“A legal mechanism has appeared”: how seriously ill children in Russia are provided with foreign medicines

- How has the situation with unregistered drugs in Russia changed lately?

- The main thing is that a legal mechanism has appeared, thanks to which these drugs can now be legally obtained in our country. It is difficult, but possible. And if, let’s say, there isn’t any kind of opposition on the ground, then in a couple of weeks the patient can get the necessary medicines. 

In Russia, the launch of production of new drugs has also begun: Midazolam in buccal form and Diazepam in microclysters, the Moscow Endocrine Plant is engaged in this. One drug will be available later this year, and another next year. That is, very soon the Russians who need these drugs will not depend on foreign manufacturers. The necessary medicines can be bought in pharmacies, all this will be much simpler and cheaper.

- Will these drugs not be inferior in their effectiveness to foreign ones?

- It is necessary to try, it is difficult to say in advance. But in Russia there is an intravenous "Diazepam", and this is a good drug that does not differ in effect from the foreign "Diazepam" in enemas. So, I think everything will be fine.

As for the Frizium preparation, he has now begun the registration phase in Russia. Sanofi company has filed an application for registration, and, in theory, if assistance is provided, in a couple of months the drug can be registered in Russia. Then the international company will calmly bring it to the country and simply sell it in our pharmacies with a prescription, like any other drug. I am very glad that it was Frizium that we did not try to do ourselves, because it was not needed by such a wide circle of people - it would be pointless to open such an expensive production for such a narrow group.

- What is the situation with the provision of these drugs to patients in the regions? 

- It seems to me that the problem in the regions concerns doctors and officials more. In Russia, for example, there was such a moment when morphine appeared in capsules - such a new form of release. It was very cool, and everyone was waiting for him. But in the end, almost no one ordered it, because many doctors did not know at all that there was such a drug and it could be used. It turns out the story is when a drug appears on the market, but in some wilderness the doctors simply do not know - and in the end the patient will not receive this drug.

Now letters from parents come to us from the regions, saying: “Our doctors do not prescribe these drugs because they have never worked with them.” It seems to me that some kind of large educational program should be launched for all doctors so that there are no such situations.

- What is the process of patients receiving drugs now?

- The drug is prescribed by a medical commission - that is, at least three doctors gather and decide together. Ideally, parents just go to the doctor, say that their child has cramps - the doctors understand that Diazepam is needed, collect a medical commission and prescribe the drug.

In reality, the opposite is true: usually parents just know what kind of drug their child needs because they collect all the information and read the forums. As a result, parents themselves are looking for a doctor and a medical institution that agrees to conduct such a medical commission and prescribe the right medicine.

After the medical commission has gathered, local departments begin to operate. Purchases of these drugs are targeted: for example, for one hundred children, one hundred packs of the drug were bought. And when the hundred and first child appears who needs such a medicine, the order must be redistributed. The problem is that departments are often afraid to take such responsibility.

- Are there any problems with the procurement of various forms of release of these drugs? The order is formed taking into account the needs of specific patients, or do they receive drugs on the principle of "how lucky someone"?

- There are no particular problems. Preparations are purchased in bulk, many different forms, and they are in stock. In general, the form of release is not such a big problem. But the problem may arise when these reserves run out - the question already arises of how timely these reserves will be replenished.

For example, we made one purchase in September, and the next only in March. And all the patients who appeared between September and March did not receive medication just because a new purchase was not carried out for a very long time. Now they have bought medicines again, everyone can get them. But when this purchase ends, it will be necessary to quickly buy more.

- We are talking about children, but what about adult patients who need these drugs?

- In March, the law was changed - initially the government decree concerned children, but now it applies equally to children and adults who need these drugs. That is, this criterion - children's age - was removed.

I do not know exactly how things are going with providing these drugs to adult patients. But until March, we were often told that adults could not get such medicines.

- The situation with unregistered drugs was largely changed due to public outcry and media coverage of the problem. But the problems with many other medicines remain unresolved. What is important to keep talking about?

- So far, you can count on the fingers the drugs for the treatment of epilepsy, available for patients in Russia. In fact, there are many more such drugs. There is, for example, the drug Sabril, not registered in the Russian Federation - it is approximately like Frizium, moreover, it is prescribed even more often. Sabril does not belong to narcotic drugs, but buying it is a huge problem, especially now that the borders are closed, and even illegal dealers can not supply it to patients.

There are still unregistered Ospolot and Rivotril - these are also anticonvulsants for children with epilepsy. A specific drug is suitable for each patient, one child, for example, Frizium, and the other Sabril and Ospolot. That is, these drugs are also very important. But the government has so far taken a “step forward” precisely in relation to those drugs for which criminal cases can be instituted — that is, those that are on the list of drugs.