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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 201504/19/23



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.



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 trainersdissemination of guidelines and reporting

tools



PV Guideline and Reporting Tools

4

Suspected ADR Reporting Form

National PV Guidelines

Form for Reporting Poor Quality Medicines



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.



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

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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

www.pv.pharmacyboardkenya.org



What is the PV ERS?

• 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

www.pv.pharmacyboardkenya.org



Suspected Adverse Drug Reaction Reporting Form (YELLOW FORM)



Poor Quality Medicinal Products Reporting Form (PINK FORM)



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



How can one access /use the PV ERS?

Two options exist:

1.Log in directly to the web application onlinewww.pv.pharmacyboardkenya.org

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



Benefits of the PV ERS? (1)

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



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


Pharmacy and Poisons BoardPost 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 PV-ERS to PPB between January and March 2015

• 117 suspected ADR (sADR) reports submitted to the Uppsala database



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 12

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 21

TOTAL # ADR Reports: 127



• 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.who-umc.org/graphics/25027.pdf

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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

• PRIORITYTargeted sensitization of health care

providers on PV-ERS use.



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 [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

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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


Pharmacy and Poisons Board MOMS-Kenya

Contact us?Directorate of Medicines Information and Pharmacovigilance


Lenana Road, Nairobi, KENYA

e-mail: [email protected]


P.O. Box: 27663-00506 Nairobi KENYA

Tel: +254-(020) 3562107 2716905/6

Fax: +254-(020) 2713431 / 2713409



Thank You

“You need not be certain…

Just be suspicious”

Report all SUSPECTED adverse medicine reactions and poor quality medicines

www.pharmacyboardkenya.org pharmacy and poisons board improving reporting of suspected adverse drug...

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