Potent opioid painkiller nalbuphine can now only be purchased with an electronic prescription - Ministry of Health
Kyiv • UNN
The Ministry of Health has tightened control over the dispensing of the opioid painkiller nalbuphine, which is now only available with an electronic prescription. This decision is aimed at solving the problem of over-the-counter sales and the increasing volume of production of this drug.
The Ministry of Health of Ukraine has changed the rules for dispensing medicinal products with the international nonproprietary name (INN) nalbuphine. From now on, these drugs can only be obtained with an electronic prescription, writes UNN with reference to the Ministry of Health.
Details
It is noted that there are exceptions for pharmacies operating in frontline areas or in active combat zones, as it is not possible to issue electronic prescriptions there. In such cases, until the end of martial law and for three months thereafter, pharmacies will be allowed to dispense nalbuphine with a paper prescription.
At the same time, they are obliged to keep these prescriptions for three years. Compliance with the rules of prescription dispensing will be monitored by the State Service of Ukraine on Medicines and Drugs Control, which conducts inspections of pharmacies.
The changes concern medicinal products classified under ATC code N02AF: nalbuphine, butorphanol, dynalbuphine sebac. According to the National Health Service of Ukraine, in 2023, 2,595 electronic prescriptions for nalbuphine were issued, of which only 341 were redeemed. In 2024, this indicator increased to 4,987 electronic prescriptions, of which 794 were redeemed.
During the same period, a significant increase in the production and sale of the drug was recorded. According to the State Service of Ukraine on Medicines and Drugs Control, in 2024 alone, 43.4% more packages were produced than in 2021, and sales (in drug packages) increased by 37.1% in 2024 compared to 2021.
At the beginning of 2025, upon the instruction of the Minister of Health Viktor Liashko, the State Service of Ukraine on Medicines and Drugs Control inspected the circulation of nalbuphine in the pharmacy network.
The results of the monitoring revealed a systemic problem – in many cases, pharmacies could not provide paper prescriptions according to which the drug was dispensed. This indicates a risk of over-the-counter sale of nalbuphine, which is a violation of the law.
The introduction of a mandatory electronic prescription for nalbuphine is a necessary step towards transparent control over the circulation of drugs with a risk of abuse. The electronic system has already proven its effectiveness in controlling the circulation of narcotic and psychotropic drugs.
For reference
Drugs with the INN "Nalbuphine" are potent opioid pain relievers that can cause addiction and whose use requires adherence to special recommendations. Nalbuphine is not controlled as an opiate in many countries due to its special pharmacological properties and relatively low potential for addiction compared to classical opioids.
The World Health Organization (WHO) has not included nalbuphine in the Schedules of Control of the 1961 UN Single Convention on Narcotic Drugs after assessing the risks and benefits, as the potential for abuse does not justify additional restrictions. At the same time, some countries have their own restrictions on nalbuphine. This depends on how they control the circulation of opioid drugs.
Supplement
The Ministry of Health has prepared a draft order regarding the dispensing of nalbuphine – a potent opioid pain reliever. It is noted that it can cause addiction, and currently, uncontrolled use of the drug is observed.