Pharmacy: accounting and taxation. Pharmacy: accounting and taxation Room highlights

From December 4 to 7, the largest industry event, the 24th International Specialized Exhibition “Pharmacy 2017,” was held at the Expocentre Fairgrounds in Moscow.

The exhibition presents the entire diversity of the medical industry: medicines, medical products, medicinal cosmetics, homeopathy, mineral water, aromatherapy, dietary supplements and herbal products, parapharmaceuticals, orthopedic and massage products, products for newborns, pharmacy equipment, information and consulting services etc.

The traditional annual International Medical and Pharmaceutical Forum took place as part of the event. Participants had the opportunity to learn new approaches to the work of pharmacy organizations in general, and also had the opportunity to ask questions of concern to practitioners directly to representatives of Roszdravnadzor, the Federal Antimonopoly Service, the Ministry of Health and other departments, which is especially important for such a tightly regulated and controlled area as pharmacy in general , and pharmacy organizations in particular.

In a brief overview of the business program, we tried to highlight newest changes in the legislation, voiced on the form, and the most interesting points for practitioners, directly related to the activities of pharmacy organizations.

Introduction of electronic prescription

According to Federal law dated July 29, 2017 N 242-FZ "On amendments to certain legislative acts Russian Federation on application issues information technologies in the field of health protection", from January 1, 2018, prescriptions for drugs with the consent of the patient can be formed in the form electronic documents. This measure is positioned as one of the mechanisms for solving the problem of the total lack of prescriptions written by doctors.

And a year later, from January 1, 2019, in in electronic format It will become possible to write prescriptions for medications containing narcotic drugs or psychotropic substances, which should simplify the provision of medications to patients in need of pain relief.

Trafficking in narcotic drugs and psychotropic substances

Several new mechanisms are being introduced to simplify the work of pharmacies with drugs in this group. Thus, the right has been granted to involve private companies in the security of premises for storing narcotic drugs and psychotropic substances belonging to the second category (pharmacies). security organizations in the absence of private security units in all settlements (not only in rural settlements, as was previously the case).

Amendments have also been made to Resolution No. 644 in terms of clarifying the form of the journal for registering transactions related to the trafficking of narcotic drugs and psychotropic substances, as well as providing the possibility of maintaining the journal in electronic form. The magazine must be printed monthly.

Dispensing of medicines

Order of the Ministry of Health of Russia dated July 11, 2017 N 403n “On approval of the rules for the dispensing of medicinal products for medical use, including immunobiological medicinal products, by pharmacy organizations and individual entrepreneurs with a license for pharmaceutical activities,” which came into force in September of this year, allows violations secondary packaging, maintaining a laboratory and packaging log is not required.

Potassium permanganate and andipal can now be dispensed in the quantities requested by the patient. There are no “two packs in one hand” supply norms.

Individual entrepreneurs with a license for pharmaceutical activities have lost the right to dispense immunobiological medicinal products (IMPs). IMPs are dispensed according to prescriptions by pharmaceutical organizations - pharmacies and pharmacy points.

Public procurement of medicines

The Government of the Russian Federation adopted Resolution No. 1380 dated November 15, 2017 “On the features of the description of medicinal products for medical use that are the object of procurement to meet state and municipal needs.” This document establishes acceptable requirements for acceptable characteristics of purchased drugs.

Quality management in pharmacy

The introduction of a risk-oriented approach into control and supervisory activities in the organization continues state control Federal service on supervision in the field of health care. On the website of this supervisory body, anyone can familiarize themselves with the latest information, including those related to inspections of pharmacy organizations. Managers will certainly be interested in the latest “list of acts containing mandatory requirements, compliance with which is assessed when carrying out control measures during licensing control of pharmaceutical activities.”

IN pharmacy organization a quality assurance system must be in place. The powers of the responsible person must be defined in the internal regulatory document organizations (position, job description). The responsible person must perform his or her duties in such a way that the pharmacy organization can demonstrate compliance of its activities with the requirements defined in the Rules of Good Pharmacy Practice.

Digitalization is lagging behind

At the same time, there are many problems in the pharmaceutical industry and in the processes of providing medicines to patients. Thus, the “digital maturity” of pharmaceuticals lags behind many other industries.

Despite the fact that in Russia there is an information and analytical system (IAS) - software package, which allows for real-time analysis of the health status of citizens and the activities of the region’s healthcare system, there are problems of various nature that impede the effectiveness of its work. Thus, in the IAS catalog, medications are written differently, the units of measurement are different, and there are no individual medications in the catalog...

