Antihistamines are sold without a prescription article. List of medicines dispensed to the population. We wonder why antibiotics don't work

Sooner or later, a modern person is faced with the need to purchase antidepressant drugs used in complex treatment for a depressed emotional state. Antidepressants are “called upon” to serve a person to elevate mood, create a positive emotional background, and ultimately.

When is a doctor's prescription required for antidepressants?

The dosage and daily regimen of medication is prescribed, of course, by the doctor. Only a qualified specialist will be able to assess the true state of your psyche, accurately calculate and schedule the dosage of medications. Compliance with the prescription when treating depression is one of the components of success in the fight against depression.

A prescription for purchasing antidepressant drugs is required only in the following cases:

exacerbation of the disease;
treatment of the most severe forms of depression;
with an atypical form of the disease.

In this situation, the doctor prescribes monoamine oxidase inhibitors (MAOIs). These are potent antidepressant drugs that are used when other types are ineffective or have severe side effects.

The most effective in treating severe forms of depression are moclobemide, phenelzine, isocarboxazid and tranylcypromine.

Phenelzine, isocarboxazid and tranylcypromine are time-tested drugs, but have been used since the 50s of the 20th century and have many side effects. Moclobemide is a new generation medicine, with a faster effect and fewer associated negative reactions.

Mild antidepressants of a new generation. What's special?

A mild form of depression can be “corrected” with the help of drugs for which pharmacies do not require a prescription. New generation antidepressants, as a rule, do not cause as much harm to the body as drugs produced in the last century. Modern “over-the-counter” antidepressants are fundamentally different from heavy medications and drugs of the older generation.

Advantages of modern antidepressants:

faster effect on the body and elimination of depression;
fewer side effects;
possibility of simultaneous use with many other medications;
absence of significant addiction to the action of the drug.

Based on the effect the drugs have on a person’s mental state, antidepressants are distinguished between stimulating and sedative properties.

It is very important to accurately determine the nature of the disease and the subsequent correct choice of antidepressant medication (to stimulate or inhibit the central nervous system). The time and effectiveness of treatment largely depends on this.

List of mild antidepressants available without prescription (15 drugs)

Over-the-counter antidepressants are divided into different groups according to the degree and type of their effect. Let us list the main groups and the drugs included in them. Let's start the list by listing stimulant antidepressants.

1. Maprotiline

Drug name: Maprotiline.

Analogues: Ludiomil, Ladiomil, Flexyx.

Indications: endogenous, involutional, psychogenic and neurotic depression, exhaustion, somatogenic, latent, menopausal depression.

Action: reducing apathy, improving mood, relieving psychomotor retardation.

Side effects: headache, lethargy, drowsiness, hearing loss, hallucinations, tachycardia, arrhythmia, vomiting, nausea, dry mouth, urticaria, swelling, weight gain, sexual disorders, stomatitis.

Contraindications: epileptic disease, kidney disease, liver disease, pregnancy.

2. Prozac

Drug name: Prozac.

Analogues: Fluoxetine, Prodel, Profluzac, Fluval.

Indications: depression, bulimia nervosa, obsessive-compulsive disorder (obsessive thoughts and actions).

Action:

relieves emotional overload and obsessive thoughts;
will alleviate anorexia nervosa;
eliminates premenstrual disorders;
reduce anxiety and panic.

Side effects: at the beginning of treatment and when the dose is increased - anxiety, drowsiness, headache, nausea. Rarely – convulsions. Possible skin rashes, pain in muscles, joints, fever

Contraindications: hypersensitivity, pregnancy, lactation.

3. Paxil

Drug name: Paxil.

Analogues: Rexetine, Adepress, Actaparoxetine, Plizil, Paroxetine hydrochloride hemihydride, Sirestill.

Indications: depression of all types in adults and children 7-17 years old.

Action: in the first weeks of use, symptoms of depression decrease and suicidal thoughts are eliminated. Prevents relapses of depression.

Side effects: drowsiness, insomnia, loss of appetite, tachycardia, nausea, constipation, seizures, sweating.

Contraindications: hypersensitivity to paroxetine and the components of the drug. Pregnancy, lactation.

Drug name: Deprim.

Analogues: Gelarium hypericum, Doppel-Hertz Nervotonic.

Indications: chronic fatigue syndrome, depression, emotional exhaustion, decreased ability to work.

Action: increased performance, mental and physical activity, normalization of sleep.

Side effects: dry mouth, changes in the gastrointestinal tract, fatigue.

