Home Smell from the mouth Meet the new rules for dispensing medications. On approval of the rules for the dispensing of medicinal products for medical use, including immunobiological medicinal products, by pharmacy organizations and individual entrepreneurs

Smell from the mouth

Meet the new rules for dispensing medications. On approval of the rules for the dispensing of medicinal products for medical use, including immunobiological medicinal products, by pharmacy organizations and individual entrepreneurs

State budget educational institution higher vocational education St. Petersburg State Chemical and Pharmaceutical Academy

Pharmaceutical College

Professional PM module. 01 "Implementation" medicines and pharmaceutical products"

MDK 01.02 “Vacation medicines and pharmaceutical products"

Section 2. Procedure for dispensing medicines and other pharmaceutical products

Topic 2.8. Procedure for dispensing medicines

Lecture notes

Procedure for dispensing medicines

Prepared by: Deputy Director of the Pharmaceutical College for Development and innovative technologies Petrova E.N.

for specialty 060301 “Pharmacy”

(a basic level of)

Saint Petersburg

Lecture outline:

1. Regulatory documents regulating the procedure for dispensing medicines. Preparing prescriptions for chronically ill patients. Prescriptions long acting. Synonymous replacement of a prescribed drug.

2. Standards for one-time leave. Terms of servicing of issued prescriptions. Shelf life of recipes.

Regulatory documents regulating the procedure for dispensing medicines:

1. dated 04.03.2003 No. 80 Order of the Ministry of Health of the Russian Federation “On approval of the industry standard”, “Rules for the dispensing (sale) of drugs in pharmacies. Basic provisions"

2. dated December 14, 2005 No. 785 Order of the Ministry of Health and Social Development of the Russian Federation “On the procedure for dispensing medications”

3. dated 05/17/2012 No. 562n Order of the Ministry of Health of the Russian Federation “Procedure for the dispensing of medicinal products containing, in addition to small quantities of narcotic, psychotropic substances and their precursors, other pharmacological active substances»

4. dated 09.15.2010 No. 805 Order of the Ministry of Health and Social Development of the Russian Federation “On the minimum range of medicines”

5. dated June 30, 1998 No. 681 P shutdown of the Russian Government“List of narcotic drugs, psychotropic substances and their precursors subject to control in Russian Federation

6. dated December 29, 2007 No. 964 Decree of the Government of the Russian Federation“List of potent and toxic substances for the purposes of Art. 234 and other articles of the Criminal Code of the Russian Federation"

7. Order of the Russian Ministry of Health dated August 1, 2012. N 54н"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"

8. Order of the Ministry of Health of Russia dated December 20, 2012.N1181н"On approval of the procedure for prescribing and issuing medical products, as well as forms of prescription forms for medical products and the order of execution of these forms, their recording and storage"

Procedure for dispensing (sales) of medicines (drugs)

The procedure for dispensing drugs is defined in the Industry Standard “Rules for dispensing (sales) of drugs in pharmacies”, approved by the Order of the Ministry of Health and social development RF dated 03/04/2003 No. 80.

The industry standard is mandatory for all pharmacy organizations, regardless of the organizational and legal form and form of ownership, engaged in the retail trade of medicines.

General provisions

1. A pharmacy organization operates on the basis of a license for pharmaceutical activities issued in accordance with the established procedure.

Purchase, storage and sale of narcotic drugs and psychotropic substances included in the List NS, PV and their precursors subject to control in the Russian Federation should be carried out only if there is licenses for activities related to the turnover of NS and PV.

2. Pharmacy organizations in their work must be guided by certain requirements established state standards, sanitary, fire regulations and other regulatory documents, labor protection and safety regulations.

3. Pharmacy organizations can be represented pharmacies, pharmacy points, pharmacy kiosks.

4. A pharmacy organization (pharmacy, pharmacy point) sells medicines registered in the manner prescribed by the legislation of the Russian Federation or manufactured in a pharmacy organization according to doctors’ prescriptions or the requirements of medical organizations.

5. The sale of drugs and other goods that have become unusable, expired, or illegal copies of drugs is not allowed.

6. A pharmacy organization must have the necessary premises, equipment and inventory to ensure, in accordance with the requirements of standards for maintaining the quality and safety of medicinal products, drugs and other goods authorized for dispensing from pharmacies.

7. In the pharmacy organizations in convenient places on the sales floor should be located:

Copies of licenses for pharmaceutical activities and other types of activities in accordance with the current legislation of the Russian Federation;

Information about telephone numbers and addresses of health and pharmaceutical authorities;

Book of reviews and suggestions;

Information about population groups entitled to free and preferential provision and extraordinary service, in accordance with the current legislation of the Russian Federation;

Information about the person responsible for providing medications to disabled people of Great Britain Patriotic War and equivalent categories of the population for benefits (for pharmacy organizations dispensing medications on preferential terms);

Information about telephone numbers and operating hours of the pharmaceutical reference service;

Information on the names of departments or distribution zones of the corresponding groups of goods;

Information on the shelf life of medicines in a pharmacy (pharmacy point);

Price lists for the proposed over-the-counter drugs and other goods approved for sale from pharmacies;

Information about the employees of the pharmacy organization directly serving the population (plates, badges, etc. indicating full name and position);

Information about the administrator on duty (full name, position) and the location of the alarm call button for the administrator on duty (with the exception of the pharmacy kiosk);

If there is a rental point, information about the list of items available for rental;

A copy or extract from Federal Law No. FZ-2300-1 dated 02/07. 1992 “On the protection of consumer rights”;

A copy or extract from the “Rules of Sale” individual species goods, a list of durable goods that are not subject to the buyer’s requirement to provide him free of charge for the period of repair or replacement of a similar product and a list of non-food products of adequate quality that cannot be returned or exchanged for a similar product of a different size, shape, dimension, style, color or configurations" (Resolution of the Government of the Russian Federation dated January 19, 1998 No. 55);

8. In the course of their activities, specialists of a pharmacy organization are obliged to comply with the norms of pharmaceutical deontology and ethics.

Requirements for the dispensing (sale) of drugs in pharmacies

1. The dispensing (sale) of medicinal products is carried out according to a prescription and without a doctor’s prescription, as well as according to requirements healthcare institutions on the basis of an agreement.

2. When a pharmacy organization receives prescriptions and requirements, a pharmacy organization specialist assesses their compliance with certain requirements and, in accordance with the tariffs, determines the cost of the dispensed drug.

3. If a prescribed drug is replaced by its synonym (generic), with the consent of the buyer or in agreement with the doctor, the trade name of the dispensed drug should be indicated on the back of the prescription, signed and the date of issue.

4. Medicines sold from pharmacies must have information in accordance with the state information standard for medicines.

The buyer, at his request, may be provided with additional information about the purchased drug, about the synonyms (generics) of the purchased drug available in the pharmacy organization and their prices.

5. When dispensing a medicine, an authorized employee of a pharmacy organization informs the buyer about the rules for taking the medicine:

Reception mode;

One-time and daily dose;

Method of administration (including food intake, etc.);

Storage rules, etc.;

Draws the buyer's attention to the need to carefully read the information about the drug.

6. When dispensing medicines, in exceptional cases, it is allowed to violate the secondary packaging with the obligatory indication of the series and expiration date of the medicine on the pharmaceutical packaging and providing the necessary information.

IT IS NOT ALLOWED TO VIOLATE THE PRIMARY PACKAGING OF THE MEDICINE

7. At the buyer’s request, an authorized employee of a pharmacy organization provides information on documents on the prices and expiration dates of drugs and other goods authorized for sale from pharmacies and on documents confirming their quality:

certificate or declaration about compliance;

copy of the certificate, certified by the holder of the original certificate, a notary or the goods certification body that issued the certificate;

Commodity accompanying documents prepared by the manufacturer or supplier (seller) and containing for each product name information on confirmation of its compliance with the established requirements (number of the certificate of conformity, its validity period, the body that issued the certificate, or the registration number of the declaration of conformity, its validity period, name of the manufacturer or supplier (seller) who accepted the declaration and the body that registered it).

These documents must be certified by the signature and seal of the manufacturer (supplier, seller) indicating his address and telephone number.

8. For information about drugs and other products allowed for dispensing from pharmacies, various types of display cases can be used, where drugs sold without a doctor’s prescription and samples of available products are displayed.

Medicines on display cases are placed separately: Medicines for internal use and drugs for external use. Within the groups, drugs are arranged according to pharmacotherapeutic criteria.

9. Cash registers of a pharmacy organization must be registered with the tax authorities at the location of the pharmacy
organizations.

10. The buyer has the right to return or replace goods of inadequate quality purchased from a pharmacy.

RULES FOR DRUG SUPPLY

Approved by order of the Ministry of Health and Social Development of the Russian Federation dated December 14, 2005 No. 785.

I. General provisions

1.1. This Procedure determines the requirements for the dispensing of medicines by pharmacies (organizations) regardless of the organizational and legal form, form of ownership and departmental affiliation.

1.2. Dispensing by pharmacies (organizations) is subject to
medicines, including narcotic drugs, psychotropic drugs,
potent and toxic substances registered in the Russian Federation
Federation in the prescribed manner.

1.3. Medicines are dispensed with a doctor's prescription and without a doctor's prescription by pharmacies (organizations) licensed for pharmaceutical activities.

1.4. Medicines prescribed by doctor must be dispensed by pharmacies and pharmacy points.

Over-the-counter medicines are subject to sale all pharmacies(organizations).

1.5. For uninterrupted supply population with medicines, pharmacies (organizations) are required to have availability minimum assortment medicines necessary to provide medical care, approved by Order of the Ministry of Health and Social Development of the Russian Federation dated September 15, 2010 No. 805.

II. General requirements for dispensing medicines

2.1. All medicines, with the exception of medicines dispensed without a doctor's prescription, must be dispensed by pharmacies (organizations) only according to prescriptions filled out in the prescribed manner on prescription forms of the relevant accounting forms.

