References in the content below refer to the PBMEF Guide.
Definitions
Percent of anti-TB medicines procured locally or internationally which meet international minimum quality standards within a country.
“International minimum quality standards” are defined and documented in the batch certificate. Standards and the reference organizations considered to be acceptable include WHO Prequalification of Medicines Programme (PQP)/ stringent regulatory authorities (SRAs)/ Expert Review Panel (ERP).
Calculation: (Numerator/Denominator) x 100
Numerator
Denominator
Ref # |
SN_MQS
|
Tier Level |
National Level Indicators
|
Category |
Sustain
|
Type |
Outcome
|
Unit of Measure |
Percent of anti-TB medicines
|
Data Type |
Percentage
|
Disaggregations |
N/A |
Reporting Level |
National Level indicators should be reported at the national level; data may also be reported subnationally or at the project level if national data are not available.
|
Reporting Frequency |
This indicator should be reported on an annual basis at a minimum. More frequent monitoring on a quarterly or monthly basis is recommended.
|
Data for this indicator can be obtained from public and private sector procurement agents.
In accordance with Good Manufacturing Practices (GMP), a manufacturer should produce a batch certificate for each batch of its product. The batch certificate documents the results of quality analysis and inspection for each batch of the product. The agency that procures the medicine should request and review the batch certificate to ensure the data are acceptable. “Acceptable” data would demonstrate the batch is of adequate quality to be used in the TB program.
In order to prevent emergence of drug-resistant (DR) TB and to sustain the treatment successes achieved to date by using quality assured medicines, we must ensure countries procuring TB medicines with domestic funding should procure drugs according to these 'International minimum quality standards.'
The percentage of anti-TB medicines that meet international minimum quality standards can be analyzed as a trend over time either on its own or against country targets. Procurement agents should be sensitized to the importance of obtaining and reviewing this documentation as basic evidence of the quality of medicine that they procure. Receipt of this documentation can be specified as a requirement in procurement contracts to help ensure the quality of medicines on the market.
Example charts/graphs:
- Trend over time comparisons
Indicator Visualizations
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