Order 647 of the Ministry of Health. Proper pharmacy practice

The date: 29.06.2020

In accordance with paragraph 18 of Article 5 of the Federal Law of April 12, 2010 No. 61-FZ "On the circulation of medicines" (Meeting of the legislation of the Russian Federation, 2010, No. 16, Art. 1815; 2012, No. 26, Art. 3446; 2013 , № 27, Art. 3477; 2014, No. 52, Art. 7540; 2015, No. 29, Art. 4367) and subparagraph 5.2.164 Regulations on the Ministry of Health of the Russian Federation, approved by Decree of the Government of the Russian Federation of June 19, 2012 No. 608 (Meeting of the legislation of the Russian Federation, 2012, No. 26, Art. 3526; 2013, No. 16, Art. 1970; No. 20, Art. 2477; No. 22, Art. 2812; No. 45, Art. 5822; 2014, № 12 , Art. 1296; No. 26, Art. 3577; No. 30, Art. 4307; No. 37, Art. 4969; 2015, No. 2, Art. 491; No. 12, Art. 1763; No. 23, Art. 3333; 2016 , No. 2, Art. 325; No. 9, Art. 1268; No. 27, Art. 4497; No. 28, Art. 4741; No. 34, Art. 5255), I order:

17. The head of the retail entity ensures that the primary and subsequent preparation (instructions) of employees on the following issues approved by it:

a) the rules for vacation drugs for medical use;

b) the rules for vacation of narcotic drugs and psychotropic substances registered as drugs, drugs containing narcotic drugs and psychotropic substances;

c) the rules for vacation of drugs subject to subject-time accounting, rules for maintaining drug accounting magazine to be subject to subject-quantitative accounting;

d) the rules for vacation drugs containing small amounts of narcotic drugs;

e) the procedure for storing recipes;

e) compliance with the requirements for the presence of a minimum range;

g) compliance with the requirements of the proper practice of storage and transportation of drugs;

h) the use of established limit sizes of retail premises to the actual selling prices of manufacturers for drugs included in the list of vital and most important drugs, the procedure for the formation of prices for such drugs;

i) compliance with the requirements of working with falsified non-commodity, counterfeit goods of the pharmacy assortment;

k) Compliance with the restrictions imposed on pharmaceutical workers in the exercise of professional activities.

l) improving the knowledge of drugs, including reproduced drugs interchangeable drugs, the ability to present comparative information on drugs and prices, including drugs of the lower price segment, on new drugs, dosage forms of drugs, testimony to use of drugs;

m) methods of data processing obtained from buyers on the use of drugs detected in the process of use, side effects, bringing this information to interested parties;

h) Compliance with labor protection requirements.

V. Infrastructure

18. The head of the retail entity provides and maintains in working condition the infrastructure necessary to fulfill licensing claims imposed on the implementation of pharmaceutical activities, which, among other things, includes:

a) buildings, workspace and related means of labor;

b) Equipment for processes (technical and software);

c) Security services (transport, communications and information systems).

19. Premises and equipment must be placed, equip and operate in such a way that they match the functions performed. Their planning solution and design should minimize the risk of errors and ensure the possibility of effective cleaning and maintenance in order to exclude the accumulation of dust or dirt and any factors capable of rendering an adverse effect on the quality of the product of the pharmacy assortment.

20. All premises of the retail entity must be located in the building (structure) and are functionally combined, isolated from other organizations and ensure the absence of unauthorized access of unauthorized persons in the premises. The entrance (output) is allowed to the territory of the retail trade subject through the room of another organization.

21. The retail entity needs to provide for the possibility of arrangement of unhindered entry and exit for persons with disabilities in accordance with the requirements of the legislation on the protection of disabled.

If a constructive feature of the building does not allow the arrangement of entry and exit for persons with disabilities, the retail entity needs to organize the possibility of calling a pharmaceutical worker to serve these persons.

22. The retail entity must have a sign indicating:

a) the type of pharmacy organization in Russian and national languages: "Pharmacy" or "pharmacy point" or "pharmacy kiosk";

b) full and (in case there is) abbreviated name, including branded name, and organizational and legal form of a retail trade;

c) work modes.

The retail trade subject that sells the goods of the pharmacy range at night should have a lighted sign with information about work at night.

When placing a retail trade entity inside the building, the signboard should be on the outer wall of the building, if this is not possible, the installation of the pointer is allowed, the requirements for which the requirements for the sign are allowed.

23. Premises must comply with sanitary and hygienic standards and requirements and to ensure the implementation of the basic functions of the retail entity in compliance with the requirements approved by these Rules.

24. The area of \u200b\u200bpremises used by the retail trade must be divided into zones intended for the following functions:

a) trade in goods of the pharmacy assortment with the provision of storage sites that do not allow free access of buyers to goods released, including prescription;

b) acceptance of goods of the pharmacy assortment, quarantine storage area, including separately for drugs;

c) separate storage of clothing workers.

In case the retail business entity is located in the building along with other organizations, the joint use of the bathroom is allowed.

25. The presence of other zones and (or) premises in the premises of the retail entity is determined by the head of the retail entity, depending on the work of the work provided.

26. Premises of the retail entity must be equipped with heating and air conditioning systems (if available), natural or supply-exhaust ventilation (subject to availability), providing working conditions in accordance with the labor legislation of the Russian Federation, as well as compliance with the requirements of appropriate practice of storage and transportation of medicinal drugs.

27. Materials used in finishing and / or repair of premises (zones) must comply with fire safety requirements established by the legislation of the Russian Federation.

The premises of the retail trade must be designed and equipped in such a way as to protect against penetration of insects, rodents or other animals.

In the premises of the retailer, intended for the manufacture of drugs, the surfaces of the walls and ceilings should be smooth, without disrupting the integrity of the coating (waterproof paints, enamels or tiled glazed tiles of light tones), are separated by materials allowing wet cleaning with the use of disinfectants (protected ceramic Tile, linoleum with mandatory welding of seams or other materials).

