In accordance with the point 3 of the Special Requirements for the Storage of Narcotic Drugs and Psychotropic Substances Registered in the Established Order in the Russian Federation as Drugs for Medical Use in Pharmacy, Medical, Scientific Research, Educational Organizations and Wholesale Organizations of Medicinal Products (approved by the order of the Ministry of Health of Russia from 24.07.2015 No. 484n), in pharmacies and medical organizations on the inner sides of safe doors or metal cabinets in which narcotic and psychotropic drugs are stored, lists of stored narcotic and psychotropic drugs should be posted with their highest single doses (hereinafter - HSD) and highest daily doses (hereinafter - HDD).
Compliance with these special requirements is one of the mandatory requirements that should be met by a licensee carrying out activities connected with the circulation of narcotic drugs and psychotropic substances. Otherwise, a pharmacy or medical organization may be brought to administrative responsibility in the prescribed manner.
Information regarding the HSD and HDD for some narcotic and psychotropic drugs was previously contained in the table included in the USSR State Pharmacopoeia of the 10th edition (1968), as well as in standard clinical and pharmacological monographs, which until 2009 were an integral part of the State Register of Medicines. The State Pharmacopoeia of the subsequent XI-XIV editions, as well as the current State Register of Medicines, do not contain similar tables and monographs.
Currently, the legislation of the Russian Federation on the circulation of drugs, on the basics of protection of the health of citizens in the Russian Federation, as well as on narcotic drugs, psychotropic substances and their precursors, does not provide a mechanism for determination of the HSD and HDD for narcotic and psychotropic drugs.
In our opinion, in the absence of legal norms or a special regulatory legal act establishing a uniform procedure for all pharmacy and medical organizations for determination of the HSD and HDD (who sets the doses, how they are calculated, etc.) for narcotic and psychotropic drugs, pharmacy and medical organizations can be guided by the information contained in the instruction for medical use of the drug (hereinafter - the Instruction).
In accordance with the provisions of the Article 18 of the Federal Law from April 12, 2010 No. 61-FZ "On the Circulation of Medicines" and the Order of the Ministry of Health of Russia from September 21, 2016 No. 724n "On the Approval of the Requirements for the Instructions for the Medical Use of Drugs", the Instruction is a part of a registration dossier for a drug is agreed with the Ministry of Health of the Russian Federation as part of the state registration procedure and is issued simultaneously with the registration certificate of the drug with the indication of the number of this registration certificate and the date of state registration of the drug. The contents of the Instruction at circulation of the drug should comply with the Instruction agreed with the Ministry of Health of Russia.
The information on the dosage regimen, methods of administration and use, if necessary, the time of taking the drug, the duration of treatment, including in children younger and older than one year (in the absence of contraindications for use in childhood) is mandatory for the Instruction.
In addition, according to the Article 37 of the Federal Law from November 21, 2011 No. 323-FZ "On the Basics of Protection of the Health of Citizens in the Russian Federation," medical care is provided on the basis of medical care standards approved by the Russian Ministry of Health. The standard includes average indicators of the frequency of use of drugs (with indication of average doses). In this case, the average dose of the drug is indicated in the standard in accordance with the Instruction.
The Instruction is a document open and generally available to all Internet users, and is posted in the State Register of Medicines in the official website of the Russian Ministry of Health.
In view of the above, if, according to the Instruction for the medical use of a narcotic or psychotropic drug product, the dose of the drug is selected individually and calculated depending on the indications and method of its use, on the condition and body weight of the patient, and the value for the HSD and HDD of the drug is not directly determined, pharmacy and medical organizations in the lists of narcotic and psychotropic drugs posted on the inside of the doors of safes or metal cabinets can indicate the upper (maximum) value of the therapeutic dose range (single and (or) daily) of the drug recommended in the relevant Instruction, while making a link to the registration certificate number of the drug and the date of its registration.
In connection with the application in the official website of the FSEU Moscow Endocrine Plant in regard to the HSD and HDD of narcotic and psychotropic drugs containing fentanyl, ketamine and diazepam, the table with the upper (maximum) dose value for these drugs produced by the enterprise is attached.
Name of a narcotic or psychotropic drug |
Upper (maximum) dose value |
The document which is the basis for determination of the dose value | |
single |
daily | ||
Fentanyl, solution for i/v and i/m administration |
Adults: i/v 200 mcg, i/m 100 mcg Children: i/v 15 mcg/kg |
– |
Р N000266/01-101011 |
Ketamine, solution for i/v and i/m administration |
Adults, children: i/v 4,5 mg/kg, i/m 13 mg/kg |
– |
Р N000298/01-171011 |
Diazepam, solution for i/v and i/m administration |
Children: up to 5 years - 5 mg, older than 5 years - 10 mg |
Adults: 3 mg/kg |
Р N002572/01-040411 |
Diazepam,tablets |
– |
Adults: 60 mg |
LS-001270-300811 |
Comment type is not specified in the component properties.