Contraindications: children under 6 years old. Individual intolerance. It should be taken with special caution during pregnancy and lactation.

Along with medications of chemical origin, herbal preparations can be taken to combat depression. Antidepressants of herbal etiology are herbal infusions that can be purchased at a pharmacy or prepared at home.

5. Leuzea extract

Drug name: Leuzea extract (Raponticum safflower).

Indications: as a complex therapy.

Action: general tonic effect, increased performance, improved mood, increased appetite .

Side effects: headache, irritability, increased blood pressure, allergic reaction, insomnia.

Contraindications: hypersensitivity, epilepsy, chronic sleep disorders, acute period of infectious diseases.

6. Ginseng tincture

Drug name: Ginseng tincture.

Indications: hypotension, increased fatigue, overwork.

Action: increased performance, decreased fatigue, increased blood pressure.

Side effects: insomnia, headache, diarrhea, nausea, nosebleeds.

Contraindications: hypertension, children under 16 years of age, hyperfunction of the thyroid gland.

7. Schisandra tincture

Drug name: Schisandra tincture.

Indications: hypotension, neurasthenia, depression.

Action: stimulating the central nervous system, increasing blood pressure, improving visual acuity.

Side effects: overexcitation of the central nervous and cardiovascular systems.

Contraindications: insomnia, high blood pressure, acute infectious diseases.

Let's take a closer look at the class of sedative antidepressants.

8. Azafen

Drug name: Azafen.

Indications: asthenodepressive syndrome, anxiety-depressive state, alcoholic depression, endogenous depression, exogenous depression, depressive states in chronic somatic diseases.

Action: elimination of anxiety and depression, manifestations of senile depression, smoothing out the negative state caused by long-term use of antipsychotics.

Side effects: nausea, vomiting, headache, dizziness.

Contraindications: hypersensitivity, myocardial infarction, coronary heart disease, diabetes mellitus, pregnancy, acute infectious diseases.

9. Persen

Drug name: Persen.

Indications: poor sleep, irritability, increased nervous excitability.

Action: sedative and antispasmodic effect.

Side effects: allergic reaction. With prolonged use - constipation.

Contraindications: hypersensitivity to the components of the drug, arterial hypotension. Children under 3 years old (tablets), children under 12 years old (capsules)

10. Mianserin

Drug name: Mianserin.

Indications: Depression of various origins.

Action: improved sleep, decreased nervous excitability.

Side effects: drowsiness, hypokinesia, convulsions.

Contraindications: manic syndrome, pregnancy, lactation, childhood (up to 18 years). Liver and kidney failure.

11. Amitriptyline

Drug name: Amitriptyline.

Indications: manic-depressive psychosis, bulimia nervosa, childhood enuresis.

Action: sedative effect, antidiuretic effect for bedwetting, analgesic effect.

Side effects: drowsiness, disorientation, excitability, hallucinations, fatigue, tachycardia, nausea, vomiting, weight gain.

Contraindications: epilepsy, intestinal obstruction, angle-closure glaucoma, pregnancy, breastfeeding.

12. Mirtazapine

Drug name: Mirtazapine.

Indications: depressive states, early awakening from sleep, loss of interest, anxious depression.

Action: restoring the ability to enjoy, adjusting sleep, eliminating suicidal thoughts.

Side effects: drowsiness, dizziness, unusual dreams, tachycardia, nausea, diarrhea, decreased libido, dry mouth, increased appetite.

Contraindications: hypersensitivity to the components of the drug, epilepsy, organic brain damage.

13. Novo-passit

Drug name: Novo-passit.

Indications: neurasthenia, “manager” syndrome, migraine, eczema of psychological etiology.

Action: sedative, relieving nervous excitability of the premenstrual and menopausal periods, eliminating anxiety.

Side effects: allergic reactions, dizziness, drowsiness, slight decrease in muscle tone.

Contraindications: hypersensitivity to the components of the drug, children (up to 12 years), alcoholism, epilepsy, diseases, brain injuries.

14. Hawthorn tincture

Drug name: Hawthorn tincture.

Indications: nervousness, cardiovascular diseases, menopause, high cholesterol.

Action: calming effect on the nervous system, normalization of heart activity, reduction of excitability during menopause.

Side effects: allergic reactions, itching, urticaria.

Contraindications: pregnancy, lactation period, individual intolerance, children under 12 years of age.

15. Valerian tincture

Drug name: Valerian tincture.