Places of climbing walls to the ceiling and floor should not have recesses, protrusions and eaves.

28. Premises of the retail entity can have both natural and artificial lighting. General artificial lighting should be provided in all premises, for individual workplaces, if necessary, local artificial lighting is provided.

29. The retail entity should have equipment and inventory that ensure the maintenance of the quality, efficiency and safety of the pharmacy assortment.

30. Premises for storing drugs must be equipped with equipment that allows them to be stored taking into account the requirements of proper practice of storage and transportation of drugs.

Premises, as well as equipment used by the retail trade subject in carrying out activities, must meet the sanitary requirements of fire safety, as well as safety technician in accordance with the legislation of the Russian Federation.

31. Installation of equipment should be carried out at a distance of at least 0.5 meters from the walls or other equipment to have access to cleaning, disinfection, repair, maintenance, calibration and (or) equipment calibration, provide access to the goods of the pharmacy assortment, free passage workers.

The equipment should not block a natural or artificial source of light and clutch the passages.

32. Access to premises (zones) should have only persons authorized by the head of the retail entity. The access of unauthorized persons in these premises is excluded.

33. Equipment used by the retail business must have technical passports stored throughout the entire operation time of the equipment.

Equipment used by the retail trade and related to measurement tools before commissioning, and also after repair and (or) maintenance is subject to primary calibration and (or) calibration, and during operation - periodic calibration and (or) calibration in accordance With the requirements of the legislation of the Russian Federation on ensuring the unity of measurements.

34. The commercial premises and / or zone must be equipped with showcases, racks (gondolas) - with an open display of goods, providing the possibility of a review of the pharmacy assortment goods, allowed for sale, as well as provide convenience in working for employees of the retailest entity.

An open layout of drugs of non-receptible vacation and other pharmaceutical range are allowed.

35. Information on drugs released without a recipe can be placed on the shelf in the form of poster, wobblers and other information carriers in order to provide the buyer with the ability to make a conscious choice of goods of the pharmacy assortment, to obtain information about the manufacturer, the method of its application and in order to preserve the external View of the goods. Also in a convenient place for review, a price tag should be placed with the name, dosage, the number of doses in the package, the manufacturer's country, the shelf life (if available).

36. Medicinal preparations released without a recipe are placed on display cases, taking into account the storage conditions provided for by the instructions for medical use and (or) on the package.

Medicinal preparations allowed by the prescription on the drug is allowed to be stored on the windows, in glass and open cabinets, provided that there is no access to buyers.

Medicinal preparations released by the prescription on the drug are placed separately from non-receptible drugs in closed cabinets with a record "on a prescription for a drug", applied to the shelf or cabinet, in which these drugs are placed.

Vi. Processes of the subject of retail trade in goods pharmaceutical range

37. All processes of the business entity affecting the quality, efficacy and safety of the pharmacy assortment goods are carried out in accordance with the approved standard operating procedures.

38. The head of the pharmacy organization, an individual entrepreneur who has a license for pharmaceutical activities is ensured by the presence of a minimum range.

39. The head of the retail entity should carry out the control of the quantitative and qualitative parameters of purchased goods of the pharmacy assortment, as well as the timing of their delivery in accordance with the agreements concluded in accordance with the requirements of the legislation of the Russian Federation.

40. The head of the retail entity must be approved by the procedure for the selection and evaluation of suppliers of pharmacy assortment goods, including the following criteria:

a) compliance with the provider with the requirements of the current legislation of the Russian Federation on licensing certain types of activities;

b) the supplier's business reputation on the pharmaceutical market, based on the availability of the recalling facts for falsified, poor-quality, counterfeit goods of the pharmacy assortment, the failure to fulfill their accepted obligations, the prescriptions of authorized state control bodies on the facts of violation of the requirements of the legislation of the Russian Federation;

c) the demand of the pharmacy assortment goods offered by the supplier for further implementation, the quality of goods of the pharmacy assortment with the requirements of the legislation of the Russian Federation;

d) compliance with the provider of the requirements established by these Rules to design documentation, the availability of a document with a list of declarations on the compliance of products by established requirements, the Protocol for coordination of drug prices included in the list of vital and most important drugs;

e) compliance with the temperature regime supplier during the transportation of thermolabile drugs, including immunobiological drugs;

e) providing the provider of quality assurance for the pharmacy assortment supplied goods;

g) the competitiveness of the terms of the contract proposed by the provider;

h) the economic validity of the provider of the delivery of goods offered by the provider (the multiplicity of the supplied packages, the minimum delivery amount);

and) the possibility of supplying a wide range;

k) Compliance with the time of delivery by working time in retail trade.

41. The business entity and the supplier conclude an agreement taking into account the requirements of the legislation on the basics of government regulation of trading activities in the Russian Federation, as well as taking into account the requirements of civil laws providing for the provider of claims for the quality of products, as well as the possibility of returning falsified concrete-quality, pharmatic counterfeit goods assortment by the Supplier, if information about this came after acceptance of the product and design relevant documents.

42. With regard to the product of the pharmacy assortment (with the exception of medical devices), the provider is allowed to provide a provider on a reimbursable basis of services, the subject of which is to perform actions, cost-effective supplier and contributing to the increase in sales of goods of the pharmacy assortment (with the exception of medical devices) and buyers' loyalty.

The supplier independently solves the question of the need to acquire such services and imposing a provider of such services to the retail trade subject.

43. Purchase of a pharmacy assortment of retail trade in the form of a state and municipal unitary enterprise is carried out in accordance with the requirements of the legislation of the Russian Federation on the contract system in the sphere of procurement of goods, works, services for providing state and municipal needs.

