Peculiarities of functioning in the market of non-prescription drugs. Section: Organization of over-the-counter dispensing of medicines and pharmacy products List of over-the-counter medicines

Expressing their opinion on the possible expansion of the list of drugs dispensed without a doctor's prescription, Volga Federal District experts disagreed. Some respondents note that it is not worth expanding the current list approved by the Russian Ministry of Health and Social Development. Others are of a different opinion.

In particular, according to Rustem Safiullin, in order to provide the necessary medical care on an outpatient basis, this list has everything necessary medicines so there is no need to expand the list. Nina Sokolova, head of the Roszdravnadzor Office for the Nizhny Novgorod Region, shares a similar position: “Currently, the list of OTC drugs is about 20% of the total number of registered drugs, on average it is about 3.6 thousand items. According to experts, about 6 thousand items are currently in constant circulation in the regions of the Volga Federal District medicines, while the volume of over-the-counter drugs is one third. In other words, this list is quite large today.”

Victor Kogurov and Alla Osokina also say that the existing list does not require expansion. According to experts, the global trend in the development of the pharmaceutical market is directed towards strict regulation of the supply of medicines without a prescription, and these principles should be transferred to the conditions of the Russian pharmaceutical market.

At the same time, according to a number of experts, the existing list should not be expanded, but even somewhat reduced. In particular, according to Alexander Nazarov and Yevgeny Vasiliev, the reserve for reducing the list is drugs that contain, albeit in small doses, narcotic and psychotropic substances.

The Dean of the Faculty of Pharmacy of KSMU, Dr. farm. sciences, prof. Airat Ziganshin: “Pills are not sweets. Their reception should not depend on the desire of the patient, but on the need. And this need should be determined only by a specialist, maybe not only a doctor, but also a pharmacist, as, for example, in the UK. However, this is a topic for a separate large discussion.”

At the same time, according to experts from a number of pharmacies in the Volga Federal District, the list of OTC drugs should still be expanded. In particular, according to Venera Agisheva from Kazan Pharmacies, this revision is necessary primarily to simplify the dispensing of drugs from pharmacies. As Marina Parshakova notes, without a prescription (if available detailed instructions for use) today it would be possible to dispense many drugs, except for those that are dangerous even when used correctly without the supervision of a doctor, often used incorrectly and therefore dangerous to health, side effects which are insufficiently studied, as well as injectable dosage forms.

Alexander Korobov also speaks about the need to expand the List of OTC drugs: “Further expansion of the list will allow the use of a sufficient range of drugs that pharmacy workers can offer their customers to treat and alleviate the symptoms of minor ailments.”

Vladimir Volkov makes an important conclusion: “Any, even the most perfect, list of over-the-counter medicines over time is recognized as not meeting modern requirements for providing medical care to the population. In our opinion, today it is necessary to reasonably expand and improve the list after a thorough analysis by specialists, including medical practitioners”

Since October 16, Russia has canceled the list of over-the-counter drugs containing a list of drugs that can be freely purchased at a pharmacy. As explained " Russian newspaper"In the Ministry of Health and Social Development, for the normal operation of pharmacies and doctors, the information contained in the instructions for use of the drug is quite enough.

Until now, all drugs sold in pharmacies can be divided into two large groups: these are over-the-counter drugs that are sold freely in pharmacies, and prescription drugs dispensed by a doctor.

Whether this or that drug is safe enough to use, or whether it should be treated according to the doctor's prescription and under his control, is decided during the examination for state registration drug. In the first case, the drug is allowed to be sold freely - it is classified as an over-the-counter drug. Most of the drugs are still prescribed to be sold by prescription, which is indicated in the instructions in the section "conditions for dispensing from pharmacies." This procedure is provided for by the Law "On the Circulation of Medicines", which entered into force in September last year.

As a result, thanks to the new drug law, the list of non-prescription drugs, annually approved by the Ministry of Health and Social Development, has, in fact, become a redundant document, the ministry explains.

“With the abolition of the list for buyers, nothing will change,” Elena Nevolina, head of the Pharmacy Guild, told RG. “Nothing terrible will happen to pharmacies either. if necessary, both pharmacists and visitors could look in, inspectors were guided by it.

Now, summary information about the status of drugs can be obtained from the state register. Or - in the same instructions for the use of the medicine.

