Drug shortages: FAQ
March 24, 2022
Drug Shortages
Drug shortages are a global issue that can significantly affect patient outcomes. CSHP plays a key role in advocating for mitigation strategies to minimize the impact of drug shortages on Canadians. Keep reading to learn more about the impacts of drug shortages, and ways CSHP and other stakeholders work to protect Canada’s healthcare system.
What are the main reasons for drug shortages?
Causes of drug shortages are multifactorial and can include the following, either alone or in combination:
- Shortage of raw materials to make API (active pharmaceutical ingredient), excipients or packaging materials
- Manufacturing difficulties and disruption in supply chain
- Regulatory issues: policies, communication with stakeholders, implementation of safety and efficacy standards.
- Voluntary recalls
- Globalization, mergers, and acquisitions of drug companies
- Supply and demand issues
- Logistical issues: transportation, natural disasters, contamination, management incompetency
What are the impacts of drug shortages?
Drug shortages and resulting issues oblige members of the healthcare team to quickly use their problem-solving skills. When encountering a drug shortage, the pharmacy team may need to find appropriate therapeutic substitutes, determine different concentrations of the drug, and adjust strengths or dosage forms of the same medication. The team may also communicate with other healthcare professionals and source scarce drugs from other hospitals or suppliers. The table below highlights the economic and clinical consequences of drug shortages.
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Impact of drug shortage
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Potential consequences
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Economic
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- Increased hospital expenses
- Increased budget for stakeholders
- Increased risk of drug shortages for alternative drugs
- Increased out-of-pocket expenses
- Importation of medication from other countries
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Clinical
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- Increased medication safety incidents
- Compromised clinical patient outcomes
- Reduced clinical work with patients
- Strained professional relationships with healthcare professionals and patients
- Potential for patients to seek counterfeit medication
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How does CSHP advocate to prevent and mitigate the impacts of drug shortages nationally?
One of CSHP’s fundamental values for pharmacy practice has been advocating for patient safety. Our objective is to minimize drug shortages and mitigate their effects by continuing to actively collaborate with governments, industry, distributors, wholesalers, major corporations, other healthcare providers, and stakeholders. CSHP’s efforts include the following examples:
Health Canada consultations
CSHP participates in calls with Health Canada and other stakeholders (including provinces and territories, manufacturers, other healthcare associations, and group purchasing organizations). CSHP’s roles are to:
- Help determine whether the current drug shortage should be considered critical
- Share this information with members
- Help the Canadian population understand the decision-making process behind these mitigation strategies.
Membership in the Alliance for Safe Online Pharmacies Canada
As a member of Alliance for Safe Online Pharmacies (ASOP) Canada, CSHP collaborates with other stakeholders to:
- Advocate to prevent American federal and state legislation proposals to import drugs from Canada.
- Prepare official submissions to federal legislatures concerning FDA’s Proposal on Importation of Prescription Drugs.
Membership in the Multi-Stakeholder Steering Committee on Drug Shortages (MSSC)
As an active member of the Multi-Stakeholder Steering Committee on Drug Shortages (MSSC), CSHP’s roles have been to:
- Actively participate in public reporting of drug shortages (since 2011)
- Collaborate with stakeholders to draft a letter requesting that Canada’s drug supply be protected against US importation proposals and legislation
- Help create reference documents regarding drug shortages (attached below in Question #6 under MSSC References).
- Participate in the International Summit on Medicines Shortages with both the International Pharmaceutical Federation and the Canadian Pharmacists Association
What other stakeholders are involved in mitigating drug shortages, and what are their respective roles?
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Stakeholders
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Roles
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Hospital pharmacy managers and technicians
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- Finding appropriate therapeutic alternatives
- Substituting another medication in the same therapeutic class as the scarce drug
- Substituting medication in a different therapeutic class from the scarce drug, but with a similar mechanism of action
- Determining different pack sizes or concentrations
- Determining different strengths or dosage forms of backordered medication
- Communicating with other healthcare professionals and suppliers to obtain medication
- Compounding medications if possible
- Determining prioritization of patient populations for distribution of scarce medication
- Notifying other stakeholders of updates on drug shortages (including high-alert medication warnings)
- Educating patients
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Group purchasing organizations
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- Serving as a link between hospitals and suppliers
- Promoting sharing of documents from hospitals such as guidance on drug shortages, mitigation strategies, and suggestions for therapeutic alternatives
- Ensuring a fair allocation of scarce medication to as many hospitals as possible
- Requesting protective allocations if a medication is at risk of being in shortage
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Manufacturers
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- Reporting any foreseeable drug shortages to Health Canada
- Participating in multi-stakeholder calls
- Communicating with global partners to ensure additional medication for Canadian drug supply
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Health Canada
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- Health Canada’s Drug Shortages Division (DSD) plays a key role in responding to drug shortages: Coordinating information sharing between impacted groups, implementing mitigation strategies, and assessing potential impact of shortages
- Expediting Establishment License Review, Submission Review, and Lot Release for medications
- Providing guidance on access to unauthorized drugs through the Special Access Programme
- In exceptional circumstances, releasing an interim order from Minister of Health to help safeguard Canadian drug supply
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How can CSHP members receive updates about drug shortages?
CSHP offers a free Pharmacy Specialty Network (PSN) for all CSHP members to stay updated on current drug shortages. This is a forum for pharmacy staff to seek support and suggestions from peers facing similar challenges with managing drug shortages in their institutions. Topics of discussion may include, but are not limited to: therapeutic alternatives, preservation strategies, obtaining SAP products, look-alike alerts, and drug shortage updates.
To access to the CSHP Drug Shortages PSN, click here. Alternatively, please follow these steps: Member Centre > Pharmacy Specialty Networks > Create Account or Log-In to QID > Search Communities > Drug Shortages PSN
Where else can I seek up-to-date information on drug shortages?
Drug Shortages Canada / Pénuries de médicaments Canada
Drug Shortages in Canada (Government of Canada)
House of Commons report on Drug Supply in Canada: A Multistakeholder Responsibility
Canadian Drug Shortage website
US Food and Drug Administration’s Report on Drug Shortages
MSSC resources:
Multi-Stakeholder Toolkit: A Toolkit for Improved Understanding and Transparency of Drug Shortage Response in Canada
Protocol for the Notification and Communication of Drug Shortages
Guidance Document to Mitigate Drug Shortages through Contracting and Procurement
Preventing Drug Shortages: Identifying Risks and Strategies to Address Manufacturing-Related Drug Shortages in Canada
References
Adams C. Understanding Drug Shortages During a Pandemic. Hospital News [Internet]. 2020 [cited 14 March 2022]. Available from: https://hospitalnews.com/understanding-drug-shortages-during-a-pandemic-2/
Drug Shortages. Canadian Society of Hospital Pharmacists (CSHP) [Internet]. 2020 [cited 14 March 2022]. Available from: https://www.cshp.ca/site/adv/advocacy/drug-shortages?nav=advocacy
Shukar S, Zahoor F, Hayat K, Saeed A, Gillani AH, Omer S, Hu S, Babar ZU, Fang Y, Yang C. Drug Shortage: Causes, Impact, and Mitigation Strategies. Frontiers in pharmacology. 2021;12.
Drug Shortages Continue to Compromise Patient Care. Institute for Safe Medication Practices (ISMP) [Internet]. 11 January 2018. [cited 16 March 2022]. Available from: https://www.ismp.org/resources/drug-shortages-continue-compromise-patient-care