Prescription drugs list. prescription tablet

From January 1, 2017, to the pharmacy for medicines - only with a prescription in hand. This innovation is now widely discussed in Russia. However, as experts say, this will not cause inconvenience. What changes await us, is it true that drugs will now be dispensed strictly according to a "document from the doctor"?

As it turned out, for pharmacy workers this is no longer news. Order No. 785 "On the procedure for vacation medicines» has been in force since December 14, 2005. It lists groups of drugs that are prohibited from being sold without a prescription. In Russia, this is two-thirds of total number medicines sold through pharmacies. The very form of the “doctor's note” is changing. Yulia Antipova, pharmacist.

Yulia Antipova: “A prescription is also considered to be just a sheet on which the doctor’s handwriting is written. And from 2017 it will change - it must be prescription form, this one is the 107th. It will be necessary to monitor the correctness of the appointments on these forms. There should be a personal seal of a doctor, a seal of a health facility, the dosage, frequency of use is correctly indicated.

Not all drugs fall under the heading “only by prescription”. Everything in the windows of pharmacies is freely available. Natalia Dementieva, chief physician Kursk City Polyclinic No. 5.

Natalya Dementieva: “We take the 1st tablet 2 times a day - in the morning and in the evening. Tablets are best taken after meals. We are already prescribing drugs. Our patients know that for many years all subsidized medicines have been prescribed only on prescriptions. The drugs are prescribed the same, there are no changes. And we have recipes enough there is".

So no patient will be left without a form. By the way, recipes have their own expiration date. Natalia Dementieva, chief physician of the Kursk city polyclinic No. 5.

Natalya Dementyeva: “Because now the prescription is valid for 60 days. We can issue up to a year for any period. A person with this prescription will go, with the same one, for the prescribed drug.”

While there is no official list of all drugs that must be dispensed strictly by prescription. They will focus primarily on instructions for medicines. State Duma deputies plan to tighten control over pharmacies. For the sale of drugs without a doctor's prescription, you can still get a fine now, but lawmakers are proposing to increase it to 10,000 rubles. most last resort should be the closure of the pharmacy for 3 months.

Olga Eremina

Since September 22, antibiotics have not been sold without a prescription in Russia. So says the order of the Ministry of Health. But in reality, the sale of such drugs looks different.

Russians are increasingly faced with the fact that they are not sold some drugs if there is no prescription or it is issued incorrectly. Pharmacies refer to the new order of the Ministry of Health, which specifies the procedure for the sale of such medicines.

True, the Business FM experiment showed that it is still possible to buy drugs without a prescription, even if one should be available. Autumn, rain, cold. Nothing new: it repeats year after year. Only today it has become difficult to buy drugs for the treatment of this very cold. Since the beginning of October, there have been reports on social networks that pharmacies require prescriptions for antibiotics.
Business FM columnist Ivan Medvedev also faced this.

Ivan Medvedev Business FM columnist“My wife got sick. She called the doctor to the house. The doctor prescribed antibiotics, in particular, the drug "Amoxiclav". But the doctor wrote it out simply on the letterhead of the hospital, that is, it is not complete recipe which, as I accidentally found out, is now of fundamental importance. I went to the pharmacy, where I was told that since September 22, pharmacies have no right to dispense antibiotics without a doctor's prescription, that is, they can dispense antibiotics only by changing them to a prescription.

Another Business FM reviewer was more fortunate. In another pharmacy, they were ready to sell him the same drug just like that, without any prescription.

Mikhail Safonov Business FM columnist"Are you for yourself?" I say yes". She assessed my complexion, said: “500 milligrams for you.” I say: “OK, but do you need a prescription?” She looked at me sternly and said: “Actually, you need a prescription!” I say, "I don't." She says: “How do you buy it? What did your doctor tell you?" And I say: “But the doctor didn’t tell me anything, because the doctor is my friend.” She says, "Well, if your friend takes responsibility, then please buy."

At the pharmacy in the supermarket, next to the Business FM office, there were no problems buying antibiotics either. Why pharmacies do not require a prescription when they should do so, no one could explain. Perhaps they are not afraid of fines, although such violations can even lead to a license suspension for three months. However, the fact remains.

In fact, pharmacies were previously not allowed to sell prescription drugs without an official prescription. And the order of the Ministry of Health, which entered into force on September 22, simply clarifies the rules for their vacation. In particular, the pharmacy now retains the so-called one-time prescription after it has sold the medicine on it. Why this is done, explains the executive director of the Russian Association of Pharmacy Chains Nelli Ignatieva.

