Second Africa TB Regional Conference on Management of TB Medicines

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

www.tfda.or.tz 2

AFRICA TB CONFERENCE 2012 2ND AFRICA TB REGIONAL CONFERENCE ON

MANAGEMENT OF TB MEDICINES 5-7 DECEMBER, 2012 ZANZIBAR-TANZANIA

TANZANIA EXPERIENCE WITH ESTABLISHING QA/QC AND PMS SYSTEM

FOR TB MEDICINES by

Yonah Hebron

Background of Country TB Profile

• Tuberculosis (TB) still claims 1.7 million victims per year worldwide, mostly in developing countries.

• Tanzania is a high-burden country with about 60,000 new TB cases annually.

• TB is very complex to treat, requiring a combination of daily drugs over a half-year treatment period.

• The biggest challenge in the treatment of TB is— – Multidrug-resistant tuberculosis (MDR-TB) – Extensively drug-resistant tuberculosis (XDR-TB)

Challenge to Quality of TB Medicines in Tanzania • It is estimated that at least 5-7% of medicines in circulation

globally may be counterfeit (up to 60% of counterfeiting claimed to occur in developing countries)

• Tanzania is importing more than 80% of its pharmaceutical supplies (possibilities of being supplied with substandard products)

• Porous borders (in addition to official port of entry [PoE]) • Inefficient cooperation between stakeholders • Lack of structured medicines’ postmarketing survey (PMS) and

inspection system

Activities to Address the QA Challenges (1) • Established medicines registration system

– TB medicines are sourced from WHO prequalified facilities – Focus on medicines listed under the National Treatment Guidelines

• Tanzania Food and Drugs Authority (TFDA) established a quality assurance (QA) program for all risk/program medicines – Medicines samples collected at PoE and screened using the GPHF

Minilab kits (2 kits at TFDA HQ and 8 QA centers [regional hospitals]) » Each center must screen medicines they receive from MSD & other sources » Must provide monthly report to the QA center desk officer » Importers motivated to give free samples to be taken (small number of units

required)

Activities to Address the QA Challenges (2) – A structured medicines consignment inspection system at all

official PoE » Collaborate with other stakeholders i.e. local Government,

private sector, Police force, TRA & other law enforcers » Inspectors trained and provided with SOPs, inspection

checklist, Decision tree – Strengthened import control (closely working with NTLP in case

of TB medicines) » Importation of medicines need TFDA approval » TB medicines only imported through MSD (initiated by NTLP) » NTLP Coordinate distribution to approved hospitals » Private sectors are not allowed to import or distribute TB

medicines

Activities to Address the QA Challenges (3)

• Established Medicines PMS – Structured PMS program in place – Quality and safety (pharmacovigilance) monitoring of

registered products in the market – Selection criteria and parameters to be tested

predetermined – A pool of trained sample collectors in place countrywide – Private sector and other stakeholders motivated to

participate in monitoring and reporting of substandard/counterfeit medicines

Verify documentation

Perform label exam

Perform physical exam

Release No

Screening

Inspection Process at POE

Are there any program medicines,

e.g., anti-TB?

Pass

Yes Quarantine

and send to lab No Yes

Inspector goes To POE

Flow Chart Minilab Screening Disintegration test

Colorimetric test

Yes

No

TLC test Proficiency testing

Identity test for class of compounds

Yes

No

No Release

to the market

Yes

Refer to NDQCL Inform the owner Lab- either Release or reject followed by appropriate actions

Passed?

Passed?

Did product fail test?

Confiscate: POE Quarantine: PMS

Confiscate: POE Quarantine: PMS

SP

KEY: -

Regions Provided with GPHF Minilab Kits

PoE & Other Samples—2008-September 2012—Minilab Results

59 667 269

54 651 264

54 648 264

Fail

Pass

Tested

Received

• Total of 995 samples received

• 969 samples tested • All anti-TB tested complied • Three batches of

antimalarial failed • Five anti-TB samples not

tested because of lack of Certified Reference Standards/microorganisms

Results: PMS 2007-2009

323

182 609

18

108274

18

93 274

0 15 0

Fail

Pass

Tested

Received

• All batches of anti-TB medicines complied

• Majority of samples expired prior to testing

• 14% of batches of antimalarial failed

Results: PMS 2011-2013 Phase I & II

157 202 83 138

130 202 83 138

130 202 81 111

Pass

Tested

Received

• All batches of anti-TB complied (screening test)

• All batches of anti-malarial samples which include quinine (tablets & syrups) and artemether-lumefantrine complied with both screening and confirmatory tests (improvement in case of quinine compared to 2007-2009 PMS failure rate was 3.8%)

• Two batches ARVs (same product) failed disintegration test (2.4%)

• 27 batches of cloxacillin (caps & oral susp) failed the confirmatory test (19.4%)

Strength and Weaknesses/Challenges of Intervention

• WHO Prequalified laboratory

• Full support from parent Ministry (MOHSW) & development partners

• 15 GPHF Minilabs (10 in place since 2002 & 5 recently received )for five other regions

• Structured PMS program for all risk/program product

• Pool of trained inspectors capable carrying out sampling and inspections at PoE & dispensing outlets

Strength Weakness/challenges • Direct released/delivered product to MSD • Porous borders/unofficial PoE • Inspectors not adhering to sampling plans &

sampling requirements • Lax inspectors for both TFDA & other law

enforcers (stakeholders) • Lack of PMS program awareness at regional

/district level • Some key players/stakeholders not fulfilling

their responsibilities, e.g., received samples screened

• Inadequate resources (manpower & financial resources for consumables & other lab equipment)

• Lenient punishments for offences

Conclusion

• A structured PMS can greatly contribute towards improving quality of medicines in the market. However, to achieve that we need to bring all stakeholders aboard.

• The public and private sectors are encouraged to participate in monitoring and reporting substandard/counterfeit medicines

• Private sector must cooperate with TFDA in facilitating PMS activities.