44. In the process of accepting goods of the pharmacy assortment, including those requiring special storage conditions and security measures, the consistency of the goods received goods and compliance with special storage conditions (with such a requirement), as well as checking damage transport packaging.

The competence of the retail trade subject to test the quality of the goods delivered goods is limited to a visual inspection of the appearance, verification of compliance with the accompanying documents, the completeness of the accompanying document set, including the register of documents confirming the quality of the pharmacy assortment goods. Subject of retail trade must be taken into account features of acceptance and pre-sales check of the pharmacy assortment goods.

45. Acceptance of the pharmacy assortment goods is carried out in a materially responsible person. If the pharmacy assortment goods are in the transport package without damage, the acceptance can be carried out by the number of places or by the number of commodity units and labeling on the container. If the verification of the actual availability of goods of the pharmacy assortment in the container is not carried out, then it is necessary to make a mark about it in the accompanying document.

46. \u200b\u200bIf the quantity and quality of goods of the pharmacy assortment corresponds to the accompanying documents specified in the accompanying documents, then on the accompanying documents (invoice, invoice, inventory invoice, the register of documents on quality and other documents certifying the amount or quality of the goods received) is affixed by an acceptance stamp, Confirming the fact of the conformity of the received pharmaceutical range of the data specified in the accompanying documents. A financially responsible person who carries out the acceptance of the pharmacy assortment, puts its signature on the accompanying documents and assures its printing of the retail entity (if available).

47. In case of inconsistencies with the retail trade in the pharmacy assortment of the contract with the terms of the contract, the data of the accompanying documents by the Commission of the retail trade in accordance with the approved standard operating procedure include an act, which is the basis for the presentation of claims to the Supplier (the compilation of the act unilaterally in a materially responsible person is possible The consent of the supplier or the absence of its representative).

An agreement with the supplier's retail trade can be approved by a different way of notification of the Supplier on the inconsistency of the accompanies of the pharmacy assortment of the accompanying documents.

48. Medicinal preparations regardless of the source of their receipts are subjected to acceptable control in order to prevent admission to the sale of falsified, poor-quality, counterfeit drugs.

Acceptance control is to verify the incoming drugs by assessing:

a) appearance, color, smell;

b) packaging integrity;

c) compliance of the marking of drugs with the requirements established by the legislation on the treatment of medicines;

d) the correctness of the design of the accompanying documents;

e) availability of registry of declarations confirming the quality of medicines in accordance with current regulatory documents.

49. For acceptance control by order of the head of the retail entity, a Reception Commission is created. Members of the Commission must be familiar with all legislative and other regulatory legal acts of the Russian Federation, which determine the basic requirements for goods of the pharmacy assortment, the design of the accompanying documents, their completeness.

50. Products of the pharmacy assortment before filing to the trading zone must pass pre-sale preparation, which includes unpacking, sorting and inspection, check the quality of goods (by external signs) and the availability of the necessary information about the product and its supplier.

51. The products of therapeutic, children's and diet nutrition, biologically active additives are food products, which before their submission to the trading zone or other place of trading should be released from containers, wrapping and linking materials, metal clips. The retail trade subject should also verify the quality of the products of therapeutic, children's and dietary food, biologically active additives on external features, check the availability of the necessary documentation and information, rejection and sorting.

Trade of products of therapeutic, children's and diet nutrition, biologically active additives are prohibited in violation of the integrity of the packaging. The quality of this group of goods is confirmed by a certificate of state registration, which indicates the scope of application and use and a manufacturer document and (or) provider confirming the safety of the product - a declaration of quality or register of declarations.

In case of violation of the integrity of the packaging, the lack of a complete packet of documents, the products of therapeutic, children's and diet nutrition, biologically active additives are subject to return to the supplier.

52. Disinfectants before serving them in the trading zone, placement at the place of sale must pass pre-sale preparation, which includes exemption from transport packaging, sorting, checking the integrity of the packaging (including the functioning of aerosol packaging) and the quality of goods on external signs, the availability of the necessary information About disinfectants and its manufacturer, instructions for use.

Perfumery-cosmetics supplied to the trading area must comply with the requirements defined by the Commission of the Customs Union of September 23, 2011 No. 799 "On the adoption of the Technical Regulations of the Customs Union" On the safety of perfumery-cosmetic products ".

VII. Sales of pharmacy assortment

53. Retail sale of a pharmacy assortment includes sale, vacation, pharmaceutical consulting.

To provide pharmaceutical counseling services, the special zone is allocated, including to expect consumers, with the installation or designation of special limiters, the organization of seating.

54. In the sale of drugs, the pharmaceutical worker is not entitled to hide information about the presence of other drugs with the same international non-payable name and prices on them relative to the requested.

55. In the trading area in a convenient place for viewing place:

a) a copy of a license for pharmaceutical activities;

b) a copy of the license of the activity on the turnover of narcotic drugs, psychotropic substances and their precursors, cultivation of drug-containing plants (if available);

c) information on the impossibility of the return and exchange of goods of the pharmacy assortment of good quality;

d) other documents and information that should be brought to the attention of buyers.

56. At the request of the buyer, the pharmaceutical worker must familiarize him with the accompanying documentation for the product containing for each product name information on the obligatory confirmation confirmation in accordance with the legislation of the Russian Federation on technical regulation (certificate of conformity, its number, its validity period, the authority issued certificate, or Information about the Declaration of Compliance, including its registration number, its validity, the name of the person who has adopted a declaration, and the authority, which has registered it). These documents must be certified by the signature and printing (if any) of the supplier or seller, indicating the address of its location and contact phone.

57. Retail sale of pharmacy products that are not related to drugs can be carried out by employees who do not have pharmaceutical education or additional vocational education in the part of the retailers of drugs in case of their work in separate divisions (ambulatory, paramedics and paramedic and obstetric items, centers (branches) of general medical (family) practice) medical organizations licensed to implement pharmaceutical activities and located in rural settlements, in which there are no pharmacy organizations.

