Medicines containing alcohol will be sold without restrictions in quantity. This follows from the order of the Ministry of Health, which was registered by the Ministry of Justice.

Previously, the draft document included a rule allowing the sale of tinctures in two bottles per person, but it was not included in the final version. Experts attribute the refusal of restrictions to the fact that alcohol-containing medicines are already not popular among the population: sales fell by 12% over the last year alone.

The Ministry of Justice did not approve the Ministry of Health’s regulation on limiting the dispensing of drugs containing alcohol from pharmacies. This follows from the final version of the document, which came into force on September 22, writes iz.ru.

The ministries did not provide Izvestia with prompt comments on the reasons for abandoning the initially proposed norm, and the Ministry of Health did not report its future plans in this matter.

Director of the National Institute of Medical Law Yulia Pavlova noted that all departmental acts are registered with the Ministry of Justice before entering into force.

Department specialists verify all lines of the document, check legal norms and their compliance with Russian legislation. If a document is returned and not registered, it means that it either contradicts higher acts or was drawn up in violation of legal rules, the lawyer explained.

Director of the Institute of Public Health Development Yuri Krestinsky noted the negative dynamics of sales of tinctures.

Even if there are no restrictions on the dispensing of alcohol-containing drugs from pharmacies, they will still not buy more of them than now. Every year over the past five years, demand for them has fallen. They are almost never used for other purposes,” the specialist said.

According to the analytical agency DSM Group, the average price of drugs containing alcohol in the first half of this year increased by 25% compared to the same period in 2016. Revenue from their sales increased by only 10%. This is explained by a drop in demand for such products: the number of packages purchased decreased by 12%. By the beginning of July 2017, the average price of a bottle had risen to 25 rubles; by the end of the second quarter of last year it was 19.5 rubles. Motherwort has increased in price the most - by 44.6%.

The general director of one of the clinic chains, Vladimir Gurdus, believes that the Ministry of Health has chosen a course to curb the use of alcohol-containing medications for other purposes. Therefore, even without the restriction norm, the department will cope with “pharmacy alcoholism.”

After such attention to this problem, even without documented norms, psychological restrictions will apply. Even pharmacies have already adapted to the stated rules. In addition, there were other restrictive measures. In any case, the problem will be completely solved, the expert is sure.

In March, after the mass poisoning of people in Irkutsk with the Hawthorn bath concentrate, Deputy Prime Minister Alexander Khloponin ordered the development of methods to protect the population from the use of surrogates. The Ministry of Health proposed two initiatives: to limit the volume of containers of tinctures and to prohibit the sale of more than two bottles of alcohol-containing preparations to one buyer. The Ministry of Justice registered the order on the first norm in the spring.

The government does not plan to ban over-the-counter drugs, said Russian Deputy Prime Minister Alexander Khloponin. “There is no goal to complicate access to these drugs for citizens,” he told reporters. Meanwhile, earlier the Deputy Prime Minister himself spoke about the dispensing of alcohol-containing medicinal tinctures strictly according to prescription and even indicated the date of innovation - the second quarter of 2017.

After the mass poisoning with Hawthorn in Irkutsk, some pharmacies, according to testimonies from customers, began to use drugs that may be of interest to alcoholics. And not only tinctures, but also valocordin, iodine and brilliant green. Correspondent Sergei Gololobov went to check the capital's pharmacies to find out if this is so.

To find out whether it has really recently become problematic to purchase drugs containing alcohol, I decided to visit three pharmacies in one microdistrict. In the first of them, however, there was no valocordin, but its analogue, “Valoserdin,” is available for free sale.

Pharmacist: We have a domestic drug called Valoserdin.

Corr.: On alcohol?

Pharmacist: Yes, they all contain alcohol. "Valoserdin", 25 milliliters, costs 66 rubles. Drunks don’t come to us, we have a pharmacy, you know? And drunks are not interested in drugs. They drink something else. This is a medicine. For that kind of money, drunks won't drink anything. Because these are still drugs. Not lotions, not some kind of cosmetic liquids.