2.2. According to prescriptions written on prescription forms, the forms of which are approved by Order of the Ministry of Health of the Russian Federation dated December 20, 2012 No. 1175n and Order of the Ministry of Health of Russia dated August 1, 2012. N 54n pharmaceutical institutions (organizations) dispense:

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, written out on special prescription forms for narcotic drugs;

Psychotropic substances included in List III of the List, prescribed on prescription forms, form N 148-1/u-88;

Other medicines subject to subject-quantitative accounting in pharmacies, drug wholesale trade organizations, medical institutions and private practitioners, the list of which is provided by order of the Ministry of Health and Social Development of the Russian Federation dated 02.12.07, No. 109 and dated 08.06.07 No. 521 written out on prescription forms N 148-1/у-88;

Medicines included in the List of medicines dispensed according to doctor's prescriptions when providing additional free medical care to certain categories of citizens entitled to receive state social assistance, written out on prescription forms N 148-1/у-04 (l), 148-1/у-06 (l);

Anabolic steroids prescribed on prescription forms, form N 148-1/u-88;

Other medications prescribed on prescription forms, form N 107/u.

2.3. Prescriptions for narcotic drugs and psychotropic substances included in List II List, valid within five days.

Prescriptions for psychotropic substances included in List III List; other medicines subject to subject-quantitative accounting; Are anabolic steroids valid? within ten days.

Prescriptions for medicines included in the List of medicines dispensed by prescription from a doctor (paramedic), as well as other medicines, sold free or at a discount, with the exception of prescriptions for narcotic drugs and psychotropic substances included in List II of the List, for psychotropic substances included in List III of the List, for other drugs subject to subject-quantitative recording, for anabolic steroids valid for one month or three months(addition to order No. 110 as amended by order No. 13).

Recipes for other medicines valid for two months from the date of prescription and up to one year.

2.4. Pharmacy institutions (organizations) are prohibited from dispensing
drugs with expired prescriptions, with the exception of drugs with prescriptions that expired while the prescriptions were on deferred service.

2.5. Medicines are dispensed by pharmacies (organizations) in the quantities specified in the prescription, with the exception of medicines whose dispensing rates are specified in Order No. 1175n dated December 20, 2012.

Medicines containing narcotic drugs, psychotropic substances and their precursors and included in the List of Medicines Dispensed Without a Prescription are subject to dispensing by pharmacies in quantities of no more than 2 packages to the consumer (Corvalol, Valocordin, Andipal).

2.6. When dispensing medicines according to a doctor's prescription, an employee of a pharmacy institution (organization) makes a note on the prescription about the dispensing of the drug (name or number of the pharmacy institution (organization), name and dosage of the drug, quantity dispensed, signature of the dispenser and date of dispensing).

2.7. If a pharmacy institution (organization) has medications with a dosage different from the dosage prescribed in the doctor’s prescription, the employee of the pharmacy institution (organization) may decide to dispense the available medications to the patient if the dosage of the drug is less than the dosage specified in the prescription doctor, taking into account recalculation for course dose.

If the dosage of a medicinal product available in a pharmacy institution (organization) exceeds the dosage specified in the doctor’s prescription, the decision to dispense the medicinal product to the patient is made by the doctor who wrote the prescription.

The patient is provided with information about changing the single dose of the drug.

In this case, the medicinal product must be dispensed in pharmaceutical packaging with the obligatory indication of:

■ name of the medicinal product,

■ factory series,

■ shelf life of the medicinal product,

■ series and dates according to the laboratory packaging register

■ and providing the patient with other necessary information (instructions, leaflet, etc.).

Tampering with the original factory packaging of medicines is not allowed.

2.9. When dispensing medicines according to doctor’s prescriptions valid in within one year, the prescription is returned to the patient with indication on the back:

■ name or number of the pharmacy institution (organization),

■ signature of an employee of a pharmacy institution (organization),

■ amount of drug dispensed

■ vacation dates.

When the patient next contacts a pharmacy institution (organization), notes on the previous receipt of the medicine are taken into account.

Upon expiration of the validity period, the prescription is canceled with the stamp “Prescription is invalid” and left at the pharmacy institution (organization).

2.11. If a pharmacy institution (organization) does not have a medicinal product prescribed by a doctor, with the exception of a medicinal product included in the List of Medicines Dispensed on the Prescription of a Doctor (Paramedic), as well as other medicinal products dispensed free of charge or at a discount, the employee of the pharmacy institution (organization) ) can implement it synonymous substitution with the patient's consent.

When dispensing a medicinal product included in the List of Medicinal Products dispensed on prescription from a doctor (paramedic), as well as other medicinal products dispensed free of charge or at a discount, pharmacy worker(organization) can carry out synonymous replacement of the drug in agreement with the doctor who wrote the prescription.

2.12. Prescriptions for drugs marked "statim" (immediately)
are serviced within a period not exceeding one business day from the date of

Prescriptions for medicines marked “cito” (urgent) are processed within a period not exceeding two working days from the moment the patient contacts the pharmacy institution (organization).

Prescriptions for medicines included in the minimum range of medicines are processed within a period not exceeding five working days from the moment the patient contacts the pharmacy institution (organization).

2.13. Prescriptions for medicines included in the List
medicines prescribed by a doctor (paramedic), and not
included in the minimum range of medicines,
are serviced within a period not exceeding ten working days from the date of
a patient's visit to a pharmacy institution (organization).

Prescriptions for medicines prescribed by decision of a medical commission approved by the chief physician of a medical institution are processed within a period not exceeding fifteen working days from the moment the patient contacts the pharmacy.

2.14. Prescriptions for medicines subject to subject-specific
quantitative accounting, medicines included in the List
medicines prescribed by a doctor (paramedic), as well as other medicines sold free of charge or at a discount;
anabolic steroids remain in the pharmacy for subsequent separate storage and destruction after the expiration of the shelf life.

2.15. The pharmacy organization must ensure conditions for the safety of prescriptions left for storage for medicines that are subject to subject-quantitative accounting, medicines included in the List of medicines dispensed according to prescriptions of a doctor (paramedic), as well as other medicines dispensed free of charge or at a discount. ; anabolic steroid.

2.16. The shelf life of prescriptions in a pharmacy organization is:

For medicines included in the List of Medicines dispensed on prescription from a doctor (paramedic), as well as other medicines dispensed free of charge or at a discount - 5 years;

For narcotic drugs and psychotropic substances included in List II of the List, and psychotropic substances included in List III of the List - 10 years;

For other medicines subject to subject-quantitative registration (with the exception of narcotic drugs and psychotropic substances included in List II of the List, and psychotropic substances included in List III of the List); anabolic steroids - 3 years.

After the expiration of the storage period, recipes are subject to destruction in the presence of a commission, about which acts of the established form are drawn up.

The procedure for destroying prescriptions left in a pharmacy after the established storage period has expired, and the composition of the commission for their destruction may be determined by the health care or pharmaceutical authorities of the constituent entity of the Russian Federation.

It is not permitted to re-dispense (sell) medicines recognized as goods of inadequate quality and returned by citizens for this reason.

2.18. Recipes for:

Tranquilizers that are not subject to subject-quantitative accounting;

Antidepressants;

Neuroleptic drugs;

To re-dispense the drug, the patient must consult a doctor for a new prescription.

2.19. Incorrectly written prescriptions are canceled with the stamp “Prescription invalid” and recorded in a journal of the established form, and returned to the patient.

Information about all incorrectly prescribed prescriptions is brought to the attention of the head of the relevant medical institution.

2.20. Pharmacy organizations carry out separate accounting of medicines included in the List of medicines dispensed according to prescriptions of a doctor (paramedic), dispensed to citizens living in the territory of the corresponding subject of the Russian Federation, and to citizens temporarily staying in the territory of this subject of the Russian Federation.

III. Requirements for the dispensing of narcotic drugs and psychotropic substances, medicines subject to subject-quantitative accounting, anabolic steroids

3.1. Vacation pharmacy organizations are subject to narcotic drugs and psychotropic substances included in List II of the List, and psychotropic substances included in List III of the List.

3.2. The right to work with narcotic drugs and psychotropic substances included in List II of the List, and psychotropic substances included in List III of the List, are only available to pharmacy institutions (organizations) that have received the appropriate licenses in the manner prescribed by the legislation of the Russian Federation.

The assignment of an outpatient clinic to a pharmacy organization can be carried out by the health care or pharmaceutical management body of a constituent entity of the Russian Federation in agreement with the territorial body for control over the circulation of narcotic drugs and psychotropic substances.

3.5. Narcotic drugs and psychotropic substances included in List II of the List prescribed by a doctor are dispensed to the patient or the person representing him upon presentation of an identity document issued in the prescribed manner.

Psychotropic substances included in List III of the List, other medicines subject to subject-quantitative recording, anabolic steroids included in the List of medicines dispensed by prescription from a doctor (paramedic), as well as those dispensed free of charge or at a discount, are dispensed upon presentation of a prescription issued on prescription form N 148-1/u-88, and a prescription written out on prescription form N 148-1/u-04 (l) or 148-1/u-06 (l).

3.7. Pharmacy institutions (organizations) are prohibited from dispensing narcotic drugs and psychotropic substances included in List II of the List; psychotropic substances included in List III of the List; other medicines subject to subject-quantitative accounting; anabolic steroids according to prescriptions from veterinary medical organizations for the treatment of animals.

3.8. Separate dispensing of medicinal products subject to subject-quantitative accounting and other medicinal products included in the composition of a combination medicinal product manufactured according to an individual prescription (hereinafter referred to as an extemporaneous medicinal product) is not allowed.

3.9. A pharmacist at a pharmacy institution (organization), upon receipt of a prescription for an individually manufactured medicinal prescription, is obliged to dispense a medicinal product subject to subject-quantitative recording in half the highest single dose if a doctor prescribes medicinal products in a dose exceeding the highest single dose.

3.10. When producing extemporaneous medicinal products containing medicinal products subject to subject-quantitative accounting, in accordance with prescriptions written by a doctor, the pharmacist of the pharmacy institution (organization) signs on the prescription for issuance, and the pharmacist of the pharmacy institution (organization) - on receipt of the required quantity of medicinal products .

3.11. Vacation ethyl alcohol produced:

According to prescriptions written by doctors with the inscription “For application of compresses” (indicating required dilution with water) or “For leather treatment” - up to 50 grams in pure form;

According to prescriptions written by doctors for individually prepared medicinal prescriptions - up to 50 grams in the mixture;

According to prescriptions written by doctors for individually prepared medicinal prescriptions, with the inscription “According to special purpose", separately certified by the signature of the doctor and the seal of the medical institution "For prescriptions", for patients with chronic course diseases - up to 100 grams in a mixture and in pure form.

