Order 1175 n on approval of the appointment procedure. How to choose a prescription form for writing out a prescription? To avoid getting caught

Order 4n of the Ministry of Health of the Russian Federation came into force in April of this year. It replaced the previous regulatory document on the rules for issuing prescriptions for drugs - order No. 1175.

The procedure for prescribing medications is regulated by Order 4n of the Ministry of Health of the Russian Federation. After entering into force in April 2019, it neutralized the effect of another document - Order of the Ministry of Health 1175n.

The new document has adjusted the current procedure. What changed?

What forms cannot be used at work? What norms remain the same? Read about all this below.

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The main thing in the article

Order of the Ministry of Health 4n

The procedure set out in the new document partially retained the provisions of the previous document.

However, there are two very important changes, which will be discussed below. In addition, some types of forms that were still in use before April 2019 were canceled.

They are only allowed to be used until a certain date. When will they end?

How to prescribe medications now?

The new order made it possible to issue prescriptions for medications electronically.

Read what two contradictions have appeared and what to do about them in the magazine “Deputy Chief Physician”.

Changes

The main changes in Order 4n of the Ministry of Health concern the possibility of issuing prescriptions for medications in electronic format, as well as the development of new forms of prescription forms.

The decision to introduce prescription forms in electronic format is made by the health authorities of a particular region.

To do this, you need to obtain the consent of the patient or his representative, after which the document is generated using the Unified State Health Information System or the MIS of the medical institution.

The appointment is certified by the personal enhanced electronic signature of the medical professional.

If the prescription involves the receipt of psychotropic drugs or narcotics, it must be certified, in addition to the enhanced electronic signature of the doctor, also with the enhanced electronic signature of the medical organization.

New procedure for prescribing medications

Order of the Ministry of Health 4n dated January 14, 2019 canceled the prescription form No. 148-1/u-06 (l). Now appointments are written out on form No. 148–1/у-04 (l). Old-style forms are allowed to be used until December 31, 2019.

The prescription for the finished dosage form must contain the amount of active ingredients (dosage) according to the instructions for use of the drug.

When it is necessary to establish the validity period of the prescription form Form 107-1/u for up to 1 year, the document must be marked “For special purposes”, indicate the validity period of the prescription and the frequency of dispensing the medication from the pharmacy.

The attending physician certifies the document form with his signature and seal, as well as the seal of the institution “For prescriptions” (previously, prescriptions were marked “For a chronic patient”).

Narcotic and psychotropic drugs are prescribed on form 107/u-NP. No. 54n allows the attending physician to draw up and certify such a prescription independently, without the participation of the clinic’s medical commission.

Order 4n dated January 14, 2019 left the possibility of agreeing on the initial prescription of a narcotic drug with a medical commission at the discretion of the institution’s chief physician.

This makes the prescription more difficult to obtain. This reduces the availability of pain relief for patients with chronic pain syndrome.

For your information

The Ministry of Health has developed a procedure for how medical organizations can issue prescriptions for drugs that are not registered in Russia. Details are in the magazine “Deputy Chief Physician”.

Explanations

The preparation of prescription forms of form No. 148-1/u-88 is regulated by Appendix No. 3 to Order 4n of the Ministry of Health of the Russian Federation dated January 14, 2019 “The procedure for issuing prescription forms for medicines, their accounting and storage.”

According to him, even old prescription forms must be issued according to the new rules.

An exception is the indication in the corresponding columns of the full number of years instead of the date of birth or the middle name in full instead of the initials.

The Department of Medicines Supply and Regulation of Medical Products clarified that this cannot be considered an error in filling out a prescription, and therefore does not invalidate it.

When filling out a prescription form, form No. 148-1/u-88, it is important to consider the following points:

  • in the upper left corner a stamp of the medical institution is required indicating its name, address and telephone number; the address of the individual entrepreneur, the number and date of the license, the name of the government authority that issued the license, printed or in the form of a stamp, must be present;
  • the form must be filled out manually in neat and legible handwriting; it is also permissible to fill in all data, except the signature of the health worker, using a printing device;
  • The patient’s full name and date of birth are indicated in the appropriate columns (if the prescription is filled out for a child under 1 year old, the number of full months must be indicated in the “Age” column);
  • in the corresponding columns the address of residence (registration or actual place of residence) of the patient and the number of his outpatient card are indicated;
  • The full name of the health worker who made the appointment and issued the prescription is indicated (permissible by hand or using a personal stamp);
  • in the appropriate columns you must indicate the medical non-proprietary name, group or chemical name of the drug in Latin, release form, dosage, quantity (indicated in the “Rp” column). If the medicine is prescribed under a trade name, a note or stamp must be made on the back of the prescription form indicating the corresponding decision of the medical commission.
  • for one name of medicine – one prescription form;
  • the method of use of the drug is indicated in Russian, the state language of the republic within the Russian Federation or other languages ​​of the peoples of Russia; You cannot limit yourself only to general instructions; you should describe in detail and clearly the method of using the medicine.
  • the prescription form is certified by the personal signature and seal of the health worker, and the stamp of the institution “For prescriptions”.

In the order of the Ministry of Health 4n dated January 14, 2019, there is no indication of the recommended number of individual drugs for prescribing on one prescription form.

It is regulated in Appendix No. 2 to the canceled order of the Ministry of Health dated December 20, 2012 No. 1175n.

It should be noted that Appendix No. 1 to the Procedure for Prescribing Medicines (Order of the Ministry of Health dated January 14, 2019 No. 4n) still regulates the amount of narcotic drugs and psychotropic substances that can be prescribed in one prescription.

Health care providers cannot violate patients' right to pain relief—they must prescribe narcotics to relieve pain associated with an illness, medical condition, or medical intervention.

However, for unknown reasons, the new regulatory document refers to the listed situations in which analgesia is necessary only to the re-prescription of drugs.

Who now has no right to write subsidized prescriptions?

The list of health workers who have the right to write prescriptions to beneficiaries has changed.

Read who is included in it and who no longer has the right to write a preferential prescription in the magazine “Deputy Chief Physician”.

All that remains is a table that limits the amount of NS or PV that can be prescribed in one prescription.

The list of drugs in it is supplemented with morphine in the form of drops and oral solution, as well as a nasal spray based on fentanyl.

New positions were introduced with the aim of expanding the use of non-invasive dosage forms of narcotic drugs, which is very important in pediatric practice and in palliative care for patients.

Otherwise, the new Order retained the provisions of Order No. 1175n.

If supervisory authorities discover that an employee who does not have special clearance is working with narcotic and psychotropic drugs, a fine of up to 130 thousand rubles may be imposed on the institution.

To prevent this, the manager and senior nurse must know the rules of admission to manipulations with the NS and PV.

The human resources department or the employee responsible for personnel work in the institution prepares a package of documents for the employee who is to manipulate drugs and psychotropic drugs.

He also fills out the employee’s request and questionnaire to the regional department of the Ministry of Internal Affairs for monitoring the circulation of NS and PV.

The employee must provide the head of the institution with a conclusion confirming his absence of alcohol and drug addiction. After this, he is sent for examination by a psychiatrist.

In the column “type of activity” in the direction it is indicated - “work related to the circulation of narcotic drugs and psychotropic substances.”

The penalty for allowing someone to work with drugs without a medical certificate is:

  • for officials - 15-25 thousand rubles;
  • for legal entities – 110-130 thousand rubles.

Registration N 28883

In accordance with paragraph 16 of part 2 of Article 14 of the Federal Law of November 21, 2011 N 323-FZ “On the fundamentals of protecting the health of citizens in the Russian Federation” (Collected Legislation of the Russian Federation, 2011, N 48, Art. 6724; 2012, N 26 , Art. 3442, 3446) and clause 5.2.179 of the Regulations on the Ministry of Health of the Russian Federation, approved by Decree of the Government of the Russian Federation of June 19, 2012 N 608 (Collected Legislation of the Russian Federation 2012, N 26, Art. 3526), I order:

1. Approve:

the procedure for prescribing and prescribing medications in accordance with Appendix No. 1;

forms of prescription forms according to Appendix No. 2;

the procedure for preparing prescription forms, recording and storing them in accordance with Appendix No. 3.

Minister V. Skvortsova

Appendix No. 1

Procedure for prescribing and prescribing medications

I. General provisions

1. This procedure regulates the issues of prescribing and prescribing medications when providing medical care in medical organizations, other organizations providing medical care, and individual entrepreneurs carrying out medical activities (hereinafter referred to as the medical organization).

2. Prescription and prescription of medications is carried out by the attending physician, paramedic, midwife in the event that they are vested with the powers of the attending physician in the manner established by order of the Ministry of Health and Social Development of the Russian Federation dated March 23, 2012 N 252n “On approval of the Procedure for entrusting to the paramedic, midwife as the head of a medical organization when organizing the provision of primary health care and emergency medical care; individual functions of the attending physician for the direct provision of medical care to the patient during the period of observation and treatment, including the prescription and use of medications, including narcotic drugs and psychotropic drugs" (registered by the Ministry of Justice of the Russian Federation on April 28, 2012, registration N 23971), individual entrepreneurs engaged in medical activities (hereinafter referred to as medical workers).

3. Medical workers write prescriptions for medications with their signature and indicating their position.

The prescription and prescription of medications is carried out by a medical professional using the international nonproprietary name, and in its absence, the generic name. In the absence of an international nonproprietary name and generic name of a medicinal product, the medicinal product is prescribed and prescribed by a medical professional under its trade name.

In case of individual intolerance and (or) for health reasons, by decision of the medical commission of a medical organization, the prescription and prescription of medications, including those not included in the standards of medical care, is carried out by trade names. The decision of the medical commission of the medical organization is recorded in the patient’s medical documents and the journal of the medical commission.

Medical workers prescribe and prescribe medications that are subject to manufacture and dispensing by pharmacies (hereinafter referred to as individually manufactured medications).

4. A prescription issued in violation of the requirements established by this Procedure is considered invalid.

5. Information about the prescribed and discharged medicinal product (name of the medicinal product, single dose, method and frequency of administration or administration, duration of the course, justification for prescribing the medicinal product) is indicated in the patient’s medical record.

A prescription for a drug is written in the name of the patient for whom the drug is intended.

A prescription for a drug can be obtained by the patient or his legal representative. The fact of issuing a prescription for a drug to a legal representative is recorded in the patient’s medical record.

6.1. medical workers:

in the absence of medical indications;

for medicinal products not registered in the Russian Federation;

for medicines that, in accordance with the instructions for medical use, are used only in medical organizations;

for narcotic drugs and psychotropic substances included in List II of the List of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation, approved by Decree of the Government of the Russian Federation of June 30, 1998 N 681 (hereinafter referred to as the List), registered as medicinal drugs for the treatment of drug addiction;

6.2. by individual entrepreneurs carrying out medical activities, for medicines containing narcotic drugs and psychotropic substances included in lists II and III of the List.

7. Prescriptions for medications are written out on prescription forms according to forms N 148-1/u-88, N 148-1/u-04 (l), N 148-1/u-06 (l) and N 107-1/ 1, approved by this order.

