug both by reporter and manufacturer Lack of efficacy : Life threatening condition : Safety issue Increase in frequency of documented ADRs General scope of information

International birth date : 

Date of first marketing authorization for the product granted to any company in any country in the world MAH submit PSUR within 60 days of data lock point International birth date

Reference safety information : 

CCDS : Safety, indications, dosing, pharmacology and other information CCSI : Reference safety information Listed Unlisted Expectedness Reference safety information

Sources of information : 

Direct reports to MAH Spontaneous notifications from healthcare professionals Spontaneous notifications from non-health care professionals or consumers MAH sponsored clinical studies Literature ADR reporting system of Regulatory authorities Epidemiological databases Sources of information

Description of events : 

Internationally accepted ICH coding terminology Controlled vocabulary or Coding dictionary Reporter’s terms Absence of diagnosis : MAH suggest a diagnosis Disagree with diagnosis Lab abnormality not addressed/evaluated by notifying reporter Description of events

Line listing and summary tabulations : 

Individual case line listings Summary tabulations All serious ADRs All non-serious unlisted ADRs All non-serious listed ADRs Line listing and summary tabulations

Slide 16: 

SAMPLE PSUR

Title page : 

PERIODIC SAFETY UPDATE REPORT FOR: (PRODUCT) MAHs NAME AND ADDRESS PERIOD COVERED BY THIS REPORT INTERNATIONAL BIRTH DATE : Date (Country of IBD) DATE OF REPORT (Other identifying information at the option of MAH, such as Report Number) Title page

Table of Contents : 

Introduction World-wide market authorization status Update of regulatory authority or MAH actions taken for safety reasons Patient exposure Presentation of Individual Case Histories Studies Other Information Overall Safety Evaluation Conclusion Appendix : COMPANY CORE DATA SHEET Table of Contents

Introduction : 

This is a periodic safety update report (PSUR) of Paracetomol covering the period…………….to…….. The report summarizes all the adverse reactions reported in connection with the administration of ABC Pharmaceutical's PARAT. ABC Pharmaceutical's PARAT got approval for 500 mg and 650 mg strengths. PARAT is an antipyretic used for oral administration. Mechanism of paracetomol,etc. Introduction

Worldwide Market Authorization Status : 

Date of market authorization and subsequent renewal Limits of indications or safety Treatment indications or special populations covered Lack of approval including explanation Withdrawal if related to safety or efficacy Dates of launch Trade name(s) Worldwide Market Authorization Status

Update of Regulatory Authority or MAH Actions taken for Safety Reasons : 

MA withdrawal or suspension Failure to obtain a marketing authorization renewal Restrictions on distribution Clinical trial suspension Dosage modification Changes in target population or indications Formulation changes Update of Regulatory Authority or MAH Actions taken for Safety Reasons

Changes to Reference Safety Information : 

Version of CCDS with CCSI Numbered, dated and Revision dates Changes to CCSI New contraindications New precautions New warnings New ADRs New Interactions Changes to Reference Safety Information

Patient’s Exposure : 

Difficult to arrive how many patients actually exposed Patient’s treatment years Calculation: Eg. Drug X 3 g daily for 7 days Vials sold : 21000 of 1g Drug X for a period of 2 years Patient treatment years : Vials sold / total dosage Total dosage : 3 g (3 vials) X 7 = 21 for each patient Hence, 21,000 / 21 = 1000 patients/ 2 years 500 patients/ year Patient’s Exposure

Presentation of Individual Case histories : 

All serious reactions and non-serious unlisted reactions from spontaneous notifications All serious reactions availed from studies All serious and non-serious unlisted reactions from literature All serious reactions from regulatory authorities Non-serious listed : as an addendum to PSUR only when requested by regulatory agencies Presentation of Individual Case histories

Presentation of Individual Case histories : 

Presentation of Individual Case histories

Presentation of the line-listing : 

MAH case reference number Country Source Age & Sex Daily dosage Date of onset Description of event Patient outcomes : Resolved/Fatal/Improved/Sequelae/Unknown Comments Presentation of the line-listing

Summary tabulations : 

An aggregate summary of each of the line listings Separate tables for serious / non-serious Separate tables for listed / unlisted Summary tabulations

MAH analysis of Individual Case Histories : 

Brief comments on data concerning individual cases Unanticipated findings ( their nature, medical significance, mechanism, reporting frequency, etc) MAH analysis of Individual Case Histories

Studies : 

Studies

Newly analyzed company sponsored studies : 

Studies containing important safety information Study design Study results Clinical and non-clinical study reports Newly analyzed company sponsored studies

Targeted new studies planned, initiated or continuing during the reporting period : 

New studies planned to examine a safety issue Objective, Starting date, Projected completion date, Number of subjects, Protocol abstract An Interim analysis Final result Targeted new studies planned, initiated or continuing during the reporting period

Published safety studies : 

Reports in scientific/medical literature Relevant published abstracts from meetings containing important safety findings Publication reference Published safety studies

Other information : 

Efficacy related information Product used to treat Serious or life threatening diseases Medically relevant lack of efficacy reporting Other information

Late breaking information : 

Any important new information received after database was frozen for review and report preparation Significant new cases Important follow-up data Late breaking information

Overall Safety Evaluation : 

Concise analysis of data presented so far Change in characteristics of listed reactions Severity, outcome, target population Serious unlisted reactions Non-serious unlisted reactions Increased reporting frequency of listed reactions Overall Safety Evaluation

Overall Safety Evaluation (Contd..) : 

Drug interactions Experience with overdosage Deliberate or accidental Drug abuse or misuse Positive or negative experience with pregnancy or lactation Experience in special patient groups Children, elderly, organ impaired Effects of long term treatment Overall Safety Evaluation (Contd..)

Conclusion : 

Should indicate which safety data do not remain in accord with previous cumulative experience and with reference to CCSI Specify and justify any action recommended or initiated Conclusion