58. Each retail subject must have a book of feedback and suggestions, which is provided to the buyer at his request.

VIII. Conducting an assessment of activities

59. The head of the retail entity conducts an assessment of activities in order to verify the completeness of the fulfillment of the requirements established by these Rules and definitions of corrective actions.

60. Questions regarding personnel, premises, equipment, documentation, compliance with the rules of trade in goods of the pharmacy assortment, activities for working with reviews and suggestions of buyers, work on identifying falsified, unfaithful, counterfeit products of pharmacy assortment, as well as internal audit activities should Analyze the head of the retail entity in accordance with the approved schedule.

61. Internal audit should be carried out independently and carefully specifically appointed by the head of the retail trade in persons consisting in the state of retail and (or) attracted on a contractual basis.

By decision of the head of the retail entity, an independent audit may be conducted, including experts of third-party retail entities.

62. The results of the internal audit are documented.

Documents drawn up by the results of an audit should include all the information and proposals received on the necessary corrective actions.

Measures taken on the results of an internal audit conducted are also documented.

63. Internal audit is also carried out in order to identify deficiencies in fulfilling the requirements of the legislation of the Russian Federation and making recommendations on corrective and preventive actions.

64. The internal audit program should take into account the results of the previous internal audit, inspections of the controls.

65. The person responsible for the scanned area of \u200b\u200bthe retail business must ensure the immediate implementation of corrective and preventive actions.

Further actions should include an audit (verification) of the adjusting and preventive actions and a report on the results of actions performed and their effectiveness.

66. The head of the retail entity should ensure the identification of pharmacy assortment goods that do not meet the requirements of regulatory documentation, in order to prevent unintentional use or sales.

Falsified, unfaithful, counterfeit products of the pharmacy assortment must be identified and isolated from the rest of the pharmacy assortment in accordance with standard operating procedures.

Marking, place and methods for isolating the quarantine zone, as well as a person responsible for working with the specified goods of the pharmacy assortment, are established by order of the head of the retail entity.

67. The head of the retail entity must constantly improve the performance of the quality system, using including internal audit results, analysis of data, corrective and preventive actions.

68. Processes should be described in standard operational procedures:

a) the analysis of complaints and suggestions of buyers and making decisions on them;

b) establishing the reasons for violation of the requirements of these Rules and other requirements of regulatory legal acts governing the issues of circulation of goods of the pharmacy assortment;

c) assessing the need and expediency of adopting appropriate in order to avoid re-emergence of a similar violation;

d) the definitions and implementation of the necessary actions in order to prevent the ingress of falsified, unfaithful, counterfeit goods of the pharmacy assortment to the buyer;

e) analyzing the effectiveness of the preventive warning and corrective actions.

______________________________

* Part 7 of Article 55 of the Federal Law of April 12, 2010 No. 61-FZ "On Contacting Medicines" (Meeting of the Legislation of the Russian Federation 2010, No. 16, Art. 1815; No. 31, Art. 4161; 2013, No. 48, . 6165; 2014, No. 52, Art. 7540; 2015, No. 29, Art. 4388; 2016, No. 27, Art. 4238).

** Resolution of the Government of the Russian Federation of December 22, 2011 No. 1081 "On Licensing of Pharmaceutical Activities" (Meeting of Legislation 2012, No. 1, Art. 126; 2012, No. 37, Art. 5002; 2013, No. 16, Art. 1970; 2016, No. 40, Art. 5738).

Overview of the document

Approved the rules for the proper pharmacy practice of drugs for medical use.

The rules are aimed at providing the population with high-quality, efficient and safe goods of the pharmacy assortment.

Provide requirements for quality system. The responsibilities of the head of the retail entity are listed. Personal requirements are prescribed.

The staff schedule is approved. Each employee must be familiar with the signature with its rights and responsibilities contained in job descriptions, professandards.

The infrastructure requirements are established necessary to fulfill licensing requirements for pharmaceutical activities.

Medicinal preparations released by the prescription are placed separately from the non-prescription.

Products of the pharmacy assortment before filing to the trading zone should be pre-soldered, which includes unpacking, sorting and inspection, test quality check (for external signs) and the availability of the necessary information about the product and its supplier.

Retail includes sale, vacation, pharmaceutical consulting.

The pharmaceutical worker is not entitled to hide from the buyer information about the presence of other drugs having the same MNN, and the prices of them are relative to the requested.

At the request of the buyer, get acquainted with the accompanying documentation for the goods. Each retail subject must have a book of feedback and suggestions.

An assessment is carried out.

On approval of proper pharmacy practice rules In the pharmaceutical sphere began to speak back in 2016. The view was distributed that this document will be the key industry act in 2017. So it happened. Consider briefly the content of the act about proper pharmacy practice with comments.

General

Order 647N, which contains a new order, was registered by the Ministry of Justice January 9, 2017. This document entered into force on March 1 of the specified year.

The order of 647n provides a set of prescriptions, the failure to comply with the relevant consequences, including administrative responsibility for the COAP. Other orders, decisions, laws This document, of course, does not cancel. The order of the Ministry of Health, however, accumulates a number of their provisions. All of them are now contained in the same regulatory act.

Rules for proper pharmacy practice: discussion

Before the entry into force, the opinion was expressed that it would be the most used act in the pharmaceutical. And the leaders of pharmacies, and provisions, pharmacists, and other employees will open exactly to clarify how one or another products need to be taken, how to organize office work, how to advise the buyer and so on. Simply put, it was expected that the act would be a benefit number 1 in the work of pharmacies.

IN Rules for proper pharmacy practice There are new recommendations and norms. Their use will certainly change the daily activities of pharmacy structures.