3.12. When dispensing narcotic drugs and psychotropic substances included in List II; psychotropic substances included in Schedule III; extemporaneous medicinal products containing medicinal products subject to subject-quantitative accounting, instead of a prescription, patients are given a signature with a yellow stripe at the top and the inscription in black on it “Signature” in the established form.

Peculiarities of registration of prescriptions for drugs for the treatment of patients with chronic diseases

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

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

2. When a medical professional writes prescriptions for finished medicinal products and individually manufactured medicinal products for patients with chronic diseases on prescription forms N 107-1/у it is allowed to set the validity period of the prescription within up to one year and exceed the recommended amount of the drug to be prescribed per prescription.

When writing such prescriptions medical worker makes a note "To a patient with chronic disease" , indicates the validity period of the prescription and the frequency of dispensing of medications 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 personal seal, as well as the seal of a medical organization "For recipes".

3. 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 up to two months.

In these cases, the prescriptions are marked "For special purposes", separately signed by a medical worker and sealed by a medical organization "For recipes."

Leave procedureindividuals medicines, 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 Russia dated May 17, 2012 N 562n)

(as amended by Order of the Ministry of Health of Russia dated June 10, 2013 N 369n)

1. Combination medicinal products containing narcotic drugs, psychotropic substances and their precursors in quantities not exceeding the maximum are subject to dispensing. permissible quantity narcotic drugs, psychotropic substances and their precursors contained in preparations that contain small quantities of narcotic drugs, psychotropic substances and their precursors included in lists II, III and IV 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.

2. Dispensing according to prescriptions written out on prescription forms form N 107-1/у , combination medicinal products containing:

A) ergotamine hydrotartrate in amounts up to 5 mg inclusive (caffeamine, nomigren, syncapton, etc.)

b) ephedrine hydrochloride in an amount up to 100 mg inclusive(per 100 ml or 100 g liquid dosage form For internal use) (broncholitin, bronchitusen, etc.)

V) pseudoephedrine hydrochloride in an amount not exceeding 30 mg(per 1 dose of solid dosage form) (Maxicold, Nurofen Stop Cold, Clarinase 12, etc.)

G) pseudoephedrine hydrochloride in an amount not exceeding 30 mg, in combination with dextromethorphan hydrobromide in an amount exceeding 10 mg and up to 30 mg inclusive (per 1 dose of solid dosage form) (Mulsinex, Caffetin Cold, Grippex, Tylenol tablets, etc.)

d) dextromethorphan hydrobromide in an amount exceeding 10 mg and up to and including 30 mg(per 1 dose of solid dosage form) (Fervex for dry cough, Toff plus caps., Alex plus paste, etc.)

e) phenobarbital in amounts exceeding 20 mg and up to 50 mg inclusive(per 1 dose of solid dosage form);

and) phenobarbital in amounts up to 20 mg inclusive in combination with ergotamine hydrotartrate regardless of quantity (per 1 dose of solid dosage form) (bellataminal, bellaspon)

h) chlordiazepoxide in an amount up to 10 mg inclusive(per 1 dose of solid dosage form).

3. Dispensing according to prescriptions written out on prescription forms N 148-1/у-88, are subject to combination medicinal products containing:

A) codeine or its salts(in terms of pure substance) in quantities up to 20 mg inclusive(per 1 dose of solid dosage form) or in quantities up to 200 mg inclusive (per 100 ml or 100 g of liquid dosage form for internal use) (panadeine, noshpalgin, solpadeine, unispaz, cough tab, prodol forte tab., codelac tab. , terpincode tab., nurofen plus, caffetin, codeterpin, neo-codion, etc.);

b) pseudoephedrine hydrochloride in an amount exceeding 30 mg and up to and including 60 mg(per 1 dose of solid dosage form) (sudafed tab., antiflu, teraflu, fervex rhinitis, nurofen stop cold., etc.)

Departments and offices of medical institutions receive medicines and other pharmaceutical items from pharmacies using invoices (p. 65). Prescribed medications can only be received by a health worker (usually a head nurse), in whose name an invoice and power of attorney are issued.

A power of attorney to receive inventory items is issued on forms standard form only to persons working in this medical institution. The power of attorney is signed by the chief physician (or his deputy) and the chief accountant of the medical institution or persons authorized to do so. If accounting of inventory items is carried out by a centralized accounting department, a power of attorney to receive them is signed by the chief physician (or his deputy) of the medical institution served by this accounting department and the chief accountant of the centralized accounting department. In the event that an authorized person must receive inventory items for several invoices (requirements), he may be issued one power of attorney indicating the number and dates of issue of all requirements, and several powers of attorney if the inventory items must be received at different pharmacies.

It is not permitted to issue powers of attorney that are not fully or partially completed, as well as without sample signatures of the persons in whose name they are written out. The validity period of the power of attorney is established taking into account the possibility of receiving and exporting the corresponding valuables from the account on the basis of which the power of attorney was issued, but, as a rule, it should not exceed 15 days.

Dispensing of poisonous medicines to health care institutions is carried out through doctors or a secondary medical staff under a separate (one-time) power of attorney. If a medical and preventive institution is attached to a pharmacy for a permanent supply, then medications containing poisonous drugs can be dispensed under a power of attorney issued for a certain period, but not more than three months.

Depending on whether the medical institution has a pharmacy or not, records are kept of the movement of medications, dressings, auxiliary materials and containers.

The above funds are dispensed from the pharmacy for the actual number of patients in the department.

Treatment-and-prophylactic and other health care institutions are required to exercise strict control over the full use and intended purpose of budgetary allocations allocated for medicines and dressings (Article 10 of the budget classification) in accordance with established standards.

The dispensing of medicines to departments and offices from the pharmacy of a medical institution is also carried out according to invoices (requirements). The procedure for extracting them is given earlier (p. 65).

When receiving valuables from the pharmacy, the recipient signs the invoice, which remains in the pharmacy.

In cases where the invoice (request) does not contain complete data on the prescribed medications, the pharmacy manager is obliged to add the necessary data in both copies or make appropriate corrections when executing the order.

Medicines containing poisonous, narcotic and potent drugs, ethyl alcohol, as well as acutely scarce and expensive medicines, for which subject-quantitative records are kept in the pharmacy, are dispensed to departments (offices) of the institution in amounts not exceeding the five-day need for them.

Packages of medicines dispensed from pharmacies must have a signature and appropriate labels. The signature requires the signatures of the pharmacists who prepared, checked and dispensed the medicine. A representative of the department, when receiving a medicine, is obliged to check its compliance with the prescription. It is strictly prohibited to dispense medications and other medical products to auxiliary staff of medical institutions.

Finished dosage forms and other medical products intended for dispensing to departments and offices are concentrated in the room for systematization and distribution of finished products of the medical institution. This room is equipped with special turntables, cabinets and tables with cells numbered according to medical departments and offices.

Medicines containing toxic substances must be kept in a locked cabinet from the moment of manufacture until dispensing. They are released by the pharmacist-technologist of the pharmacy of the medical institution.

Together with a medical professional, he checks the medicine being dispensed and gives an explanation of the prescriptions, storage conditions, expiration dates, etc.

In departments (offices) of the institution, records of these medicines are kept in special book according to the form given below (page 114).

The pages in the book must be numbered and laced, and the book must be certified by the signature of the head of the institution. The pharmacy manager periodically checks the availability and accuracy of medication records in the departments (offices) of the institution.

Medicines intended for the treatment of patients in hospitals are dispensed by pharmacies of medical institutions to the paramedic or nurse on duty only in the original packaging.

Reception and issuance of medicines and other medical products are carried out using invoices indicating the date and signatures of representatives of the pharmacy and departments.

In large medical institutions, it is advisable to organize the delivery of drugs prepared in pharmacies, as well as medical equipment, directly to departments and offices. The order of delivery of property and its reception in departments and offices is established by the chief physician of the medical institution, taking into account specific local conditions.

Medicines are dispensed to inpatients as prescribed by a doctor by paramedical workers, who receive them as needed from older sister. Responsible for the correct dispensing of drugs to inpatients, as well as for compliance with the rules for storing poisonous, narcotic and potent drugs in the departments and offices of medical institutions are the head of the department (office) and the senior nurse.

Inpatients are given medications in accordance with the treatment plan detailed in the medical records.

In the pharmacy of a medical institution, in addition to the medicines listed in Table 13, subject-quantitative records are also kept:

radioactive isotopes, new drugs for clinical trials and research in accordance with the current instructions of the USSR Ministry of Health;

acute shortage and expensive medicines according to the list approved by the higher-level organization;

containers both empty and filled with medicines.

There is a special book for this:

The pages of this book must be bound, numbered and signed by the head of the institution. A separate page opens for each name, packaging, dosage form, dosage of medications and drugs counted by quantity, and container.

The basis for entries in the book are: upon receipt - supplier invoices; for expenses - invoices (requirements), acts and other expense documents.

Every day, invoices for valuables issued from the pharmacy are registered in the “Book of Taxed Invoices”. At the end of the month, this book calculates the total amount for each group of released valuables: medicines, dressings, containers and total amount per month, which is entered in numbers and words.

In large medical institutions, if necessary, each department in the “Book of Taxed Invoices” is given a separate page.

Invoices for dispensed poisonous, narcotic and potent medicines, ethyl alcohol, as well as acutely in short supply and expensive medicines are recorded daily, in addition, in the “Statement of a sample of consumed medicines subject to subject-quantitative accounting” in the form below:

In this statement, records are kept for each item separately. The statement is signed by the head or deputy head of the pharmacy. Total valuables released per day, according to the sample for the day, are transferred to the “Book of subject-quantitative accounting” (p. 115).

The final data of taxed invoices (claims) fulfilled by the pharmacy for the month are recorded in the monthly “Pharmacy Report on the receipt and expenditure of medicines in monetary (total) terms” using a special form.

The report is compiled at the end of each month. The balance of the cost of medicines for each group at the beginning of the reporting month is displayed, which is transferred from the approved report for the previous month. The parish records the cost of medicines received by the pharmacy from suppliers during the month, according to the invoices registered in the “Invoice Registration Book”.

The cost of the report includes the cost of medicines dispensed by the pharmacy to departments (offices) using invoices registered in the “Book of Taxed Invoices”.

