Managing a Critical
Drug Shortage Utilizing
an Ethical Framework
14 April 2015
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Overview of Presentation
• Context of Cancer Care in Saskatchewan
• Discuss the BCG Drug Shortage and its implications
• Discuss actions taken
• Ethical Principles and framework utilized
• Lessons learned
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Saskatchewan Cancer Agency (SCA)
• Responsible for providing
leadership in cancer control
through prevention, early
detection, treatment, and
research.
• 2 Comprehensive Cancer
Centres – Saskatoon Cancer
Centre & Allan Blair Cancer
Centre in Regina
• 16 Community Oncology
Centres (COPS Centres)
• SCA/SHR Joint Ethics
Committee
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Media
http://www.theglobeandmail.com/life/health-and-fitness/health/shortage-of-vital-bladder-cancer-drug-prompts-rationing/article20464929/
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BCG Drug Shortage
BCG Live (Intravesical) OncoTICE®
• FDA: “Requirements related to complying with good manufacturing
practices”
• Canadian Drug Shortage Database: “Manufacturing constraints in
conjunction with an increased demand. Limited quantities available
through allocation.”
• Merck:
• Informed the Sask Cancer Agency on August 20, 2014
• Reason for shortage were air quality concerns at the manufacturing plant
resulting in inability to release any BCG product until cleared
• Unknown how long the shortage will last – working on addressing air quality
concerns and quality testing for existing BCG product “reason for the shortage is
manufacturing delay.”
• SCA:
• Centralized purchasing, inventory management and distribution of all cancer
drugs in Saskatchewan (Advantage in drug shortage situation)
• Identified that a shortage BCG affects patient management – NEED A PLAN
ASPH: http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=915
Canadian Drug Shortage Database: http://www.drugshortages.ca/drugshortages.asp?x=
FDA: http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/Shortages/ucm351921.htm
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Implications of BCG Shortage
• BCG (live attenuated Mycobacterium) is the standard of care for the
treatment of non-muscle invasive bladder cancers
• BCG is considered the most efficacious agent to delay tumor
progression, decrease the need for surgical removal of the bladder and
improve overall survival
• Administered directly into the bladder
• Induction treatment is weekly for 6 treatments, and depending on
response, given as maintenance therapy weekly for 3 treatments for up
to 3 years (generally at months 3, 6, 12, 18, 24 and 36)
Lack of access to BCG therapy:
• Use of other alternatives – e.g. bladder instillation with Mitomycin and
Gemcitabine – have not routinely used and have not shown to be more
efficacious than BCG
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SCA Actions
• Establish exact count of BCG stock levels (locations in Regina and Saskatoon,
and rural outreach centres)
• Identify all patients in the province currently receiving BCG bladder
instillations (centralized pharmacy computerized dispensing system).
• Decision not to interrupt BCG therapy for patients currently in the middle of a
weekly treatment protocol – remove the # of vials required from stock to
complete each patient’s therapy and label per patient (dedicated stock)
• Sequester drug centrally. All sites return remaining (undedicated) stock to
the central Cancer Centre locations of Regina and Saskatoon.
• Inform prescribers and treatment centres that we would develop a strategy
for BCG patient allocation, and would be communicating this as soon as
available.
• Communication of strategy communicated to stakeholders : August 28th
• Clinical triage process put in place immediately
• Allocation and management of the drug shortage through the Cancer Agency
pharmacy program and BCG dispensed only on an individual patient-labelled
basis.
• Close collaboration with supplier (Merck) regarding ongoing drug availability
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Ethics
Framework
Development
(9 days)
Timeline
8/20/2014 - 8/28/2014
8/28/2014 10/18/2014
Ethics Framework Revised (52 Days)
Day 1
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11
16
21
26
31
36
41
46
51
56
2014
9/9/2014
SHR/SCA Ethics Committee Review of Framework
9/8/2014
8/28/2014
Media: The Globe and Mail Article
SCA memo outlining BCG Drug Shortage Framework
8/27/2014
Development of Ethics Framework with Urology Physicians
8/26/2014
Stakeholder identification & SHR Pharmacy media release
10/18/2014
Ethics Framework revised due to
increased drug availability.
Appeals committee & process completed
8/25/2014
Temporary prioritization initiated: First Come First Serve basis
8/24/2014
Ethics Meeting with Urology Dept Head & Staff
8/22/2014
Ethics Meeting with SCA Pharmacy Dept Head
8/21/2014
Ethics Services Informed
8/20/2014
SCA Pharmacy notified of BCG Drug shortage by Merck
All BCG drugs sequestered.
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Overarching Ethical Principles
Utility: (Utilitarian Approach)
• Maximize the greatest possible good for the greatest possible number of individuals.
Beneficence:
• Maintain highest quality of safe and effective care within resource constraints.
Solidarity:
• Build, preserve and strengthen inter-professional, inter-institutional, inter-sectorial, and
where appropriate, inter-provincial/territorial collaborations and partnerships.
