1. 43rd KMA Annual Scientific Conference
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
4/22/2017 1

2. 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.

3. Pharmacovigilance PPB established the PV department in 2004
June 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
Management Sciences for Health, Strengthening Pharmaceutical Systems (SPS) and Health Commodities and Services (HCSM) Programs worked with the Pharmacy and Poisons Board (PPB) and other stakeholders to implement : “one-national” integrated pharmacovigilance system 3

4. PV Guideline and Reporting Tools
National PV Guidelines
Suspected ADR Reporting Form
Form for Reporting Poor Quality Medicines

5. 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 health care providers were sensitized/trained on PV by end 2012.
Twelve sites have been identified to provide ARV ADR boosted surveillance and facility medicines and therapeutic committee representatives trained.
PMS reports for anti-TB, antiretroviral (ARVs) and anti-Malarial medicines were disseminated in April 2012
This influx of information has resulted in quarantining, recalling, or withdrawing some medicines; changes in labeling; line inspections for continuous Good Manufacturing Practices; and, in one case, the closure of a pharmaceutical company that was not meeting regulatory requirements

6. 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
4/22/2017

7. 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

8. What is the PV ERS? www.pv.pharmacyboardkenya.org
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
Based on the manual reporting forms for ADRs and PQMPs

9. Suspected Adverse Drug Reaction Reporting Form (YELLOW FORM)

10. Poor Quality Medicinal Products Reporting Form (PINK FORM)

11. Key Features Multi-user capability
Keyed in reports can be exported to other databases (e.g VigiBase)….E2B format compliant
‘Print’ feature
Ability to export reports to Microsoft Excel
Accurate, consistent data entry facilitated through “drop down” menus and lists

12. Key Features
4/22/2017

13. How can one access /use the PV ERS?
Two options exist:
Log in directly to the web application online
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

14. Benefits of the PV ERS? (1)
Environmental friendly: Saves on paper
Ubiquity : Available everywhere to everyone
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 ®
Efficient : Saves time spent filling manual reports and analyzing

15. 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

16. Post April 2013 PV ERS Launch
Cumulatively sADRs and 765 sPQMPs reports at PPB by 31st March 2015
8116 sADRs submitted to WHO database
298 sADRs and 71 sPQMPs submitted via PV- ERS to PPB between January and March 2015
117 suspected ADR (sADR) reports submitted to the Uppsala database

17. ADR Reports Submitted to Vigiflow
4/22/2017

18. sADRs Reports per Drug Class
4/22/2017

19. 4/22/2017

20. 4/22/2017

21. 4/22/2017

22. NB: In most instances it cannot be proven that a pharmaceutical product or ingredient is the cause of an event. See full disclaimer here: umc.org/graphics/25027.pdf
4/22/2017

23. 4/22/2017

24. 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.

25. Conclusion
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
WHO- UMC launch of the open access to data on Adverse Drug Reactions on 17th April 2015
4/22/2017

26. Acknowledgements Pharmacy and Poisons Board
MSH/Health Commodities and Services Management Program
USAID
Intellisoft Consulting
MOH
WHO-UMC
KMA
Health Facilities

27. Contact us? Directorate of Medicines Information and Pharmacovigilance
Pharmacy and Poisons Board
Lenana Road, Nairobi, KENYA
P.O. Box: Nairobi KENYA
Tel: (020) /6
Fax: +254-(020) /

28. Thank You “You need not be certain…
Just be suspicious”
Report all SUSPECTED adverse medicine reactions and poor quality medicines 28