Based on acts and other documents that serve as the basis for writing off as expenses, the cost of spoiled products, returned containers and the total differences in laboratory and packaging work are also recorded.

In cases where a pharmacy receives and dispenses medicines, reagents and other valuables intended for clinical trials, research and scientific (special) purposes, their cost is reflected in the report both on receipt and expense separately in additional columns entered for this purpose.

At the end of the report, the remaining cost of medicines is indicated. Supporting documents are attached to the report, with the exception of taxed invoices, which remain in the pharmacy. The pharmacy stores the first copies of invoices along with the “Registration Book of taxed invoices”, which are kept by the head of the pharmacy and are stored for one calendar year (not counting the current one) in bound form by month.

Invoices for the dispensing of poisonous, narcotic and potent medicines, ethyl alcohol, as well as acutely scarce and expensive medicines are kept by the pharmacy manager for three years.

After the specified storage periods, invoices (claims) can be destroyed in cases where the controlling or higher organization conducted a documentary audit of the institution, which verified the correctness of the invoices, their taxation and entries in the books of taxed claims and subject-quantitative accounting.

An act on the destruction of invoices is drawn up and approved in the prescribed manner.

The pharmacy report is prepared in two copies. The first copy of the report, signed by the manager, is submitted to the institution’s accounting department no later than the 5th day of the month following the reporting month, the second remains with the manager.

After an appropriate check by the accounting department and approval by the head of the institution, the pharmacy report serves as the basis for the accounting department to write off the consumed medications.

Senior accountant (accountant) of the institution for which job description entrusted with the responsibility of maintaining accounting records of medicines, carries out systematic control over the correctness of maintaining the “Book of subject-quantitative records”, “Sampling sheet” and “Book of taxed invoices”, taxation and calculation of totals in invoices.

The correctness of book balances of medicines subject to subject-quantitative accounting is confirmed by the signature of the inspector.

Medical and preventive institutions that do not have their own pharmacies purchase medicines from self-supporting pharmacies only for current needs.

Issued and taxed invoices in a self-supporting pharmacy are registered by the accountant or the manager (if there is no accountant) in the “Record Book for Small Wholesale Issues and Payments to Customers”, in the following form:

The representative of the institution confirms the receipt of medicines from the pharmacy with a receipt on both copies of the invoice, and the pharmacy employee signs for the issuance of goods and the correctness of taxation of the invoices.

Medicines received from a self-supporting pharmacy are stored in departments (offices) only in quantities necessary for the current need, the volume of which is established by a higher organization.

Poisonous, narcotic and potent medicines, ethyl alcohol, as well as acutely scarce and expensive medicines are dispensed from a self-supporting pharmacy using a separate invoice signed by the head of the institution, and are stored with the main (senior) nurse of the institution, responsible for the storage of these medicines. The chief (senior) nurse keeps records of them in a book according to the form given on page 114.

These medications are released to departments (offices) only for current needs using invoices signed by the head of the department and with the authorization signature of the head of the institution. The invoices indicate the numbers of medical records, surnames, first names and patronymics of patients.

At the end of each month, the chief (senior) nurse submits a report to the accounting department in the following form:

The report is approved by the head of the institution.

Due to the fact that payments between medical institutions and self-supporting pharmacies are systematic, payment for the cost of medicines received should be made on the basis of planned payments. The amount of quarterly transferred funds and other valuables should not exceed the estimated allocations of the institution provided for these purposes.

To do this, the institution or a higher organization transfers through the State Bank to the current account of a self-supporting pharmacy or pharmacy management in advance the amounts necessary to pay for medicines and other products medical purposes for the next two weeks.

Based on the invoices issued for two weeks, according to which the goods were sold, the self-supporting pharmacy presents an invoice to the medical institution with the invoices attached, where it indicates the date and number of each invoice, the cost of medicines and other valuables and the total amount.

The accounts of a self-supporting pharmacy are checked by the accounting department of the medical institution using the attached invoices.

Calculations are updated monthly.

At least once a quarter, a reconciliation report is drawn up for mutual settlements. The medical institution must transfer the underpaid amount to the pharmacy's current account before the start of the next quarter; within the same period, the overpaid amounts must be returned by the pharmacy at the request of the institution to its current account to restore cash expenses under Article 10 or counted against further supply of goods.

Plan

Introduction

1. Organization of a workplace for receiving prescriptions and dispensing medications

2. The main responsibilities of a pharmacist for taking prescriptions

2.1 Procedure for taking prescriptions

2.2 Forms of prescription forms

3. Organization of work on dispensing medicines

3.1 Dispensing prescription drugs

3.2 Features of dispensing medicines to cancer patients and chronically ill patients

3.3 Procedure for dispensing medicines provided free of charge or at a discount

4. Norms for one-time dispensing of certain medicines

Conclusion

The main goal of a pharmacy organization is to provide the population with medicines, which means that the production function of any pharmacy is:

Monitoring the correct prescription of medications;

Taking prescriptions;

Manufacturing of medicines according to doctors' prescriptions;

In-pharmacy quality control;

Correct dispensing of medications from pharmacies.

To perform the functions of accepting prescriptions, manufacturing drugs according to doctors’ prescriptions and the requirements of health care facilities, monitoring their quality, as well as dispensing manufactured drugs in pharmacies, a prescription production department (RPO) can be created. To accept prescriptions and dispense finished medicinal products (FPP), a department of ready-made forms (FDF) is created in pharmacies. Some pharmacies combine these two functions.

Departments are managed by department heads and their deputies. The RPO staff includes positions of pharmacists and pharmacists. Pharmacists are allocated to accept prescriptions for individually manufactured drugs and over-the-counter drugs, carry out quality control of prepared drugs, dispense drugs, and control drugs manufactured in pharmacies. The positions of pharmacists may also be allocated to carry out information work, monitoring the work of pharmacists, etc. In addition to pharmaceutical personnel, RPOs should have auxiliary personnel positions: packers and nurse-washers. The presence of a production function in a pharmacy is an indicator of quality drug provision population, medical institutions, accessibility medicinal assistance, the breadth of the range of pharmaceutical services provided by pharmacies.

The workplace is organized in the sales area of the pharmacy. The department's area, available equipment and facilities comply with current building codes (SNiP), technical and economic equipment standards.

The equipment and equipment of workplaces in a pharmacy depends on the volume of work of the pharmacy. The prescription and dispensing workstation is usually isolated from visitors, although modern equipment does not always provide for such isolation. At this workplace, standard equipment is installed, which includes a sectional table, cabinets for storing medications, and turntables for storing manufactured dosage forms.

In addition, the workplace for receiving and dispensing prescriptions is equipped with a refrigerator for storing heat-labile medications, a cabinet for storing poisonous and potent medications, as well as a computer. Currently, many pharmacies are equipped with automated workstations - prescription workstations. It is quite well suited to speed up the sales process using barcoding.

Workplaces are equipped in accordance with the nature of the work performed. The following rules are observed:

There should be no items in the workplace that are not required during the work process;

Each item must have a permanent place; - all objects frequently used in work should be on the floor by hand;

When using various objects, the pharmacist-technologist should not make unnecessary movements.

The workplace for receiving and dispensing medications must be equipped with the necessary reference literature, in particular - the latest edition of the State Pharmacopoeia, tables of highest single and daily doses, literature on compatibility and interactions of drugs, orders of the Ministry of Health regulating the acceptance and dispensing of prescriptions and drugs according to them .

There are also reference books of medicines, including Vidal and Mashkovsky, the State Register of Medicines, price tables, tariffs for the manufacture of medicines, accounting documents, in particular a prescription journal or receipt journal and a log of incorrectly prescribed prescriptions. In addition, there must be labels and signatures at the workplace for taking and dispensing medicines.

When taking and dispensing medications, a pharmacist must be guided by a number of documents:

Laws of the Russian Federation “On Medicines”, “On narcotic drugs and psychotropic substances”, “On the protection of consumer rights”, etc.;

List of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation;

Lists of the Standing Committee on Narcotics Control (PCNC);

List of medicines of lists A and B;

Current orders, regulatory documents of the Ministry of Health of the Russian Federation and other departments;

Pharmacist's Code of Ethics.

In addition, this list also includes Decrees of the Government of regions and territories on issues of pharmaceutical activity.

Recipe– this is a written request from the specialist who prescribed it to the pharmacist (pharmacist) about the manufacture and dispensing of medicines. A prescription is at once a medical, legal and financial document.

When accepting prescriptions and dispensing medications, pharmacists must be guided by Order of the Ministry of Health of the Russian Federation No. 328 dated August 23, 1999. “On the rational prescribing of medicines, the rules for writing prescriptions for them and the procedure for their dispensing by pharmacies (organizations”).

All medicines, with the exception of those named in the List of Medicines Dispensed Without a Prescription, approved by the Ministry of Health of Russia, must be dispensed only with prescriptions in established forms. Medicines are prescribed if there are appropriate indications for citizens who have sought medical help and, if necessary, treatment after discharge from the hospital. It is prohibited to write prescriptions for drugs:

Not approved for medical use by the Russian Ministry of Health and not registered in the Russian Federation;

Used only in health care facilities (anesthetic ether, chloroethyl, sombrevin, etc.);

In the absence of medical indications.

The pharmacist-technologist for taking prescriptions and dispensing medicines is assigned the following responsibilities:

Receiving prescriptions and requirements, checking their correctness, compatibility of ingredients and compliance of prescribed doses with the patient’s age, determining the cost of the medicine and preparing the relevant documentation;

Accounting for incoming prescriptions and transferring them for the manufacture of prescribed medications;

Monitoring the accuracy of prescriptions prescribed by doctors and informing your immediate supervisor about all cases of violation by doctors of the rules for prescribing prescriptions;

Registration of medicines that are unavailable and refused to the population, daily information about this to the heads of the department or pharmacy;

Prescription dispensing of finished medicines.

2.1 Procedure for taking prescriptions

When taking prescriptions and dispensing medications, it is advisable to follow the following algorithm of actions:

1.Checking the compliance of the form of the prescription form with the medicinal prescription. Any prescription, regardless of the procedure for paying for the medicine and the nature of the action of the medications included in it, must contain the following mandatory and additional details.

