Labeling or life: why Russian pharmacies run out of medicines

Irina Mishina

In the context of the pandemic, Russia found itself virtually without essential medicines. At the disposal of our editors were panicky letters from pharmaceutical companies - manufacturers due to the inability to supply vital medicines to Russia. They were provided by NI, the Patient Rights League.

- “ JSC Gedeon Richter RUS is forced to deploy vehicles from the border of the Russian Federation due to the lack of 613 messages in the MDLP system (marking, ed.). From September 30, it is expected that the problem with the release of vital and essential medicines (VED) into civilian circulation is expected. Every day the company addresses the responsible persons, but there is still no solution. "

“The goods cannot be cleared through customs, they are in pharmacy warehouses (they cannot be put into circulation), the goods are in distributors' warehouses. The volume of stuck goods is estimated at millions of packages. There is no cure in a pandemic . "

- “ Registration of the shipment of 16 thousand packages of Coronavir does not pass due to an error in the identification tool. The leadership of the CLO of the Moscow Healthcare Department is sounding the alarm, because they urgently need to ship goods that they cannot accept due to this problem. "

As we managed to find out, the pharmaceutical company Gedeon Richter Rus announced the suspension of drug supplies to Russia until approximately October 29-30. This is due to technical failures in the system for monitoring the movement of medicinal products (MSDS), which began at the end of September. It was a difficult decision for the company, but it was impossible to carry out the customs procedure under the current conditions.

What actually happened?

On December 27, 2019, Federal Law No. 462-FZ “On Amendments to the Federal Law“ On Circulation of Medicines ”came into force. According to this document, labeling of medicinal products with an identification tool (DataMatrix code) became mandatory from July 1, 2020. The purpose of drug labeling is to protect the population from counterfeit, substandard and counterfeit drugs coming into circulation.

Preparations for the launch of the labeling system began a long time ago, a year ago: pharmacies were equipped with special scanners for reading bar codes, tested the system with distributors, and trained personnel. The development team spent about 40 million rubles on preparation, but problems and failures were still not avoided. The monitoring system could not cope with the load, systematic technical failures slowed down the processing of documents. Now the developers are "on their knees" trying to make some changes, but at this moment the system is unavailable for 4-5 hours. During the crash on September 30, it completely hung for two days. In addition, technical work often takes place without warning. All this leads to a reduction in sales at each outlet and in the chain as a whole.

“You need to read the QR code for each package accepted. And there are many of them, and the code is not always read the first time. Every day, up to 100,000 packages are accepted at the Eapteka warehouse, the acceptance process has slowed down 6-8 times. There are huge problems in our networks in all 76 cities of Russia, ”complains Vasily Artamonov, executive director of the Eapteka network of online pharmacies.

A paradoxical situation has developed: in the context of a pandemic, we actually found ourselves without drugs.

“As far as I know, 14 billion rubles were spent on the provision of the drug labeling system . And now this system is failing. Billions down the drain. As a result, the drug market in Russia has practically collapsed. We launched the labeling system from July 1. And then it turned out that it didn't work! Pharmacies cannot accept manufacturer's medicines. Now they are selling stocks that were purchased earlier. There are no new drugs. The most unpleasant thing in this story is that pharmacies cannot accept new drugs for the coronavirus, ” Aleksandr Saversky, head of the League for the Protection of Patients' Rights , told NI .

“Failures in the labeling system lead to a shortage of medicines in the regions,” said Olga Khrutskaya , chairman of the board of the Novgorod Professional Association of Pharmaceutical Workers, director of the NV Pharmacy House chain (Veliky Novgorod) . - The population was left without medicines. And these medicines are not recorded in the quarantine zone for two weeks , ”said O. Khrutskaya.

The expert believes that in such a situation, the project on monitoring the movement of drugs should be suspended for a year, and then "resumed taking into account errors and failure analysis."

SOS signals come from different regions. The shortage of medicines in retail trade became one of the issues at the meeting of the government of the Perm Territory. This was acknowledged by the head of the region Dmitry Makhonin. “The problem lies in the plane of the labeling. We have informed the federal government about this. We believe that work here needs to be structured more clearly, ”the head of the region believes.

"NI" sent a request for ways out of the situation to the Moscow Department of Health. At the time of publication of the material, no response had been received. The appeal of colleagues from "Pharmaceutical Bulletin" to the Ministry of Health of Russia also remained unanswered.

