Report on Post-Market Surveillance of First Line Anti-Tuberculosis Medicines in Kenya

Download File


Background: The number of TB cases notified in Kenya has increased tenfold since 1990 while the incidence of all forms of TB increased from 11,625 in 1990 reaching a peak of 116,723 in 2007. A slow decline to 106,083 in the year 2010 has since been noted.

Kenya has made significant progress in the prevention and control of tuberculosis. Notably, it achieved the WHO medium term targets of case detection rate of 70% and treatment success rate of 85% in 20062 . It has continually improved on these targets reaching a case detection rate of 85% and treatment success rate of 85.86% as at the end of 2010.3

Despite the significant gains in the prevention and control of TB, there are other emerging challenges such as multi-drug resistant strains of tuberculosis. Scientific evidence suggests that development of resistant strains may result from irrational use and poor quality of medicines.

It is therefore important that anti-TB medicines are safe, efficacious, of high quality and administered according to the Directly Observed Therapy, Short-course (DOTS). In Kenya, there are limited reports on the quality of fixed dose combinations for antiTB drugs available in public and private health facilities.

Aims and Objectives

The aim of this survey was to establish baseline data on availability, range; quality and registration status of anti-tuberculosis medicines in Kenya’s public, mission and private health sectors. The objectives were:

  1. To establish the availability and range of anti-TB drug formulations in Kenya.
  2. To determine the quality of anti-TB drugs at public, mission and private sector health facilities in Kenya.
  3. To determine the registration status of the first line anti-TB medicines in Kenya.

Methods: A cross sectional survey was carried out at 77 TB treatment sites sampled across the country. Questionnaires were administered to obtain qualitative data on storage and distribution of anti-TB medicines. In addition, 400 batches were sampled randomly from all these sites and out of these, 120 samples randomly selected and sent to the National Quality Control Laboratory for quality control tests.

Results: The recommended first line medicines used for the treatment of TB were generally available in all the eight provinces in Kenya. Notably unavailable in the sites visited was streptomycin in two provinces and EH in one province. Current treatment guidelines, however, do not advocate use of EH in the management of TB. The entire recommended oral fixed dose combinations used in both the intensive and continuation phases of TB treatment were available in all the sites in the country. 25% of the anti-TB formulations were RHZE fixed dose combination. 88% were adult antiTB formulations whereas 12% percent were pediatric dosage forms.

Overall, most facilities (78%) had acceptable storage conditions with the exception of those in North Eastern Province where significantly high storage temperatures were recorded. All regions had relative humidity levels (33-62%) within the recommended range. Most facilities had inadequate storage infrastructure and lacked pallets and appropriate shelving.

A total of 120 product samples were analyzed. Ten failed to comply with one or more of the test parameters, representing a failure rate of 8.3%. All the non-compliant products were two- component fixed dose combination samples with RH combination accounting for 80% of non-compliance and the EH combination accounting for the remaining 20% of failures.

Out of the 26 RH samples that were submitted for laboratory analysis, 8 (31%) failed assay tests because of having higher average content of active ingredients than specified.