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Checking the authenticity of drugs by series online. Current list of low-quality drugs

I prepared this reminder for myself back in the fall, and decided to publish it after the post. poletta o using a false certificate. Perhaps it will be useful to someone.

How to check the authenticity of Herceptin from Roche/Ortat

First, there is a certificate at the pharmacy. Pharmacies are required to issue a certificate at the request of the buyer, and the law sets a period within which the pharmacy is obliged to do this (if my memory serves me, a maximum of three days). If the pharmacy refuses to do this or they answer: we’ll bring it in 2 weeks (and there have been such cases) - know that this is at least suspicious, and most likely not legal (I haven’t dug deeper into this topic, so there will be no link to the law). The pharmacy must either have a copy of the certificate or declaration of conformity, or the administration prepares the documents within several hours (this was the maximum period in a normal pharmacy). But often pharmacies themselves issue documents when purchasing an expensive medicine.

For convenience, I requested the data by phone, you can ask for it to be sent by mail, but then everything is double-checked when purchasing. If you check at a pharmacy, it is convenient to open links to sites on your phone in advance from the post below, so as not to slow down during the check.

So, to check we need: drug series , certificate number and registration date , in some cases they issue a declaration of conformity, which also contains useful information.

In the case of Herceptin, which is sold in the Russian Federation, we get:

Herceptin Ortate
Series №3715/3 (the series number may contain letters, in which case you must remember that this is Cyrillic)
Certificate No. ROSS RU.FM08.A02755
Certificate registration date: dd.mm.yyyy

What can you do with this information?

Check the drug series on the Roszdravnadzor website . The website has two sections: Medicines on sale and withdrawn medicines. This information will allow you to see when a given batch of medicine began to be sold or when it was withdrawn from sale (if it was withdrawn, of course).
Check certificate on the Pharmtechexpert website. Pharmtechexpert is a company that certifies Herceptin from Ortat/Roche; its name is indicated in the certificate. If you are testing another medicine, then most likely another company will certify it, and accordingly the website address will be different. The verification occurs based on the certificate number and the date of issue; if you do not enter the date or enter it with an error, the certificate will not pass verification.
Call Ortat for production (in the Kostroma region) and clarify what the actual packaging should look like for a given batch of goods . The last point appeared after a conversation with a hotline employee. I asked, isn’t it easy to fake a certificate? It’s just a piece of paper, and it’s easy to find out the attributes of a batch of medicine. The employee confirmed the concerns and suggested an additional method. As I understand, the company changes something in the packaging from time to time, or when a medicine is counterfeited, it is not possible to accurately copy the appearance of the packaging. Such changes may not be noticeable to the average buyer, but the manufacturer can tell you what to look for. In general, I never got to the last point, so I can’t evaluate the practicality of this advice.

I realized for myself that you need to buy expensive medicine from a pharmacy or a supplier you trust.

Counterfeit drugs, at best, simply will not bring any benefit; at worst, they can cause irreparable harm to health, even death. Medicines in pharmacies are checked for quality by the relevant regulatory authorities, but they are only able to cover about 20% of medicines. We will tell you in our article how to buy medicine at a pharmacy without counterfeiting.

Types of counterfeit medicines

There are 4 main types of counterfeit drugs in our pharmacies:

“Dummy” - drugs that do not contain the substances specified in the instructions. Usually chalk, flour, starch, and sugar are used instead. In principle, pacifiers are safe, but only until recovery depends on their use;

medicines in which more expensive and effective ingredients are replaced with less effective cheap analogues. The result from using such drugs is several times lower than expected;

with a reduced dosage of active ingredients. The positive effect of their use is negligible;

manufactured in violation of technology. The composition and dosage of such medicines are kept within normal limits, but the quality is quite poor due to non-compliance with the production regime. Such medications may have a shorter shelf life than indicated on the package or may have a weak effect.

