Orders for the release of medicines. New drug dispensing rules: stop panicking

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We are all used to change. We are no longer so afraid of reports of the next economic crisis, because in our memory there have already been several of them. Innovations in the educational standard of schools and higher educational institutions are not surprising. But the news in the field of health care and access to medicines cannot but cause concern. There are practically no healthy people in the modern world. We all have some kind of chronic disease and are often forced to purchase certain medicines. And when there is information in the news feeds that changes are coming in this process from a certain period, we experience feelings.

From the beginning of 2017, a new order of the Ministry of Health on the rules for dispensing medicinal products from pharmacy chains comes into force. The new order will directly affect every inhabitant.

In particular, a ban is introduced to sell a number of medicines in large quantities in one hand. This restriction is introduced for alcohol-containing tinctures and syrups, the mass fraction of ethyl alcohol in which is above 15%. Now they will be sold in one hand in the amount of no more than two bottles. Namely, with such means, many of us treat our colds at home on our own. We advise you to take care of their availability in advance, since at the peak of the incidence you will often have to visit the pharmacy under the new vacation conditions. The advice is especially relevant, taking into account the long shelf life of the latter.

Fans of online shopping should also listen to the innovations, since any online pharmacy in Moscow will follow them from the new year.

A pleasant change can be called the fact that according to prescriptions, patients with chronic diseases will be able to purchase the necessary medicines for the future. Today it is possible to do this only for the next two months. In this case, documentary evidence of the fact of departure or the impossibility of getting to the pharmacy in the future is required. Since January 2017, this period has been extended to a calendar year.

If the pharmacy does not have drugs from the list of vital and necessary drugs, then it will have to purchase them and provide them for sale no later than a week after the patient's request. Today, this period is prescribed as five calendar days. But if it is necessary for the buyer to take the medicine immediately, which is indicated on the prescription by the doctor's mark “statim”, the pharmacy is obliged to provide this product on the day of the request.

Under the new document, pharmacy workers are prohibited from advising the buyer of more expensive drugs if a cheaper analogue is available. Also, pharmacists will have to give detailed advice about the properties and contraindications of a particular drug, its expiration date, storage methods and doses used. Currently, such information is provided only at the request of the pharmacy employee himself and is not necessarily regulated in any way. Therefore, even when purchasing medicines in an online pharmacy. In 2017, you can count on the professional participation of a specialist in choosing one or another product, on advice on its use and storage.

We can only hope that all these innovations will be implemented and will benefit the interests of pharmacy customers.

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What drugs will be available on prescription from 2017?

In- first, according to the recipes in 2017 In 2016, all the drugs that were dispensed by prescription in 2016 will be dispensed in Russia. No easing is planned in this list, unfortunately for drug buyers.

In Secondly, in Rospotrebnadzor (its head) they made a rather unexpected statement-suggestion that it is very desirable to sell all the drugs that are in pharmacies exclusively by prescription. That is absolutely everything. Maybe, with the exception of those medicines that are necessary for completing all kinds of first-aid kits. Read about it. The Ministry of Health proposes to soften this proposal, and we will see to what extent this softening will take place.

In a word, drug consumers are waiting for, if not a revolution in the dispensing system, then at least a reorganization of the list of prescription drugs in the direction of a clear increase. The list will be replenished with those medicines that are not required urgently, but negatively affect the body during self-medication.

All new medicines containing narcotics are psychotropic. And such funds in the pharmaceutical market are only increasing every year. Alas, people do not solve problems, but for years they accept everything.

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The third group is combined drugs: narcotics, psychotropic substances and their precursors. It was decided to designate this group separately: antibiotics. We are used to prescribing them ourselves, but sometimes there is no other way, especially if you get sick on the weekend. Many send their relatives to the pharmacy for antibiotics.

How it will be in practice, we will see.

Definitely, new tranquilizers and antidepressants will also join the ranks of prescription drugs.

Here are some drugs that will be sold by prescription.

It is sometimes surprising that the drug has remained the same, the same active ingredient, but the packaging is different 3D, and the price is already higher and the prescription may be asked.

Many live completely without drugs! Well done!

Currently, work is underway to compile such a list. Enough time was allocated to the Ministry of Health of the Russian Federation for such work, up to January 31, 2017.

It is already known that the list will definitely include drugs in the prescription form of which the line is indicated:

Presumably, it will be possible to buy without a prescription only thirty percent of the medicines that are presented for sale in pharmacies.

The following list of medicines also goes

Since January 2017, the dispensing of medicines in pharmacies has become more strict. Many medicines that could previously be bought without a doctor's prescription are now simply not sold. Most of these drugs are antibiotics, but there are also conventional painkillers.

In the instructions for these drugs and previously there was a clause "dispensed by prescription." But pharmacies sold them without any prescriptions. Now it is planned to organize unscheduled inspections, which will entail the issuance of fines to those pharmacies where medicines are sold without a prescription.

Another question arises - how should patients receive prescriptions? Everyone knows what queues are at the offices of district therapists. Therefore, now they are actively solving this issue so that the system of "prescription drugs only" will work in full.

