who programme for international drug monitoring
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TITLE from VIEW and SLIDE MASTER | April 22, 20231 |
Developing pharmacovigilance: new
challenges and opportunities
Mary Couper and Shanthi PalQuality Assurance and Safety of Medicines
TITLE from VIEW and SLIDE MASTER | April 22, 20232 |
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
TITLE from VIEW and SLIDE MASTER | April 22, 20233 |
Pharmacovigilance in WHO HQ
1. Exchange of Information
2. Policies, guidelines, normative activities
3. Country support
4. Collaborations
5. Resource mobilisation
TITLE from VIEW and SLIDE MASTER | April 22, 20234 |
WHO ProgrammeOctober 2008
TITLE from VIEW and SLIDE MASTER | April 22, 20235 |
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
TITLE from VIEW and SLIDE MASTER | April 22, 20236 |
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
TITLE from VIEW and SLIDE MASTER | April 22, 20237 |
Juggling some questions….
TITLE from VIEW and SLIDE MASTER | April 22, 20238 |
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%
TITLE from VIEW and SLIDE MASTER | April 22, 20239 |
Thalidomide was the reason for the programme …..in the 60s
2007
Primary reason remains!!
TITLE from VIEW and SLIDE MASTER | April 22, 202310 |
125 Patients
24 Patients experienced ADRs (19%)
(59%) were avoidable
TITLE from VIEW and SLIDE MASTER | April 22, 202311 |
Why do preventable errors occur
TITLE from VIEW and SLIDE MASTER | April 22, 202312 |
4 million+ reports
So What?
Where is the denominator?
TITLE from VIEW and SLIDE MASTER | April 22, 202313 |
XX number of countries trained
So What?
Why don’t they report?
TITLE from VIEW and SLIDE MASTER | April 22, 202314 |
What more can we do?
Can we use our database more effectively?
TITLE from VIEW and SLIDE MASTER | April 22, 202315 |
Some ideas………
TITLE from VIEW and SLIDE MASTER | April 22, 202316 |
Consider traditional trendsAdverse drug reaction
Adverse drug event
Medicine safety
Medicine toxicity
Benefit /harm profile of a medicine
Product emphatic
Where is the patient?
TITLE from VIEW and SLIDE MASTER | April 22, 202317 |
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?
TITLE from VIEW and SLIDE MASTER | April 22, 202318 |
Am I SAFE with this
medicine?
PV is about me!!
TITLE from VIEW and SLIDE MASTER | April 22, 202319 |
Can we become more patient centred ?
Yes, we can!!
TITLE from VIEW and SLIDE MASTER | April 22, 202320 |
Reports of medication errors in WHO ICSR database in 2005
2%
98%
Medication errors
Total reports
TITLE from VIEW and SLIDE MASTER | April 22, 202321 |
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
TITLE from VIEW and SLIDE MASTER | April 22, 202322 |
Pharmacovigilance system
Records medication related errors
Analyses those errors
Implements interventions
Promotes patient safety
Prevent 'preventable errors'
Actionable learning system
TITLE from VIEW and SLIDE MASTER | April 22, 202323 |
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
TITLE from VIEW and SLIDE MASTER | April 22, 202324 |
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
TITLE from VIEW and SLIDE MASTER | April 22, 202325 |
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
TITLE from VIEW and SLIDE MASTER | April 22, 202326 |
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
TITLE from VIEW and SLIDE MASTER | April 22, 202327 |
Lack of denominator / exposure data
Active surveillance to complement
Cohort Event Monitoring
Malaria, HIV
Pregnancy registers
To complement and NOT replace spontaneous reporting
TITLE from VIEW and SLIDE MASTER | April 22, 202328 |
What more with the database
EML
Dependence liability
Counterfeit detection
Support RUD programme with evidence
TITLE from VIEW and SLIDE MASTER | April 22, 202329 |
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
TITLE from VIEW and SLIDE MASTER | April 22, 202330 |
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
TITLE from VIEW and SLIDE MASTER | April 22, 202331 |
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
TITLE from VIEW and SLIDE MASTER | April 22, 202332 |
Pharmacovigilance is about me!!
Thank you
Thank you
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