Required details include:

Stamp of the healthcare facility, indicating the name of the healthcare facility, its address and telephone number;

Prescription date;

FULL NAME. the patient and his age;

FULL NAME. doctor;

Name and quantity of drugs;

Detailed method of drug use;

Doctor's signature and stamp.

Additional prescription details depend on the composition of the drug and the form of the prescription form. Prescriptions are written out on printed forms according to the forms established by the Russian Ministry of Health.

2. Verification of the eligibility of the person who wrote the prescription. Medicines are prescribed by the doctor directly caring for the patient. When providing emergency and emergency medical care, medications are prescribed by a doctor visiting team emergency medical services or department doctor emergency care outpatient clinic. In some cases, medications can be prescribed by a specialist with secondary medical education (dentist, paramedic, midwife).

3.Checking the correctness of the prescription and the method of application of the drug. The composition of the medicinal product, the designation of the dosage form and the doctor’s request to the pharmacist about the manufacture and dispensing of the medicinal product are written out on Latin. The names of narcotic drugs, psychotropic and toxic substances, as well as list A drugs are written at the beginning of the prescription. The method of administration of the drug is written in Russian, indicating the dose, frequency, time of use in relation to food intake. If emergency dispensing of a drug is necessary, the designations cito or statum are placed at the top of the prescription form. Only abbreviations accepted by the rules are allowed.

4.Checking the compatibility of ingredients in the recipe. In a prescription that requires individual preparation, the compatibility of the ingredients included in the medicinal product is checked. In cases where it is necessary to change the composition or quantity of active ingredients, replace one dosage form with another, etc. This issue must be discussed with the doctor who wrote the prescription.

MINISTRY OF HEALTH AND SOCIAL
DEVELOPMENT OF THE RUSSIAN FEDERATION

ORDER

About the procedure for dispensing medicines

(as amended on April 22, 2014)

Lost force on September 22, 2017 on the basis
Order of the Ministry of Health of Russia dated July 11, 2017 N 403n
____________________________________________________________________

____________________________________________________________________
Document with changes made:
(Russian newspaper, N 108, 05.24.2006);
by order of the Ministry of Health and Social Development of Russia dated October 13, 2006 N 703 (Rossiyskaya Gazeta, N 256, 11/15/2006);
(Rossiyskaya Gazeta, N 69, 04/04/2007);
by order of the Ministry of Health and Social Development of Russia dated February 12, 2007 N 110 (Rossiyskaya Gazeta, N 100, 05/15/2007);
(Rossiyskaya Gazeta, N 194, 04.09.2007);
by order of the Ministry of Health of Russia dated April 22, 2014 N 183n (Rossiyskaya Gazeta, N 174, 08/05/2014).
____________________________________________________________________

In accordance with Article 32 of the Federal Law of June 22, 1998 N 86-FZ “On Medicines” (Collection of Legislation of the Russian Federation, 1998, N 26, Art. 3006; 2003, N 27, Art. 2700; 2004, N 35, Art. 3607)

I order:

1. Approve the attached Procedure for dispensing medicines.

2. The clause has lost force since May 26, 2007 - order of the Ministry of Health and Social Development of Russia dated February 12, 2007 N 110..

Minister
M. Zurabov

Registered
at the Ministry of Justice
Russian Federation
January 16, 2006,
registration N 7353

Procedure for dispensing medicines

APPROVED
by order of the Ministry
health and social
development of the Russian Federation
dated December 14, 2005 N 785

I. General provisions

1.1. This Procedure determines the requirements for the dispensing of medicines by pharmacies (organizations)*, regardless of the organizational and legal form, form of ownership and departmental affiliation.

________________

1.2. Medicinal products, including narcotic drugs, psychotropic, potent and toxic substances registered in the Russian Federation in accordance with the established procedure, are subject to dispensing by pharmacies (organizations).

1.3. Medicines are dispensed with a doctor's prescription and without a doctor's prescription by pharmacies (organizations) licensed for pharmaceutical activities.

1.4. Medicines prescribed by doctor must be dispensed by pharmacies and pharmacy points.

Medicines in accordance with the List of Medicines Dispensed Without a Doctor's Prescription, approved by Order of the Ministry of the Russian Federation dated September 13, 2005 N 578 (registered with the Ministry of Justice of the Russian Federation on September 29, 2005 N 7053) (hereinafter -), are subject to sale by all pharmacies (organizations)*.

________________

* Pharmacies, pharmacy points, pharmacy kiosks, pharmacy stores.

1.5. To ensure an uninterrupted supply of medicines to the population, pharmacies (organizations) are required to have in stock a minimum range of medicines necessary to provide medical care, approved by Order of the Ministry of Health and Social Development of the Russian Federation dated April 29, 2005 N 312.

II. General requirements for the dispensing of medicines

2.1. All medicines, with the exception of those included in the List of Medicines Dispensed Without a Doctor's Prescription, must be dispensed by pharmacies (organizations) only according to prescriptions filled out in the prescribed manner on prescription forms of the relevant accounting forms.

2.2. According to prescriptions written on prescription forms, the forms of which are approved, pharmacies (organizations) dispense (paragraph as amended, put into effect on September 15, 2007 by order of the Ministry of Health and Social Development of Russia dated August 6, 2007 N 521:

- 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 (Collected Legislation of the Russian Federation, 1998, N 27, Art. 3198; 2004, N 8, Art. 663; N 47, Art. 4666) (hereinafter referred to as the List), written out on special prescription forms for a narcotic drug;

- psychotropic substances included in List III of the List of form N 148-1/у-88;

- other medicines that are subject to subject-quantitative registration in pharmacies (organizations), drug wholesale trade organizations, medical institutions and private practitioners, the List of which is provided in Appendix No. 1 to this Procedure (hereinafter referred to as medicines subject to subject-quantitative registration). registration), written out on prescription forms, form N 148-1/u-88, by order of the Ministry of Health and Social Development of Russia dated April 24, 2006 N 302;

- medicines included in the provision of additional free medical care to certain categories of citizens entitled to receive state social assistance, approved by order of the Ministry of Health and Social Development of the Russian Federation dated September 18, 2006 N 665 (registered with the Ministry of Justice of the Russian Federation on September 27, 2006 year N 8322) (hereinafter - medicines included in the List of medicines dispensed by prescription from a doctor (paramedic), as well as other medicines dispensed free of charge or at a discount, prescribed on prescription forms form N 148-1/u-04 ( l) and form N 148-1/u-06 (l) (paragraph supplemented from April 15, 2007 by order of the Ministry of Health and Social Development of Russia dated February 12, 2007 N 109; as amended, put into effect on September 15, 2007 by order of the Ministry of Health and Social Development of Russia dated 6 August 2007 N 521;

- anabolic steroids prescribed on prescription forms, form N 148-1/u-88;

Other medicines not included in the List of medicines dispensed without a doctor's prescription, prescribed on prescription forms, form N 107/u.

2.3. Prescriptions for narcotic drugs and psychotropic substances included in List II of the List are valid for five days.

Prescriptions for psychotropic substances included in List III of the List; other medicines subject to subject-quantitative accounting; anabolic steroids are valid for ten days (paragraph as amended, put into effect on June 4, 2006 by order of the Ministry of Health and Social Development of Russia dated April 24, 2006 N 302.

Prescriptions for medicines included in the List of medicines dispensed by prescription from a doctor (paramedic), as well as other medicines dispensed free of charge or at a discount, with the exception of prescriptions for narcotic drugs and psychotropic substances included in List II of the List, for psychotropic substances , included in List III of the List, for other medicines subject to subject-quantitative registration, for anabolic steroids are valid for one month (paragraph as amended, put into effect on June 4, 2006 by order of the Ministry of Health and Social Development of Russia dated April 24, 2006 N 302.

Prescriptions for other medicines are valid for two months from the date of their issuance and up to one year in accordance with paragraph 1.17 of the Instructions on the procedure for prescribing medicines and issuing prescriptions and invoice requirements, approved by order of the Ministry of Health and Social Development of the Russian Federation dated February 12, 2007 year N 110 (hereinafter referred to as the Instructions) (paragraph as amended, put into effect on September 15, 2007 by order of the Ministry of Health and Social Development of Russia dated August 6, 2007 N 521.

2.4. Pharmacy establishments (organizations) are prohibited from dispensing drugs on expired prescriptions, with the exception of drugs on prescriptions that expired while the prescriptions were on deferred service.

2.5. Medicines are dispensed by pharmacies (organizations) in the quantities specified in the prescription, with the exception of medicines, the dispensing rates of which are specified in paragraph 1.11 of the Instructions and Appendix No. 1 to the Instructions (paragraph as amended, put into effect on September 15, 2007 by order of the Ministry of Health and Social Development of Russia dated August 6, 2007 N 521.

Medicines containing narcotic drugs, psychotropic substances and their precursors, and included in the List of medicines dispensed without a doctor's prescription, are subject to dispensing by pharmacies in quantities of no more than 2 packages to the consumer (the paragraph was additionally included from April 15, 2007 by order of the Ministry of Health and Social Development of Russia dated 12 February 2007 N 109).

2.8. In exceptional cases, if it is impossible for a pharmacy institution (organization) to fulfill the doctor’s (paramedic’s) prescription, violation of the secondary factory packaging is allowed.

In this case, the medicinal product must be dispensed in a pharmacy package with the obligatory indication of the name, factory batch, expiration date of the medicinal product, series and date according to the laboratory packaging register and providing the patient with other necessary information (instructions, package insert, etc.).

Tampering with the original factory packaging of medicines is not allowed.

2.9. When dispensing medicines according to a doctor’s prescription valid for one year, the prescription is returned to the patient indicating on the back the name or number of the pharmacy institution (organization), the signature of the employee of the pharmacy institution (organization), the quantity of the drug dispensed and the date of dispensing.

When the patient next contacts a pharmacy institution (organization), notes on the previous receipt of the medicine are taken into account. Upon expiration of the validity period, the prescription is canceled with the stamp “Prescription is invalid” and left at the pharmacy institution (organization).

2.10. In exceptional cases (a patient leaving the city, the inability to regularly visit a pharmacy institution (organization), etc.), pharmaceutical workers of a pharmacy institution (organization) are allowed to make a one-time dispensing of a medicine prescribed by a doctor according to prescriptions valid for one year, in an amount equal to necessary for treatment for two months, with the exception of medicines subject to subject-quantitative registration, the List of which is provided in Appendix No. 1 to this Procedure (the clause was supplemented on June 4, 2006 by order of the Ministry of Health and Social Development of Russia dated April 24, 2006 N 302.