Where big problems, according to experts, are associated with the free treatment of doctors, patients, and pharmacists with prescription drugs. According to prescriptions, if you follow the established rules, about 8 out of every ten medicines should be sold. Which, by the way, is quite comparable with European and North American drug market. But in Europe and the USA, the rule "strictly according to the recipe" is strictly observed. And in our country, on the contrary, almost any medicine (with the exception of narcotic and potent drugs, which are taken into account in a special way) can be bought in a pharmacy today without a prescription.

The love of Russians for self-treatment is understandable: who wants to rush to the clinic every time they get a prick in their side and stand in long queues. But a light attitude to taking many drugs is fraught with serious health troubles.

However, it has not yet been possible to restore order in this area. The Ministry of Health and Social Development reported to RG that they are not planning any other measures, except for the standard checks by Roszdravnadzor of the correct dispensing of drugs in pharmacies. The Pharmacy Guild admits that there are violations and will not stop until the entire prescribing system changes. Doctors have forgotten how to write prescriptions, they everywhere give recommendations either verbally or by writing down the name of the drug on an ordinary piece of paper. And patients go to the pharmacy not with a prescription, but with this scrap. Perhaps the situation will improve when the responsibility of the doctor for prescription prescriptions is introduced, suggests Elena Nevolina. In any case, such responsibility is provided for by the draft law on protecting the health of citizens, which has so far been adopted in the first reading.

Samvel Grigoryan talks about a 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 IBLP leave is spelled out separately, which is not in order No. 785. It will be regulated by paragraph 13 of the first of the mentioned acts. This paragraph, in particular, determines that when the IBLP is dispensed, the exact time of this very issue, in hours and minutes, is indicated on the prescription or prescription spine, which remains with the buyer.

Violation of the secondary

With the entry into force of Order No. 403n, new accents will appear on the topic of the possibility of violating the secondary (consumer) packaging of medicines. The norm of the "retiring" order No. 785 allows this to be done in exceptional cases, if the pharmacy organization cannot fulfill the doctor's prescription.

Order No. 403n, which replaces it, is more specific in this regard and more in line with modern requirements, medical practice and consumer needs. Clause 8 of the order determines that violation of secondary packaging and dispensing medicinal product in the primary package is allowed 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 package.

In this case, the buyer must be provided with instructions for use or a copy of it, and violation of the primary packaging is prohibited. By the way, the new order does not contain a rule that, in case of violation of the secondary drug, the drug should be dispensed in a pharmacy package with the obligatory indication of the name, manufacturer's batch, expiration date of the drug, series and date according to the laboratory packing journal, which is determined by order No. 785.

"Medication 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, Form No. 107/u-NP dispenses narcotic and psychotropic drugs of Schedule II, with the exception of narcotic and psychotropic drugs in the form of transdermal therapeutic systems.

The remaining prescription drugs, as you know, are dispensed according to the forms of the form No. 107-1 / y. 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 drugs, as well as forms of prescription forms ...”, prescriptions written out on the forms of this form are valid for two months from the date of issuance. However, for patients with chronic diseases it is allowed to set the validity period of the prescription form No. 107-1 / y 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 the amount of dispensing of the medicinal product (in each period), is returned to the buyer, of course, with the appropriate notes on the date of dispensing, dosage and quantity of the dispensed drug. This is prescribed by paragraph 10 of order No. 403n. He also determines that the next time the patient contacts the pharmacy with the same prescription, the first-timer must take into account the notes on the previous release of the drug.

The prescription remains in 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 retailer retains (with the mark "Drug product dispensed") and stores:

within 5 years prescriptions for:

within 3 years prescriptions for:

within 3 months recipes for:

The order of the Ministry of Health of Russia No. 403n did not do without a cherry on the cake, however, a dubious one. In paragraph 15 of the order, it is written that prescriptions that are not indicated in the previous paragraph 14 (we listed them a little higher) are marked with the stamp “The drug is dispensed” and returned to the indicator. This seems to imply that Form 107-1/2-month-validity prescriptions become "single use." We advise readers to pay special attention to this new norm.

The topic of combating the abuse of alcohol-containing drugs in the pharmacy range, which was recently trumpeted by the media, was 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 stamp "released"); under the new order, they must remain in the pharmacy organization.

To not get caught

The procedure for working with incorrectly written prescriptions is now described in a little more detail (paragraph 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 preparation of the prescription, the full name of the health worker who wrote it, the name medical organization in which he works, the measures taken.

