Drug treatment victory in Ukraine
Since 2017, in Ukraine, people who use drugs have experienced frequent side effects from taking government-procured, methadone and buprenorphine produced by Kharkiv pharmaceutical company ‘Zdorovye Narodu’. Aside from listed side effects, the main concern was the lack of defined daily dose and rapid onset of abstinence. Despite numerous online complaints to the responsible government authorities, no action had been taken. As a result, VOLNA’s activists submitted an online application together with 171 hard copies of official complaints from all over the country to the State Expert Centre of the Ministry of Health (SEC) and the Public Health Centre of the Ministry of Health (PHC). Charitable Foundation ‘Hope and Trust’, which runs Ukraine’s National opioid substitution therapy hotline, has helped to collect complaints.
Much to the regret of advocates, SEC and PHC dismissed the complaints on the grounds that the reported side effects of taking methadone and buprenorphine were normal. In addition, the mounting pressure of medical staff on the complainants to withdraw their complaints had resulted in patients retracting their complaints.
Worrying test results
In response to the decision of SEC and PHC, in June 2019, VOLNA sent the samples of ‘Zdorovye Narodu’ produced methadone (10 mg pills) and buprenorphine (2 mg pills) to the State Service of Ukraine on Medicines and Drugs Control for testing. The lab results revealed that buprenorphine did not meet the prescribed quality criteria as the concentration of active substance was 25% less than the norm, resulting in additional side effects among people receiving treatment. However, methadone, besides some of the tested tablets breaking up too easily, showed no signs of manufacturing irregularity.
Triumph for opioid users
Following the concerning lab results of buprenorphine, the series of the medicine has been successfully removed from the market. To ensure that high-quality medicine is provided to people receiving treatment, VOLNA had requested PHC to test all the procured series of buprenorphine and methadone against quality criteria and, above all, make testing mandatory before the supply process. As a result, PHC has selected another national buprenorphine producer (InterChem, Odessa) as a winner of the 2019 tender and promised to perform random testing on all earlier procured opioid substitution therapy medicines.
Serious concerns remain for the situation of the quality of Kharkiv-made opioid substitution therapy medicines. As Ukraine is one of the suppliers of such medicines in the wider region of Eastern Europe and Central Asia, the issue may have far-reaching consequences.
As of now, VOLNA is building a strong case, and will make an official appeal to the Security Service of Ukraine, the country’s law-enforcement authority and main government security agency, to conduct further investigation into the production of buprenorphine in Ukraine. In addition, VOLNA will officially inform the Global Fund about the gaps and challenges of Ukraine’s transition from donor to public health funding which is relevant for other countries.
We are grateful to Anton Basenko, PITCH Country Focal Point in Ukraine for his contribuion to this story.