Indications: insomnia, migraine, hysteria, increased excitability, smooth muscle spasms.

Action: calming, antispasmodic, choleretic, normalizing effect for the gastrointestinal tract.

Side effects: decreased performance, drowsiness, depression.

Contraindications: individual intolerance.

Contraindications for over-the-counter antidepressants

Antidepressants sold without a prescription have a beneficial effect on the elimination of neurotic conditions of various etiologies. But this does not mean at all that you can take these drugs for a very long time and without negative consequences.

Many antidepressant medications that are freely available in pharmacies may have a number of contraindications.

These “prohibitions” apply to almost all antidepressants:

individual intolerance to the components of the drug;
pregnancy;
breastfeeding period;
children under 18 years of age.

It must be said that each drug with antidepressant action, along with the contraindications listed above, may also have its own, unique to this drug.

If you are in doubt about whether or not to take antidepressants, watch a video that will enlighten you and destroy a number of myths about drugs of this kind:

Constant stressful situations and the very fast pace of modern life lead to many people becoming overly irritable, nervous, and susceptible to various types of phobias. Depressive conditions, unfortunately, have ceased to be something unique and isolated.

Nowadays, even young children are familiar with the term “depression.”

The chemical composition and clinical use of these drugs may vary. The search for new pharmacological compounds to combat depression in medical science does not stop.

The first medications to combat depression began to be prescribed to patients in the 50s of the 20th century. The drug iproniazid is at the origins of antidepressants. Currently, there are about 125 drugs with antidepressant effects in pharmacology. Be careful when choosing antidepressants!

The Ministry of Health is discussing introducing a de facto ban on the sale of antibiotics without a prescription. As Izvestia found out, an interdisciplinary commission has already been created, which, in addition to specialists from the Ministry of Health, also includes representatives of other federal departments. The commission's task is to create a national action plan to curb antimicrobial resistance. And the development of an effective mechanism to control the prescription sale of antibiotics is one of the points of the national plan.

According to the president of the League of Patient Defenders, Alexander Saversky, the inability to purchase antibiotics without a prescription will lead to an increase in the flow of patients to clinics.

With the current work of clinics, when you get to the doctor in four days, it’s like death. We conducted a survey and based on its results we found out that the waiting time for an appointment with a therapist reaches a week,” Alexander Saversky explained to Izvestia. - Imagine if a person needs an antibiotic, and he waits a week to see a therapist. It's easiest to tighten the nuts, but you need to restore order in the system as a whole.

However, the expert agrees that under certain conditions such measures are necessary.

There are a lot of prescription drugs, not just antibiotics. And here is a question for pharmacies that break the law. “Everyone knows this,” said Alexander Saversky. - But when we put up some kind of barrier, we must think about what it will lead to. With a normally functioning healthcare system, I am in favor of such a ban with both hands. But with the system we have, I am against it with all my limbs.

That “antimicrobial resistance poses a growing threat to global public health and requires special attention from all stakeholders,” Health Minister Veronika Skvortsova said in her speech at the 71st session of the UN General Assembly, held in late September in New York. Simply put, antibiotics stop working on us, and hundreds of thousands of people die from infections every year. Actually, doctors encountered the problem of resistance to antimicrobial drugs back in the 40s of the last century, when the widespread clinical use of antibiotics began.

Resistance is a natural biological phenomenon. At the same time, the rate of its growth depends on various reasons, one of which is the frequency of use of antibiotics,” Director of the Research Institute of Antimicrobial Chemotherapy of the Smolensk State Medical Academy of the Ministry of Health of the Russian Federation, Doctor of Medical Sciences, Professor Roman Kozlov told Izvestia. - This problem became extremely relevant in the 1980s, and now it has reached a critical level.

Experts call a frightening figure: resistance to antibiotics kills 700 thousand people every year. And it will get worse.

By 2050, while maintaining growth rates at the current level, this figure is expected to increase to 10 million, explained Roman Kozlov. - The losses of the world economy from this problem will amount to 7% of global GDP, that is, about $210 trillion. Therefore, international organizations (UN, WHO) perceive the problem of antibiotic resistance as a threat to global stability, and at the level of individual countries - as a threat to national security. In Russia, an interdisciplinary commission will create a national action plan to curb antimicrobial resistance.

