New orders on pharmacy. Prescription pill. What do the new rules for dispensing drugs promise for Russians?

Since the end of September, new rules on release and goods have come into force pharmacy assortment− established by order of the Ministry of Health of the Russian Federation dated July 11, 2017 No. 403n “On approval of the rules for the dispensing of drugs,” which determines the process of dispensing these drugs by Russian pharmacies. It left neither consumers nor pharmacists indifferent, creating a kind of confusion regarding one point or another of the order. In order to clarify compliance with the new rules for dispensing drugs from pharmacies (order 2017) and eliminate gossip and discrepancies, we will formulate a number of popular questions about the new law on dispensing drugs (September 2017) and answer them.

Do the new dispensing rules classify all types of drugs as prescription drugs?

Of course not. The rules for dispensing prescription drugs have been partially updated and apply only to the dispensing of a clearly defined range of drugs. As for popular medications that do not require a prescription, there are no restrictions on dispensing, as before.

And after this order, you can just buy a medicine, although it requires a prescription?

As is known, the over-the-counter supply of medicines that require a doctor's prescription was prohibited. For violations, pharmacy personnel were subject to a hefty fine, and the pharmacy lost its license. However, to be honest, absolute law-abidingness is not observed by all citizens and institutions, not excluding pharmacies. Nevertheless, the adoption of a new law on the dispensing of drugs also has a psychological impact on the unconscious part of our citizens, pharmacy clients. Moreover, pharmacy workers had to become more attentive and strict regarding the prohibited over-the-counter dispensing of drugs.

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

Firstly, whether a prescription is actually required is reflected in the attached instructions for use of any drug.

Secondly, there is no longer any need to rack your brains in despair if you accidentally lost the instructions - visit or call the doctor who prescribed this medication for you. By the way, approximately 70% of all registered Russian drugs have prescription status. Prescriptions are written out on special forms, most often drawn up in accordance with form No. 107-1/u.

Thirdly, you can solve this problem yourself, through the online store of our pharmacy at the address (if you have a computer in the house and know the name of the medicine). If the right drug is marked on our website with the label “dispensing drugs by prescription”, which means that the problem of needing a prescription for it has been solved, but an appointment with a doctor cannot be avoided. If there is no such mark, then over-the-counter dispensing of medicines is allowed.

How do you understand: “The prescription remains at the pharmacy”?

With regard to changes in the rules for the dispensing of drugs according to doctor’s prescriptions, the following is noted here. If medications are included in the list of narcotic or psychotropic drugs that require strict accounting, then prescriptions for them are not returned to the patient and remain in pharmacies to control their sale. Control is carried out by both Roszdravnadzor and the Ministry of Internal Affairs.

According to the new law on the dispensing of drugs (September 2017), this list has been expanded by a number of drugs:

• antidepressants,
• sleeping pills,
• neuroleptics,
• tranquilizers,
• alcohol-containing medications with an alcohol content of more than 15%.

“Alcohol-containing medicines”?.. It turns out that now you need a prescription for valerian or Corvalol?

No. According to the new order, as mentioned above, not all alcohol-containing drugs require a prescription. or no less popular, like a large number of other well-known elixirs and tinctures, has been given the status of over-the-counter medications. The proportion of alcohol in them is small, and, accordingly, in the instructions for use there is no note about the need for a prescription.

So, let’s say that there is a prescription, but several drugs are prescribed at once, and the name of one of them is marked “remains in the pharmacy.” However, at the moment, as a patient, I only need one medicine. Will they take my prescription?

Yes. Exceptions include only annual prescriptions, provided that you do not need all the medications listed at once, but only need one package of one of them. In this case, the pharmacy is deprived of the right to pick up this long-term prescription. The seller will only record the quantity purchased remedy, and will return the recipe.

Is it possible to receive medications if the prescription is written for a recipient other than the patient?

Yes. The dispensing of medicines according to a doctor's prescription is permitted to any holder of a prescription. In fact, all drugs are dispensed without problems - whether it is the patient himself, his relatives, friends or acquaintances. All you need to do is present a prescription.

