We overestimate medicines and underestimate their specialists

Anastasia Dolgosheva, "St. Petersburg Vedomosti", 08.10.2008

The third scientific congress "Rational Pharmacotherapy and Clinical Pharmacology" is opening in St. Petersburg today. Specialists will gather from all over Russia, whose professional task is to make sure that the attending doctor prescribes you exactly the "right" medicine: researched, effective, as safe as possible. How willingly doctors listen to the opinion of drug specialists, how these specialists manage not to drown in a sea of new drugs and much more, our columnist Anastasia DOLGOSHEVA talked with the president of the congress, the chief clinical pharmacologist of the city Alexander HADZHIDIS.

– Alexander Kiriakovich, not only clinical pharmacologists will gather at the congress – gastroenterologists, cardiologists, therapists will speak...– Because doctors and clinical pharmacologists need to work together.

A clinical pharmacologist does not treat. But 95% of doctor's appointments are drugs, and we are specialists in this field. However, imagine the picture: you are a doctor with many years of experience, you may be communicating with representatives of a certain pharmaceutical company, and suddenly a drug specialist appears and says: "I'll teach you now what medications to prescribe." Perhaps you will say: "Roll sausage on Malaya Spasskaya."

– How often do they offer to roll?– How old is medicine?

And there are only 20 clinical pharmacology in Russia. It originated when a drug boom began in the country.

In the Soviet Union, drugs were not studied for evidence, but this was much less relevant: there were only two thousand names of medicines for the whole Union. And now – if last year 17 thousand names of original drugs were registered in Russia, then this year there are already more than 18 thousand. I emphasize: original! And generics – about 500 thousand.

And clinical pharmacologists, together with attending physicians, should develop protocols, standards, and forms that would limit the number of medications and regulate the doctor's activities.

– Do you want to reduce the list of medications that a doctor can prescribe?– There is a serious problem in Russia: we initially have less stringent requirements for the study of drugs.

When you see the speed with which departments studying the biological equivalence of drugs issue conclusions, you understand: it's unreal. There are a lot of unexplored drugs. And we create a database, choosing only the most researched and safe ones.

A generic, that is, a drug created according to the formula of the original medicine, should be equally effective and safe. If everything seems to be in order with efficiency, then there is a problem with safety: the cooking technology is not always maintained.

Besides. In the civilized world practice, the medicine must be examined and registered for a specific indication. And we will register one at a time, and appoint another "twenty diseases" for which it is not registered, which means it has not been investigated.

– And in the world, how are they managed with this shaft of drugs?– In America, for example, the picture is as follows: the doctor decided to prescribe paracetamol.

In the computer there is a database where all registered trade names of the drug are indicated, and two columns: in group A – corresponding to WHO requirements, they can be prescribed safely; in group B – unexplored. So, an American colleague in the group of those studied will conditionally have 200 out of 250 trade names; and our doctor has 125 names out of those present on the Russian market – only 3-5 have been studied. That is, the problem of unexplored drugs is everywhere, but its relevance is different in countries.

The unregulated prescribing of drugs that I have already mentioned also exists in the West, especially for children who are prescribed "adult" medications...

– This is what we have been arguing about so much: whether to test drugs on children?– Yes, yes.

If the word "test" cuts the ear – say "explore". So, since the beginning of 2007, the main European organization for medicines EMEA has introduced a norm: when registering a new drug in adults, it is mandatory to investigate its effect in children.

At the same time, regulatory documents prohibit the study of drugs on a number of groups of patients, and Russian ones, including children. But they also get sick, and it turns out that we prescribe unexplored medications to them. Wouldn't it be better to investigate?

– Recently, the Ministry of Health has changed the list of medicines received for DLO. It is believed that the list has become "more rational". Did clinical pharmacologists take part in this "rationalization"?– Unfortunately, no.

If we were related to the list of drugs – I am sure – it would be much better. Now there is a discrepancy: there is a certain drug in the list (which means that the doctor has the right to prescribe it), while this drug is not specified in the standard of treatment (that is, it cannot be prescribed).

Moreover, the role of a clinical pharmacologist is not indicated at all in the creation of a medical standard. Although, I repeat, 95% of doctor's prescriptions are medications.

– As far as I understand, so far clinical pharmacologists are not very favored in medical institutions.– Here a lot is determined by the head of a particular medical and preventive institution, a medical institution.

