PSURs 11 & 12 Dec 2011

Periodic Safety Update

Reports

Adel Alrwisan B.Sc, M.Sc, PPC

Head of PSUR Evaluation Section
Pharmacovigilance Workshop, Cairo
11-12/12/2011

Outlines
• What are PSURs
• Why they are needed
• Regulatory requirements
• Structure of PSURs

Clinical Pharmacist Adel Alrwisan - Head

of PSUR Evaluation Section (SFDA) 1
PSURs 11 & 12 Dec 2011

What is a PSUR

Choose the best answer

• A • B
– P= Punishing – Purely
– S= Scary – Sick
– U= Ugly – Unpalatable
– R= Report – Reports
• C • D
– P= Pretty – None of the above
– S= Sophisticated
– U= Unnecessary
– R= Report

Clinical Pharmacist Adel Alrwisan - Head

of PSUR Evaluation Section (SFDA) 2
PSURs 11 & 12 Dec 2011

Definition
• Periodic Safety Update Reports (PSURs)
are a regulatory requirement for
authorised medicines at specified intervals
• They are valuable source for PhV data
• Give an opportunity for MAHs to review
the safety of their products
• Main focus is new or changing safety data
• Not to be confused with ASR

Submission Frequency

1st two yrs,

Next 2 yrs, After that,
every 6
every year every 3yrs
months

Clinical Pharmacist Adel Alrwisan - Head

of PSUR Evaluation Section (SFDA) 3
PSURs 11 & 12 Dec 2011

Submission Frequency
• Could be changed if:
– Adding paediatric indication
– Different salt
– Specific safety concern
– New indication, population, dosage form, or
route of administration
– Biological!

Scenario 1
Beautine drug was approved in Jordan in
January 2000
What is the submission frequency
A.Every 6 months
B.Annually
C.Every three years
D.None of the above

Clinical Pharmacist Adel Alrwisan - Head

of PSUR Evaluation Section (SFDA) 4
PSURs 11 & 12 Dec 2011

Scenario 2
Supermanox was approved in Egypt in
August 2010
What is the reporting frequency should be?
A.Every 6 months
B.Annually
C.Every three years
D.None of the above

Scenario 3
Wonderfulux was firstly approved by EMA in 2009,
but approved in UAE in 2011
What are the POSSIBLE submission frequency in
UAE?
A. Every 6 months
B. Annually
C. Every three years
D. A & B
E. B & C
F. None of the above

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Clinical Pharmacist Adel Alrwisan - Head

of PSUR Evaluation Section (SFDA) 5
PSURs 11 & 12 Dec 2011

Regulatory Requirements:
SFDA
Generics
• Several generics
• When to submit it?
• Waiving?

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Clinical Pharmacist Adel Alrwisan - Head

of PSUR Evaluation Section (SFDA) 6
PSURs 11 & 12 Dec 2011

Regulatory Requirements:
International
• EU and US are similar to SFDA
concerning reporting
• In the US there is no renewal
• Other countries in MENA region?

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Content of the PSUR

Intro
Other safety MA
info status

Overall safety
Evaluation PSUR Changes

Patient
Studies
Exposure
ICSH

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Clinical Pharmacist Adel Alrwisan - Head

of PSUR Evaluation Section (SFDA) 7
PSURs 11 & 12 Dec 2011

Introduction
• What is the reporting period
• What is the product
• Indications
• What it covers

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Intro: Example
• Scope of the report
– This PSUR No (#) for Gentamicin is prepared for RA
as per guideline…covers the period #### to ####
– IBD
• Formulation
– Eye drops and ointment
• Pharmacology
• Indications
– Approved indication in the US, Europe, and other
countries

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Clinical Pharmacist Adel Alrwisan - Head

of PSUR Evaluation Section (SFDA) 8
PSURs 11 & 12 Dec 2011

Marketing Authorisation
Status
• Where and when it was approved
• Update on regulatory status for safety
reasons
• Rejection, withdrawal or limitation

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MAS: Example
• Gentamicin was firstly approved in Bahrain in
2004
• The IBD was 2004
• During the current period it was approved in
Tunisia and Italy. The approval was rejected
in Jordan…
• DHCPL was requested in a Egypt and Saudi
Arabia. Available in annex 3

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Clinical Pharmacist Adel Alrwisan - Head

of PSUR Evaluation Section (SFDA) 9
PSURs 11 & 12 Dec 2011

Changes to Reference Safety

Information

CDS

CCSI

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Example
• CDS and SPC are attached to the PSUR
• The CDS document date and version are
stated
• Include all updates requested by RAs to
either CDS or SPC

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Clinical Pharmacist Adel Alrwisan - Head

of PSUR Evaluation Section (SFDA) 10
PSURs 11 & 12 Dec 2011

Patient Exposure
• How much is sold
• How many patients

Example
• Current and cumulative sales data in term of packs,
weight, dose…etc
• During the current period the estimated patient
exposure was 200,000 patient-years. Cumulative
exposure is 4,300,000 patient-years

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Still
interested

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Clinical Pharmacist Adel Alrwisan - Head

of PSUR Evaluation Section (SFDA) 11
PSURs 11 & 12 Dec 2011

Presentation of Individual Case

Histories
• Covers reports by:
– Spontaneous reports, studies, consumers,
RA, literature, registries and other
• MedDRA compliant
• Contains a description and analysis of
selected cases containing new safety
information

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Presentation of individual case

histories
Line-listing
• All unlisted ADR from SR, and literature
• All serious ADR from studies

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Clinical Pharmacist Adel Alrwisan - Head

of PSUR Evaluation Section (SFDA) 12
PSURs 11 & 12 Dec 2011

Presentation of individual case

histories
Summary tabulation
• Similar to line listing conditions

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Presentation of individual case

histories
• Discussed by SOC
• Contains company comment about
events/cases
• Emphasis on unlisted and fatal events

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Clinical Pharmacist Adel Alrwisan - Head

of PSUR Evaluation Section (SFDA) 13
PSURs 11 & 12 Dec 2011

Studies
• All studies yielding safety information
• All studies part of the RMP
• Pregnancy studies

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Other Information
• Efficacy-related Information
• Late-breaking Information
• Risk Management Plan

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Clinical Pharmacist Adel Alrwisan - Head

of PSUR Evaluation Section (SFDA) 14
PSURs 11 & 12 Dec 2011

Overall Safety Evaluation

• Organised by SOC rather than listedness
or seriousness
• Interactions
• Overdose
• Abuse or misuse
• Pregnancy exposure
• Special group
• Medication errors
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Choose the best answer

• A • B
– P= Punishing – Purely
– S= Scary – Sick
– U= Ugly – Unpalatable
– R= Report – Reports
• C • D
– P= Pretty – All the above
– S= Sophisticated
– U= Unnecessary
– R= Report

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Clinical Pharmacist Adel Alrwisan - Head

of PSUR Evaluation Section (SFDA) 15
PSURs 11 & 12 Dec 2011

Take home messages

• Be familiar with submission frequency
• Generic companies be prepared!
• Templates and guidance for compiling
PSUR are available
• Not an easy task and need proper
planning.

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Clinical Pharmacist Adel Alrwisan - Head

of PSUR Evaluation Section (SFDA) 16