Clause 17 of Order No. 403n contains a rule that a pharmacist is not entitled to provide false or incomplete information about the availability of drugs in the assortment of a pharmacy facility - including drugs that have the same INN - and also hide information about the availability of drugs that have a lower price. Similar provisions are contained in subparagraph 2.4 of Article 74 of the Law of November 21, 2011 No. 323-FZ “On the Fundamentals of Protecting the Health of Citizens in the Russian Federation” and paragraph 54 of the Rules for the Proper pharmacy practice(Order of the Ministry of Health of the Russian Federation of August 21, 2016 No. 647n). Here, the only new thing is that this norm first appears in the order on the rules of leave.

It was a review of the order, so to speak, "on a fresh trail." Probably, readers will 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 “one-time” 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 drugs are dispensed. As soon as the pharmacists had time to return from their summer vacation and look around, a new order of the Ministry of Health of the Russian Federation dated July 11, 2017 No. medical use, including immunobiological drugs, pharmacy organizations, individual entrepreneurs licensed for pharmaceutical activities. Order No. 403n on the vacation procedure was registered with the Ministry of Justice of the Russian Federation on September 8; the beginning of its action is September 22 of the current year.

The first thing I want to say in this regard is to forget now the number "785". New order 403n, with amendments and additions, recognizes as invalid the well-known order of the Ministry of Health and Social Development dated December 14, 2005 No. 785 “On the procedure for dispensing medicines”, as well as the orders of the Ministry of Health and Social Development No. 302, No. 109 and No. 521 that amended it. -of a legal act, they repeat - sometimes almost verbatim - the corresponding fragments of the predecessor order. But there are also differences, new provisions, on which we will focus to a greater extent, setting out the first observations and notes in the margins of the freshly baked 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 dispensing medicinal products, including immunobiological medicinal products (IBLP); the second - the requirements for the release of narcotic and psychotropic drugs, drugs with anabolic activity, and other drugs subject to subject-quantitative accounting (PKU). The third annex establishes the rules for dispensing medicines according to the requirements of invoices of medical organizations, as well as individual entrepreneurs (IEs) who have a license for medical activities.

The release of over-the-counter drugs and under the new procedure will be allowed both for pharmacies and pharmacy points, and for individual entrepreneurs and pharmacy kiosks. Otherwise, if we sum up points 2 and 3 of order No. 403n and the list of drugs, the following picture emerges.

The release of narcotic and psychotropic drugs can only be carried out by pharmacies and pharmacy points that have the appropriate license.
The rest of the prescription drugs are dispensed by pharmacies, drugstores and individual entrepreneurs (of course, those who have a license for pharmaceutical activities - this clarification will be further considered accepted by default and omitted).
The release 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 IBLP drugs is prescribed separately, which is not in order No. 785. It will be regulated by paragraph 13 of the first of the mentioned acts. This paragraph, in particular, determines that when the IBLP is dispensed, the exact time of this very issue, in hours and minutes, is indicated on the prescription or prescription spine, which remains with the buyer.

It is possible to release IBLP under two conditions. Firstly, if the buyer has a special thermal container, in which it is possible to comply with the required mode of transportation and storage of these thermolabile drugs. The second condition is an explanation (pharmacy worker 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.

Recall in this regard that this topic is also regulated by subparagraph 8.11.5 of the Sanitary and Epidemiological Rules "Conditions for the transportation and storage of immunobiological preparations" (SP 3.3.2.3332-16), which are approved by the Decree of the Chief State Sanitary Doctor of the Russian Federation of February 17, 2016 No. 19 It obliges the pharmacy worker to instruct the buyer on the need to comply with the "cold chain" when transporting IBLP.

The fact of this briefing is recorded by a mark - on the drug package, prescription or other accompanying document. The mark is certified by the signature of the buyer and the first owner (or other representative of the pharmacy organization) and also includes the date and time of the vacation. However, SanPiN does not specify that the time in this case should be entered in hours and minutes.

Violation of the secondary

With the amendments and additions to Order No. 403n, new accents will appear on the topic of the possibility of violating the secondary (consumer) packaging of medicines. The norm of the "retiring" order No. 785 allows this to be done in exceptional cases, if the pharmacy organization cannot fulfill the doctor's prescription.

Order No. 403n, which replaces it, with a list of drugs in this regard, is more specific and more in line with modern requirements, medical practice and consumer needs. Clause 8 of the order determines that violation of the secondary packaging and dispensing of the medicinal product in the primary packaging is allowed in cases where the amount of the drug indicated in the prescription or required by the consumer (in case of 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 of it, and violation of the primary packaging is prohibited. By the way, in the new order of the Ministry of Health of the Russian Federation No. 403n there is no rule that, in case of violation of the secondary drug, the drug should be dispensed in a pharmacy package with the obligatory indication of the name, factory batch, expiration date of the drug, series and date according to the laboratory packing journal, which is determined by order No. 785.