Since the beginning of 2017, a list has been posted, which includes a list of drugs that are prohibited from being released without a prescription.

People, now, really cannot live without drugs, and pills, as they help us to increase our lifespan when we are sick.

This year, only those medicines that contain Khlopinin will be dispensed by prescription:

Also on this list is the well-known Valocordin:

And here is a complete list of medicines that will not be given to everyone, but only to those who will have a special piece of paper "prescription" from a doctor:

In 2017, changes took place in the pharmaceutical sector, which are now being actively discussed.

The list of drugs that cannot be purchased without a prescription from a doctor has become longer. It contained drugs with a psychotropic effect, and good old antibiotics. Some indignation was caused by the fact that the cardiac remedy Valocordin was included in this list. Curantyl, so often prescribed for pregnant women, was also there, as well as Nimesil, a well-known painkiller.

Most likely, the list will be replenished with new names.

Since 2017, pharmacies will not be able to sell prescription drugs if instead of an official document with a doctor’s signature and seal there is a “handwritten piece of paper”

Going to the pharmacy for medicines, do not be lazy, open the Internet. Type in the search engine the desired medication and look at the instructions for it. If there is a note “Only by prescription”, it means that without this very prescription, the remedy you need will not be sold.

Medicines are divided into those that can be freely bought at a pharmacy, and those that are dispensed only by prescription. In relation to the latter, from January 1, 2017, the rules for their vacation are being tightened. Under the heading "only by prescription" do not fall medicines that are freely available - on the windows of pharmacies. without problems, you can buy antiviral, many cough and cold medicines, some enzyme and painkillers.

And although the innovation caused a lot of controversy, for pharmacy workers this is by no means news. Order No. 785 "On the procedure for dispensing medicines" has been in force since December 14, 2005. But now the very form of the “doctor's note” is changing.

If before a prescription was considered a banal sheet on which the scribbles of the prescribed medicine were drawn by the doctor’s hand, this “gag” will no longer pass from the new year. A prescription form (form No. 107 / y) is required. With the personal seal of the doctor, the seal of the medical institution, dosage and frequency of use.

Remember, recipes also have an expiration date. Now it is 60 days. For chronic patients, the duration of the prescription may be longer.

So far, the official list of all drugs that must be dispensed strictly by prescription. In January, the Ministry of Health will draw up a list of medicines that will be dispensed only by prescription. In the meantime, they will focus on the instructions for medicines.

State Duma deputies plan to tighten control over pharmacies. For the sale of drugs without a doctor's prescription, even now you can "run into" a fine, but the deputies propose to increase the administrative penalty to 10 thousand rubles. And as a last resort, it is proposed to close the pharmacy for three months.

Since 2017, control over the sale of medicines will be strengthened Is it worth buying medicines? (TV and radio company "Seim")

in recent years, they have had a mania to prohibit everything, limit punishment, etc., all laws are directed at the negative; there is not a single law to give provision to provide an increase in favor of the people, even with authoritarianism you rarely see such a well, well, let's see where this curve leads

Here you go. I've been reading nonsense) Comments about nothing. Why stand in line with a pressure of 180 when there is an ambulance for such a situation. Although, in general, it is supposed to stock up on medicines as soon as they come to an end, and not on the day of the crisis (. Someone wrote about an antibiotic that should always be in the first aid kit Are you sure? And what (read, from what) should be at home? Do you think that one antibiotic cures everything? Nonsense! And they will do the right thing not to sell it. Otherwise, citizens drink "a harmful antibiotic for 2.5 days .. and so most cause its resistance to bacteria (addiction to the drug), the next time it no longer affects the microbe.So we returned to society tuberculosis, which became difficult to select drugs and increased mortality.Afraid of the drug, do not start drinking..it will be completely bad , then the doctor will write out a prescription, And in a difficult situation, you yourself will drink it to the end. And Valocordin is not at all a harmless drug, because it contains Phenobarbital (read on Wiki), but it does not save from death at all. rather from fear)) So, an ambulance and another ambulance if you really feel bad. PS. I ALWAYS take a coupon through the Internet, I have never sat at the office for 3 hours. strictly on time and almost always on time. Doctors are not interested in accepting 35 instead of 15 people. why "get unrealistic"?!

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You give me a paper. Starting from the new year, the sale of medicines without a prescription will be tightened

In recent months, while shopping at a pharmacy, Kursk residents have been hearing from pharmacists a warning that from January 1, 2017, most drugs will be dispensed strictly by prescription. But is this true and what barriers will now be put up for patients?

Whose order?

On June 21, 2016, the State Duma adopted in the first reading the government bill No. 1093620-6 "On Amendments to the Code of Administrative Offenses of the Russian Federation in terms of improving administrative responsibility in the healthcare sector." And in September, at a meeting with Roszdravnadzor of the Russian Federation, it was announced that from January 1, 2017, prescription drugs will be under special control of the department.

