STRUCTURE AND PROCESS OF
PERIODIC SAFETY UPDATE
REPORTING SYSTEM MEDICINES IN
KENYA
KIOGORA MWITI GATIMBU
REG NO.U51/64042/2013
M.PHARM-EPIVIGIL
24TH NOVEMBER, 2014
Outline
 Introduction
 Rationale
 Objectives
 Methodology
 Results
 Conclusion
 Acknowledgements
Introduction
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.
•
Introduction
This
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 PSURs
ADRs
are a public health concern - Aim to protect
health of population.
For
early detection of ADRs pharmacovigilance (PV)is
of essence.
PSURS
The
form part of tools used in PV reporting.
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.
Objectives
Broad objective
To assess the structure, content and process of
periodic safety update reports in Kenya
Specific objectives
 To examine the content of PSURs in Kenya.

To explore the organizational structure of PSURs in
Kenya.

To examine the processes of PSURs in Kenya.
Methodology
•
A cross-sectional qualitative study of
documentary material.
•
Scotts adapted version of Leavitt’s Diamond
model.
Methodology
•
Descriptive interviews with key informants
at PPB,Kenya.
•
A universal sampling was done.
Methodology

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
Results
Submitted documents marked as
PSURs
All 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)
Safety update
Global data sheet
Amendment package insert update
Package insert update
Prescribing information update
Amendment for prescribing information
Core safety risk management plan
Worldwide pharmaceutical operation
Periodic benefit risk evaluation
Application to spc
Package leaflet
Summary bridging report
Core data sheet
PSUR assessment
32
2
2
2
8
23
9
2
1
1
1
3
1
1
1
Exposure number calculation method
25%
50%
22%
3%
Defined Daily Dose
Patients/day
Number of doses
Other
Studies and other information
Risk-Benefit Analysis Report
Risk Management Plan
Late Breaking Information
Efficacy-related Information
Other studies
Published Studies (literature)
Targeted New Safety Studies
Newly-Analyzed company sponsored
Studies
0
Yes
20
No
40
Missing
60
80
100
120
Overall safety components
Off label use
Medication errors
Long-term treatment
Special populations
Pregnancy/ lactation
Abuse or misuse
Overdose
Drug interaction
0
20
Yes
40
No
60
missing
80
100
120
Process of PSUR reporting

Marketing 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.
Conclusion

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.
Conclusions
 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
Recommendations
 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.
Recommendations

Local MAHs to submit PSURs to the
regulatory authority.

To set aside funds to facilitate regular reviews.
Acknowledgements

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 YOU