Posted Order of the Ministry of Health Rules for proper pharmacy practice Contain, among other things, a detailed description of actions, mechanisms, pharmacy processes. For example, there are details of the implementation of acceptance control of products.

International Practice

It is worth saying that the work on the arrangements of the rules is carried out for a long time. So, in 1993, MFF (International Pharmaceutical Federation) developed a document whose name is translated into Russian as " Proper pharmaceutical practice. "

In 1997 and 2001, this document was processed. At the same time in revision " Proper pharmacy practice"She participated not only MFF, but WHO.

It is worth saying that there was no some specific leadership. The document did not have a detailed description of all procedures and aspects of pharmacy work. " Proper pharmacy practice"- This is a common basic scheme, on the basis of which the rules were to be developed in different countries, taking into account the specifics of a state. National appearance, in turn, should be detailed.

Prerequisites for the adoption of the document

Implementation of proper pharmacy practice rules It is determined, according to experts, two reasons.

First of all, the Ministry of Health, together with Roszdravnadzor, significantly increased their activities on the improvement of the regulatory framework of the pharmaceutical sphere.

Secondly, experts believe that the emergence of proper pharmacy practice rules in the Russian Federation is associated with participation in EAEU. The fact is that Russia's partners on this organization have long have their own. One of the directions of work of authorized structures of the EAEU is to bring into the unified form of pharmacological legislation of the member countries.

Structure

Rules for proper pharmacy practice Consist from 8 sections:

The first and second are general provisions and terms.
Third, fourth - reveal the features of the quality management system and management processes.
In the fifth, issues related to resources (personnel, equipment, infrastructure, and so on) are covered.
In the sixth - there is a description of different processes in the framework of the activity of the pharmacy organization. For example, the purchasing, acceptance, storage, sale of goods are detailed.
The seventh section is devoted to the self-analysis - an assessment of the activity of the pharmacy.
In the eighth, it refers to a continuous increase in the efficiency of work.

Innovations in terminology

IN new rules for proper pharmacy practice The concept of "pharmaceutical service" is revealed. Under it, they understand the service provided by the pharmacy organization and aimed at ensuring the needs of the buyer in drugs and other products of the pharmacy assortment. As part of its provision, consumers and health workers should receive information on the presence, storage, application of products.

Consultation is aimed at ensuring responsible self-treatment. Under it, in turn, one should understand the reasonable use of the buyer sold without a recipe drugs. According to the rules No, they should be applied to prevent easy-to-face health disorders before providing medical assistance. From this we can conclude that the independent use of prescription medicines, for example antibiotics, is regarded as irresponsible self-treatment.

Article 2.4 discloses the concept of "pharmaceutical assortment". It is believed that this term is first fixed at the regulatory level. However, the innovation can be called formally, since the definition almost completely duplicates Article 55 clause 7. retail. Pharmacy Productslisted in it quite detailed.

Showcase

One of the novel " Proper pharmacy practice"It is a position on the storage of medicines. It is present in a section containing equipment information.

Attention should be paid to the wording that the storage of prescription drugs on the shop windows is allowed, in open, glass cabinets, if consumers do not have physical access to them. This provision caused a lot of disputes before adoption standards for proper pharmacy practice.

In international practice, three approaches to vacation and display of prescription drugs are applied. In some countries, vacation is carried out exclusively by recipes, and such funds are not laid out onto the showcases. In other states there are no restrictions on this issue.

Provisions " Proper pharmacy practice "in Russia Experts call the third approach. Conditions must be met:

Strict observance of the order of vacation
The display on the showcase is allowed if the buyer's access to medicines is guaranteed.

The indication of open and glass cabinets is directed, among other things, to pharmacy organizations do not use penalties for funds on the showcases behind the forefinger (pharmacist serving consumers), which have no way out of the pharmacy hall, but addressed to it . Checking faces often consider glass "facade" showcase, as it is visible from the hall. Accordingly, complaints are presented to the pharmacy. Now everything will depend on the clear compliance with the conditions.

It is worth noting that the wording "can be stored" does not mean "necessary".

Experts predicted that the probability of expanding the prescription calculation in pharmacies is very small. The fact is that some organizations do not have sufficient areas, employees of other structures seek to minimize contacts with consumers who saw the medicine on the shop window and require or asking to sell it without a recipe.

Receiving products

This process is maximally detailed in new rules. Experts, and the representatives of the pharmaceutical sphere themselves react positively to this innovation.

The procedure for accepting the goods is dedicated to Article 6.2. It describes in detail in particular, there are instructions on which parts of the primary and secondary packaging, the marking should be paid attention to.

The acceptance process is detailed not only for pharmacological substances and medicines. It is also described in detail about the bauds, products of dietary, children's, medical nutrition, facilities and objects to care for children, perfumery and cosmetic products, mineral waters, medical products.

Consulting features

Article 6.4 states that the sale of products in pharmacy organizations implies not only direct leave and implementation, but also the provision of information within the competence of pharmaceutical workers. It should be noted such provisions of the norm as:

At the request of the buyer, the staff of the pharmacy organization must familiarize the citizen with a certificate or a declaration of compliance of the goods of interest.
The implementation of non-hospital products can be carried out by specialists who do not have pharmaceutical education.
To provide advisory and other pharmaceutical services, it is advisable to highlight the zone for a personal conversation. This can be done by installing special limiters, applying a bright color of the border for expectation, organization of places, etc.

According to experts, this situation is definitely correct. After all, every buyer has the right to receive a consultation in a private conversation on their own health, including with pharmacist. Experts emphasize that these rules are advisory, and not mandatory. The fact is that within the framework of the current legislation and the established pharmaceutical practice, not in all pharmacies it is possible to allocate such zones purely technically, not everywhere it will be appropriate.

In small pharmacies there is no place, and on large objects, on the contrary, the area allows you to spend a private conversation and without separating a special zone.

