Access to Quality anti-TB Drugs

The time is now!

Turning the tide on drug-resistant TB and TB/HIV co-infection in Myanmar Yangon, Myanmar – 22 -23 August 2013

SAFE – EFFECTIVE – DO NO HARM Quality Assured Medicines

Carole Zen Ruffinen Disease Focused Pharmacist for TB and Neglected Diseases; MSF International

The time is now!

Turning the tide on drug-resistant TB and TB/HIV co-infection in Myanmar Yangon, Myanmar – 22 -23 August 2013

What are Quality Assured Medicines?

• Quality Assurance includes all steps to ensure that drugs are

– SAFE – EFFECTIVE – DO NO HARM • Quality Assurance is the same process for – – – –

All medicines All diseases All populations WORLDWIDE, everywhere

The time is now!

Turning the tide on drug-resistant TB and TB/HIV co-infection in Myanmar Yangon, Myanmar – 22 -23 August 2013

What do we mean by Quality Assured Medicines?

• (Safe and efficient) • Contain correct Active Pharmaceutical Ingredient (API) of good quality • Contain the right concentration of API • Contain no toxics and control/knowledge of the products of degradation • Stable in environment where stored and used • Generics are therapeutic equivalent • Labelled correctly

The time is now!

Turning the tide on drug-resistant TB and TB/HIV co-infection in Myanmar Yangon, Myanmar – 22 -23 August 2013

Quality Problems Found Failed Anti-tuberculosis and Antimalarial Samples (n=479) in Selected USAID-assisted Countries (16 countries represented in 12 reports: 1997-2003)

Others

24%

e.g. contamination, unusual appearance, wrong labeling

Incorrect amount of API 8%

No API

68%

The time is now!

Turning the tide on drug-resistant TB and TB/HIV co-infection in Myanmar Yangon, Myanmar – 22 -23 August 2013

Can be life or death …  2004 Darfur, MSF reported a local donation of Ringers lactate infusions contaminated with a fungal growth  2005 Niger, during a meningitis epidemic MSF teams noticed vaccine didn’t look right – after analysis, they contained no active ingredient – estimated 50,000 people received this vaccine  2009 – 25 children died from paracetamol liquid containing diethylene glycol  1995 - 88 children died in Haiti  1998 – 30 children died in India  2013 – examples of latest reported quality complaints 5

The time is now!

Turning the tide on drug-resistant TB and TB/HIV co-infection in Myanmar Yangon, Myanmar – 22 -23 August 2013

2013 Contaminated IV bottles in MSF project Kenya “Nipple Head bottles” are not the most appropriate containers for IV fluids.

The time is now!

Turning the tide on drug-resistant TB and TB/HIV co-infection in Myanmar Yangon, Myanmar – 22 -23 August 2013

2013 MSF TB projects First Line TB medicines

The time is now!

Turning the tide on drug-resistant TB and TB/HIV co-infection in Myanmar Yangon, Myanmar – 22 -23 August 2013

Driving Factors of Resistance Development in TB Key factors of resistance development to any TB drug, and therefore increasing the burden of M/XDR TB in patients are • Low completion and low cure rates • Poor adherence due to long regimens with serious side effects • Poor treatment follow-up and patient support • Inadequate infection control measures • Irrational drug prescribing practices • Poor quality of TB medicines • Insufficient market regulation for TB drugs  availability of TB medicines on private markets without prescription  use of TB drugs for other diseases • High costs for patients, who are left to buy full treatment course out of pocket.

Conclusion Objectif

The time is now!

Turning the tide on drug-resistant TB and TB/HIV co-infection in Myanmar Yangon, Myanmar – 22 -23 August 2013

TB Drug Resistance: the Global Picture Total estimated MDRTB cases (among all TB notifications) among new and previously treated TB notifications.

WHO data on TB Drug Resistance survey and surveillance data of 2010

any resistance %

Royce S. Multidrug resistance in new tuberculosis patients: burden and implications, INT J Tuberc Lung Dis 2013

The time is now!

Turning the tide on drug-resistant TB and TB/HIV co-infection in Myanmar Yangon, Myanmar – 22 -23 August 2013

National Drug Regulatory Authority (NDRA)  Responsible to ensure safety of drugs on their market  Registration / Marketing license  Different rules for each country  Importation  Different rules for humanitarian, clinical trials, commercial cargo  Different rules in different countries

….BUT….  Broad range of capacities of the different NDRA

10

The time is now!