“In fact, the order of the Ministry of Health and Social Development of the Russian Federation No. 785 “On the procedure for dispensing medicines” is valid from December 14, 2005. It is he who regulates the procedure for dispensing medicines from pharmacies, regardless of the form of ownership. Therefore, we still fine pharmacies for selling drugs without a prescription, ”explained Lyudmila Ilyukhina, deputy head of the department for licensing, supervision and control in the field of medical and social activities of the regional department of Roszdravnadzor.

Lethal injection. Kursk children are dying from a "harmless" medicine

Recall that 70% of drugs registered in the Russian Federation are dispensed strictly according to prescriptions, and only 30% - without it. But what will change in the new year? Nothing but tougher legislation in terms of control and supervision of pharmacies. Now Roszdravnadzor is constrained by the current legislation and cannot effectively influence pharmacies for violating the quality and safety of medical and pharmaceutical activities. It's just that pharmacists did not always pay attention to these requirements, and the population did not see the problem and did not understand it.

How will they punish?

The current version of the Code of Administrative Offenses does not establish administrative liability for a number of violations in the field of laboratory and clinical practice rules during clinical and preclinical studies of medicinal products for medical use, procedures for the provision of medical care in terms of non-compliance with the mandatory requirements established by them, procedures for conducting medical examinations, examinations and examinations , as well as the procedure for prescribing and prescribing drugs. Therefore, amendments were made to the Code of Administrative Offenses of the Russian Federation (CAO).

The price of health. Do beneficiaries have enough medicines?

The new law proposes completely different fines and penalties for violating the drug trade rules, including over-the-counter dispensing of prescription drugs.

So from January 1, 2017, if the fact of selling a medicine without a prescription is revealed, Roszdravnadzor can fine a pharmacist who violated the law in the amount of 5 to 10 thousand rubles (now - from 1,500 to 3 thousand rubles); the official will have to pay from 20 to 30 thousand rubles (now - from 5 to 10 thousand rubles); legal - from 100 to 150 thousand rubles (now - from 20 to 30 thousand rubles). Closing of a drugstore for 3 months (90 days) can become apogee.

Therefore, you understand, most pharmacies, if not all, will not want to take risks and will work strictly according to the letter of the law.

Blame self-medication

The impetus for the changes was the level of self-treatment of the population, which has recently gone off scale, and sometimes turns into very tragic consequences. Here it is already worth dealing with another problem - the lack of doctors and queues in hospitals that force people to go to the pharmacy and consult a pharmacist, which medicines should be taken for a particular disease.

“But the pharmacy must follow the doctor's recommendation, draw the buyer's attention to the storage conditions and the frequency of administration, no more. And the prescription itself is an appeal from a doctor to a pharmacist, what exactly he should give to the patient, - Ilyukhina notes. - And now it also happens that a person really visited a doctor, but came to the pharmacy not with a prescription written on official letterhead, but with a piece of paper on which the doctor indicated the name of the drug. And on these scraps pharmacists dispense drugs. This whole situation needs to change.”

The level of self-medication may be off scale, but this trend has a logical explanation - how long will a person have to sit in a hospital queue for a prescription? Especially considering that the majority prefer not to go on sick leave with every cold, but to carry it on their feet, since hospital authorities do not favor hospitals, and many of us do not consider sluggish SARS to be a real disease, supporting our immunity with medicines (not even antibiotics) from the nearest pharmacy. But now, before going to the pharmacy, you will have to go on a “crusade” to the hospital and sit there in line, most likely not an hour or two.

Shortage and queues

It is impossible to say right now which drugs will be dispensed only by prescription: a clear list does not exist in fact, it was abolished in 2011, as it was too long and cumbersome. So you will have to focus on the packaging of the drug, which should indicate the name, doses, form of release, manufacturers, expiration date, storage conditions and the release rule - with or without a prescription.

On September 22, new rules for dispensing medicines came into force - Order of the Ministry of Health of the Russian Federation dated July 11, 2017 No. 403n “On approval of the rules for dispensing medicines”, which regulates the sale of medicines in pharmacies. The document caused a lot of noise and confusion among both patients and pharmacy staff. Today we tried to answer the most important questions about the new order that a simple pharmacy visitor may have.

Does the new order make all drugs prescription drugs?

No. The new dispensing rules only slightly change how certain prescription drugs are sold. It does not impose any restrictions on conventional over-the-counter drugs.

And now you can't just buy a prescription drug?

In fact, selling prescription drugs without a prescription has always been illegal. For this, the pharmacy faces a rather big fine and deprivation of the license. But, as everyone knows, the severity of the law is compensated by the optionality of its implementation. Therefore, a number of pharmacies neglect the rules. However, the emergence of new dispensing rules means close attention to their implementation, and therefore, pharmacies are now more reverent about prescription dispensing.

How do you know if you need a prescription for a drug?

Whether the drug is prescription or not - this is stated in the instructions for use. In addition, such information is always indicated on the packaging. Approximately 70% of all drugs registered in Russia are prescription drugs.

In an ideal world, the doctor knows by heart which drugs require a prescription and which do not. But in the harsh reality, very often such information has to be checked independently. Therefore, when a doctor advises you on any medications, you can check them via the Internet right at the appointment and immediately ask for a prescription.

