Posted 17 августа 2023,, 06:35

Published 17 августа 2023,, 06:35

Modified 17 августа 2023,, 09:02

Updated 17 августа 2023,, 09:02

From the original to the analogue: The Ministry of Health offers treatment with generics

From the original to the analogue: The Ministry of Health offers treatment with generics

17 августа 2023, 06:35
Ирина Мишина
The information letter of the Ministry of Health «On the regulation of the circulation of medicines», which mentions a list of 196 drugs to be replaced, was placed at the disposal of NI. Most of all, our experts were interested in the recommendation on the «interchangeability» of drugs, that is, the use of analogues with controversial benefits


Recall what was discussed in the document of the Ministry of Health, which was at the disposal of our editorial office.

The Ministry of Health has sent information to doctors for use in their work on the cessation of production and import of medicines included in the list of vital drugs, a total of 196 items. There were also 2 more points in the letter, which at first little attention was paid to. We quote: «the information and analytical system of the Government of the Russian Federation contains information on the interchangeability of medicines.» And again: «We ask you to take into account the above information when prescribing medications to patients, including using other treatment regimens

Are we interrupting relations with Western partners?

In other words, drugs, mostly imported, which we all used to take, are now recommended to be replaced with generics, that is, analogues of Russian production. Not always an indisputable property. The intrigue is further aggravated by the fact that the next meeting of the government commission on Vital medicines on August 10 was once again postponed. The final list of medicines from the list of VED is a mystery shrouded in darkness.

The information letter of the Ministry of Health was eventually withdrawn, but many doctors took it as information for action.

«This is definitely a notification letter. It is very similar to the fact that we are interrupting all relations with Western partners. It is difficult logistically, unaffordable for the budget, given the ruble exchange rate… The costs for the state, apparently, outweighed all the advantages, » says Maxim Rykov, MD, oncologist.
«It is quite possible that Western companies will leave, » Vladislav Shafalinov, MD, shared with NI.

How useful or harmful generic — reproduced drugs are is a moot point. To begin with, a generic is a copy of the original drug. A company that has registered a drug with a new molecule or combination of molecules receives a patent and for some time may enjoy the exclusive right to produce this medicine. How much the properties of the drug change in this case is also a debatable question. However, public opinion polls show that more than 50% of patients who switched from the original drug to the generic drug had problems when replacing the drug (side effect, effect change). For example, patients note a change in the effect when prescribing an analogue of pulmicort — a drug that is used for asthma. «They are now giving asthmatics another drug. But even doctors say that he is worse, » Tatiana Efimova complains. Drugs that are used for hypertension also differ in properties. «I picked up an adequate minimum dose of Enalapril Hexal (Salutas Pharma Germany) and lived like a person… Now the drug produced by Novartis Neva is in pharmacies in the same packages. I can't figure out what's wrong. The condition after the reception is disgusting. Although our Nimesulide is three times cheaper, but in terms of quality, it does not reach the Cut at all. In general, when everything has been fine—tuned for years, it is very unpleasant to switch to other drugs, and this should not be the case ideally, » Marina Filatova complains.

Resuscitation after generic

The generic may differ from the original medicine depending on the source of raw materials or production technology. For some substances, this can lead to a significant change in pharmacological properties and, accordingly, effectiveness. It is transferred differently. The differences may depend on the excipients, and even on the packaging, which can be very important for stability during storage. For example, doctors of the Center for Pediatric Oncology and Hematology at the CSTO (Yekaterinburg) over the past two years have sent 19 notices to the regional Roszdravnadzor complaining about the quality of anticancer drugs and accompanying therapy drugs.

«Generics, or substitutes that are used in the treatment of cancer patients, have significantly more „side effects“. All over the world, only original drugs are used in oncology. Will the generic treatment protocol be effective? I'm not sure. Especially considering that the drugs used in oncology have a very high level of toxicity. This is especially critical for pediatric oncology. For example, when the original drug Vincristine was replaced with a domestic generic, patients began to complain: it is much harder to tolerate, » says Maxim Rykov, MD, oncologist.

Experts also pay attention to the fact that not all generics pass all phases of clinical trials.

«Now the EAEU, which includes Russia, has introduced such a concept as „extrapolation of testimony.“ That is, it seems like it is not necessary to prove the usefulness of the recreated analogue at all. Meanwhile, there are a lot of complaints from patients about generics. Especially for side effects. After all, everyone has different raw materials, production technology, too. Plus, monitoring of undesirable phenomena works very poorly for us. Here recently, the FAS recommended almost all diseases to be treated with activated charcoal. Allegedly, it removes toxins. There are many complaints about generics among patients with endocrine and cardiological diseases. For example, what kind of insulin to inject to diabetic patients is not at all indifferent, sometimes it is a matter of life and death, » says Alexander Saversky, head of the League of Patient Defenders, to NI.

The results of taking generics are often sad. To date, in Russia has already registered two fatal cases directly related to the use of unauthorized generics. Several patients who were diagnosed with cirrhosis of the liver with hepatitis C and who started taking unregistered copies of antiviral medications, after taking a generic drug, required emergency hospitalization in the intensive care unit due to liver failure.

Pill to pill discord

There is practically no monitoring of adverse events in generics, and no one can even really establish how harmful or useful a new drug is.

«For example, a vaccine is injected into a child, and he begins to have side effects, the baby does not feel well. And the doctor says: „This is not a vaccine, it's just that your child has most likely recently had ARVI, and the vaccine is good, “ says Alexander Saversky, head of the Patient Protection League.
In fairness, it should be noted that there are other opinions about generics. So, a well-known infectious disease specialist, Doctor of Medical Sciences Pavel Vorobyov believes: «The whole world lives on generics, and they are several times cheaper than the original. All new medicines undergo toxicological examination.»
«Generics are now used all over the world, they allow providing medicines to the maximum number of people. But there are fakes and low-quality production, it certainly needs to be fought. If falsification is carried out in an accelerated manner, this is another question, » State Duma deputy Alexey, surgeon, candidate of medical Sciences Alexey Kurinnoy told NI.

However, it is necessary to proceed primarily from the benefits for the patient — otherwise why take the medicine at all if it makes it worse? It is also saddening that geopolitics seems to have begun to invade medicine.