The Russian Ministry of Health has developed a draft Rules for the Dispensing of Medicines for Medical Use” (project ID 01/02 / 04-21 / 00114788) (hereinafter referred to as the Rules).
According to the explanatory note to this draft, new Rules for the dispensing of medicinal products have been developed to replace those approved by order of the Ministry of Health of Russia dated July 11, 2017 No. 403n “On approval of the rules for dispensing medicinal products for medical use, including immunobiological medicinal products, by pharmacy organizations, individual entrepreneurs licensed to pharmaceutical activity”, the order of the Ministry of Health and Social Development of the Russian Federation of 05/17/2012 No. 562n “On approval of the Procedure for dispensing medicinal products for medical use to individuals containing, in addition to small amounts of narcotic drugs, psychotropic substances and their precursors, other pharmacological active substances” and the order Ministry of Health and Social Development of the Russian Federation dated 26.08.2010 No. 735n “On approval of the Rules for the dispensing of medicinal products for medical use by medical organizations that have licenses for pharmaceutical activities, and their separate subdivisions (outpatient clinics, feldsher and feldsher-obstetric points, centers (departments) of general medical (family) practice) located in rural settlements in which there are no pharmacy organizations”.
The new Rules contain lists of types of medicinal products dispensed according to one or another currently approved form of the prescription form. Namely, for each form of the prescription form, a specific list of the corresponding types of drugs to be dispensed is provided.
The Rules have settled the case of the lack of a drug indicated in the prescription in a drug retail organization. In this case, the recipe is accepted for execution in the following terms:
- a prescription marked “statim” (immediately) is served within 1 business day from the date of application;
- a prescription marked “cito” (urgent) is served within 2 working days from the date of application;
- a prescription for a medicinal product included in the minimum range of medicinal products for medical use required for the provision of medical care is serviced within 5 working days from the date of application;
- a prescription for a drug dispensed free of charge or at a discount and not included in the minimum assortment is serviced within 10 working days from the date of application;
- a prescription for medicinal products prescribed by the decision of the medical commission is served within 15 working days from the date of the person's appeal to the retail entity.
The Rules also clarify in which cases it is permissible to dispense drugs in case of violation of the primary or secondary packaging. Namely, a violation of the primary packaging of a medicinal product when it is dispensed at the request of a medical organization is allowed by a pharmacy organization that has a license for pharmaceutical activities with the right to manufacture medicinal products. When dispensing medicines to individuals, it is allowed to violate the secondary (consumer) packaging of the medicinal product if its amount specified in the prescription is less than the amount of the medicinal product contained in the secondary (consumer) packaging.
In pursuance of the instructions provided for by subparagraph 7 of paragraph 2 of Section I of the minutes of the meeting of the Council under the Government of the Russian Federation on issues of guardianship in the social sphere, chaired by Deputy Prime Minister of the Russian Federation T.A. Golikova dated July 28, 2020, No. 5, the draft order includes the possibility of dispensing medicines to persons caring for incurable patients. Namely, if it is impossible for incurable patients at the final stage of life to issue a power of attorney for the right to receive the narcotic and psychotropic medicinal products specified in paragraph one of this clause, such medicinal products are dispensed to other persons caring for them, upon presentation of a document certifying identity, and a document confirming the incurable state of the patient, containing information about the person who receives medications by prescription (name, type, series and (or) number of the identity document), certified by the signature and seal of the medical worker, who remains in the pharmacy organization/
The Rules stipulate that in order to dispense medicinal products using electronic prescriptions, pharmacy organizations must have a connection to the state information system in the field of healthcare of the constituent entity of the Russian Federation.
In fact, the Rules have concretized and combined into one all the currently valid rules for the dispensing of medicines.
May 15, 2021