Prescriptions are written only on special forms. The most common is form No. 107-1 / y. It looks like this:

To check if a drug is a prescription, you can go to the site and enter the name of the drug. All prescription drugs on our website are marked "prescription". By the way, not so long ago we had a special label for drugs, the prescription for which remains in the pharmacy.

How is it - "the prescription remains in the pharmacy"?

The pharmacy has a list of drugs that are subject to strict accounting. As a rule, these are medicines containing narcotic or psychotropic substances included in a special list. Prescriptions for such drugs always remain in the pharmacy to control their sale. The turnover of narcotic substances is checked not only by Roszdravnadzor, but also by the structures of the Ministry of Internal Affairs.

But now, according to the new dispensing rules, the pharmacy must also keep prescriptions for certain drugs (antidepressants, tranquilizers, antipsychotics, hypnotics and sedatives, as well as alcohol-containing drugs with an alcohol content of more than 15%) *.

"Alcohol-containing drugs"? So, now you need to get a prescription for Corvalol or valerian?

No. Again, the new order does not make prescription drugs. This applies only to prescription drugs. Corvalol, valerian tincture, and many other popular tinctures and elixirs are available over the counter. Accordingly, no one can require a prescription for them, if this is not stated in the instructions for use.

Okay, let's say I have a prescription, but it contains several drugs, and one of them is marked "remaining in the pharmacy." And I want to buy just one. Will they take my prescription?

Yes. Exceptions are made only for annual prescriptions, provided that you do not buy the entire prescribed amount of the drug at one time (this also requires the permission of the doctor who wrote the prescription).

For example, you are prescribed a course of antidepressants for a year, and you only need to purchase one package. In this case, the pharmacy has no right to take your prescription. The pharmacist only makes a note of how much of the drug you bought and returns the prescription.

Can I get medicine if the prescription is not for me?

Yes. Almost all drugs are dispensed simply to the bearer of the prescription. Both the patient himself and his friend, relative, or just an acquaintance can get the drug in a pharmacy. The main thing is the presence of the recipe.

An exception is made only for narcotic or psychotropic drugs. Prescriptions for such drugs are issued on a special form No. 107 / u-NP. It is easy to distinguish from other recipes because it is pink in color. When receiving such drugs at a pharmacy, you must have a power of attorney to receive medicines and a passport confirming that you are the one to whom the power of attorney was issued.

At the same time, the Ministry of Health emphasizes that the power of attorney can even be handwritten. You can write in it that "I trust such and such drugs to receive such and such medicines according to such and such a prescription to such and such a person." And be sure to indicate the passport data of this person. In addition, the date of its compilation must be indicated in it. Notarization of such a power of attorney is not required.

What else has changed with the new order of drug dispensing?

Now all prescriptions are stamped that "the drug is dispensed." Thus, they cannot be reused. Therefore, if you suddenly need another standard of the drug, you will need to get a new prescription.

Also, the pharmacist is now obliged to inform the buyer about the rules for storing the medicine, its interaction with other drugs, as well as about its method and doses of administration. In addition, a pharmacy employee cannot hide information about the availability of drugs with the same active ingredient, but cheaper. Such a norm existed earlier in the law “On the Fundamentals of Protecting the Health of Citizens” and the Rules of Good Pharmacy Practice, but now it has been duplicated in the order of leave.

* Below is a list of INNs, prescriptions for which, according to the new order, will now remain in the pharmacy. Please note that active ingredients (INN) are listed here, not specific brand names.

INN
agomelatine
asenapine
aminophenylbutyric acid
amisulpride
amitriptyline
aripiprazole
belladonna alkaloids + phenobarbital + ergotamine
bromod
buspirone
venlafaxine
vortioxetine
haloperidol
hydrazinocarbonylmethy
hydroxyzine
dexmedetomidine
doxylamine
duloxetine
zaleplon
ziprasidone
zuclopenthixol
imipramine
quetiapine
clomipramine
lithium carbonate
lurasidone
maprotiline
melatonin
mianserin
milnacipran
mirtazapine
olanzapine
paliperidone
paroxetine
periciazine
perphenazine
pipofezin
pirlindol
podophyllotoxin
promazine
Prudnyak fruit extract
risperidone
sertindole
sertraline
sulpiride
tetra
tiapride
thioridazine
tofisopam
trazodone
trifluoperazine
morpho
fluvoxamine
fluoxetine
flupentixol
fluphenazine
chlorpromazine
chlorprothixene
citalopram
escitalopram
etifoxine

Main photo istockphoto.com

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. Paragraph 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, 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/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 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 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 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 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 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 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 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 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 that remains with the buyer.

You can 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. Paragraph 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 break 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 clause 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 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 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 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:

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 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 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 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-shot” 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. D., 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.

