challenges for the who programme for international drug monitoring shanthi pal quality assurance and...

Challenges for the WHO Programme for International Drug Monitoring

Shanthi PalQuality Assurance and Safety of Medicines

Cecilia BiriellReports, Analysis and Country Support

Challenges for the WHO Programme for International Drug Monitoring

Shanthi PalQuality Assurance and Safety of Medicines

Cecilia BiriellReports, Analysis and Country Support

Technical Briefing Seminar, 1- 5 November 20102 |

Technical Briefing Seminar, 1- 5 November 20103 |

RiskRisk

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.

Technical Briefing Seminar, 1- 5 November 20104 |

What is Pharmacovigilance?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

Technical Briefing Seminar, 1- 5 November 20105 |

What is the scope of pharmacovigilance?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

Technical Briefing Seminar, 1- 5 November 20106 |

Why pharmacovigilance?Why pharmacovigilance?

Humanitarian concerns– Hippocrates admonition

at least do not harm

Economical concerns

Technical Briefing Seminar, 1- 5 November 20107 |

Examples of product recalls due to toxicityExamples of product recalls due to toxicity

MedicineYear

Examples of serious and unexpected adverse events leading to withdrawal

Thalidomide 1965Phocomelia

Practolol1975Sclerosing peritonitisClioquinol1970Subacute nephropathyBenoxaprofen1982Nephrotoxicity, cholestatic

jaundice

Terfenadine1997Torsade de pointesRofecoxib2004Cardiovascular effectsSibutramine2010Anxiety, depression, movement

disorders

Technical Briefing Seminar, 1- 5 November 20108 |

Studies of ADR related deathsStudies of ADR related deaths

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

Lazarou et al, 1998

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

Pirmohamed et al, 2004

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

Jönsson et al, 2010

UK:

US:

Sweden:

Technical Briefing Seminar, 1- 5 November 20109 |

125 Patients

24 Patients experienced ADRs (19%)

59% were avoidable

Technical Briefing Seminar, 1- 5 November 201010 |

Cost of ADRs in the US?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

Technical Briefing Seminar, 1- 5 November 201011 |

Pharmacovigilance in WHO HQPharmacovigilance in WHO HQ

1. Exchange of Information

2. Policies, guidelines, normative activities

3. Country support

4. Collaborations

5. Fund raising

Technical Briefing Seminar, 1- 5 November 201012 |

WHO HQ Pharmacovigilance staffWHO HQ Pharmacovigilance staff

Dr Shanthi Pal, Acting ManagerMedicines Saftey, QSM +3 support staff

Technical Briefing Seminar, 1- 5 November 201013 |

1. Exchange of Information 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)

Technical Briefing Seminar, 1- 5 November 201014 |

2. Policies, Guidelines and Normative Activities

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)

Technical Briefing Seminar, 1- 5 November 201015 |

3. Country support3. 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

Technical Briefing Seminar, 1- 5 November 201016 |

4. Collaborations & Partnerships within WHO

4. Collaborations & Partnerships within WHO

Malaria

HIV/AIDS

Leprosy

Lymphatic Filariasis

Leishmaniasis

Chagas

Patient Safety

Poisons and Chemicals Safety

Traditional Medicines

Vaccines

Over a 100 million people targeted for either

diethylcarbamazine citrate (DEC) plus albendazole or ivermectin

plus albendazole.

