Russia may introduce a “covid” moratorium on drug labeling

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The State Duma deputies proposed to Deputy Prime Minister Tatyana Golikova to introduce a moratorium on monitoring the movement of medicines (MDLP) until the epidemiological situation in the country stabilizes. Regular failures of the labeling system lead to an acute shortage of drugs in pharmacies, including those needed to treat COVID-19.

Harnessed for a long time, drove slowly

how reports “Parlamentskaya Gazeta”, the deputies also called for the abolition of fines imposed on pharmacies for violations of the rules for submitting data to the labeling system and not to introduce new ones until the pandemic is over. The MPs cite a large number of complaints about a shortage of drugs in pharmacies, including those needed to treat coronavirus.

“Starting from October 5, a 4-fold increase in demand for antiviral and symptomatic drugs of seasonal demand has been recorded throughout the country,” the appeal says.

Today, a collective letter of similar content was sent to Prime Minister Mikhail Mishustin by the heads of nine industry associations and the All-Russian Union of Public Associations of Patients. According to “Pharmaceutical Bulletin”, the authors of the petition asked to develop a special procedure for the IMDLP during a pandemic and leave the opportunity for a temporary supply of unlabeled products in exceptional cases in the absence of similar labeled drugs.

The experiment on mandatory labeling of drugs began in 2017, on October 1, 2019, the procedure became mandatory for some drugs, and from July 1, 2020 – for all others. Long-term preparation of the system’s operation did not eliminate problems: in the fall, pharmacies and distributors began to complain about failures in the IMDLP and talk about the fact that labeling could lead to a shortage of medicines.

One of the biggest system failures happened On September 30th, the uploaded drug data was lost, after which the delivery of labeled drugs was delayed. To date, a little more than a third of the lost data has been recovered. A similar incident happened on June 26, when some of the labeled drugs were blocked. On October 22, during a meeting of the State Duma, Deputy Minister of Health Natalya Khorova acknowledged that there were interruptions in the provision of necessary medicines to the regions.

Center for the Development of Advanced Technologies (CRPT), which is the operator of the drug labeling system, explained interruptions in the sale of drugs for fear of pharmacy chains to violate the rules for the circulation of labeled goods and incur a fine for this.

“Not even lidocaine”

For the end consumer, failures in the system turn into the inability to buy the necessary medicines, including those recommended by the Ministry of Health for the treatment of coronavirus. According to “Novaya Gazeta”, in pharmacies there is a shortage of antibiotics necessary to prevent bacterial lungs with COVID-19.

“Our sumamed is at the customs. TEVA owes us 30 thousand packages. Hundreds of thousands of packages of sumamed are in customs warehouses, and they cannot release them on the market, “the publication quotes the general director of the Farmland chain Adelya Kalmetyeva.

“There are no antibiotics, no anticoagulants, not even lidocaine. The manufacturer has a half-baked product, and he cannot release the product on the market, because he has not received the codes, and the pharmacy cannot register, because he also did not receive the codes, ”the expert said.

System failures can even lead to a shortage of dexamethasone, a steroid needed to prevent a cytokine storm.

The initiative to introduce a moratorium on drug labeling is supported by many participants in the pharmaceutical market.

“The second wave of the epidemic is not the right moment for drug shortages” – quotes Forbes General Director of the network of pharmacies “36.6” Alexander Kuzin.

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