First of all, the innovation threatens with disturbing rumors and panic. If people in advanced Moscow are nervous that soon you won’t be able to buy simple brilliant green without a prescription, then in the regions it’s a real emergency - they buy antibiotics, valocardin, unknown to many reforts, and even Viagra, which, supposedly, are about to disappear from free sale in pharmacies. The list of drugs, now sold only by prescription, has been circulating on the Internet for the second year. It contained drugs with a psychotropic effect, and good old antibiotics. Some indignation was caused by the fact that Valocardin, a cardiac remedy, was also included in this list. Curantyl, so often prescribed for pregnant women, was also there, as well as Nimesil, a well-known pain reliever.It is not clear who compiled this list and from what ceiling it came from, but any user can add “his own prohibited” drug to the initial positions,this makes the horror of horrors even more terrible.

The NI correspondent tried to figure out how it all began and what kind of order the Ministry of Health was, which made life so difficult for already unhealthy Russians.

Rospotrebnadzor has been trying for several years to ban the sale of medicines in Russia without prescriptions. However, if earlier it was only about antibiotics (which, by the way, according to the law, are already considered strictly prescription drugs), then last summer the head of the department, Anna Popova, took the initiative to sell all medicines by prescription in general - even potent, even homeopathic and categorically prohibit the sale of medicines over the Internet.

The position is generally understandable. How else to deal with self-medication, which everyone is fond of today? Moreover, there are no harmless drugs - each has its own side effects, indications and contraindications. And only a doctor can really figure out what a particular patient needs.

By the way, today, if you follow the letter of the law, from 60 to 80% of drugs in our pharmacies must be dispensed by prescription. And you really can’t buy some without it: narcotic analgesics, potent and psychotropic drugs. Their dispensing without a prescription is a serious crime. The share of over-the-counter drugs on the market is very small. However, Rospotrebnadzor was trying to ensure that we could not even buy nasal drops without visiting a doctor.

It could be foreseen that the introduction of prescriptions for all medicines in the face of a shortage of doctors and difficulties with making an appointment would significantly complicate the lives of patients, - Eduard Gavrilov, head of the Foundation, told NI. - According to the Ministry of Health, the shortage of professional therapists in Russia is almost 27%. And the prescription of medicines is, first of all, the burden on these primary care specialists. People with diseases today cannot wait to see a doctor, and if the queue to see him grows due to those who came for a prescription for a simple drug, then paid clinics can celebrate another victory, their clientele will increase.

However, experts do not argue with the fact that the idea of prescription drugs is not inherently bad and even correct. “You need to be treated according to the prescription and under the supervision of a doctor, but now we have a low availability of medical care, and it is impossible to do everything “as it should be”. And when there is no doctor in the state polyclinic, the patient will have to go to a paid one, that is, in fact, “buy” a prescription,” the Health Foundation says. There is another problem: in most cases, patients receive oral prescriptions from doctors at best - the name of the drug is written on a piece of paper. Previously, this filkin's letter was accepted in a pharmacy without asking for either an official prescription or a seal with a doctor's signature. Now the patients are being turned around. One can imagine what - in the literal sense - "going through the throes" turns a patient's trip with a headache or back pain to the clinic. “This creates the prerequisites for the growth of the shadow pharmaceutical sector and entails risks for the health of patients,” Gavrilov notes.

However, the revolution started by Rospotrebnadzor did not die out. In August last year, she was “brought to mind by the Ministry of Health by order No. 647-n. "On Approval of the Rules of Good Pharmacy Practice for Medicinal Products for Medical Use". I must say that this order does not contain any norms, in any way changing the division of drugs into prescription and non-prescription drugs, in principle:In 2017, prescription drugs in Russia will be dispensed with all the drugs that were dispensed in 2016 as well. No easing has been made on this list, but no new strictness has been added either.And in general, the information provided in the document is 90% devoted to the organization of pharmacy activities, the regulation of the work of management and staff, the rules for accepting and storing medicines, and similar technical issues that ordinary buyers do not affect.

It seems that everything, there are no reasons for panic and reasons to urgently stock up on medicines today. Then where do the legs grow from? But from March 1 this year, new rules for the release of prescription drugs and control over compliance with the rules for their sale came into force.Fines for dispensing medicines without a prescription have grown: a pharmacist or pharmacist can now be fined 5,000 to 10,000 rubles. (earlier 1.5-3 thousand rubles), an official - by 20-30 thousand rubles. (earlier 5 - 10 thousand rubles), legal entity - by 100-150 thousand rubles. (earlier 20-30 thousand) or suspend the pharmacy for up to 90 days.

For six months, the regulatory authorities looked closely, warmed up interest in the work of pharmacies, by October some of them got real money, and the hype around prescriptions reached its climax. Consumers, caught between two fires, took the side of pharmacists. Not everyone likes that only a pharmacy is still recognized as a violator; for some reason, Rospotrebnadzor has no complaints against doctors who do not write prescriptions as expected.

Other trends have emerged that may have an impact on the further development of this situation.

The logic of the regulatory authorities is clear, and in general we support the new requirements for pharmaceutical activities. But the devil, as you know, is in the details. We already had a case: the buyer has a severe asthma attack, he knows the name of the medicine and its dosage very well, but at the same time he does not have a prescription with him. The choice in this case is small: either refuse a suffocating person, or break the law. Therefore, in this matter, the most important thing is to do without excesses, ”the director for external communications of PJSC Pharmacy Chain 36.6 told NI.Alexey Kiselev - Romanov.

