MALMED will approve Ivermectin, but then will ask the pharmaceutical companies to bring it because "it is not a cure for business"
The Drug Agency MALMED is seriously determined to bring the drug Ivermectin to Macedonia, claims for "Free Press" the director of the institution Ljirim Shabani.
According to him, it is only a matter of days before all administrative procedures are completed so that the import of the drug can start legally, which gives great hope in the treatment of coronavirus patients in Macedonia, because it has been proven to help reduce the length of hospitalization and mortality. if given in the first stage of the disease, then it helps the symptoms not to progress.
However, MALMED will face a serious challenge, how to convince companies, suppliers and pharmaceutical companies to start distributing and importing this drug since it is very cheap, 12 euros per box and simply, it is not a cure for business ”.
- Unofficially, we also received information that there is a positive opinion from the expert commission for Ivermectin. We want to ensure the availability of medicine in our country as soon as possible. Once the medicine has passed through our commission in MALMED, because it is an intervention import and it is not registered, it can be approved for import. I think that in a few days it will all be cleared up. We do not know where it will be imported from. We are just starting to talk to companies, suppliers, companies, it is another dimension and another challenge, how many companies will be able to find Ivermectin on the world market, on the European market and from where. That is another challenge. We will approve the medicine for the need we need. In the other part, we will help as much as we can as soon as we can bring together the pharmaceutical companies, the state and private hospitals, said the director Shabani.
None of our pharmaceutical companies has applied to produce Ivermectin.
- I think we will find a common language to import this drug, some of the companies that will want to help patients. This is a very cheap medicine, not a business medicine. We all stand for the good of the patients. We will ask the companies to meet. Unofficially 12 euros per box of the medicine, which means that it is not a medicine for business and that is why we will ask the private companies, all the hospitals, to stimulate them to bring that medicine here faster. We are maximally committed, realistically and seriously to bring that medicine here and we will do it, it is a matter of days, added the director of the Agency for Drugs and Medical Devices.
The expert commission formed by the Minister of Health Venko Filipce, yesterday gave a positive opinion about Ivermectin, that it has been proven to be a safe drug and that all studies on its use against Covid 19 have shown that it is safe. No study has shown ineffectiveness, on the contrary, all have extremely positive results.
Ivermectin, as reported by the Ministry of Health for "Free Press" is included in the protocol for treatment of patients with Covid 19 which is adopted by the expert collegium of the PHI University Clinic for Pulmonology and Allergology and Covid 19 centers in the internal medicine block.
According to the expert commission formed by the Minister of Health Venko Filipce, ivermectin is an antiparasitic drug with a wide range of action, high efficiency and extremely high safety. It was first used in humans in 1987.
In the last three decades, this drug has been prescribed in 3.7 billion doses worldwide with no or insignificant side effects. Used to eliminate head lice. It is available in several forms, but only oral use is allowed for humans. In the last few decades, ivermectin has also been shown to be very effective against a range of viruses such as HIV, dengue, West Nile virus and other RNA and DNA viruses. It is a proven safe drug.
The director of the Clinic for Infectious Diseases and Febrile Conditions, Dr. Milena Stevanovi рече, told us that they have no experience with Ivermectin at this clinic. but that their colleagues at the Faculty of Pharmacy who have analyzed the drug a little more, from a pharmacological point of view, suggest that it should be given a chance. The WHO has not yet released anything official about him. There are studies in Argentina and New Zealand where they say it has some effect.
It is not available at the Infectious Diseases Clinic for procurement because it has not passed structures, forms of consent, ethical commissions. It is not possible to bring medicine from a pharmacy from any country and give it to a hospital, the legal procedures must be followed, explains Dr. Stevanovic.
The procedure for registration of the drug is not small. If a drug is not registered for a specific disease but is given off-label based on protocols and research, a survey is conducted which is then passed to an ethics committee to confirm that it meets ethical standards. As such an off label enters the country and as such it is recommended to take. Each patient signs an agreement that he will receive the medicine at his own risk.
The health authorities decided to give the green light to the medicine that costs only ten euros and has been proven to help in the treatment of Covid. Ivermectin, the drug that in numerous scientific studies has been proven to help patients with Covid 19 not reach the hospital bed, but to withdraw their symptoms early, in the first stage of the disease, Macedonian citizens through smugglers have been receiving from Greece. It was not registered in the Macedonian pharmacies, and it was not in the hospitals either.
"Free Press" got in touch with several patients from Macedonia who ordered Ivermectin through their own channels from Greece, and paid 1200 denars for four pills of three milligrams. The price in Greece is lower, ie it is ten euros, and our sources paid a delivery margin, ie the profit of the suppliers. Greece is not the only country in the region where Ivermectin is used as a medicine. In Bulgaria it is already an integral part of hospital protocols.
Acibadem City Clinic is a hospital in Sofia, where Ivermectin was officially introduced in the hospital treatment of Kovid 19. Professor Dr. Ivo Petrov from this hospital, told the Bulgarian media that it is too early to say more, but when the drug is applied in the first few days after the onset of symptoms, they resolve significantly faster, the disease progresses more severely, and less often requires intensive oxygen therapy, including intubation. As a health worker, he takes the medicine for his personal prevention, because he is in daily contact with over 20 positive patients in the covid ward.