Forecast for the near future

The introduction of drug labeling will affect pharmaceutical market, the cost of medications may increase. However, the same labeling will prevent the secondary circulation of drugs, when drugs purchased at the expense of the state budget are sold again.

The pharmaceutical market, according to experts, will grow weakly in 2018, at 9% per year, and the trend of the population purchasing cheap medicines will continue.

Decree of the Government of the Russian Federation dated November 10, 2017 No. 1353 “On amendments to certain acts of the Government of the Russian Federation on issues related to the circulation of narcotic drugs and psychotropic substances” Revision and adoption of new ones regulatory acts on pharmaceutical activities and activities related to the circulation of narcotic drugs, psychotropic substances and their precursors. Nikolaeva Natalya Mikhailovna - Head of the Department of Legal Regulation of Pharmaceutical Activities, Trafficking in Narcotic Drugs and Psychotropic Substances of the Ministry of Health of the Russian Federation (based on materials from the International Business Medical-Pharmaceutical Forum 2017) On the measures proposed by the FAS to improve pricing for medicines and increase the availability of medicines - Sharavskaya Nadezhda Aleksandrovna - Deputy Head of the Control Department social sphere and trade of the Federal Antimonopoly Service (based on materials from the International Business Medical and Pharmaceutical Forum 2017) http://50reg.roszdravnadzor.ru/about/reform/requirements/documents/46970 Modern forms control and supervision in the field of pharmaceutical circulation and circulation of medical devices. Risk-oriented model of control and supervisory activities. Categorization of pharmacy organizations. New requirements for personnel and infrastructure of pharmacy organizations. Irina Viktorovna Krupnova - Head of the Department of Licensing and Compliance Control mandatory requirements Roszdravnadzor (based on materials from the International Business Medical-Pharmaceutical Forum 2017) Drug provision during the transition to digital healthcare - Larisa Dmitrievna Popovich - Director of the Institute of Health Economics of the National Research University " graduate School economy" (based on materials from the International Business Medical-Pharmaceutical Forum 2017) Russian pharmaceutical market, main trends in 2017, development forecast - Nikolay Vladimirovich Bespalov - development director of the analytical company RNC Pharma (based on materials from the International Business Medical-Pharmaceutical Forum 2017)

In 2017, more than 5 million packages of medicines worth 940.7 billion rubles in retail prices were sold through the pharmacy chain, which is 6.5% higher in in value terms and 3.5% higher in volume compared to 2016. This data is provided by the analytical company DSM Group.

Positive dynamics in physical terms indicate an improvement in the purchasing power of the population and a decrease in the influence of financial and economic factors on the pharmaceutical market, analysts say.

In their opinion, the growth of the pharmacy market in 2017 was also influenced by the price factor. This is largely due to a change in the sales structure in favor of more expensive medicines. “In 2017, consumers continued to switch to more expensive medicines. The price segment “over 500 rubles” grew the most – by 12% in rubles and by 13% in packages. Due to this increase, the share of this segment increased by almost 2% in terms of money,” analysts note.

Nevertheless, drugs costing up to 50 rubles still remain popular among consumers - in 2017 they occupied about 40% of the market in volume terms. However, the share of such drugs is gradually decreasing, both in physical (by 0.7%) and in value (by 0.4%) terms.

Inflation in drug prices in 2017 turned out to be practically zero - at the end of December 2017, prices increased by only 0.3% compared to December 2016. Prices for vital and essential drugs (VED) increased by 0.06%. “A low increase in prices for drugs is observed in all subgroups: imported drugs increased in price by 0.6%, Russian drugs fell by 0.5%. On average, prescription drugs became 0.1% more expensive for consumers, while over-the-counter drugs increased by 0.4%,” the DSM report says.

It is worth noting that the Ministry of Industry and Trade has slightly different data on changes in prices for vital and essential drugs in 2017 - according to the ministry, prices did not increase and even decreased by 1.8%. Based on these data, the department concluded that prices for vital and essential drugs in 2018 were also the same.

As DSM analysts note, until 2017, the main increase in prices was observed for drugs in the cheap segment (up to 50 rubles), but in 2017 they fell in price by an average of 3.4%, while drugs belonging to the “expensive” segment (from 500 rubles and above) began to cost 0.2% more. The main “rise in price” affected the segment from 150 to 500 rubles – 1.2%.