Nelly Ignatieva Executive Director of the Russian Association of Pharmacy Chains"If a medicines according to all the documents, the pharmacy received ten, and in the balance it has five - we fix this, these are separate accounting documents - therefore, there should be five prescriptions, moreover, correctly written prescriptions. If something is written incorrectly in the prescriptions, again this is a violation. In this system, a doctor, a patient, a pharmacy are involved, and for some reason, responsibility for all violations is currently only assigned to the pharmacy. In fact, the problem is completely different. Our doctors have stopped writing prescriptions and, accordingly, confused all patients, and for some reason patients do not demand their rights to issue a prescription.”

The official prescription must be issued on a standard form, stamped, indicating the international generic name drug in Latin. The use of specific trade names is permissible if the drug has no analogues. Why doctors violate these rules, David Melik-Guseinov, head of the Moscow Healthcare Research Institute, told Business FM.

Director of the State Budgetary Institution Research Institute of Health Organization and Medical Management“Only 10% come with some kind of recommendation, and about half of these 10%, that is, only 5% of the population, come with correctly executed prescriptions. Doctors, of course, strove not to write prescriptions, because any prescription with a seal and signature is official document. A document that can be presented in a court of law, a document that can be presented to the executive branch so that they conduct appropriate checks. So medical workers, doctors very often shied away from the obligation to issue an official prescription.

Pharmacies, by the way, are also self-willed. They are required to return to customers the so-called multi-dose prescriptions valid for up to a year, which prescribe drugs for the treatment of chronic diseases. In this case, the pharmacy must make a note in such a prescription about the sale of the medicine. But sometimes such recipes are also trying to withdraw. The Ministry of Health wanted to put things in order with the sale of prescription drugs. We wanted the best, but it turned out as always.

Lyudmila Lapa therapist “It can’t lead to anything good, because antibiotics are now - here, for example, I prescribed them today, and the girl says she doesn’t need a prescription. She didn't even ask because she was told she would buy it, no problem. That is, she has some kind of pharmacy nearby, which gives out everything. And now, who is right, who is wrong, it is very difficult to determine. Confusion, in fact, exists. This is an undeniable fact."

To the question of what to do if you have not been sold the medicine, there are two answers so far. Either go to the doctor and demand that he write you an official prescription, or look for a pharmacy where prescriptions are not required. As our experiment showed, they can still be found.

In the last century, when antimicrobials were first invented, it seemed that a panacea had been found. For the discovery Nobel Prize and began to treat everyone with penicillin. However, why only in the last century? Not so long ago it was easy to buy antibiotics without prescriptions. List prescription drugs was very narrow. But medical statistics and research recent years changed the situation significantly. Things didn't turn out as rosy as many had hoped.

We start with the most important

A photo of the names of antibiotics without a prescription is given below.

Only these drugs today in the pharmacy can be bought freely. All others are subject to a restriction, non-compliance with which is punishable by a decent fine. And persuasion in the style of “until recently they sold me everything” does not work - in May of this year, in our country they adopted new law, which severely limits the possibility of implementing medications. However, often the townsfolk do not even realize that this was done for their own good. We rarely think about the ability different forms life to adapt to aggressive conditions, but the smaller this very life, the higher such qualities it has. This is especially true for viruses and microbes - penicillin, which killed them several decades ago, today does not frighten harmful microflora, since resistance has been developed. To understand the essence of this phenomenon, it is worth looking not for a list of permitted antibiotics without prescriptions, but for the principle of the drugs.

And how was it before?

In fact, the list of over-the-counter antibiotics has always been rather narrow: most drugs were legally allowed to be purchased only if available. official reference the doctors. The exception concerned only a few items included in the special list of essential medicines. Only now the law did not contain serious punishments for misconduct, so it was observed very conditionally. And yet there was no officially free sale before. The problem of compliance with established rules worried the government long time, on the basis of which they adopted this year a new normative act designed to make the situation more stable.

Many are rightly indignant: it is very difficult to get to the clinic to get a prescription for the necessary medication. Huge queues, a flea market, infections - you can get sick even more than before going to the doctor. So the inhabitants are interested in the names of antibiotics without a prescription, hoping to bypass the unpleasant need to visit a specialist. The government does not deny that hospitals are really overwhelmed, and the impossibility of free purchase of antimicrobial drugs only increases this volume.

Why is this needed?