Annex to Article 6.4

There are only two of them. Applications secure the simplest consulting schemes in cases where the consumer:

Asks the goods.
It needs consulting on symptoms. For example, a person comes to the pharmacy and says that his stomach hurts, runny nose or something else.

The rules noted that for each symptom of the pharmacy should have a separate survey scheme. However, it does not explain where to take at least a sample.

Controversial moment

Experts sharpen attention in another position of Article 6.4. It provides that the pharmaceutical worker is obliged to make every effort to ensure that the buyer who has decided to acquire a medicine has been formed a sufficient idea of:

his action;
duration and method of application;
probable adverse reactions;
house storage rules;
cost;
combination with other medicines and food products;
contraindications;
need to consult a doctor while maintaining symptoms;
it is impossible to return the medication of improper quality and so on.

Of course, most of these information is present in the instructions for the means. However, about it in Art. 6.4 does not say.

When analyzing the wording, many questions arise. For example, what does it mean to "make every effort"? How to measure "sufficiency of the presentation" buyer about the product?

Experts note the vagueness, the subjectivity of the wording. Some experts suggest that these gaps give an extra reason to control the structures to apply sanctions to pharmacies.

The first-timer is definitely able to answer all the buyer's questions (within its competence, of course), provide reliable information and so on. However, pharmacist even with all this can not guarantee the formation of a "sufficient presentation" from the client about the product. What if a person did not listen very carefully or did not sleep today? In addition, perhaps the consumer at all came to the pharmacy to make complaints.

In addition, it is necessary to understand that such detailed counseling may take a certain time. How, in this case, do it with other buyers in the queue? After all, they are also entitled to get a "sufficient presentation" about the goods you are interested in.

Staff

To fulfill the requirements enshrined in the rules, the head of the pharmacy must be approved by the staffing. It should be present:

Names of posts, specialties, professions, qualifications information.
Data on the number of regular units.
Information about the photo (payment fund).

Each employee needs to be familiar with his responsibilities and rights to painting.

Employees with the necessary qualifications and work experience can be allowed to activities that affect the quality of products.

Actually, all these rules are present in other sectoral regulations, standards, etc.

Adaptation program

It is being implemented for newly accepted employees. After passing the program, knowledge, qualifications, work experience are periodically checked.

The adaptation program includes:

Induction training.
Preparation in the immediate place of work (primary and repeated).
regulatory acts on the treatment of medicines, public health, consumer protection, the procedure for the provision of pharmaceutical services, including counseling on the use of medical products at home; Rules hygiene.
Development of communication skills and conflict prevention.
Briefing on from and TB (labor protection and safety).

Requirements for the experience and qualifications of the head and staff of the pharmacy organization are fixed in the Regimental Licensing Regulations.

Questions of preparation

The head of the pharmacy organization provides instruction on the rules of leave:

medicines for medical use;
narcotic / psychotropic drugs;
drugs in respect of which subject-quantitative accounting is maintained;
medications containing a small amount of narcotic compounds.

In the course of training, employees also explain issues related to:

Procedure for storing recipes.
Compliance with minimum range requirements.
Applications of the limit sizes of retail premises for vacation prices for drugs included in the list of vital drugs, the procedure for forming their value.
Compliance with the requirements of storage and transportation of medicines.
Fulfillment of prescriptions when working with counterfeit, counterfeit, unfaithful goods.
Compliance with the restrictions provided for for pharmaceutical workers when they are fulfilling their professional duties.
Improving knowledge of medicines, including reproduced and interchangeable means, the ability to provide comparative information on drugs and prices.
Information processing methods received from consumers about the use of drugs, side effects, bringing these information to stakeholders.

Evaluation of activities

First of all, it is performed by the head of the pharmacy organization. The assessment is aimed at checking the completeness of compliance with the requirements enshrined in the Rules of Nap, to determine the corrective activities.

Analysis of issues related to personnel, premises, equipment, compliance with the rules for the implementation of pharmacy assortment products, documentation, activities for working with suggestions and consumer reviews, activities to detect counterfeit, falsified, non-qualitative goods, internal audit, is carried out by the head in accordance with the schedule plan approved in the prescribed manner.

Internal audit

It must be independent and thorough. It is carried out by persons from among employees, specially authorized by the head of the pharmacy organization. It is allowed to attract third-party subjects on a contractual basis.

The test results must be documented. The documentation includes all information obtained during the inspection, as well as proposals for corrective measures, if there was a need for them.

Measures taken on the results of the audit are also recorded by acts.

The verification is also aimed at detecting deficiencies in the process of compliance with the requirements of legislation and formulate recommendations for preventing and corrective actions.

The internal audit program should take into account the results of the preceding checks, including those conducted by controlling government agencies.

The subject appointed responsible for the verifiable activity of the pharmacy organization should ensure immediate execution of warning and corrective activities.

Samvel Grigoryan about the most controversial and important innovations of proper pharmacy practice rules

The rules for proper pharmacy practices that should be taken into force on March 1, in all likelihood, will become the most important sectoral document of 2017. This is a thorough set of rules that will constantly use the staff of pharmacies - from the heads to the first-timers. What innovations are contained in it, our analyst Samvel Grigoryan disassembled.

January 9, 2017 The Ministry of Justice of the Russian Federation registered the order of the Ministry of Health of the Russian Federation No. 647n of August 31, 2016 "On Approval Proper pharmacy Medicinal medications for medical use. " Order, and, accordingly, the rules come into force on March 1 of the current year.

Why is this document so important? Because it represents a set of rules mandatory in pharmacy work - even if not all, but very many. Other orders, laws and regulations, it, of course, does not cancel, but accumulates in itself many of their provisions that are now collected in one regulatory act.

We also emphasize: since the rules of proper pharmacy practice (hereinafter referred to as the Rules or Nod) are decorated in the form of the order of the Ministry of Health, then their non-compliance is a violation of legislation, with the consequences arising from this, in particular, administrative liability according to the CACAP.

