Current information on manipulated drugs
EU situation:
In addition to individual cases of tampered Italian Herceptin distributed in parallel, tampered MabThera of Romanian origin distributed in parallel has now occurred in Germany (as of 9/16/2014).
The Paul Ehrlich Institute warns of possible manipulations of a parallel distributed batch of the drug MabThera of Romanian origin.
The drug MabThera is approved throughout Europe for the treatment of non-Hodgkin's lymphoma, chronic lymphocytic leukemia as well as rheumatoid arthritis and granulomatosis with polyangiitis and microscopic polyangiitis. It is used primarily in hospitals, under the supervision of physicians experienced in the use of anti-neoplastic drugs. It contains the active ingredient rituximab and is available as 100 mg concentrate for the preparation of an infusion solution and as 500 mg concentrate for the preparation of an infusion solution.
Three vials with irregularities or tampering have been identified in batch H0656B03 of the drug product MabThera (active ingredient rituximab) with marketing authorization number EU/1/98/067/001-002. These vials were from a shipment of a total of 14 vials that a German parallel distributor had purchased from a Romanian wholesaler.
MabThera batches brought to market by the marketing authorization holder Roche itself are not affected.
Various anomalies were found in the tampered vials:
- Missing package insert
- Inconsistent batch designation of vial and outer packaging
- Missing flip-off cap of the vial and optical deviations on the stopper.
Analysis of one vial found a significantly lowered active ingredient content.
Information about illegally traded drugs in Romania
The Romanian Medicines Regulatory Agency has informed that some medicines traded by Romanian wholesaler Chemomed are being recalled. A large part of the recalled medicines entered Germany through parallel distribution. Chemomed had obtained the drugs from four different Romanian wholesalers who had purchased these drugs from pharmacies in Romania. However, the pharmacies did not have a license to wholesale drugs. Apparently, the three manipulated MabThera ampoules mentioned above were delivered via this unauthorized trade route.
Situation in Austria:
So far, no tampered MabThera has been encountered.
No tampered MabThera has been detected in Austria to date, nor have there been any reports of patient harm.
These statements are based on the information currently available. If users and pharmacists notice suspicious medicinal products, it is imperative to contact BASG / AGES Medizinmarktaufsicht.
The following medicinal products of Romanian origin are affected by the illegal distribution chain:
- Avastin 25 mg/ml concentrate for solution for infusion (Z-No.: EU/1/04/300/001-002).
- MabThera 100 mg concentrate for solution for infusion (Registration No.: EU/1/98/067/001)
- MabThera 500 mg concentrate for solution for infusion (Z-No.: EU/1/98/067/002)
In Austria, Avastin and MabThera of Romanian origin that illegally entered the distribution chain have been distributed exclusively through the parallel distributor "INOPHA GmbH". A recall of the affected drug shipments was initiated as a precautionary measure.
Recommendations of the BASG
Recommendations for users and pharmacists:
- Before using/preparing the above-mentioned medicinal products or other high-priced or parallel imported/distributed medicinal specialties and their packaging, please pay attention to possible tampering. Indications of tampering may be, for example, inconsistencies in packaging or delivery bills, recognizable tampering with ampoules and other containers and differing batch numbers of the bottles and outer packaging.
- In case of detection of tampering / conspicuousness / possible counterfeiting, we request immediate notification to the Medical Market Surveillance of the Institute Surveillance of the BASG / the AGES Medical Market Surveillance in accordance with § 75q Medicines Act at enforcement@ages.at.
Manipulated / falsified medicinal products must not be used under any circumstances!
Further information:
Safety information of the Paul Ehrlich Institute: http://www.pei.de/DE/infos/fachkreise/fachkreise-node.html
Queries (technical):
Dr. Christoph Baumgärtel, Tel.: 050555/36004 E-mail: christoph.baumgaertel@ages.at
Queries (for media):
Communications Management, Tel.: 050555/25000 E-mail: presse@ages.at