Corr.: And iodine, brilliant green - is everything on sale?

Pharmacist: We have everything at the moment: iodine and brilliant green - please!

The second pharmacy also has everything, but they sell drugs only by prescription. In addition, the supply of alcohol-containing medications is limited:

Pharmacist: Currently, the supply of alcohol-containing medications is limited for a month. I don’t know what will happen next.

Corr.: What does "limited" mean?

Pharmacist: It is advisable that eitherwasa prescription or statement from a doctor for these medications.

Corr.: And if I really want it, will you sell it?

Pharmacist: No. That is, if you really want to, go to the doctor. Firstly, it already states that it contains phenobarbital, so even if you really want it, I still won’t sell it to you.

Corr.: Can iodine and brilliant green also be subject to restrictions?

Pharmacist: They are not suitable for oral administration, as a cosmetic product is. I think they are unlikely to get there.

And finally, the third pharmacy is the strictest. No recipes, no “up to two bottles in one hand” - down with all alcohol-containing products. The ban on sales is explained by a certain decree of the chief sanitary doctor:

Pharmacist: Now the order, you know, came out like this, from today. The 195th resolution states that the ban will last for 30 days. Please feel free to read it.

Corr.: And what does it include?

Pharmacist: It doesn't say what's included. It says about all alcohol-containing products containing more than 25% alcohol. And with us everything fits this. Even iodine with brilliant green. Do you understand?

Corr.: But can I still buy greens and iodine or is that no longer possible?

Pharmacist: From today - no. The resolution has arrived - that's it.

Corr.: Is Valocordin included?

Pharmacist: Everything is included. Valocordin, "Valoserdin", Corvalol - all alcohol-containing tinctures that are for oral administration.

The restrictions have been introduced for a month. That is, until the end of January. What will happen next, none of the pharmacists know: they have not yet received any circulars. They do not believe in the introduction of prescription sales of iodine and brilliant green, because alcoholics do not drink them. Well, the prospects for selling Valocordin, as well as all other alcoholic medicinal tinctures according to prescriptions, are treated with understanding.

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Sales of alcohol-containing medicines in pharmacies have fallen. Since the end of last year, in physical terms they have decreased by 26.5%, and revenue decreased by 28%. The decline in sales is due to the lack of goods on the shelves of pharmacies, caused, in turn, by a decrease in the production of alcohol-containing drugs after the introduction of the Unified State Automated Information System for pharmaceutical manufacturers.

The head of the Association of Russian Pharmaceutical Manufacturers, Viktor Dmitriev, told Izvestia that drug manufacturers began to produce fewer alcohol-containing drugs. And pharmacies, in turn, are purchasing less due to the introduction of restrictions on the sale of alcohol-containing drugs.

The decline in retail sales is confirmed by data from the analytical agency DSM group. If in December 2016, 33.2 million packages of alcohol-containing medicines were sold for 2.6 billion rubles, then in February 2017 - only 24.5 million packages for 1.8 billion rubles.

Sales of Valocordin dropped the most. In January 2017, they decreased by 35% compared to December and continued to fall in February, when the drop was 55%. In February, only 302.5 thousand packages were sold for 65.6 million rubles. For comparison: in December last year, 660.6 thousand packages were sold for 1.5 billion rubles. According to DSM group, Valocordin is the only alcohol-containing medicine for which the price has steadily fallen: from 222.5 rubles in December last year to 216.8 rubles in February 2017.

Sales of hawthorn and valerian tinctures have also decreased. In February of this year, pharmacies sold 40% less hawthorn than in December last year. In December 2016, revenue from the sale of hawthorn amounted to 30.3 million rubles for 1.6 million vials. A sharp decline in physical sales was observed in January - by 42.5% - from 1.5 million packages to 900 thousand.

The decline in sales of valerian amounted to 39% in physical and monetary terms. It also started in January and continued into February. At the end of last year, pharmacies sold 2 million packages and earned 42 million rubles, and in February 2017 - 29.9 million rubles for 1.5 million packages.

