Description of Event or Problem · 1
TEVA PHARMACEUTICALS CHANGED THE FORMULATION OF BENDAMUSTINE FROM A POWDER TO A LIQUID. THE LIQUID CONTAINS SOLVENT N, N-DIMETHYLACETAMIDE - WHICH IS NOT COMPATABLE WITH POLYCARBONATE FOUND IN THE SYRINGE ADAPTOR OF THE CLOSED SYSTEM TRANSFER DEVICE ON GUARD - DISTRIBUTED BY BBRAUN. I AM A PHARMACIST AT (B)(6). BENDAMUSTINE IS MARKETED AS TREANDA BY TEVA PHARMACEUTICAL INDUSTRIES LTD. BENDAMUSTINE (TREANDA) RECENTLY CHANGED FORMULATIONS FORM A POWDER FORM TO A LIQUID FORM. (B)(4), THE NEW FORMULATION CONTAINS THE SOLVENT N,N-DIMETHYLACETAMIDE. ADVERTISEMENT ANNOUNCING THE CHANGE OF FORMULATION DID NOT MENTION THAT THIS SOLVENT IS NOT COMPATABLE WITH DEVICES CONTAINING POLYCARBONATE. THE PACKAGE INSERT DOES NOT MENTION THIS IN THE MIXING INSTRUCTIONS OR IN THE WARNINGS. THE ONLY MENTION IS IN FINE PRINT UNDER THE PRODUCT DESCRIPTION. TO REDUCE THE RISK OF EXPOSURE TO CHEMOTHERAPY MEDICATIONS, IT IS RECOMMENDED INDUSTRY WIDE THAT CHEMOTHERAPY BE PREPARED NOT ONLY IN A BIOLOGICAL SAFETY CABINET, BUT ALSO WITH THE USE OF A CLOSED SYSTEM TRANSFER DEVICE. THERE ARE ONLY A HAND FULL OF CLOSED SYSTEM TRANSFER DEVICES MARKETED IN THE US. WE USE THE ONGUARD SYSTEM MARKETED BY B/BRAUN IN THE US WHICH USES TEVADAPTOR COMPONENTS MADE BY TEVA MEDICAL LTD. BENDAMUSTINE DOSES ARE DILUTED IN 500 ML SALINE SOLUTION FOR ADMINISTRATION. WHEN THE NEW BANDAMUSTINE WAS DRAWN INTO THE SYRINGE TO TRANSFER INTO THE BAG OF SALINE USING TEVADAPTOR, THE HUB OF THE SYRINGE ADAPTOR SEEMED TO "MELT" AND THE BENDAMUSTINE LEAKED OUT. WE INITIALLY THOUGHT IT WAS A DEFECTIVE ITEM, SO WE ATTEMPTED IT AGAIN. THE SAME THING HAPPENED. WE PREPARED THE NEXT DOSE WITHOUT USING THE ONGUARD SYSTEM. I CONTACTED TEVA IMMEDIATELY. I EVEN SENT THEM A PHOTO FROM MY (B)(6). THEY SEEMED TO BE UNAWARE OF ANY PROBLEM AND TOLD ME THEY WERE NOT AT FAULT, AND THAT IT MUST BE A PROBLEM WITH THE TRANSFER DEVICE. I CONTACTED B/BRAUN WHO MARKETS THE ONGUARD SYSTEM, AND THEY WERE UNAWARE ALSO. THE NEXT DAY TEVA CALLED ME BACK TO GATHER MORE INFORMATION. I ASKED IF THEY HAD TESTED THE NEW FORMULATION WITH ANY OF THE CLOSED SYSTEM TRANSFER DEVICES USED IN THE USA. THEY DIDN'T KNOW, SO I ASKED TO BE TRANSFERRED TO SOMEONE IN CLINICAL. A WOMAN NAMED (B)(6) TOOK THE CALL AND WAS EXTREMELY EVASIVE AND CONDESCENDING. SHE SAID IT WAS UP TO ME TO CONTACT ANY COMPANY TO SEE IF IT HAD BEEN TESTED. I TOLD HER THAT HER PRODUCT WAS THE MOST RECENT TO BE MARKETED, AND THAT THE BURDEN OF SAFE COMPATABILITY SHOULD FALL ON THEM. THAT IS WHEN SHE TOLD ME THE NEW FORMULATION CONTAINS N,N-DIMETHYLACETAMIDE AND THAT IT WAS KNOWN TO BE INCOMPATIBLE WITH POLYCARBONATE IN THE TEVADAPTOR. I ASKED FOR HER FULL NAME, AND SHE WOULD NOT GIVE ME HER LAST NAME, STATING THAT IT WAS AGAINST POLICY TO GIVE FULL NAMES. THAT IS WHEN I BECAME SUSPICIOUS THAT THEY WERE NOT FORTHCOMING WITH INFORMATION. THE REACTION DOES NOT APPEAR TO HAPPEN IMMEDIATELY, BUT IT TAKES A FEW MINUTES TO HAPPEN. UNFORTUNATELY WE HAD BEEN USING THIS COMBINATION FOR A FEW WEEKS BEFORE WE NOTICED IT. I BELIEVE THIS INFORMATION NEEDS TO BE QUICKLY DISTRIBUTED TO EVERYONE WHO IS DISPENSING BENDAMUSTINE. I DO NOT KNOW WHAT CHEMICAL IS FORMED WITH THIS COMBINATION, NOR WHETHER IT COULD CAUSE PATIENT HARM. TEVA DID NOT SEEM TO BE DOING ENOUGH TO WARN ABOUT THIS PROBLEM.