Good pharmacy practice. Rules for the proper pharmacy practice of medicinal products (Order of the Ministry of Health of the Russian Federation No. 647n)

On approval of the rules of proper pharmacy practice in the pharmaceutical sphere began to speak back in the2016 year. It was widely believed that this document would become a key sectoral act in 2017. So it happened. Consider briefly the contents of the act on proper pharmacy practice with comments.

General information

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

AT Order 647n there is a set of instructions whose non-fulfillmententails corresponding consequences, including administrative responsibility under the Code of Administrative Offenses. Other documents, decrees, 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 one normative legal act.

Rules for proper pharmacy practice: discussion

Before the document came into force,the opinion that it will become the most used act in pharmaceuticals. And the heads of pharmacies, pharmacists, pharmacists, and other workers will open exactly Rules for proper pharmacy practiceto clarify how to take this or thatproducts, how to organize office work, how to properly advise the buyer and so on. Simply put, it was expected that the act would be the No. 1 aid in the work of pharmacies.

AT The rules of proper pharmacy practice there are new recommendations and norms. Their use, of course, will somewhat change the daily activities of pharmacy structures.

Fixed Order of the Ministry of Health Rules of proper pharmacy practice contain, among other things, a detailed description of the actions, mechanisms, work processes of pharmacies. For example, they contain details of the acceptance control of products.

International practice

It is worth saying that work on the arches of the Ruleshas been going on for a long time. So, in 1993, the IFP (International Pharmaceutical Federation) developed a document whose name in Russian is translated as "Good Pharmaceutical Practice. "

In 1997 and 2001 this document was processed. At the same time, in the revision of the "Proper pharmacy practice"Not only IFF, but also WHO participated.

It is worth saying that the NAP was not any specific direction. The document did not contain a detailed description of all procedures and aspects of pharmacy work. "Good pharmacy practice"- this is a general basic scheme, based on whichRules should be developed in different countries taking into account the specifics of a particular state. National NAPs, in turn, should be detailed.

Prerequisites for the adoption of the document

Implementation of the Rules of Good Pharmacy Practice according to experts, two reasons.

First of all, the Ministry of Health together with Roszdravnadzor significantly stepped up its activities to improve the regulatory framework for the pharmaceutical sector.

Secondly, experts believe that the emergence ofThe rules of proper pharmacy practice in the Russian Federation are associated with participation in the EAEC. The fact is that Russia's partners in this organization have long had their own NAPs. One of the directions of the work of the authorized structures of the EAEC is the harmonization of the pharmacological legislation of the member countries.

Structure

Rules for proper pharmacy practice consist of 8 sections:

• The first and second are general terms and terms.
• The third, fourth - reveal the features of the quality management system and management processes.
• In the fifth - the issues related to resources (personnel, equipment, infrastructure, etc.) are highlighted.
• In the sixth - there is a description of different processes within the pharmacy organization. For example, details of operations for the purchase, acceptance, storage, sale of goods.
• The seventh section is devoted to self-analysis - evaluation of pharmacy activities.
• In the eighth - it is said about the continuous increase of the efficiency of work.

Innovations in terminology

AT new Rules for Good Pharmacy Practice the term "pharmaceutical service" is disclosed. It is understood as a service provided by a pharmacy organization and aimed at meeting the needs of the buyer in medicines and other products of the pharmacy range. As part of its provision, consumers and health workers should receive information about the availability, storage, use of products.

Counseling is aimed at ensuring responsible self-treatment. Under it, in turn, should be understood the reasonable use by the buyer of products sold without a prescription drugs. According to the rules NAP, they should be used for preventionmild health disorders before the provision of medical care. From this we can conclude that the independent use of prescription medications, for example antibiotics, is regarded as irresponsible self-medication.

In Article 2.4 reveals the notion of "goods of pharmacy range." It is believed that this term is first fixed at the normative level. However, its innovation can be called formally, since the definition almost duplicates clause 7 of Article 55 of the "Order retail trade. " listed in it in some detail.

