Alberta Health Services dealing with sodium bicarbonate shortage

Like other jurisdictions across North America, Alberta Health Services is facing a shortage of the injectable drug sodium bicarbonate.

The shortage is due to “a manufacturing issue by Hospira Inc., a Pfizer company,” an AHS news release explained.

AHS was alerted to the initial shortage on June 8. At that point, Alberta had about six or seven weeks’ worth of the drug in reserve, AHS’ Mauro Chies said.

“It wasn’t really critical at that time.”

But then, on June 15, a recall notice was issued.

“Our understanding is they’ve detected microbial growth and they issued a voluntary recall,” Chies said.

AHS is tracking use of the drug within its hospitals and will notify patients, and their clinical teams, if there is a possibility that they have been impacted.

“Right now in reserve, we have approximately six to seven days of stock in reserve as a result of the second recall.

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“We’re looking obviously to extend that timeline as far as possible. We’ve implemented some more rigorous rationing protocols.”

Some actions being taken to deal with the shortage include:

• Reserving the drug for use in critical situations and implementing an approval process before use
• Working to carefully prioritize procedures and choose alternative treatments
• Working with Health Canada to pursue alternative sources, where possible
• Working with physicians and clinicians to provide them with the latest information on affected drugs, as well as alternatives and other options

Alberta’s health agency said this drug is used in critical care and other urgent clinical areas.

“It’s commonly used in life-threatening situations when the blood becomes too acidic,” AHS said.

“It is used every day and it is used in the critical care setting,” Dr. Francois Belanger, Chief Medical Officer with AHS, said. “There’s really three main areas where it’s used. It’s used mostly in our critical care unit, it’s also used in the OR and in emergency departments.

“It is used frequently. It is used for patients who are critically ill… Mostly for patients who have a massive infection called septic shock or patients that have renal failure.”

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According to AHS, some of the conditions that would benefit from IV sodium bicarbonate include metabolic acidosis, open heart surgery, continuous renal replacement therapy, as an antidote to certain poisons, and some types of cancer chemotherapy.

AHS is working on alternative therapies where possible. It is also working with Health Canada and other provincial jurisdictions on sourcing the drug from somewhere else. Officials are investigating whether an Australian producer is an option.

“We’re also looking at other ways to obtain the drug as well,” Belanger said. “Obviously looking at things like producing the drug ourselves within AHS… It’s very complicated, so it’s not the first option, but we’re looking at everything.”

AHS officials said patient safety is always its first priority.

“This is a serious issue and we are working hard to mitigate the effects of the shortage,” said Belanger. “We are considering all options and will do all we can to ensure patients receive the best quality care possible.”

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AHS is working with Health Canada, both directly and through the pan-Canadian Provincial/Territorial Drug Shortage Task Team, to confirm timelines of when manufacturing of the drug will recommence and to evaluate off-shore supply options.

In a statement to Global News, Pfizer Canada said:

“The current sodium bicarbonate injection supply backorder is due to a manufacturing delay and is related to a third-party supplier. Pfizer has a dedicated team focused on working with suppliers to address this situation and has already taken several steps to expedite supply recovery of this drug.

“Pfizer Canada expects the backorder to last several weeks with an anticipated return to market in August.

“Pfizer is working hard to restore supply of sodium bicarbonate injection. We understand and regret the challenges the backorder poses to clinicians and patients. We have prioritized the manufacture of this medicine, and we will continue to work diligently to alleviate backorders while ensuring the highest quality and safety standards for all of our products.

“At this time, Pfizer is asking clinicians to make every effort to reserve supplies for critical care uses only, and avoid using product for non-essential purposes.”