8. Narcotic and psychotropic drugs of List II of the List are prescribed on a special prescription form in the form approved by Order of the Ministry of Health of the Russian Federation dated August 1, 2012 N 54n “On approval of the form of prescription forms containing the prescription of narcotic drugs or psychotropic substances, the procedure for their preparation , distribution, registration, accounting and storage, as well as registration rules" (registered by the Ministry of Justice of the Russian Federation on August 15, 2012, registration N25190).

9. Prescription form N 148-1/у-88 is intended for prescribing:

1) psychotropic substances included in List III of the List, registered in the prescribed manner as medicinal products (hereinafter referred to as psychotropic medicinal products of List III of the List);

2) other medicinal products subject to subject-quantitative accounting;

3) drugs with anabolic activity;

4) medicines specified in paragraph 5 of the Procedure for dispensing medicines for medical use to individuals, containing, in addition to small quantities of narcotic drugs, psychotropic substances and their precursors, other pharmacological active substances, approved by order of the Ministry of Health of the Russian Federation dated May 17, 2012 N 562n (registered by the Ministry of Justice of the Russian Federation on June 1, 2012, registration N 24438);

5) individually manufactured medicinal products containing a narcotic drug or psychotropic substance of List II of the List, and other pharmacological active substances in a dose not exceeding the highest single dose, and provided that this combined medicinal product is not a narcotic or psychotropic medicinal product of List II of the List .

10. Prescription forms of forms N 148-1/u-04 (l), N 148-1/u-06 (l) are intended for prescribing medications to citizens who have the right to receive medications free of charge or to receive medications at a discount.

11. Prescription form form N 107-1/у is intended for prescribing:

medicines specified in paragraph 4 of the Procedure for dispensing medicines for medical use to individuals, containing, in addition to small quantities of narcotic drugs, psychotropic substances and their precursors, other pharmacological active substances, approved by order of the Ministry of Health of the Russian Federation dated May 17, 2012 N 562n;

other medications not specified in paragraphs 8-10 of this Procedure.

12. When writing a prescription for an individually manufactured medicinal product, the names of narcotic and psychotropic medicinal products of lists II and III of the List, other medicinal products subject to subject-quantitative accounting are written at the beginning of the prescription, then all other ingredients.

13. When writing a prescription, it is prohibited to exceed the maximum permissible quantity of a medicinal product for prescribing per prescription, established by Appendix No. 1 to this Procedure, except for the case specified in paragraph 15 of this Procedure.

14. When prescribing narcotic and psychotropic drugs of lists II and III of the List, other drugs subject to subject-quantitative recording, the dose of which exceeds the highest single dose, the medical worker writes the dose of this drug in words and puts an exclamation point.

15. The number of prescribed narcotic and psychotropic drugs of lists II and III of the List, other drugs subject to subject-quantitative recording, when providing palliative care to patients, can be increased by no more than 2 times compared to the maximum permissible number of drugs for prescription per prescription, established by Appendix No. 1 to this Procedure, or the recommended quantity of medications for prescribing per prescription, established by Appendix No. 2 to this Procedure.

16. The composition of the combined medicinal product, the designation of the dosage form and the medical worker’s request to the pharmacist about the manufacture and dispensing of the medicinal product are written out in Latin.

The prescription abbreviations allowed for use are provided in Appendix No. 3 to this Procedure.

It is not allowed to abbreviate the ingredients that make up the medicinal product with similar names, which do not make it possible to determine which medicinal product is prescribed.

17. The method of use of the drug is indicated indicating the dose, frequency, time of administration relative to sleep (morning, at night) and its duration, and for drugs that interact with food - the time of their use relative to meals (before meals, during meals , after meal).

18. If there is a need for immediate or urgent dispensing of a medicinal product to the patient, the designations “cito” (urgent) or “statim” (immediate) are placed at the top of the prescription.

19. When writing a prescription for an individually manufactured medicinal product, the amount of liquid pharmaceutical substances is indicated in milliliters, grams or drops, and other pharmaceutical substances - in grams.

20. Prescriptions written out on prescription form Form N 148-1/у-88 are valid for 10 days.

21. Prescriptions for medications written out on prescription forms Form N 148-1/u-04 (l) and Form N 148-1/u-06 (l) are valid for one month from the date of prescription.

Prescriptions for medications written out on prescription forms Form N 148-1/u-04 (l) and Form N 148-1/u-06 (l) for citizens who have reached retirement age, disabled people of the first group and disabled children are valid in within three months from the date of discharge.

For the treatment of chronic diseases, these categories of citizens can be issued prescriptions for medications for a course of treatment of up to 3 months.

22. Prescriptions for medications written out on prescription forms of form N 107-1/u are valid for two months from the date of prescription.

When a medical professional prescribes prescriptions for finished medicinal products and individually manufactured medicinal products for patients with chronic diseases on prescription forms of form N 107-1/u, it is allowed to set the validity period of the prescription within up to one year and exceed the recommended amount of the medicinal product for prescribing per prescription, established by Appendix No. 2 to this Procedure.

When writing such prescriptions, the medical worker makes a note “For a patient with a chronic disease”, indicates the validity period of the prescription and the frequency of dispensing of drugs from a pharmacy organization or an individual entrepreneur with a license for pharmaceutical activities (weekly, monthly and other periods), certifies this indication with his signature and a personal seal, as well as the seal of the medical organization "For prescriptions".

23. Prescriptions for barbituric acid derivatives, ephedrine, pseudoephedrine in pure form and in mixtures with other drugs, drugs with anabolic activity, combination drugs containing codeine (its salts) for the treatment of patients with chronic diseases can be prescribed for a course treatment for up to two months.

In these cases, the prescriptions are marked “For special purposes”, separately signed by the medical worker and the seal of the medical organization “For prescriptions”.

II. Prescribing medications when providing medical care in inpatient settings

24. When providing medical care to a patient in a hospital setting, medications are prescribed by a medical worker alone, except for the cases specified in subparagraphs 1-2 of paragraph 25 of this Procedure, without issuing a prescription.

25. Coordination of the prescription of medications with the head of the department or the responsible doctor on duty or another person authorized by order of the chief physician of a medical organization, as well as with a clinical pharmacologist, is necessary in the following cases:

1) simultaneous prescription of five or more drugs to one patient;

2) prescribing medications that are not included in the list of vital and essential medications, in case of an atypical course of the disease, the presence of complications of the underlying disease and (or) concomitant diseases, when prescribing medications, the features of interaction and compatibility of which, according to the instructions for their use, lead to reduce the effectiveness and safety of pharmacotherapy and (or) create a potential danger to the life and health of the patient.

In these cases, the prescription of medications is recorded in the patient’s medical documents and certified by the signature of the medical worker and the head of the department (responsible doctor on duty or other authorized person).

26. A medical worker of a medical organization located in a rural settlement or a settlement located in remote and hard-to-reach areas prescribes medications in the cases specified in paragraph 25 of this Procedure, individually.

27. By decision of the medical commission, when providing medical care in a hospital setting, patients are prescribed medications that are not included in the list of vital and essential medications, in case of their replacement due to individual intolerance, for health reasons.

The decision of the medical commission is recorded in the patient’s medical documents and the medical commission’s journal.

28. In cases of examination and treatment of a citizen in a hospital setting as part of the provision of medical services on a reimbursable basis at the expense of the personal funds of citizens, funds of legal entities and other funds on the basis of an agreement, including a voluntary health insurance agreement, he may be prescribed medications, not included in the list of vital and essential drugs, if this is stipulated by the terms of the contract.

29. In some cases, by decision of the head of a medical organization, upon discharge from a medical organization of a patient who has appropriate medical indications and is sent to continue treatment on an outpatient basis, narcotic and psychotropic drugs of lists II and III of the List may be prescribed or issued simultaneously with an extract from the medical history for a patient's admission period of up to 5 days.

III. Prescribing and prescribing medications in primary health care, emergency care and palliative care

30. When providing primary health care and palliative care in an outpatient setting, the prescription and prescription of medications is carried out by a medical professional in cases of the typical course of the patient’s disease based on the severity and nature of the disease.

31. Prescribing and prescribing medications by decision of the medical commission when providing primary health care and palliative care in an outpatient setting is carried out in the following cases:

1) simultaneous prescription to one patient of five or more medications within one day or more than ten items within one month;

2) prescribing medications for an atypical course of the disease, the presence of complications of the underlying disease and (or) concomitant diseases, when prescribing medications, the interaction and compatibility features of which, according to the instructions for their use, lead to a decrease in the effectiveness and safety of pharmacotherapy and (or) create a potential danger for the life and health of the patient;

3) prescribing narcotic and psychotropic drugs of lists II and III (if the head of the medical organization decides on the need to coordinate the prescription with the medical commission).

32. The prescription and prescription of narcotic and psychotropic drugs of lists II and III is carried out to patients with severe pain syndrome of any origin independently by a medical worker or by a medical worker by decision of the medical commission (if the head of the medical organization decides on the need to coordinate the prescription with the medical commission).

33. When providing emergency medical care, medications are prescribed by a medical worker of a mobile ambulance team, a medical worker of a medical organization when providing medical care to citizens in case of diseases, accidents, injuries, poisoning and other conditions requiring urgent medical intervention.

IV. Prescribing and prescribing medications to citizens entitled to receive free or discounted medications as part of their primary health care

34. Prescription and prescription of medicines to citizens entitled to receive medicines free of charge or to receive medicines at a discount when providing them with primary health care is carried out by a medical worker in cases of the typical course of the patient’s disease based on the severity and nature of the disease as approved in the established in accordance with medical care standards, including:

1) certain categories of citizens entitled to receive state social assistance in the form of a set of social services, in accordance with the list of medicines approved by order of the Ministry of Health and Social Development of the Russian Federation dated September 18, 2006 N 665 “On approval of the list of medicines, dispensed by prescription from a doctor (paramedic) when providing additional free medical care to certain categories of citizens entitled to receive state social assistance" (registered by the Ministry of Justice of the Russian Federation on September 27, 2006, registration No. 8322) as amended by orders of the Ministry of Health and Social Development of the Russian Federation dated October 19, 2007 N 651 (registered by the Ministry of Justice of the Russian Federation on October 19, 2007, registration N 10367), dated August 27, 2008 N 451n (registered by the Ministry of Justice of the Russian Federation on September 10, 2008, registration N 12254), dated December 1, 2008 N 690н (registered by the Ministry of Justice of the Russian Federation on December 22, 2008, registration N 12917), dated December 23, 2008 N 760н (registered by the Ministry of Justice of the Russian Federation on January 28, 2009, registration N 13195), dated November 10, 2011 N 1340n (registered by the Ministry of Justice of the Russian Federation on November 13, 2011, registration N 22368);

2) citizens suffering from malignant neoplasms of lymphoid, hematopoietic and related tissues, hemophilia, cystic fibrosis, pituitary dwarfism, Gaucher disease, multiple sclerosis, as well as citizens after transplantation of organs and (or) tissues, in accordance with the list of centrally purchased funds from the federal the budget of medicines approved by the Government of the Russian Federation;

3) citizens who have the right to receive medicines free of charge or to receive medicines at a discount from the budgets of the constituent entities of the Russian Federation, in accordance with the List of population groups and categories of diseases, for the outpatient treatment of which medicines and medical products are dispensed free of charge according to doctors’ prescriptions , and the List of population groups for outpatient treatment of which drugs are dispensed according to doctor’s prescriptions with a 50% discount, approved by Decree of the Government of the Russian Federation of July 30, 1994 N 890.

