Management Response and Action Plan: Audit of Drug Shortage Reporting, Monitoring and Compliance Activities

Health Canada

Office of Audit and Evaluation
May 2024

Recommendation 1

The Assistant Deputy Minister (ADM) of the Regulatory Operations and Enforcement Branch (ROEB) should review the existing governance framework supporting drug shortage activities, once Drug Shortages Task Force (DSTF) roles and responsibilities are completely within ROEB, in order to:

• Ensure roles and responsibilities are updated and communicated.
• Streamline ROEB's membership and participation in drug shortage committees and multi-stakeholder communication efforts to support increased time effectiveness and efficiency.

Management response and planned management action

Management agrees with this recommendation.

The dissolution of the DSTF and the creation of the Health Product Shortages Directorate (HPSD) serves as an opportune time for ROEB to review the governance framework and committee structure supporting drug shortage activities to reduce possible duplication and to ensure effective and efficient information sharing among stakeholders.

Deliverables

1. Review and make recommendations on the streamlining of internal and external governance, including committee membership, mandates, and roles and responsibilities. Expected completion date: October 2024. Responsibility: Director General, HPSD, ROEB
2. Develop and implement a communication plan to engage stakeholders on opportunities to streamline the governance framework Expected completion date: December 2024. Responsibility: Director General, HPSD, ROEB.
3. Approve and implement refreshed governance and committee structure with updated roles and responsibilities. Expected completion date: February 2025. Responsibility: Director General, HPSD, ROEB.

Recommendation 2

The ADM of ROEB should:

• Ensure that an updated medium- to long-term strategic plan is completed and implemented to address and manage drug shortages, including the identification of strategic risks, as well as associated risk mitigation strategies and processes.
• Ensure that a consolidated information management system is implemented to formally and systematically collect, track and, analyze data to inform the prevention, management, and mitigation of operational risks.
• Develop, disseminate, and implement guidance on the application of SGBA+ to drug shortages, and implement processes to monitor for compliance.
• Develop an updated recruitment, retention, and learning and development plan to support drug shortage activities.

Management response and planned management action

Management agrees with this recommendation.

• Considering the evolving landscape for drug shortages, continue to update the medium- to long-term strategic plan, identifying strategic risks and associated mitigation measures.
• Implement an interim case management system for drug shortages, to support more effective and efficient data practices and case management.
• The system will systematically collect and track drug shortage cases to support continued data analysis to inform prevention, management and mitigation opportunities.
• ROEB acknowledges the importance of intersectionality for mitigating risks associated with drug shortages. Continued integration of SGBA+ analysis within drug shortage management.
• Strengthen planning around recruitment, retention and learning and development for ROEB staff.

Deliverables

1. Renew strategic plan for managing drug shortages in Canada that identifies current strategic risks and mitigation measures. Expected completion date: November 2024. Responsibility: DG HPSD, ROEB.
2. Launch Drug Shortage Application (DSA) for case management. Expected completion date: June 2024 Responsibility: DG Planning and Operations Directorate (POD), ROEB.
3. Establish process for using the DSA, which will include data collection, tracking, and analysis. Expected completion date: October 2024. Responsibility: DG HPSD, ROEB
4. Complete exploration phase for an enterprise compliance and enforcement system in ROEB that would include shortage case management. Expected completion date: June 2025. Responsibility: DGPOD, ROEB.
5. Develop guidance on the application of SGBA+ analysis to critical drug shortages. Expected completion date: July 2024. Responsibility: DG HPSD, ROEB.
6. Communicate and implement guidance and processes to monitor, for compliance, the application of SGBA+ analysis to drug shortages. Expected completion date: October 2024. Responsibility: DG HPSD, ROEB.
7. Develop and implement a HR plan for the new HPSD focused on recruitment, retention, and learning. Expected completion date: September 2024. Responsibility: DG HPSD, ROEB.

Recommendation 3

The ADM of ROEB should formalize and implement regular compliance monitoring, as well as reporting on the results of monitoring and compliance promotion efforts, in order to strengthen the regulated mandatory reporting of prescription drug shortages.

Management response and planned management action

Management agrees with this recommendation.

• Formalize and implement a process for regular compliance monitoring and promotion around drug shortage mandatory reporting requirements.
• Examine ways to increase transparency on industry compliance, to strengthen regulated mandatory reporting.

Deliverables

1. Formalize and implement a process for monitoring and promoting industry compliance with mandatory reporting requirements. Expected completion date: December 2024. Responsibility: DG HPSD, ROEB.
2. Develop a report that summarizes the results of monitoring and compliance promotion efforts. Expected completion date: March 2025. Responsibility: DG HPSD, ROEB.