There are many reasons for antimicrobial resistance. But among the main ones, Professor Kozlov names “the irrational use of antibiotics to treat people, unjustified use in agriculture and veterinary medicine, and insufficient infection control measures.” Simply put, if a person starts treating a viral disease with antibiotics every time he has a common runny nose, then when he gets sick, for example, with pneumonia or a sore throat, the antimicrobial drug will no longer help him.

However, a significant portion of the population self-medicates and uses antibiotics without a doctor’s prescription. In many countries this is simply impossible - not a single pharmacy will sell such a drug without a prescription. Actually, this should be the case in Russia too. But in practice, even strong antibiotics can be purchased at almost any pharmacy.

In the Russian Federation, in accordance with the existing legislative framework, antibiotics should be sold only with a doctor's prescription. The problem here is not the absence of laws, but their implementation,” said Roman Kozlov.

Apparently, the inability to buy antibiotics without a prescription will cause discontent among Russians. To prevent this from happening, the Ministry of Health will have to conduct more than one information campaign and constantly explain the dangers of uncontrolled use of such drugs.

We are actively engaged in informing the population about this problem - we conducted a pilot project with the support of the administration of the Smolensk region and WHO in Smolensk - these materials are available on the website www.antibiotic-save.ru, - said Roman Kozlov. - It’s nice to know that, according to online surveys, 82% of the population have heard about this problem. But resistance to antimicrobial drugs is dangerous not only due to “direct” human and financial losses. Just imagine the decrease in the effectiveness of organ transplantation programs and cancer treatment due to the fact that infections will be caused by multi- and pan-resistant bacteria! New antibiotics alone cannot solve this problem; an integrated approach is needed. But first of all, everyone - the state, the population, and medical workers - understands the fact that antimicrobial drugs are the most important and irreplaceable resource of humanity that saves people's lives.

And here's more news on the same topic. Not only will prescription drugs be sold strictly according to the prescription, but now pharmacists will be punished for violating the sale. In these conditions, it will become difficult to “pressure pity” on customers, because the punishment is serious: from a five thousand fine for a pharmacy employee to a three-month closure of the pharmacy itself.

In light of new legislative trends, antibiotics, a number of painkillers, cardiovascular and other drugs disappeared from free sale in March. Supervisory authorities claim that this was done for the sake of the health of patients, while many refer to foreign experience. Why are patients not happy with such care?

In fact, the ban on the free sale of prescription drugs has existed for a long time, since 2005. But neither pharmacists nor their clients were in a hurry to implement it. The doctors continued to scribble prescriptions on scraps of paper. Unless drugs from special lists, subject to strict accounting, were dispensed and purchased strictly according to a prescription.

The Ministry of Health and Rospotrebnadzor decided to take the violators seriously. However, in the fight for our health, the patients themselves, faced with the need to sit under the doctor’s door for every sneeze, and pharmacists turned out to be at the extreme.

If a pharmacy employee sells a prescription drug without a doctor's prescription, he or she will face a serious fine. Minimum five thousand rubles. And for the pharmacy itself, the punishment can result in 100 thousand rubles. But that's not all. it may even be closed for up to three months.

Medicines marked “dispensed only by prescription” are now prohibited from even being displayed on display. About 70% of the entire pharmacy assortment is subject to restrictions. These are not only psychotropic and narcotic drugs, but also all antibiotics, hormonal drugs (including contraceptives), potent painkillers, ampoule dosage forms, a number of cardiovascular drugs, medications for diabetics and others.

No queue!

If you need the drug, but have neither the time nor the desire to sit in a long-hour line, you can pay for consultations with a doctor at a private medical center. In most cases, you can get a prescription there too. A doctor in a private clinic has the right to write prescriptions for medications, with the exception of those included in lists II and III of the “List of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation.”

The most unpleasant thing is that there is still no exact and complete list of medicines that cannot be commercially available. The list should have been approved by the Ministry of Health back in January; it could be found at this link. But it’s unlikely to be found there! Therefore, pharmacists are advised to follow the instructions. If it contains the entry “dispensed with a doctor’s prescription,” then it cannot be sold just like that.
However, some believe that the instructions in the medicines are the very document that you need to rely on without any orders from the Ministry of Health.

In Gubkin and Stary Oskol pharmacies they sell herbs, ointments, antipyretics, some antivirals and nasal drops without a prescription. But pentalgin, ketorol, festal - only by prescription. Papaverine and no-spa are needed in tablet form; some pharmacists dispense them freely, but in ampoules - with a prescription. Ketonal is similar: a cream or gel is sold for external use, but to get it in other forms of release, it is advised to consult a doctor.

