New drug dispensing law. The procedure for dispensing medicines

On September 22, new rules for the sale of medicines in pharmacies came into force. Buy Now the right drug may be difficult or impossible. Pharmacies require prescriptions and even store them. And the medicine may not be sold to relatives at all: they will ask for a power of attorney.

We have reviewed the new rules and will explain how they work. The order of the Ministry of Health is complex and incomprehensible even for pharmacists, so clarifications have already been issued to it. We also studied them.

As it was before?

Prescription drugs have always had to be sold by prescription. Each category has its own sales and accounting rules. Such drugs are marketed subject to strict federal requirements, but pharmacies have not always complied with them.

It used to be possible to take one prescription and buy as many medicines as you like with it. Doctors did not indicate the terms, and pharmacists did not pay attention to it. And they could take away prescriptions only in rare cases and for dangerous drugs.

No one followed the dosages of conventional sedatives and did not note on the prescription how much and when it was already bought. And often the recipe was not asked at all.

Even if you used to buy an antibiotic, sedative or medicine for your grandmother without a prescription, this does not mean that the drug is really on sale. Even common drugs are on the prescription list, and buying them can now be a problem.

As it is now? Where can I buy medicines?

It depends on whether a prescription is needed and what category the drug belongs to. There are several such categories, it is pointless to study them all in advance, but you need to keep in mind.

Narcotic and psychotropic drugs can only be sold by licensed pharmacies. its limitations for immunobiological preparations: for example, a vaccine for vaccination of a child can only be bought at a pharmacy and pharmacy, and only if there is a thermal container. There are also differences in prescription forms.

If your doctor has prescribed a prescription drug, it is best to find out in advance where you can buy it. And do not be surprised if some pharmacies do not sell the drug. This is not their whim, but the requirement of the law.

If a prescription is needed for a medicine, what should I do?

You need to get this prescription: otherwise the pharmacy will not sell the drug. Even if the medicine is needed urgently or it is taken constantly, and there is no time to go to the doctor, it still will not sell. Maybe in some cities there are pharmacies that manage to get around the rules, but it’s better not to count on this: the law is the law.

If you need a prescription for a medicine, you will have to present it at the pharmacy. And the pharmacy has the right to take this prescription if it is required by the new rules. That is, the second time to buy this medicine according to the same prescription will not work.

Recipes are also divided into several types. There are recipes for one time, urgent, for a free vacation and various others. The prescription may be valid for several days, months or a year. You can buy a prescription drug only while it is valid. The pharmacy can take it away permanently or return it with a note: how much and when sold, in what dosage and for how long this is enough.

Can I buy a spare? More antibiotics, painkillers and blood pressure pills.

No, you won't be able to buy in reserve now. According to the rules, the prescription will sell as much of the drug as prescribed by the doctor.

This should be monitored by pharmacists. Even if you ask the doctor for a prescription with a margin, the pharmacy will not sell that much, and even report a violation.

How do you know how long a prescription is valid?

Not all prescriptions have an expiration date. Some doctors do not pay attention to this, but pharmacists generally did not care: the main thing is that the prescription is.

Pharmacists must keep track of deadlines and report irregularities if they are found.

It turns out, now the recipe will be taken away? And you have to go for a new one every time?

Pharmacies must collect and store prescriptions for certain drugs. They are listed in paragraph 14 of the new rules. Read and check the medication instructions. Suddenly this is your case.

If you or someone in your family regularly takes these medicines, you will have to go for a new prescription for each batch. Even if these pills are needed all the time - for example, painkillers for a seriously ill person. Or sleeping pills and sedatives for regular intake. The same situation with alcohol-containing drugs - the prescription will remain in the pharmacy.

Is it possible to write out a prescription not for one time, but for a long period, the doctor decides and checks the pharmacies.

If the prescription is issued for a year, will it also be taken away? Will I have to go to the same pharmacy all the time or get a new prescription every time?

No, this recipe will not be taken away. Although there are rumors that they are being taken away. Do not believe the rumors - read the law. They can pick it up only if the prescription was issued before September 22, and then the sales rules for this drug changed.

How to deal with prescriptions for a long time is written in paragraph 10 of the new rules.

When a pharmacy sells a prescription drug that is valid for a year, the pharmacist must note when and how much the drug was sold. And the prescription is returned. The next time, this prescription will be sold again in the right amount of the medicine: past sales will be taken into account and again put a mark.

