On this answer I tried to give the experts in the field of medicine.
The beginning of the XXI century in which we live, pleased former residents of the Soviet system an important achievement – a large selection of different products. And if the quality of the products, clothing or even technology, we more or less learned to understand, and sometimes to demand it, the quality of the medicines we have still a big problem.
Even worse, the practice shows that the visitors of pharmacies often become victims of banal desire to earn on our health and lives, and we, instead of having to require medications that will really help us, continue to buy the dummy medication, or even drugs that can bring our health harm instead of good.
How to cheat the pharmacists – those who seek to save us from our ills in today’s article in the category “Browser. Medabot”.
Original drugs and analogues – what is the difference?
We know the difference between a Ford and a Cossack and do we know, what is different, for example, the original drug from analog, or as they call them pharmacists – generic?
Pharmacists and doctors assure us that there is no difference, then why is the original antibiotic – treated, and copies of them just ruin the liver. Came to the pharmacy and horrified from the high prices of the drug (vague principles of medicines pricing is another big separate topic of conversation), we agree to the proposal of a pharmacist to buy a copy of it and replacing it with more cheap. My conscience is clear, skim the instructions, the rest is well written, specific contraindications or side effects. And buy.
However, inflammation from the throat moves into the bronchi, the cough increases, health deteriorates, and the doctor is puzzled – why is this happening, because he has appointed quite a strong antibiotic. But it turns out that the patient is prescribed the drug they bought another, and wonders why the recovery is not happening. A possible side effect may occur such that after undergoing the common cold will have to treat the liver or even restore the quality of the blood. That is – not only that we are given an ineffective drug, but also do not indicate to the user any side effects.
In the end, the doctor wonders why his treatment is not working, the patient considers the doctor an idiot who can’t heal, and his health is deteriorating. Profit in this situation receive only the pharmaceutical business and the pharmacy network. Well, even the officials who work without straining such things as the quality and effectiveness of drugs, and even more – tracking the veracity of the information in the instructions or control for side effects of drugs in circulation.
What is the difference between the original drug and a generic equivalent?
In order to market the original drug, synthesizing a new molecule before releasing it to the market in the form of medications in the package is up to 10 years, and is this process from $ 500 million to $ 1 billion. Of course, there are only large companies and such in the world only a few dozen, and in the year produced only about 10 to 15 new molecules.
Is it any wonder that the original medications are so expensive? Because during this time the drug is undergoing a lot of research. Dozens of molecules are eliminated as ineffective, sometimes even in the last stages of clinical trials. As a consequence, the market entry must “recapture” all expenses of the company. So after the release to the market some time the drug has a so-called “right of patent protection” – that is the time, usually 10-20 years, when other pharmaceutical companies are prohibited to copy and sell.
Once patent protection ends if the drug has shown itself really effective, dozens of companies are beginning to release its copy – “analogues”, “generics”. Of course, the cost they had disproportionately less because the drug is cheap. The price difference is something like this – if the original is 300 UAH, the analogue may cost 30-40 UAH. However, this difference is often justified because the original is almost a perfect drug, has a minimum of side reactions and has a high efficiency. But for the production of copies of such effort is not necessary – the manufacturer simply makes a clone, using someone else’s formula. But the formula can be copied, but the technology is not. Therefore, the generic often has a different effectiveness and different side effects that what is called multiply their use for the same zero.
Alas, wanting to simplify my problem, companies that produce analogues, not too concerned about the quality and effectiveness of the drug. And regulatory authorities often does not resemble Asclepius with weights in the hands, but rather the justice with the blindfold, carefully oblivious to the questionable effect of treatment with such drugs, no unspecified side effects or contraindications that are hurting people or other lies in the instructions.
Lies in the instructions
Market researchers in different countries of the world interested in this topic. And even in neighboring Russia, despite all its shortcomings, unlike us, decided to find out – what is the difference between originals and counterparts.
The researchers of the company “Kordag” and Medical Academy after S. I. Georgievsky (RF) undertook an analysis of the instructions to medicines.
As it turned out after a study of 11 thousand instructions, many manufacturers do not report serious contraindications to the use of the drug than directly jeopardize their health and sometimes life.
Thus, the Russian state life were considered, the difference between the original drug and generic the example of the drug under the name no-Spa. The main active ingredient – drotaverine. This so-called international non-proprietary name of the substance, which is the basis of several dozen trade names of medicines – they are known as “no-Spa”, “Spasma”, “Spaceman”, “Driverin”. This means that relieves spasms of smooth muscles, and along with them – and the pain these spasms cause. All of these drugs have the same medicinal formula. Initially, the company “Chinoin” (Hungary) invented the formula and released to the market an innovative drug, and then other pharmaceutical companies this formula was copied and put on the market generic medicines, or copy.
And these drugs hundreds. The idea is that they must all have the same instructions. What’s more – your copy should have more side effects and contraindications, but often the opposite is true – the instructions to the original more detailed, simply – manufacturers of the originals more responsible and honest towards their patients.
What is written in the instructions to numerous drotaverina?
The use of drotaverine in childbirth. The study says: “There is evidence that the reception of drotaverine in the form of injections during labor and delivery increases the amount of bleeding”. What we see in the instructions? – only 47% of producers give this information, others are limited to modest “to use in childbirth is possible, but with caution.”