What to expect from the appearance of First, order No. 647n for pharmacy specialists will most likely become the most used regulatory legal act - this is the regular fate of the pharmacy rules. Officers of pharmacies, first-timers, other provisions and pharmacists will most often flip it to it, to clarify how to accept one or another product, how to advise visitors, how to organize internal office work and so on. In other words, N., most likely, will be a benefit number 1 in pharmacy work.

Secondly, the appearance of new standards, recommendations that will definitely affect everyday pharmacy practice. Thirdly, it is not only a set of rules, but in some cases detailing actions, processes, pharmacy work mechanisms. For example, it features details of acceptance control of drugs and other groups of pharmacy product range.

All this combined, in theory, is designed to facilitate the pharmacy work. Let's make the first review or focus on some novels and important items.

International Panorama

But first a little story. And she is already almost a quarter of a century. In 1993, the International Pharmaceutical Federation (MFF) developed a document called Good Pharmacy Practice (GPP). It is translated into Russian as "proper pharmacy practice." Subsequently, twice - in 1997 and 2011 - this document was reviewed and approved by MFC and the World Health Organization (WHO). This is not a detailed text about all parties and pharmacy work procedures, namely general guidelines for the development of appropriate practices in various states containing the main principles of the profession, one can say its philosophy. And the national nap / GPP should go from in common to particular, that is, to be more detailed, taking into account the realities and features of the pharmacy practice of each country.

It is possible to make an assumption of two reasons, because of which the adoption in Russia (the need for the document we have already spoken the quarter of a century), finally happened. First, the Ministry of Health and Roszdravnadzor significantly increased their work on improving pharmaceutically, in Latania, its "holes" - orders began to be developed more. Secondly, it can be associated with EAEU. Our partners in this organization are in particular Kazakhstan, Belarus - already have their own. This probably served as a spurious factor for the development and adoption of our appropriate practice, especially since the harmonization of pharmaceutical support in the framework of the EAEU is.

Eight sections

If you take the text of the bottom with a height, so to speak, a bird flight, then it can be noted that it is structured as follows:

in the first two sections - General Provisions and Concepts (Terms);

The 3rd and 4th are devoted to the quality management system and the control processes of the pharmacy organization;

The 5th highlights its resource management issues (personnel, infrastructure, equipment, etc.);

in the 6th, various processes of the pharmacy life cycle (purchase, acceptance, storage, sales of goods) are written;

7th - conducting an assessment of the activity of the pharmacy organization, simply speaking, self-analysis;

and, like apotheosis, section 8 - a steady increase in performance.

In the second, the terminological, the innovation section is a bit. You can pay separate attention to the definition of pharmaceutical services.

E. that is the service provided by the pharmacy organization and aimed at ensuring the needs of the consumer in providing drugs and other goods a pharmacy assortment, as well as in obtaining consumers and medical workers information on their presence, storage and application, including in order to ensure responsible self-treatment.

As you can see, counseling, according to this definition, is an integral part of Pharmaceutle. Also deserves attention determination of responsible self-treatment. This is a reasonable use by the consumer of drugs in a free sale, with the aim of preventing light health disorders, before providing medical care.. It follows from it that the independent application by the consumer of prescription drugs, such as antibiotics, is an irresponsible self-treatment.

In art. 2.4 The form contains " products of pharmacy assortment"- Finally, it has gained legal importance. Formally, it can be called innovation, but since it almost completely repeats p. 7. Art. 55 "Retail trade order" of the law "On the circulation of medicines", where groups of goods that can be implemented by pharmacy organizations are listed, the importance of this innovation is not so great.

What's new on the shop window?

In the section on equipment, an experienced pharmacy glance will certainly allocate the following fragment: "Prescription drugs can be stored on shop windows, in glass and open cabinets subject to the lack of physical access to consumers" Approval of this provision by order is a novel.

It is hardly necessary to doubt that it will cause more disputes than other positions. But the fact remains a fact - if nothing changes, this rate from March 1 will be approved by order.

In world practice exist three models of vacation calculation of prescription drugs. In some states they are released strictly according to the recipe and do not lay out on pharmacy showcases at all. In others, this is quite desperate places - there is no rigor and restrictions in the first, nor in the second.

The logic of the approach of the Order No. 647n to this issue can be called the third model. For a) strict compliance of prescription drugs and b) guaranteed lack of access to them on the consumer showcase Make them showcase.

The reference to the fragment of glass and open cabinets is directed, including that the pharmacies are not fined for prescription drugs lying on the shelves of cabinets located behind the back of the first-timer and have no way out to the pharmacy, but facing it. The glass "facade" of such cabinets is often considered to be a showcase, since it is visible from the hall - and, accordingly, claims.

It must be admitted that the author of these lines is a supporter of the first model. But the truth is that for its introduction in our country, there is still a lot of things to change in the field of health care, more precisely, in order of recipes, the availability of medical reception and many other things. So now everything will depend on how strictly compulsory requirements A) and b).

And one more remark. "You can store on the shop windows" does not mean "need" or "necessarily".

It is unlikely that pharmacy organizations will strive to expand the recipe calculation - the majority does not have enough space or the squares, or the desire to interrupt consumers who saw the drug on the storefront and seek / requiring it to release it without a recipe.

How to take goods

Among the positive sides of the rules, it is possible to note the intelligible detailing of the process of acceptance of the goods (Art. 6.2). In particular, acceptance control is described in detail - for example, on which parts of the secondary and primary packaging, labeling, the accompanying documentation should be paid attention to.

Moreover, the parts of this control are painted not only for drugs and farmsubstations, but also separately for dietary supplements, the products of therapeutic, children's and diet food, perfumery and cosmetic products, items and equipment for children, medical products, mineral waters. This part of the rules can be printed separately and keep as a "primary" manual in the receiving area of \u200b\u200bthe goods. In order for the pharmacist - from time to time, overlooking this text - could conduct acceptance control of each group and the unit of goods is populated according to Article 6.2.