When the prescription expires, you will no longer be able to buy the medicine with it. If the prescription is to be kept, the pharmacy will collect it. If you don’t need to store it, they will give it away, but you still won’t be able to use it.

What are the rules for the sale of vaccines?

The vaccine for vaccination will be sold only if the buyer has a thermal container. It is impossible to deliver it to the clinic in an ordinary bag: the vaccine will deteriorate and the vaccine will be useless.

You can buy a container directly at the pharmacy. These are additional costs that you need to consider: you will have to pay extra or go with your own. You cannot buy a vaccine in advance. You can store such drugs for a maximum of two days. If you are going to vaccinate your child with a paid vaccine, consider these restrictions.

By the way, you can’t buy a vaccine without a prescription either. You will first have to take a prescription from a doctor, then buy a drug on it and get back to the clinic within 48 hours - already for vaccination.

Sometimes it’s easier to sign up for a paid clinic: they will conduct an examination there, give a referral and do all the procedures at once. Or agree to free vaccination cheap vaccine from the state.

Since 2017, control over the dispensing of prescription drugs from pharmacies has been strengthened. At the same time, there is currently no official list of all drugs that must be dispensed strictly by prescription. Everything is controlled by Roszdravnadzor.

Mikhail Khaustov

Pharmacists themselves should focus primarily on instructions for medicines, where there are indications for sale with or without a prescription. As a result, antibiotics, antiviral drugs, modern tranquilizers and antidepressants, as well as “harmless”, according to many consumers, drugs fell into disgrace. Everything is controlled by Roszdravnadzor.

1 What really happened?

Order "On the procedure for vacation medicines” has been operating in the Altai Territory for more than 10 years.

But since January 1, 2017, Roszdravnadzor, in connection with changes to the law "On the Protection of Consumer Rights", conducts test purchases in pharmacies and severely fines those who sell any of these drugs without a prescription. this is due to changes in the federal. Now any citizen or legal entity can complain that a prescription drug was freely sold to him in a pharmacy.

2 Why are consumers dissatisfied?

People are especially dissatisfied with the fact that now it will be difficult to buy popular painkillers, such as Nise, Nimesil and Ketanov (prescription drug).

3 Why were the restrictions introduced?

The official explanation for the tightening of requirements for dispensing medicines is as follows: the level of self-treatment of citizens is extremely high, and uncontrolled reception a number of drugs leads to sad consequences for health.

This is especially true of the ability to freely purchase potent drugs, including antibiotics. Taking them without the supervision of specialists undermines the immune system and leads to a decrease in the effect of drug treatment generally.

4 Are pharmacies ready?

The Ministry of Health of the Altai Territory assured that in all state medical institutions currently have the required stock various forms prescription forms, and doctors are ready to prescribe and prescribe drugs.

Cold, flu.

5 Will there be concessions?

• for chronic patients, it is allowed to set the validity of the prescription up to one year, that is, the doctor does not have to go to the doctor every month for a new prescription. But this is if the course of the disease does not change. However, usually these people are already regularly observed by specialists;
• contraceptives: first you have to go to the gynecologist, but the doctor can write a prescription for a quarter or even a year, indicating the frequency of his leave.

6 What drugs should be sold by prescription only?

• antibiotics;
• neuroleptics;
• psychotropic substances;
• ampoule and hormonal (contraceptives and other) preparations;
• agents for the regulation of blood pressure.

Cold, flu. Medicines.

7 What can be bought without a prescription?

All drugs for the treatment of transient diseases are antiviral and antipyretic.

There is no complete official list of drugs that must be sold strictly by prescription.

8 How to understand: by prescription or not?

If the pharmacy refused to sell you the drug, citing the lack of a prescription, then you can immediately double-check the information. Just ask your pharmacist to give you a prescription for the medicine or look it up on the internet.

In the instructions for each medicine there is a line "Rules for dispensing from pharmacies" and then it is indicated: "by prescription" or "without". That's all.

9 What should be on the prescription?

• data about the patient (surname, initials and address of residence);
• surname of the doctor;
• two seals are put - a doctor and medical institution;
• name of the medicinal product according to INN (international non-proprietary name, not according to trade name);
• in one recipe there can be up to three items with an indication of the frequency of their sale: month, quarter or year.
• Prescriptions are required to be accepted at any pharmacy in any locality, while personal documents do not need to be presented.