What does this mean in practice? Let's assume two situations: the first - preparation X tablets (or pills) No. 56, primary packaging - blister; the second - the preparation of N tablets No. 56, in a vial. And in both cases, there is a question about his release to the patient who presented the prescription to the head of state, on which, say, 28 tablets or 42 tablets (pellets) are written.

It is clear that in the first case this is permissible, since it is possible to release 28 or 42 tablets without violating the primary packaging (blister), and in the second it is unacceptable, since the primary packaging in this situation is a vial, and it is strictly forbidden to violate it. So, our pioneers do not have the right to count pills or dragees from a bottle, as they do in pharmacies in some foreign countries.

"Medication Released"

According to the form No. 148–1 / y-88, the following are released:

psychotropic drugs of Schedule III;
narcotic and psychotropic medicinal products of Schedule II in the form of transdermal therapeutic systems;
drugs included in the list of medicines subject to PKU, with the exception of those drugs that are dispensed in accordance with the form No. 107 / y-NP;
drugs with anabolic activity and related to the anatomical-therapeutic-chemical classification (ATC) recommended by the World Health Organization as anabolic steroids (code A14A);
preparations specified in paragraph 5 of the "Procedure for dispensing individuals medicinal products containing, in addition to small amounts 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 or psychotropic substance included in Schedule II and other pharmacologically active substances in a dose not exceeding the highest single dose, and provided that this combination medicinal product is not a narcotic or psychotropic medicinal product Schedule II drug.

The list of other prescription drugs, as you know, are released according to the forms of the form No. 107-1 / y. 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 drugs, as well as forms of prescription forms ...”, prescriptions written out on the forms of this form are valid for two months from the date of issuance. However, for patients with chronic diseases, it is allowed to set the validity period of the prescription form No. 107-1 / y 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 the amount of dispensing of the medicinal product (in each period), is returned to the buyer, of course, with the appropriate notes on the date of dispensing, dosage and quantity of the dispensed drug. This is prescribed by paragraph 10 of order No. 403n. He also determines that the next time the patient contacts the same prescription for the list of drugs at the pharmacy, the first-timer must take into account the notes on the previous release of the drug.

At the time when the maximum amount indicated in the prescription is purchased, it must be stamped “Medicinal product dispensed”. And a one-time vacation of the entire amount, according to the same paragraph, is allowed only in agreement with the doctor who wrote out this prescription.

The prescription remains in 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 retailer retains (with the mark “Drug product dispensed”) and stores:

within 5 years prescriptions for:

narcotic and psychotropic drugs of Schedule II, psychotropic drugs of Schedule III (according to the outgoing Order 785, 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 / y-04 (l) or No. 148-1 / y-06 (l));
combined medicinal products containing narcotic drugs or psychotropic substances included in Schedules II and III, manufactured in a pharmacy organization, drugs with anabolic activity, drugs subject to PKU;

within 3 months recipes for:

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

Note that in the 785th order there is no this group of recipes for three-month storage.

Order No. 403n of the Ministry of Health did not do without a cherry on the cake, however, a dubious one. In paragraph 15 of the order, it is written that prescriptions that are not indicated in the previous paragraph 14 (we listed them a little higher) are marked with the stamp “The drug is dispensed” and returned to the indicator. This seems to imply that Form 107-1/2-month-validity prescriptions become "single use." We advise readers to pay special attention to this new norm.

The topic of combating the abuse of alcohol-containing drugs in the pharmacy assortment, which was recently trumpeted by the media, was 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 stamp "released"); under the new order, they must remain in the pharmacy organization.

To not get caught

The order of vacation with incorrectly written prescriptions is now described in a little more detail (paragraph 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 preparation of the prescription, the full name of the health worker who issued it, the name of the medical organization in which he works, and the measures taken.

According to this paragraph, during drug dispensing, the pharmacist informs the buyer not only about the regimen of its administration and doses, but also about the rules for storage at home and interaction with other drugs.

Theoretically, 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 primate, dispensing the medicine, does not inform him, for example, that this medicine must be stored at a temperature not exceeding 25 ° C, or will not ask if it accepts given time other medicines, then the inspector can “throw off the mask” and draw up an act on an administrative offense. So the norm of paragraph 16 is serious and fraught. And, of course, it requires that the pervostolnik be thoroughly savvy on the complex and voluminous topic of drug interaction.