Another case of “wrong” drugs that cannot be classified as counterfeit, but from which people suffer, is drug substitution. For example, instead of pills that lower blood pressure, the blister may contain pills that increase it.

For more information about counterfeit medicines, watch the video:

What drugs are counterfeited most often?

In most cases, drugs are counterfeited:

whose cost is in the price range from $4 to $35. There is no point in making very cheap ones, since their production simply may not pay off, and producing counterfeits of expensive drugs is unprofitable, since consumer demand for them is low;

actively advertised. Advertising stimulates demand and guarantees high levels of sales and profits.

In most cases, the following are fake: medicines in pharmacies:

Methods for identifying counterfeit drugs

Alas, there is no method that would allow us to select original pharmaceutical products and weed out counterfeit products with 100% probability. However, there are a number of rules that, if followed, will significantly reduce the chances of buying counterfeit medicines in pharmacies.

According to the law, in Ukraine and the Russian Federation, medications cannot be returned. However, you can return a low-quality medicine, but you will have to provide an expert opinion proving that you were sold a counterfeit medicine. In Ukraine, laboratory tests will have to be done at your own expense, but in Russia such a service is provided only to legal entities. So it is unlikely that you will be able to defend your right. Therefore, it is better to try to prevent this by checking medications in pharmacies before purchasing.

Instructions

Buy medications only from trusted pharmacies that have worked well for you and your friends. Under no circumstances take medications from your hands or from the market. Nowadays it has become popular to buy medicines -. On the one hand, it’s very convenient when you don’t have to rush around the city looking for the right product, but on the other hand, the risk of running into a fake is very high. Therefore, you should use such services very carefully.

When purchasing a medicine, carefully consider and study its packaging. It must be intact, undamaged, and made of high-quality material. All inscriptions and colors on it must be clear, crisp and bright. The name of the medicine and the active substance must exactly match what the doctor prescribed to you. If it is in at least one letter, then refuse to purchase this drug.

Look at the leaflet for the medicine. It should be printed, not photocopied. The text must be clear and easily readable. Again, the drug and active ingredient must match what the doctor prescribed. In modern medicines, it is folded in such a way that the blister or bottle is divided in half. In counterfeit drugs, both the annotation and the medicine itself are kept separately.

Check the batch, production date and expiration date indicated on the box and on the blister (or bottle). If the data does not match, then this is a fake.

Ask the seller for a certificate of conformity if you doubt the authenticity of the medicine. It must indicate the trade and international name of the product, the company and country where the medicine was produced, information that this batch has passed quality control and has a quality control certificate and a manufacturer’s quality certificate.

Ask your doctor who prescribed the drug to show you what it should look like. Manufacturers usually put various distinctive features on the packaging of their medicine in the form of a hologram, inscriptions on tablets, etc.

If the medicine is unknown to you, then study the information about it in the reference book of medicines (RLS). This directory has a section “Drug Identifier”, where there is not only information about all drugs, but also photographs of all dosage forms and packaging of those drugs that are most often at risk of counterfeiting.

An experiment on drug labeling began in six regions of the country on February 1. Following fur coats and alcohol, medicines will also have their own “black mark”. However, the mark is not completely black: the DataMatrix marking looks like a drawn labyrinth (see photo on the first page), it will be applied using a special printer to each package, complementing the existing barcode. The “pilot” will start with several types of medicines, and over time they will “tag” all the medicines produced in a row. Why is this necessary? What will it give to buyers? And, in the end, how much will it cost and will the drugs become more expensive?

In the Kaluga region, in the Vorsino industrial park, there is a modern pharmaceutical plant: several dozen types of tablets are produced and packaged here. Packs of tablets packaged in blisters run along the conveyor belt. Here is a printer that can “draw” a labyrinth of the required configuration in a split second.