But pharmacists believe that there is no reason to panic. After all, even before, many medications were only available by prescription. Those same diabetics knew this very well. There are painkillers, stomach and heart medications, which have always been and remain on the market. Anything more potent is a no. And this is justified: serious drugs have more serious side effects. In addition, if you need strong medications, then you need serious treatment and go to the doctor.

In general, if you are going to the pharmacy, look on the Internet and look at the instructions for the medicine you are going to buy. It may be available only by prescription, in which case you must first visit a doctor.

IP and IBLP

In general, in order No. 403n the topic of IBP release is spelled out separately, which is not in order 785. It will be regulated by paragraph 13 of the first mentioned act. This paragraph, in particular, determines that when an IBP is dispensed, the exact time of this same dispensing, in hours and minutes, is indicated on the prescription or prescription counterfoil, which remains with the buyer.

Violation of secondary

With the entry into force of Order No. 403n, new emphasis will appear on the topic of the possibility of violation of secondary (consumer) packaging of medicines. The “retiring” norm of Order No. 785 allows this to be done in exceptional cases, if the pharmacy organization is unable to fulfill the doctor’s prescription.

The order No. 403n that replaced it is in this regard more specific and more in line with modern requirements, medical practice and consumer demands. Paragraph 8 of the order determines that violation of secondary packaging and dispensing of a medicinal product in primary packaging is permitted in cases where the amount of the drug indicated in the prescription or required by the consumer (for 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 thereof, and tampering with the original packaging is prohibited. By the way, the new order does not contain the rule that in case of violation of the secondary order, the drug must be dispensed in pharmaceutical packaging with the obligatory indication of the name, factory batch, expiration date of the drug, series and date according to the laboratory packaging register, which is determined by order No. 785.

"The medicine has been 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, narcotic and psychotropic drugs of Schedule II are dispensed using Form No. 107/u-NP, with the exception of narcotic and psychotropic drugs in the form of transdermal therapeutic systems.

The remaining prescription drugs, as is known, are dispensed using forms No. 107-1/u. According to paragraph 22 of the order of the Ministry of Health of the Russian Federation dated December 20, 2012 No. 1175n “On approval of the procedure for prescribing and prescribing medications, as well as forms of prescription forms...”, prescriptions written on the forms of this form are valid for two months from the date of prescription. However, for patients with chronic diseases, it is allowed to set the validity period of the prescription form No. 107-1/u within 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 quantity of the drug dispensed (in each period), is returned to the buyer, of course, with the required notes on the date of dispensing, dosage and quantity of the drug dispensed. This is prescribed by paragraph 10 of order No. 403n. He also determines that the next time the patient comes to the pharmacy with the same prescription, the chief must take into account the notes on the previous dispensing of the drug.

The prescription remains at 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 retail trade entity retains (with the mark “The medicinal product is dispensed”) and stores:

within 5 years prescriptions for:

within 3 years prescriptions for:

within 3 months recipes for:

Order No. 403n of the Russian Ministry of Health did not come without a cherry on the cake, albeit a dubious one. Paragraph 15 of the order states that prescriptions not specified in the previous 14th paragraph (we listed them just above) are marked with the stamp “The drug has been dispensed” and are returned to the indicator. It seems to follow from this that prescriptions of form No. 107-1/y with a two-month validity period become “disposable”. We advise readers to pay special attention to this new norm.

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

To avoid getting caught

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

Paragraph 17 of Order No. 403n contains the rule that a pharmacist does not have the right to provide false or incomplete information about the availability of drugs in the pharmacy’s assortment - including drugs that have the same INN - and also to 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 dated August 21, 2016 No. 647n). The only thing new here is that this rule appears for the first time in the order on vacation rules.

This was a review of the order, so to speak, “on fresh trail.” Readers will probably 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 “disposable” prescriptions with a two-month validity period, which was mentioned above, as well as the dispensing of ethyl alcohol and alcohol-containing drugs in the light of the provisions of the new order No. 403n.

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

What could be more important for a pharmacy organization than the order in which medications are dispensed. Pharmacists barely had time to return from their summer vacation and look around when a new order of the Ministry of Health of the Russian Federation dated July 11, 2017 No. 403n was published with appendices “On approval of the rules for the dispensing of drugs for medical use, including immunobiological drugs, by pharmacy organizations, individual entrepreneurs with license for pharmaceutical activities." Order No. 403n on the vacation procedure was registered with the Ministry of Justice of the Russian Federation on September 8; its validity begins on September 22 of the current year.

