Second Africa TB Regional Conference on Management of TB Medicines

Africa TB Conference 2012, Zanzibar December 5-7, 2012

Philippine Experience with establishing quality control and quality assurance system for TB

medicines Maria Lourdes C. Santiago, MSc, MM

Chief, Laboratory Services Division Food and Drug Administration, Philippines

Africa TB Conference 2012 2nd Africa TB Regional Conference on Management of TB Medicines

December 5-7, 2012

Outline

• Background • Description of TB medicines’ quality challenge • Intervention identified and implemented • Process of implementation of the intervention • Monitoring and evaluation (M&E) of intervention • Strengths and weaknesses/challenges of intervention • Conclusion

Background of Philippines Tuberculosis— current status of country • Ranks 15th on the list of 22 high-burden TB countries

in the world (WHO Global TB Report 2011) • Second highest number of cases in the WPRO (2007) • TB is the sixth greatest cause of morbidity and

mortality in the country • Affected age group ranges from 14 to 55 years old • NTP has served as the country’s prime motivator in

its commitment to stop TB – 2010 Objective : 79-85% CDR with active TB cases ; TSR 89 -90% by 2015

Description of TB Medicine Quality Challenge in the Country • High burden country for TB • Patients have limited access to a variety of anti-TB

medicines especially when patients are not cured with the first line treatment

• Documented existence of poor quality medicines • Limited resources and capacity in post market

surveillance (PMS) to monitor the quality of ATB

Intervention Identified and Implemented

• Established anti-TB (4 drugs and/or FDC) quality monitoring program in order to obtain evidence-based data from the field on the quality of ATBs– FDA, NTP, USP PQM – rifampicin, pyrazinamide, ethambutol, isoniazid

• Organized training courses on sampling, basic tests using Minilab kits, drug quality data management, and reporting

• Engaged the national, provincial, and local government units to take appropriate action

• Protocol for quality monitoring was prepared and authorized by the Secretary of Health through a Department Order.

Process of Implementation of Interventions • Coordinated with the National TB Program • Selected 6 sentinel sites where the pilot implementation will be

held – Based on their geographic location and documentation of high level of

TB cases and/or drug resistance • Distribution and use of Minilab kits developed by GPHF to the sites

– Visual inspection, semi quantitative analysis using TLC, disintegration test

• Collection of samples to be done by the FDA field inspectors and/ or “mystery shopper”

• Confirmatory testing using the pharmacopeial methods done at the central laboratories

• Regular meetings with stakeholders – NTP, FDA, NCPAM, MMD (Procurement & Supply), representative from the sentinel sites

Monitoring and Evaluation of the Interventions • Used indicators to measure the progress and

outcome of the ATB Quality Monitoring Project – Background indicators – Process indicators – Impact indicators

• Stakeholders together with US Pharmacopeia (USP) Promoting the Quality of Medicines program staff meet regularly to discuss the progress, challenges, gaps (Technical Working Group)

Monitoring and Evaluation of the Interventions (2) • FDA Philippines analyzed a total of 637 ATB drugs from

January 2008 to September 2012. • Based on quality parameters, 569 ATB drugs met the

regulatory specifications. • 59 TB drugs were considered doubtful even though they

have passed the confirmatory testing because they did not apply for batch notification.

• Meanwhile, 9 (1. 41%) ATB drugs failed as they did not conform to quality specifications – Recalled and withdrawn from the shelf

• There was no incidence of counterfeiting for ATB drugs from the start of the project up to the present.

Strengths and Weaknesses/Challenges of the Intervention (1) Strengths • Dedication of concerned personnel to the project • Availability and willingness of the private sector to

provide assistance. • Support from the public sector is also evident

(purchasing of medicines by LGU) • Keen understanding by FDA central enabled adapting

to situation.

Strengths and Weaknesses/Challenges of the Intervention (2) Weaknesses • Lack of time to perform the Minilab® tests • Problems in performing the confirmatory tests using

the USP compendial method (i.e., fixed-dose combination difficulty in the analysis of ethambutol)

• Problems with the reporting system (data are not being reported properly)

• Lack of samples collected at the sentinel sites • Frequent sampling collection and testing

Conclusion

• To ensure success in the implementation of the quality assurance program, there is a need to: – Engage the participation and commitment of ALL concerned

health care providers – Regulate and make available quality TB drugs

• Strengthen and continue post-marketing surveillance of ATB medicines and other essential medicines at the sentinel sites – Assist manufacturers to comply with the GMP requirements – Recall product when quality is compromised

• Advocate the importance of quality of medicines globally to ensure patient safety