Until all problems with Rigvir medication have been resolved, State Agency for Medicines (SAM) has decided to put its registration on hold.
SAM explains that several quality defects have been found for several Rigvir medication series this year. This is why the decision was made to halt its distribution. The company that has registered Rigvir – SIA Latima – still has not determined any specific, clear reason for the quality defect, SAM explains.
The agency also notes the company has not fulfilled its duty in accordance with requirements of the post-registration period to update medication’s documents. This is why SAM has halted Rigvir’s registration certificate until all problems have been resolved. The company has several tasks to perform to restore medication’s registration.
38 patients, 5 healthcare institutions and 16 oncologists have turned to the Health Inspectorate (HI) with a request to permit them to continue therapy using Rigvir. In response to requests, HI permitted distribution of a single type of Rigvir medication for patients already undergoing melanoma treatment.
The inspectorate notes that requirements of the Cabinet of Ministers provide an order that dictates that in the event of an emergency it is allowed to supply medication to patients who have already started using medication. At the same time HI stresses that medication will not be provided to new patients.
The inspectorate notes that treatment is allowed to be continued only if the doctor responsible for the prescription has assessed all risks for each patient individually. Before accepting treatment using Rigvir, the patient needs to sign a document detailing their informed decision to accept treatment as well as the possible risks involved.
HI urges doctors to reassess initiated treatment of diseases and switch from Rigvir to an alternative type of medication or therapy as soon as possible.
More information in relation to Rigvir will be provided to doctors in a special informative letter.
According to HI, the series of Rigvir in question was manufactured in January and based on test results this series met quality requirements. However, the quality test was performed using a method that was not appropriately evaluated and approved. A decision was made to permit use of this series of Rigvir, but both patients and doctors have to take full responsibility for using it in medical treatment.
The inspectorate reminds that the medication compensation system is not applied to Rigvir. (ERR/Business World Magazine)