Showcase

One of the short stories "Proper pharmacy practice"is the provision on the storage of medicines, it is present in the section containing information about the equipment.

Attention should be paid to the wording,that it is allowed to store prescription medicines in storefronts, in open, glass cabinets, if consumers do not have physical access to them. This provision has caused a lot of controversy even before the adoption standards of good pharmacy practice.

In international practice, three approachesto the release and laying of prescription medications. In some countries, vacation is carried out exclusively on prescriptions, and such means are not laid out on display cases. In other states, there are no restrictions on this issue.

The provisions of "Good Pharmacy Practice "in Russia experts call the third approach. The following conditions must be met:

1. Strict adherence to the procedure for the release of prescription drugs.
2. The display on the display is allowed if the buyer is not guaranteed access to medicines.

Indication of open and glass cabinetsis directed, inter alia, to the fact that pharmacies are not penalized for funds on display windows behind the back of the primary (pharmacist serving consumers) who do not have access to the pharmacy room, but addressed to him. Inspectors often consider the glass "façade" as a showcase, since it can be seen from the hall. Accordingly, claims are made against the pharmacy. Now everything will depend on a clear compliance with the set conditions.

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

Experts predicted that the probabilityexpansion of prescription in pharmacies is very small. The fact is that some organizations do not have sufficient areas, workers of other structures tend to minimize contacts with consumers who saw the medicine in the window and demand or ask to sell it without a prescription.

Acceptance of products

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

The article 6.2 is devoted to the acceptance procedure for the goods. It describes in detail the acceptance control. In particular, there are instructions on which parts of the primary and secondary packaging, accompanying documentation, marking must be paid attention.

The acceptance process is detailed not only forpharmacological substances and medicines. Details are also given about dietary supplements, dietary, children's, medical nutrition products, products and items for the care of children, perfumes and cosmetics, mineral waters, medical products.

Experts recommend to print out the rules of acceptance control and keep it in a conspicuous place as a visual aid.

Features of counseling

In Article 6.4 states that the sale of products in pharmacy organizations involves not only direct release and sale, but also the provision of information within the competence of pharmaceutical workers. Particular mention should be made of such provisions of the norm as:

• At the request of the buyer, the employees of the pharmacy organization should familiarize the citizen with the certificate or declaration of conformity of the product of interest.
• The sale of non-medicinal products can be carried out by specialists who do not have a pharmaceutical education.
• To provide consulting and otherIt is advisable to allocate a zone for personal conversation. This can be done by installing special limiters, applying a bright color border for waiting, organizing places, etc.

According to experts, this provision,certainly, correct. After all, every buyer has the right to receive a consultation in the private conversation on his own health, including with the pharmacist. Experts emphasize that these rules are recommendatory, not mandatory. The fact is that within the current legislation and the existing pharmaceutical practice, it is far from possible to allocate such zones purely technically in all pharmacies, not everywhere it will be expedient.

In small pharmacies there is no place, and on large objects, on the contrary, the area allows for a private conversation and without the separation of the special zone.

Annexes to Article 6.4

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

1. Asks the goods.
2. Needs counseling for symptoms. For example, a person comes to a pharmacy and says that his stomach hurts, a runny nose or something else.

The Rules note that for each symptom, the pharmacy must have a separate survey scheme. However, the NAP does not explain where to take at least a sample.

Controversial moment

Experts draw attention to one morethe provision of Article 6.4. It stipulates that the pharmaceutical worker must make every effort to ensure that the buyer who made the decision to purchase the medicine has a sufficient idea about:

• its action;
• duration and mode of application;
• likely adverse reactions;
• rules of house storage;
• cost;
• combination with other medicines and food products;
• contraindications;
• need to see a doctor if symptoms persist;
• impossibility to return medication of inadequate quality and so on.

