"Even expired drugs are used." How do people with cystic fibrosis live after original medicines disappeared in Russia

In November 2019, imported original medicines for people with cystic fibrosis began to disappear in Russia. Until now, these vital drugs have not returned to the Russian market. Now all that the funds and people with this disease have is the remnants of drugs in pharmacies and in warehouses, sometimes with an expired shelf life. “Such things” tell what difficulties patients face.

Cykovyskidosis in Russia

The genetic disease "cystic fibrosis" affects all organs secreting secrets. Healthy lungs produce mucus, which lubricates them and protects from bacteria, the pancreas with the help of mucous substance passes enzymes for digestion of food into the intestines. With cystic fibrosis, or cystic fibrosis, all the mucus in the body thickens, the food ceases to be absorbed, the child is rapidly losing weight, and its lungs are subject to severe infections.

According to the register of patients with cystic fibrosis in Russia, the average life expectancy of people with this disease in 2018 was 22.6 years. Until 2010, cystic fibrosis was not even in the list of diseases exempting from service in the Russian army, since with this diagnosis they rarely survived up to 18 years.

With the terminal stage of cystic fibrosis, a person stands in line for lung transplantation. Svetlana Belousova, coordinator of programs in the Assistance Fund for people with oxygen cystic fibrosis, says that in Russian patients this stage often occurs in childhood. “Among our wards there are children who need transplantation. In foreign countries they come to this after 20 years, ”said Svetlana.

"Patients agree to use expired drugs"

According to Belousova, the terminal stage of the disease occurs in patients already in childhood, including due to the quality of generics-substitutes for original drugs. “In Europe, there are two or three truly high-quality generics for one original drug, and we have [original] medicines that account for 18-30 generies. Who checks their quality? Are they really checked? " - says Belousova.

To feel normally, a person with cystic fibrosis must take antibiotics, mucolytics - sputum dilution, enzymes and special nutrition with high calorie content. Medicines are especially important during the exacerbation of the disease. Patients say that since November 2019, expensive medicines have become almost unattainable: it has become unprofitable for one foreign companies to sell them in Russia, while others have gone to re -register.

Belousova indicates that in many cases, generics either do not act or worsen the patient's condition. “There are those [wards of the fund] who did not come out of exacerbation on these drugs, there are those who have intensified, there are those who have gone terrible side effects. We treat, say, an exacerbation that develops in the lungs, ”the liver or gall bladder refuses,” says Belousova.

In such a situation, the oxygen fund has to be content with those drugs that can still be found. “Patients agree, as in the distant 90s, to use expired [original] drugs so that there is at least some chance to get out. Even the distributors who have never given an expired drug to anyone, now they give it to us, and people accept at least something, while there is nothing, ”Belousov comments.

The regional Ministry of Health did not issue the drug

In 2017, a son George was born in the family of Oksana and Vladimir Kamanins from Sochi. Even during pregnancy, he found intestinal obstruction. Immediately after childbirth, he had surgery in Krasnodar, after which the doctors decided that Goshi had atresia (obstruction. - approx. TD ) of the biliary tract. The Kamanins went to the second operation in Moscow, and only on the operating table did the doctors find out that the diagnosis was made erroneous. At 10 months, churexicidosis was diagnosed with Gaucher. During pregnancy, Oksana already reported suspicion of disease. “When I came to a consultation with the genetics, they told me:“ Why do you need to take an analysis? To interrupt it is too late, ” Kamanina recalls. In the first months of the child’s life, all the screening were clean.

While the Kamanins traveled around the hospitals, Gosha was infected with a blue -legged stick - a pathogenic bacterium, which is dangerous for patients with cystic fibrosis. The bacterium was not sensitive to all antibiotics, except for “colistine”. In November 2019, the Kamanins received a letter from the manufacturer Teva: Kolistin goes to re -register, in connection with the change in production sites, the company must pass the commission, and there will be no supplies until spring. In April, the letter came again with information about extended terms: now the drug will not be until June. On November 22, Kamanins received two packages of Kolistin from the Ministry of Health of the Krasnodar Territory, but they were enough until March 1. The need to look for antibiotics remains.

