What drugs will be sold by prescription. Special Purpose Recipe

The Ministry of Health has published clarifications on the order approving the new list of medicines subject to subject-quantitative accounting. Despite the fact that it has been in effect for almost a month - since August 16, it is on the part of pharmacy workers who do not know how to work with the new list.

The new list consists of three sections:

1. First includes pharmaceutical substances and drugs that are considered in Russia as narcotic, psychotropic substances and their precursors. They, as before, are subject to subject-quantitative accounting.

Accounting for drugs such as diethyl ether (at a concentration of 45% or more) and potassium permanganate (at a concentration of 45% or more) when handling up to 10 kg per month is carried out according to "simplified" requirements (an entry in the registration log on the total number of dispensed, of sold, purchased or used substances is made on a monthly basis, and documentary confirmation of each transaction is not required), ”the Ministry of Health writes.

That is, potassium permanganate in powder, as explained by the department, 3, 5 or 15 grams, as before, is sold without a doctor's prescription, but is subject to accounting as a precursor of narcotic and psychotropic substances.

2. Second This section includes preparations and substances considered to be highly toxic substances. Ointments, creams and gels containing bee and snake venom and 1-testosterone are excluded from accounting. But testosterone preparations for internal use were banned: "Testosterone propionate" (solution for intramuscular injection), "Andriol TK" (capsules), "Nebido" (solution for intramuscular injection), "Sustanon-250" (solution for intramuscular injection), "Omnadren-250" (solution for intramuscular introductions).

The Ministry of Health reports that drugs are subject to registration as the only active substance and calls them - Slimia (capsules), Meridia (capsules), Goldline (capsules) and Lindaxa (capsules). At the same time (capsules) are not subject to quantitative accounting, since they contain a combination of active substances: sibutramine + microcrystalline cellulose, and therefore do not apply to potent substances.

Only medicines containing the amount of belladonna alkaloids as the only active ingredient are subject to strict accounting. That is rectal suppositories "Beauty extract" and tablets "Bellataminal" not subject to accounting, according to the Ministry of Health.

He was included in the list of strict accounting and ethanol, which means that the drug in its pure form is subject to subject-quantitative accounting.

3. In the third section includes combined preparations. Subject-quantitative accounting, as the Ministry of Health explains, is subject to:

• Medicines containing codeine "Caffetin", "Codelac", "Solpadein" (effervescent tablets), "Terpinkod", "Unispaz" and others), in which the amount of codeine exceeds 20 mg in 1 tablet;
• Medicines containing pseudoephedrine from 30 to 60 mg per tablet - "Rinasek";
• Medicines containing up to and including 200 mg dextromethorphan hydrobromide per 100 ml/100 g liquid dosage form (syrups Glycodin, Coldrex Night, Tussin Plus, Terasil-D);
• Preparations containing up to 75 mg inclusive of phenylpropanolamine in one tablet ( "Dietrin", "Koldakt", "Contact") or up to 300 mg of substance per 100 ml/100 g of syrup ( "Triaminic");
• Medicines containing up to and including 20 mg of phenobarbital with codeine, regardless of the amount per dose of medicine ( "Pentalgin Plus", "Pentalgin-N", "Piralgin", "Sedalgin-Neo", "Sedal-M", "tetralgin" and others);
• Medicines containing up to 20 mg of phenobarbital with ephedrine hydrochloride, regardless of the amount per dose of medicine ( "Neo-Teofedrin", "Teofedrin-N").

Wherein NOT The following medicines are subject to quantitative accounting: "Nurofen Stopkold", "Kaffetin Cold", "Toff Plus", "Bellataminal", "Amiksid", "Kofetamine"- they are dispensed according to "regular" prescriptions of form No. 107-1 / y. WITHOUT prescription drugs are sold "Grippeks", "Gripend", "Alex Plus" (lozenges), "Andipal".

Dr. Peter

We continue to reveal the secrets of the order of the Ministry of Health No. 403n "On approval of the rules for dispensing medicines ...".

Today, the questions of our readers - pharmacists and pharmacists - are answered by Executive Director of the Association of Pharmacy Institutions "SoyuzPharma" Dmitry Tselousov.

I would like to know about the norms for the release of ethyl alcohol in its pure form for external use. In what weight units should it be released now?

The Ministry of Health tried to regulate the issue of dispensing alcohol-containing medicines.