At the world level, doctors are sounding the alarm: microscopic life forms have developed a stable immunity to antibiotics. Lists that are dispensed without a prescription, of course, attract attention, but by doing so, the person himself classifies himself as a member of the group increased risk: microscopic life forms in his body learn to survive even under the influence of substances so unfavorable for them, so in the future the disease will be more and more difficult to eliminate. There is a possibility lethal outcome from a simple flu and its complications, and all because of the resistance of microbes to the drugs designed to fight them. And it was developed precisely because of the uncontrolled use of medicines by the masses. Doctors voice predictions: millions of people are in danger due to established medical practices.

And what to do?

As activists say, a ban on the sale of antimicrobial agents can only bring real benefits in the conditions of a well-established system for providing medical services to the population, because in the current situation, a person either has to literally wait a week to get to the doctor, or independently search for names from the list of allowed over-the-counter antibiotics, as well as persuading pharmacists to break the law to sell him useful drug. By the way, not only antimicrobial, but also many other medicines that are now freely sold in pharmacies, according to the law, should be distributed only if the patient has a properly executed prescription with all seals and signatures.

How to get a prescription?

If the over-the-counter antibiotics on the list don't work, or if the person doesn't want to hurt themselves by using the drugs in an uncontrolled manner, it's easiest to get an appointment at paid clinic. True, this is not cheap: even on the periphery, private clinics ask up to a thousand rubles for an appointment, and in the metropolitan region this figure is two to three times more. But if there is no way to pay, and waiting too long for an appointment at the clinic, the person continues to be treated on his own - otherwise, a serious illness, numerous complications, up to death, threatens.

Is everything so clear?

Many say that the list of antibiotics without prescriptions in Russia is insignificant information, since a relatively small percentage of people who want to purchase medicines have a real permission from a doctor. If you refuse to all those who do not have a piece of paper, pharmacies will lose a significant percentage of their profits. Far from everyone is ready to do this, especially in a competitive and crisis market situation. Experts predict that drugs will continue to be sold in violation of established laws It is the protection of enterprises from ruin.

Is it useful for the client? On the one hand, you do not need to be limited to a list of antibiotics without a prescription, you can hope that you can buy everything you need. On the other hand, do not forget about the immunity accumulated by microscopic life forms. In addition, during self-medication, many stop drinking drugs not after the course duration has elapsed, but with the initial improvement in the situation, and this is the most efficient way development of resistance for microbes.

WHO: forecasts are disappointing

Scientists speaking on behalf of the World Health Organization informed that by 2050, each year, the death rate of about 10,000,000 people will be provoked by the immunity of microscopic life forms to antimicrobials. Against this background, the dispensing rules have been tightened in all countries, the list of antibiotics without a prescription has been significantly reduced.

Drug resistance is a natural process that is stimulated misuse medicines. However, not only medicine plays a role, but also Agriculture where such compounds are widely distributed. Nowadays, some diseases can no longer be cured, although decades ago they were effectively eliminated with the help of antibiotics. Good example- new subtypes of tuberculosis, drug-resistant gonorrhea. And it's not full list dangerous infections. The consequences, especially in the analysis of the near future, seem large-scale, if not catastrophic.

What about today?

Extensive medical practice and uncontrolled reception antibiotics from the list without a prescription (and even with prescriptions, if the average person can buy such a drug just like that) led to the fact that about 700,000 people die from infection during the year. This forces us to look for new approaches to market regulation. The economy is good, the profits of pharmaceutical companies are also good, but the health of future generations is more important.

And what to do?

Instead of expanding the list of over-the-counter antibiotics, the authorities decided to go the other way: to limit the sale of drugs as severely as possible in order to force people to visit a doctor before starting treatment. It is currently assumed that state enterprises will gradually begin to capture the sector of private medical clinics. A mechanism for cooperation between the authorities and non-budgetary institutions is being developed.

This is possible, since in many state clinics not all areas are used, while maintenance costs are calculated from everything that is available. That is, the conclusion of contracts will make it possible to recoup the costs of housing and communal services, security, give sick people the opportunity to choose, lower the cost of private services and a chance to get to the doctor on time without a long queue.

Antibiotics: which are sold without a prescription?

At the beginning of the material, a list of drugs that can be freely purchased at the present time is already listed. Most of of the above - medicines intended for external use, that is, gels and ointments, suppositories. Among them are those designed for ophthalmic use. The exception is:

• "Furazolidone".
• "Gramicidin C".
• "Fluconazole".

To buy any other names, you will have to provide the pharmacist with a prescription drawn up in a special form.

Against the law: what will happen?

If it is possible to identify a violation of established regulations, the pharmacist will be fined - 5,000 rubles or more. The enterprise itself can be closed for a three-month period.

