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


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


• 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


• 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


Location map of East Africa


Pharmacy and


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


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


• 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


• 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


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


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


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



Pharmacy and


• 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



Pharmacy and


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


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



Pharmacy and


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



Pharmacy and


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



Pharmacy and


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



Pharmacy and


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


Thank You


Pharmacy and


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

mailto:[email protected]

http://www.pharmacyboardkenya.org/

pv in east africa what have we learnt?pharmaconnect.co.za/wp-content/uploads/2018/03/edward... ·...

Documents