Darnytsia Supports Strengthening Control Over the Use of Nalbuphine
Darnytsia Pharmaceutical Company, which produces nalbuphine*, deeply understands its responsibility for the quality, efficacy, and safety of every medicinal product released to the market.
We also recognize that opioid drugs, even those with a relatively favorable safety profile like nalbuphine, require not only state regulation but also high standards of corporate self-control.
We began developing nalbuphine in 2020, even before the full-scale invasion, focusing on approved medical protocols and the growing need for effective pain relief in critical conditions. The production of nalbuphine started in May 2023, and its distribution began in July of the same year.
We clearly understand the potential risks of non-medical use inherent in any opioid.
Darnytsia does not advertise nalbuphine, does not conduct commercial promotion, and maintains ethical communication with the medical community regarding its use.
We work exclusively based on orders from state purchasers, hospitals, distributors, and pharmacy chains, without inducing demand.
As of 2024, the company's share of the nalbuphine market was 9.5%**, indicating a limited market share but not absolving us of our responsibility for the product and its circulation.
According to current legislation, nalbuphine should only be dispensed by prescription***. However, a prolonged period of inadequate control over prescription turnover at the market level has led to excessive availability of the drug, which in some cases resulted in its non-medical use. This challenge requires a joint response from the state, manufacturers, the medical community, and the pharmacy retail sector.
In response to public signals of abuse, the company has already initiated an internal audit of distribution channels, supply volumes, and demand geography, as well as strengthened monitoring of orders from the commercial market.
We do not distribute the drug in charitable programs where we cannot ensure reliable control. We are also open to developing recommendations for physicians on the justified use of nalbuphine, in collaboration with professional associations.
We fully support the initiatives of the Ministry of Health of Ukraine to strengthen control over the circulation of opioid analgesics, including nalbuphine, which includes the introduction of electronic prescriptions, expanding analytics, and developing a pharmacovigilance system. In the event of a decision to include nalbuphine in the List of Narcotic Drugs, we will ensure full compliance of production and logistics processes with the new requirements.
We also support the creation of joint information campaigns for physicians and patients regarding the responsible use of opioid drugs, and we participate in professional discussions concerning the clinical appropriateness, efficacy, and safety of pain relief.
Our goal is to provide patients and physicians with high-quality, effective, and controlled tools for pain relief while remaining a socially responsible manufacturer that sees not only market needs but also human vulnerability.
*Under nalbuphine, the active substance nalbuphine hydrochloride is meant.
**According to the PharmXplorer market research system.
***Order of the Ministry of Health of July 19, 2005, No. 360 "On the approval of the Rules for prescribing prescriptions and requirements-orders for medicinal products and medical devices, the Procedure for dispensing medicinal products and medical devices from pharmacies and their structural subdivisions, Instructions on the procedure for storing, accounting, and destroying prescription forms."