Concern about the availability of extremely important injectable drugs is growing across Canada. Previously, the reason behind our increasing number of shortages was a mystery. The reason for this shortage is however, quite clear. Sandoz Canada, a major producer of injectable antibiotics, pain medication and anti-cancer drugs, had to shut down its plant in Quebec after receiving and ignoring warning letters from the Food and Drug Administration. The warnings began early in 2011 when it was found that Sandoz was violating the Current Good Manufacturing Practice regulations.
(To view a copy of one of these letters visit: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm281843.htm ).
The plant was responsible for producing 90% of Canada’s injectable drugs. Without the production from this plant, other companies are trying to increase their production to ward of supply issues. However, they are fighting from behind as no one expected this major injectables producer to shut down. This brings about the question, if there was any threat that this plant may be shut down why were other companies that could solve distribution shortages not notified before it was too late? The government is taking heat over this issue and is trying to find a solution to prevent this problem in the future, for now it is too late.
The Sandoz plant is stated to be up and running in the near future, what this means no one knows, but in the meantime obtaining required injectable medications maybe difficult if not impossible. These medications are a necessity for treating serious infections, pain, cancer treatment and drugs used during surgeries or as post-surgical care. In an effort to conserve these medications, some hospitals are choosing to postpone elective surgeries, saving these drugs for emergencies and serious cases. Until now the shortage has been every dosage form except those drugs intended for intravenous use. That has meant everything from antibiotics, pain medications, drugs for diabetes, for the control of high blood pressure, asthma, hypothyroidism and more. It doesn’t seem to have any rhyme or reason as it includes all dosage forms including tablets, capsules, liquids, suppositories, topical creams and ointments – the list is long an varied.
At Stafford Pharmacy, we have managed to stay just slightly ahead of these growing shortages as we source the necessary antibiotic medications required for our patients, in particular those on home parenteral therapy. The Sandoz plant shutdown has added some additional challenges, necessitating that our technicians spend a growing amount every day securing adequate quantities of antibiotics for intravenous use. We currently focus on the needs of one patient at a time as each day becomes a new adventure in drug procurement. Although we are staying just ahead of the demand this may very well change if these shortages continue to grow. For now all we can do is hope that the situation does not get any worse and that companies like Sandoz correct whatever problems they have been experiencing at that manufacturing level.
We’ll keep you posted in the coming weeks and months of any developments or changes. Better or worse, we will be certain to share with you the industry updates as all of us here agree that a permanent solution to the industry troubles will be found, but it appears that it may yet get worse before it gets better.