Module 7: Drug Shortages Flashcards
1
Q
Since the mid-2000’s, both the _________ and ________ of drug shortages have been trending upwards
A
frequency; duration
2
Q
What types of drugs seem to have more shortages?
A
- Seen as more of an issue with generic drugs and, more specifically, generic injectable products and other complex formulations.
- Shortages also tend to occur within certain therapeutic classes, thus affecting some groups more than others.
- e.g. critically ill patients (ICU), and individuals with rare metabolic diseases.
3
Q
What are 3 classes of drug shortage causes?
A
- Supply issues
- Demand issues
- Regulatory issues
4
Q
What are the 3 sub-categories of “demand issues”?
A
- Just-in-time
- Increased marketing
- Tendering system
5
Q
What are the 4 sub-categories of “supply issues”?
A
- Manufacturing issues
- Unavailability of raw material
- Business issues
- Logistic issues
6
Q
What are “just-in-time inventory systems”?
A
Under pressure to control costs, health systems, and individual institutions and pharmacies attempt to free up resources by reducing inventories; but…more susceptible to shortages if there is a supply side disruption
7
Q
What is “increased marketing”? (2)
A
- Resulting in a sudden increase in demand due to an unexpected change in how a drug is marketed.
- A surge in demand can also occur if there is a serious disease outbreak. - Lead time for drug manufacturing is long and the ability to respond constrained by capacity limits and competing production demands of other medicines.
- Especially if the other drugs are more profitable.
8
Q
What is “tendering system”? (4)
A
- Those that fund or purchase drugs often seek bids from competing suppliers to obtain the best possible price.
- Entities such as the pCPA, and other large purchasing groups (LPG), use their size and market power to secure very low prices, and extract much more value for themselves, and those they represent.
- The persistent exercising of monopsony or oligopsony power forces drug prices ever lower; but…
- Leads to the inevitable response from suppliers to find ways to reduce their costs to maintain profitability. - As a result, the quality of the drug supply, both the drugs themselves, and the robustness of processes and supply chains, have declined, especially for generics.
9
Q
What are “regulatory issues”? (2)
A
- One response of companies squeezed on price has been declining adherence to standards as they look to cut costs.
- This has caused some regulatory authorities concerned about the quality of the drug supply to demand changes to ensure “good manufacturing practices” - The result has been more shutdowns or curtailed production as firms respond to these directives
10
Q
What are “manufacturing issues”? (2)
A
- Often related to aging facilities and infrastructure, insufficient upgrades, and/or poor-quality control systems
- Shutdowns due to concerns of regulators
- Voluntary recalls - Changes in manufacturing procedures.
- Delays due to multiple products using the same equipment.
11
Q
How do raw materials (and other inputs) affect supply issues? (3)
A
- Limited sources
- Tends to affect generics more than brand - Contamination
- An over-reliance on low-price suppliers resulting in:
- Both impurities and ingredient degradation
- Poor quality management (due to cost cutting) - Use of single suppliers
- More sensitive to supply line disruptions
12
Q
How do business decisions leading to industry concentration affect supply issues? (2)
A
- Market withdrawal due to limited markets and revenues.
- Reduced number of drug suppliers. - Manufacturer consolidations and mergers (portfolio re-evaluation)
- Drop redundant manufacturing and less profitable drugs.
13
Q
How do logistic issues due to outsourcing and globalization affect supply issues? (2)
A
- Few license holders carry out all aspects of manufacturing and distribution.
- Tasks are outsourced to global third-parties to secure lowest costs. - Results in less oversight and control of processes with extended, often complex supply lines vulnerable to disruption.
- Exacerbate input and manufacturing issues.
14
Q
What did the major hurricane in Puerto Rico in 2017 illustrate about drug shortages? (4)
A
- Unpredictable nature of shortages;
- Fragility of low-cost manufacturing infrastructure;
- Risks associated with relying on single source vendors; and
- Long, unsecure supply chains.
15
Q
What are 4 big categories of drug shortage mitigation strategies?
A
- Management of current drug shortage
- Improvement of operations
- Changes in governmental policy
- Education and training
16
Q
What are some short term mitigation strategies? (4)
A
- Reuse single-use vials
- Extra available due to overfill
- Increases the risk for contamination. - Allow expired drugs to be used
- Expiration dating may not reflect loss of potency or safety
- Increases risk of loss of potency possibility. - Accessing poorer quality suppliers
- Balancing benefit and risk
- Increases potential for counterfeit drugs. - Stockpiling
- Creates a buffer against random variations in supply and demand.