The first thing I want to say in this regard is that now forget the number “785”. The new order 403n with amendments and additions invalidates 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. At the same time, many points of a new regulatory legal act repeat - sometimes almost verbatim - the corresponding fragments of the predecessor order. But there are also differences, new provisions, on which we will focus more, setting out the first observations and notes in the margins of the freshly issued 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 the dispensing of medicinal products, including immunobiological medicinal products (IBP); the second is the requirements for the dispensing of narcotic and psychotropic drugs, drugs with anabolic activity, and other drugs subject to subject-quantitative accounting (SQR). The third appendix establishes the rules for the dispensing of medicines according to the invoice requirements of medical organizations, as well as individual entrepreneurs (IP) with a license for medical activities.

Under the new order, the dispensing of over-the-counter drugs will be allowed both to pharmacies and pharmacy points, as well as individual entrepreneurs and pharmacy kiosks. For the rest, if we summarize points 2 and 3 of order No. 403n and the list of drugs, the following picture emerges.

The dispensing of narcotic and psychotropic drugs can only be carried out by pharmacies and pharmacy points that have the appropriate license.
The remaining prescription drugs are dispensed by pharmacies, pharmacy points and individual entrepreneurs (of course, those with a license for pharmaceutical activities - this clarification will be further considered accepted by default and omitted).
The dispensing 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 IBP drugs is prescribed separately, which is not in order 785. It will be regulated by paragraph 13 of the first mentioned act. This paragraph, in particular, determines that when an IBP is dispensed, the exact time of this same dispensing, in hours and minutes, is indicated on the prescription or prescription counterfoil, which remains with the buyer.

IBLP can be released if two conditions are met. Firstly, if the buyer has a special thermal container in which the required mode of transportation and storage of these thermolabile drugs can be observed. The second condition is an explanation (from the pharmacist to the buyer) of the need to deliver this drug to a medical organization, despite the fact that it can be stored in the mentioned container for no more than 48 hours.

Let us recall in this regard that this topic is also regulated by subclause 8.11.5 of the Sanitary and Epidemiological Rules “Conditions for transportation and storage of immunobiological preparations” (SP 3.3.2.3332–16), which were approved by Resolution of the Chief State Sanitary Inspector of the Russian Federation dated February 17, 2016 No. 19 It obliges the pharmacy employee to instruct the buyer on the need to comply with the “cold chain” when transporting biopharmaceutical products.

The fact of this instruction is recorded with a mark on the drug packaging, prescription or other accompanying document. The mark is certified by the signature of the buyer and the chief clerk (or another representative of the pharmacy organization) and also includes the date and time of dispensing. However, the SanPiN does not specify that the time in this case should be indicated in hours and minutes.

Violation of secondary

With the amendments and additions to Order No. 403n, new emphasis will appear on the topic of the possibility of violation of secondary (consumer) packaging of medicines. The “retiring” norm of Order No. 785 allows this to be done in exceptional cases, if the pharmacy organization is unable to fulfill the doctor’s prescription.

The order No. 403n that replaced it with a list of drugs in this regard is more specific and more in line with modern requirements, medical practice and consumer demands. Paragraph 8 of the order determines that violation of secondary packaging and dispensing of a medicinal product in primary packaging is permitted in cases where the amount of the drug indicated in the prescription or required by the consumer (for 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 thereof, and tampering with the original packaging is prohibited. By the way, in the new order of the Ministry of Health of the Russian Federation No. 403n there is no provision that in case of violation of the secondary drug must be dispensed in pharmaceutical packaging with the obligatory indication of the name, factory series, expiration date of the drug, series and date according to the laboratory packaging register, which is determined by order No. 785.

What does this mean in practice? Let's assume two situations: first - drug X tablets (or dragees) No. 56, primary packaging - blister; the second is drug N tablets No. 56, in a bottle. And in both cases, the question arises about its release to the patient who has presented the chief of staff with a prescription on which, say, 28 tablets or 42 tablets (dragées) are prescribed.

It is clear that in the first case this is acceptable, since it is possible to dispense 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 bottle, and breaking it is strictly prohibited. So, our first capital officials do not have the right to count out tablets or dragees from a bottle, as they do in pharmacies in some foreign countries.