The decline in sales affected the least amount of green stuff. They began to buy less by only 9% in monetary terms: from 20 million to 18.3 million rubles; and by 12% in physical terms - from 861 thousand packs to 764 thousand. Note that the average cost of a bottle of brilliant green has increased by 3.5% since the end of last year.

Sales of calendula (by 31% in volume terms), Corvalol (by 34%), and iodine (by 40%) also decreased.

The head of the Association of Russian Pharmaceutical Manufacturers, Viktor Dmitriev, explained that the decline in sales was due to a drop in the production of alcohol-containing drugs.

Our companies (as part of the association - Izvestia) do not produce alcohol-containing preparations at all. Such tinctures are a thing of the past. After the state “tightened the screws” on all alcohol markets: alcoholic, pharmaceutical, and perfumery, it became unprofitable, said Viktor Dmitriev.

After the mass poisoning of people with the Hawthorn bath concentrate, which occurred in Irkutsk before the New Year, the government limited the sale of alcohol-containing preparations to two bottles per person, and also limited the container volume to 25 ml.

Manufacturers of pharmaceutical alcohol, in turn, note that the reason for the decrease in the production of alcohol-containing preparations may also be the connection of medical alcohol to the EGAIS system from January 1, 2017. This makes it difficult to certify alcohol, and therefore to send it to drug manufacturers. In addition, due to innovations, additional financial costs have appeared.

In order to equip one plant with EGAIS meters, 3 million rubles are required. Due to the EGAIS system, problems with certification arose. Now after production and before receiving the certificate, at least 3-4 weeks must pass. Because of this, many factories have an excess of alcohol in their warehouses. And as a result, there is a shortage of alcohol-containing products in pharmacies,” said Vladimir Cherny, a representative of RFK CJSC.

As Izvestia previously reported, over the past year alcohol-containing medicines have risen in price significantly - the price increase ranged from 5.5 to 45.5%. Manufacturers also explained this by the extension of the EGAIS system to medical products.

Order of the Ministry of Health of Russia No. 403 n dated July 11, 2017 “On approval of the rules for dispensing medications...” continues to raise many questions among pharmacy workers. We are publishing explanations of some provisions of this order, which were given in the online magazine “Katren Style” by the executive director of the Association “Pharmacy Guild” and the National Chamber of Pharmaceuticals, Elena Nevolina.

Article from the newspaper "LekOboz"

Wrong prescription! Release the drug?

If the drug is a narcotic, then despite all the sympathy and desire to help the patient, criminal liability may arise. So it's not worth it. And if we are talking about the “regular” form 107, then, of course, you can let it go. In this case, an incorrectly completed recipe must be entered into the journal.

How can a pharmacy justify dispensing drugs based on an incorrectly filled prescription for those checking?

Information about incorrectly completed prescriptions should be recorded in a journal, and such information should be conveyed to the heads of medical organizations. By the way, the chief physician can also give feedback to the pharmacy and say that, for example, it is better not to dispense drugs for such and such prescriptions. Such cases have happened.

In case of inspections, a log of incorrectly completed prescriptions will help pharmacies. If it is filled out correctly, indicating all the details, as well as with notes that measures have been taken to work with medical institutions, then the inspectors, even from the prosecutor’s office, should not have any questions.

But again, it is worth noting that the number of drugs dispensed for such prescriptions will play an important role here. If the difference between the number of prescriptions and dispensed drugs is large, then the journal will most likely not help.

The recipe is for three packages, but the visitor wants to buy one. What to do?

Such a prescription is issued with a stamp “medicine dispensed” along with an indication of the amount of the drug. The recipe is back.

What if the patient presents a prescription that also contains three medications. He wants to purchase only one thing, but this drug falls under clause 14 of the new order, i.e. the prescription for it must be kept in the pharmacy for three months. Should a pharmacy pick up such a prescription if the other two drugs have not yet been dispensed?