2.11. If a pharmacy institution (organization) does not have a medicinal product prescribed by a doctor, with the exception of a medicinal product included in the List of Medicines Dispensed on Prescriptions of a Doctor (Paramedic), as well as other medicinal products dispensed free of charge or at a discount, the employee of the pharmacy institution (organization) ) can carry out its synonymous replacement with the consent of the patient. *2.11)

When dispensing a medicinal product included in the List of Medicinal Products Dispensed on the Prescription of a Doctor (paramedic), as well as another medicinal product dispensed free of charge or at a discount, an employee of a pharmacy institution (organization) may carry out a synonymous replacement of the medicinal product (paragraph as amended by effective from April 15, 2007 by order of the Ministry of Health and Social Development of Russia dated February 12, 2007 N 109.

2.12. Prescriptions for medicines marked “statim” (immediately) are processed within a period not exceeding one working day from the moment the patient contacts the pharmacy institution (organization).

Prescriptions for medicines marked “cito” (urgent) are processed within a period not exceeding two working days from the moment the patient contacts the pharmacy institution (organization).

Prescriptions for medicines included in the minimum range of medicines are processed within a period not exceeding five working days from the moment the patient contacts the pharmacy institution (organization).

2.13. Prescriptions for medicines included in the List of medicines dispensed by prescription from a doctor (paramedic) and not included in the minimum range of medicines are serviced within a period not exceeding ten working days from the moment the patient contacts the pharmacy institution (organization).

Prescriptions for medicines prescribed by decision of a medical commission approved by the chief physician of a medical institution are processed within a period not exceeding fifteen working days from the moment the patient contacts the pharmacy institution (organization).

2.14. Prescriptions for medicines subject to subject-quantitative recording, the list of which is provided in Appendix No. 1 to this Procedure; medicines included in the List of medicines dispensed on prescription from a doctor (paramedic), as well as other medicines sold free of charge or at a discount; anabolic steroids remain in the pharmacy institution (organization) for subsequent separate storage and destruction after the expiration of the storage period (the clause was supplemented on June 4, 2006 by order of the Ministry of Health and Social Development of Russia dated April 24, 2006 N 302.

2.15. The pharmacy institution (organization) must ensure conditions for the safety of prescriptions left for storage that are subject to subject-quantitative recording, the List of which is provided in Appendix No. 1 to this Procedure; medicines included in the List of medicines dispensed on prescription from a doctor (paramedic), as well as other medicines sold free of charge or at a discount; anabolic steroids (the clause was supplemented on June 4, 2006 by order of the Ministry of Health and Social Development of Russia dated April 24, 2006 N 302.

2.16. The shelf life of prescriptions in a pharmacy institution (organization) is:

For medicines included in the List of Medicines dispensed by prescription from a doctor (paramedic), as well as other medicines dispensed free of charge or at a discount - five years;

- for narcotic drugs and psychotropic substances included in List II of List List III of List - ten years;

- for other medicines subject to subject-quantitative registration, with the exception of narcotic drugs and psychotropic substances included in List II of the List List III of the List; anabolic steroids - three years (paragraph as amended, put into effect on June 4, 2006 by order of the Ministry of Health and Social Development of Russia dated April 24, 2006 N 302.

After the expiration of the storage period, the recipes are subject to destruction in the presence of the commission, about which acts are drawn up, the form of which is provided for in Appendices No. 2 and No. 3 to this Procedure.

The procedure for the destruction of prescriptions left in a pharmacy institution (organization) after the established storage periods have expired, and the composition of the commission for their destruction may be determined by the health care or pharmaceutical authorities of the constituent entity of the Russian Federation.

2.17. Medicines of good quality purchased by citizens are not subject to return or exchange in accordance with the List of non-food products of good quality that cannot be returned or exchanged for a similar product of a different size, shape, size, style, color or configuration, approved by the Decree of the Government of the Russian Federation dated January 19, 1998 No. 55 (Collected Legislation of the Russian Federation, 1998, No. 4, Art. 482; No. 43, Art. 5357; 1999, No. 41, Art. 4923; 2002, No. 6, Art. 584; 2003, No. 29, Art. 2998; 2005, N 7, art. 560).

It is not permitted to re-dispense (sell) medicines recognized as goods of inadequate quality and returned by citizens for this reason.

2.18. Prescriptions for tranquilizers that are not subject to subject-quantitative accounting; antidepressants, neuroleptics; alcohol-containing medicines industrial production are canceled with the stamp of the pharmacy institution (organization) “Medicine dispensed” and returned to the patient’s hands.

To re-dispense the drug, the patient must consult a doctor for a new prescription.

2.19. Incorrectly written prescriptions are canceled with the stamp “Prescription is invalid” and registered in a journal, the form of which is provided in Appendix No. 4 to this Procedure, and returned to the patient in his hands (paragraph as amended, put into effect on June 4, 2006 by order of the Ministry of Health and Social Development of Russia dated April 24, 2006 N 302.

Information about all incorrectly prescribed prescriptions is brought to the attention of the head of the relevant medical institution.

2.20. Pharmacy institutions (organizations) carry out separate accounting of medicines included in the List of medicines dispensed according to prescriptions of a doctor (paramedic), dispensed to citizens living in the territory of the corresponding subject of the Russian Federation, and to citizens temporarily staying in the territory of this subject of the Russian Federation.

III. Requirements for the supply of narcotic drugs and psychotropic substances; medicines subject to subject-quantitative accounting; anabolic steroids

3.1. Narcotic drugs and psychotropic substances included in List II of the List, and psychotropic substances included in List III of the List are subject to dispensing by pharmacies (organizations).

3.3. The dispensing to patients of narcotic drugs and psychotropic substances included in List II of the List, and psychotropic substances included in List III of the List, is carried out by pharmaceutical workers of pharmacy institutions (organizations) who have the right to do so in accordance with the order of the Ministry of Health and Social Development of the Russian Federation dated 13 May 2005 N 330 (registered with the Ministry of Justice of the Russian Federation on June 10, 2005 N 6711).

3.4. In a pharmacy institution (organization), the dispensing of narcotic drugs and psychotropic substances included in List II of the List is carried out by patients assigned to a specific outpatient clinic, which is assigned to the pharmacy institution (organization).

The assignment of an outpatient clinic to a pharmacy institution (organization) can be carried out by the health care or pharmaceutical management body of a constituent entity of the Russian Federation in agreement with the territorial body for control over the circulation of narcotic drugs and psychotropic substances.

3.6. Narcotic drugs and psychotropic substances included in List II of the List and included in the List of medicines dispensed by prescription from a doctor (paramedic), as well as those dispensed free of charge or at a discount, are dispensed upon presentation of a prescription written out on a special prescription form for a narcotic medicine, and prescription written out on prescription form form N 148-1/u-04 (l).

Psychotropic substances included in List III of the List, other medicines subject to subject-quantitative registration, anabolic steroids included in the List of medicines dispensed by prescription from a doctor (paramedic), as well as those dispensed free of charge or at a discount, are dispensed upon presentation of a prescription issued for prescription form N 148-1/у-88, and a prescription written on the prescription form N 148-1/у-04 (l) (paragraph as amended, put into effect on June 4, 2006 by order of the Ministry of Health and Social Development of Russia dated April 24, 2006 year N 302.

3.7. Pharmacy institutions (organizations) are prohibited from dispensing narcotic drugs and psychotropic substances included in List II of the List, List III of the List; other medicines subject to subject-quantitative accounting; anabolic steroids according to prescriptions from veterinary medical organizations for the treatment of animals (clause as amended, put into effect on June 4, 2006 by order of the Ministry of Health and Social Development of Russia dated April 24, 2006 N 302.

3.11. Ethyl alcohol is released:

- according to prescriptions written by doctors with the inscription “For applying compresses” (indicating the required dilution with water) or “For treating the skin” - up to 50 grams in pure form;

- according to prescriptions written by doctors for individually prepared medicinal prescriptions - up to 50 grams in the mixture;

- according to prescriptions written by doctors for individually prepared medicinal prescriptions, with the inscription “For special purposes”, separately certified by the doctor’s signature and the seal of the medical institution “For prescriptions”, for patients with a chronic course of the disease - up to 100 grams in a mixture and pure form (paragraph supplemented on June 4, 2006 by order of the Ministry of Health and Social Development of Russia dated April 24, 2006 N 302.

3.12. When dispensing narcotic drugs and psychotropic substances included in List II of the List; psychotropic substances included in List III of the List; extemporaneous medicinal products containing medicinal products subject to subject-quantitative registration, instead of a prescription, patients are given a signature with a yellow stripe at the top and the inscription in black font on it “Signature”, the form of which is provided for in Appendix No. 5 to this Procedure.

IV. Control over the dispensing of medicines by pharmacies (organizations)

4.1. Internal control over compliance by employees of a pharmacy institution (organization) with the procedure for dispensing medicines (including those subject to subject-quantitative accounting; medicines included in the List of medicines dispensed according to prescriptions of a doctor (paramedic), as well as other medicines dispensed free of charge or at a discount) is carried out by the head (deputy head) of a pharmacy institution (organization) or a pharmaceutical employee of a pharmacy institution (organization) authorized by him.

4.2. External control of compliance by pharmacies (organizations) with the procedure for dispensing medicines is carried out Federal service for supervision in the field of health care and social development and authorities for control of the circulation of narcotic drugs and psychotropic substances within their competence.