Technical Briefing Seminar, 1- 5 November 201017 |

5. Resource Mobilisation5. Resource Mobilisation

Gates foundation

European Commission

Global Fund

Others

Human resources: WHO Consultants Network for Pharmacovigilance (PV) in Africa (PvSF – Pharmacovigilance Sans Frontières)

Technical Briefing Seminar, 1- 5 November 201018 |

WHO International Pharmcovigilance ProgrammeFull and Associate Members

WHO International Pharmcovigilance ProgrammeFull and Associate Members

November 2010, 102 member countries

Technical Briefing Seminar, 1- 5 November 201019 |

Uppsala Monitoring Centre (UMC)WHO Collaborating Centre for International Drug Monitoring

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

Technical Briefing Seminar, 1- 5 November 201020 |

UMC main tasks - summaryUMC main tasks - summary

Collect and analyse ICSRs worldwide

Communicate potential drug safety issues

Actively support and provide training

Develop the science of pharmacovigilance

Technical Briefing Seminar, 1- 5 November 201021 |

WHOWHO Programme for International Programme for International Drug MonitoringDrug Monitoring

WHOWHO Programme for International Programme for International Drug MonitoringDrug Monitoring

WHO-HQWHO-HQGenevaGeneva

UMCUMCWHO-CCWHO-CC UppsalaUppsala

NationalNational CentresCentres

UMC-A UMC-A WHO-WHO-

CCCCAccraAccra

MedicalMedical practicespractices

PharmaPharma companiescompanies

Technical Briefing Seminar, 1- 5 November 201022 |

Number of members of the WHO International Drug Monitoring Programme

Number of members of the WHO International Drug Monitoring Programme

Technical Briefing Seminar, 1- 5 November 201023 |

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

Weaknesses

Inadequate representation in Africa

Only Spontaneous reporting

no denominator data poor quality reports

Little or no budget

PHPs: Vertical approach

Technical Briefing Seminar, 1- 5 November 201024 |

Opportunities

Donor interest in PV

New partners

Malaria, HIV AIDS, neglected diseases

•urgent PV needs•investing in new methods

Threats

Lucrative business

Lack of harmonization

Duplication of efforts

Technical Briefing Seminar, 1- 5 November 201025 |

Challenges to PharmacovigilanceChallenges to Pharmacovigilance

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

– Sten Olssona, Shanthi Palb, Andy Stergachisc, Mary Coupera

– Drug Safety 2009/2010

(a: WHO CC, Uppsala; b: WHO QSM; c: UWa)

Technical Briefing Seminar, 1- 5 November 201026 |

Challenges to PharmacovigilancChallenges to Pharmacovigilanc

Technical Briefing Seminar, 1- 5 November 201027 |

Type of assistance neededType of assistance needed

Technical Briefing Seminar, 1- 5 November 201028 |

WHO - UMC relationshipsWHO - UMC relationships

OtherTropicalDiseases

Malaria HIV/AIDSPatient Safety

Alliance

UMC

Vaccinesafety

WHOClassifi-cations

MedicinesPolicy andStandards

Technical Briefing Seminar, 1- 5 November 201029 |

3 tiers-approach for WHO3 tiers-approach for WHO

1. As before– Spontaneous reporting

Regional trainings – WHO and UMC Country support – WHO, UMC and UMC-A

2. More than before- Active surveillance

Tools - CEMFlow for Cohort Event Monitoring

Handbooks Nigeria, Tanzania, Ghana –

Cohort Event Monitoring in Public Health Programmes

Maintain as the cheapest,

easiest, most sustainable

method

Technical Briefing Seminar, 1- 5 November 201030 |

Expecting the Worst - Crisis Management                                                                                         

Support, guidelines & technical resourcesSupport, guidelines & technical resources

Technical Briefing Seminar, 1- 5 November 201031 |

3 tiers-approach for WHO3 tiers-approach for WHO

3. As never before Indicators

Minimum requirements for a Functional National PV System

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

Technical Briefing Seminar, 1- 5 November 201032 |

Activities the last few monthsActivities 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

Technical Briefing Seminar, 1- 5 November 201033 |

Members of PV Consultants Network for Africa

Members of PV Consultants Network for Africa

Technical Briefing Seminar, 1- 5 November 201034 |

Challenges for the futureChallenges 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

Technical Briefing Seminar, 1- 5 November 201035 |

Thank you for your attention Thank you for your attention

www.who.int info@who-umc.org www.who-umc.org