This applies to the injection of the drug. Manufacturers of drotaverine tablets more concise, and the instructions to them, only 9% of producers indicate that its use in childbirth is prohibited. The remaining 91% did nothing about it – apparently, to save ink or paper.
The use of drotaverine during pregnancy. As much as 6% of manufacturers wrote that during pregnancy it can not be used. Other write that can only cautiously. What does the word “caution” in the use of the two lives, is unclear.
The instructions drotaverine tablets a wide variety of opinions on this subject. So, 1 producer, wrote that the use during pregnancy. 2 – what is not in the first trimester of pregnancy. 1 – nothing writes about it. Others use the meaningless phrase whose purpose is simply to shift the responsibility for the possible consequences on the patient – the “apply with caution”. That is to take a pill and then go to the hospital for safekeeping? A mystery never solved.
The use of drotaverine in children. 65% of manufacturers of drotaverine (injection and tablets) have restrictions on age, all – different (is prohibited the use of up to 3 years up to 6, 12 and even up to 18. The rest, or still, or they believe that the use of this drug there are no age restrictions.
To estimate the order of the instructions in the study used the Shannon index (measure of diversity). The higher the index, the greater the chaos in the document.
Discrepancies in the instructions recognized by all. Doctors note – self-treatment among the patients is quite common, often succumbing to television advertising. Therefore, the concealment of truthful information in the instructions to the drug carries additional risks.
Doctors prefer to prescribe the original drugs to ensure their effectiveness. After all, they know how big the difference between the large scale tests, which are original pharmaceutical company. Thus the user of the originals are always more detailed and conscientious.
Although doctors recognize and in some cases generics are not worse than the originals. But this is the exception rather than the rule.
Who monitors the effectiveness and quality of medicines in Ukraine?
If in other countries this problem has already been noticed, that in Ukraine the quality and effectiveness of drugs is not controlled. It is not an exaggeration. Outright ban on inspections of pharmacies, manufacturers and distributors valid from 2014.
But we at the Ministry of health is for two of the authority that should care of the quality and efficacy of medicines. Is GP the State expert centre (hereinafter – SEC) and the State service on drugs and drug control (hereinafter – Gosleksluzhba).
The first entity or state enterprise detects drugs and the idea is that even when registration needs to weed out the inefficient. Also after the drug is registered, it GETS track side effects and in this organ must be removed from the register, if doctors and patients poured their grievances on the quality of the drug, a so – called pharmacovigilance system. However, remember if someone of us at least one case, the medication in Ukraine was removed from the register for too many side effects?
Experts recall the sad situation of nimesulide (a drug that is used as an anti-inflammatory agent in children). These powders, which upon dissolution become sweet water, well and at one time was very popular with parents. However, in children nimesulide hurts more than helps, as it is very toxic to the liver. Therefore, in Europe its use is limited to 12 long years. And the forums are mentioned cases when the child is then medication for 3 months in a coma.
But in other countries this system works, and quite successfully. The case when for many years in our market felt good the drug Bioparox. The French company, the Laboratory Servier, which it produces, has sent in 2016-m to year in all countries of the requirement to withdraw it from circulation. The reason is that in European countries, revealed a huge number of these side effects that were not indicated in the instructions. Some of the victims died.
Why in Ukraine is not known that there were complaints from doctors and patients on excessive effects from the use of Bioparox? Or Ukrainians he was affected differently than the people of Western Europe? Or maybe just the EMA (European medicines Agency) just can cope better with their responsibilities than domestic officials?
In the Republic all the more sadder. Their task is to issue licenses to companies that produce drugs, as well as distributors and pharmacies. The license is unlimited. Yet they are supposed to monitor the quality of drugs, – that is to regularly take the test in their laboratory medicine, checking whether their composition is the same substance that was claimed by the manufacturer when registering, or there has long been an active substance, and empty? Unfortunately, in 2014, the year nobody does it. Although Prepared in 2011 among the member countries of the organization, which United all the organs that control in their countries, the quality of drugs according to the most stringent requirements in the world (PIC/S), however, for several years, the quality of the medicines we have not checked. The word “all”. So we can only hope on the honesty of manufacturers – because there is no one to protect us.
That is why almost every week we read in the news about the next revealed by militiamen of the party of counterfeit drugs, and no this is not scary and not shocking. And doctors ceased to wonder why the meds stopped working – the government simply don’t care what we treat.
All officials are doing to the Republic and GEC – pushing papers, sophisticated in the ability to respond to the request for not to undermine. Oh and to issue licenses, certificates and registration certificates for medicines for big money. Not surprisingly, in our pharmacies peplomycin so much – after all, the main purpose of the existence of these organizations, where even a minor official receives the same salary as soldiers every day risk their lives in the ATO area – to earn money, filling the pockets of our budget and their pockets along with the pockets of businessmen from pharmaceutical business.
Of course, it is very important to fill the budget. But if, as they say in the government, life in Ukraine is getting better – isn’t it time to start caring about our health? This means:
– monitor the quality and effectiveness of drugs;
– to force manufacturers to write the truth in the instructions to medicines;
– to monitor the side effects in reality, not in words (pharmacovigilance system).
That is to finally start doing all the things for which we pay them such a big salary to take care of our health.
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