If the pharmacy cannot fully fill the visitor's prescription, then such a prescription should be issued with a stamp that the medicine has been dispensed, and the prescription should be returned. Otherwise, the patient will not receive proper medication. And the pharmacy that completely “closes” the prescription can keep it.

In the case of inspectors, everything depends on the specific case. If a pharmacy dispensed 50 packs without a prescription and argues that the prescriptions were for a year, most likely, such an excuse will not be accepted. It will be difficult to prove anything here. And if 3–5 such drugs were dispensed, then the inspectors can always explain the situation. Namely, that it was a prescription for which the pharmacy could not fully serve the patient, or a prescription was issued with a validity period of 1 year or 2 months.

Doctors write only the trade name!

This is a violation only if the prescription is preferential. If the prescription is full price, then we must serve that prescription. If the doctor wrote such a prescription, then most likely he explained to the patient the need to use this particular drug.

What liability measures are provided for medical institutions for incorrectly written prescriptions? Does Roszdravnadzor control this issue?

Roszdravnadzor will monitor this issue. In parallel with the tightening of requirements for the rules for dispensing drugs, the doctor’s responsibility for writing a prescription is now being introduced. Now a doctor can be financially punished for not issuing a prescription or for filling it out incorrectly. Therefore, it is very important for pharmacists to keep a log of “incorrect prescriptions” and enter information there with whom exactly the conversation was held in the medical organization. Roszdravnadzor, having looked at such a journal, can use data from it as a basis for inspecting a medical organization.

What measures should a pharmacist take regarding an incorrectly completed prescription if the patient is from another city or region?

Here it is worth looking at what drug is prescribed. It is clear that there is little point in contacting another region. But depending on the drug, it may not make sense to dispense it with the wrong prescription. In any case, calling such a medical organization will not be superfluous. Contacts must be in the stamp.

In the prescription, the drug is prescribed by trade name. Where can I find a note in the prescription that it was written out by decision of a medical commission?

Order of the Ministry of Health No. 1175 n dated December 20, 2012 lists all the requirements for filling out a prescription. Among other things, there is a description of prescriptions issued by decision of a medical commission. If this is not a preferential form, then there should be no reason not to dispense the medicine.

If a prescription is written out on form 148, but should be on form 107, is dispensing a violation?

Such a prescription must be recorded in the journal as incorrectly filled out, but the medicine must be dispensed. Because the 148th is conditionally “higher” than the 107th.

Is it considered a violation if the stamp on the 148th prescription does not indicate the telephone number of the medical organization? What if there are extra stamps on the recipe?

If there is no telephone number, then there must be at least an address and still a telephone number, if not of the organization, then of the doctor who wrote the prescription. Regarding the extra stamps: if this is a recipe 107 NP, then this is a serious violation. We record other forms in the journal and dispense the drug.

Is it possible to dispense a drug according to a prescription in which the words “for a special purpose” or “for a chronic patient” are written abbreviated, i.e., not in full?

If the seals are present and signed by a medical worker, then you can release them. But again, put such a recipe in the “wrong” magazine.

Are there standards for dispensing alcohol-containing tinctures (valerian, hawthorn)? What regulations currently regulate this?

There are no vacation standards. We dispense as much as is written in the prescription or as much as the visitor requests if the drug is over-the-counter. This applies not only to alcohol-containing drugs, but also to other over-the-counter drugs.

What about potassium permanganate? No vacation standards!

It’s simple here - as much as they ask, we release as much.

How to properly dispense lidocaine aerosol?

An aerosol is, in accordance with the State Pharmacopoeia, an “independent” dosage form. This is not a “liquid dosage form”.

Do I need to leave a prescription for chloramphenicol at the pharmacy for three months? Are there vacation restrictions?

If it is 1% alcohol, then this drug is over-the-counter, therefore, we sell it as much as the buyer needs. There are no vacation norms in the order.

There are always instructions in the instructions. By studying GRLS, we did not find dosage forms that should be dispensed with a doctor's prescription.

If the prescription is 60 days or 1 year, then mark it and return it. How can you confirm your vacation then?

