MeTA KYRGYZSTAN

1
MeTA KYRGYZSTAN

• Medicines Quality Assessment from Retail Market
  using Mini-Lab Kits

2
Situational analysis

• An estimated 30 of medicines are imported
  illegally and most of the population is inclined
  to the self-treatment.
• No surveys have been conducted at the retail
  level for assuring quality of medicines in the
  Kyrgyz Republic.
• Despite the efforts undertaken by the National
  DRA the illegal trade of medicines still exists
  in the black market in the country (eg. Osh
  bazar, Dordoy bazar in Bishkek where some people
  seek cheap medicines sources).
• The National DRA is the only body which has
  mandate to ensures quality of medicines.
• There is a contradiction in the regulatory
  management between obligations of the DRA on
  ensuring medicines quality and judicial powers.
  For example, DRA inspectors are not permitted to
  carry out unannounced inspections in the
  pharmacies and wholesale drugstores without prior
  10 days notice and given permission of the Public
  Prosecutors Office and Ministry of Economic
  Regulation.

3
How MeTA has addressed quality

• Two mini-labs were procured (GPHF- minilab)
  within MeTA activities
• The USP trainers trained 9 people on using
  mini-labs, including lab assistants of the DRA QC
  Lab and a private QC Lab Pharmacia, and a
  teacher of Pharmaceutical Department of the
  Kyrgyz State Medical Academy
• The medicines samples were gathered in
• Bishkek (capital) 227 samples (84 143)
• Karakol town 82
• Osh city 100
• Djalalabat town 138
• Totally 547 samples

4
How MeTA has addressed quality

• 6 INN were selected
• 1. Amoxicillin
• 2. Ciprofloxacin
• 3. Metronidazole
• 4. Acetylsalicylic acid
• 5. Aminophyllin
• 6. Paracetamol

5
Results of TLC and physical examination
(investigators reports)

• It should be noted that there are examples of
  drugs that do not match the following criteria
• - labeling (Acetylsalicylic acid, Amoxicillin) -
  the same manufacturer, but the addresses and
  phone numbers are different, the color of packs
  are the same, but shades are of different
  intensity, sometimes the manufacturer is not
  specified
• - appearance - samples are contaminated in
  bottles (Aminophyllin), and are not uniform in
  color (blotches of darker shades)
• - for some samples the TLC-analysis was altered
  up to 3 times (three different tablets), because
  the intensity of emission comparing with the
  standard differed significantly we assumed that
  the samples were not homogeneous in content of
  active substances within the series, (or one
  package), this is mainly about the samples of
  Paracetamol and Acetylsalicylic acid
• - many samples of acetylsalicylic acid were
  disintegrated in 30-50 seconds already.

6
Results of TLC and physical examination
(investigators reports)
INN No. samples N, Problems with Quality , Quantity (TLC, Rf) No. Problems Labelling No. Expired date No. Suspicious tablets apperance No. Satisfactory samples of satisfactory samples
Amoxicillin 104 6 23 1 4 70 68
Ciprofloxacin 104 26 1 3 1 73 71
Aminophyllin 53 1 0 0 2 50 95
Metronidazole 102 15 3 0 15 69 68
Acetylsalicylic acid 91 9 3 0 0 79 87
Paracetamol 93 7 0 0 3 83 90
Totally 547 64 30 4 25 424 78
7
Survey Findings
8
Successes

• The results are indicative of need to amend and
  improve current legislation, for example
• Enhancing authority/power of inspectors/DRA
• Development of post-marketing surveillance over
  drug quality
• The country has acquired a new method for testing
  Quality of medicines in the market
• Additional skills have been acquired by way of
  trained personnel other than DRA staff to apply
  the Mini Labs for testing Quality of Medicines
• The Pharmacia Department of the Kyrgyz State
  Medical Academy has skills on using mini-labs and
  can train the students
• Statistical data on the number and location of
  pharmacies inside and near to the Family Medicine
  Centers of Bishkek have been accquired as a
  result of the Survey
• The samples of illegally sold medicines have been
  gathered (Osh bazar) and are currently in the
  process of testing

9
Challenges

• There is no separate data on the pharmacies
  located in every administrative district in
  Bishkek (capital city)
• The addresses of the pharmacies included into a
  DRA Reference Book do not correspond to the
  factual locations
• Many pharmacies do not have cash registers,
  making it difficult to provide financial
  statements for the purchased samples ?f medicines
• QC Laboratory/DRA was not convinced of the
  advantages / benefits to use the mini-labs to
  assess the quality of medicines. This led to
  significant delay in getting the test results

10
Lessons learned

• Post marketing Surveillance is essential for
  assuring Quality of medicines circulating in the
  market
• Weaknesses in Legislation do not allow the DRA to
  perform its regulatory role efficiently and
  effectively
• Only 78 of samples collected met the quality
  requirements hence it is evident that quality of
  medicines in the market is unreliable
• Currently the following questions should be
  solved
• - who will be using the mini-labs after
  completion of MeTA activity? (quite expensive
  chemicals and USP standards)
• - who will be getting the samples, how often and
  how many as it is the issue on expenditures
  related to buying samples in the pharmacies
• - who will be paying expenditures involved into
  full analysis of the questionable quality
  medicines?
• - coverage? Urban areas, rural areas, regions?

11
RECOMMENDATIONS OR FURTHER ACTIONS TO BE
UNDERTAKEN

• Strengthen regulatory control of medicines and
  enforcement by national DRA to prevent and detect
  counterfeit/substandard medicines (through
  improvement of current legislation, see above).
• A range of stakeholders not just health
  professionals is needed. The aim is to involve a
  range of stakeholders in collaborative efforts to
  protect people from buying and taking
  counterfeit/substandard medicines.
• Make all findings with regards to actions held
  by NDRA publicly available.
• Regular Public media campaigns to raise public
  awareness on public health risk of the
  self-treatment and buying medicines from
  non-regulated outlets, where the incidence of
  substandard drugs is likely to be higher.

12
Thank you

• Prepared by Kyrgyz MeTA Secretariat
• Email kg_meta_council_at_googlegroups.com
• Phone number 996 (312) 900-411
• Skype asuluke
• Website www.metakg.org