Appendix No. 1. List of medicines subject to subject-quantitative accounting in pharmacies (organizations), drug wholesale trade organizations, medical institutions and private practitioners

Appendix No. 1

health and social development
Russian Federation
dated December 14, 2005 N 785
(as amended as put into effect
since April 15, 2007
by order of the Ministry of Health and Social Development of Russia
dated February 12, 2007 N 109, -
see previous edition)

LIST OF MEDICINES,
subject to subject-quantitative recording in pharmacies
institutions (organizations), wholesale trade organizations
medicines, therapeutic and prophylactic
institutions and private practitioners

____________________________________________________________________
Invalid as of August 16, 2014 -

ACT
on the destruction of prescriptions for medicines,
subject to subject-quantitative accounting, medicinal
drugs included in the List of Medicines,
dispensed according to prescriptions from a doctor (paramedic), as well as other
medicines sold free of charge or at a discount,
anabolic steroids after their shelf life has expired*

_______________
* The act is issued monthly.

Commission consisting of:

chairman

members of the commission:

(position and full name)

produced

d. seizure and destruction in

(name of company)

prescriptions for obtaining medicines subject to subject-quantitative accounting, medicines included in the List of medicines dispensed by prescription from a doctor (paramedic), as well as other medicines sold free of charge or at a discount, anabolic steroids after their shelf life has expired:

1) prescriptions for medicines subject to subject-specific

quantitative accounting, for

(month year)

in quantity

(in numbers and words)

2) prescriptions for medications included in the List

medicines prescribed by a doctor (paramedic),

in quantity

(month year)

(in numbers and words)

3) prescriptions for medicines dispensed free of charge or with

discount for

in quantity

(month year)

(in numbers and words)

4) prescriptions for anabolic steroids for

(month year)

in quantity

(in numbers and words)

Total according to the act destroyed by burning or rupture and subsequent

soaking in a bleach solution (underline as appropriate)

recipes

(quantity - in numbers and words)

Chairman of the commission:

(signature)

Members of the commission:

(signature)

Appendix No. 4. Log of incorrectly prescribed prescriptions

Appendix No. 4
to the Procedure for Dispensing Medicines,
approved by order of the Ministry
health and social development
Russian Federation
dated December 14, 2005 N 785


Ministry of Health and social development Russian Federation

(name of institution (organization)

MAGAZINE
registration of incorrectly prescribed prescriptions


Name of therapeutic preventive institution	FULL NAME. doctor	Violation nia	Taken measures	FULL NAME. special list of the pharmacy institution nia (organization tions)

Note.

Information about violations in the issuance of prescriptions is brought to the attention of the head of the relevant medical institution at least once a month.

Appendix No. 5. Signature*

Appendix No. 5
to the Procedure for Dispensing Medicines,
approved by order of the Ministry
health and social development
Russian Federation
dated December 14, 2005 N 785


Name of the governing body healthcare or pharmaceutical activities subject of the Russian Federation
Name or N of the pharmacy institution (organization)



FULL NAME. and age of the patient

Address or medical outpatient card number

FULL NAME. doctor, telephone number of a medical institution











Prepared

Checked

Let go

________________

* To repeat the dispensing of the drug, it is required new recipe doctor

Note.

The signature must have a size of 80 mm x 148 mm and a stripe yellow color width of at least 10 mm.

Revision of the document taking into account
changes and additions prepared
JSC "Kodeks"

Order of the Ministry of Health of Russia dated July 11, 2017 No. 403n “On approval of the Rules for the dispensing of drugs for medical use, including immunobiological drugs, pharmacy organizations, individual entrepreneurs who have a license for pharmaceutical activities" (hereinafter referred to as the Order) came into force in September. Everyone had been waiting for this order for a long time, its drafts had been in existence for about three years. This order canceled the effect of Order No. 785. I note that the order applies not only to pharmacy employees, but and doctors.

The order approved the rules for dispensing drugs without a prescription, with a prescription, and according to the requirements of invoices of medical organizations and individual entrepreneurs with a license for medical activities.

Already following the order, clarifications from the Russian Ministry of Health dated September 27, 2017 were issued, which regulated certain provisions of Order No. 403n. But questions still remain.

The order determined which pharmacies can dispense prescription and over-the-counter drugs. Let me remind you that all pharmacy organizations (pharmacies and kiosks) and individual entrepreneurs with a license to carry out pharmaceutical activities can dispense without a prescription. Prescription drugs still cannot be sold by pharmacy kiosks and individual entrepreneurs with a pharmaceutical license. As for the dispensing of narcotic and psychotropic drugs, they can be dispensed by pharmacies and pharmacy points that have a license to operate in the circulation of such drugs.

The order presented an unpleasant surprise regarding the dispensing of immunobiological drugs. According to the new order, pharmacies and pharmacy points can dispense them, while individual entrepreneurs are denied the right to dispense immunobiological drugs. In the clarification of the Russian Ministry of Health on this issue, reference is made to the federal law No. 157-FZ (which states that only pharmacies can dispense immunobiological drugs to individuals). With the fact that individual entrepreneurs were not included in the list of those who are allowed to release immunobiological preparations, formally you can’t do anything, because from a legal point of view, individual entrepreneurs are not organizations. Organizations are legal entities. Although this is justified formally, I don’t think it is morally justified. Let me remind you that the Federal Law of November 21, 2011 No. 323-FZ “On the fundamentals of protecting the health of citizens in the Russian Federation” (Article 12) states that individual entrepreneurs are equated to pharmaceutical organizations in order to comply with the law. That is, their responsibilities are the same as those of legal entities, and much less rights. I believe that if the issue of dispensing immunobiological drugs is relevant for individual entrepreneurs, it makes sense to defend their rights to dispense them by making official requests to the Ministry of Health. My advice is to emphasize in your letters and appeals that by dispensing immunobiological drugs, you are improving the availability of these drugs to the population. The definition of an immunobiological drug is given in Federal Law No. 61-FZ (Article 4).

RULES AND PROCEDURE FOR WRITING PRESCRIPTIONS

Let me remind you that we have rules and procedures for writing prescriptions for medicines. The order of the Ministry of Health of Russia 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” is still in effect. The recipe is prepared in accordance with the rules of the adj. No. 2 (hereinafter referred to as the Rules). The order of registration remains the same.

√ Appendix No. 2 to the order of the Ministry of Health of Russia No. 54n.

The prescription form must be filled out legibly, clearly, using ink or a ballpoint pen or using a printing device. Corrections when filling out the prescription form are not allowed. One name of narcotic (psychotropic) drug is written on one prescription form. The quantity of narcotic (psychotropic) drugs prescribed on the prescription form is indicated in words. The method of taking a narcotic (psychotropic) drug is indicated in Russian or in Russian and the state languages of the republics that are part of the Russian Federation.

The prescription form is stamped by the medical organization (indicating the full name of the medical organization, its address and telephone number) and the date the prescription for the narcotic (psychotropic) drug was issued.

The recipe is certified:

for the initial appointment - with the signature and personal seal of the doctor/signature of the paramedic (midwife);
signature of the head (deputy or head of a structural unit or a person authorized by the head) of the medical organization that issued a prescription for a narcotic (psychotropic) drug (indicating his last name, first name, patronymic);
seal of the medical organization (structural unit) “For prescriptions”;
when re-prescribing, you must indicate “Repeated” in the upper left corner of the prescription; certify with the signature and personal seal of a doctor/signature of a paramedic (midwife); seal of the medical organization (structural unit) “For prescriptions”.

Let me remind you that more than a year ago, the certification of prescriptions with the legal seal of a medical organization for drugs from List II was canceled.

Narcotic and psychotropic drugs of Schedule II, with the exception of drugs in the form of transdermal therapeutic systems(TDTS), are issued upon presentation of an identification document: to the person indicated in the prescription, his legal representative, or a person who has a power of attorney issued in accordance with the legislation of the Russian Federation for the right to receive such narcotic and psychotropic drugs. The power of attorney is issued in simple written form (Article 185 of the Civil Code of the Russian Federation) and can be notarized at the request of the patient or if it is impossible for him to write a power of attorney (Articles 163 and 185.1 of the Civil Code of the Russian Federation); the validity period is indicated in the power of attorney; if not specified, then 1 year from the date of its signing (clarifications of the Russian Ministry of Health). When dispensing narcotic and psychotropic drugs of List II and psychotropic drugs of List III, a signature is issued with a yellow stripe at the top and the inscription in black font: “Signature”.

Nowhere in regulatory documents It does not say that the pharmacy must copy, take into account or take away these powers of attorney. There is no need to do this.

The order canceled the effect of order No. 785 - now there is no assignment to a specific pharmacy for the dispensing of narcotic drugs, psychotropic substances and their precursors from List II. A pharmacy organization must now service prescriptions for such drugs prescribed by any medical organization anywhere in the Russian Federation. The main thing is that the recipe is prepared according to the current rules.

The norm for vacation without prescription drugs that contain narcotic drugs, psychotropic substances and their precursors. Previously, the norm was no more than 2 packages; Now the same Corvalol and others like it can be dispensed in the quantities required by the person who contacts the pharmacy.

As for issuing prescriptions on form No. 148-1/u-88, the Rules for issuing prescriptions are in effect, approved by Order of the Ministry of Health of Russia 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 completing the specified forms, recording and storing them.” In accordance with it, on the prescription form No. 148-1/u-88, narcotic and psychotropic drugs of List II in the form of TDTS, psychotropic drugs of List III, other drugs subject to PCU, drugs with anabolic activity related to ATC are prescribed anabolic steroids(code A14A) - (order of the Ministry of Health of Russia dated July 11, 2017 No. 403n), drugs specified in paragraph 5 of the order of the Ministry of Health and Social Development of Russia dated May 17, 2012 No. 562n, individually manufactured drugs containing NS or PV of List II and other pharmacologically active substances.

√ Order of the Ministry of Health No. 183n dated April 22, 2014:

potent and toxic drugs in the PKU list (extract): Sodium thiopental, Tramadol (Tramal), Trihexyphenidyl (Cyclodol), Gestrinone (nemestran), 1-Testosterone (Sustanon-250, Omnadren-250, Nebido), Sibutramine (Goldline, Slimia, Syndax), ethyl alcohol (Ethanol), etc.;
combined drugs containing, in addition to small quantities of NS, PIs and their precursors, other pharmacologically active substances (clause 5 of the order of the Ministry of Health and Social Development of Russia dated May 17, 2012 No. 562n);
other drugs subject to subject-quantitative accounting: Pregabalin (Algerica, Lyrica, Prabegin, Pregabalin canon), caps.; Tropicamide (Mydriacyl, Tropicamide), eye drops; Cyclopentolate (Cyclomed, Cycloptic), eye drops.