“We support the idea of introducing markings, so we decided to enter the experiment without delay,” said production director Gennady Pyatsky. “Although the government decree has already entered into force, there are no precise instructions on the marking technology, and it is also not clear what data will be encoded in it. The product identifier, serial number and batch number, expiration date - this is a minimum. The system is flexible, it can “fit” a lot of information until the summer. Our equipment allows you to apply DataMatrix, because everything. Our factories - both in Europe and in Russia - are built according to the same standards and equipped in the same way. And in Europe they have been introducing such markings since 2010.” According to Pyatsky, if labeling rules similar to European ones are introduced on the Russian pharmaceutical market, the process here can go quite quickly and painlessly.

Why was it decided to choose a special two-dimensional DataMatrix code for marking? Firstly, this is not an expensive technology (according to calculations, the cost of one package of medicine will increase by 1-1.5 rubles, or, if we talk about drugs in the middle price segment, by only 1%). On the other hand, such identification will make it possible to automatically identify substandard and counterfeit medicines. Finally, thirdly, such labeling has already been introduced in European countries, Turkey, the USA, India, and Brazil. It is also being implemented in Ukraine - so a single type of drug identification will help different countries unite and better fight counterfeiting together. “In EU countries such marking is already mandatory; in any case, we print a two-dimensional code on all our products,” says Pyatsky.

“Labelling contains undoubted advantages for business,” says Dmitry Bagley, a specialist in marking technologies. “It will not only reduce the losses of bona fide manufacturers and sellers from counterfeit goods, but will also improve logistics, since it will be possible to quickly track the movement of goods.”

It is clear that special equipment will be needed to apply the markings. Equipping one production line, according to Dmitry Bagley, will cost pharmaceutical companies from 30 to 150 thousand euros. But the investments are long-term, and besides, thanks to labeling, manufacturers will reduce image losses from “fraudulent” drugs going on sale.

“Imagine: a person buys a medicine from a specific manufacturer, and inside there is a “dummy” that does not cure. But the patient does not know that he bought a counterfeit and transfers all the negativity to the pharmaceutical company indicated on the label,” explained Gennady Pyatsky. “That’s why all companies are interested that if a fake or counterfeit is discovered, this batch will be withdrawn from sale immediately. The barcode does not provide such efficiency, but DataMatrix - please put the scanner against the brand - and in a second you will receive an answer: is a particular pack of medicine legal or not.”

It is interesting that not only specialists - distributors, pharmacists - will be able to arrange such a “falsity” check. In the pharmacy there will be special scanners for each seller, and also publicly available in the sales area for customers. So anyone can verify the legality of the purchased medicine using such a scanner. Moreover, it will be possible to “read” the markings using a regular smartphone if you install a special application on it.

How much will DataMatrix cost the buyer?

The biggest concern is how the introduction of labeling will affect the price of the medicine. It’s one thing to label a fur coat worth several tens or even hundreds of thousands of rubles, and quite another when it comes to a socially significant product.

However, the experts interviewed by RG do not see a serious price threat in the innovation. “It is difficult to talk about the rise in prices of drugs due to labeling, since this percentage will vary for different drugs. We can only talk about the costs of applying labeling to the packaging, this is about 1.5 rubles without taking into account the costs of informatization and equipment necessary for the functioning of the system , from distributors and pharmacies,” says Sergey Shulyak, CEO of DSM Group.

The head of the Pharmacy Guild, Elena Nevolina, agrees with the expert. The cost of a scanner for a pharmacy is approximately 20 thousand rubles, the investment is feasible, and will not seriously affect the cost of medicines. “Of course, several scanners will be needed, but I think, since the program is state-owned, pharmacies will be helped with re-equipment,” Nevolina suggested. She recalled that from July 1, all pharmacies, like other retail enterprises, are switching to the use of new cash registers equipped with scanners to record trade turnover in the Federal Tax Service. “It is important that the equipment is compatible. If you have to work with two different scanners, there is a risk of errors,” the expert believes.