Orders of the Ministry of Health No. 47n dated February 8, 2017 and No. 979n dated December 21, 2016, which are designed to limit the volume of containers of alcohol-containing drugs, do not apply to pure ethyl alcohol, since these orders indicate drugs in the form of tinctures containing alcohol.

Paragraph 23 of Order No. 403n of the Ministry of Health refers to the dispensing of alcohol specifically for external use, since it is hardly possible for a patient to use pure alcohol otherwise. However, this paragraph does not take into account the possibility of packaging alcohol for external use in industrial pharmacies.

What to do with the maximum allowable norms for dispensing medicines? Sometimes a patient comes with a prescription where they are exceeded...

The prescription should contain a note from the doctor why the patient needs more medicine than prescribed. This applies not only to the maximum allowable rate, but also to the recommended number of drugs per prescription.

If there are no such explanations, the pharmacy worker dispenses medicines within the maximum allowable norm or recommended amount. This must be noted in the recipe. It is necessary to warn the patient and the medical organization about exceeding the norm.

There is a subtle point here: according to the order of the Ministry of Health No. 1175n "On approval of the procedure for prescribing and prescribing drugs ...", such a prescription is invalid, and medicine cannot be dispensed according to an invalid prescription - this is indicated by the same order No. 1175n (if the drug is potent, the pharmacist and pharmacist generally subject to criminal liability).

From the point of view that if we are talking about the usual form 107, you can release the drug and it is enough just to record violations of the prescription in the journal, I do not agree. And I would like to warn experts that the inspectors may also disagree with this. However, Order No. 403n still allows medicines to be dispensed if the excess of the maximum allowable norm and the recommended amount in the prescription is not justified.

By order of the Ministry of Health and Social Development No. 785 of December 14, 2005, which has become invalid, the pharmacy has a stamp “The medicine has been dispensed”. In accordance with order No. 403n, there should be another stamp - "The drug is released." Does the stamp need to be redone?

The meaning of the inscriptions "Medicine dispensed" and "Medicine dispensed" is identical, so the stamp should not be changed.

According to paragraph 16 of Order No. 403n, a pharmaceutical worker informs the person purchasing the drug about the interaction with other drugs. How to do this if the patient is already taking some medications prescribed to him earlier (sometimes he cannot even remember their names)?

Of course, the pharmaceutical worker cannot know what the patient is taking. And the patient himself will not always remember the ornate names of his drugs. In this regard, I believe that advice on drug interactions should be based solely on the instructions for the purchased product.

Patients choose pharmacy organizations for specialists who can competently provide pharmaceutical consulting services. In part, this information is mastered during training within the framework of the course of pharmaceutical chemistry, and in part it is learned at trainings during training from manufacturing companies. In this case, the pharmaceutical specialist is guided solely by the knowledge base that he has managed to accumulate during his work activity.

- What about the release of immunobiological preparations?

In accordance with clause 8.11.5. “Conditions for the transportation and storage of immunobiological medicinal products”, approved by the Decree of the Chief State Sanitary Doctor of the Russian Federation of February 17, 2016 No. 19 “On approval of the sanitary and epidemiological rules SP 3.3.2.3332-16” (registered with the Ministry of Justice of Russia on April 28, 2016 No. 41968), vacation It is allowed to carry out immunobiological medicinal products in retail sales provided that they are delivered to the place of their direct use in a thermal container or thermos in compliance with the requirements of the cold chain. That is, the retail sale of immunobiological preparations is allowed subject to the cold chain - this means that if a pharmacy wanted to sell immunobiological preparations, it was obliged to provide the buyer with a thermal container. The ordinance is still in effect. But now, in accordance with order 403n, the drug is dispensed if the visitor has a thermal container.

Is this condition feasible, because a sick person is not required to understand the categories of medicines? And is it worth interpreting it as the right of a pharmacy to refuse a vacation?

Apparently, the pharmacy organization will look for ways to provide the patient with such a container, or at least with cold elements. For example, dry ice packs.

- Will the patient have to pay for the thermal container?

Of course, the patient is obliged to pay for the thermal container, because he must have it in stock.

Expired prescription drugs may not be filled unless the prescription expired while the prescription was on deferred maintenance. In such a situation, the release of the drug is carried out without reissuing the prescription. But often, due to procurement and supply problems, drugs reach pharmacies already when both the prescription that was on deferred maintenance has expired and the deferred maintenance period (10 or 15 days) has also expired. Is it possible to release the remedy according to such a prescription without reissuing the document?