At the end of 2017, the average cost of a package of a domestic drug at retail prices was 90 rubles, which is approximately 3.6 times lower than the cost of a package of an imported drug (about 321 rubles). The average cost of a package of the original drug was 646 rubles (+3.5% compared to 2016), the generic one was 141 rubles.

Analysts also note an increase in the share of domestic drugs both in value and in physical terms. “In 2017, the share of domestic drugs was 28.5% in value terms and 58.7% in physical terms. At the same time, we note that sales of domestic drugs in rubles increased by 7.4%, while sales of imported drugs increased by 6.1%. Due to this, the share of Russian drugs in the structure of pharmacy sales has increased, and the increase in the share occurs both in value and in physical terms,” the report says.

It also lists the TOP 20 brands that lead in sales volume on the Russian commercial market. Together they occupy 10.9% of the market.

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

IP and IBLP

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

Violation of secondary

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

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

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

"The medicine has been released"

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

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

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

The prescription remains at the pharmacy

There are some changes on the topic indicated in the title of this chapter. Paragraph 14 of the new order establishes that the subject retail remain (with the mark “The drug is dispensed”) and are stored:

within 5 years prescriptions for:

within 3 years prescriptions for:

within 3 months recipes for:

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

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

To avoid getting caught

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

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

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

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

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

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

IP and IBLP

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

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

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

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

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

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

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

Violation of secondary

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

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

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

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

It is clear that in the first case this is acceptable, since it is possible to dispense 28 or 42 tablets without breaking the primary packaging (blister), and in the second case it is unacceptable, since the primary packaging in this situation is a bottle, and breaking it is strictly prohibited. So count out tablets or dragees from the bottle, as they do in some pharmacies foreign countries, our leaders have no rights.

"The medicine has been released"

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

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

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

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

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

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

The prescription remains at the pharmacy

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

within 5 years prescriptions for:

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

within 3 years prescriptions for:

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

within 3 months recipes for:

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

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

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

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

To avoid getting caught

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

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

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

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

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

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

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

With the entry into force of a number of new legal norms, noticeable innovations are appearing in the activities of Russian pharmacies. They concern a variety of aspects of the work of pharmacists. Let's study them.

What's new in legislation?

From March 1, 2017, Russian pharmacies must operate in accordance with the “Rules of Good Pharmacy Practice” (approved by Order of the Russian Ministry of Health No. 647n, adopted on August 31, 2016). This source of law regulates, in particular:

• requirements for premises for the sale of medicines;
• criteria for selecting drug suppliers;
• checks of pharmacy employees;
• customer service.

For example, with regard to the selection of suppliers, it should be carried out taking into account business reputation economic entity, as well as the quality of goods. This regulatory measure is aimed at improving the assortment of pharmacies, especially in terms of goods in which delays are unacceptable.

​The next innovation is the application of stricter regulations establishing sanctions for the sale of drugs without a prescription. In accordance with them, pharmacies can be inspected more often, they can be fined large sums (up to 200 thousand rubles) and even have their activities suspended for 3 months. Similar sanctions are established for violating the rules for storing medicines.

It may also be noted that pharmacists cannot display drugs that are prescription drugs in public display windows. The buyer should not take these drugs without the knowledge of the pharmacy employee.

Previously existing regulations were significantly softer, which allowed many pharmacists to ignore the ban on selling drugs without a prescription. For example, it was possible to easily purchase an antibiotic, a medicine to normalize blood pressure, or cough syrup, although formally they should have been dispensed without a prescription. It was requested mainly when selling custom-made drugs, drugs with strict dosage rules, psychotropic and drug-containing drugs.

It is worth noting that among experts there are discussions regarding the interpretation of the rules establishing sanctions for the sale of drugs by pharmacies without prescriptions. The fact is that at the level of federal legal acts this sale was prohibited even before the innovations under consideration. In fact, information about the strict restrictions began to spread among pharmacists in the form of rumors.

Representatives of the leading media, who checked the work of pharmacies in practice, were convinced that most of them comply with current standards and refuse to sell drugs without a prescription - however, it has not yet been possible to find out any official details regarding why the sales policy of pharmacies has changed. According to some pharmacists, this is due to the increased frequency of inspections of organizations selling drugs. Experts suggest that changes in the policy for selling drugs without prescriptions may be associated with the publication by Roszdravnadzor of internal regulations on tightening control over the activities of pharmacies.