Clause 17 of Order No. 403n, as amended, contains a rule that a pharmacist is not entitled to provide false or incomplete information about the availability of drugs in the assortment of a pharmacy facility - including drugs that have the same INN - and also hide information about the availability of drugs that have a lower price . Similar provisions are contained in subparagraph 2.4 of article 74 of the Law of November 21, 2011 No. 323 FZ “On the fundamentals of protecting the health of citizens in the Russian Federation” and paragraph 54 of the Rules of Good Pharmacy Practice (order of the Ministry of Health of the Russian Federation of August 21, 2016 No. 647n). Here, the only new thing is that this norm first appears in the order on the order of vacation.

These were explanations of order No. 403n, so to speak, "on a fresh trail." Probably, readers will 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 “one-time use” of prescriptions with a two-month validity, which was discussed 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, our website will host a webinar by Larisa Garbuzova, Ph.D. in Economics, Associate Professor, Department of Management and Economics of Pharmacy, North-Western State medical university(St. Petersburg), dedicated, and on October 25, Executive Director of the "National Pharmaceutical Chamber" Elena Nevolina on the same topic. Register for both webinars.

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

"Moscow pharmacies", 2003, N 5

When developing the OTC policy, the interests of a wide range of pharmaceutical market participants intersect: regulators, physicians, advertising agencies, manufacturing companies and drug consumers. That is why, despite the well-established mechanism for resolving the issue in developed countries, the OTC policy in Russia has been recent years has not been developed, and at the moment the country does not have a complete approved list of over-the-counter drugs corresponding to the range of drugs sold.

In world practice, over-the-counter drugs are referred to as OTC drugs. They are intended to relieve symptoms of non-life-threatening diseases, they are used in those clinical situations where the symptoms of the disease are quite obvious, recognizable, and do not require clarification by a specialist. In addition, the effectiveness of this group of drugs must be proven not only clinical research, but also a long experience of their practical application - usually medicines are not available for over-the-counter sales, practical use which are less than five years old.

OTC dispensing of drugs implies the possibility of the population to engage in self-medication. Despite the fact that in our everyday life the word "self-medication" has long acquired a negative connotation, according to WHO, self-medication is one of the elements of health care and corresponds to the desire of consumers to take greater responsibility for protecting their own health. The economic aspect of self-treatment is that the costs of healthcare are reduced, the burden on the medical staff of health facilities.

Over the past decades, attitudes towards self-medication have been transformed, moving from the concept of "self-medication" that existed in the 1980s to the concept of "responsible self-medication" in the 1990s. In practice, this meant expanding the criteria for OTC dispensing of drugs. In 2002, the World Association of Manufacturers of OTC Drugs began to promote the concept of patient self-help with full information not only about the features of taking this or that drug, but also about therapeutic standards for the treatment of various pathologies.

Currently, the European Union has Directive 92/26, which provides clear criteria for delimiting the forms of dispensing drugs. So, prescription drugs include those drugs that can pose a danger to human health even if they are correct application; which, due to misconceptions, are widely used incorrectly or contain substances that require further clinical investigation; as well as drugs used parenterally and recently brought to the pharmaceutical market. Non-prescription medicines include all other medicines.

The question of the form of drug dispensing is fundamental for their marketing. The cardinal difference between the marketing of over-the-counter drugs and prescription drugs is that information about these drugs can be focused not only on specialists, but also on a wide range of consumers. This fact dramatically increases the income from sales of this group of funds. However, at the same time, a whole range of problems arises related to the regulation of advertising of over-the-counter drugs.

Currently, there are three main mechanisms for regulating the OTC advertising market:

legislative method (in our country - the Laws "On Medicines", "On Advertising");
self-regulation (codes public organizations working in the pharmaceutical market; WHO ethical criteria);
a unified system of concepts, recommendations, terms developed by specialists.

Self-regulation of the advertising market is accepted in many developed countries as the norm of marketing practice. At the same time, advertising companies themselves monitor compliance with advertising standards and the compliance of their activities with national legislation. In case of violation of generally accepted rules, the state threatens them with severe sanctions, up to a ban on their activities.

In international practice, the most general requirements for drug advertising are the following postulates:

the advertiser must not mislead consumers;
should not advocate ignoring medical care;
information must be complete, sufficient for the consumer and accurate.