According to Boris Gorodetsky, an expert at the Vash Provisor service, an increase in fines or the introduction of additional measures, such as suspension or revocation of a license, will have the effect of raising prices for all medical products, the prices of which are not regulated by the state.

“Pharmacists will need to make up for lost revenue from prescription drugs,” he explained. “Pharmacists regularly pay fines but continue to sell over-the-counter prescription drugs as they make up a significant portion of revenue.”

Rostislav Milenkov, marketing director of the Pharm-line pharmacy, believes that the tightening of legislation will not lead to fundamental changes in this matter, since it does not affect the problem of fake prescriptions at all.

Enter the query “buy a recipe” in the search engine - you will see for yourself how many sites with offers will pop up, he advised Novy Izvestia. There are plenty of offers, some, along with a prescription, immediately impose a medicine with home delivery. The price of the issue is tolerable, at least for those who need to get a prescription in a timely manner, and not sit it out in the clinic for weeks.

However, Milenkov warns that a forged prescription is a dangerous business, just like a hand-bought drug. Experts consider the ban on the sale of prescriptions and medicines on the Internet to be a timely and overdue measure, but the devil is again in the details. “Before introducing such norms, it is necessary to answer the following questions: will all patients be able to receive a prescription in a timely manner? For example, if there is already a waiting list for appointments with doctors of certain specialties for compulsory medical insurance for several weeks in advance, is there any understanding of how the burden on the healthcare system (primarily in compulsory medical insurance) will increase with the introduction of such norms and what measures should be taken to avoid this?"

Some experts are in favor of tougher penalties for non-prescription prescription drugs. “In no European country does it exist to independently prescribe treatment for oneself and choose a medicine for oneself on the advice of a pharmacist or on the advice of friends - there is only a doctor’s prescription,” recalls the head physician of the Sfera clinic Erika Eskin . The general director of the pharmaceutical company Apteka+ calls this situation an extremely positive trend.”Alexander Koshkin:“Since the entry into force of Order No. 647 of the Ministry of Health of the Russian Federation, the requirements for the sale of prescription drugs have become tougher ... And, in my opinion, only the patient will benefit from this measure.”

According to market participants, the situation associated with the release of prescription drugs should change for the better due to the expansion of telemedicine capabilities. The burden, both from doctors and pharmacy workers, will be removed by the widespread introduction of electronic prescriptions. These are the main innovations that the pharmacy business is waiting for.

Despite the fact that everyone is calming the agitated consumers and not predicting storms in the pharmaceutical industry, the NI correspondent decided to check what is really happening in the nearest pharmacy from home. I went in and asked for monopril (pills such as high blood pressure). Gave it easy. Already at the exit I looked at the inscription on the box “Vacation from pharmacies by prescription. Use as directed by a doctor. "

Under the current regulations, OTC sale of such drugs is prohibited if there is a record of sale by prescription. It seems that pharmacies are ignoring the rule in order to increase revenue.

What did you just give me without a prescription? - I say to the girl with reproach.

You didn't write it yourself, did you? she answers. - Surely the doctor advised?

Yes, it was 15 years ago...

The girl leafed through some list - it looks like a prescription, from the Ministry of Health. Monoprila was not found.

Not your profile. The list contains only psychotropic and potent drugs. And these harmless ones are from Poland. Drink to your health! This Europe is always reinsured.

Yes, not according to ours there ...

In accordance with the requirements of the legislation on licensing pharmaceutical activities, employees of pharmacy organizations engaged in retail trade in medicines and their dispensing are responsible for compliance with the rules for the circulation of medicines. Pharmacy employees need to know the modern procedure for prescribing medicines and the rules for issuing prescription forms, know the algorithms for conducting a pharmaceutical examination of a prescription in order to avoid errors when dispensing medicines.

About the requirements of the legislation for the preparation of prescription forms for medicines tells Natalia Zolotareva, Candidate of Pharmaceutical Sciences, Associate Professor of the Department of Management and Economics of Pharmacy, St. Petersburg State Chemical and Pharmaceutical Academy.

Decree of the Government of the Russian Federation of December 22, 2011 No. 1081 "Regulations on Licensing Pharmaceutical Activities" is a key document that defines the list of licensing requirements and conditions that the state imposes today on licensees engaged in retail trade in medicinal products for medical use, namely for pharmacy organizations , individual entrepreneurs with a license for pharmaceutical activities.

These licensees must comply with the rules for dispensing medicinal products for medical use without fail. The same document defines the concept of "gross violation of licensing requirements and conditions", which include issues related to the dispensing of medicines. If the established leave rules are violated, the control authorities have the right to regard the identified violations as gross with all the ensuing consequences, ranging from fairly serious penalties and including suspension of the licensee's activities.

WHAT ARE THE VACATION RULES DETERMINED TODAY?

