Pals New Challenges and Opportunities 2

8/14/2019 Pals New Challenges and Opportunities 2

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TIT LE fr om VIEW an d SLIDE MAST ER | Septembe r 28 , 20 09 |

Developing pharmacovigilance:

new challenges andopportunities

Mary Couper and Shanthi Pal

Quality Assurance and Safety of Medicines


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WHO Programme for International Drug

Monitoring

WHO HQ +WHO HQ +

6 Regional6 Regionalofficesoffices

WHOWHO

CollaboratingCollaboratingCentre, UppsalaCentre, Uppsala

NationalNational

CentresCentres


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Pharmacovigilance in WHO HQ

2. Exchange of Information

3. Policies, guidelines, normative activities

4. Country support

5. Collaborations

6. Resource mobilisation


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WHO Programme

October 2008


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Functions

Receive and manage ADR data

Develop tools; innovate

Analyse: Signal detection :Identification of previously unknown drug reactions

Communicate

Support countries: train; search; technical assistance


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What have we achieved in 40 years

118 National PV centres (89 full members +29Associate members)

Global ADR database: over 4 million reports

In 2006: 37 Signals generated from database

Some public health programs incorporating PV

Gaining donor support


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Juggling somequestions.


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Why is PV NOT getting the attention it deserves

About 40 years later: less than100 'full' members

4 million+ reports

But from where?

Most reports from developed

countries.

Why is PV still a non event

globally?

Country Di stri bution in VigiBaseOct ober 2 0 0 8

Spa i n2%

U n i t ed S t a t e s50 %

U n i t ed K i ngdom11 %

Ot he r C oun t r i e s11 %

Ne t he r l and s2%Tha i l and2%

G e r m a n y6%

France5%

C anada5%

Aust ra l ia4%

S w e d e n2%


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Thalidomide was the reason for the

programme ..in the 60s

2007

Primaryreason!!remains


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125 Patients

24 Patients experienced ADRs (19%)

(59%) were avoidable


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Why do preventable errors occur


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4 million+ reports

So What?

Where is the denominator?


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XX number of countries trained

So What?

Why dont they report?


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What more can we do?

Can we use our database more

effectively?


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Some ideas


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Consider traditional trends

Adverse drugreaction

Adverse drugevent

Medicine safety

Medicine toxicity

Benefit /harm profile of a medicine

Product emphatic

Where is the patient?


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Need to humanize what we do

Let's give pharmacovigilance a 'face'

Let's talk about patient safety, not just medicine safety

Ask the right question

Instead of asking 'Is the medicine safe'

Need to ask:

Is the patient safe taking this medicine?


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Am I SAFE

with this?medicine

PV is about

!! me


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Can we become more patient centred ?

Yes, we can!!
http://www.ssinformer.com/news/world/north_americal/usa/politics/2008/images/barack__obama.jpg


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Reports of medication errors in

WHO ICSR database in 2005

2%

98%

Medication errors

Total reports


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Pharmacovigilance system

Records medication related errors

Analyses those errors

Implements interventions

Promotes patient safety

Prevent 'preventable errors'

Actionable learning system


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WHO Patient Safety- Pharmacovigilance alliance

Collaborative project for the development ofpharmacovigilance centres for patient safety

Building on medication related expertise of the WHO-PVprogramme

Reporting and learning through Root Cause Analysissystems

Improve patient safety

Partners: WHO-PV, WAPS, UMC, Moroccan centre forpoison control and pharmacovigilance


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Infectious

diseases

RHR

NCD

ICD etc

TB

MalariaTDR

Regional

Offices

ParasiticDiseases

HIV/AIDS

Chemical

Safety

Herbals

Patient

Safety

Vaccines

Safety of

Medicinesin WHO HQ

Safety of

medicinesin WHO HQ


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Low presence of some countries in the

programme

Capacity building : multi regional, multilingual trainings,regional centres of excellence in PV

Local evidence for the need for pharmacovigilance

What gets measured, gets done (DG, WHO) Indicators for PV


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Post-training: improving reporting

The knowdo gap: understanding it

Reporting tools expensive

Vigiflow : free when used only as a reporting tool

Also discuss 'incentives'

CME points

Feedback

Access to Information


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Lack of denominator / exposure data

Active surveillance to complement

Cohort Event Monitoring

Malaria, HIV

Pregnancy registers

To complement and NOT replace spontaneous reporting


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What more with the database

EML

Dependence liability

Counterfeit detection

Support RUD programme with evidence


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Optimising 'Donor' interest

BMGF:

HIV/AIDS proposal Malaria pregnancy registry

Developing a global strategy

EC:

EC/ACP/WHO Partnership on Pharmaceutical Policies now in

its 5th year Working with African countries to ensure a quality

pharmaceutical response to malaria entering its second year

Optimizing drug safety monitoring to enhance patient safetyand achieve better health outcomes


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What does the future look like

1.As before(global spontaneous reporting, training)

3. Better than before

(Active surveillance studies in some countries, multilingual,

sentinel sites)

As never before

(ISMN, WAPS, EML, RUD, Indicators, capital)

Maintain as the cheapest,easiest, most sustainablemethod

Cohort event

monitoring

Network, support,

measure, fundraise


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Major planned activities for 2009

Development of a global strategy for pharmacovigilance to increase

awareness PV landscape assessment for ascertaining state of the art

Expansion of the programme with a focus on China and India

More Francophone countries supported in PV

Cohort event monitoring method developed, piloted in 2 African

countries (in malaria)

Indicators for PV

Expansion and development of database

Pilot project on medication errors strengthened / expanded to othercentres

Strengthening PV in HIV/AIDS

PV capacity in countries supported


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Pharmacovigilance

!! is about me

Thank you

Thank you

Pals New Challenges and Opportunities 2

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