Either cure or kill

In Russia, a center for monitoring of the side effects of drugs appeared - pharmacon supervision at the College of Roszdravnadzor, held in the last week of September, a center for monitoring the side effects of drugs was created - pharmacon supervision. He will be headed by a member of the RAMS, Professor Vladimir Lepakhin. The Monitoring Center will operate on the basis of the FSU Scientific Center for Expertise of Medical Application. The main goal of the new unit will be the collection of statistics on the harmful effects of drugs on the human body.

There are no statistics

The thoughtless prescription and consumption of drugs (drugs), according to the European journal of clinical pharmacology, not only does not cure the patient, but, for example, brings to residents of the United States such new problems in the form of undesirable side effects, which in 70% of cases require the use of other, additional drugs. But the worst thing is that 0.32% of all patients entering hospitals die from medicinal complications.

In Russia, with practically free sale of prescription drugs in pharmacies, the widespread uncontrolled consumption of side effects from the drugs should be recorded no less, but there is no such statistics today.

Professor Vladimir Lepakhin, who has been involved in this problem for many years as a special representative of the Director General of the WHO in Russia, believes that at least 40-60 thousand reports of side effects should come from Russian doctors, and only 400 messages came from enthusiasts in 2006, 2005-200.

“In the field of drug circulation, we are no different from European countries, only the data collection and analysis system in the Russian Federation is not established,” said Vladimir Lepakhin. “For this, the Federal Monitoring Center is created.” “You should not think that all Russian doctors are lobbied by the pharmaceutical industry and will not report information about the side effects of drugs,” he said in an interview with the newspaper. “Firstly, we have more than 600 thousand doctors, and this is their duty, civilian and professional duty. There are already some experience of such monitoring centers in Omsk and Moslavinsk. Secondly, it is important for the pharmaceutical companies themselves to know The truth about already registered drugs in order to prevent disaster. "

Memo to the patient The annotation for drugs always contains information on the rules of the release of the drug. Even if the pharmacy sells drugs without a prescription, you should not self -medicate if there is a warning inscription in the annotation: "Apply as prescribed by a doctor." Consult with a specialist. In addition, the patient should always be alarming for a simultaneous administration of more than three drugs. It is necessary to check whether the various forms of drugs are written out - syrup, tablets, suppositories - options for the drug with the same chemical formula. If, when taking, effects such as itching, vomiting or other unpleasant consequences are observed, first of all, stop taking the drug and report your sensations to the doctor. If the condition worsens sharply, call an ambulance. Do not throw back the packaging of drugs before her arrival.

There are many examples of such pharmaceutical disasters. The tragedy with talidomide occurred in the 1960s: Americans who took the drug during pregnancy gave birth to children with congenital heavy anomalies. This case has increased attention to the problem of drug control. Talidomide was discontinued in 1962 (US FDA agency controlled its use again allowed its use for the treatment of Liah in 1998). At this time, the services of pharmacon supervision appeared.

In the USSR, the Functions of the Pharmacon supervision was performed by the All -Union Center for the study of the side effects of drugs (the All -Russian Central Executive Committee): it received about 1.5 thousand messages per year, he published a specialized journal, and helped in the creation of regional centers. After the collapse of the USSR, the All -Russian Central Executive Committee was dissolved, and an information vacuum was formed. Researchers saved only the opportunity to use WHO messages. For doctors, the databases of Coran -Cooperation, which have evidence -based data of randomized studies, are also always available. But these bases do not always allow you to identify the true picture of the frequency of adverse reactions when using drugs in Russian hospitals and clinics.

Of course, certain studies in this area were conducted. So, at the Department of Clinical Pharmacology of the RSMU, a retrospective analysis of 810 stories of patients older than 18 years of age (311 women and 499 men) was carried out. The average age of patients was 48.5 years. The data obtained allowed scientists to argue that the use of OFF-Label (not for its intended purpose) antibiotics statistically reliably lengthened the recovery from 16.5 to 18.7 days. In addition, it was established that adverse reactions not only slow down the recovery, but the dependence became clear: the more drugs are used in the treatment of each patient, the more its risk becomes reactions that deviate from the instructions. This is costly and not beneficial to either the patient or the health care of Russia as a whole.

Pharmbusiness is also interested

Today, 97 states participate in the WHO program for international monitoring of drugs. As a rule, the work is financed by the state, or these functions are transferred to a special agency along with financing. It is especially important that the structure independent of the pharmine industry is engaged in this work.

Pharmacoadzor and pharmaceutical business, of course, are not enemies, although there is a conflict of interest. Solid manufacturers of drugs are interested in the earlier detection of serious side effects of the drug that are not detected in clinical trials. You can make restrictions on the annotation, in the end, to withdraw the drug from the market and avoid multimillion -dollar lawsuits.

So, for example, the Rezulin diabetics drug was produced by Warner-Lambert, which was acquired by Pfizer in the summer of 2000. The medicine has been on the pharmaceutical market from 1997 to the spring of 2000. Rezulin was removed from the sale after the FDA received data indicating that the drug can negatively affect the patient's liver. Doctors recorded 63 cases of death of diabetics from liver diseases, the cause of which could presumably be the intake of Rezulin. About 4.5 thousand people filed claims against the company in connection with the side effect of Rezulin. Part of the lawsuit against Pfizer was settled out of court, a number of families received tens of millions of dollars as compensations.

The sad experience of the pharmaceutical company American Home Products is known, which was forced to direct $ 13.2 billion to resolve lawsuits aroused in connection with the side effects of its weight loss - Fen -Phen.

We can cite numerous examples that scandals on side effects resulted in the decline in the cost of shares of companies in the market. Treatment of side effects of drugs always leads to significant costs in healthcare. In the secondary school, the cost of treatment of all side effects of drugs per year is from $ 76 million to $ 177 million, while comparison, the cost of treatment of diabetes of all patients in the country is $ 45.2 million, and cardiovascular diseases - $ 117-154 million.

01.10.2007 / Irina Vlasova, the material was published in the "newspaper" No. 183 dated 02.10.2007.