Only narcotic or psychotropic medications fall under the exception. The prescription for them is written out on a specially designed sheet No. 107/u-NP Pink colour. To receive such drugs in a pharmacy, a power of attorney is required from the patient (including in handwritten form, without notarized confirmation) with a mandatory indication of the date of its preparation and a passport confirming the identity of the recipient.

What else is new in the distribution of medicines and pharmaceutical products?

When selling, pharmacies are now required to stamp “The drug has been dispensed” on prescriptions, so their reuse is excluded. Keep in mind that if you want to refill the same medication, you will need to fill a new prescription.

Regardless of the fact that the drug received has instructions for use, the pharmacy employee is obliged to inform the buyer:

• about how to properly store the medicine;
• about compatibility with others medicines;
• about methods and doses of administration;
• about the availability of cheaper analogues of this medicine in the pharmacy.

This is important!

1. The new order No. 403n canceled the effect of order No. 785, concerning the dispensing of narcotics and psychotropics only by an attached pharmacy. The pharmacy is now obliged to service prescriptions for such drugs prescribed in a clinic in any region of the Russian Federation.
2. According to the new order No. 403n, the standard for dispensing (no more than two packages) of over-the-counter drugs has now been abolished.

Thanks to changes in recommendations and orders of the Ministry of Health Russian Federation, many medications will be available by prescription starting March 1, 2017. The beginning of this year turned out to be stormy for many pharmacy chains, as well as the pharmaceutical industry in general. Some instructions have already entered into force, others will come into force soon. Some orders introduced a moratorium on the work of pharmacists, while others made dispensing prescription drugs significantly more difficult.

What prescription drugs are available as of March 1, 2017?

By order of the Ministry of Health, certain restrictions are introduced on the sale of drugs medicinal purposes. Implementation medical supplies in one hand is carried out in limited quantities. This refers to the trade in syrups and tinctures that contain ethanol in a concentration of at least 15%. Pharmacists can sell no more than two packages per person. The purpose for which they do this is clear to many. Today, not all drugs are bought by people to fight illnesses. This fact is confirmed by the mass poisoning with hawthorn tinctures in Irkutsk, where more than 70 people were injured.

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

Pharmacists are also required to provide their clients with information about the characteristics and contraindications of medications, as well as their shelf life, storage conditions and dosage. Previously, such things were not talked about at all.

Prescription drugs

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

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

Opinion of representatives of the pharmacy business

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

Today, the sale of prescription drugs without availability necessary documents threatens with a fine of up to 50 thousand rubles. Authorities are considering making penalties for selling prescription drugs without a prescription more severe. We are talking about a potential cessation of activity for a period of up to 90 days.

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

Barcode on medical products

In addition, another important innovation comes into force - markings on each medicine. A pilot project of the appropriate type is being launched in several Russian cities. the main objective The measures are to combat counterfeit and counterfeit medical products.

According to preliminary data, this project will help track about six billion packs of medical supplies. On initial stage in March, barcodes will be placed on 60 product items. Including 10 drugs for the treatment of rare ailments, as well as more than 30 types of drugs that have been included in the list of vital prescription drugs since March 2017. It is planned that by the end of this year, automation of the accounting system is considered voluntary. Next year it will be compulsory.

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

Difficulties in using the barcode

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

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

Are medicines becoming more expensive?

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

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

List of free medicines for 2017

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

By the way, in 2017 the film “A Cure for Health” was released, which colorfully illustrates the situation with medications in our country.

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

We've looked at 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 for 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 under strict federal regulations, but pharmacies have not always complied with them.

Previously, you could take one prescription and use it to buy as much medicine as you wanted. Doctors did not indicate the timing, and pharmacists did not pay attention to this. And they could only pick up prescriptions at in rare cases and on dangerous drugs.

No one monitored the dosages of conventional sedatives and did not mark on the prescription how much and when it had already been purchased. And often they didn’t ask for the recipe at all.