Equity: (Justice)
• Promote just/fair access to resources.
Stewardship:
• Use available resources carefully and responsibly.
Trust:
• Foster and maintain public, patient, and health care provider confidence in the health
system.
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Accommodation for Reasonableness
1. Empowerment:
 There should be efforts to minimize power differences in the decision-making context
and to optimize effective opportunities for participation (Gibson et al., 2005).
2. Publicity:
 The framework (process), decisions and their rationales should be transparent and
accessible to the relevant public/stakeholders (Daniels & Sabin, 2002).
3. Relevance:
 Decisions should be made on the basis of reasons (i.e., evidence, principles,
arguments) that “fair-minded” people can agree are relevant under the circumstances
(Daniels & Sabin, 2002).
4. Revisions and Appeals:
 There should be opportunities to revisit and revise decisions in light of further
evidence or arguments. There should be a mechanism for challenge and dispute
resolution (Daniels & Sabin, 2002).
5. Compliance (Enforcement):
 There should be either voluntary or public regulation of the process to ensure that the
other four conditions are met (Daniels & Sabin, 2002).
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Allocation Principles
1. Justice :
Continue treatment of patients currently on tx.
• All patients currently on treatment are
prioritized to enable them to complete their
current treatment cycle (induction or
maintenance) regardless of risk.
• After completion of their current treatment
cycle they will receive treatment according to
this framework.
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Allocation Principles
2. Maximizing Therapeutic Benefit:
Initiate treatment of newly diagnosed high risk pts.
a) New Patients:
Patients who are newly diagnosed with high risk disease
(T1 high grade, Ta high grade, or CIS) or recurrent and
require BCG induction therapy of weekly x 6 treatments.
b) Maintenance Therapy Patients:
Those who have high risk disease (T1 high grade, Ta high
grade, or CIS) who are in remission and who will begin a
maintenance course of weekly x 3 treatments at 3 months
or 6 months post‐induction.
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Allocation Principles
3. Maximizing Utility: Delay in treatment/ tx. on hold:
a) Delay in Maintenance Treatment:
• Those who have high risk disease (T1 high grade, Ta high
grade, or CIS) who are in remission and are to begin a
maintenance course of weekly x 3 treatments at 12
months, 18 months, or 24 months post-induction.
• These patients will be re‐evaluated after 1 month.
b) Maintenance Treatment on Hold:
• Those who are in remission and are to begin a maintenance
course of weekly x 3 treatment >24 months post‐induction,
usually at 30 months or 36 months.
• Those who are to begin BCG therapy for any low grade
disease, including those with multiple recurrences.
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Allocation Principles
4. Reprioritization when resources increase:
a). Maximize benefit to patients in category 3a first.
b). Maximize benefit to patients in category 3b
second.
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Strategies
Implement strategies to preserve standard of care and best practices to the
greatest extent possible within available drug supply.
Conserve existing supply of drugs.
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Consolidate all available BCG drug at the Saskatchewan Cancer Agency and
distribute provincially according to this framework.
Standardize treatment practices across the province.
Develop an inventory of available drugs across care settings based on available
supply and criticality of need and/or demand
Review current drug prescribing practices based on available evidence of clinical
efficacy
Reduce wastage of drugs
Ensure adherence to standard of practice that is evidence based.
Use alternative drugs or treatments where evidence suggests similar clinical
efficacy to the drug in short supply
Delay enrolment in research studies using drugs in short supply and all elective
use of the drug as well as off label use.
Reassess patients' medical needs on an ongoing basis to identify any changes in
level of priority, and
Maintain therapeutic relationship with patients and provide ongoing support.
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Strategies
Access new supply of drugs by:
• Collaborating with other provinces and Health
Canada to identify and procure alternative
sources.
• Redistributing drugs between care settings in
coordination with key stakeholders in accordance
with the ethical framework.
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Lesson’s Learned
• Benefit of having one organization in control of the
drug
• Importance of managing the shortage quickly
• Importance of a Communication strategy
• Don’t assume that Standard of Care is followed by
all
• Patient involvement early on
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References
• Based on the Ontario Ethical Framework for Resource
Allocation During the Drug Supply Shortage.
• Modified and used with permission from Jennifer Gibson,
Ph.D., Director of Partnerships & Strategy at the Joint Centre
for Bioethics at the University of Toronto, 30 March 2012.
• The IDEA: Ethical Decision-Making Framework builds upon
the Toronto Central Community Care Access Centre
Community Ethics Toolkit (2008), which was based on the
work of Jonsen, Seigler, & Winslade (2002); the work of the
Core Curriculum Working Group at the University of Toronto
Joint Centre for Bioethics; and incorporates aspects of the
accountability for reasonableness framework developed by
Daniels and Sabin (2002) and adapted by Gibson, Martin, &
Singer (2005).
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Questions
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