How to advise

In the initial position of Art. 6.4 Rules It is indicated that the implementation of goods in pharmacy organizations includes not only their sale and vacation, but also the provision of consulting services, of course, within the competence of pharmacematic workers. We highlight the following provisions of this article:

at the request of the consumer, the pharmacy workers are obliged to familiarize him with a certificate of conformity or with a declaration on the compliance of its items of interest;
sale of non-good pharmaceutical assortment products can be carried out by specialists who do not have pharmaceutical formation;
to provide pharmaceutical services and other pharmaceutical services, it is considered to be expediently allocated - by applying a bright border to expect, installing special limiters, the organization of seating places, etc. - zone for individual conversation.

This is definitely the correct position, since each consumer has the right to a private conversation on their health, including the pharmacist. It is also very correct that this provision is not mandatory, because in the context of our legislation and the current pharmacy practice far from each pharmacy, the allocation of such a zone is possible, necessary and appropriate. In small objects, a small area of \u200b\u200bthe pharmacy hall prevents this. And some network companies, on the contrary, have sufficiently large areas, where sometimes the privacy of the individual conversation is achieved and without the designation of a separate zone.

Article 6.4, there are two applications related to pharmaceutical and responsible self-treatment. These are minimal polling schemes in cases where

a) the client asks the drug;

b) The client needs consultation on the symptoms (that is, comes to the pharmacy and to begin with, he says the first-timer, that, for example, he has a headache, flowing from the nose, torments cough or tricks in the throat).

The rules also noted that for each symptom of malaise in the pharmacy there must be a separate survey procedure.

But does not explain, unfortunately, where to take it, it is desirable officially approved. Concerning i would like to express a wish that these procedures - in the form of additional applications, included in the bottom as a legislatively approved manual in the Proper Consultation.

In pharmacies now there will be an idea

Article 6.4 has another important position: pharmaceutical man should make every effort to consumehaving decided to buy the drug there was a sufficient picture regarding its action, method and duration of use, possible side effects, contraindications, combinances with food and other drugs, prices, storage rules at home, the impossibility of returning the drug of appropriate quality, the need to appeal to the doctor if the symptoms are not disappeared, and so on .

It is clear that a significant part of this information is transmitted to the consumer along with the instructions for use. But it is just not mentioned in this fragment, because of what the question is especially "convex": what does the "make every effort" mean? And how to measure if the buyer has a "sufficient representation" on the listed issues or not?

These are all very vague subjective formulations, which seem to give a checking lever to punish "at a level place." The first-timer can supply the consumer with necessary and reliable information, can answer all his questions as part of its competence, but it cannot be responsible for whether it has a sufficient presentation on specific issues. What if the consumer did not sleep today? Suddenly he listened badly? Suddenly, he at all came to the pharmacy exclusively in order to present claims, using this provision of this provision?

And then, if the counseling of one person will delay until the final appearance in that "full view", as to be with the following in the queue, which also have the right to "complete performance", but who already have no strength for it? In this matter, in our opinion, the accuracy of the wording is needed, taking into account interests and one particular consumer, and other consumers too.

We summarize: Order No. 647n is a very important regulatory act, and there has already been a lot of questions. In the near future, we will ask them to Elena by the Unbolina, the executive director of the non-profit partnership "Pharmacy Guild" and the Union "National Pharmaceutical Chamber" - it was one of the authors of the text.

The official position of Roszdravnadzor about Ned You can learn at the webinar the head of the licensing management and monitoring compliance with the mandatory requirements of Roszdravnadzor Irina Larovna, dedicated to the "proper pharmacy practice". It will be held in February, information about it will soon appear in the "Katren-Style" webinars section.

In conclusion, we invite readers to discuss all of interest and exciting issues of proper pharmacy practice.

Acceptance control in the pharmacy regulates the order of 647 N dated August 31, 2016 of the Ministry of Health of the Russian Federation. We will deal with what you need to pay attention.

Order 647 n applies not only to acceptance control, but also the general rules of retail trade drugs in the pharmacy:

quality management;
head and Personnel Pharmacies;
infrastructure organizations;
activity processes;
sales of goods;
evaluation of activities.

In the complex, the order of the Ministry of Health 647 H determines the rules for the proper pharmacy practice of drugs for medical use.

Organization of acceptance control

Acceptance of goods in the pharmacy produce on:

assortment;
quantity;
quality;
storage conditions;
conservation of transport packaging.

Important! It is necessary to distinguish the acceptance of the pharmacy assortment of acceptance control.

Acceptance control is carried out in order to prevent counterfeit, falsification or poor-quality drugs on sale. A commission is appointed for acceptance control, and be sure to under the written order signed by the head.

In the process of acceptance control in the pharmacy, members of the Commission estimate:

appearance of drugs;
color;
smell;
compliance with labeling;
packaging integrity;
the presence and correctness of the design of accompanying documents and the quality declarations of drugs.

Therefore, members of the Commission must be informed in advance with all the necessary information, requirements and regulations of documentation.

In case of inconsistency, the requirements of the tested drugs or their packaging, the Commission includes an act for presenting claims to the supplier. In the act, you must specify the disadvantages detected during acceptance control and refer to the regulations in which these requirements are reflected.

Checking the biologically active additives and products of children's, dietary and medical nutritions should be carried out within acceptance of goods, and not acceptable control, as they relate to food products. Their quality is checked by external features, packaging integrity and accompanying documents, especially declarations on compliance.

If poor-quality, counterfeit or falsified drugs were discovered after acceptable control and signing the act, it should be isolated from the rest of the pharmaceutical range before resolving the dispute with the supplier.