March 22, 2021
Never events: Why our drug shortages present preventable, unnecessary risks
In healthcare, we talk about “never events” – those incidents that result in serious patient harm or death and are preventable using organizational checks and balances. My view is that drug shortages should also classify as never events since they pose preventable, unnecessary risks to patients’ health.
At HealthPRO, we know drug shortages are a complex challenge that reach deep into all parts of the system. We also know this isn’t just a data problem – these are stories of real people who’ve experienced care denied or care delayed as a result of drug shortages. So, it was with great interest that I attended a Summit on Drug Shortages in mid-February, hosted by Canada’s esteemed healthcare writer André Picard.
Throughout the half-day session, Picard kept coming back to the central questions on everyone’s mind: “What are the causes of these shortages and what can we do about them?”
Being small costs us
Picard’s first interview was with Dr. Jacalyn Duffin, Professor Emerita at Queen’s University. Dr. Duffin’s website (canadadrugshortage.com) lists 17 causes of drug shortages, and while I agree that natural disasters and increased demand created by health threats like COVID-19 can lead to significant shortages, my own experience of these shortages shows they really come down to profitability in a global market. COVID-19 has certainly hastened domestic production in several parts of the country, but we are still very dependent on the global market.
Take cisatracurium, a critical COVID drug, for example. It was produced in Canada but positioned to be exported to alternate jurisdictions if Canadian hospitals did not step up and purchase large stockpiles of the product. What this did was essentially transfer the cost of warehousing, refrigerating, and storing of this molecule onto publicly funded hospitals. Hospitals had no choice, we needed this drug, but that was an unnecessary and expensive undertaking.
In order to manufacture a drug in Canada, you need Active Pharmaceutical Ingredients (APIs). Chinese manufacturers make around 40% of all APIs used worldwide and China and India are the source of 75% to 80% of the APIs imported to North America. That dependence has a huge impact on our ability to increase domestic manufacturing.
“As a pharmacist, managing drug shortages can take up to about 20 per cent of my day, so in an eight-hour day we could potentially be looking at about an hour and a half managing drug shortages.”
Patients put faith and trust in their pharmacists
Patients participating in the first panel discussion reminded us of the critical role played by pharmacists in mitigating the risks associated with drug shortages. Jillian Kuchard, a patient living with rheumatoid arthritis, takes Hydroxychloroquine and knows her world would be completely disrupted if she couldn’t get the drug.
Fortunately, her pharmacist made sure she had enough to get through until the next shipment came.
Depending on their location, pharmacists manage scarce supply by either collaborating with the prescriber, making recommendations for an alternate therapy, or working with the Pharmacy and Therapeutics team in hospitals to endorse substitutions. In some provinces they have the authority to make therapeutic interchanges independently.
Panelist Christina Tulk, a Pharmacist in Corner Brook, Newfoundland and Chair of the Canadian Pharmacists Association, described that pressure: “As a pharmacist, managing drug shortages can take up to about 20 per cent of my day, so in an eight-hour day we could potentially be looking at about an hour and a half managing drug shortages.”
The supplier’s perspective
In the interview that kicked off Part II of the Summit, Kevin Mohamed, Canada Lead for the Pfizer Hospital Business Unit knew he’d get some tough questions from Picard about vaccine supply. Mohamed began by explaining that group purchasing organizations (like HealthPRO), through their contract awarding process, play a huge role in deciding which products are chosen and purchased for Canadian hospitals.
He made a valid point that when the decision criteria is price alone – without consideration of quality, service, sustainability, supplier performance and conduct – this does not serve the healthcare system.
Fortunately at HealthPRO, we’ve been aware of this mindset for a long-time. That’s why our contracts are never awarded on price alone. Our process is built around supporting elements like product quality, procurement costs and quality of service that account for backorders, recalls and other product concerns. All these elements are weighted and factored into contract outcomes.
We have to do better
James Scongack, EVP of Corporate Affairs and Operational Services at Bruce Power, was on my wavelength when he said that building greater reserve in our supply chain is essential and the burden of responsibility should not be assigned to any one stakeholder disproportionately.
Our hospitals are that overburdened stakeholder, forced, because of the unreliability and unpredictability of our supply chain, to stock exceptionally large amounts of critical drug supply. Putting all the onus on the end user is a costly and inefficient solution.
At HealthPRO, we’ve devised some contract strategies – split awards, multi-supplier awards and new market entry strategies – in an effort to create a healthy and sustainable supply market.
A missed opportunity
I applaud the spirit of exchanging ideas and considering different approaches, but I think there was also a missed opportunity with the Summit by not involving Health Canada and the Provincial and Territorial Drug Shortage Task Force (P/T-DST). Their work and the investment from both levels of government has mitigated many shortages and the resulting impact on patients. Health Canada’s Drug Shortage Unit is a strong presence, and new legislation and regulations have dramatically changed the shortages landscape.
The Tier 3 Assignment Committee or TAC is a great example – it assesses the gravity of shortage, the exercise of enforcement discretion, including letters of non-objection for the importation and sale of foreign-labelled product when the risk of not having product outweighs the risk of foreign-labelled product. They recently issued an Interim Order which expedites authorization for the importation, sale and advertising of drugs used in the treatment of COVID-19.
Engagement and collaboration with Health Canada about our medication supply shortages has never been stronger and it would definitely have added a valuable dimension to the conversation.
 Mordor Intelligence, ACTIVE PHARMACEUTICAL INGREDIENTS (API) MARKET- GROWTH, TRENDS, COVID-19 AND FORECASTS (2021 - 2026).