FREQUENTLY ASKED QUESTIONS:

What is Project GOLD?

1. Angels for Change and our founding pilot members Cencora, McKesson, and Fresenius Kabi USA have come together to launch an innovative program, Project GOLD (Generic Oncology Lifesaving Drugs). This program is a testament to our stakeholders' crucial role in the pharmaceutical industry. Phase 1 of this program pilot is designed to protect cancer patients from harm through an extended runway of buffer inventory for six vulnerable to shortage oncology medicines.

2. A proactive process for sharing and distributing essential oncology medicines to patients in need without care disruption through the Angels for Change Drug Shortage Hotline. 

3. Utilizing buffer stock of shortage vulnerable oncology products to support hospitals in need for disparity free emergent patient care.

4. GOLD is a new mitigation strategy that increases "just in case supply" by adding a buffer inventory of lifesaving cancer therapies vulnerable to the shortage.

5. Angels for Change Drug Shortage Hotline (DSH) is the nation’s only place for patients, physicians, pharmacists, facilities and hospitals to gain access to emergency supplies during a scarce event. Our DSH is 98% effective in ensuring emergency supply access to patients in an Oncologic Drug Shortage.

Why Project GOLD?

1. Sustainability and reliability must be built into the supply chain to achieve an enduring solution to end drug shortages. Pilot members make a commitment to proactively increase buffer supply of the selected oncology medicines. Then Angels for Change coordinates with pilot members to steward the supply and ensure access.

2. We are starting with oncology medicines because oncology patients are the most vulnerable to life-saving generic injectable shortages. They rely on these medicines for care. There are often no suitable alternatives to treatment and generic injectable medicines are the most vulnerable to shortage.

Project GOLD  - Program Description

1. The short-term goal of Project GOLD is modest in scope (slightly increasing supply of 6 oncology medicines) and is centered around Guardianship—guarding the supply of lifesaving cancer therapies vulnerable to shortage through proactive increased stakeholder collaboration, transparency, a commitment to increase safety stock inventories, early warning practices, and safe distribution of patient-level emergency supplies for those generic injectable oncology drugs at risk. Our proactive approach is designed to instill confidence in the supply chain, pilot a new mitigation process that ensures patient care, enhance stakeholder coordination, build policies to navigate shortage without disparity, measure the success of the project, and activate for scalability.

Overall Program Goals & Objectives

1. Manage emergency supplies for patients proactively, ensuring access using the Angels for Change Drug Shortage Hotline.

2. Ensure patient continuum of care and eliminate patient access disparity during a shortage.

3. Promote supply chain resiliency through redundant supply of shortage vulnerable medicines.

4. Showcase the importance of proactive work, resiliency practices, and the critical roles of advocacy, manufacturing, and distribution in ending drug shortages. Our patient-centric design ensures that the needs of the patients are at the forefront of our efforts.

When is Project GOLD Starting?

1. Monday, January 6, 2025, with the initiation six products in Phase 1

Who & How - The Companies Roles / How is Project GOLD Going to Work?

1. Overall Program - Focus on patients experiencing a problem obtaining an oncology drug during shortage.

2. Angels for Change serves as the manager for pilot member entry into Project GOLD. A4C also receives the initial correspondence from the Customer (Provider, Health System) or Patient experiencing a problem obtaining an oncology drug due to shortage.

3. Distributor/Wholesaler — Will be responsible for performing inventory management services. They will implement the program to procure and manage inventory of critical drug products and distribute them to provider facilities as directed by Angels for Change. The distributor/wholesaler responsibilities also include safely distributing patient-level emergency supplies for those generic injectable oncology drugs at risk, ensuring that the medicines reach the patients promptly and securely. 

• Manage emergency supply for patients

• The buffer inventory of GOLD drugs will be stored by the distributor/wholesaler in a secure and controlled environment. 

• This buffer inventory ensures the safety and integrity of the drugs, as well as facilitates easy access when needed for distribution.

• Inventory for GOLD will be shipped directly from the distributor/wholesaler to the patient care facilities. 

• Product shipment will happen expediently and the distributor/wholesaler will directly invoice facilities/customers for payment.

• Distributors have the ability to select their own manufacturers.

4. Manufacturer – Responsible for manufacturing and supplying drug products of the program. They will increase just in case capacity for distribution to increase supply. Additionally, they will increase patient emergency supply of selected oncology medicines for Angels for Change DSH to access in emergency.

Project GOLD – Products

Oncology Patients are uniquely vulnerable to shortage becuase their medicines are more vulnerable to shortage. Each product has a higher than average vulnerability score using the US Pharmacopeia Medicine Supply Map (MSM) for supply chain risk. They are life-saving and have no suitable treatment alternative. Pharmaceutical distributors and generic injectable manufacturers have supported the inclusion of these products in Project GOLD for a pilot program to test a new buffer supply program. The utilization of these products is lower than other high use medicines. This allows the pilot to test its objectives with more modest patient and resource risk. Using a multi-phased approach, GOLD will endevor to buffer the supply of all generic oncology life-saving essential medicines.

1. Angels for Change selected these products using our 4 step Drug Shortage Product Selection Process. 

• Vulnerability: Is this a vulnerable patient population needing additional drug shortage support? Is the drug vulnerable to shortage as identified by the USP Medicine Supply Map (MSM)?

• Patient Impact: Is the medicine Life Saving? Is there a suitable alternative?

• Feasibility: Is this a model or process that can help these patients ensure access then scale building resiliency for all patients?

• Resource Allocation: Given limited resources and emergent crises, what is the best use of the resources to ensure supply?

2. Additional products and members will be considered for inclusion in Project GOLD after the first six months of the pilot and upon the consent of the relevant stakeholders. 

3. The first products targeted for inclusion in Project GOLD are:

• Azacitidine

• Dactinomycin

• Decitabine

• Docetaxel

• Leucovorin

• Levoleucovorin