Scheduled drugs and their place in the pharmacy

Medical organizations that handle medicinal products for medical use, in accordance with Part 3 of Article 58_1 of the Federal Law of 12.04.2010 N 61-FZ "On the Circulation of Medicinal Products", are required to maintain quantitative records of medicinal products.

Item-quantity accounting (IQA) of medicinal products for medical use is the registration of any transactions related to their circulation, during which their quantity and (or) condition changes, in special journals for recording transactions related to the circulation of medicinal products for medical use.

The list of medicines for medical use subject to quantitative accounting was approved by order of the Ministry of Health of Russia dated 01.09.2023 N 459n.

Pharmacies refuse to sell the above-mentioned drugs due to high costs, frequent inspections and incorrectly filled prescriptions. Consequently, the availability of scheduled drugs decreases. At the moment, the situation is becoming critical for Russia: the situation with the availability of scheduled drugs is particularly difficult in Chechnya, Tuva and Altai, and in the Voronezh region, the only dispensing point recently closed due to bankruptcy.

According to DSM Group, the total sales volume of scheduled drugs in 2024 amounted to 4 billion 163 million rubles, or more than 11 million packages. The share of pharmacy sales of this volume is 0.3% in rubles and 0.2% in packages. Over the year, the market volume grew by 11% in monetary terms and fell by 2.6% in packages. Over the two months of 2025, the growth was 1.4% in rubles compared to the same period in 2024 and 6.3% in packages. The share of pharmacy sales was 0.3%.

The main problem is excessive requirements for pharmacies. Any pharmacy that has sold even one package of the scheduled drug automatically moves into the "high risk" category. This means frequent inspections, the need to attract additional resources, re-equipment of the pharmacy space, installation of metal cabinets and emergency call buttons for the Russian National Guard.

Pharmaceutical market participants propose a number of measures. For example, to reduce the burden on pharmacies by separating the requirements for storage and dispensing based on the risk category of scheduled drugs. Also, to cancel mandatory metal cabinets, introduce a single federal system of electronic prescriptions and strengthen control through self-regulatory bodies such as the SRO "Association of Independent Pharmacies" and AAU "Soyuzpharma".

Solving this problem may negatively affect patients who will have to travel hundreds of kilometers to get the necessary drug, or they will lose access to it altogether.

Open hearings will be held in April-May 2025, where regulators and businesses will try to find a way out of the crisis.