- Ability to amass a stockpile may not reflect actual need, further exacerbating shortages for those less able to acquire limited supply.
- Potential for exploitation if in control of critical items.
17
Q
What are some intermediate mitigation strategies? (3)
A
- Lower manufacturing standards
- Some reflect labelling requirements only
- Can lead to a less predictable effect and great potential for contamination. - Expediting drug approval processes
- Give priority to essential drugs
- May increase exposure to unknown risks. - Acquire from other jurisdictions
- Need and supply may be different elsewhere
- Has the potential to shift the problem to another jurisdiction.
18
Q
What are some long-term mitigation strategies? (8)
A
- Create incentives for manufacturers to re-enter markets
- Require manufacturers to have contingency plans
- Incentives to produce drugs in times of shortage
- Establish best practices for widely-used critical drugs
- More manufacturer transparency
- Consider risk of shortages when reviewing drug company mergers and acquisitions
- Require manufacturers to inform regulators of causes of shortages (most not reported)
- Mandatory reporting
19
Q
Explain what “create incentives for manufacturers to re-enter markets” means (3)
A
- Pricing based on actual costs to provide a reasonable level of profit.
- Pricing to reflect higher quality.
- Reduce the time and cost needed to bring new generics to the market
20
Q
What does mandatory reporting entail? (2)
A
- Require manufacturers to notify buyers and regulators regarding shortages and discontinuations
- USA (FDA) 2012
- Canada (Health Canada) 2017 - By informing buyers and regulators there is more opportunity to develop strategies to mitigate the effects of a pending shortage.
- Health Canada’s Tier Assignment Committee
21
Q
What are 2 ethical issues of drug shortages?
A
- “Drug shortages threaten the capacity for clinicians and (systems) to fulfill their moral obligations to patients and society”
- Drug shortages and the solutions that are employed often require a trade-off between access and safety
22
Q
How do drug shortages cause direct patient harm? (3)
A
- If there is no alternative effective therapy, care may be delayed or even prevented.
- Alternatives may have unexpected adverse effects or are harder to manage.
- Higher probably for medication error if alternatives are unfamiliar.
23
Q
How do drug shortages cause system-level harm? (3)
A
- Harder to follow evidence-based clinical practice or to add to evidence.
- Diversion of time and resources to deal with shortages.
- Increased cost to purchase existing supplies, or high-priced alternatives.
24
Q
Our willingness to leave decisions to private industry increases the likelihood of shortages. How so?
A
- Shifting resources to more profitable ventures
- Seeking cheaper (less robust) production options
25
What were the demand side reasons of drug shortages during COVID-19? (2)
1. Substantial increase in use of medications used to treat Covid-19 and post-Covid-19 infections, and respiratory problems.
- Antibiotics, antivirals, salbutamol, etc.
2. Also, other medications seen to prevent or mitigate Covid-19, even if benefits were questionable or non-existent
- Deprives access to those with legitimate needs for these medications
- e.g. hydroxychloroquine
26
What were the supply side reasons for drug shortages during COVID-19? (2)
1. Closed factories and restricted supply lines around the world.
2. Government policies to limit critical drug exports from major supplier countries.
27
What is the Tier Assignment Committee?
Assesses the potential scale and impact of drug shortages and assigns a tier status using the Tier Notification & Communication Framework (TNCF)
28
What are the 3 tiers of the tier assignment committee?
Tier 1 - all anticipated drug shortages
Tier 2 - all actual shortages with available alternatives
Tier 3 - shortages without an available alternative
(Allows for special policy measures to secure an ongoing supply such as allowing for the exceptional importation and sale of a foreign-authorized drug)
29
How was mitigation being used in 2020 during COVID in Canada? (3)
1. Health Canada engages with industry to monitor and mitigate drug shortages
- Also allows importation of designated drugs not fully meeting regulatory requirements
2. CPhA advises pharmacies to limit prescriptions to 30-day supplies (limit stockpiling)
3. Health Canada web-site lists actual and potential shortages of critical drugs.
- Asks prescribers to ration critical drugs supplies based on available options.