10 How many medicines are sold without a prescription?

Only 30% of drugs registered in the Russian Federation can be sold without a prescription. The use of the rest requires control by the attending physician and presentation prescription form at the time of buying.

On June 21, 2016, the State Duma adopted in the first reading government bill No. 1093620-6 “On Amendments to the Code Russian Federation on administrative offenses 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, medicines prescription will be under the special control of the department.

“Actually, the order of the Ministry of Health and social development Russian Federation No. 785 “On the procedure for dispensing medicines” is effective 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 medicines 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.

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 when conducting clinical and preclinical studies of drugs for medical use, order of rendering medical care in terms of non-compliance with the mandatory requirements established by them, the procedures for conducting medical examinations, examinations and examinations, as well as the procedure for prescribing and prescribing medicines. Therefore, amendments were made to the Code of Administrative Offenses of the Russian Federation (CAO).

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 in recent times goes 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 the doctor's appeal to the 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 prefers 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 a sluggish SARS a real illness, supporting your 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 in line there, 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.

By the way, a similar “innovation” was introduced on the territory of Crimea in June. But this was more likely due to the widespread sale of near-narcotic drugs, which was widespread even when Crimea was part of Ukraine. Using the peninsula as an example, it can be assumed that from January 1, 2017, it will not be possible to buy blood pressure relievers, stimulants, such as caffeine, drugs with a narcotic effect (any codeine-containing pain reliever) in a pharmacy without a prescription, hormonal preparations, antihistamines, causing drowsiness. By the way, prescriptions for most drugs have long term- three months.

Of course, it makes no sense to panic and stock up on drugs on an industrial scale, but it’s worth reconsidering your home first aid kit and replenish it with some drugs of paramount importance. After all, the New Year holidays are coming, during which it will be possible to see a doctor only by calling an ambulance. And judging by the fact that the Office of Rospotrebnadzor in the Kursk region predicted the peak incidence of SARS precisely for the New Year holidays, the number of people who want to see a doctor and receive a cherished prescription from him will increase dramatically.

IP and IBLP

In general, in order No. 403n, the topic of IBLP leave is spelled out separately, which is not in order No. 785. It will be regulated by paragraph 13 of the first of the mentioned acts. This paragraph, in particular, determines that when the IBLP is dispensed, the prescription or prescription spine that remains with the buyer is indicated exact time this very vacation, in hours and minutes.

Violation of the secondary

With the entry into force of Order No. 403n, new accents will appear on the topic of the possibility of violating the secondary (consumer) packaging of medicines. The norm of the "retiring" order No. 785 allows 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 demands. 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 specified in the prescription or required by the consumer (in case of over-the-counter dispensing) less quantity 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, according to Form No. 107/u-NP, narcotic and psychotropic drugs of Schedule II are dispensed, with the exception of narcotic and psychotropic drugs in the form of transdermal therapeutic systems.

The rest of the 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 of December 20, 2012 No. 1175n “On approval of the procedure for prescribing and prescribing drugs, as well as forms of prescription forms ...”, prescriptions written out on the forms of this form are valid for two months from the date of issuance. However, for patients with chronic diseases it is allowed to set the validity period of the prescription form No. 107-1 / y up to one year and exceed the recommended amount of the drug for prescribing per prescription, installed by the application No. 2 of this order.

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

The prescription remains in the pharmacy

There are some changes on the topic indicated in the title of this chapter. Paragraph 14 of the new order establishes that the subject retail remain (marked "Drug product dispensed") and stored:

within 5 years prescriptions for:

within 3 years prescriptions for:

within 3 months recipes for:

The order of the Ministry of Health of Russia No. 403n did not do without a cherry on the cake, however, a dubious one. In paragraph 15 of the order, it is written that prescriptions that are not 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 theme of the fight against the abuse of alcohol-containing drugs pharmacy assortment, which was recently trumpeted by the media, was also reflected in the new order on the rules of leave. According to the current procedure, prescriptions for such drugs are returned to the patient (with a stamp "released"); under the new order, they must remain in pharmacy organization.

