Developing Pharmacovigilance: New Challenges And Opportunities

Developing pharmacovigilance: new challenges and opportunities Mary Couper and Shanthi Pal Quality Assurance and Safety of Medicines

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WHO Programme for International Drug Monitoring

WHO HQ + 6 Regional offices

WHO Collaborating Centre, Uppsala

National Centres

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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 +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 Country Di stri buti on in VigiB ase Oct ober 2008

 4 million+ reports Spa in 2%

 But from where?

Sw ede n 2%

Thailand 2%

Austr alia 4%

N eth erlands 2%

Canada 5% France 5% Unite d Sta te s 50%

Ge rm any 6%

 Most reports from developed countries.

Un ite d K ingd om 11%

Oth er Cou ntr ies 11%

 Why is PV still a non event globally?

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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? 12 |

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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 trends  Adverse drug reaction  Adverse drug event  Medicine safety  Medicine toxicity  Benefit /harm profile of a medicine  Product emphatic

Where is the patient? 16 |

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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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PV is about !! me Am I SAFE with this ?medicine

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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% Medication errors Total reports 98%

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Reports of medication errors by therapeutic groups in WHO database 20%

18.7%

7%

6%

5% 2.4%

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Antithrombotic agents

Antipsychotic agents

Antineoplastic agents

Antidepressants

Analgesics

0%

Pharmacovigilance system  Records medication related errors  Analyses those errors  Implements interventions  Promotes patient safety  Prevent 'preventable errors'

Actionable learning system 22 |

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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 23 |

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Infectious diseases

Vaccines

Patient Safety Herbals

RHR

NCD

Chemical Safety

Safety of Safety of Medicines medicines WHO HQ HQ ininWHO

ICD etc

HIV/AIDS Parasitic Diseases

TB Malaria 24 |

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TDR

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Regional Offices

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

Maintain as the cheapest, easiest, most sustainable method

1. As before

(global spontaneous reporting, training)

3. Better than before

Cohort event monitoring

(Active surveillance studies in some countries, multilingual, sentinel sites) Network, support, measure, fundraise

 As never before (ISMN, WAPS, EML, RUD, Indicators, capital) 30 |

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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

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