Drug shortages

Drug shortages: Background

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. We continue to call for collaboration between industry, governments, wholesalers, healthcare providers and other stakeholders to minimize drug shortages and mitigate their effects. Keep reading to learn more about the impacts of drug shortages, and ways CSHP and other stakeholders work to protect Canada’s healthcare system.

 

July 9, 2024

 

Action on IV pantoprazole shortage

In this collaborative reference document, CSHP and the Canadian Association of Gastroenterology make specific recommendations on how to handle the current shortage of IV pantoprazole. This shortage, affecting the Canadian market due to backorders from the primary suppliers, is expected to persist until October 2024. In the interim, healthcare facilities are encouraged to implement conservation strategies, such as transitioning from IV to oral pantoprazole, restricting IV pantoprazole use, and considering intermittent dosing to manage the shortage effectively. This letter underscores the importance of these measures to ensure the prolonged availability of this essential medication.

CSHP has requested that Health Canada consider other IV options for approval, including making another IV alternative available in the Canadian landscape.

 

May 24, 2022

CSHP CPO, Christina Cella, interviewed in the U.S. congressional briefing on drug importation

"Those patients who have been directly impacted by drug shortages...they see that they can't access the medications that they're looking for. And so, when they hear that another country is looking to take more medications from Canada, it's something, certainly, that's of concern to patients."

"We don't have a very robust domestic manufacturing supply so we rely on other countries to access our medications. Even for those medications that we do produce here in Canada 90% of the raw ingredients are coming from foreign sources as well."

"When we're looking at proposals to export our drugs to other countries, it can risk our drug supply..."


FAQs about drug shortages: March 2022

 
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.

Impact of drug shortage

Potential consequences

Economic

  • 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

Clinical
  • 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

 
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?

Stakeholders

Roles

Hospital pharmacy managers and technicians
  • 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

Group purchasing organizations

 
  • 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

Manufacturers

 
  • 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  

Health Canada

 
  • 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

 

 

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 for FAQs

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

 

March 2020

On March 3, 2020, Christina Adams, CSHP's Chief Pharmacy Officer, delivered testimony   before the Connecticut legislators against US plans to import drugs from Canada.

CSHP is a member of the Alliance for Safe Online Pharmacies (ASOP) Canada. Together, Alliance members are working to prevent both federal and state legislation that would allow the importation of Canadian drugs into the US.

In addition to this testimony before Connecticut legislators, CSHP prepared a submission  to federal legislatures regarding FDA’s Proposal on Importation of Prescription Drugs.

Read the testimony , federal legislature submission , and the Canadian Multi-Stakeholder Response to Importation of Prescription Drugs .

Canada’s Drug Supply is Under Threat (Infographic)

November 2019

On November 6, 2019, CSHP signed a letter, along with other stakeholders, requesting that the government take swift and decisive actions to protect Canada’s drug supply in response to U.S. importation proposals. The signatories urge the government "[...] to prioritize the use of levers to protect Canada’s drug supply from U.S. drug importation plans, and to engage our members whose experience and expertise will contribute to an optimal policy solution for Canadians." 

You can read the letter in English  or French .

July 2019

CSHP, along with other stakeholders, signed a letter on July 25, 2019 written to the Hon. Ginette Petipas Taylor, Minister of Health. The signatories of the letter are requesting that "[...] Health Canada provide clarity and assurances to Canadians that U.S. legislation will not inadvertently disrupt Canada’s pharmaceutical supply and negatively impact patient care through greater drug shortages.” You can read the full letter in: 

The The Multi-Stakeholder Steering Committee (MSSC) has produced the following documents, which are available in English and French on the Drug Shortages Canada website: 

March 2017

On March 14, 2017, the federal regulations regarding the mandatory public reporting of drug shortages and discontinuances, introduced in 2016, came into force. At the same time, Health Canada launched the new public, independent drug shortage and discontinuance reporting website: 

You can read the full news release in: 


The mandatory public reporting of drug shortages and discontinuances through the new public, independent website will go down in history.