To not get caught

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

Clause 17 of Order No. 403n contains a rule that a pharmacist is not entitled to provide false or incomplete information about the presence of medicines in the assortment of a pharmacy facility - including drugs that have the same INN - and also hide information about the presence of drugs that have more than low price. Similar provisions are contained in subparagraph 2.4 of article 74 of the Law of November 21, 2011 No. 323-FZ “On the 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 “one-time” issue of prescriptions with a two-month expiration date discussed above, as well as vacation ethyl alcohol and alcohol-containing preparations in the light of the provisions of the new order No. 403n.

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

What could be more important for a pharmacy organization than the order in which drugs are dispensed. As soon as the pharmacists had time to return from their summer vacation and look around, a new order of the Ministry of Health of the Russian Federation dated July 11, 2017 No. 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". New order 403n, with amendments and additions, recognizes as invalid the well-known order of the Ministry of Health and Social Development dated December 14, 2005 No. 785 “On the procedure for dispensing medicines”, as well as the orders of the Ministry of Health and Social Development No. 302, No. 109 and No. 521 that amended it. -of a legal act, they repeat - sometimes almost verbatim - the corresponding fragments of the predecessor order. But there are also differences, new provisions, on which we will focus to a greater extent, setting out the first observations and notes in the margins of the freshly baked order of the Ministry of Health No. 403n.

IP and IBLP

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

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

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

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

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 for delivery this drug to a medical organization, despite the fact that it can be stored in the mentioned container for no more than 48 hours.

Recall in this regard that this topic is also regulated by subparagraph 8.11.5 of the Sanitary and Epidemiological Rules "Conditions for 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, to anabolic steroids(code A14A);
• preparations specified in paragraph 5 of the "Procedure for dispensing individuals medicinal products containing, in addition to small amounts of narcotic drugs, psychotropic substances and their precursors, other pharmacological active substances"(Order of the Ministry of Health and Social Development of the Russian Federation dated May 17, 2012 No. 562n);
• preparations manufactured according to a prescription for a medicinal product and containing a narcotic drug or psychotropic substance included in Schedule II, and other pharmacologically active substances in a dose not exceeding the highest single dose, and provided that the combination medicinal product is not a Schedule II narcotic or psychotropic medicinal product.

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 of 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));
• combination medicines containing drugs or psychotropic substances included in Schedules II and III, manufactured in a pharmacy organization, drugs with anabolic activity, drugs subject to PKU;

within 3 months recipes for:

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

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

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

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

To not get caught

The order of vacation with incorrectly written prescriptions is now described in a little more detail (paragraph 15 of order No. 403n). In particular, when they are registered by a pharmacist in the journal, it is necessary to indicate the identified violations in the preparation of the prescription, the 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, medicinal leave the pharmacist informs the buyer not only about the mode of administration and doses, but also about the rules for storage at home and interaction with other drugs.

Theoretically, this means the following. The pharmaceutical inspector can approach the first table in the guise of an ordinary buyer - so to speak, make a test purchase. And if the primate, dispensing the medicine, does not inform him, for example, that this medicine must be stored at a temperature not exceeding 25 ° C, or if he does not ask if he is currently taking other medications, 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. in Economics, Associate Professor, Department of Management and Economics of Pharmacy, North-Western State medical university(St. Petersburg), dedicated, and on October 25, Executive Director of the "National Pharmaceutical Chamber" Elena Nevolina on the same topic. Register for both webinars.

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

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, allegedly, 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 cardiac remedies Valocardin. 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 - everyone has their 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 the simplest 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 state polyclinic, the patient will have to go to the paid one, that is, actually “buy” a prescription, ”says the Health Foundation. 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. It can be imagined in what literally- "going through the throes" turns into a trip of a patient 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 do not affect ordinary buyers.

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. (before 1.5-3 thousand rubles), executive- for 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 affect further development 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 violent attack asthma, 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, ”said the Director for External Communications of PJSC“ NI ” Pharmacy chain 36.6"Alexey Kiselev - Romanov.

According to Boris Gorodetsky, an expert of 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 the entire medical products, prices for 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. "Not one European country self-appointment there is no treatment for oneself and choosing a medicine for oneself on the advice of a pharmacist or on the advice of friends - there is only a doctor’s prescription, ”reminds chief physician clinics "Sphere" 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 in better side by expanding the possibilities of telemedicine. 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 prescribed 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 reproachfully.

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 ...