In addition to antibiotics, similar severe restrictions are imposed on painkillers intended for blood vessels and the heart, affecting the psyche and some other special groups. As the responsible authorities explain, this practice was introduced on the basis of the successful experience of foreign colleagues, where the normalization of the sale of medicines led to an increase medical results: resistance in sources of pathology is developed much less frequently.

It is important

The ban on the sale of prescription drugs without the presentation of an appropriate permission from a doctor has been introduced on the territory of the state since 2005, however, it was observed rather conditionally. In addition to the Ministry of Health, Rospotrebnadzor has now taken up the normalization of sales. Now it is not only forbidden to sell prescription medicines without an appropriate piece of paper, but even to place them on the window. A pharmacy can be fined for a violation in the amount of 100,000 rubles or more.

The prescription must be issued on official letterhead, sealed by the doctor and the institution, and signed by the doctor. The name indicated in the recipe is non-proprietary. Be sure to prescribe the dose, frequency of administration. The prescription can be used for up to two months, but for chronic patients it is extended for a year, indicating how often drugs can be bought.

Buy what?

Currently, the ban is imposed on 70% of all pharmacy products. In addition to antibiotics, this includes hormonal preparations, drugs in ampoules, diabetic medicines, narcotic, psychotropic active substances. And here complete list names allowed for sale without a prescription have not been released. Officially, they promised to publish it at the beginning of this year on the website of the Ministry of Health, but they did not bother about it. Officials require pharmacists to "focus on the instructions." If it states that a prescription is needed, then it is unacceptable to sell the drug without the official permission of the doctor.

What happens in practice?

Heads of pharmaceutical sales outlets have different attitudes to the new rules. Somewhere they require pharmacists to strictly adhere to the established rules, and on the free market there are only drops for the nose, ointments, herbs and a couple of medications for stopping the virus and lowering the temperature. Other enterprises are ready to sell both antibiotics and painkillers, but only in the form of gels and ointments. Somewhere you can buy pills, but you won’t be able to buy ampoules, and someone doesn’t pay attention to prohibitions at all.

Before going to the pharmacy, as experts recommend, you should first read the instructions for the necessary medication on the Internet. If it does not indicate the sale strictly by prescription, you can safely purchase such a drug. If there is such a phrase, you should first familiarize yourself with side effects and carefully weigh for yourself what is more important: the immediate benefit and the possible danger in the future or the discomfort associated with visiting a doctor who will definitely choose the right medicine and tell you how to use it.

Thanks to changes in the recommendations and orders of the Ministry of Health Russian Federation, many prescription drugs will be dispensed from March 1, 2017. The beginning of the current year for many pharmacy chains, as well as the pharmacological sector as a whole, turned out to be stormy. Some guidelines have already entered into force, others will soon come into force. Some of the orders introduced a moratorium on the work of pharmacists, while others make it much more difficult to dispense prescription drugs.

What kind of prescription drugs are dispensed from March 1, 2017?

By order of the Ministry of Health, certain restrictions are introduced on the sale of medicinal products. Implementation medical devices in one hand is carried out in limited quantities. This refers to the sale of syrups and tinctures that contain ethyl alcohol in a concentration of at least 15%. Pharmacists can sell no more than two packages per hand. For what purpose they do this, it is clear to many. Today, far from all drugs people buy to fight ailments. This fact confirms the mass poisoning with hawthorn tinctures in Irkutsk, where more than 70 people were injured.

In addition, pharmacists are prohibited from advising a client on more expensive medicines if there are inexpensive analogue. Although, according to many representatives of the pharmacological industry, such standards were previously prescribed in the instructions for pharmacy workers.

Also, pharmacists are required to provide their client with data on the characteristics and contraindications of medications, as well as on their shelf life, storage conditions and dosage. Previously, such things were not discussed at all.

Prescription drugs

According to the Law of the Ministry of Health No. 785, since March 1, 2017, medicines are dispensed by prescription. An exception is the list of those drugs that can be dispensed without a prescription.

The list of prescription drugs since March 1, 2017 is quite extensive. It includes drugs from literally all medicinal groups. Most on the list are antibiotics. According to the idea of ​​the Ministry, they should all be prescription. Therefore, if we act strictly according to the law, more than 50% of all drugs in pharmacies must be sold only if there is a prescription from the attending physician.

The opinion of representatives of the pharmacy business

According to representatives of the pharmacological industry, there are practically no recipes in the classical sense at present. Doctors write appointments on pieces of paper. At the same time, according to the director of one of the pharmacy chain Kakhaber Bakuradze, today many pharmacy pharmacists are being retrained for new way. He also reports that every day everything more people they come to the pharmacy with prescriptions, and pharmacists work exclusively according to the instructions, that is, in accordance with the current legislation.

