structure and process of periodic safety update reporting system medicines in kenya kiogora mwiti...
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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