35. The right to write prescriptions for medicines to citizens who have the right to receive medicines free of charge or to receive medicines at a discount also have:

1) medical workers working part-time in a medical organization (within their competence);

2) medical workers of inpatient social service institutions and correctional institutions (regardless of departmental affiliation);

3) medical workers of medical organizations providing medical care in inpatient settings, in the case provided for in paragraph 29 of this Procedure;

4) medical workers of medical organizations providing primary health care, subordinate to federal executive authorities or executive authorities of constituent entities of the Russian Federation:

a) citizens whose costs for free drug provision, in accordance with the legislation of the Russian Federation, are covered from the federal budget;

b) other categories of citizens whose costs for free drug provision, in accordance with the legislation of the Russian Federation, are covered by funds from budgets of various levels and compulsory health insurance;

5) individual entrepreneurs engaged in private medical practice and included in the register of medical organizations operating in the field of compulsory health insurance.

36. It is not allowed to write prescriptions for medicines for the treatment of citizens entitled to receive medicines free of charge or to receive medicines at a discount by medical workers of sanatorium-resort organizations, medical workers of medical organizations providing medical care inpatient or in a day hospital, for except for the case provided for in paragraph 29 of this Procedure.

37. When writing prescriptions for medicines for the treatment of citizens entitled to receive medicines free of charge or to receive medicines at a discount, a telephone number is indicated by which an employee of a pharmacy organization, if necessary, can agree with a medical worker on a synonymous replacement of the medicine.

38. On the prescription form of form N 148-1/у-04 (l) and form N 148-1/у-06 (l), the prescription is written by a medical worker in 3 copies, with two copies of which the patient applies to the pharmacy.

39. Narcotic and psychotropic drugs of List II of the List for the treatment of citizens entitled to receive drugs free of charge or to receive drugs at a discount are prescribed on a special prescription form for narcotic drugs and psychotropic substances, to which prescriptions are additionally written in 3 copies on the prescription form, form N 148-1/u-04 (l) or form N 148-1/u-06 (l).

40. Psychotropic drugs of list III of the List, other drugs subject to subject-quantitative registration, drugs with anabolic activity, combined drugs specified in subparagraph 4 of paragraph 9 of this procedure, intended for the treatment of citizens entitled to receive free drugs medications or receiving medications at a discount, are written out on prescription form N 148-1/u-88, to which prescriptions are additionally written in 3 copies on prescription form Form N 148-1/u-04 (l) or Form N 148 -1/у-06(l).

1 Article 2 of the Federal Law of November 21, 2011 N 323-FZ “On the fundamentals of protecting the health of citizens in the Russian Federation” (Collected Legislation of the Russian Federation, 2011, N 48, Art. 6724; 2012, N 26, Art. 3442, 3446 ).

2 In relation to the person specified in part 2 of Article 20 of the Federal Law of November 21, 2011 N 323-FZ “On the fundamentals of protecting the health of citizens in the Russian Federation” (Collected Legislation of the Russian Federation, 2011, N 48, Art. 6724; 2012, N 26, art. 3442, 3446).

3 Collection of Legislation of the Russian Federation, 1998, No. 27, Art. 3198; 2004, N 8, art. 663, N 47, art. 4666; 2006, N 29, art. 3253; 2007, N 28, art. 3439; 2009, N 26, art. 3183, N 52, art. 6572; 2010, N 3, art. 314, N 17, art. 2100, N 24, art. 3035, N 28, art. 3703, N 31, art. 4271, N 45, art. 5864, N 50, art. 6696, art. 6720; 2011, N 10, art. 1390, N 12, art. 1635, N 29, art. 4466, art. 4473, N 42, art. 5921, N 51, art. 7534; 2012, N 10, art. 1232, N 11, art. 1295, N 19, art. 2400, N 22, art. 2864, N 37, art. 5002, N 48, art. 6686, N 49, art. 6861.

4 Order of the Government of the Russian Federation of December 7, 2011 N 2199-r (Collection of Legislation of the Russian Federation, 2011, N 51, Art. 7544; 2012, N 32, Art. 4588).

5 Decree of the Government of the Russian Federation of October 4, 2012 N 1006 “On approval of the Rules for the provision of paid medical services by medical organizations” (Collected Legislation of the Russian Federation, 2012, N 41, Art. 5628).

6 Collection of Legislation of the Russian Federation, 1994, No. 15, Art. 1791; 1995, N 29, art. 2806; 1998, N 1, art. 133, N 32, art. 3917; 1999, N 14, art. 1724, N 15, art. 1824; 2000, N 39, art. 3880; 2002, N 7, art. 699.

Appendix No. 3

The procedure for preparing prescription forms for medications, recording and storing them

I. Preparation of prescription forms

1. On prescription forms of form N 107-1/у, which do not have a number and (or) series, a place for applying a barcode, N 148-1/у-88, N 148-1/у-04(l) and N 148-1/у-06(l) a stamp of the medical organization is affixed in the upper left corner indicating its name, address and telephone number.

Additionally, on prescription forms of form N 107-1/у, having a number and (or) series, a place for applying a barcode, N 148-1/у-04(l) and N 148-1/у-06(l) The code of the medical organization is entered.

The series of prescription form Form N 148-1/у-04(l) and Form N 148-1/у-06(l) includes the code of the subject of the Russian Federation, corresponding to the first two digits of the All-Russian Classifier of Administrative-Territorial Division Objects (OKATO).

2. On prescription forms issued by individual entrepreneurs who have a license for medical activities, the doctor’s address, the number and date of the license, and the name of the government authority that issued the license must be indicated in the upper left corner in a typographical way or by affixing a stamp.

3. Prescription forms of forms N 148-1/у-88, N 107-1/у and N 148-1/у-04(l) are filled out by the doctor legibly, clearly, in ink or with a ballpoint pen.

4. It is allowed to register all details of prescription forms of form N 107-1/у, having a number and (or) series, a place for applying a barcode and form N 148-1/у-06(l) using computer technology, as well as registration of prescription forms of form N 148-1/у-88 and form N 107-1/у (not having a number and (or) series, place for applying a barcode) using computer technology, with the exception of the column “Rp” (name drug, its dosage, quantity, method and duration of use).

5. Registration of prescription forms of form N 148-1/у-04(l) and form N 148-1/у-06 (l) includes digital coding.

Digital coding of these prescription forms includes:

1) code of the medical organization in accordance with the Main State Registration Number (OGRN), affixed when producing prescription forms;

2) code of the category of citizens (SSS) entitled to receive medications in accordance with Article 6.1 of the Federal Law of July 17, 1999 N 178-FZ “On State Social Assistance”, and nosological form code (LLLLL) according to ICD-10 , filled out by the attending physician by entering each number in empty cells, with a dot placed in a separate cell;

3) a note about the source of funding (federal budget, budget of a constituent entity of the Russian Federation, municipal budget) and the percentage of payment for the prescription (free, 50%) carried out by a medical worker;

4) the code of the medical worker is indicated by the medical worker in accordance with the list of codes of medical workers who have the right to prescribe medications established by the executive body of the constituent entity of the Russian Federation in the field of protecting the health of citizens;

5) the code of the medicinal product, affixed to the pharmacy when dispensing medicinal products prescribed on prescription forms of form N 148-1/u-04(l) and form N 148-1/u-06(l).

6. In prescription forms of form N 148-1/u-88, N 107-1/u, form N 148-1/u-04(l) and form N 148-1/u-06(l) (hereinafter - prescription forms) in the columns “Full name of the patient” the full last name, first name and patronymic of the patient are indicated.

7. In the prescription forms of form N 148-1/y-88 and form N 107-1/y, the number of full years of the patient is indicated in the “Age” column.

In prescription forms of form N 148-1/у-04(l) and form N 148-1/у-06(l), the patient’s date of birth (date, month, year) is indicated in the “Date of Birth” column.

8. In the prescription forms of form N 148-1/u-04(l) and form N 148-1/u-06(l) in the columns “SNILS” and “N of the compulsory health insurance policy” the insurance number of the citizen’s individual personal account is indicated in the Pension Fund of the Russian Federation (SNILS) and the compulsory health insurance policy number.

9. In prescription forms of form N 148-1/у-88, form N 148-1/у-04(l) and form N 148-1/у-06(l) in the column “Address or N of the outpatient medical card (history of child development)" indicates the address or number of the outpatient medical record (history of child development).

10. In the column “Full name of the attending physician” of the prescription forms, the full last name, first name, and patronymic of the medical worker who has the right to prescribe and prescribe medications are indicated.

11. In the “Rp” column of the prescription forms the following is indicated:

1) in Latin, the name of the medicinal product (international non-proprietary or group, or trade name), its dosage;

2) in Russian or Russian and national languages, the method of administration of the medicinal product.

Only abbreviations accepted by the rules are allowed; solid and bulk pharmaceutical substances are prescribed in grams (0.001; 0.5; 1.0), liquid - in milliliters, grams and drops.

13. A prescription written out on a prescription form is signed by a medical professional and certified by his personal seal.

Additionally, a prescription written on the prescription form of form N 148-1/u-88, form N 148-1/u-04(l) and form N 148-1/u-06(l) is certified by the seal of the medical organization "For prescriptions" ".

14. On one prescription form of form N 148-1/у-88, form N 148-1/у-04(l) and form N 148-1/у-06(l) it is allowed to prescribe only one name of the medicinal product; on one prescription form form N 107-1/u - no more than three names of drugs.

15. Corrections to the prescription written out on the prescription form are not allowed.

16. Validity period of a prescription written on the prescription form Form N 148-1/у-88 (10 days), Form N 107-1/у (2 months, up to 1 year), Form N 148-1/у-04( l) and form N 148-1/u-06(l) (5 days, 10 days, 1 month, 3 months) is indicated by crossing out or underlining.

17. On the reverse side of the prescription form form N 107-1/у (with the exception of the prescription form, which is completely filled out using computer technology), the prescription form form N 148-1/у-88 and form N 148-1/у-06( k) a table with the following content is printed:

18. When prescribing a medicinal product by decision of the medical commission, a special mark (stamp) is placed on the back of the prescription form, form N 148-1/u-04(l) and form N 148-1/u-06(l).

19. On the prescription form of form N 148-1/у-04(l) and form N 148-1/у-06(l) at the bottom there is a tear line separating the prescription form and the spine.

The counterfoil of a prescription written out on the specified prescription form is given to the patient (the person representing him) in the pharmacy organization; a mark is made on the counterfoil about the name of the drug, dosage, quantity, method of use, and it remains with the patient (the person representing him).