Let's start with legal regulation in order to figure out how to properly accept prescriptions, namely from Federal Law 04/12/10 No. 61-FZ "On the Circulation of Medicines" (Chapter 10 "Pharmaceutical Activities", Article 55), which reads: "The rules for dispensing drugs (MP) for medical use by pharmacy organizations and individual entrepreneurs are approved by the authorized federal executive body." What legislative acts have been approved that regulate the procedure for dispensing medicines?

Federal Law No. 323-FZ "On the Fundamentals of Protecting the Health of Citizens in the Russian Federation";
Federal Law of February 7, 1992 No. 2300-I "On Protection of Consumer Rights";
Decree of the Government of the Russian Federation of 19.01.98 No. 55 "On approval of the rules for the sale of certain types of goods ...";
Order of the Ministry of Health of the Russian Federation of August 31, 2016 No. 647n "On Approval of the Rules for Good Pharmacy Practice of Medicinal Products for Medical Use" (entered into force on March 1, 2017);

and departmental regulations - orders of the Ministry of Health of Russia:

No. 1175n of 2012.12 (entered into force on July 1, 2013), which determines the procedure for prescribing and prescribing drugs, as well as prescription forms;
No. 54n dated 01.08.12 (entered into force on 1 July 2013), dedicated to a special prescription form for a narcotic drug and a psychotropic substance;
No. 785 of December 14, 2005 "On the procedure for dispensing medicines";
No. 157n dated March 16, 2010 "On approval of the maximum allowable amount of a narcotic drug, psychotropic substance and their precursor contained in preparations."

The process of dispensing medicines by prescription involves close interaction between a medical and pharmaceutical worker. The first one is responsible for prescribing the drug subject to the necessary requirements, and the second one must, before dispensing the drug on prescription, conduct its pharmaceutical examination, if necessary, transfer it for manufacturing, then release the drug. The requirement for feedback between pharmaceutical and medical organizations remains important. Literally, the regulatory requirement involves the regular sending of information about all incorrectly written prescriptions to a medical organization. Such feedback, regular and properly established, removes a number of questions about the identified violations in terms of prescription drug dispensing.

FIVE RECIPES FORMS

Two key regulatory documents are directly related to the procedure for prescribing the drug, the forms of the prescription form - this is order No. 1175n and order No. 54n (both came into force on July 1, 2013).

Traditionally valid regulatory documents have determined the forms of prescription forms. To date, there are 5 forms of prescription forms: No. 107-1 / y, 148-1 / y-88, 148-1 / y-04 (l), No. 148-1 / y-06 (l), a special prescription form . From January 1, 2016, by order No. 385n, separate changes were made to the forms of prescription forms 148-1 / y-88, 107-1 / y. But in order to use the stocks of previously purchased prescription forms for their intended purpose, it was allowed to use old-style forms before the entry into force of the order of the Ministry of Health of Russia dated 06/30/15 No. 385n "On Amendments to the Order of the Ministry of Health of the Russian Federation dated August 1, 2012 No. 54n" On approval of the form of prescription forms containing the prescription of narcotic drugs or psychotropic substances, the procedure for their manufacture, distribution, registration, accounting and storage, as well as the rules for registration, "that is, until July 1, 2016. After that, pharmacy workers must demand those forms prescription forms, the structure of which has been changed in accordance with the current regulatory documents.

Order No. 1175n brought a lot of new things to the procedure for prescribing and prescribing drugs. The first place in terms of the importance of innovation can be given to the very paradigm of prescribing drugs. If earlier a health worker could use any name of the drug: INN, grouping or trade, as it was convenient for him, then in connection with the entry into force of this regulatory document, prescribing drugs according to INN is clearly established as a priority. If it is missing, then the grouping name should be used, and in the absence of both names, by trade name.

Specialists with a secondary medical education have appeared in the list of those who have the right to prescribe and write out prescriptions: paramedics, midwives. Only if such powers are assigned to them by the relevant order of the head of the medical organization. Individual entrepreneurs traditionally also have the right to prescribe drugs, write prescriptions, but there are certain restrictions, for example, related to the fact that medical professionals engaged in private medical activities do not have the right to prescribe narcotic and psychotropic drugs from Lists 2 and 3.

If a prescription comes under a trade name, what should be done with it? Can it be rejected, or is it written out correctly? The answer to this question is in the order of the Ministry of Health No. 1175n - the health worker has the right to use the trade name when prescribing in case of individual intolerance and / or for health reasons, but this decision must be confirmed by the medical commission, as evidenced by the corresponding stamp on the back of the prescription.

DIFFERENCES FOR RECIPES FORMS

What is the difference between these forms of prescription forms and how to correctly issue them to health workers in order to prevent incorrect pharmaceutical examination at the pharmacy?

√ Special prescription form(the most difficult one is in terms of the composition of the details, the structure, although from the point of view of its use there is only one case when a health worker can and should use this form). This form of strict accounting has several degrees of protection and is intended for prescribing narcotic and psychotropic drugs from List 2 of the List approved by Decree of the Government of the Russian Federation of March 21, 2011 No. 181 "On the procedure for importing into the Russian Federation and exporting from the Russian Federation narcotic drugs, psychotropic substances and their precursors" (for example, morphine, promedol, prosedol, etc.). List 2 is updated regularly. Working with Schedule 2 and 3 narcotic drugs requires a separate license, unlike working with potent poisonous drugs.

