Pharmacovigilance: challenges facing WHO

Shanthi PalLeader, Medicines Safety

Safety and Vigilance,WHO, Geneva

What is pharmacovigilance

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

(The Importance of Pharmacovigilance, WHO 2002)

• A tool for generating evidence to influence policies

WHO Global PV ProgrammeWhy??

• World Health Assembly Resolution 16.36

• INVITES Member States to arrange for a systematic collection of information on serious adverse drug reactions observed during the development of a drug and, in particular, after its release for general use.

Who?

WHO-HQGeneva

> 50 years

UMCWHO-CC Uppsala

> 40 years

NationalCentres

WHO-CCAccra(2009)

WHO-CCRabat(2010)

(2012)

WHO-CCOslo

>30 years

Policies,Norms, Guidance,Donor LiaisonResources

Technical supportCapacity buildingDatabase, tools , Signals

Capacity : Africa focusedPublic health focused

Capacity : Francophone & Arabic countries

ATC DDD

PV in academiaPatient reporting

ImplementCollect ADRsShare with WHO database

Challenges to PV in low and middle income countries (LMIC)

• Lack of political support• Lack of resources• Lack of competence• Lack of PV systems and/ or inadequate function• Lack of communication and

information exchange

% Implemented out of the

total countries in the region

% Implemented (of those with data available)

Number of Countries

with Indicator Implemented

Number of Countries with data available

Number of

Countries

Group of countries

94 94 45 48 48 A. Industrialized

13 38 5 13 39 B. Upper middle income

9 29 5 17 57 C1.Lower middle income

4 12 2 17 49 C2.Low income

Capacity to detect significant vaccine safety issue

WHO survey of PV systems in 55 countries

North America

Europe

Why is this a problem?

• More than 300 products in the pipeline for neglected diseases, HIV AIDS, TB and malaria

• At least half of them will be launched in the coming years in those very settings where there is little or no capacity for post approval monitoring

Developer Analysis, BVGH, 2012

Lead Optimization Preclinical Development

GLP Tox. Phase I Phase II Phase III

Delamanid (OPC-67683)GatifloxacinMoxifloxacinRifapentine

AZD5847Bedaquiline (TMC-207)LinezolidNovel Regimens2

PA-824RifapentineSQ-109Sutezolid (PNU-100480)

CPZEN-45DC-159aQ201SQ609SQ641

Preclinical DevelopmentDiscovery1 Clinical Development

DiarylquinolineDprE InhibitorsGyrB inhibitorsInhA InhibitorsLeuRS InhibitorsMGyrX1 inhibitorsMycobacterial Gyrase InhibitorsPyrazinamide AnalogsRiminophenazinesRuthenium (II) complexesSpectinamidesTranslocase-1 Inhibitors

Global TB Drug Pipeline

Updated: June 18, 2012

BTZ043TBA-354

www.newtbdrugs.org

4 Repurposed Drugs6 New Drugs

3 New Classes

Drugs currently in the regulatory review process

http://www.who.int/medicines/areas/quality_safety/safety_efficacy/saf_pub/en/

What can we do about it?

Build PV systems

Innovative solutions to support those systems

Network of WHO Collaborating Centres (CC) to support PV systems in countries

• Uppsala Monitoring Centre, Sweden

• WHO CC Accra, Ghana• WHO CC Rabat, Morocco• WHO CC Oslo, Norway• WHO CC Netherlands (Lareb) PV consultants in Africa, for Africa

Dedicated resources

Overcome technical barriers to PV in LMIC

• for receiving and storing ADR reports.

• The entered reports can be extracted as XML files

• can be transferred to other (E2b)databases

• A search and statistics module is built into the system

• Easy to use and error-checking ensures accuracy. Vigiflow

Task shifting: patients as partners

• Conventional models can't work in some settings

• All hands on board– Task shifting

• Patient reporting (more data, timely data, additional information)

Forward looking strategies through broad networks

Expanding and implementing the full scope of PV

Links with SSFFC networksLinks with medication errors networks

Pharmacovigilance investments will yield multiple benefits

• As an insurance for investments in public health interventions: – A comprehensive disease control approach must include quality

and safety as a component.• By Investing in PV, countries will have data on medicines

– To assist decision making by regulators, improve treatment strategies, health care practices, and treatment outcomes

• Pharmacovigilance data can guide procurement of effective medicines and reduce wastage

• Robust safety monitoring also provides a quality assurance mechanism and helps monitor programmatic implementation.