20. Registration of a special prescription form for narcotic drugs and psychotropic substances is carried out in accordance with the order of the Ministry of Health of the Russian Federation dated August 1, 2012 N 54n “On approval of the form of prescription forms containing the prescription of narcotic drugs or psychotropic substances, the procedure for their production, distribution, registration, accounting and storage, as well as registration rules."

II. Accounting for prescription forms.

21. Accounting for prescription forms of forms N 107-1/у, N 148-1/у-88 and N 148-1/у-04(l), produced by printing (hereinafter referred to as prescription forms subject to accounting), is carried out in accounting journals , numbered, laced and sealed with the signature of the head and the seal of the medical organization or the signature of an individual entrepreneur with a license for medical activities.

22. The register of prescription forms of form N 107-1/у contains the following columns:

1) number in order;

2) in the "Arrivals" section:

d) Full name and the signature of the responsible health care professional who received the prescription forms from the provider;

3) in the "Consumption" section:

b) the number of prescription forms issued;

c) Full name the responsible medical professional who received the prescription forms;

d) signature of the responsible medical professional who received the prescription forms;

23. The register of prescription forms of forms N 148-1/у-88 and N 148-1/у-04(l) contains the following columns:

1) number in order;

2) in the "Arrivals" section:

a) date of registration of the receipt document;

b) number and date of the receipt document, name of the supplier;

c) the total number of received prescription forms;

d) series and numbers of prescription forms;

e) number of prescription forms by series;

i) Full name and the signature of the responsible health care professional who received the prescription forms from the provider;

3) in the "Consumption" section:

a) date of issue of prescription forms;

b) series and numbers of prescription forms issued;

c) the number of prescription forms issued;

d) Full name the responsible medical professional who received the prescription forms;

e) signature of the responsible medical professional who received the prescription forms;

4) Full name and the signature of the responsible medical professional who issued the prescription forms;

5) the balance of prescription forms.

24. Accounting for special prescription forms for narcotic drugs and psychotropic substances is carried out in accordance with the order of the Ministry of Health of the Russian Federation dated August 1, 2012 N 54n “On approval of the form of prescription forms containing the prescription of narcotic drugs or psychotropic substances, the procedure for their production, distribution, registration, accounting and storage, as well as registration rules."

III. Storing prescription forms.

25. In each medical organization, by order of the head, a person is appointed who is responsible for storing and recording all types of prescription forms.

26. Prescription forms to be accounted for are stored by a responsible person appointed by the head of a medical organization under lock and key in a metal cabinet (safe) or metal box.

27. An individual entrepreneur who has a license for medical activities stores prescription forms that are subject to accounting under lock and key in a metal cabinet (safe) or metal box.

28. A permanent commission created in a medical organization checks the state of storage, accounting, actual availability and consumption of prescription forms subject to accounting once a quarter.

If the book balance of prescription forms subject to accounting does not coincide with the actual availability, the person responsible for storing and recording prescription forms bears responsibility under the legislation of the Russian Federation.

29. Prescription forms subject to registration are issued to medical workers who have the right to prescribe prescriptions by order of the chief physician or his deputy.

Received prescription forms that are subject to accounting are stored by medical workers in premises that ensure their safety.

30. The storage of special prescription forms for narcotic drugs and psychotropic substances and the issuance of these prescription forms to a medical worker is carried out in accordance with the order of the Ministry of Health of the Russian Federation dated August 1, 2012 N 54n “On approval of the form of prescription forms containing the prescription of narcotic drugs or psychotropic substances , the procedure for their production, distribution, registration, accounting and storage, as well as registration rules."

1 Collection of Legislation of the Russian Federation, 1999, No. 29, Art. 3699; 2004, N 35, art. 3607.

Samvel Grigoryan talks about the new document regulating the procedure for dispensing medicines and coming into force on September 22

IP and IBLP

In general, in order No. 403n the topic of IBP release is spelled out separately, which is not in order 785. It will be regulated by paragraph 13 of the first mentioned act. This paragraph, in particular, determines that when an IBP is dispensed, the exact time of this same dispensing, in hours and minutes, is indicated on the prescription or prescription counterfoil, which remains with the buyer.

Violation of secondary

With the entry into force of Order No. 403n, new emphasis will appear on the topic of the possibility of violation of secondary (consumer) packaging of medicines. The “retiring” norm of Order No. 785 allows this to be done in exceptional cases, if the pharmacy organization is unable to fulfill the doctor’s prescription.

The order No. 403n that replaced it is in this regard more specific and more in line with modern requirements, medical practice and consumer demands. Paragraph 8 of the order determines that violation of secondary packaging and dispensing of a medicinal product in primary packaging is permitted in cases where the amount of the drug indicated in the prescription or required by the consumer (for over-the-counter dispensing) is less than the amount of the drug contained in the secondary packaging.

In this case, the buyer must be provided with instructions for use or a copy thereof, and tampering with the original packaging is prohibited. By the way, the new order does not contain the rule that in case of violation of the secondary drug must be dispensed in a pharmaceutical package with the obligatory indication of the name, factory series, expiration date of the drug, series and date according to the laboratory packaging register, which is determined by order No. 785.

"The medicine has been released"

Clause 4 of Order No. 403n of the Ministry of Health of the Russian Federation regulates the topic of prescription forms and the list of drugs dispensed on them. In particular, narcotic and psychotropic drugs of Schedule II are dispensed using Form No. 107/u-NP, with the exception of narcotic and psychotropic drugs in the form of transdermal therapeutic systems.

The remaining prescription drugs, as is known, are dispensed using forms No. 107-1/u. According to paragraph 22 of the order of the Ministry of Health of the Russian Federation dated December 20, 2012 No. 1175n “On approval of the procedure for prescribing and prescribing medications, as well as forms of prescription forms...”, prescriptions written on the forms of this form are valid for two months from the date of prescription. However, for patients with chronic diseases, it is allowed to set the validity period of the prescription form No. 107-1/u within up to one year and exceed the recommended amount of the drug for prescribing per prescription, established by Appendix No. 2 of this order.

Such a prescription, which also indicates the periods and quantity of the drug dispensed (in each period), is returned to the buyer, of course, with the required notes on the date of dispensing, dosage and quantity of the drug dispensed. This is prescribed by paragraph 10 of order No. 403n. He also determines that the next time the patient comes to the pharmacy with the same prescription, the chief must take into account the notes on the previous dispensing of the drug.

The prescription remains at the pharmacy

There are some changes on the topic indicated in the title of this chapter. Paragraph 14 of the new order establishes that the retail trade entity retains (with the mark “The medicinal product is dispensed”) and stores:

within 5 years prescriptions for:

within 3 years prescriptions for:

within 3 months recipes for:

Order No. 403n of the Russian Ministry of Health did not come without a cherry on the cake, albeit a dubious one. Paragraph 15 of the order states that prescriptions not specified in the previous 14th paragraph (we listed them just above) are marked with the stamp “The drug has been dispensed” and are returned to the indicator. It seems to follow from this that prescriptions of form No. 107-1/y with a two-month validity period become “disposable”. We advise readers to pay special attention to this new norm.

The topic of combating the abuse of alcohol-containing drugs in pharmacies, which was recently trumpeted by the media, is also reflected in the new order on the rules of dispensing. According to the current procedure, prescriptions for such drugs are returned to the patient (with a “dispensed” stamp); under the new order, they must remain in the pharmacy organization.

To avoid getting caught

The procedure for working with incorrectly written prescriptions is now described in a little more detail (clause 15 of order No. 403n). In particular, when they are registered by a pharmacist in a journal, it is necessary to indicate the identified violations in the execution of the prescription, the full name of the health worker who wrote it, the name of the medical organization in which he works, and the measures taken.

Paragraph 17 of Order No. 403n contains the rule that a pharmacist does not have the right to provide unreliable or incomplete information about the availability of drugs in the pharmacy’s assortment - including drugs that have the same INN - and also to hide information about the availability of drugs that have a lower price. Similar provisions are contained in subparagraph 2.4 of Article 74 of the Law of November 21, 2011 No. 323-FZ “On the fundamentals of protecting the health of citizens in the Russian Federation” and paragraph 54 of the Rules of Good Pharmacy Practice (Order of the Ministry of Health of the Russian Federation dated August 21, 2016 No. 647n). The only thing new here is that this rule appears for the first time in the order on vacation rules.

This was a review of the order, so to speak, “on fresh trail.” Readers will probably find in it other points and norms that deserve special attention. Write to the editors of Katren-Style magazine about them, and we will address your questions to leading industry experts. We will also ask them about the problem of “disposable” prescriptions with a two-month validity period, which was mentioned above, as well as the dispensing of ethyl alcohol and alcohol-containing drugs in the light of the provisions of the new order No. 403n.


Materials about the order of the Ministry of Health No. 403n:

What could be more important for a pharmacy organization than the order in which medications are dispensed. Pharmacists barely had time to return from their summer vacation and look around when a new order of the Ministry of Health of the Russian Federation dated July 11, 2017 No. 403n was published with appendices “On approval of the rules for the dispensing of drugs for medical use, including immunobiological drugs, by pharmacy organizations, individual entrepreneurs with license for pharmaceutical activities." Order No. 403n on the vacation procedure was registered with the Ministry of Justice of the Russian Federation on September 8; its validity begins on September 22 of the current year.

The first thing I want to say in this regard is that now forget the number “785”. The new order 403n with amendments and additions invalidates the well-known order of the Ministry of Health and Social Development dated December 14, 2005 No. 785 “On the procedure for dispensing medicines,” as well as the orders of the Ministry of Health and Social Development No. 302, No. 109 and No. 521 that amended it. At the same time, many points of a new regulatory legal act repeat - sometimes almost verbatim - the corresponding fragments of the predecessor order. But there are also differences, new provisions, on which we will focus more, setting out the first observations and notes in the margins of the freshly issued order of the Ministry of Health No. 403n.

IP and IBLP

Order of the Ministry of Health of the Russian Federation No. 403n consists of three appendices. The first approves new rules for the dispensing of medicinal products, including immunobiological medicinal products (IBP); the second is the requirements for the dispensing of narcotic and psychotropic drugs, drugs with anabolic activity, and other drugs subject to subject-quantitative accounting (SQR). The third appendix establishes the rules for the dispensing of medicines according to the invoice requirements of medical organizations, as well as individual entrepreneurs (IP) with a license for medical activities.

Under the new order, the dispensing of over-the-counter drugs will be allowed both to pharmacies and pharmacy points, as well as individual entrepreneurs and pharmacy kiosks. For the rest, if we summarize points 2 and 3 of order No. 403n and the list of drugs, the following picture emerges.

  • The dispensing of narcotic and psychotropic drugs can only be carried out by pharmacies and pharmacy points that have the appropriate license.
  • The remaining prescription drugs are dispensed by pharmacies, pharmacy points and individual entrepreneurs (of course, those with a license for pharmaceutical activities - this clarification will be further considered accepted by default and omitted).
  • The dispensing of immunobiological prescription drugs is carried out by pharmacies and pharmacy points. Individual entrepreneurs are not mentioned in this provision of paragraph 3, which means that they cannot dispense drugs of this group, which we advise you to pay special attention to.