June 2016 

Health Canada published final regulations requiring mandatory reporting by industry of drug shortages and discontinuances of sales on June 29, 2016.

February 2015

The Government of Canada announced on February 10, 2015 that it was advancing regulations on the mandatory reporting of drug shortages.

June 2014

Health Canada led a consultation on the strengths and weaknesses of the current approach to the notification of drug shortages in June 2014. CSHP participated in a focus group discussion and provided feedback. 

June 2013

The International Pharmaceutical Federation (FIP) and the Canadian Pharmacists Association co-hosted the International Summit on Medicines Shortage in Toronto, Ontario on June 20-21, 2013.The report is available on the FIP website. CSHP participated in the Summit. A provincial-territorial task team was formed. Its members include representatives from the respective provincial/territorial governments, (regional) health authorities, and group purchasing organizations. The task team meets frequently to share information, to plan in response to drug shortages, and to escalate national issues to the federal government as needed.  

March to June 2012

The Parliament of Canada’s Standing Committee on Health issued a report in June 2012, Drug Supply in Canada: A Multi-stakeholder Responsibility . The Standing Committee heard from a variety of stakeholders, including CSHP, over 3 days in 2012. The proceedings of the presentations to the Standing Committee are provided for:

CSHP has been intimately involved in the issue of the public reporting of drug shortages since 2011, from the Multi-Stakeholder Working Group on Drug Shortages through the Multi-Stakeholder Steering Committee on Drug Shortages to the Web Optimization Working Group.

The Multi-Stakeholder Working Group on Drug Shortages first came together in April 2011 and was composed of representatives from BIOTECanada, the Canadian Association for Pharmacy Distribution Management, the Canadian Association of Chain Drug Stores, the Canadian Generic Pharmaceutical Association, the Canadian Medical Association, the Canadian Pharmacists Association, CSHP, and Canada’s Research-Based Pharmaceutical Companies to tackle the escalating problem of drug shortages. The formation of this working group was prompted by a letter from the federal Minister of Health to the three major associations of pharmaceutical manufacturers, asking that they voluntarily disclose information about drug supply. The Working Group participated in the development and design of www.drugshortages.ca, a voluntary drug shortage reporting website administered by industry associations from March 2012 to March 2017.

April 2012

During drug shortages, the work of hospital pharmacists becomes significantly more complex and the risk to patients grows. In April 2012, the Institute for Safe Medication Practices in the United States released the results of a survey  that revealed an association between drug shortages and medication safety incidents. The necessity of using alternative medications (or alternative concentrations, strengths or dosage forms of the same medication) may introduce additional complexity and opportunities for error into the processes of prescribing, preparing, administering, and monitoring medications. What’s more, these alternatives are often less effective, more toxic and more expensive for patients and hospitals. Furthermore, there is a significant potential for errors when hospital pharmacists and pharmacy technicians compound medications from raw materials without adequate expertise, facilities, equipment, staffing, and other resources. Patient safety remains a fundamental value of CSHP and its members. The MSSC on Drug Shortages in Canada was created by the Government of Canada and the Government of Alberta in 2012 to provide a forum for pharmaceutical industry associations, healthcare associations, group purchasing organizations, distributors, and federal/provincial/territorial governments to collectively address drug shortages. CSHP was a founding member of MSSC and continues to be an active participant in the committee, which is co-chaired by Health Canada and one of the provincial or territorial Ministries of Health. 

Learn more about drug shortages

CSHP Drug Shortages eForum 

Through this eForum, CSHP members share information related to drug shortages, e.g., clinical alternatives. Joining the eForum is easy and free of charge for CSHP members. Log onto and select Pharmacy Specialty Networks in My Profile to join today and participate in the discussion!

Presentations

Reports

Media releases and enquiries

Consultations

More resources