Transcript KMA Improving Reporting and Analysis of Suspected Adverse Drug

Pharmacy and
Poisons Board
Improving Reporting of Suspected Adverse
Drug Reactions and Poor Quality Medicines
In Kenya ( PV-ERS)
43rd KMA Annual Scientific Conference
Nobel Hotel Eldoret
Dr Christabel N.Khaemba
Head Pharmacovigilance and Post-Market
Surveillance
23rd April 2015
4/2/2016
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Background: Pharmacy and Poisons Board
• PPB was established in 1957 under the Pharmacy
and Poisons Act, Chapter 244 of the Laws of
Kenya.
• PPB has six directorates and one of them is the
Directorate of Medicines Information and
Pharmacovigilance (MIPV).
• MIPV responsible for PV, Post-market
surveillance, Clinical Trials and Medicines
Information activities.
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Pharmacovigilance
• PPB established the PV department in 2004
• June 2009 saw the national launch of the
pharmacovigilance in Kenya.
• A national rollout planned and implemented:
capacity building of focal champions and
regional trainers
dissemination of guidelines and reporting tools
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PV Guideline and Reporting Tools
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National PV
Guidelines
Suspected ADR Reporting Form
Form for Reporting Poor Quality
4
Medicines
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Results
• 23rd April 2010: Kenya became 98th full
member of World Health Organization (WHO)
Programme for International Drug Monitoring.
• A post-market surveillance (PMS) strategy was
developed and PMS undertaken for anti-TB
antiretroviral (ARVs) and anti-Malarial
medicines.
• Over 15000 health care providers were
sensitized/trained on PV by end 2012.
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Results
• The PPB received about 175 reports on poor
quality medicines and over 5000 reports on ADRs
(over 80% related to ARVs) .
..........However reporting of both suspected ADRs
and poor quality medicines was via manual forms
utilizing a courier system......
......and this called for innovative solution....the
PV-ERS of 2013
4/2/2016
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PV Electronic Reporting System Launch
2013
The innovative digital system has
made reporting easier, more
cost effective, and prompt,
and will serve to build its own
database for future reference.
Influx of PV information to PPB
results in:
quarantining, recalling, or
withdrawing some medicines;
changes in labeling; line
inspections for continuous GMP;
Government Officials at the PV ERS launch
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What is the PV ERS?
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• Suite of software applications implemented by the PPB
for collection and processing of information on
suspected Adverse Drug Reactions (sADRs) and Poor
Quality Medicinal Products (sPQMPs)
• Enables electronic submission of sADR and sPQMP reports
via a web portal using either a computer or mobile
device.
• Developed in Kenya by Intellisoft Consulting with financial
and technical support from MSH/HCSM through USAID
funding
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Suspected Adverse Drug Reaction Reporting Form
(YELLOW
FORM)
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Poor Quality Medicinal Products Reporting Form (PINK
FORM)
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Key Features
1. Multi-user capability
2. Keyed in reports can be exported to other
databases (e.g VigiBase)….E2B format compliant
3. ‘Print’ feature
4. Ability to export reports to Microsoft Excel
5. Accurate, consistent data entry facilitated
through “drop down” menus and lists
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Key Features
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How can one access /use the PV ERS?
Two options exist:
1. Log in directly to the web application online
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2. Download the appropriate application for the
device being used e.g. desktop, Nokia phone
• Enables both online and offline access to the
reporting forms
• Useful when internet is fluctuating or
unreliable
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Benefits of the PV ERS? (1)
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1. Environmental friendly: Saves on paper
2. Ubiquity : Available everywhere to everyone
3. Portability and interoperability: Usable across
various systems and platforms and can exchange
data with local and international health
information systems e.g. EMRs and VigiFlow/
Vigibase ®
4. Efficient : Saves time spent filling manual
reports and analyzing
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Benefits of the PV ERS? (2)
5. Fast: Allows reporter to instantly report sADRs and
sPQMPs
6. Instant Feedback features: Allows users to know
whether reports have been submitted successfully
7. Database : Stores all the submitted reports
8. Analysis features for the reporter/ institution’s use
9. Assisted reporting: Features that ease reporting
process
10. Linked to PPB-ERP
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Post April 2013 PV ERS Launch
• Cumulatively 8431 sADRs and 765 sPQMPs
reports at PPB by 31st March 2015
• 8116 sADRs submitted to WHO database
• 298 sADRs and 71 sPQMPs submitted via PVERS to PPB between January and March 2015
• 117 suspected ADR (sADR) reports submitted to
the Uppsala database
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ADR Reports Submitted to Vigiflow
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sADRs Reports per Drug Class
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Top Reporting Sites in the Country: Jan – Mar 2015
1. Nanyuki District Hospital
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2. Riruta Health Centre
11
3. Lumumba Health Centre
10
4. Kisii Level 5 Hospital
10
5. Akala H/C
9
6. Liverpool Care & Treatment
9
7. Nakuru PGH
9
8. Kisii District Hospital
7
9. Bahati District Hospital
7
10. Dream Centre Lang'ata
6
11. Karen Health Centre
3
12. Kionyo Dispensary (Gucha)
3
13. 17 other health facilities
TOTAL # ADR Reports:
21
127
4/2/2016
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• NB: In most instances it cannot be
proven that a pharmaceutical product
or ingredient is the cause of an event.
See full disclaimer here:
http://www.whoumc.org/graphics/25027.pdf
4/2/2016
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Conclusion
• The Pharmacovigilance E-Reporting System is an
example of how PPB is:
 implementing innovative, cost effective
strategies to save lives and
 create the conditions where donor assistance
is no longer necessary for sustainability
• PRIORITY
Targeted sensitization of health care providers
on PV-ERS use.
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Conclusion
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•
Regional Centre for Regulatory Excellence (RCORE)
in Pharmacovigilance in Africa by New Partnership
for Africa’s Development (NEPAD) Agency May 2014.
•
E-shot subscription via [email protected]
•
WHO- UMC launch of the open access to data on
Adverse Drug Reactions on 17th April 2015
 http://www.vigiaccess.org/
 www.takeandtell.org
4/2/2016
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Acknowledgements
• Pharmacy and Poisons Board
• MSH/Health Commodities and Services
Management Program
• USAID
• Intellisoft Consulting
• MOH
• WHO-UMC
• KMA
• Health Facilities
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MOMS-Kenya
Contact us?
Directorate of Medicines Information and
Pharmacovigilance
Pharmacy and Poisons Board
Lenana Road, Nairobi, KENYA
P.O. Box: 27663-00506
Nairobi KENYA
Tel: +254-(020)
3562107 2716905/6
Fax: +254-(020) 2713431 / 2713409
e-mail: [email protected]
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Thank You
“You need not be certain…
Just be suspicious”
Report all SUSPECTED
adverse medicine
reactions and poor quality
medicines
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