All prescription forms differ in terms of purpose of use, structure, composition of details, validity period and shelf life.

The current regulatory documents require that in the event that a narcotic drug or psychotropic substance is prescribed for privileged categories of citizens, in addition to a special prescription form, it is necessary to provide forms 148-1 / y-04 (l), No. 148-1 / y-06 (l) . The special prescription form has undergone changes - it has become larger, and from June 30, 2015, the validity period of this prescription form has also been significantly increased - from 5 to 15 days from the date of issue. The stamp of the medical organization must be clearly legible (its name, address and telephone number). The form of the form has a series, number, date of issue of the prescription, an indication of "child" or "adult" (underlined); Full name of the patient, age (number of full years (children under one year - number of months), series and number of the compulsory medical insurance policy, number of the outpatient medical record. In Latin, according to INN, indicating the dosage, packaging and quantity, the corresponding drug is indicated. Only in In this form of the prescription form, the number of prescribed psychotropic and narcotic drugs from Schedule 2 must be indicated not only in numbers, but also in words.

All this is certified by the personal signature of the doctor, as well as the personal seal of the health worker. This form must indicate the full name of the authorized person, which may be the head or deputy head of the medical organization, structural unit, or an appointed authorized person who certifies these forms (full name, signature). It is additionally certified by the seal of the medical organization or the seal for prescriptions. Further, in the prescription form, there is a mark of the pharmacy organization on the release of the medicinal product. If the pharmacy worker is satisfied with everything in the design of the prescription form, he indicates what is dispensed, dosage, packaging. It is certified by the full name (in full), the date of issue and the seal of the pharmacy organization.

√ Prescription form 148-1/u-88- the form of which is simpler in terms of the composition of the details, but if we talk about the purposes of the form, we get 5 options for use.

Narcotic and psychotropic drugs from Schedule 2, but in the form of transdermal therapeutic systems, i.e. any other dosage form of a narcotic drug or psychotropic substance included in Schedule 2 must be written out on a special prescription form. Traditionally, this form is used to prescribe and prescribe psychotropic drugs from Schedule 3.
Other drugs subject to quantitative accounting, but there is an addition - with the exception of drugs sold without a doctor's prescription.
For prescribing drugs with anabolic activity (anabolic steroids).
Also, since 2012, the procedure for dispensing combined preparations containing small amounts of narcotic and psychotropic substances and their precursors, as well as other pharmacologically active substances, has changed. We are talking about combinations that are indicated in clause 5 of the order of the Ministry of Health of Russia dated May 17, 2012 No. 562 “On approval of the Procedure for dispensing to individuals drugs for medical use containing, in addition to small amounts of narcotic drugs, psychotropic substances and their precursors, other pharmacological active substances” .
When prescribing individually manufactured medicinal products that contain narcotic drugs and psychotropic substances from Schedule 2 of the List of Decree No. 681, provided that the content of narcotic and psychotropic drugs in these combined drugs does not exceed the highest single dose, and the drug itself is not included in List 2.

This form is valid for 15 days. Since August 2016, either the full address of the patient with an index or the number of the patient's medical record is indicated on the prescription form.

√ Prescription Form 107-1/y- the simplest form of a prescription form. At the same time, the regulatory documents indicate the following: this form should be used to prescribe and prescribe combined drugs containing small doses of narcotic, psychotropic substances, their precursors and other pharmacologically active substances, but those combinations that are indicated in paragraph 4 of the order of the Ministry of Health of Russia No. 562 .

The form must contain the stamp of the medical organization, name (in full), address, phone number, date, indication of "adult" or "child", the patient's full name (in full), his age, the name of the doctor (in full), the name of the drug in Latin according to INN with indication of dosage, packing and dosage.

Up to three drug names can be written on this prescription form (unlike other forms, where only one name can be indicated). Personal signature and seal of the doctor on the form. Valid up to 60 days. For chronic patients, an extension up to 1 year is possible.

MAJOR VIOLATIONS IN PRECISING

The St. Petersburg State Chemical-Pharmaceutical Academy conducted a study during which the prescriptions placed in the journal of incorrectly written prescriptions were analyzed. Sometimes health workers do not indicate the expiration date of the prescription, incorrectly fill out the “full address” requisite, the name of the doctor and patient is not fully indicated, the stamps are not clearly readable, the details regarding the age of the patient are incorrectly filled out, there are no notes from the medical commission, when the prescription is issued under the trade name, there are extra seals and inscriptions, exceed the norm of LP release.

The last one is a common mistake. The current regulations set the maximum allowable dispensing rates and the recommended amount per prescription. But any rule allows an exception, it is marked by order No. 1175n (clause 15, clause 22, clause 23), which makes it possible to legally exceed the established norms for the release of medicines.

Based on materials from an online seminar organized by the St. Petersburg Union of Doctors