HealthPRO’s Dawn Jennings speaks about the scope and steps needed to deal with our persistent drug shortages at the 2020 Canadian Society of Hospital Pharmacists (CSHP) Professional Practice Conference.

“Thank you for your interest in this less than sexy topic,” laughed Dawn Jennings as she stepped up to address the overflowing crowd who had come to hear her speak at the CSHP Professional Practice Conference (PPC) on the subject of “Drug Shortages: A Multi-Stakeholder Responsibility”. If they didn’t know it before, the audience of hospital pharmacists and suppliers would soon learn that the persistent and dangerous effects of drug shortages are anything but sexy.

“I’m here to tell you that drug shortages are not an occupational hazard, they’re not a nuisance or inconvenience to be managed by pharmacy,” she said. “The impact of drug shortages on the healthcare system is real, it’s severe and in some cases, it’s actually tragic.” Drug shortages – and their mitigation – are a key focus of Jennings’ role as HealthPRO’s Clinical Director, Pharmacy, but she’s been observing the growing problem for years, first as an oncology pharmacist in northern Ontario and then as a healthcare administrator.

“An ISMP (Institute of Safe Medication Practices) Canada survey found that 1 in 3 near misses could be directly related to a drug shortage, and that 1 in 5 had an adverse patient outcome directly related to a drug shortage,” she said. Almost 50% of Canadian anaesthetists responding to a survey by the Journal of Anesthesia stated that as a result of a drug shortage, they had to administer a less than optimal anesthetic. “How does that make you feel?” asked Jennings.

Real people with tragic stories

This isn’t just data, there are real people with stories about care denied or delayed as a result of drug shortages. “Imagine the angst of a parent being told that their child’s possibly life-saving bone marrow transplant surgery is being delayed because they cannot get the right medication?” asked Jennings.

Patients and families aren’t the only ones who are suffering. Shortages are putting intense pressure on staff and resources in hospitals around the country. “If we could get that time and those resources back, imagine what that would mean for patient care, medication reconciliation, antibiotic and narcotic stewardship?” she asked rhetorically.

Is it getting better?

It’s not just the scope of the problem that is concerning, it’s the persistence. HealthPRO has been tracking shortages since 2009 and the situation is anything but stable. “Health Canada's website Drugshortagescanada.ca clearly show that from 2017-2019, shortages have been increasing by about 4% a month,” she said. What does that mean in hard numbers? As of November, last year over 1,900 active shortages had been reported. “That represents about 1,600 actual drugs or 12% of our marketed drugs in Canada.”

Tier 3 creates a nimble path to resolution

Things started looking up in 2013 with the formation of the Multi-Stakeholder Steering Committee (MSSC) on Drug Shortages, with HealthPRO as an active member, and through them the creation of the Provincial & Territories Drug Shortages Task Force. Then in March of last year, the MSSC launched an exciting pilot project that Jennings says is already showing promising results: A Tier 3 Assignment Committee (TAC). “They consider the evidence, then they look at the supply that is remaining and decide whether this is a critical shortage where there is no other reasonable therapeutic alternative.”

“Once it meets a Tier 3 status, that’s the trigger for Health Canada to get engaged.”

Since the committee was formed, the TAC has convened on 10 shortage files. One of those was resolved through the responsible stewardship of Fresenius Kabi Canada and Steri-Max, whose collaborative efforts resulted in cefazolin being supplied to all hospitals equitably. “It resolved a serious shortage and so a big shout-out to those two supplier partners,” said Jennings.

Even without supplier partners, productive mitigation measures saw the expedited delivery of three products and six proposals to access foreign supply. “Prior to the TAC pilot, shortages were measured in half years often taking 6- 8 months from signaling a shortage to resolution,” she says. “The whole process with TAC is quicker and much more agile, and some shortage resolutions can be measured in weeks.”  

Diversifying the supply

According to a recent presentation to the Multi-Stakeholder Steering Committee by Health Canada, from 2017-2019, most drug shortages were a result of manufacturing disruption[1].

“We know that 55% of shortages are related to manufacturing disruptions and another 17% are due to shipping delays,” she said.

That strikes at the heart of one of our core vulnerabilities – problems with procurement and distribution, specifically sole source supplying.

With insights like that, industry stakeholders like HealthPRO are moving to close the gaps. Jennings takes pride in HealthPRO’s multi-pronged approach that includes implementing deliberate strategies that mitigate shortages including split awards. “Under this strategy we award 40% of the business to one supplier and 60% to another; we’re happy to report that in 2019, we mitigated 88% of shortages under split awards.”  They’re also trying to inject some diversity into the market. “If we have a sole supplier and a new manufacturer invests and comes into the market, we’ll open up the contract in order to give them an opportunity to bid,” she says. “It encourages that behaviour and security of supply. Because of this, today, we no longer depend on a single supplier for ten critical drugs.”

In a report on how to address some of the manufacturing challenges, The International Society for Pharmaceutical Engineering recommends creation of a corporate quality culture, building capacity, Continuous Quality Improvement (CQI), quality metrics and investing in ongoing maintenance at existing manufacturing sites.

Time to work on prevention

With the moves by Health Canada, the cooperation of industry partners, and the actions of the TAC, Jennings sees momentum. What we need to work on now is prevention, and we need to engage our industry partners if we are to succeed.

“In the UK, they permitted pharmacists to prescribe without notification to the original prescriber and they gave them scope to consider therapeutic alternatives,” she said. “So, I’m challenging you that perhaps this is a role for CSHP – this is where we plant our flag, this is our call to action to mitigate shortages in Canada and make them a never event.”

 

^[1] Health Canada Multi-Stakeholder Steering Committee presentation on December 6, 2019