Help "RG"

Participation in the experiment was announced by: Moscow and the Moscow region, St. Petersburg, Nizhny Novgorod, Novgorod, Belgorod regions. The “pilot” included 23 pharmaceutical manufacturers, large distribution companies, over 30 hospitals and clinics and more than 250 pharmacies, including large chains.

The entire technological chain will have to be launched by June: install equipment and software, train specialists. And as we are ready to cover more and more names of drugs with labeling.

If the experiment justifies itself and the labeling covers all manufactured medicines, in a year the monitoring system will track about 6 billion packages of medicines and cover more than 350 thousand participants in the circulation, including about 1000 domestic and foreign drug manufacturers, over 100 thousand hospitals and 250 thousand pharmacies

On February 1, the government launched an experiment to label medicines with individual QR codes. Manufacturers will put them on each package, and the buyer will be able to check the origin of each specific box of medicine at the pharmacy. This is similar to how elite alcohol is now checked according to the Unified State Automated Information System.

So far, this experiment is voluntary and is being carried out in six regions: Moscow, Moscow region, St. Petersburg, Belgorod, Veliky and Nizhny Novgorod. The system will be tested on expensive and important drugs. Manufacturers, wholesalers and pharmacy chains will decide for themselves whether to install labeling equipment and code readers or not.

From 2018, drug labeling will become mandatory.

Cure for cunning 💉

How was it before?

Manufacturers and sellers are not required to label medications and enter codes into a unified system. The buyer could not verify that the blood pressure pills or cough syrup were genuine. Distributors and pharmacies did not have uniform control mechanisms.

What has changed?

The government has figured out how to protect drug buyers from counterfeits. Manufacturers will apply an individual security code to each package and indicate it in the general monitoring system. Using these codes, you can track the package from the factory to the pharmacy.

Distributors and pharmacy chains will be able to control the authenticity of each batch. Readers will be installed at points of sale so that customers can scan codes and check medications themselves. Later they will write an application for a smartphone to make checking even easier.

Who needs this and why?

The state needs it so that distributors and pharmacies do not sell counterfeit goods and pay taxes. If there are no counterfeits on the market, people will be healthier and less money will be needed from the budget for healthcare. Pharmacies and customers themselves will be able to identify counterfeits, and the state will save on inspections. Hospitals will not purchase drugs with an expiration date under government orders and will not waste budget money.

Manufacturers need this. When people buy a counterfeit product, the manufacturer does not receive any revenue. This revenue is received by some Chinese factory. The counterfeit product does not relieve pressure or headaches, and buyers stop trusting the brand. If there are no fakes on the market, manufacturers will receive more money.

Pharmacies need this. When customers think that a pharmacy sells counterfeits, they stop going there. If a counterfeit product is found in a pharmacy, it will be closed and fined. Counterfeits will be confiscated, and no one will compensate for losses. When the monitoring system starts working, pharmacies will check each batch themselves and reduce their risks. The system will notify you if the tablets have expired, and the pharmacist will send a request to the supplier in a timely manner. And pharmacies will earn more because customers will trust them.

Buyers need this. Medicines will no longer be counterfeited. Pharmacies will stop selling gelatin instead of vitamins and calcium gluconate instead of cholesterol pills. People will recover faster.

Why do an experiment? Let them immediately launch the scheme in all regions!

The experiment is needed to evaluate the performance of the equipment and information system. You need to test the software and find monitoring weaknesses. The Federal Tax Service, the Ministry of Telecom and Mass Communications and the Ministry of Health will learn to exchange data and reports. Pharmacy chains will gradually purchase readers and train employees.

Even during the experiment, the state calculates the costs and approves the list of equipment.

When the drug labeling law becomes mandatory, it will be convenient for everyone to work.

There is an experiment going on in my region. What should I do?

Check with pharmacies for the availability of a reader. If there is a reader, check your medications before paying at the checkout. If the pharmacy is not participating in the experiment, ask when it plans to join. The more customers ask these questions, the faster the pharmacy will install the equipment.