Indeed, in accordance with paragraph 6 of Order No. 403n of the Ministry of Health, it is prohibited to dispense medicines on expired prescriptions, except for the case when the prescription expired while it was on deferred maintenance.

I would also like to draw attention to an issue that remains unresolved. What to do with the minimum assortment if it has a persistent defect? Order No. 403n retains the old norm from Order No. 785 - a drug from the minimum range must be dispensed within five days. But this period does not save the pharmacy. If the check recorded the absence of a drug, a fine is still issued. The jurisprudence is very extensive…

With the entry into force of a number of new legal norms, noticeable innovations appear in the activities of Russian pharmacies. They relate to various 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 Ministry of Health of Russia 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 choice of suppliers, it should be carried out taking into account the business reputation of an 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 more stringent regulations that establish sanctions for the sale of medicines without a prescription. In accordance with them, pharmacies can be checked more often, they can be fined for large sums (up to 200 thousand rubles) and even suspend their activities for 3 months. Similar sanctions are established for violating the rules for storing medicines.

It can also be noted that pharmacists cannot display drugs that are prescription drugs in open access on display windows. The customer must not take these drugs without the knowledge of the pharmacy staff.

Previous regulations were significantly lenient, allowing many pharmacists to ignore the ban on the sale of medicines without a prescription. For example, it was possible to easily purchase an antibiotic, a medicine to normalize blood pressure, cough syrup, although they formally had to be dispensed without a prescription. It was requested mainly in the sale of 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 that establish sanctions for the sale of medicines 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 severe 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 the current regulations and refuse to sell medicines without a prescription - however, it has not yet been possible to find out any official details regarding the reason for the change in pharmacy sales policy. According to some pharmacists, this is due to the increased frequency of inspections of organizations that sell medicines. As experts suggest, changes in the policy of selling medicines without prescriptions may be associated with the publication by Roszdravnadzor of internal regulations on tightening control over the activities of pharmacies.

Informing about cheap analogues and consulting

Under the new rules, the pharmacist must inform the consumer that cheaper analogues of the requested medicine are available on the market. For example, if a person came for a rather expensive No-Shpa, then he should also be offered drotaverine, an analogue that costs several times cheaper. For violation of this norm, a pharmacist can be fined 10 thousand rubles, the pharmacy itself - 30 thousand rubles.

The obligation of pharmacists is also to advise the consumer. At the same time, it can be carried out in places where a specialist can be asked quite personal questions about taking medications so that other visitors do not hear the conversation.

At the request of the buyer, pharmacists are required to show all available documents for the drug - for example, a certificate, declaration or certificates. Also, the consumer can request documents proving the authenticity of the drug.

1. If possible, always get a prescription for a particular medicine from your doctor. In some cases, a prescription can be written for a fairly long time - for example, for a year. It is also recommended to assist relatives in obtaining prescriptions in advance.
2. It is advisable to buy medicines in the same pharmacies. Pharmacists who know the buyer by sight will sometimes not ask him for a prescription if he accidentally does not happen to be 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 first aid kit to identify those medicines that are sold by prescription. If certain important medicines run out, it is necessary to issue a prescription for them in advance.
5. You should always be ready to go to a paid doctor for a prescription - if it's 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 ones provide services inexpensively.

Pharmacy retail: foreign experience

Thus, the norms of the legislation of the Russian Federation in terms of regulating the circulation of medicines are becoming more and more stringent. But how is this the case in other countries?

In general, the policy of the Russian legislator corresponds to global trends. Moreover, in some states, the rules may be even stricter: for example, in the United States, a pharmacist is not entitled to give advice on medicines, only a doctor is obliged to do this. In America, buying drugs without a prescription is not accepted.

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

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 that 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 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 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 assortment, 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 name of the health worker who issued it, the name of the medical organization in which he works, and 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). 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 summer vacation and look around, a new order of the Ministry of Health of the Russian Federation dated July 11, 2017 No. 403n was published with annexes “On approval of the rules for dispensing drugs for medical use, including immunobiological drugs, by pharmacy organizations, individual entrepreneurs with pharmaceutical license. 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". The 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 made changes to it. 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 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 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 leave to the patient who presented the prescription to the head of state, on which, say, 28 tablets or 42 tablets (drops) 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, 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"

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 as anabolic steroids (code A14A);
• preparations specified in paragraph 5 of the "Procedure for the sale of medicinal products to individuals 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 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 specified 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:

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

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, 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 first-timer, dispensing the medicine, does not inform him, for example, that this medicine must be stored at a temperature not exceeding 25 ° C, or does not ask if he is currently taking 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 period, 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. n., Associate Professor of the 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.

