Sandoz manufacturing woes prompt Canada to release stockpiles
This article was originally published in Scrip
The Public Health Agency of Canada (PHAC) is offering stockpiles of the medicines, including morphine, anaesthetics and antibiotics, which are in short supply following manufacturing issues at Sandoz' Boucherville plant in Quebec, Health Canada has confirmed.
According to Health Canada, "very limited quantities of medicines are available for addressing short term gaps in supply". However, none of Canada's provincial health authorities has yet requested assistance.
Health Canada says it is working hard to address the problem. For example, it is reviewing replacement drugs more rapidly, although not at the cost of patient safety, it emphasises.
So far it has carried out six expedited approvals in response to the Sandoz problems. On 26 March it approved two new drugs: Hospira's Midazolam, used to induce relaxation, drowsiness or sleep before surgery or diagnostic procedures; and Alveda's Naloxone, for preventing or reversing the effects of opiods used in surgery to prevent pain. Then on 27 March it approved changes to marketing authorisation for Pfizer's Dalacin C phosphate (clindamycin) for bacterial infections, and Omega's granisetron hydrochloride for preventing nausea and vomiting associated with anticancers.
Earlier this month it has approved Accord Healthcare's Ondansetron, also for preventing nausea in cancer patients, and Omega's Rocuronium bromide, an injectable muscle relaxant.
Only Alveda's Naloxone submission was received during the current situation, the others were not but were expedited in response. Health Canada usually takes six months to approve a generic.
Manufacturing Issues
In November, Sandoz manufacturing issues began after the company received a warning letter from the US FDA outlining issues with general documentation, validation and investigation practices at Sandoz' US and Canadian manufacturing facilities. The company subsequently halted production of "non-essential" products including ointments, ophthalmics, suppositories and certain injectables to focus on its core injectable portfolio and to prioritise production the production and supply of critical medicines. Then, in early March a fire saw the firm halt production, which again resumed on 23 March.
The company says that it is now meeting more than 70% of current market needs for its portfolio and that it is not in a backorder situation. "Sandoz stands behind the safety, efficacy and quality of its products and is treating the situation with the utmost priority."
The company declined to comment on any losses caused by the problems and said only that it was investing "significantly" in improving its facilities.
Health Canada says it is aware of the FDA's letter and that the concerns relate to one product, Testosterone 200mg/ml, which is not sold in Canada. The authority reviewed the FDA’s findings buts said its investigation did not identify any risk to Canadian patients using products manufactured at the plant.