In general, in order No. 403n the procedure for dispensing IBP drugs is prescribed separately, which is not in order 785. It will be regulated by paragraph 13 of the first mentioned act. This paragraph, in particular, determines that when an IBP is dispensed, the exact time of this same dispensing, in hours and minutes, is indicated on the prescription or prescription counterfoil, which remains with the buyer.

IBLP can be released if two conditions are met. Firstly, if the buyer has a special thermal container in which the required mode of transportation and storage of these thermolabile drugs can be observed. The second condition is an explanation (from the pharmacist to the buyer) of the need to deliver this drug to a medical organization, despite the fact that it can be stored in the mentioned container for no more than 48 hours.

Let us recall in this regard that this topic is also regulated by subclause 8.11.5 of the Sanitary and Epidemiological Rules “Conditions for transportation and storage of immunobiological preparations” (SP 3.3.2.3332–16), which were approved by Resolution of the Chief State Sanitary Inspector of the Russian Federation dated February 17, 2016 No. 19 It obliges the pharmacy employee to instruct the buyer on the need to comply with the “cold chain” when transporting biomedical products.

The fact of this instruction is recorded with a mark on the drug packaging, prescription or other accompanying document. The mark is certified by the signature of the buyer and the chief clerk (or another representative of the pharmacy organization) and also includes the date and time of dispensing. However, the SanPiN does not specify that the time in this case should be indicated in hours and minutes.

Violation of secondary

With the amendments and additions to Order No. 403n, new emphasis will appear on the topic of the possibility of violation of secondary (consumer) packaging of medicines. The “retiring” norm of Order No. 785 allows this to be done in exceptional cases, if the pharmacy organization is unable to fulfill the doctor’s prescription.

The order No. 403n that replaced it with a list of drugs in this regard is more specific and more in line with modern requirements, medical practice and consumer demands. Paragraph 8 of the order determines that violation of secondary packaging and dispensing of a medicinal product in primary packaging is permitted in cases where the amount of the drug indicated in the prescription or required by the consumer (for over-the-counter dispensing) is less than the amount of the drug contained in the secondary packaging.

In this case, the buyer must be provided with instructions for use or a copy thereof, and tampering with the original packaging is prohibited. By the way, in the new order of the Ministry of Health of the Russian Federation No. 403n there is no provision that in case of violation of the secondary drug must be dispensed in pharmaceutical packaging with the obligatory indication of the name, factory series, expiration date of the drug, series and date according to the laboratory packaging register, which is determined by order No. 785.

What does this mean in practice? Let's assume two situations: first - drug X tablets (or dragees) No. 56, primary packaging - blister; the second is drug N tablets No. 56, in a bottle. And in both cases, the question arises about its release to the patient who has presented the chief of staff with a prescription on which, say, 28 tablets or 42 tablets (dragées) are prescribed.

It is clear that in the first case this is acceptable, since it is possible to dispense 28 or 42 tablets without breaking the primary packaging (blister), and in the second case it is unacceptable, since the primary packaging in this situation is a bottle, and breaking it is strictly prohibited. So, our first capital officials do not have the right to count out tablets or dragees from a bottle, as they do in pharmacies in some foreign countries.

"The medicine has been released"

Clause 4 of Order No. 403n of the Ministry of Health of the Russian Federation regulates the topic of prescription forms and the list of drugs dispensed on them. In particular, narcotic and psychotropic drugs of Schedule II are dispensed using Form No. 107/u-NP, with the exception of narcotic and psychotropic drugs in the form of transdermal therapeutic systems.

According to form No. 148–1/у-88 the following are issued:

  • Schedule III psychotropic drugs;
  • narcotic and psychotropic drugs of Schedule II in the form of transdermal therapeutic systems;
  • drugs included in the list of drugs subject to PCU, with the exception of those drugs that are dispensed in form No. 107/u-NP;
  • drugs that have anabolic activity and are classified as anabolic steroids according to the anatomical-therapeutic-chemical classification (ATC) recommended by the World Health Organization (code A14A);
  • drugs specified in paragraph 5 of the “Procedure for the dispensing to individuals of drugs containing, in addition to small quantities of narcotic drugs, psychotropic substances and their precursors, other pharmacological active substances” (order of the Ministry of Health and Social Development of the Russian Federation dated May 17, 2012 No. 562n);
  • preparations manufactured according to a prescription for a medicinal product and containing a narcotic drug or psychotropic substance included in Schedule II and other pharmacological active substances in a dose not exceeding the highest single dose, and provided that this combined medicinal product is not a narcotic or psychotropic drug Schedule II drug.

The list of other prescription drugs, as is known, is dispensed on form No. 107-1/u. According to paragraph 22 of the order of the Ministry of Health of the Russian Federation dated December 20, 2012 No. 1175n “On approval of the procedure for prescribing and prescribing medications, as well as forms of prescription forms...”, prescriptions written on the forms of this form are valid for two months from the date of prescription. However, for patients with chronic diseases, it is allowed to set the validity period of the prescription form No. 107-1/u within up to one year and exceed the recommended amount of the drug for prescribing per prescription, established by Appendix No. 2 of this order.

Such a prescription, which also indicates the periods and quantity of the drug dispensed (in each period), is returned to the buyer, of course, with the required notes on the date of dispensing, dosage and quantity of the drug dispensed. This is prescribed by paragraph 10 of order No. 403n. It also determines that the next time the patient comes to the pharmacy with the same prescription for a list of drugs, the chief must take into account the notes on the previous dispensing of the drug.

When the maximum quantity specified in the prescription is purchased, it must be stamped “Dispensed.” And a one-time release of the entire quantity, according to the same paragraph, is allowed only in agreement with the doctor who wrote this prescription.

The prescription remains at the pharmacy

There are some changes on the topic indicated in the title of this chapter. Paragraph 14 of the new order No. 403n of the Ministry of Health establishes that the retail trade entity retains (with the mark “The medicinal product is dispensed”) and stores:

within 5 years prescriptions for:

  • narcotic and psychotropic drugs of Schedule II, psychotropic drugs of List III (according to the outgoing 785th order, they are stored for 10 years);

within 3 years prescriptions for:

  • drugs dispensed free of charge or at a discount (according to forms No. 148–1/u-04 (l) or No. 148–1/u-06 (l));
  • combination drugs containing narcotic drugs or psychotropic substances included in Schedules II and III, manufactured in a pharmacy, drugs with anabolic activity, drugs subject to PCU;

within 3 months recipes for:

  • drugs in liquid dosage form containing more than 15% ethyl alcohol by volume of the finished product, other drugs classified by ATC as antipsychotics (code N05A), anxiolytics (code N05B), hypnotics and sedatives (code N05C), antidepressants (code N06A ) and not subject to PCU.

Note that Order 785 does not contain this group of recipes for three-month storage.

Order No. 403n of the Ministry of Health did not come without a cherry on the cake, albeit a dubious one. Paragraph 15 of the order states that prescriptions not listed in the previous 14th paragraph (we listed them just above) are marked with the stamp “The drug has been dispensed” and are returned to the indicator. It seems to follow from this that prescriptions of form No. 107-1/y with a two-month validity period become “disposable”. We advise readers to pay special attention to this new norm.

The topic of combating the abuse of alcohol-containing drugs in pharmacies, which was recently trumpeted by the media, is also reflected in the new order on the procedure for dispensing drugs. According to the current procedure, prescriptions for such drugs are returned to the patient (with a “dispensed” stamp); under the new order, they must remain in the pharmacy organization.

To avoid getting caught

The procedure for dispensing incorrectly written prescriptions is now described in a little more detail (clause 15 of order No. 403n). In particular, when they are registered by a pharmacist in a journal, it is necessary to indicate the identified violations in the execution of the prescription, the full name of the health worker who wrote it, the name of the medical organization in which he works, and the measures taken.

According to this clause, when dispensing a drug, the pharmacist informs the buyer not only about the regimen and doses, but also about the rules for storing it at home and interactions with other drugs.

In theory this means the following. The pharmaceutical inspector can approach the first table in the guise of an ordinary buyer - so to speak, make a test purchase. And if the inspector, when dispensing the medicine, does not inform him, for example, that this medicine must be stored at a temperature no higher than 25 ° C, or does not ask whether he is currently taking other medicines, then the inspector can “throw off the mask” and draw up an act of administrative violation. So the norm in paragraph 16 is serious and fraught. And, of course, it requires that the chief captain be thoroughly versed in the complex and voluminous topic of drug interactions.

Paragraph 17 of Order No. 403n, as amended, contains the rule that a pharmacist does not have the right to provide false or incomplete information about the availability of drugs in the pharmacy product range - including drugs that have the same INN - and also to hide information about the availability of drugs that have a lower price . Similar provisions are contained in subparagraph 2.4 of Article 74 of the Law dated November 21, 2011 No. 323 Federal Law “On the fundamentals of protecting the health of citizens in the Russian Federation” and paragraph 54 of the Rules of Good Pharmacy Practice (Order of the Ministry of Health of the Russian Federation dated August 21, 2016 No. 647n). The only thing new here is that this rule appears for the first time in the order on the vacation procedure.

These were explanations of order No. 403n, so to speak, “on a fresh trail.” Readers will probably find in it other points and norms that deserve special attention. Write to the editors of Katren-Style magazine about them, and we will address your questions to leading industry experts. We will also ask them about the problem of “disposable” prescriptions with a two-month validity period, which was mentioned above, as well as the dispensing of ethyl alcohol and alcohol-containing drugs in light of the provisions of the new Order No. 403 of the Ministry of Health.

On October 5, a webinar by Larisa Garbuzova, Ph.D. will be held on our website. D., Associate Professor of the Department of Management and Economics of Pharmacy at Northwestern State Medical University (St. Petersburg), dedicated, and on October 25, Executive Director of the National Pharmaceutical Chamber Elena Nevolina on the same topic. Register for both webinars.


Materials on the order of the Ministry of Health No. 403n.

  • Order of the Ministry of Health of the Russian Federation dated April 21, 2016 No. 254n “On amendments to the order of the Ministry of Health of the Russian Federation dated December 20, 2012 No. 1175n “On approval of the procedure for prescribing and prescribing medicines, as well as forms of prescription forms for medicines, the order registration of these forms, their recording and storage" and Appendix No. 2 to the order of the Ministry of Health of the Russian Federation dated August 1, 2012 No. 54n "On approval of the form of prescription forms containing the prescription of narcotic drugs or psychotropic substances, the procedure for their production, distribution, registration, accounting and storage, as well as registration rules"
  • Order of the Ministry of Health of the Russian Federation dated December 20, 2012 N 1175n “On approval of the procedure for prescribing and prescribing medicines, as well as forms of prescription forms for medicines, the procedure for completing these forms, their recording and storage” (with amendments and additions)

    Order of the Ministry of Health of the Russian Federation of December 20, 2012 N 1175n
    “On approval of the procedure for prescribing and prescribing medicines, as well as forms of prescription forms for medicines, the procedure for completing these forms, their recording and storage”

    With changes and additions from:

    On the application of this order, see the information letter of the Ministry of Health of Russia dated October 17, 2013 N 25-4/10/2-7719

    In accordance with paragraph 16 of part 2 of Article 14 of the Federal Law of November 21, 2011 N 323-FZ “On the fundamentals of protecting the health of citizens in the Russian Federation” (Collected Legislation of the Russian Federation, 2011, N 48, Art. 6724; 2012, N 26 , Art. 3442, 3446) and clause 5.2.179 of the Regulations on the Ministry of Health of the Russian Federation, approved by Decree of the Government of the Russian Federation of June 19, 2012 N 608 (Collection of Legislation of the Russian Federation 2012, N 26, Art. 3526), ​​I order:

    the procedure for prescribing and prescribing medications in accordance with Appendix No. 1;

    forms of prescription forms according to Appendix No. 2;

    the procedure for preparing prescription forms, recording and storing them in accordance with Appendix No. 3.

