Challenges for the WHO Programme for International Drug Monitoring

Shanthi Pal Quality Assurance and Safety of Medicines Cecilia Biriell Reports, Analysis and Country Support

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Technical Briefing Seminar, 1- 5 November 2010

Risk No medicinal product is entirely or absolutely safe for all people, in all places, at all times. We must always live with some measure of uncertainty

.

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Technical Briefing Seminar, 1- 5 November 2010

What is Pharmacovigilance?

WHO definition:

The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.

This applies throughout the life-cycle of a medicine equally to the pre-approval stage as to the post-approval.

ADR monitoring – Medicines safety – Drug Monitoring

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Technical Briefing Seminar, 1- 5 November 2010

What is the scope of pharmacovigilance?



improve patient care

and safety in relation to the use of medicines, and all medical and paramedical interventions, 

improve public health

and safety in relation to the use of medicines,  contribute to the

assessment of benefit, harm

, effectiveness and risk of medicines, encouraging their safe, rational and more effective (including cost-effective) use, and  promote understanding,

education

and clinical training in pharmacovigilance and its effective

communication

to the public

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Technical Briefing Seminar, 1- 5 November 2010

Why pharmacovigilance?

 Humanitarian concerns – Hippocrates admonition

at least do not harm

 Economical concerns

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Technical Briefing Seminar, 1- 5 November 2010

Examples of product recalls due to toxicity

Medicine Year Examples of serious and unexpected adverse events leading to withdrawal

Thalidomide Practolol Clioquinol Benoxaprofen Terfenadine Rofecoxib Sibutramine 1965 1975 1970 1982 1997 2004 2010 Phocomelia Sclerosing peritonitis Subacute nephropathy Nephrotoxicity, cholestatic jaundice Torsade de pointes Cardiovascular effects Anxiety, depression, movement disorders

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Technical Briefing Seminar, 1- 5 November 2010

Studies of ADR related deaths

UK: It has been suggested that ADRs may cause 5700 deaths per year in UK

Pirmohamed et al, 2004

US: ADRs were 4 th -6 th commonest cause of death in the US in 1994

Lazarou et al, 1998

Sweden: ADRs were 7 th commonest cause of death in Sweden in 2001

Jönsson et al, 2010

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Technical Briefing Seminar, 1- 5 November 2010

 125 Patients  24 Patients experienced ADRs (19%)

59% were avoidable

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Technical Briefing Seminar, 1- 5 November 2010

Cost of ADRs in the US?

Cost of drug related morbidity and mortality exceeded $177.4 billion in 2000

Ernst FR & Grizzle AJ, 2001: J American Pharm. Assoc

ADR related cost to the country exceeds the cost of the medications themselves

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Technical Briefing Seminar, 1- 5 November 2010

Pharmacovigilance in WHO HQ

1.

2.

3.

4.

5.

Exchange of Information Policies, guidelines, normative activities Country support Collaborations Fund raising

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Technical Briefing Seminar, 1- 5 November 2010

WHO HQ Pharmacovigilance staff

Dr Shanthi Pal, Acting Manager Medicines Saftey, QSM 12 |

Technical Briefing Seminar, 1- 5 November 2010

+ 3 support staff

1. Exchange of Information

 National Information Officers  Publications (WHO Pharm Newsletter, Restricted Pharm List, Drug Alerts, WHO Drug Information)  International Conference of Drug Regulatory Authorities (ICDRA)

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Technical Briefing Seminar, 1- 5 November 2010

2. Policies, Guidelines and Normative Activities

Guidelines – The Importance of Pharmacovigilance (2002) – Safety Reporting - A guide to detecting and reporting adverse drug reactions (2002) – Policy perspectives on medicines (Pharmacovigilance) 2004 – Safety monitoring of herbal medicines (2004) – Pharmacovigilance in Public Health – Advisory Committee for the Safe Use of Medicinal Products (ACSoMP)

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Technical Briefing Seminar, 1- 5 November 2010

3. Country support

 Training courses on pharmacovigilance (Regional Training Courses, biennial course by UMC and HQ)  Address specific / stated needs: kava, ARVs, antimalarials….

 Annual Meeting of Pharmacovigilance Centres

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Technical Briefing Seminar, 1- 5 November 2010

4. Collaborations & Partnerships within WHO

 Malaria  HIV/AIDS  Leprosy  Lymphatic Filariasis  Leishmaniasis  Chagas

Over a 100 million people targeted for either diethylcarbamazine citrate (DEC) plus albendazole or ivermectin plus albendazole

.

