By Christina Adams
For many years, hospital pharmacists and pharmacy technicians have been managing significant drug shortages in Canadian hospitals.
The reasons for drug shortages are complex and multifactorial. One of the simplest reasons for a drug shortage would be a shortage of the raw materials required to make the Active Pharmaceutical Ingredient (API). Secondly, there could be a disruption in the supply chain, whereby some countries might close their borders temporarily or not be able to manufacture these medications at the same levels they were before. This was seen in the early weeks of the COVID-19 pandemic, when India temporarily halted export of medications and API, and when Chinese manufacturing capabilities were significantly impacted by the effect of the virus on their workforce.
A third issue is that over the last 20-25 years, globalization, mergers, and acquisitions of drug companies have been significant, and the net result is fewer manufacturers for any given generic medication. If one of the four or five manufacturers left have an issue with their supply chain, it puts additional pressure on the others to make up for that lack of supply in the Canadian market.
Natural disasters are unpredictable and can have a huge impact on the supply chain. A shortage of minibags to mix intravenous medications had a huge impact on hospitals in North America in early 2018. This shortage could not have been foreseen but speaks to the fragility of the supply chain when one manufacturer has such an impact on the operation of so many hospitals.
Finally, increased demand can result in drug shortages. This is the core issue affecting Canada’s drug supply during the COVID-19 pandemic. An unanticipated, significant increase in the demand for specific medications results in shortages because manufacturers cannot quickly ramp up production of these medications. The globalization of the drug supply means that production schedules are established 12-18 months or more in advance, and quickly pivoting to increase production of a specific medication is not always possible in the timeframe required.
There are many stakeholders involved in managing drug shortages, and each has a specific role to ensure that the impact of drug shortages is minimized to the greatest extent possible. In hospitals, pharmacy managers and pharmacy technicians involved in drug distribution spend a considerable amount of time managing drug shortages. Some of the mitigating strategies are: to obtain different pack sizes or concentrations of backordered medications; to use other medications from the same therapeutic class; to compound medications in-house, if possible; to use medications from a different therapeutic class but with a similar mechanism of action; and, most significantly, to help determine which patient populations are prioritized for access to the limited supply of the medication.
Group purchasing organizations have a role in managing drug shortages for their member hospitals. They are the bridge between the hospitals and suppliers and can request protective allocations be put in place if a critical medication is at risk of being in shortage. They work to ensure a fair allocation to as many hospitals as possible, and they also help to promote the sharing of any clinical guidance documents, alternative medication suggestions and mitigation strategies developed by their member hospitals.
Manufacturers have a role in managing drug shortages, and it starts with advising Health Canada of any impending shortages that they foresee. Manufacturers also participate on multi-stakeholder calls to have holistic discussions on the supply availability for any medications that are actually or potentially in shortage which would have a significant impact on the health of Canadians, and they work with their global partners to secure additional supply of a medication for the Canadian market, where possible.
Health Canada has several options available to mitigate drug shortages. When a medication is assessed as being critically important for Canadians and at risk of being unavailable, Health Canada can expedite Establishment License Review, Submission Review and Lot Release for medications. There is also the Special Access Program, which allows small-scale importation of medications not marketed in Canada. And in exceptional circumstances, such as the COVID-19 pandemic, an Interim Order from the Minister of Health gives Health Canada additional flexibility in securing a stable drug supply for the Canadian market.
The Canadian Society of Hospital Pharmacists (CSHP) also has a role to play in mitigating drug shortages. CSHP participates in calls with Health Canada and other stakeholders such as the Provinces and Territories, the manufacturers, the group purchasing organizations and other healthcare associations. These multi-stakeholder calls help to determine if a drug shortage will be considered critical, and they allow CSHP to gather and share information with their members. CSHP also helps to bring attention to the issue so that the Canadian public understands the rationale for some of the decision-making around drug shortages.
Canadians would face less risk with their drug supply if effective measures could be put into place to reduce drug shortages. Unfortunately, because the drug supply chain is so complex, there is no simple solution to this problem and any measures that are taken would have to involve legislative, regulatory, diplomatic, and practical considerations. The COVID-19 pandemic has highlighted the amount of work involved in managing these shortages, and that stakeholders must work together to ensure that Canadians have the medications they need, when they need them.
Christina Adams is Chief Pharmacy Officer at CSHP.