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Medicines Transparency Alliance20/04/23 1
«Medicines Quality Assessment from
Retail Market using Mini-Lab Kits»
MeTA Kyrgyzstan
Djusupova Djanyl Deputy director of NDRA under the MoH KGJune 2010
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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 Prosecutor’s Office and Ministry of Economic Regulation.
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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
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How MeTA has addressed quality
6 INN were selected:
1. Amoxicillin
2. Ciprofloxacin
3. Metronidazole
4. Acetylsalicylic acid
5. Aminophyllin
6. Paracetamol
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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.»
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Results of TLC and physical examination (investigators’ reports)INN No.
samplesN, 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%
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Survey FindingsSurvey Findings
0
5
10
15
20
25
30
items
Perc
en
tag
e (
%)
Problems with Quality&Quantity:TLC ,Rf
Problems Labelling
Expired date
’Suspicious tablets,apperance:inclusionscrumbling ,different shapes
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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
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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 оf 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
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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?
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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.
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Thank you
Prepared by: Kyrgyz MeTA Secretariat Email: [email protected]
Phone number: 996 (312) 900-411
Skype: asuluke
Website: www.metakg.org