Today, the sale of prescription drugs without availability necessary documents threatens with a fine of up to 50 tr. The authorities are considering the possibility of making a punishment for trading prescription drugs over the counter more stringent. It's about about the potential termination of activities for a period of up to 90 days.

Information about over-the-counter medicines is allowed to be placed on the shelves, in the formats of wobblers and posters, as well as on other media so that the buyer can fully familiarize himself with the product. In a comfortable view, it is necessary to place a price tag with the name, number of doses in the package, dosage, manufacturer.

Barcode on medical products

In addition, another important innovation comes into force - labeling on each drug. In several Russian cities a pilot project of the corresponding sample is launched. the main objective measures is to combat counterfeit and counterfeit medicines.

According to preliminary data, this project will help track about six billion packs of medical supplies. At the initial stage in March, the barcode will be placed on 60 products. Including - 10 drugs for the treatment of rare ailments, as well as more than 30 types of drugs that are included in the list of vital essential medicines prescription from March 2017. It is planned that by the end of this year, the automation of the accounting system is considered voluntary. AT next year it will be coercive.

According to Rospotrebnadzor, each pack of a medical product in production will be equipped with a two-dimensional barcode. It will be located next to information about the period until which the medicine may be valid. Such a system will allow you to determine the origin of the drug without leaving the pharmacy cash desk.

Difficulties in operating a barcode

However, some problems were also found. A program for reading the code must be installed on the mobile device. There is another option. The buyer can use a pharmacy scanner, which must be installed in the pharmacies participating in the project. The system will give the buyer comprehensive information about where, who and when the drug was manufactured.

Kakhaber Bakuradze argues that there should be no problem with the new barcodes. The IT department specialists produced all the required templates a long time ago. This will make it possible to forever forget about counterfeit and gray drugs, the origin of which is unknown. Honest pharmacological businessmen will only benefit from such changes.

Are medicines getting more expensive?

Many are interested in the question of whether these changes will affect ordinary people in a financial sense? According to pharmacological market experts, the changes will not affect the cost of drugs in any way. As they say, the new requirements will be useful to buyers, as well as owners of honest pharmacies that do not use illegal drug sales schemes.

The cost of drugs should not be higher. This is evidenced by the prices of drugs in pharmacies in January. Prices have hardly changed.

List of free medicines for 2017

It is worth noting that there is a specific list of free medicines for 2017 for preferential categories population. However, information about free medicines provided by the attending physician. He himself is obliged to inform the patient. If the doctor ignores his duties, the patient has the right to clarify the information. Information about free medicines is also provided by the insurance company.

By the way, in 2017 the film “The Cure for Health” was released, which vividly illustrates the situation with medicines in our country.

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 prescription or prescription spine that remains with the buyer is indicated exact time this very vacation, in hours and minutes.

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 doing this 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 demands. 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, 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, factory 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/y-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 medicines, 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 subject retail remain (marked "Drug product dispensed") and stored:

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 specified 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 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 pharmaceutical worker is not entitled to provide false or incomplete information about the presence 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 basics 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). What is new here is that this norm first appears in the leave regulations order.

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 “one-time” issue of prescriptions with a two-month expiration date discussed above, as well as vacation ethyl alcohol and alcohol-containing preparations 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 activity - 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 that 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 for delivery 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 transportation and storage immunobiological preparations» (SP 3.3.2.3332-16), which are approved by the Decree of the Main State sanitary doctor RF dated February 17, 2016 No. 19. It obliges a pharmacy employee 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 breaking the primary packaging (blister), and in the second case it is unacceptable, since the primary packaging in this situation is a vial, and it is strictly forbidden to violate it. So count out pills or dragees from a bottle, as they do in some pharmacies foreign countries, our pervostolniki do not have the right.

"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/y-NP dispenses narcotic and psychotropic drugs of Schedule II, with the exception of narcotic and psychotropic drugs in the form of transdermal therapeutic systems.

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, to anabolic steroids(code A14A);
• preparations specified in paragraph 5 of the "Procedure for dispensing individuals medicines containing, in addition to small amounts of narcotic drugs, psychotropic substances and their precursors, other pharmacologically 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 medicines, 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 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 finished products, other drugs related to ATC to antipsychotics(code N05A), anxiolytics (code N05B), sleeping pills 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 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, medicinal leave the pharmacist informs the buyer not only about the mode of 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 if he does not take an interest in whether he is currently taking other medications, then the inspector can “throw off the mask” and draw up an act of 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.