There is an order of the health committee 11 years ago. The order says: there should be one clinical pharmacologist in the hospital for every 150 beds. In a large multidisciplinary hospital, thus, there may be five of them. But if there are clinical pharmacologists in large hospitals in St. Petersburg, then not always in smaller hospitals. There are no clinics at all, although, by order, they should be. This is the tenth year I have been the chief specialist at the committee, and during this time only one head physician of the polyclinic has applied for a clinical pharmacologist.

That is, there is an order, but they do not punish for its non-fulfillment.

Why is the system not working? Yes, because insurance medicine does not work. We just want it to work. And the patient is, in fact, legally unprotected: we don't even have a definition of medical error.

It is clear that the doctor is not wrong out of malice, but if he were called to account through an insurance company, why, for example, he treated the disease with a medicine for 2 thousand rubles, when there is a medicine for 500 rubles, more effective and without side effects, then the role of a clinical pharmacologist would increase significantly.

– Why are insurance companies not interested in controlling this?– Theoretically interested.

But the laws must be appropriate.

Tell me how you can fight counterfeiting if the definition of this concept appeared in regulatory documents only last year! In countries with much greater transparency of the drug business, even then they say that 5-6% of counterfeit is present on the market. Third world countries call 50-70%. Our high officials once talked about 12-15%. I don't think it's not enough.

– If I went to the pharmacy – how likely is it that I will buy counterfeit?– We don't have such information.

Although, according to the head of the North-Western Center for Quality Control and Certification of Medicines Sergey Nekrasov, the topic of counterfeit in St. Petersburg is greatly exaggerated. He claims that out of a sample of thousands of medicines, only dozens are falsified.

– Excuse me, Alexander Kiriakovich, is there anything good in your field? Have you achieved anything?- of course.

A formulary commission has been created in the health committee, where 8 clinical pharmacologists out of 24 people will now participate in decisions on certain drugs. This has never happened before.

The hospital form, which was developed by the Association of Clinical Pharmacologists of St. Petersburg, was recognized. Let's see how it will work.

There is a draft order on the creation of a regional center for monitoring side effects. Also an important topic: the drug may be of high quality, but as massive use, "unplanned" effects are revealed. Aspirin has been on the market for about 120 years, and it took almost half a century to discover that it can cause ulcers, as it affects the mucous membrane.

Further. Clinical pharmacologists of St. Petersburg, together with epidemiologists and bacteriologists, worked out the regulations on the work of the so-called reference laboratory for the determination of antibacterial resistance at the Janelidze Research Institute of Emergency Medicine, where the topic of antibiotics should be supervised. Man exists against the background of the fight against harmful microbes, and in recent decades man has totally lost to microbes: they adapt to the drugs. In the field of creating new antibiotics, we can talk about a crisis: only two new drugs have been created recently.

Finally, we were probably the first in Russia to create a neonatal form – a list of medicines recommended for newborns.

– Who do the congress participants want to reach?– Now a new structure has been introduced in the Ministry of Health – the Department for the Development of the pharmaceutical market and the medical equipment market; its head, Diana Mikhailova, has been invited to the congress.

In particular, we will bring our opinion to her attention.

After such congresses, after the adoption of a consolidated decision, it is easier to go to the authorities – the Ministry of Health, Roszdravnazdor, the State Pharmacological Committee – and ask: why is there a problem with generics? Why is registration not regulated, the effectiveness of treatment is not monitored? Why does the topic of side effects "stand still"? Why have we developed more than 900 medical standards in our country, but they become obsolete already at the exit, and in the standard you can see a medicine that has no registration in Russia... In addition, work on the standard involves a significant, but justified increase in funding, which is not planned in the budget.

– Alexander Kiriakovich, I see you have a cold. What are you being treated with?– And I'm not being treated with anything.

I understand, it's strange to hear this from the chief clinical pharmacologist of the city. But we are now very overestimating medicines, and the main principle is not to harm.

After all, as is customary with us: the temperature has risen (and at the same time interferon, which protects the body, is being intensively produced), we are prescribed a drug that reduces the temperature and, accordingly, interferon production – and an immunostimulator is immediately prescribed to increase interferon production...

It is necessary to initially understand what goal you are pursuing when taking the drug. There are so–called etiotropic drugs that affect the cause of the disease - an antibiotic will really cure a sore throat. But there is a symptomatic treatment: using drops from a runny nose, you need to understand that you are not being treated, but eliminate the inconvenience.

So anyway: there are diseases that will pass without treatment in seven days. And with treatment – in a week.

Portal "Eternal youth" www.vechnayamolodost.ru08.10.2008