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Developing pharmacovigilance: new

challenges and opportunities

Mary Couper and Shanthi PalQuality Assurance and Safety of Medicines

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WHO Programme for International Drug

Monitoring

WHO HQ + WHO HQ + 6 Regional 6 Regional

officesoffices

WHO WHO Collaborating Collaborating

Centre, UppsalaCentre, Uppsala

National National CentresCentres

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Pharmacovigilance in WHO HQ

1. Exchange of Information

2. Policies, guidelines, normative activities

3. Country support

4. Collaborations

5. Resource mobilisation

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WHO ProgrammeOctober 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 +29 Associate 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 some questions….

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Why is PV NOT getting the attention it deserves

About 40 years later: less than 100 'full' members

4 million+ reports

But from where?

Most reports from developed countries.

Why is PV still a non event globally?

Country Distribution in VigiBaseOctober 2008

Spain2%

United States50%

United Kingdom11%

Other Countries11%

Netherlands2%

Thailand2%

Germany6%

France5%

Canada5%

Australia4%

Sweden2%

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Thalidomide was the reason for the programme …..in the 60s

2007

Primary reason 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 don’t 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 trendsAdverse drug reaction

Adverse drug event

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!!

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Reports of medication errors in WHO ICSR database in 2005

2%

98%

Medication errors

Total reports

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18.7%

7% 6% 5%2.4%

0%

20%

Ana

lges

ics

Ant

idep

ress

ants

Ant

ineo

plas

ticag

ents

Ant

ipsy

chot

icag

ents

Ant

ithro

mbo

ticag

ents

Reports of medication errors by therapeutic groups in WHO database

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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 of pharmacovigilance centres for patient safety

Building on medication related expertise of the WHO-PV programme

Reporting and learning through Root Cause Analysis systems

Improve patient safety

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

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Infectious diseases

RHR

NCD

ICD etc

TB

MalariaTDR

Regional Offices

Parasitic Diseases

HIV/AIDS

Chemical Safety

Herbals

Patient Safety

Vaccines

Safety of Medicines

in WHO HQ

Safety of medicines

in 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 know–do 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 safety

and achieve better health outcomes

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What does the future look like

1. As before

(global spontaneous reporting, training)

2. Better than before

(Active surveillance studies in some countries, multilingual, sentinel sites)

3. As never before

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

Maintain as the cheapest, easiest, most sustainable method

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 other

centres Strengthening PV in HIV/AIDS PV capacity in countries supported

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Pharmacovigilance is about me!!

Thank you

Thank you