CHANGES CONCERNING THE RULES FOR DRUG DISpensing

First, a mark is made on the prescription about the dispensing of the drug: a stamp (or mark) is placed on all prescriptions: "The drug has been released"(clauses 14, 15 of the Order), indicate the name of the pharmacy organization / full name. individual entrepreneur, trade name, dosage and quantity of the drug dispensed.

FULL NAME. a medical worker is indicated in cases of dispensing drugs of a higher dosage (paragraph 4 of clause 7 of the Rules), one-time dispensing of drugs on a prescription, the validity of which is 1 year, indicating the frequency of dispensing (paragraph 3 of clause 10 of the Rules).

The details of the identity document of the person who received narcotic or psychotropic drugs of List II (except for TDTS) are indicated (clause 20 of the Rules), full name. the pharmaceutical worker who dispensed the drug and his signature, the date of issue of the drug, a round seal of the joint-stock company is affixed, the imprint of which must identify the full name of the joint-stock company when dispensing narcotic or psychotropic drugs of list II (clause 12 of the Order and appendix 2 to the order of the Ministry of Health of Russia No. 54n ).

When dispensing a medicinal product, the pharmacist informs the person purchasing (receiving) the drug about the regimen and doses of its administration, storage rules at home, and interactions with other drugs. When dispensing, a pharmacist does not have the right to provide false and (or) incomplete information about the availability of medicinal products, including medicinal products that have the same INN, incl. hide information about the availability of drugs that have a lower price.

The sale of falsified, substandard and counterfeit drugs is prohibited. - It is prohibited for a retail trade entity to dispense medicinal products specified in clause 4 of these Rules (prescription dispensing) according to prescriptions from veterinary organizations.

As for the shelf life of prescriptions in the pharmacy, this is where the most surprises await us in paragraph 14 of the Order.

If a prescription is issued for narcotic drugs or psychotropic substances of Schedule II, except for TDTS, in the form of prescription form No. 107-1/u-NP, then the validity of the prescription is 15 days, the shelf life is 5 years. For medicines containing List III pharmaceuticals and Schedule II pharmaceuticals in the form of TDTS, the shelf life is also 15 days and 5 years, respectively. The validity period of medicines subject to PCU is 15 days, and the shelf life is 3 years.

Medicines containing potent and toxic substances, combined drugs... (clause 5 of the Order of the Ministry of Health and Social Development of Russia dated May 17, 2012 No. 562n), other drugs subject to PCU: Pregabalin, Tropicamide, Cyclopentolate, drugs with anabolic activity (ATC code A14A) , written out on prescription form No. 148-1/u-88 - prescription validity - 15 days, shelf life - 3 years.

Medicines dispensed free of charge or at a discount, prescribed on form No. 148-1/u-04 (l), No. 148-1/u-06 (l), - the validity of prescriptions is 30/90 days, and the shelf life in a pharmacy - 3 years.

Medicines not subject to PCU: containing more than 15% ethyl alcohol by volume, antipsychotics (ATC code No. 05A), anxiolytics (ATC code No. 05B), hypnotics and sedatives(code No. 05C according to ATC), antidepressants (code No. 06A according to ATC), prescribed on prescription form No. 107-1/u, - prescription validity period is 60 days/1 year, shelf life in the pharmacy is 3 months after dispensing to the patient last batch of drugs ( clarifications from the Russian Ministry of Health).

Other prescription medications for a patient with a chronic disease have a shelf life of 60 days to 1 year and the prescriptions are returned to the patient.

The simplest way to prove that a prescription has been serviced and will be returned to the patient is to make a copy of it with a pharmacy stamp. If it is not possible to copy, it makes sense to enter information about this in the journal. Or do nothing until there are clear instructions from the Ministry of Health on this issue.

STORING RECIPES IN THE PHARMACY

After the adoption of the Order, many questions arose regarding the order in which recipes were stored.

The order of storage and subsequent destruction of prescriptions in pharmacies is not approved by the Order. A pharmacy organization (PI) must (can) develop and approve an internal document regulating the procedure for storing prescriptions left in the pharmacy and the procedure for their subsequent destruction.

Clause 2.16 approved by Order of the Ministry of Health and Social Development of Russia dated December 14, 2005 No. 785 of the Procedure for Dispensing Medicines with adj. No. 2 and 3 (forms of acts on the destruction of prescriptions for obtaining NS and PV; medicines subject to PCU, and within the framework of DLO upon expiration of their storage periods).

On the norms for prescribing narcotic and psychotropic drugs and other drugs that are subject to subject-quantitative accounting.

Adj. 1 to the order of the Russian Ministry of Health No. 1175. When prescribing narcotic and psychotropic drugs of Lists II and III, other drugs subject to PCU, the dose of which exceeds the highest single dose, the healthcare worker writes the dose of this drug in words and puts an exclamation point.

The drug is dispensed in the quantity specified in the prescription, except in cases where the maximum permissible or recommended quantity for prescription per prescription is established for the drug (Appendices No. 1 and 2 to the procedure for prescribing and prescribing medications, approved by Order No. 1175n).

When presenting a prescription that exceeds the maximum permissible or recommended amount of a medicinal product, the pharmacist:

informs the person who submitted the prescription about this;
dispenses the drug in the established maximum permissible or recommended quantity;
makes a note in the prescription about the amount of the drug dispensed;
informs the head of the relevant medical organization about violations of the procedure for writing prescriptions.

FEATURES OF DELIVERY OF IMMUNOBIOLOGICAL PREPARATIONS

When dispensing an immunobiological medicinal product (IMP) on a prescription or a prescription counterfoil, which remains with the person purchasing (receiving) the medicine, indicated exact time(in hours and minutes) dispensing of the drug.

The release of an immunobiological medicinal product is carried out to the person purchasing (receiving) the drug, if he has a special thermal container in which the drug is placed, with an explanation of the need to deliver this drug to medical organization subject to storage in a special thermal container for a period not exceeding 48 hours after its purchase.

According to the resolution of Rospotrebnadzor and the Chief State Sanitary Doctor of Russia dated 02.17.16 No. 19, the release of ILP for retail sale is permitted subject to delivery to the place of direct use in a thermal container, thermos, or other devices (clarifications of the Ministry of Health of Russia dated 09.27.17) in compliance with the requirements " cold chain."

An employee of a pharmacy institution engaged in retail sale of pharmaceutical products instructs the buyer on the need to comply with the “cold chain” when transporting pharmaceutical products (no more than 48 hours).

Each dose of IMP sold to the population is supplied with instructions for use of the drug in Russian, which indicate the conditions for its storage and transportation. A note about the instructions given is made on the prescription form, drug packaging or other document.

Paragraph 8 of the Order allows for violation of the secondary (consumer) packaging of a medicine if the quantity of medicine indicated in the prescription or required by the person purchasing the drug (for over-the-counter distribution) is less than the quantity of medicine contained in the secondary (consumer) packaging.

Medicines are dispensed: carried out in primary packaging, instructions (a copy of the instructions) for the use of the drug being dispensed are provided. Tampering with the primary packaging of the medicine during its dispensing is prohibited.

Differences from the requirements of Order No. 785 of the Ministry of Health and Social Development of Russia:

no need for “pharmacy packaging indicating the name, factory series, etc.”;
There is no need to keep a laboratory packaging log in such cases.

Recipe service times:

statim(immediately) - within 1 business day from the date the person contacts the retail trade entity;
cito(urgent) - within 2 working days from the date the person contacts the retail trade entity;
included in the minimum assortment - within 5 working days from the date of the person’s application to the retail trade entity;
sold within the framework of DLO and not included in the minimum assortment - within 10 working days from the date of the person’s application to the retail trade entity;
as prescribed by the medical commission - within 15 working days from the date of the person’s application to the retail trade entity.

Important! It is prohibited to dispense drugs with expired prescriptions, except in cases where the prescription expired while it was under deferred maintenance.

Paragraph 6 of the Order establishes the rule that if a prescription has expired while it is on deferred servicing, then the pharmacy must dispense the drug according to such a prescription without reissuing it.

Explanations from the Ministry of Health of Russia dated September 27, 2017 explain that the norm provided for in paragraph 6 (9) of the Procedure applies to all groups of drugs, incl. subject to PCU, with the exception of narcotic and psychotropic drugs included in List II. For the above-mentioned narcotic and psychotropic drugs, the norm provided for in Part 6 of Art. 25 of the Federal Law of 01/08/98 No. 3-FZ “On Narcotic Drugs and Psychotropic Substances”, regarding the prohibition of their dispensing on prescriptions issued more than 15 days ago.

REQUIREMENTS AND RESPONSIBILITIES

Licensing requirements for retail trade are determined:

Decree of the Government of Russia dated December 22, 2011 No. 1081);
Rules of the NAP of medicinal products for medical use (order of the Ministry of Health of Russia dated 08/31/16 No. 647n);
Rules of good practice for storage and transportation of medicinal products for medical use (order of the Ministry of Health of Russia dated 08/31/16 No. 647n);
Rules and procedures for dispensing medications, incl. narcotic and psychotropic drugs: order of the Ministry of Health of Russia No. 1175 of December 20, 2012; Order of the Ministry of Health and Social Development of Russia No. 110 dated February 12, 2007 (with amendments and additions); Order of the Ministry of Health of Russia No. 403n dated July 11, 2017; Order of the Ministry of Health of Russia No. 183n dated April 22, 2014 “On approval of the list of drugs for medical use, subject to subject-quantitative accounting”;
Rules for registering transactions and rules for maintaining and storing special logs of transactions related to the circulation of medicines subject to PCU: Order of the Ministry of Health of Russia No. 378n dated June 17, 2013 (Article 55 “Procedure for retail trade in medicines”), Federal Law “On Circulation of Medicines” ".

Liability for violations of the requirements of the Order provides for penalties (Code of Administrative Offenses): Art. 14.1, part 3. Implementation entrepreneurial activity violation of the requirements and conditions provided for by a special permit (license) entails a warning or the imposition of an administrative fine: officials— from 3 thousand rubles. up to 4 thousand rubles; for legal entities - from 30 thousand rubles. up to 40 thousand rubles.

Part 4. Carrying out business activities in gross violation of the requirements and conditions provided for by a special permit (license) entails the imposition of an administrative fine: for officials - from 5 thousand rubles. up to 10 thousand rubles; for legal entities - from 100 thousand rubles. up to 200 thousand rubles. or administrative suspension of activities for up to 90 days.