By Order 403 n we do not have to confirm this in any way. The Ministry of Health does not indicate that this is necessary.

What to do after storing recipes for three months? If we destroy, then by what form of act?

After three months of storage they are destroyed. The act is approved by the head of the organization independently. We enter all the necessary details into it to show that such a recipe has really been destroyed.

Is violation of secondary packaging allowed during retail sales?

At the visitor's request is permissible. He may ask, for example, to split the drug because he is unable to buy the drug for economic reasons.

Is it possible to dismantle drugs if they are on the Vital and Essential Drugs list?

The norm of the order does not establish any restrictions in terms of violation of secondary packaging. The only requirement is that the price per unit of supply does not exceed the total cost recorded in the register plus the retail markup. The most important thing here is that when dividing a package, its cost can only be rounded down.

What logs should be kept when secondary packaging is broken?

There is no need to keep a laboratory packaging register if the secondary packaging is damaged. This norm has been abolished. Instructions for use or a copy thereof must be attached to the drug.

When on leave, should I indicate the employee's full name or initials?

The pharmacist can only indicate the surname and initials.

Prescription 107 NP: is it necessary to attach photocopies of the patient’s and recipient’s passports to the power of attorney?

A power of attorney note is placed on the back of the form when leaving. The order itself does not impose any requirements for storing powers of attorney or their copies.

What should a pharmacist do if the prescription must remain in the pharmacy, but the patient needs it to submit a claim?

It's in another order. More specifically, in the order of the Ministry of Health No. 1175 n dated 12/20/12. According to it, the patient is issued a prescription with a copy for reimbursement.

Please comment on the dispensing of immunobiological drugs in a special container.

The Ministry of Health responded in clarification that a thermos can be used for transportation. It is also necessary to notify the patient about the peculiarities of transportation and storage. If a visitor refuses a thermal package, and you find out that this will disrupt the temperature regime during transportation, then you can refuse to dispense such a drug.

How can you comment on the ban on the dispensing of immunobiological drugs for individual entrepreneurs in the new dispensing procedure?

The leave procedure must comply with legal requirements. Unfortunately, the law “On Immunoprophylaxis of Infectious Diseases” (No. 157 Federal Law of September 17, 1998) does not mention individual entrepreneurs. However, if you look at the SanPiN for the transportation and storage of immunobiological medicinal products (No. 19 of 02/17/16), then there is already an indication of IP in the cold chain.

Can the defect journal be kept in electronic form?

Can. This is established by order of the head of the organization.

How to confirm the patient's consent to a different dosage?

There is no such requirement in the order.

Can recipe printing be round or triangular?

This is again order No. 1175 n. If there are no requirements for the form of printing, then the pharmacist has nothing to demand.

How to correctly draw up the reverse side of preferential prescriptions?

Considering that the benefit is attached to a specific pharmacy, you do not need to indicate all the details here, except for those that are variable. For example, a trade name that was actually released.

Important documents:

• DECISION of May 27, 2019 No. 667 ON AMENDMENTS TO THE DECREE OF THE GOVERNMENT OF THE RUSSIAN FEDERATION OF DECEMBER 29, 2007 N 964 From December 1, 2019, Pregabalin, Tapentodol and Tropicamide are included in the List of potent substances.
• LETTER dated May 20, 2019 No. 1127/25-4 About new forms of prescription forms for drugs The Ministry of Health clarified some issues regarding the registration of prescriptions for drugs Director of the Department of Drug Supply and Regulation of Medical Products E.A. MAKSIMKINA
• LETTER dated May 20, 2019 No. 01i-1269/19 ABOUT COMPLIANCE WITH APPLICABLE LEGISLATION Roszdravnadzor explains the procedure for the participation of medical and pharmacy organizations in the drug monitoring system and provides "INSTRUCTIONS FOR CONNECTING MEDICAL ORGANIZATIONS AND PHARMACIES TO THE INFORMATION SYSTEM FOR MONITORING THE MOVEMENT OF MEDICINES"
  

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