"The medicine has been released"

According to form No. 148–1/у-88 the following are issued:

Schedule III psychotropic drugs;
narcotic and psychotropic drugs of Schedule II in the form of transdermal therapeutic systems;
drugs included in the list of drugs subject to PCU, with the exception of those drugs that are dispensed in form No. 107/u-NP;
drugs that have anabolic activity and are classified as anabolic steroids according to the anatomical-therapeutic-chemical classification (ATC) recommended by the World Health Organization (code A14A);
drugs specified in paragraph 5 of the “Procedure for the dispensing to individuals of drugs containing, in addition to small quantities 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 pharmacological active substances in a dose not exceeding the highest single dose, and provided that this combined medicinal product is not a narcotic or psychotropic drug Schedule II drug.

The list of other prescription drugs, as is known, is dispensed on form No. 107-1/u. According to paragraph 22 of the order of the Ministry of Health of the Russian Federation dated December 20, 2012 No. 1175n “On approval of the procedure for prescribing and prescribing medications, as well as forms of prescription forms...”, prescriptions written on the forms of this form are valid for two months from the date of prescription. However, for patients with chronic diseases, it is allowed to set the validity period of the prescription form No. 107-1/u within 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 quantity of the drug dispensed (in each period), is returned to the buyer, of course, with the required notes on the date of dispensing, dosage and quantity of the drug dispensed. This is prescribed by paragraph 10 of order No. 403n. It also determines that the next time the patient comes to the pharmacy with the same prescription for a list of drugs, the chief must take into account the notes on the previous dispensing of the drug.

When the maximum quantity specified in the prescription is purchased, it must be stamped “Dispensed.” And a one-time release of the entire quantity, according to the same paragraph, is allowed only in agreement with the doctor who wrote this prescription.

The prescription remains at 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 retail trade entity retains (with the mark “The medicinal product is dispensed”) and stores:

within 5 years prescriptions for:

narcotic and psychotropic drugs of Schedule II, psychotropic drugs of List III (according to the outgoing 785th order, 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/u-04 (l) or No. 148–1/u-06 (l));
combination drugs containing narcotic drugs or psychotropic substances included in Schedules II and III, manufactured in a pharmacy, drugs with anabolic activity, drugs subject to PCU;

within 3 months recipes for:

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

Note that Order 785 does not contain this group of recipes for three-month storage.

Order No. 403n of the Ministry of Health did not come without a cherry on the cake, albeit a dubious one. Paragraph 15 of the order states that prescriptions not listed in the previous 14th paragraph (we listed them just above) are marked with the stamp “The drug has been dispensed” and are returned to the indicator. It seems to follow from this that prescriptions of form No. 107-1/y with a two-month validity period become “disposable”. We advise readers to pay special attention to this new norm.

The topic of combating the abuse of alcohol-containing drugs in pharmacies, which was recently trumpeted by the media, is 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 “dispensed” stamp); under the new order, they must remain in the pharmacy organization.

To avoid getting caught

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

According to this clause, when dispensing a drug, the pharmacist informs the buyer not only about the regimen and doses, but also about the rules for storing it at home and interactions with other drugs.

In theory 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 inspector, when dispensing the medicine, does not inform him, for example, that this medicine must be stored at a temperature no higher than 25 ° C, or does not ask whether he is currently taking other medicines, then the inspector can “throw off the mask” and draw up an act of administrative violation. So the norm in paragraph 16 is serious and fraught. And, of course, it requires that the chief captain be thoroughly versed in the complex and voluminous topic of drug interactions.

Paragraph 17 of Order No. 403n, as amended, contains the rule that a pharmacist does not have the right to provide false or incomplete information about the availability of drugs in the pharmacy product range - including drugs that have the same INN - and also to 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 dated November 21, 2011 No. 323 Federal Law “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 dated August 21, 2016 No. 647n). The only thing new here is that this rule appears for the first time in the order on the vacation procedure.

These were explanations of order No. 403n, so to speak, “on a fresh trail.” Readers will probably 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 “disposable” prescriptions with a two-month validity period, which was mentioned 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, a webinar by Larisa Garbuzova, Ph.D. will be held on our website. D., Associate Professor of the Department of Management and Economics of Pharmacy at Northwestern 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.

When I was in medical school, Latin seemed magical and mysterious. Each recipe contained melodious words: recipe, da, signa. Take it, give it, mark it. They sounded like exquisite music that only a few understand. Today doctors have almost forgotten them, and prescriptions in pharmacies have become rare...