At the disposal of our editors is a document that the Association of International Pharmaceutical Manufacturers sent to the deputy. V. Kosenko, Head of the Federal Service for Surveillance in Healthcare of the Russian Federation . It proposes to urgently convene a working group to conduct an experiment with drug labeling. In conclusion, the Executive Director of the Association writes: " In the current critical situation, when the operation of the MDLP system is actually paralyzed ... it seems necessary to immediately amend the regulatory legal acts in terms of temporary reduction of operations for market participants, prolongation of the possibility of delivering unmarked products ... until the operator normalizes the system operation " ...

Meanwhile, a glitch in the labeling system created another problem - drug shortages, which immediately affected selling prices. The cost of some drugs has increased several times. So, the purchase of an antiviral drug at a pharmacy, personal protective equipment (5 pairs of gloves and 10 masks), as well as a means to relieve a sore throat cost me the other day in the Gorzdrav network almost 2 thousand rubles.

“These are producer prices. Pharmacies sell medicines at factory price, you can ask him all these questions, "- said" NO "and spolnitelny director of the Russian Association of Pharmacy Chains (RAAS) Nelly Ignatieff. She refused to continue the conversation, citing busyness.

But 2 thousand for 2 medicines for colds and personal protective equipment are still mere pennies in comparison with the drugs that are included in the treatment protocol for coronavirus infection. As you know, in Russia at the end of September several drugs for the outpatient treatment of Covid-19 appeared in pharmacies at once : Areplivir, Coronavir and Avifavir. The declared cost of drugs was 12.3 thousand, 11.5 thousand and 8 thousand rubles, respectively . Manufacturers explained the price by the complexity of the synthesis of the active substance. It is clear that very few people have the opportunity to treat coronavirus for such amounts. And the Ministry of Health made, probably, one of the most useful decisions in recent years: it included Favipiravir, the main active ingredient of all drugs for COVID-19 approved for use in the Russian Federation, in the list of vital and essential drugs and registered the maximum prices for drugs for coronavirus. However, with the caveat: "The maximum selling prices do not include value added tax (VAT), wholesale and retail markups." It is reported that preparations containing Favipiravir in a dosage of 200 milligrams will cost 1,000 rubles for 10 tablets. A package of 40 tablets will cost 4 thousand rubles. In addition, on March 26, 2020, Federal Law No. 67-FZ "On Amendments to Article 60 of the Federal Law" On the Circulation of Medicines "and Article 38 of the Federal Law" On the Fundamentals of Health Protection of Citizens in the Russian Federation "were adopted . : in the event of an emergency or the emergence of a threat of the spread of a dangerous disease, the Government of the Russian Federation has the right to set maximum selling prices for drugs that are not included in the list of vital and essential drugs.In other words, this bill allows the government of the Russian Federation in emergency situations to make a decision to fix the price of drugs for up to 90 days ...

We decided to check how the government's decisions on fixed prices for drugs containing Favipiravir are being implemented. And what? The Gorzdrav network told us that Favipiravir had just finished, it was on sale at a price of 11 320 rubles . In the network of Internet pharmacies "Main is Health" (ProjectGN), Favipiravir was sold at a price of 11 thousand 900 rubles per pack (30 tablets). In the network of Internet pharmacies Natco24, Favipiravir appeared at a price of 16 thousand rubles per pack (30 tablets).

How so?

“If a drug is included in the VED list and a maximum price is set for it, the pharmacy chain has no right to change it. This is a violation that must be immediately reported to Roszdravnadzor. The reason for the "cheating" of prices for drugs for coronavirus can be explained, firstly, by advertising, and secondly, by the fact that they are included in treatment protocols. Each such case must be suppressed, reported in the media and in the supervisory authorities, ”said Alexei Starchenko , a member of the Public Council for the Protection of Patients' Rights at Roszdravnadzor, Doctor of Economics.

But visitors to pharmacies in a pandemic are ready for any sacrifice for the sake of health. Pharmacy chains are well aware of this and are taking advantage of the moment. And the Ministry of Health, it seems, is just watching the ongoing drug collapse in a rather philosophical and detached way. To date, this department has not taken even one radical step to provide the population with affordable medicines. And the labeling, which turned into wasted billions and a shortage of drugs during the pandemic, was somehow unobtrusively transferred into the format of discussions and video conferencing.

And now I'll make you laugh. The other day, a "covid brigade" arrived at a member of my family. After filling out the quarantine papers, we asked the question whether any recommendations for treatment or medications would be issued. “Take arbidol, we have plenty of it with us! - answered the doctor. “Why is that?” I asked. - Nobody takes it. And now it is a rare success to get real drugs for coronavirus at an affordable price. So my advice to you is: drink some water and the disease will go away! "