Of course, most of this information is present in the instruction to the facility. However, about her in art. 6.4 does not say.

When analyzing the formulation, many questions arise. For example, what does it mean to "make every effort"? How to measure the "adequacy of representation" of a buyer about a product?

Experts note the vagueness, subjectivity of the wording. Some experts suggest that these gaps provide an additional reason for the controlling structures to apply sanctions to pharmacies.

The primalist is certainly able to answeron all issues of interest to the buyer (within his competence, of course), provide reliable information and so on. However, even with this, the pharmacist can not guarantee the formation of a "sufficient representation" of the client about the product. And suddenly a person did not listen very attentively or did not get enough sleep today? In addition, it is possible that the consumer generally came to the pharmacy to make claims.

In addition, we must understand that such a detailedcounseling may take some time. How, in this case, should I deal with other customers in the queue? After all, they also have the right to get a "sufficient view" of the product of interest.

Staff

To fulfill the requirements set out in the Rules, the head of the pharmacy must approve the staffing table. It should include:

1. Names of posts, specialties, professions, information about qualifications.
2. Data on the number of staff units.
3. Information about the FOT (payroll fund).

Every employee should be acquainted with his duties and rights against the signature.

Employees with the necessary qualifications and work experience may be admitted to activities that affect product quality.

Actually, all these rules are present in other industry standard acts, standards, etc.

Adaptation program

It is being introduced for new employees. After passing the program, knowledge, qualifications, and work experience are periodically checked.

The adaptation program includes:

• Induction training.
• Preparation at the immediate place of work (primary and secondary).
• Updating knowledge of normative acts ontreatment of medicines, public health, the protection of consumer rights, the provision of pharmaceutical services, including advice on the use of medical products at home; rules of hygiene.
• Development of communication and conflict prevention skills.
• Instruction on health and safety (safety and health).

Requirements for length of service and qualifications of the head and employees of the pharmacy organization are fixed in the Regulation on licensing of pharmacological activity.

Preparation questions

The head of the pharmacy organization provides a briefing on the rules of leave:

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

In the course of training, employees are also clarified questions related to:

• How to store recipes.
• Compliance with the minimum assortment requirements.
• The application of the maximum sizes of retail mark-ups to the selling prices for medicines included in the list of vital preparations, the procedure for the formation of their value.
• Compliance with storage and transportation of medicines.
• Fulfillment of orders when working with falsified, counterfeit, inferior goods.
• Compliance with the restrictions foreseen for pharmaceutical workers in the performance of their professional duties.
• Improvement of knowledge about medicines, including about reproduced and interchangeable means, ability to provide comparative information on drugs and prices.
• Methods of processing information received from consumers about the use of medicines, side effects, bringing this information to interested persons.

Evaluation of activities

First of all, it is performed by the managerpharmacy organization. The evaluation is aimed at verifying the completeness of compliance with the requirements set out in the NAP Rules for determining corrective actions.

Analysis of issues related to staff,premises, equipment, compliance with the rules for the sale of products of the pharmacy range, documentation, activities for working with proposals and consumer reviews, activities for the detection of counterfeit, falsified, inferior goods, internal audit is carried out by the manager in accordance with the schedule approved in due course.

Internal audit

It must be independent and thorough. Internal audit is conducted by persons from among employees, specially authorized by the head of the pharmacy organization. It is allowed to attract outside parties on a contractual basis.

The results of the inspection must be formalizeddocumented. The documentation includes all information received during the audit, as well as proposals for corrective measures, if there is a need for them.

Measures taken as a result of the audit are also recorded by the acts.

The audit also aims to identify shortcomings in the process of compliance with the requirements of legislation and formulate recommendations for preventive and corrective actions.

The internal audit program should take into account the results of previous inspections, including those conducted by the controlling state bodies.

The subject appointed as responsible for the monitored activity of the pharmacy organization must ensure the immediate execution of preventive and corrective measures.