Drug Shortages Flashcards
What types of drugs experience shortages more frequently?
Seen as more of an issue with generic drugs, and more specifically, generic injectable products and other complex formulations
What are the three broad causes of drug shortages?
- Supply issues
- Demand issues
- Regulatory Issues
What are some examples of demand issues that cause drug shortages?
Just-in-time inventory systems
- Under pressure to control costs, health systems, and individual institutions and pharmacies
Increased marketing of a product/drug
- Difficuly to change production levels quickly
Tendering system
- drug cost minimization causes supply lines to become less robust
What are some examples of regulatory issues that cause drug shortages?
Production shut downs
- Firms cut corners to save costs, but causes lower product quality which causes regulatory authorities to shutdown production
What are some examples of supply issues that cause drug shortages?
Manufacturing issues
- aging facilities
- changes in manufacturing procedures
Raw materials
- Limited sources (affect generics more than brand)
- Contamination due to relying on lower cost suppliers
- Use of single suppliers
Industry concentration
- drug supplier consolidation
- firms leave market due to limited revenues
Outsourcing
- Less oversight and control over processes (complex supply lines)
What are some short term mitigation strategies for drug shortages?
Reuse single-use vials (increases risk for contamination)
Allow expired drugs to be used (increased risk of loss of potency)
Accessing poorer quality suppliers (increases potential for counterfeit drugs)
Stockpiling (may worsen shortages for others)
What are some intermediate term mitigation strategies for drug shortages?
Lower manufacturing standards (less predictable effect and potential for contamination)
Expediting drug approval process (may increase exposure to unknown)
Acquire from other jurisdiction (may shift problem to another jurisdiction)
What are some long-term mitigation strategies for drug shortages?
Create incentives for manufacturers to re-enter markets (provide reasonble level of profit or improving regulatory process)
Require manufacturers to have contigency plans (esp. when there are a small number of suppliers)
Incentives to produce drugs in times of shortage
Establish best practices for widely used critical drugs (prescribing only when necessary and alternates do not exist)
More manufacturer transparency
Consider risk of shortages when revewing mergers and acquisitions
Require manufacturers to inform regulators of causes of shortages and time to resolution
What are the consequences of drug shortages?
Direct patient harm (care may be delayed or prevented)
System-level harm (harder to follow EBM practices, time lost to deal woth shortages, increased costs of procurement)
What is the tier assignment committee?
Established with reps from federal and provincial governments to assess the potential scale and impact of drug shortages and assigns a tier status using the TNCF framework
What is the TNCF (Tier Notification & Communication Framework)?
Assigns severity level of drug shortage
Tier 1: All anticipated drug shortages
Tier 2: All actual shortages with available alternatives
Tier 3: Shortages without an available alternative
What happens to when a drug is facing Tier 3 drug shortages?
Special policy measures allow exceptional measures to ensure ongoing supply (ex. importing foreign-authorized drug)
Are drug shortages still lingering after the pandemic?
Yes
What proportion of all marketed drugs in Canada are currently facing Tier 3 shortages?
1.3%
