For more than two months, patients in Macedonia who take the medication “Sintrom 4” from the Canadian company “Merus Labs” can not get hold of the drug because it has not been imported. According to latest information, the drug will not be available until next year, some optimistic predictions believe it could be available in February.
“For days I have been going to pharmacies and asking for “Sintrom 4”. I have thrombosis and I have to abide by a certain regime and I cannot skip a dose. Pharmacies do have the drug, but from other manufacturers such as “Replek” and “Jaka Radovis”, and I have been told by my doctors that it is essential that I take “Sintrom 4”. If I miss a dose, I have to go to hospital for a blood test, and then wait and see what happens”, said a patient from Skopje.
The Drugs Bureau told “Meta” that the problem was not at their end, but the importers, and that the importer would only import more medication when all the reserves have been used up.
The Director of the Drugs Bureau, Marija Darkovski, said that a month ago, she had signed off on the decision to import 5,000 boxes of the drug.
“I personally signed the decision to import the medication. I do not know why we still do not have it. I’m currently abroad, and am defending my doctoral thesis and I cannot answer any more questions, because this is very important to me”, said Darkovska on the telephone.
She pointed out that the problem maybe because the drug is no longer produced by the Swiss company “Novartis” and has been bought by a different manufacturer, while the Skopje branch of “Novartis” has yet to sort out the transfer of rights with the new importer, “Evropa Lek”. In other words, from February this year, the drug “Sintrom 4”, which used to be owned by Swiss company, NOVARTIS Pharma Services inc., was bought by Canadian company “Merus Labs”. Previously the drug was imported by the Macedonian branch of “Merus Labs”.
“Evropa Lek” are now importing “Sintrom 4”. They stated that they had requested permission from the Drugs Bureau to import 25,000 boxes, but the Commission only approved 5,000 boxes.
“We have asked for more, but the Drugs Bureau only approved of 5,000 boxes. The company that produces the drug have told us that it is not worth producing so little and told us to increase the order. Now, we have sent a new request to the Bureau and we are waiting for their approval so that we can import more”, said Monika Naumovski, Head of Regulation at “Evropa Lek”.
However, she also said that the drug will not be available this year because there were no more English instructions, and it would take too much time for the company to print out Macedonian instructions for the medicine.
“It is more than likely that the year will end without the drug. Hopefully, if the Drugs Bureau hurry up with their decision, “Sintrom 4” will be back in pharmacies by February next year”, Naumovska told us.
Among Skopje pharmacies, in all the major pharmaceutical outlets ( “Zegin”, “Eurofarm” and “Viola”) the Novartis product has not been available for two months.
Distributors, “Phoenix Pharma,” said that only one pharmacy in Skopje had the medication, but after checking to determine whether the drug was there, they discovered that the pharmacy no longer had it. This is the case in many pharmacies across Macedonia.
“Sintrom 4” or “Acenocoumarol” belongs to a group of medicines called anticoagulants (a medication that is referred to as a “blood thinner”). “Acenocoumarol” is used to prevent and treat the formation of blood clots (thrombus) that clog the blood vessels, especially in people who suffer from deep venous thrombosis. Patients also take this medicine for heart conditions (operations, arrhythmias), myocardial and cerebral strokes and thrombosis.