 Patient Safety  Poisons and Chemicals Safety  Traditional Medicines  Vaccines

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Technical Briefing Seminar, 1- 5 November 2010

5. Resource Mobilisation

 Gates foundation  European Commission  Global Fund  Others  Human resources: WHO Consultants Network for Pharmacovigilance (PV) in Africa (PvSF – Pharmacovigilance Sans Frontières)

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Technical Briefing Seminar, 1- 5 November 2010

WHO International Pharmcovigilance Programme Full and Associate Members November 2010, 102 member countries 18 |

Technical Briefing Seminar, 1- 5 November 2010

Uppsala Monitoring Centre (UMC)

WHO Collaborating Centre for International Drug Monitoring

 the operational centre of the WHO PV Programme  established as a foundation 1978  based on agreement Sweden - WHO  international administrative board  WHO Headquarters responsible for policy  self financed

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Technical Briefing Seminar, 1- 5 November 2010

UMC main tasks - summary

 Collect and analyse ICSRs worldwide  Communicate potential drug safety issues 

Actively support and provide training

 Develop the science of pharmacovigilance

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Technical Briefing Seminar, 1- 5 November 2010

WHO Programme for International Drug Monitoring UMC-A WHO CC Accra WHO-HQ Geneva UMC WHO-CC Uppsala Pharma companies Medical practices 21 |

Technical Briefing Seminar, 1- 5 November 2010

National Centres

Number of members of the WHO International Drug Monitoring Programme 22 |

Technical Briefing Seminar, 1- 5 November 2010

Strengths

 Global PV network  National Centres Meetings  Only available global database of ADRs  Over 40 years track record in medicine safety  Public health approach  No hidden agendas

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Technical Briefing Seminar, 1- 5 November 2010

Weaknesses

 Inadequate representation in Africa  Only Spontaneous reporting  no denominator data  poor quality reports  Little or no budget  PHPs: Vertical approach

Opportunities

 Donor interest in PV  New partners  Malaria, HIV AIDS, neglected diseases • • urgent PV needs investing in new methods

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Technical Briefing Seminar, 1- 5 November 2010

Threats

 Lucrative business  Lack of harmonization  Duplication of efforts

Challenges to Pharmacovigilance



An analysis of pharmacovigilance activities in 55 low- and middle-income countries

– Sten Olsson a , Shanthi Pal b , Andy Stergachis c , Mary Couper a – Drug Safety 2009/2010 (a: WHO CC, Uppsala; b: WHO QSM; c: UWa)

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Technical Briefing Seminar, 1- 5 November 2010

Challenges to Pharmacovigilanc

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Technical Briefing Seminar, 1- 5 November 2010

Type of assistance needed

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Technical Briefing Seminar, 1- 5 November 2010

WHO - UMC relationships

WHO Classifi cations Vaccine safety Other Tropical Diseases Medicines Policy and Standards Malaria HIV/AIDS Patient Safety Alliance 28 |

Technical Briefing Seminar, 1- 5 November 2010

UMC

1.

3 tiers-approach for WHO

As before

– Spontaneous reporting

Maintain as the cheapest, easiest, most sustainable method

 

Regional trainings – Country support –

2.

More than before

Active surveillance WHO and UMC WHO, UMC and UMC-A   

Tools -

CEMFlow for Cohort Event Monitoring

Handbooks Nigeria, Tanzania, Ghana –

Cohort Event Monitoring in Public Health Programmes

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Technical Briefing Seminar, 1- 5 November 2010

Support, guidelines &

Expecting the Worst - Crisis Management

technical resources

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Technical Briefing Seminar, 1- 5 November 2010

3 tiers-approach for WHO

3.

As never before



Indicators

   

Fundraising

 EuropeAid; UNITAID, GFATM, PEPFAR; FP7 etc

Centres of excellence

 Ghana – WHO Collaborating Centre for Advocacy and training in PV  Morocco – training for francophone countries

Developing networks

   PV Consultants Network for Africa Global Network for ADR reporting in prequalified vaccines National Centres meeting in Ghana

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Technical Briefing Seminar, 1- 5 November 2010

Activities the last few months

 Ghana, May – PV conference arranged by West African Health Organization  Morocco, June – Training course for francophone countries  Togo, October – PV Consultants Network for Africa  Ghana, November – Stakeholders meeting, Donors and WHO  Activities in other parts of the world: – Training course in Singapore for Asian countries – – – UMC country visits in eastern European countries Restart of PV in India Coming – training course in Mexico

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Technical Briefing Seminar, 1- 5 November 2010

Members of PV Consultants Network for Africa

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Technical Briefing Seminar, 1- 5 November 2010

Challenges for the future

To make PV systems sustainable through: – – stable financing trained and dedicated staff Create a culture of reporting – – from health professionals the public

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Technical Briefing Seminar, 1- 5 November 2010

Thank you for your attention

www.who.int [email protected]

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Technical Briefing Seminar, 1- 5 November 2010 www.who-umc.org