    Registration N 28883

    A new procedure for prescribing and prescribing medications has been developed.

    Now the prescription indicates not the trade name, but the international nonproprietary name (INN) of the drug. If it is missing, the group name is displayed.

    Medicines are prescribed by trade name only in the following cases. Firstly, if the drug does not have an international nonproprietary and generic name. Secondly, if such a decision was made by a medical commission (due to individual intolerance or for health reasons).

    Let us remind you that these measures were taken to prevent collusion between doctors and pharmaceutical companies. It is assumed that this will allow the patient to independently (by consulting a pharmacist) choose a specific medicine. However, we note that this position is also subject to criticism. In particular, this is due to the fact that the average person does not have sufficient knowledge to navigate the pharmaceutical market. Consequently, this may cause abuse of trust on the part of pharmacists (pharmacists).

    It is provided that upon discharge from the hospital, by decision of the head physician, the patient may be given (or prescribed) the drugs (psychotropic drugs) he needs for a course of 5 days. In addition, in palliative care, the prescription of these drugs is possible at the sole decision of a medical professional if the patient suffers from pain.

    Limit dosages dispensed per prescription have been established. At the same time, the doses of some drugs are increased (for example, promedol, fentanyl).

    New prescription forms have been approved. It is regulated how they are processed and stored.

    Order of the Ministry of Health of the Russian Federation dated December 20, 2012 N 1175n “On approval of the procedure for prescribing and prescribing medicines, as well as forms of prescription forms for medicines, the procedure for processing these forms, their recording and storage”

    Registration N 28883

    This document is amended by the following documents:

    The changes come into force 10 days after the official publication of the said order, with the exception of subparagraph 3 of paragraph 1 of the changes that come into force on January 1, 2017.

    The changes come into force 10 days after the official publication of the said order, with the exception of subparagraphs 9-12 of paragraph 1, paragraph 2 and subparagraphs 3 and 5 of paragraph 3 of the changes, which come into force on January 1, 2016.

    Order of the Ministry of Health of the Russian Federation dated April 21, 2016 No. 254n “On amendments to the order of the Ministry of Health of the Russian Federation dated December 20, 2012 No. 1175n “On approval of the procedure for prescribing and prescribing medicines, as well as forms of prescription forms for medicines, the order registration of these forms, their recording and storage" and Appendix No. 2 to the order of the Ministry of Health of the Russian Federation dated August 1, 2012 No. 54n "On approval of the form of prescription forms containing the prescription of narcotic drugs or psychotropic substances, the procedure for their production, distribution, registration, accounting and storage, as well as registration rules"

    1. Approve the attached changes that are being made to the order of the Ministry of Health of the Russian Federation dated December 20, 2012 No. 1175n “On approval of the procedure for prescribing and prescribing medications, as well as forms of prescription forms for medications, the procedure for processing these forms, their recording and storage "(registered by the Ministry of Justice of the Russian Federation on June 25, 2013, registration No. 28883) as amended by orders of the Ministry of Health of the Russian Federation dated December 2, 2013 No. 886n (registered by the Ministry of Justice of the Russian Federation on December 23, 2013, registration No. 30714) , dated June 30, 2015 No. 386n (registered by the Ministry of Justice of the Russian Federation on August 6, 2015, registration No. 38379), and Appendix No. 2 to the order of the Ministry of Health of the Russian Federation dated August 1, 2012 No. 54n “On approval of the form of prescription forms containing the purpose of narcotic drugs or psychotropic substances, the procedure for their manufacture, distribution, registration, accounting and storage, as well as registration rules" (registered by the Ministry of Justice of the Russian Federation on August 15, 2012, registration No. 25190) as amended by order of the Ministry of Health of the Russian Federation Federation dated June 30, 2015 No. 385n (registered by the Ministry of Justice of the Russian Federation on November 27, 2015, registration No. 39868).

    2. Subclause 3 of clause 1 of the changes approved by this order comes into force on January 1, 2017.

    Changes,
    which are included in the order of the Ministry of Health of the Russian Federation dated December 20, 2012 No. 1175n “On approval of the procedure for prescribing and prescribing medicines, as well as forms of prescription forms for medicines, the procedure for processing these forms, their recording and storage” and Appendix No. 2 to Order of the Ministry of Health of the Russian Federation dated August 1, 2012 No. 54n “On approval of the form of prescription forms containing the prescription of narcotic drugs or psychotropic substances, the procedure for their production, distribution, registration, accounting and storage, as well as registration rules”

    1. In the order of the Ministry of Health of the Russian Federation dated December 20, 2012 No. 1175n “On approval of the procedure for prescribing and prescribing medicines, as well as forms of prescription forms for medicines, the procedure for processing these forms, their recording and storage” (registered by the Ministry of Justice of the Russian Federation on June 25, 2013, registration No. 28883) as amended by orders of the Ministry of Health of the Russian Federation dated December 2, 2013 No. 886n (registered by the Ministry of Justice of the Russian Federation on December 23, 2013, registration No. 30714), dated June 30, 2015 . No. 386n (registered by the Ministry of Justice of the Russian Federation on August 6, 2015, registration No. 38379):

    1) in Appendix No. 1 “Procedure for prescribing and prescribing medications” to the order (hereinafter referred to as the Procedure):

    a) clause 3.1 should be stated as follows:

    "3.1. Prescribing medications when providing medical care in a hospital setting and prescribing them in invoice requests in accordance with the Instructions on the procedure for prescribing medications and issuing prescriptions and invoice requests, approved by order of the Ministry of Health and Social Development of the Russian Federation dated February 12, 2007 No. 110 “On the procedure for prescribing and prescribing medicines, medical devices and specialized medical nutrition products” (1.1) is carried out according to the international non-proprietary, group or trade name.”;

    b) paragraph two of paragraph 21 should be stated as follows:

    “Prescriptions for medications written on prescription forms No. 148-1/u-04 (l) and form No. 148-1/u-06 (l), citizens who have reached retirement age, disabled people of the first group, disabled children, as well as for citizens suffering from chronic diseases requiring long-term course of treatment, valid for 90 days from the date of prescription.”;

    c) in paragraph 39, after the words “List II of the List”, add the words “(except for medicinal products in the form of transdermal therapeutic systems)”;

    d) in paragraph 40, the words “Psychotropic drugs of list III of the List” are replaced with the words “Narcotic and psychotropic drugs of list II of the List in the form of transdermal therapeutic systems, psychotropic drugs of list III of the List”;

    2) the column “Form of release and dosage” of position 6 of Appendix No. 1 “Maximum permissible quantity of certain narcotic and psychotropic drugs for prescribing per prescription” to the Procedure should be stated as follows: “Solution for subcutaneous administration, ampoules 0.72+5, 75+2.7+0.36+0.05 mg/ml and 1.44+11.5+5.4+0.72+0.1 mg/ml”;

    4) in Appendix No. 2 “Forms of prescription forms” to the order:

    a) in the prescription form “Form No. 148-1/u-04 (l)”, delete the words “5 days”;

    b) in the prescription form “Form No. 148-1/u-06 (l)” the words “5 days” should be deleted;

    5) in Appendix No. 3 “Procedure for issuing prescription forms for medications, their accounting and storage” to the order:

    a) in paragraph 2, replace the words “doctor’s address” with the words “address of an individual entrepreneur”;

    6) in paragraph 3, the words “filled out by a doctor” should be replaced with the words “filled out by a medical professional”;

    c) paragraph 6 after the word “patronymic” should be supplemented with the words “(if any)”;

    d) paragraph one of paragraph 7 should be supplemented with the words “and for children under 1 year of age - the number of full months”;

    e) in paragraph 9, replace the words “and medical card number” with the words “or medical card number”;

    f) subclause 1 of clause 11, after the words “its dosage”, add the word “quantity”;

    g) in paragraph 16, replace the words “5 days, 10 days” with the words “15 days”.

    2. In Appendix No. 2 to the order of the Ministry of Health of the Russian Federation dated August 1, 2012 No. 54n “On approval of the form of prescription forms containing the prescription of narcotic drugs or psychotropic substances, the procedure for their production, distribution, registration, accounting and storage, as well as rules registration" (registered by the Ministry of Justice of the Russian Federation on August 15, 2012, registration No. 25190) as amended by order of the Ministry of Health of the Russian Federation dated June 30, 2015 No. 385n (registered by the Ministry of Justice of the Russian Federation on November 27, 2015, registration No. 39868 ), invalidate paragraph 10 as follows:

    "10. A prescription for a narcotic (psychotropic) drug is certified by the signature and personal seal of a doctor or the signature of a paramedic (midwife), the signature of the head (deputy head or head of a structural unit) of the medical organization that issued the prescription for a narcotic (psychotropic) drug (indicating his last name, first name , patronymic (the latter - if available)), as well as the round seal of the medical organization, the imprint of which must identify the full name of the medical organization."

    (1.1) Registered by the Ministry of Justice of the Russian Federation on April 27, 2007, registration No. 9364, as amended by orders of the Ministry of Health and Social Development of the Russian Federation dated August 27, 2007 No. 560 (registered by the Ministry of Justice of the Russian Federation on September 14, 2007, registration No. 10133), dated September 25, 2009 No. 794n (registered by the Ministry of Justice of the Russian Federation on November 25, 2009, registration No. 15317), dated January 20, 2011 No. 13n (registered by the Ministry of Justice of the Russian Federation on March 15, 2011, registration No. 20103), orders of the Ministry of Health of the Russian Federation dated August 1, 2012 No. 54n (registered by the Ministry of Justice of the Russian Federation on August 15, 2012, registration No. 25190), dated February 26, 2013 No. 94n (registered by the Ministry of Justice of the Russian Federation 25 June 2013, registration No. 28881).

    Document overview

    Changes are being made to the procedure for prescribing and prescribing medications, as well as the forms of prescription forms for them, the procedure for completing these forms, their recording and storage.

    In particular, it is clarified that the prescription of medications when providing medical care in a hospital setting and their prescribing in invoices in accordance with the instructions on the procedure for prescribing medications and issuing prescriptions and invoices is carried out using an international nonproprietary, group or trade name.