In addition, in all countries without exception, only registered drugs are allowed to be advertised. In the countries of the European Union, according to Directive 92/28, it is not allowed to use not only the image of a doctor/pharmacist, but also a white coat in general when advertising medicines; it is not recommended to use links to famous people; absolutize medicinal properties drugs, presenting them as a panacea; talk about the natural origin of the drug as a guarantee of its safety; call for the use of artificial products, encouraging the refusal of breastfeeding; target drug advertisements to children under 14, etc.

The task of advertising is not only to ensure the popularity of medicines, but also to inform consumers. Today, having become an important element of any field of activity, advertising in no area can cause as much harm as in pharmaceuticals, therefore, in a state with developed market relations, there must be strict norms for advertising pharmaceutical products.

Directive 92/27 of the European Union is devoted to standards in the field of informing the public about over-the-counter drugs, as well as requirements for packaging, inserts, annotations of OTC drugs.

In general, the development of the OTC drug market is on the path of ever greater expansion and liberalization. So, in the 1980s. in developed countries, over-the-counter drugs helped relieve only symptoms such as mild pain; cough, cold, runny nose; cuts, scratches, bruises. In the 1990s there has been a significant expansion of indications for which the use of drugs of the OTC group is recommended: rheumatic pain, allergic diseases, dyspeptic syndrome, mycoses, baldness, herpes on the lips. At present, in Europe, there are freely available drugs used for the prevention and treatment of the following nosologies: migraine, colds and flu, allergic diseases, peptic ulcer stomach and gastritis, vaginal dryness, thrush, herpes (including genital), as well as contraception and cholesterol control.

The global trend towards the liberalization of OTC dispensing of drugs leads to a change in the role of the pharmacist/pharmacist. Pharmacy specialists working on the trading floor and influencing the consumer's choice of drugs become figures whose competence, diligence and conscientiousness really affect the health of the nation. A pharmacist / pharmacist in a modern civilized society is less and less like a drug seller.

In Russia, the situation with compliance with drug dispensing forms is far from ideal. Meanwhile, one of the real steps towards putting things in order in this area would be the approval of the list of OTC drugs.

In 1998, such a list was developed by the Institute of Pharmacy and approved by the Ministry of Health of the Russian Federation. Despite the fact that the list of registered drugs in subsequent years was rapidly replenished and there was a rapid process of transferring prescription drugs to OTC, the List of OTC drugs was never re-approved. Newly registered and re-registered drugs only received the Instructions for the use of the drug approved by the Pharmacological Committee, which indicated the form of dispensing of this drug, which only partly corresponds to the norm of the law.

One of the reasons for this situation is that in the very legislation of the Russian Federation, concerning the issue of non-prescription dispensing, there is already a contradiction. So, in Art. 32 of the Law "On Medicines" refers to the List of medicines dispensed without a doctor's prescription, approved once every five years by the federal executive body, Supplements to it are published annually. In paragraph 9 of Art. 16 of the same Law refers to the Instructions for the use of the medicinal product. Among other information about the drug, it should indicate the conditions for dispensing this tool. Thus, on the one hand, the legislation provides for the existence of a List of OTC drugs approved by the Ministry of Health of the Russian Federation (a federal executive body); on the other hand, the Instruction for the use of drugs, approved by the Pharmacological Committee, is recognized as a sufficient document for approving the form of dispensing a medicine.

Currently, the policy regarding the development of a list of OTC drugs in our country has been delegated to the Federal Formulary Committee of the Ministry of Health of the Russian Federation. As stated in the Order of the Ministry of Health of the Russian Federation N 304 of 02.08.2000 "On the Formulary Committee of the Ministry of Health of the Russian Federation", the functions of this Committee include the development of lists of essential drugs, over-the-counter drugs and the annual revision of these lists. Currently, this Committee has developed an internal Regulation on the transfer of drugs to OTC; in the near future, it is planned to start to develop a new complete List of non-prescription drugs.

The need to create this document is all the more obvious in connection with the introduction of the new OST "Rules for the release (sale) of medicines in pharmacy organizations. Basic provisions", in clause 2.9. which states that in a pharmacy organization, in a place convenient for familiarization on the trading floor, a list of drugs dispensed without a doctor's prescription, approved in the prescribed manner, should be placed.

The creation of a new List of OTC drugs and the publication of an annual Supplement to it will be a significant step in the domestic regulatory system towards international legal norms that ensure patient safety and the responsibility of pharmaceutical market entities.