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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=915Canadian 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

2014Day 1 6 11 16 21 26 31 36 41 46 51 56

SCA Pharmacy notified of BCG Drug shortage by Merck All BCG drugs sequestered.

8/20/2014

Ethics Services Informed8/21/2014

Ethics Meeting with SCA Pharmacy Dept Head8/22/2014

Ethics Meeting with Urology Dept Head & Staff 8/24/2014

Temporary prioritization initiated: First Come First Serve basis8/25/2014

Stakeholder identification & SHR Pharmacy media release8/26/2014

Development of Ethics Framework with Urology Physicians8/27/2014

SCA memo outlining BCG Drug Shortage Framework8/28/2014

SHR/SCA Ethics Committee Review of Framework9/9/2014

Ethics Framework revised due to increased drug availability.Appeals committee & process completed

10/18/2014

8/20/2014 - 8/28/2014

Ethics Framework

Development (9 days)

8/28/2014 - 10/18/2014Ethics Framework Revised (52 Days)

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Timeline

Media: The Globe and Mail Article9/8/2014

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Overarching Ethical PrinciplesUtility: (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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StrategiesImplement strategies to preserve standard of care and best practices to the greatest extent possible within available drug supply. Conserve existing supply of drugs.

• 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