    It has also been established that prescriptions for medications written out on prescription forms N 148-1/u-04 (l) and N 148-1/u-06 (l) for citizens who have reached retirement age, disabled people of the first group, children - for disabled people, as well as citizens suffering from chronic diseases requiring long-term treatment, are valid for 90 days from the date of issue.

    It is clarified that narcotic and psychotropic drugs of List II of the List in the form of transdermal therapeutic systems intended for the treatment of citizens entitled to receive free or discounted drugs are also prescribed on prescription form N 148-1/u-88. For the latter, prescriptions are additionally written out in 2 copies on the prescription form Form N 148-1/u-04 (l) or Form N 148-1/u-06 (l).

    From the form of prescription forms containing the prescription of narcotic drugs or psychotropic substances, the clause stating that the prescription for a narcotic (psychotropic) drug is certified by the signature and personal seal of the doctor or the signature of the paramedic (midwife), the signature of the head (his deputy or the head of a structural unit) of the medical organization is excluded who issued the prescription (indicating his full name (the latter - if available)), as well as the round seal of the medical organization, the imprint of which must identify its full name.

    3. To recognize as invalid:

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    ORDER of the Ministry of Health of the Russian Federation dated December 20, 2012 N 1175n “ON APPROVAL OF THE PROCEDURE FOR PRESCRIPTION AND PRESCRIPTION OF MEDICINES, AS WELL AS FORMS OF RECIPTION FORMS, THE PROCEDURE FOR executing THESE FORMS, THEIR RECORDING AND STORAGE”

    This document is being registered with the Ministry of Justice of the Russian Federation. When registering with the Ministry of Justice of the Russian Federation, the text of the document may be changed.

    In accordance with paragraph 16 of part 2 of Article 14 of the Federal Law of November 21, 2011 N 323-FZ “On the fundamentals of protecting the health of citizens in the Russian Federation” (Collected Legislation of the Russian Federation, 2011, N 48, Art. 6724; 2012, N 26 , Art. 3442, N 26, Art. 3446) I order:

    1.1 The procedure for prescribing and prescribing medications in accordance with Appendix No. 1;

    1.2 Forms of prescription forms according to Appendix No. 2;

    1.3 The procedure for preparing prescription forms, recording and storing them in accordance with Appendix No. 3.

    2. In the order of the Ministry of Health and Social Development of the Russian Federation dated February 12, 2007 N 110 “On the procedure for prescribing and prescribing medicines, medical products and specialized medical nutrition products” (registered by the Ministry of Justice of the Russian Federation on April 27, 2007 N 9364 ) invalidate:

    clauses 1.1. - 2.10 and 4.1. — 4.4. Appendix No. 13 “Instructions on the procedure for prescribing medications and issuing prescriptions and invoice requirements” to the order.

    3. To recognize as invalid:

    Order of the Ministry of Health and Social Development of the Russian Federation dated August 27, 2007 N 560 “On invalidating clause 2.5. Instructions on the procedure for prescribing medicines and processing prescriptions and requirements - invoices, approved by order of the Ministry of Health and Social Development of the Russian Federation dated February 12, 2007 N 110" (registered by the Ministry of Justice of the Russian Federation on September 14, 2007 N 10133);

    Order of the Ministry of Health and Social Development of the Russian Federation dated September 25, 2009 N 794n “On amendments to the order of the Ministry of Health and Social Development of the Russian Federation dated February 12, 2007 N 110 “On the procedure for prescribing and prescribing medicines, medical devices and specialized medical nutrition products" (registered by the Ministry of Justice of the Russian Federation on November 25, 2009 N 15317);

    paragraphs 1 - 12, subparagraphs 1 - 22, 32 - 39, paragraph 13, paragraph 15 of Amendments to the order of the Ministry of Health and Social Development of the Russian Federation dated February 12, 2007 N 110 “On the procedure for prescribing and prescribing medicines and medical products and specialized medical nutrition products”, approved by order of the Ministry of Health and Social Development of the Russian Federation dated January 20, 2011 N 13n (registered by the Ministry of Justice of the Russian Federation on March 15, 2011 N 20103).

    Appendix No. 1 to the order
    Ministry of Health of Russia
    dated _______ 2012 N ____

    1. This procedure regulates the issues of prescribing and prescribing medications when providing medical care by medical workers of medical organizations and individual entrepreneurs engaged in medical activities.

    2. Prescription and prescription of medications is carried out by: the attending physician; doctor, paramedic, midwife of a mobile ambulance team; paramedic, midwife in other cases established by order of the Ministry of Health and Social Development of the Russian Federation dated March 23, 2012 N 252n “On approval of the Procedure for assigning certain functions to a paramedic, midwife by the head of a medical organization when organizing the provision of primary health care and emergency medical care the attending physician for the direct provision of medical care to the patient during the period of observation and treatment, including the prescription and use of medications, including narcotic drugs and psychotropic drugs" (registered by the Ministry of Justice of the Russian Federation on April 28, 2012 N 23971) .

    3. Prescription and prescription of medications is carried out in accordance with the standards of medical care.

    The prescription of medications that are not included in the relevant standard of medical care is allowed in case of medical indications (individual intolerance, for health reasons) by decision of the medical commission.

    4. Paramedics and midwives, if the head of a medical organization entrusts them with certain functions of the attending physician for the direct prescription and use of drugs, including narcotic drugs and psychotropic drugs, write prescriptions for drugs signed and indicating their position.

    5. The prescription of medications (name of drugs, single dose, method and frequency of administration or administration, approximate course duration, rationale for prescribing medications) is recorded in the patient’s medical documents.

    6.1. to attending physicians:

    in the absence of medical indications;

    for medicinal products that are not registered in accordance with the established procedure;

    for medicines that, in accordance with the instructions for medical use, are used only in medical organizations;

    for narcotic drugs and psychotropic substances included in List II of the List of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation, approved by Decree of the Government of the Russian Federation of June 30, 1998 N 681 (hereinafter referred to as the List), registered as medicinal drugs for the treatment of drug addiction.

    6.2. by individual entrepreneurs carrying out medical activities, for medicines containing narcotic drugs and psychotropic substances included in lists II and III of the List.

    7. Prescriptions for medications are written out on prescription forms N 148-1/у-88, N 148-1/у-04 (l), N 148-1/у-06 (l) and N 107-1/у approved by this order.

    Narcotic and psychotropic drugs of List II of the List are prescribed on a special prescription form in the form approved by Order of the Ministry of Health of the Russian Federation dated August 1, 2012 N 54n “On approval of the form of prescription forms containing the prescription of narcotic drugs or psychotropic substances, the procedure for their manufacture, distribution, registration, accounting and storage, as well as registration rules" (registered by the Ministry of Justice of the Russian Federation on August 15, 2012 N 25190).

    8. Prescription forms of form N 148-1/у-88 are intended for prescribing:

    1) psychotropic substances included in List III of the List, registered in the prescribed manner as medicinal products (hereinafter referred to as psychotropic medicinal products of List III of the List);

    2) other medicines subject to subject-quantitative accounting;

    3) drugs with anabolic activity;

    4) combination medications containing:

    a) codeine or its salts (in terms of pure substance) in an amount of up to 20 mg (per 1 dose of a solid dosage form) or in an amount of up to 200 mg (per 100 ml or 100 g of a liquid dosage form for internal use);

    b) pseudoephedrine hydrochloride in an amount exceeding 30 mg and up to 60 mg (per 1 dose of solid dosage form);

    c) pseudoephedrine hydrochloride in an amount exceeding 30 mg and up to 60 mg in combination with dextromethorphan hydrobromide in an amount exceeding 10 mg and up to 30 mg (per 1 dose of solid dosage form);

    d) dextromethorphan hydrobromide in an amount of up to 200 mg (per 100 ml or 100 g of liquid dosage form for internal use);

    e) ephedrine hydrochloride in an amount exceeding 100 mg and up to 300 mg (per 100 ml or 100 g of liquid dosage form for internal use) or in an amount up to 50 mg (per 1 dose of solid dosage form);

    f) phenylpropanolamine in an amount of up to 75 mg (per 1 dose of solid dosage form), or up to 300 mg (per 100 ml or 100 g of liquid dosage form for internal use);

    5) individually manufactured medicinal products containing a narcotic drug or psychotropic substance of List II of the List, and other pharmacological active substances in a dose not exceeding the highest single dose, and provided that this combined medicinal product is not a narcotic or psychotropic medicinal product of List II of the List .

    9. For prescribing and dispensing medications to citizens entitled to preferential drug coverage, prescription forms of forms N 148-1/u-04 (l), N 148-1/u-06 (l) are intended.

    10. Other medications are prescribed on prescription forms, form N 107-1/u.

    11. When writing a prescription for an individually prepared medicinal prescription, the names of narcotic and psychotropic medicines of lists II and III of the List, other medicines subject to subject-quantitative recording, are written at the beginning of the prescription, then - all other ingredients.

    12. When prescribing narcotic and psychotropic drugs of lists II and III of the List, other drugs subject to subject-quantitative recording, the dose of which exceeds the highest single dose, the attending physician writes the dose of this drug or substance in words and puts an exclamation mark.

    13. When writing a prescription, it is prohibited to exceed the maximum permissible quantity of medicines for prescribing per prescription established by Appendix No. 1 to this Procedure, except for the cases specified in paragraphs 14 and 22 of this Procedure.

    14. The number of prescribed narcotic and psychotropic medicines of List II of the List and other medicines subject to subject-quantitative recording, when providing palliative medical care to patients, can be increased by 2 times compared to the maximum permissible number of medicines for prescribing per prescription, established in Appendix No. 1 to this Procedure.

    15. The composition of the combined medicinal product, the designation of the dosage form and the attending physician’s request to the pharmacist regarding the manufacture and dispensing of the medicinal product are written out in Latin.

    The prescription abbreviations allowed for use are provided in Appendix No. 2 to this Procedure.

    It is not allowed to abbreviate the designations of ingredients with similar names that do not allow one to determine which particular medicinal product is prescribed.

    16. The method of use of the drug is indicated indicating the dose, frequency, time of administration relative to sleep (morning, at night) and its duration, and for drugs that interact with food, the time of their use relative to meals (before meals, during meals , after meal).

    17. If it is necessary to immediately or urgently dispense a medicinal product to the patient, the designations “cito” (urgent) or “statim” (immediate) are placed at the top of the prescription.

    18. When writing a prescription for an individually prepared medicinal prescription, the amount of liquid pharmaceutical substances is indicated in milliliters, grams or drops, and other pharmaceutical substances - in grams.

    19. Prescriptions written on special prescription forms for narcotic drugs and psychotropic substances are valid for 5 days from the date of issue, prescriptions written on prescription forms of form N 148-1/u-88 - for 10 days.

    20. Prescriptions for medications (except for medications specified in paragraphs 8 and 10 of this Procedure), written out on prescription forms of form N 148-1/u-04 (l) and form N 148-1/u-06 (l ), citizens entitled to preferential drug coverage, are valid for one month from the date of discharge, except for the cases specified in paragraph 21 of this Procedure.