During Soviet healthcare, a prescription was a sacred document; everyone knew, . Without a form on which letters vaguely reminiscent of Latin were written in a practiced medical manner, the pharmacy sold only vitamins, citramon and a couple of medications. Then it was impossible to imagine that the doctor, instead of a signed and sealed prescription, would suddenly give you a piece of paper with gobbledygook.

In the 1990s, the decades-long order dissipated like the specter of communism. And although theoretically all orders of the Ministry of Health continued to function, their compliance became a mere formality. Instead of neat forms, doctors now have sheets with manufacturers’ symbols and trade names of drugs. Sometimes, on scraps of paper, an entire treatment regimen consisting of a dozen drugs is written out, in order to save money, written out in small handwriting that fills all the available space.

More than once I have had to deal with the fact that doctors give the patient... a medical card as a prescription. They say the pharmacy will sort it out. And if not?

Doctor's interests

Any leader knows that giving orders is only half the battle. An order released on the air can hang there forever, forgotten and abandoned by everyone, like old galoshes. To ensure that orders are not ignored, their implementation must be monitored.

As soon as total Soviet control loosened its iron grip, prescriptions began to be written less and less often. Today, doctors see virtually no need for them, except in cases where they prescribe psychotropic, narcotic drugs and tranquilizers.

The reluctance of doctors to tie themselves in knots with additional documentary circulation is quite understandable. Firstly, any doctor already has a lot of paperwork - sometimes filling out various cards and forms takes more time than communicating with patients.

Secondly, this is a document. You can find it at any time and, in case of an incorrect prescription, call the doctor to account.

And thirdly, according to the order of the Russian Ministry of Health No. 1175n, “the prescription and prescription of drugs is carried out<…>by international nonproprietary name." This means that the doctor does not have the right to write the trade name of the medicine in the prescription, with the exception of rare cases when the international or generic name is absent. This approach does not always suit the doctor: he will not be able to officially prescribe the original drug or an analogue, which, in his personal opinion, is the most effective. In addition, we should not exclude the possibility that the doctor simply does not remember the international name.

What about the patient? Doesn't he care what piece of paper he leaves the doctor's office with?

Patient interests

When a doctor prescribes a medicine “orally” or limits himself to notes at hand, most patients do not feel there is a catch. And there is one, and a considerable one.

The recipe is a protection. It's no secret that everyone can make mistakes. But popular wisdom claims that the mistakes of teachers and doctors cost us more, and this is true. If the doctor prescribed the medicine incorrectly, which led, for example, to the development of side effects or worsening of the condition, the patient can seek satisfaction from higher authorities. However, this possibility exists only if he has evidence: a prescription or an entry in a medical record, or better yet, both. When there is no written evidence of the appointment, you can forget about the search for justice.

The recipe is a guarantee. The medicine is prescribed on a prescription form in accordance with the requirements of Order No. 1175n. In this case, the doctor indicates the international name and dosage in full (not in an abbreviated version). In addition, in the signature - the last Russian-language chapter of the prescription intended for the patient - the doctor briefly describes the application regimen.

It is difficult to confuse the medicine prescribed in the prescription with anything else: the document contains comprehensive information. But if the pharmacist is handed a piece of paper instead of the official form, there is no guarantee that the dose or even the name of the medicine is indicated correctly on it. The doctor will write the prescription illegibly and “forget” in the bustle to indicate the release form, and now instead of cefazolin, the pharmacist looks at cefotaxime, and the antiherpetic ointment Zovirax becomes the antibiotic Zyvox. In a properly prepared recipe, such oversights are excluded.

Seriously, in my practice there was a pediatrician who wrote out prescriptions in such a “professional” handwriting that the whole team gathered to decipher them. And each time the doctor limited himself to pages from notebooks instead of prescription forms. Where is the guarantee that pharmacists in some pharmacy will not “supply” the patient with a “consonant” drug?

The recipe is confidence. Do not forget that even uncontrolled orders remain valid. And if in the vast majority of pharmacies antibiotics can be purchased only with a vague note or even without one, this does not mean that a prescription is not needed. Any pharmacist at any time can refuse to sell an antibiotic without a prescription and will be absolutely right. Therefore, the official form is a guarantee that the medicine will be purchased.

It turns out that when writing a prescription, the doctor acts primarily in the interests of the patient, sometimes to his own detriment. This is why prescriptions are so rarely written. But we, potential patients, have every right to insist on compliance with the order. It's so easy to protect your rights and health using a regular prescription form.

Marina Pozdeeva

Photo thinkstockphotos.com