PV in East Africa What have we learnt?pharmaconnect.co.za/wp-content/uploads/2018/03/Edward... ·...
Transcript of PV in East Africa What have we learnt?pharmaconnect.co.za/wp-content/uploads/2018/03/Edward... ·...
Pharmacy and Poisons Board
Pharmacy and
Poisons Board, Kenya
PV in East Africa
What have we learnt?
PharmaConnect Africa 2018 Midrand Conference Centre
Edward Abwao
27th March 2018
Pharmacy and Poisons Board
Pharmacy and
Poisons Board, Kenya
Introduction
• The key regulatory functions of any National Medicines
Regulatory Authority include;
– Marketing Authorization
– Licensing
– Marketing Surveillance and Control
– Import and Export Control
– Regulatory Inspections
– Clinical Trials Authorization
– Pharmacovigilance
Pharmacy and Poisons Board
Pharmacy and
Poisons Board, Kenya
• In the African region, Pharmacovigilance is one of the
newest regulatory functions.
• Older healthcare workers (HCW) did not learn in details
about PV in colleges and for the graduating HCW only
limited information is being taught
Pharmacy and Poisons Board
Pharmacy and
Poisons Board, Kenya
• The East African Community (EAC) comprises of 6 Partner
States: Burundi, Kenya, Rwanda, South Sudan, Tanzania, and Uganda
• The EAC is home to 150 million citizens, of which 22% is
urban population. With a land area of 1.82 million KM2 and a combined Gross Domestic Product of US$ 146 billion (EAC Statistics for 2016),
• EAC Headquarters: Arusha, Tanzania
• Regional cooperation on Health provided in the Treaty
Chapter 21 (Article 118) of the EAC Treaty
Provides for medicines regulation harmonization
EAC Background
4
Pharmacy and Poisons Board
Pharmacy and
Poisons Board, Kenya
EAC Medicines Regulatory Harmonization
Programme
Official launch The East African Community MRH Programme was officially launched on 30th
March, 2012, in Arusha, Tanzania
First REC to launch the project in Africa
Purpose To improve access to safe, efficacious and quality essential medicines for the
treatment of conditions of public health importance in the East Africa Community
Partner States in order to increase the rapid availability of essential
medicines in the region and enable free movement of medicines within the
region
Goal To have a harmonized and functioning medicines regulatory system within the East
Africa Community in accordance with national and internationally recognized
policies and standards [WHO & ICH]
Pharmacy and Poisons Board
Pharmacy and
Poisons Board, Kenya
Pharmacovigilance in EAC
• Differences in regulatory functions development
• Varying capacities in terms of financial and human
resources (number and skills), infrastructure
• Different institutional arrangements (NMRAs of Rwanda
and Burundi are still units under their respective MoH)
• The six countries are at different PV development levels
Pharmacy and Poisons Board
Pharmacy and
Poisons Board, Kenya
• Different countries are at different PV levels
• All are important so as to push the PV agenda in the
region
• Support for the less developed countries important
• Having harmonized system is critical for the compliance
of the industry
• Started with harmonization of marketing authorization,
moving to PV
• Good as it will help in avoiding the challenges
experienced in marketing authorization
• Important to have PV dedicated staff who are interested
and supported on matter PV
Pharmacy and Poisons Board
Pharmacy and
Poisons Board, Kenya
• The six countries joined WHO Programme for
International Drug Monitoring at different
Tanzania 1993
Uganda 2007
(South) Sudan 2008
Kenya 2010
Rwanda 2013
Burundi
• Since joining, the countries have contributed differently
to the ADR database
Pharmacy and Poisons Board
Pharmacy and
Poisons Board, Kenya
Cumulative ADR Reports by EAC
Countries
-
10,618
30 51
1,744
2,589
-
2,000
4,000
6,000
8,000
10,000
12,000
Burundi Kenya Rwanda SouthSudan Tanzania Uganda
ReportsbyCountries
Pharmacy and Poisons Board
Pharmacy and
Poisons Board, Kenya
ADR Reports
851
3 712
6 249
9 011
10 729
12 242
13 559
15 032
-
2 000
4 000
6 000
8 000
10 000
12 000
14 000
16 000
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018
Cummulative ADR Reports
Pharmacy and Poisons Board
Pharmacy and
Poisons Board, Kenya
Important Lessons
• Buy in from Healthcare workers is critical for the
success of Pharmacovigilance system
• Healthcare workers are concerned about their
patients and want the best for their clients
• HCW are ready and willing to be part of the PV
monitoring system
• HCW workers want simple and convenient way
to submit reports as they are most of the time
overworked
Pharmacy and Poisons Board
Pharmacy and
Poisons Board, Kenya
• PV is an interesting field for healthcare workers and they
have a lot of interest in it
• Information about PV needs to be continuously spread
• Regular reminders to HCW ensure continuous receipt of
reports
• HCW want feedback from the reports they send in
Pharmacy and Poisons Board
Pharmacy and
Poisons Board, Kenya
Patients
• Adverse Drug Reactions (ADR) are a serious concern to
patients
• ADRs may affect compliance to medicines and
especially so for the long term medications
• More patients are becoming more enlightened about the
safety of their medicines although some are still ignorant
• Patients want assurance of the safety of the medicines
they are taking
Pharmacy and Poisons Board
Pharmacy and
Poisons Board, Kenya
Stakeholders
• Proper and comprehensive stakeholder involvement is
critical for the success of a PV system
• PV Stakeholder mapping is important before embarking
on regulation
• E.g media, they can make or break your system
• Public Health Programs are key to the success of PV
system in Africa due to the public health conditions
• Universities and colleges of health sciences are
important stakeholders in curriculum development of PV
courses (MSc. Pharmacoepidiemiology)
Pharmacy and Poisons Board
Pharmacy and
Poisons Board, Kenya
Industry
• Industry are supportive on matters PV
• Everyone include the Pharma industry are concerned
about medicines safety
• They should be consulted so as to reduce resistance
• For increased compliance, develop guidelines that align
with international standards
• Regular consultation with the industry is important in
order to get feedback on how you are performing
• As the Pharmaceutical companies operate in different
regulatory environments, they are a good source of
information
Pharmacy and Poisons Board
Pharmacy and
Poisons Board, Kenya
Human Resources and Finances
• It is important to have adequate, dedicated and well
trained human resources to run PV system
• There is need for adequate finances to support PV work
• Reporting tools should be readily available; electronic
system makes work much easier
• Political and Government support is important
Pharmacy and Poisons Board
Pharmacy and
Poisons Board, Kenya
Lessons Learnt from EAC Marketing
Authorization
• Strong leadership and prompt decision making
(exemplified by EAC) critical to harmonization
• Regional expertise harnessed for capacity building
• Stakeholder involvement is key
• Training in regulatory skills is of paramount
• Political will
• Government commitment required for sustainability of
harmonization activities
• Advocacy by NEPAD, WHO and other partners has been
instrumental
Pharmacy and Poisons Board
Pharmacy and
Poisons Board, Kenya
In conclusion
Key to success:
•Harmonized regulatory requirements,
• Information sharing among countries,
• trust building and
• Financial sustainability strategies for
NMRAs
• Looking forward to a single regional
Regulatory Agency
Pharmacy and Poisons Board
Pharmacy and
Poisons Board, Kenya
Our contact …
Pharmacy and Poisons Board Lenana Road
P.O. Box: 27663-00506 Tel: +254-(020) 3562107
Nairobi KENYA 2716905/6
Fax: +254-(020) 2713431 / 2713409
e-mail: [email protected]
www.pharmacyboardkenya.org