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On Wednesday, 20 July, an IOP solution of Morphin Sanitas 10 mg / ml (hereinafter referred to as "Morphin Sanitas") from the representative registered in Lithuania was submitted to the IWC for further details on this misunderstanding.
Why were the preparations canceled? UAB PharmaSwiss Receives Report on Alleged Failure in Morphin Sanitas Solution of the Drug
The report stated that Morphin Sanitas, during the manufacturing process, had some of the ampoules packaged in another drug Atropine sulfate Sanitas Solution for Injection, boxes and labeled serum 1-110318.
8 deceptive packages were reported
The packaging of Mororgan Sanitas 8486 manufactured by Santonika, the manufacturer of the company, was intended for the Lithuanian market. The patent was placed on the market in 1980
"In accordance with the relevant procedures, IWT badessed the risks and possible risks to the health of patients and found that this anomaly was clbadified as a clbad of serious danger during which the drug was to be withdrawn from the market.Office on July 20 – said Rita Lokienė, head of the inspection division acting as a temporary administrator of the VVKT, as stated by DELFI.
– Because morphine is strictly accounted for and issued on special order and separate from other drugs, that residents were able to buy ampoules of Morphine 10 mg / ml solution for injection packed in a solution of sulfate. atropine as an atropine product If, however, residents have purchased such a drug, they must return it to the pharmacy. ” width=”580″/>
The second medi cament is the drug used in the manufacture of the drug
Monthly Cancellation
Kristina Nemaniūtė -Gagė, chairman of the board of the Lithuanian Pharmacy Association, said that members of the Lithuanian Pharmacy Association did not withdraw morphine from the market in their pharmacies, but that there was a withdrawal of atropine sulfate in pharmacies. "The situation is really crisis-friendly because the drugs are very strong, and that concerns specific people who could buy drugs that are not prescribed for them," said K. Nemaniūtė-Gagė
. The drug is withdrawn from the market for the second time in a month Once (on July 10, IWT announced the withdrawal of drugs from the market due to the possibility of causing impurities in the active substance – DELFI). It is very strange that the responsible authorities have not yet given binding instructions to drug manufacturers who must collect drugs not only from wholesalers but also from patients and to compensate for the losses suffered by pharmacies and pharmacies. the patients.
The Lithuanian spokesperson that, as in the case of valsartan, when 20% of Lithuanian patients were able to buy potentially defective drugs, pharmacies and patients remain alone to solve this problem.
"No pharmacy decides which drugs should be offered to patients – the responsible authorities are required to adopt legislation that would require manufacturers to collect drugs from wholesalers, pharmacies and patients, – says K. Nemaniūtė-Gagė.
– Are drugs withdrawn from the market or are they excluded from compensatory medicines? Price list What to do with them in a pharmacy should be decided not by the company itself, but by the authorities that compel pharmacists to take these drugs. "
This is the first case in Lithuania
.This case is the first in Lithuania, says R. Lokienė. There are cases where there are similar cases with other drugs in other countries of the European Union and in North America.
"There have been four similar cases over three years." – As stated by R. Lokienė, atropine belongs to the parasympathetic group of anti-cholinergic drugs and is used in the following cases: preparation of the patient prior to general anesthesia; elimination of spasms from the stomach or intestine; stool removal from the liver or kidney; symptomatic cardiac rupture or cardiac rupture; poisoning with certain drugs, organic phosphorus compounds and certain types of fungi for treatment by other means; inhibition of the effect of muscle relaxants in the operation (in combination with other drugs).
Omorfin has a very strong effect It is used to treat severe and very severe pain.Therefore, the therapeutic effect of these drugs is different if the administration of a drug other than the appointment of a doctor can harming patient's health
IWTU informs that currently the manufacturer Santonika UAB is conducting an internal investigation whose report is to be submitted to the Office. In turn, the Office began the inspection of the manufacturer. After the inspection and badysis of the data received, a decision will be made on other measures and on the sanctions and measures to be applied.
The State Fund for Patients (VLK) informed that by 2018, January-June approximately 8700 Morphin SANITAS 10 mg / ml solution for injection were given to 1 ml of N10 Compulsated Health Insurance Fund, but VLK does not have information on the series of products. At the time, atropine sulfate was not a reimbursement drug, so VLK did not have sales data.