Turning the tide on drug-resistant TB and TB/HIV co-infection in Myanmar Yangon, Myanmar – 22 -23 August 2013

Global Pharmaceutical Market: Quality Assurance and Risks Stringent Regulated Authorities

Quality Assurance

Innovators

Generics

Weakly Regulated Countries

Export to

Export to Export to Domestic

WR countries

HR countries WR countries

Market

Manufacturing site

GMP standards

YES

YES

+/-

YES

NO

WEAK

Active Ingredients

Pharmacopoeias

YES

YES

NO

YES

NO

NO

Finished product

Pharmacopoeias

YES

YES

NO

YES

NO

NO

Therapeutic Equivalence

N/A

YES

NO

YES

NO

NO

Stability studies

YES

YES

NO

YES

NO

NO

Packaging/Labelling/Leaflet

YES

YES

NO

YES

NO

NO

Independent Quality Control

YES

YES

NO

YES

NO

NO

Distribution Channels

YES

YES

NO

YES

NO

NO

Pharmacovigilance

YES

YES

NO

YES

NO

NO

Re-inspection

YES

YES

WEAK

YES

NO

NO

WHO/ICH

GDP standards

The time is now!

Turning the tide on drug-resistant TB and TB/HIV co-infection in Myanmar Yangon, Myanmar – 22 -23 August 2013

Availability of Quality Assured TB Drugs Internationally recognized mechanisms assessing the quality of TB drugs according to ICH standards: • WHO pre-qualification program (WHO PQ) • Qualified through Expert Review Panel (ERP) of Global Fund (temporarily approval, risk-based assessment) focused on HIV, TB, Malaria • Stringent Regulatory Authorities (e.g. EMA, US FDA)

ICH (Int. Conference for Harmonisation) : increases international harmonisation of technical requirements to ensure that safe, effective, and high quality medicines are developed and registered in the most efficient and cost-effective manner.

The time is now!

Turning the tide on drug-resistant TB and TB/HIV co-infection in Myanmar Yangon, Myanmar – 22 -23 August 2013

How to Identify Quality Assured TB Medicines?

• Comprehensive list of quality assured TB medicines sources (Drug sensitive and Drug resistant TB) on Global Fund website http://www.theglobalfund.org/en/procurement/quality/pharmaceutical/

• List of WHO Prequalified TB medicines http://apps.who.int/prequal/

Key information to identify a QA source: WHO PQ Number, SRA Registration Number and the Manufacturing Site

The time is now!

Turning the tide on drug-resistant TB and TB/HIV co-infection in Myanmar Yangon, Myanmar – 22 -23 August 2013

How to Procure Quality Assured TB Medicines?

Global Drug Facility (GDF) A supplier of Quality Assured TB medicines worldwide International pooled procurement mechanism for quality assured TB medicines http://www.stoptb.org/gdf/drugsupply/drugs_available.asp

• •

WHO Stop TB Partnership Quality Assurance Policy – WHO Report: A Model Quality Assurance System for Procurement Agencies, 2007 http://apps.who.int/medicinedocs/en/m/abstract/Js14866e/ – GDF QA policy implemented June 2010 and in full harmonisation with Global Fund QA

policy

http://www.stoptb.org/gdf/drugsupply/quality_sourcing_process.asp

•

GDF exclusive procurement agent for TB medicines IDA (FL, SL, TL)

The time is now!

Turning the tide on drug-resistant TB and TB/HIV co-infection in Myanmar Yangon, Myanmar – 22 -23 August 2013

GDF: supplier of Quality Assured TB medicines

(GDF 2012)

The time is now!

Turning the tide on drug-resistant TB and TB/HIV co-infection in Myanmar Yangon, Myanmar – 22 -23 August 2013

SAFE – EFFECTIVE - DO NO HARM

The time is now!

Turning the tide on drug-resistant TB and TB/HIV co-infection in Myanmar Yangon, Myanmar – 22 -23 August 2013

How to get there?

To ensure safety of patients AND preserve efficacy of TB medicines and avoid fuelling resistance

Governments, Donors, International Agencies and NGOs Commit to use TB medicines, which meet WHO quality standards

Governments Strengthen the market regulation for TB medicines Improve national drug production and allow for importation and marketing of TB medicines that meet high quality standard

The time is now!

Turning the tide on drug-resistant TB and TB/HIV co-infection in Myanmar Yangon, Myanmar – 22 -23 August 2013

THANK YOU

Contact: Carole Zen Ruffinen Pharmacist - Focused on Tuberculosis and Neglected Diseases MSF international Email: carole.zenruffinen@geneva.msf.org