Dear residents and guests of Krasnoyarsk and the Krasnoyarsk Territory!

Since March 1, 2017 pharmacies work in accordance with the order of the Ministry of Health of the Russian Federation of August 31, 2016 N 647n "ON APPROVAL OF THE RULES OF GOOD PHARMACY PRACTICE FOR MEDICINES FOR MEDICAL USE" and the order of the Ministry of Health and Social Development of the Russian Federation No. 785 "On the procedure for dispensing medicines"

The law states that all medicines, with the exception of those included in List of medicines available without a doctor's prescription should only be dispensed by prescription.

Many patients have already experienced these innovations in their real life. Having fallen ill with a viral infection, they could not buy antibiotics for treatment. Currently, a consultation with a general practitioner is required to prescribe the correct treatment and prescribe an antibiotic strictly according to the prescription.

This list is quite large and includes funds from almost all drug groups. Not all medicines will be sold by prescription, but only those that are in a special list published on the website of the Ministry of Health. This list will be updated every year.

Available for prescription only:

LIST OF MEDICINES SUPPLIED ON THE PRECIPATIONS OF A DOCTOR (PARADICTHER) WHEN PROVIDING ADDITIONAL FREE MEDICAL ASSISTANCE TO CERTAIN CATEGORIES OF CITIZENS WHO HAVE THE RIGHT TO RECEIVE STATE SOCIAL ASSISTANCE

I. Anticholinesterase agents

II. Opioid analgesics and mixed action analgesics

III. Non-narcotic analgesics and non-steroidal anti-inflammatory drugs

IV. Means for the treatment of gout

V. Other anti-inflammatory drugs

VI. Means for the treatment of allergic reactions

VII. Anticonvulsants

VIII. Remedies for the treatment of parkinsonism

IX. Anxiolytics

X. Antipsychotics

XI. Antidepressants and normothymic drugs

XII. Means for the treatment of sleep disorders

XIII. Other drugs affecting the central nervous system

XIV. Means used in narcology

XV. Means for the prevention and treatment of infections

Antibiotic

Synthetic antibacterial agents

Anti-tuberculosis drugs

XVI. Antivirals

XVII. Antifungals

XIX. Antineoplastic, immunosuppressive and concomitant drugs

Cytostatic and immunosuppressive agents

Hormones and antihormones for the treatment of tumors

Concomitant drugs for the treatment of tumors

XX. Means for the treatment of osteoporosis

XXI. Means that affect hematopoiesis, the coagulation system

XXII. Drugs affecting the cardiovascular system

Antianginal agents

Antihypertensive drugs

Medicines for the treatment of heart failure

XXIII. Drugs that affect the functions of the organs of the gastrointestinal tract

Means for the treatment of diseases accompanied by erosive and ulcerative processes in the esophagus, stomach, duodenum

Antispasmodics

Laxatives

Antidiarrheals

pancreatic enzymes

Hepatoprotectors

Cholagogue

XXIV. Hormones and drugs that affect the endocrine system

Non-sex hormones, synthetic substances and antihormones

Anabolic steroid

Means for the treatment of diabetes

sex hormones

Gestagens

Androgens

Estrogens

XXV. Means for the treatment of prostate adenoma

XXVI. Means affecting the respiratory system

XXVII. Means used in ophthalmology

XXVIII. Medications affecting the uterus

XXIX. Vitamins and minerals

XXX. Antiseptics and disinfectants

XXXI. Other funds

The list of drugs that are freely dispensed includes some antipyretic and antiviral, sorbents for the stomach, dietary supplements, iodine, brilliant green, hydrogen peroxide.

The new rules for dispensing prescription drugs should discourage people from self-medicating.

A prescription issued by a doctor will be valid for two months - 60 days or 1 year.

If pharmacists do not comply with the order for selling prescription drugs without appropriate documents, they face a fine of up to 50 thousand rubles. More severe penalties may be imposed for selling prescription drugs without a prescription, up to and including suspension of activities for up to 90 days.