Information about cheap analogues and advice

According to the new rules, the pharmacist must inform the consumer that cheaper analogues of the requested medicine are available for sale. For example, if a person comes for a rather expensive No-Spa, then he should also be offered drotaverine, an analogue that costs several times less. For violating this norm, the pharmacist can be fined 10 thousand rubles, the pharmacy itself - 30 thousand rubles.

Pharmacists also have an obligation to provide advice to consumers. At the same time, it can be carried out in places where the specialist can be asked rather personal questions about taking medications without other visitors hearing the conversation.

At the buyer's request, pharmacists are required to show all available documents for the drug - for example, a certificate, declaration or certificates. The consumer can also request documents certifying the authenticity of the drug.

1. If possible, always obtain a prescription for a particular medicine from your doctor. In some cases, a prescription may be issued for a fairly long period of time—for example, a year. It is also recommended to assist relatives in obtaining prescriptions in advance.
2. It is advisable to buy medications from the same pharmacies. Pharmacists who know the buyer by sight will sometimes not ask him for a prescription if he does not happen to have one with him.
3. If you can’t get around the formalities, then you need to ask pharmacists for over-the-counter analogues of drugs.
4. You should regularly check your home medicine cabinet for prescription medications. If you run out of certain important medications, you must fill out a prescription for them in advance.
5. You must always be prepared to contact a paid doctor for a prescription - if it is urgent. To do this, it is useful to study the market for relevant medical services in the city in advance in order to know which paid clinics operate close to home, as well as which of them provide inexpensive services.

Pharmacy retail: foreign experience

Thus, the legal norms of the Russian Federation regarding the regulation of drug circulation are becoming increasingly strict. But what about this in other countries?

In general, the policy of the Russian legislator corresponds to global trends. Moreover, in some countries the rules may be even stricter: for example, in the USA, a pharmacist has no right to give advice on medications; only a doctor is required to do this. In America, it is not customary to buy medications without a prescription.

In European countries there are rules according to which only a person with a pharmaceutical education can be the owner of a pharmacy. In addition, in some states, authorities may strictly control the number of pharmacies in the country. The qualification requirements for pharmacists can also be very high.

New articles for the leader and chief captain from the eighth issue of the magazine "New Pharmacy". The main topic of the issue was the material “Phenazepam, Grandaxin and other non-PKU psychoactive drugs. Instructions for dispensing.”

The main thing in the room

Pharmacies often refuse to stock psychotropic drugs to avoid additional problems. But psychotropic medications are registered in Russia, which do not require not only PCU, but also a prescription. I offer instructions on the circulation of such drugs. Share it with your employees.

Salespeople, consultants and managers do not notice that they use provocative words in their speech. They don’t notice because often neutral words become aggressors.

I propose that lists of such provocateurs should be placed within the visibility range of the primary commanders, so that they do not forget about hidden enemies. Over time, the habit of constructing phrases differently will become firmly rooted in the mind and will allow you to avoid mistakes in communication.

Federal and regional media periodically report that the first capital leaders sometimes show miracles of heroism. But it is better to take preventive measures than to risk your health and life.

A buyer came to the pharmacy to buy an over-the-counter drug. The pharmacist silently sold the medicine. As a result of taking the medicine, the consumer developed a stomach ulcer. In this situation, the pharmacy worker is under attack

The state abolished a number of fines and introduced new ones, changed the amount of sanctions for individual violations fire safety. New fire inspection rules legalized the institute independent assessment fire risk and expanded the circle of fire safety inspectors

Part 1

Pharmaceutical order

Pharmacy supervisors are always uninvited guests, and it’s good if you can prepare for their arrival. The author of the article talks about when auditors will warn about an inspection in advance and in what cases they may suddenly appear.

The state is consistently tightening the requirements for prescription drugs. Therefore, we suggest checking whether you are ready to conduct a pharmaceutical examination of prescription forms for medical products. Will help you practical recommendations authors and samples of prescription forms of three forms.

Purchasing and sales

From January 1, 2017, the government transferred state and municipal pharmacies to state procurement in accordance with Federal Law No. 44-FZ. The innovation caused a protest from unitary pharmacy enterprises. But did the amnesty take place? The author offers his version of the answer to the question.

Governance and Economics

Only a competent leader will improve the work of his subordinates and achieve financial results. But what are competencies and which of them are important for a manager, says the author of the article.

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