Medicines Transparency Alliance04/19/23 1

MeTA KYRGYZSTAN

«Medicines Quality Assessment from Retail Market using Mini-Lab Kits»

Medicines Transparency Alliance04/19/23 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 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 Findings

Survey Findings

0

5

10

15

20

25

30

Amox

icillin

Cipro

floxa

cin

Amin

ophy

llin

Met

ronida

zole

Acety

lsalic

ylic

acid

Para

ceta

mol

Tota

lly

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: kg_meta_council@googlegroups.com

Phone number: 996 (312) 900-411

Skype: asuluke

Website: www.metakg.org