The attending physician prescribed Gosher "Kolistiflex" - a high -quality German counterpart "Kolistina", not registered in Russia. The Kamanins received a personal document on their son, indicating that the Ministry of Health of the Russian Federation approved the transfer of 22 packages of the drug to the family. In December 2019, Kamanin held a federal consultation in the Federal State Budgetary Institution “Medical and Genetical Scientific Center named after Academician N.P. Bochkov”. “A lot of respected people, the chief freelance geneticist of the Ministry of Health of the Russian Federation Professor Sergey Kutsev, the head of the scientific and clinical department of the micactocidosis of the MSTC Elena Kondratyeva-specialists who maintained the science of cystic fibrous in Russia,” confirmed that the child needs the drug, ”Kamanina notes.

Based on this conclusion, Kamanin turned to the Ministry of Health of the Krasnodar Territory with a request to provide the child with “colistiflex”, but they were refused that the family had already allocated two packages of Kolistin. Despite the same active substance - sodium coli -metathetics, these are different drugs. “Constructiflex” is suitable for intravenous injections shown by Gaucher, but the issued “Kolistin” - no.

Court with the Ministry of Health of the Krasnodar Territory

Kamanins sought drugs for more than six months. At first they sued the Ministry of Health of the Krasnodar Territory and won it. The court decision was transferred to the bailiffs with the wording “immediately”: the next day the regional Ministry of Health was obliged to carry out claims. On the last possible to appeal the court decision, the ministry appealed to the court with the same wording with which it lost. “The court unleashed his hands on the Ministry of Health of the Krasnodar Territory: by a court decision, they were given the right to [purchase an unregistered drug]. Why an appeal in which the same words: "We have no right"? " - Comments Kamanin.

The family sent an appeal to the President of the Russian Federation to the Ministry of Health of the Russian Federation, Roszdravnadzor of the Russian Federation and the Krasnodar Territory, the administration and prosecutor's office of the Krasnodar Territory, authorized to protect children. “In the correspondence with Roszdravnadzor the region answered us that they were not engaged in the courts. We wrote that the rights of the child are violated, he does not receive the antibacterial therapy laid for him according to life indications, he may die. Roszdravnadzor must control the provision of medical care, but they replied that they were not endowed with the authority to take measures to enforce the court decision, ”says Kamanina. After a long correspondence, Roszdravnadzor still made a warning to the Ministry of Health of the Krasnodar Territory.

Once in the middle of April, the second - in mid -May, the bailiffs sent a warning of criminal liability with a fine of 50 thousand rubles to the Kuban Ministry of Health and to issue the drug immediately, but the family received Kolistiflex only at the end of June. These drugs are enough for three months, after which they will be required again. “The bailiff says that it will be easier further,” says Kamanina. - The first experience was difficult. But I do not fully understand how the medicine scheme will work. Will it be necessary to go to court again? "

Cystic fibrosis during pandemia

The Kamanins family encountered another problem: the recipient of Fortum - the second drug recommended by Gauche - a children's regional hospital in Krasnodar, and so far it is possible to take a course of droppers only there. However, people with cystic fibrosis are not recommended without the need to contact a hospital flora due to a high risk of infection. The Kamanins wrote a letter to the Ministry of Health of the Krasnodar Territory with a request to take a drop of droppers in the clinic of Sochi without hospitalization, but they were refused. “During the pandemic, a special risk for a child with problems with the lungs, we must risk his health and take him to Krasnodar. What is the need for this if you can make this dropper in your clinic without enduring the child without distracting doctors? ” - Comments Kamanin.

In the midst of the pandemic, part of hospitals suitable for hospitalization of patients with cystic fibrosis, including the Research Institute of Pulmonology based on GKB No. 57, where people with cystic fibrosis from all over the country come, re-equipped under Covid-19. There were situations when the exacerbation of cystic fibrous was confused with coronavirus due to a similar picture in computed tomography. So, Lera Ivleva, the ward of the Oxygen Foundation, mistakenlygot into the Covid detachment of the Yaroslavl hospital, where the doctors did not know how to correctly configure the non-invasive ventilation apparatus.

“Initially, the hospital had the necessary equipment, albeit a little outdated, but it approached. Doctors put on another regime, and Lera could not breathe, she was choking. Each breath is an effort, and in a state of exacerbation, when already wild weakness, inflammation, temperature and low saturation (blood saturation with oxygen. - Approx. TD ), getting a sip of air is a non -trivial task, ”says Belousova.

Gradually, hospitals are opened, the equipment is tuned, but the issue of obtaining drugs is still acute. “The most important thing is to understand that we are not to blame for the diseases of our children. We must protect their interests, but the state is in no hurry to help us in this. Unfortunately, it only interferes. But from this we do not become wrong, ”Kamanina concludes.