Even if you previously bought an antibiotic, a sedative, or medicine for your grandmother without a prescription, this does not mean that the drug is actually on sale. Even common medications are on the prescription list, and purchasing them can now be a problem.

As it is now? Where can I buy medicine?

It depends on whether a prescription is needed and what category the drug belongs to. There are several such categories; it makes no sense to study them all in advance, but you need to keep it in mind.

Narcotic and psychotropic drugs can only be sold by pharmacies with special permission. Immunobiological preparations have their own limitations: for example, a vaccine for inoculating a child can only be purchased at a pharmacy and pharmacy and only if there is a thermal container. There are also differences in the prescription forms.

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

If you need a prescription for a medicine, what should you do?

You need to get this prescription: otherwise the pharmacy will not sell the drug. Even if the medicine is needed urgently or is taken constantly, and there is no time to go to the doctor, it still won’t sell. Maybe in some cities there are pharmacies that manage to circumvent 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 away this prescription if required by the new rules. That is, you will not be able to buy this medicine a second time using the same prescription.

Recipes are also divided into several types. There are recipes for one time, urgent, for free holidays and various others. The prescription may last for several days, months or a year. You can buy a prescription medication only while it lasts. The pharmacy can take it away for good or return it with a note: how much and when it was sold, in what dosage and for how long it will last.

Is it possible to buy in reserve? More antibiotics, painkillers and blood pressure pills.

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

Pharmacists should monitor this. Even if you ask the doctor for a prescription with a reserve, the pharmacy will not sell that much, and they will even report a violation.

How do I know how long a prescription lasts?

Not all prescriptions indicate an expiration date. Some doctors don’t pay attention to this, but pharmacists generally didn’t care: the main thing is that there is a prescription.

Pharmacists must monitor deadlines and report violations if they are discovered.

So now the prescription will be taken away? And will you have to go for a new one every time?

The pharmacy is required to pick up and store prescriptions for some drugs. They are listed in clause 14 of the new rules. Read and check the instructions for your medications. Maybe this is your case.

If you or someone in your family takes these medications regularly, you will need to get a new prescription for each batch. Even if these pills are needed constantly - for example, painkillers for a seriously ill person. Or sleeping pills and sedatives for regular use. The situation is the same with alcohol-containing drugs - the prescription will remain in the pharmacy.

Is it possible to write 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 you need to go to the same pharmacy all the time or get a new prescription every time?

No, such a recipe will not be taken away. Although there are rumors that they are taking it away. Don't believe 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 long-term prescriptions is described in paragraph 10 of the new rules.

When a pharmacy fills a prescription that is valid for a year, the pharmacist must note when and how much of the drug was sold. And the recipe is returned. Next time, the required amount of medicine will be sold for this prescription again: past sales will be taken into account and the mark will be marked again.

Once your prescription expires, you will no longer be able to buy the medicine using it. If the prescription is stored, the pharmacy will pick it up. If you don’t need to store it, they’ll give it away, but you still won’t be able to use it.

What are the rules for selling vaccines?

The vaccine for vaccination will be sold only if the buyer has a thermal container. You cannot deliver it to the clinic in an ordinary bag: the vaccine will spoil and the vaccination will be useless.

You can buy the container directly at the pharmacy. These are additional costs that need to be taken into account: you will have to pay extra or bring your own. You cannot buy the vaccine in advance. Such drugs can be stored for a maximum of two days. If you are going to vaccinate your child with a paid vaccine, keep these restrictions in mind.

By the way, you cannot buy the vaccine without a prescription either. You will first have to get a prescription from the doctor, then buy the drug using it and within 48 hours go to the clinic again - this time for vaccination.

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

With the entry into force of a number of new legal norms, noticeable innovations are appearing in the activities of Russian pharmacies. They concern the most different aspects the work of pharmacists. Let's study them.

What's new in legislation?