    21. Prescriptions for medications (except for medications specified in paragraphs 8 and 10 of this Procedure), written out on prescription forms of form N 148-1/u-04 (l) and form N 148-1/u-06 (l ), citizens entitled to preferential drug coverage who have reached retirement age, disabled people of the first disability group and disabled children are valid for three months from the date of discharge.

    For the treatment of protracted and chronic diseases, these categories of citizens can be issued prescriptions for medications for a course of treatment of up to 3 months.

    22. Prescriptions for barbituric acid derivatives, ephedrine, pseudoephedrine in pure form and in mixtures with other drugs, drugs with anabolic activity, combination drugs containing codeine (its salts) for the treatment of patients with protracted and chronic diseases can be prescribed for a course of treatment of up to two months.

    In these cases, the prescriptions are marked “For special purposes”, separately signed by the attending physician and the seal of the medical organization “For prescriptions”.

    23. When the attending physician prescribes prescriptions for finished medicinal products and individually manufactured medicinal products for patients with chronic diseases, on prescription forms of form N 107-1/u, it is allowed to set the validity period of the prescription within up to one year.

    When writing such prescriptions, the attending physician makes a note “For a patient with a chronic disease”, indicates the validity period of the prescription and the frequency of dispensing of drugs from a pharmacy organization or an individual entrepreneur with a license for pharmaceutical activities (weekly, monthly, etc.), certifies this indication with your signature and personal seal, as well as the seal of the medical organization “For Prescriptions”.

    24. Prescriptions for all other medications, except for the cases specified in paragraphs 19-21, 23 of this Procedure, are valid for 2 months from the date of discharge.

    25. A prescription issued in violation of the requirements established by this Procedure, or containing incompatible drugs, is considered invalid.

    26. When providing medical care to a patient in a hospital setting, medications are prescribed by the attending physician alone, except for the cases specified in subparagraphs 1-3 of paragraph 27 of this Procedure, without issuing a prescription.

    27. Coordination of the prescription of medications with the head of the department or the responsible doctor on duty or another person authorized by order of the chief physician of a medical organization, as well as with a clinical pharmacologist, is necessary in the following cases:

    1) simultaneous prescription of five or more drugs to one patient;

    2) prescribing narcotic drugs and psychotropic substances included in lists II and III of the List;

    3) prescribing medications that are not included in the list of vital and essential medications, in case of an atypical course of the disease, the presence of complications of the underlying disease and (or) concomitant diseases (conditions), when prescribing dangerous combinations of medications, as well as in case of drug intolerance, included in the territorial list of vital and essential medicines.

    In these cases, the prescription of medications is recorded in the patient’s medical documents and certified by the signature of the attending physician and the head of the department (responsible doctor on duty or other authorized person).

    28. In medical organizations that employ one doctor (local hospital, maternity hospital, located in rural areas, etc.), the prescription of medications in the cases specified in paragraph 27 of this Procedure is carried out by the attending physician alone and is recorded in the patient’s medical documents .

    29. The prescription of medications not included in the list of vital and essential medications to patients when providing medical care in a hospital setting in cases of their replacement due to individual intolerance, for health reasons, is carried out only by decision of the medical commission, which is recorded in medical documents patient and the medical commission journal.

    30. In cases of examination and treatment of citizens in a hospital setting, on the basis of a voluntary medical insurance agreement and (or) an agreement for the provision of paid medical services, they may be prescribed medications that are not included in the list of vital and essential medications, if this is stipulated by the terms of the agreement .

    31. In some cases, by decision of the head of a medical organization, when discharging a patient who has appropriate medical indications and is sent to continue treatment on an outpatient basis, narcotic drugs of List II of List may be prescribed or issued simultaneously with an extract from the medical history in the amount necessary for pain relief for a period of time up to 5 days.

    32. When providing primary health care and palliative care in an outpatient setting, medications are prescribed in cases of the typical course of the patient’s illness based on the severity and nature of the disease, in accordance with duly approved standards of medical care, including:

    1) certain categories of citizens entitled to receive state social assistance in the form of a set of social services, in accordance with the list of medicines approved by order of the Ministry of Health and Social Development of the Russian Federation dated September 18, 2006 N 665 “On approval of the list of medicines, dispensed by prescription from a doctor (paramedic) when providing additional free medical care to certain categories of citizens entitled to receive state social assistance" (registered by the Ministry of Justice of the Russian Federation on September 27, 2006 N 8322) as amended by orders of the Ministry of Health and Social Development of the Russian Federation Federation dated October 19, 2007 N 651 (registered by the Ministry of Justice of the Russian Federation on October 19, 2007 N 10367), dated August 27, 2008 N 451n (registered by the Ministry of Justice of the Russian Federation September 10, 2008 N 12254), dated December 1 2008 N 690н (registered by the Ministry of Justice of the Russian Federation on December 22, 2008 N 12917), dated December 23, 2008 N 760н (registered by the Ministry of Justice of the Russian Federation on January 28, 2009 N 13195), dated November 10, 2011 N 1340n (registered by the Ministry of Justice of the Russian Federation on November 13, 2011 N 22368);

    2) citizens suffering from malignant neoplasms of lymphoid, hematopoietic and related tissues, hemophilia, cystic fibrosis, pituitary dwarfism, Gaucher disease, multiple sclerosis, as well as citizens after transplantation of organs and (or) tissues, in accordance with the list of centrally purchased funds from the federal the budget of medicines approved by the Government of the Russian Federation;

    3) citizens who have the right to receive medicines free of charge and at a discount from the budgets of the constituent entities of the Russian Federation, in accordance with the list of medicines dispensed to the population, approved by the state authorities of the constituent entities of the Russian Federation, in accordance with the List of population groups and categories of diseases, for outpatient treatment of which medicines and medical products are dispensed according to doctors’ prescriptions free of charge, as well as in accordance with the List of population groups for which outpatient treatment medicines are dispensed according to doctors’ prescriptions with a 50% discount (hereinafter referred to as citizens entitled to preferential medicine security).

    33. In the case of living in rural areas, where there is only a medical organization or its separate division that does not have a doctor, prescribing and prescribing medications, including narcotic drugs and psychotropic drugs, when organizing the provision of primary health care and emergency medical care are carried out by a paramedic or midwife of a given medical organization (separate unit), to whom the corresponding functions are assigned by the head of the medical organization.

    The prescription and prescription of narcotic and psychotropic drugs of lists II and III of the List by a paramedic or midwife is carried out:

    1) patients with severe pain syndrome according to the recommendations of a medical specialist, local physician, general practitioner (family doctor);

    2) patients with severe cough syndrome for a period of no more than 5 days, followed by consultation, if necessary, with a specialist (codeine preparations);

    3) patients staying in a local hospital when they are receiving emergency or emergency medical care.

    The list of such medical organizations (their separate divisions) and the procedure for prescribing narcotic and psychotropic drugs of lists II and III of the List in these cases is determined by the executive authority of the constituent entity of the Russian Federation in the field of protecting the health of citizens.

    To provide narcotic and psychotropic drugs on List II of the List, patients are assigned to medical and pharmacy organizations in the manner determined by the executive authority of the constituent entity of the Russian Federation in the field of protecting the health of citizens.

    34. Prescription of medications is made according to the decision

    medical commission in the following cases:

    1) simultaneous prescription to one patient of five or more medications within one day or more than ten items within one month;

    2) prescribing medications in cases of an atypical course of the disease, in the presence of complications of the underlying disease and (or) concomitant diseases (conditions), when prescribing dangerous combinations of medications, as well as in case of individual intolerance;

    3) prescribing narcotic and psychotropic drugs of lists II and III of the List (if the head of the medical organization decides on the need to coordinate the prescription with the medical commission).

    35. The prescription of narcotic and psychotropic drugs of lists II and III of the List is made to patients with severe pain syndrome of any origin independently by a medical specialist or by the attending physician or by the attending physician by decision of the medical commission (if the head of the medical organization decides on the need to coordinate the prescription with the medical commission ).

    Zakonbase: In the electronic document, the numbering of sections corresponds to the official source.

    36. The right to write prescriptions for drugs to citizens entitled to preferential drug coverage also has:

    1) doctors working part-time in a medical organization (within their competence);

    2) doctors of inpatient social protection institutions and correctional institutions (regardless of departmental affiliation);

    3) doctors of medical organizations providing medical care in inpatient settings, in the case provided for in paragraph 31 of this Procedure;

    4) doctors of medical organizations providing primary health care, subordinate to federal executive authorities or executive authorities of constituent entities of the Russian Federation:

    a) citizens who have professional status, the costs of free drug provision for whom, in accordance with the legislation of the Russian Federation, are covered from the federal budget;

    b) other categories of citizens whose costs for free drug provision, in accordance with the legislation of the Russian Federation, are covered by funds from budgets of various levels and compulsory medical insurance as agreed and in the manner determined by the executive authorities of the constituent entity of the Russian Federation, if in the budgets of the relevant federal executive authorities the authorities have not allocated financial resources for these purposes;

    4) individual entrepreneurs who have a license for medical activities, working under an agreement with the territorial executive body in the field of protecting citizens’ health and (or) the territorial compulsory health insurance fund and providing medical care to citizens entitled to preferential drug coverage.

    37. It is not allowed to write prescriptions for medications for the treatment of citizens entitled to preferential drug coverage by doctors of sanatorium-resort organizations, doctors of medical organizations providing medical care in an inpatient setting or a day hospital, as well as doctors of other medical organizations during their stay patients undergoing inpatient treatment, except for the case provided for in paragraph 31 of this Procedure.

    38. When writing prescriptions for medications for the treatment of citizens entitled to preferential drug coverage, a telephone number must be indicated by which an employee of a pharmacy organization, if necessary, can agree with the attending physician (specialist doctor, medical commission of a medical organization) on a synonymous replacement medicinal product.

    39. On the prescription form of form N 148-1/у-04 (l) and form N 148-1/у-06 (l), the prescription is written by the attending physician in 3 copies, with two copies of which the patient applies to the pharmacy.

    The place and conditions for storing the third copy of the prescription are established by the executive authority of the constituent entity of the Russian Federation in the field of protecting the health of citizens.

    40. Narcotic and psychotropic drugs of List II of the List for the treatment of citizens entitled to preferential drug coverage are prescribed on a special prescription form for narcotic drugs and psychotropic substances, to which prescriptions are additionally written in 3 copies on prescription form Form N 148- 1/у-04 (l) or form N 148-1/у-06 (l).

    41. Psychotropic drugs of list III of the List, other drugs subject to subject-quantitative registration, drugs with anabolic activity, combination drugs specified in subparagraph 4 of paragraph 8 of this Procedure, intended for the treatment of citizens entitled to preferential drug coverage , are written out on prescription form N 148-1/u-88, to which prescriptions are additionally written out in 3 copies on prescription form form N 148-1/u-04 (l) or form N 148-1/u-06 ( l).

    Appendix No. 1
    to the Procedure for appointment and prescribing
    medicines,
    approved by order
    Ministry of Health of Russia
    dated ________ 2012 N____

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