STRUCTURE AND PROCESS OF STRUCTURE AND PROCESS OF PERIODIC SAFETY UPDATE PERIODIC SAFETY UPDATE

REPORTING SYSTEM MEDICINES REPORTING SYSTEM MEDICINES IN KENYAIN KENYA

KIOGORA MWITI GATIMBUREG NO.U51/64042/2013M.PHARM-EPIVIGIL

24TH NOVEMBER, 2014

OutlineOutline

Introduction

Rationale

Objectives

Methodology

Results

Conclusion

Acknowledgements

IntroductionIntroduction • Periodic safety update report(PSUR) is a document that Marketing Authorization Holders(MAHs) submit to regulatory authority to evaluate medicinal products safety data for a particular interval of time.

• PSURs owe its origin to the Council of International Organization of Medical sciences(CIOMS) guideline of 1992.

IntroductionIntroductionThis guideline became widely accepted in all International Conference for Harmonization(ICH) regions.

ICH brings together regulatory authorities of Europe, Japan and USA to discuss scientific and technical aspect of product registration.

PSUR aim is to provide an update of world wide safety experience of specific medicinal products.

Rationale for study of PSURsRationale for study of PSURsADRs are a public health concern - Aim to

protect health of population.

For early detection of ADRs

pharmacovigilance (PV)is of essence.

PSURS form part of tools used in PV reporting.

The study aimed at analyzing the content,

process and structure of PSURs to find out

whether they are able to collect relevant

information for regulatory action.

ObjectivesObjectivesBroad objective To assess the structure, content and process

of periodic safety update reports in Kenya

Specific objectivesTo examine the content of PSURs in Kenya.

To explore the organizational structure of PSURs in Kenya.

To examine the processes of PSURs in Kenya.

MethodologyMethodology

• A cross-sectional qualitative study of

documentary material.

• Scotts adapted version of Leavitt’s

Diamond model.

MethodologyMethodology

• Descriptive interviews with key

informants at PPB,Kenya.

• A universal sampling was done.

MethodologyMethodology

Data was abstracted from the PSURs by

use of a PSUR review tool and key

informant interview tool.

Descriptive and univariate analysis was

done on all the variables.

The data was analyzed using stata version

10.0

ResultsResults

Submitted documents marked Submitted documents marked as PSURsas PSURsAll documents labeled as PSURs dated

between January, 2013 to January, 2014 were eligible for inclusion in the study.

A total 120 documents were identified for review.

However, 31 documents were excluded because of being in a poor physical condition.

A further 57 documents were excluded because, though they had been filed as PSURs, they did meet the minimum criteria for PSURs

Type of document submitted Total

Periodic safety update reports(PSURs) 32

Safety update 2

Global data sheet 2

Amendment package insert update 2

Package insert update 8

Prescribing information update 23

Amendment for prescribing information 9

Core safety risk management plan 2

Worldwide pharmaceutical operation 1

Periodic benefit risk evaluation 1

Application to spc 1

Package leaflet 3

Summary bridging report 1

Core data sheet 1

PSUR assessment 1

Exposure number calculation Exposure number calculation methodmethod

Studies and other Studies and other informationinformation

Overall safety componentsOverall safety components

Process of PSUR Process of PSUR reportingreportingMarketing authorization

holders(MAHs),submit 2 hard copies.

A soft copy

A cover letter is signed and a copy is retained at the department.

They are coded and entered in an excel sheet awaiting assessment and review.

ConclusionConclusion

PPB had a well laid structure for PSUR reporting.

Lacked harmonized format for capturing information.

Non mandatory requirement by the regulatory authority to submit PSURs.

No regular PSURs reviews.

ConclusionsConclusions

Nearly half of reviewed PSURs reported drug interactions.

50% of PSURs reviewed had potential safety concerns.

Nearly two-thirds reported medication errors and medicine abuse and misuse.

Local MAHs do not submit PSURs

RecommendationsRecommendations Urgent need for policies on PSURs.

PV team to develop and implement structured PSURs review tools.

The board to employ adequate staff to facilitate regular PSURs reviews for timely detection of signals.

The regulatory authority to develop comprehensive guidelines and SOPs on PSURs.

RecommendationsRecommendations

Local MAHs to submit PSURs to the regulatory authority.

To set aside funds to facilitate regular reviews.

AcknowledgementsAcknowledgements I wish to acknowledge the contribution

and guidance of my supervisors;

• Dr George Osanjo• Dr James Riungu • Dr Wesley Ronoh

My course coordinator Dr Faith Okalebo

Pharmacovigilance team at the PPB.

THANK YOUTHANK YOU