From March 1, 2017, Russian pharmacies must operate in accordance with the “Rules of Good Pharmacy Practice” (approved by Order of the Russian Ministry of Health No. 647n, adopted on August 31, 2016). This source of law regulates, in particular:

• requirements for premises for the sale of medicines;
• criteria for selecting drug suppliers;
• checks of pharmacy employees;
• customer service.

For example, with regard to the selection of suppliers, it should be carried out taking into account the business reputation of the business entity, as well as the quality of the goods. This regulatory measure is aimed at improving the assortment of pharmacies, especially in terms of goods in which delays are unacceptable.

​The next innovation is the application of stricter regulations establishing sanctions for the sale of drugs without a prescription. In accordance with them, pharmacies may be inspected more often, they may be fined large sums(up to 200 thousand rubles) and even suspend their activities for 3 months. Similar sanctions are established for violating the rules for storing medicines.

It may also be noted that pharmacists cannot display drugs that are prescription drugs in public display windows. The buyer should not take these drugs without the knowledge of the pharmacy employee.

Previously existing regulations were significantly softer, which allowed many pharmacists to ignore the ban on selling drugs without a prescription. For example, it was possible to easily purchase an antibiotic, a medicine to normalize blood pressure, or cough syrup, although formally they should have been dispensed without a prescription. It was requested mainly when selling custom-made drugs, drugs with strict rules dosage of psychotropic and narcotic medications.

It is worth noting that among experts there are discussions regarding the interpretation of the rules establishing sanctions for the sale of drugs by pharmacies without prescriptions. The fact is that at the level of federal legal acts this sale was prohibited even before the innovations under consideration. In fact, information about the strict restrictions began to spread among pharmacists in the form of rumors.

Representatives of the leading media, who checked the work of pharmacies in practice, were convinced that most of them comply with current standards and refuse to sell drugs without a prescription - however, it has not yet been possible to find out any official details regarding why the sales policy of pharmacies has changed. According to some pharmacists, this is due to the increased frequency of inspection of organizations selling medications. Experts suggest that changes in the policy for selling drugs without prescriptions may be associated with the publication by Roszdravnadzor of internal regulations on tightening control over the activities of pharmacies.

Information about cheap analogues and advice

According to the new rules, the pharmacist must inform the consumer that cheaper analogues of the requested medicine are available for sale. For example, if a person comes for a rather expensive No-Spa, then he should also be offered drotaverine, an analogue that costs several times less. For violating this norm, the pharmacist can be fined 10 thousand rubles, the pharmacy itself - 30 thousand rubles.

Pharmacists also have an obligation to provide advice to consumers. At the same time, it can be carried out in places where the specialist can be asked rather personal questions about taking medications without other visitors hearing the conversation.

At the buyer's request, pharmacists are required to show all available documents for the drug - for example, a certificate, declaration or certificates. The consumer can also request documents certifying the authenticity of the drug.

1. If possible, always obtain a prescription for a particular medicine from your doctor. In some cases, a prescription may be written for sufficient long time- for example, for a year. It is also recommended to assist relatives in obtaining prescriptions in advance.
2. It is advisable to buy medications from the same pharmacies. Pharmacists who know the buyer by sight will sometimes not ask him for a prescription if he does not happen to have one with him.
3. If you can’t get around the formalities, then you need to ask pharmacists for over-the-counter analogues of drugs.
4. Should be checked regularly home first aid kit to identify those drugs that are sold by prescription. If one or another important medications will run out - you need to fill out a prescription for them in advance.
5. You must always be ready to contact paid doctor for a prescription - if it is urgent. To do this, it is useful to study the market of the relevant medical services in the city to know what paid clinics work close to home, as well as which of them provide inexpensive services.

Pharmacy retail: foreign experience

Thus, the legal norms of the Russian Federation regarding the regulation of drug circulation are becoming increasingly strict. But what about this in other countries?

In general, the policy of the Russian legislator corresponds to global trends. Moreover, in some countries the rules may be even stricter: for example, in the USA, a pharmacist has no right to give advice on medications; only a doctor is required to do this. In America, it is not customary to buy medications without a prescription.

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