Rutgers Cancer Institute of New Jersey

New Jersey’s only National Cancer Institute (NCI) – designated Comprehensive Cancer Center, Rutgers Cancer Institute of New Jersey’s team of internationally recognized physicians and researchers is driven by a singular focus and mission, to help individuals fight cancer. Through the transformation of laboratory discoveries into clinical practice, we target cancer with precision medicine, immunotherapy and clinical trials and provide the most advanced, comprehensive, and compassionate world-class cancer care to adults and children. This mission is being accomplished in partnership with RWJBarnabas Health. Rutgers Cancer Institute physicians and scientists work side-by-side to make sure the most sophisticated treatments are delivered to our patients quickly and safely - the future of cancer treatments today.

In 2021, Rutgers Cancer Institute

• Cared for nearly 55,000 outpatient clinic visits to the center,
• Treated over 25,000 patient treatment-visits to Adult Infusion and Pediatric Infusion.
• Dispensing more than 83,000 doses

Of these treatment-visits, 11.3% (or 2862) of patient visits involved a patient enrolled onto a therapeutic clinical trial.

To support these service, Rutgers Cancer Institute of New Jersey employs:

7 Board Certified Oncology Pharmacist supporting clinical care
7 PharmDs supporting the infusion center operations and cleanroom
7 Certified Pharmacy Technicians (CPhT) with certification in Compounding Sterile Preparations (CSPT)

Researchers from Rutgers Cancer Institute have made outstanding scientific contributions towards the national goal of reducing the incidence of cancer and improving the outcomes for cancer patients. Rutgers Cancer Institute coordinates basic, clinical and population research through five comprehensive research programs comprised of faculty who form cohesive, interdisciplinary groups supported by peer-reviewed grants and Rutgers Cancer Institute shared resources. Close to 250 Rutgers Cancer Institute faculty members garner more than $100 million annually in federal, state and philanthropic grant support.

Rutgers Cancer Institute of New Jersey is a part of Rutgers Health, one of the most comprehensive academic health care provider organization in New Jersey, offering a breadth of accessible clinical care throughout the State supported by the latest health-related research and education. Rutgers Health connects health care providers across disciplines, including doctors, nurses, dentists, physician assistants, pharmacists, clinical psychologists and social workers, with a single focus: helping people and populations get well and stay well by delivering consistent, coordinated, value based health care.

As oral chemotherapeutic agents become used more readily for the care of cancer patients, Rutgers Cancer Institute of New Jersey, Research Pharmacy along with Qualitas Specialty Pharmacy are working in conjunction to better the patient treatment experience. The goal of this Oral Oncolytic program (Specialty Rx Access) is to dispense specific medications to patients so as to reduce the cost of filling unnecessary medications, reduce distribution costs, ensure patient safety and adherence, and to comply with risk evaluation and mitigation strategy programs. To overcome the traditional, specialty pharmacy model as stand-alone or mail-order operations with no affiliation with the patient’s practice-based oncology care team, our Health-System now has an internal specialty pharmacy services, which are highly integrated with the patient’s oncology care team. This model matches best practice in the literature described as a closed-loop collaboration between the oncology practices and an internal specialty pharmacy access programs and results in positive clinical outcomes as well as both patient and provider satisfaction. The model includes two full-time pharmacists and 1 technician within the Cancer Institute and 1 dedicated FTE at Monmouth Medical Center and Newark Beth Israel Medical Center. This service has grown to a $27mil revenue generating program locally and a $47mil revenue generating program when including all RWJBH sites under the oncology service line.

The Pharmacy at Rutgers Cancer Institute of New Jersey is also an NCI Comprehensive Cancer Center Shared Resource that provides support for Rutgers Cancer Institute of New Jersey members who conduct research with investigational agents in human subjects. The overall goal of this shared resource is to support the rigorously reviewed Rutgers Cancer Institute’s clinical research by providing an efficient, centralized service of extraordinary quality.

The specific goals of this shared resource are to:

• Develop and maintain proper methods for preparation and handling of investigational agents
• Ensure that all issues involving drug accountability, dosing, and administration are (a) clearly defined in the protocol; (b) consistent with Rutgers Cancer Institute, State, and Federal policies and procedures; and (c) followed to ensure the proper use of all study agents in clinical trials
• Facilitate procurement, maintain accountability, and provide secure and appropriate storage for all investigational agents, and ensure that these agents are dispensed according to protocol guidelines; for the basic science programs, the Research
• Pharmacy shared resource procures investigational and commercial agents for laboratory use Assist Cancer Institute investigators, along with the Rutgers Cancer Institute of New Jersey’s Office of Human Re-search Services (OHRS), in maintaining regulatory compliance
• Provide expert consultation on the use of new agents regarding drug interactions, sequencing, formulation and administration
• Provide an additional level of quality assurance in clinical trials through a) verification of informed consent; b) verification of eligibility and enrollment through the OHRS before dispensing any agent to clinical trial participants; c) verification of dose assignments in phase I trials; d) verification of investigators’ active National Cancer Institute (NCI) status; e) review of dose modifications; f) assessment for potential drug interactions; g) maintenance of randomization schemas for investigator-initiated trials; and h) assessment of patient adherence for self-administered protocol therapy

Preparation and Handling for all Investigational Agents

The shared resource develops methods and manages the preparation and delivery of investigational agents in a USP 797/800 compliant clean room. Policies and procedures are in place that ensure (1) proper storage, handling, and dispensing of investigational agents according to protocol; (2) dose modifications occur as described in the protocol; and (3) all federal and state regulatory requirements are met. It also develops policies for the management of investigational agents used in Cancer Institute multicenter trials through the RWJBarnabas Partnership of hospitals and our Affiliates for clinical trials. All policies and procedures are based on NCI guidelines and the recommendations of the Research Pharmacy Advisory Committee.

Drug Accountability, Dosing, and Administration

All protocols are reviewed by the shared resource before submission to the Institutional Review Board (IRB) to ensure that drug accountability, preparation, dosing, and administration are clearly defined. This helps to minimize the risk of medication errors and protocol deviations. Policies and procedures are in place in the shared resource to ensure drug accountability to supplying agencies.

Procurement

The shared resource works with principal investigators and sponsoring organizations to coordinate the procurement of Investigational drugs. Upon receipt of the investigational agent, all shipping documents are verified against materials received, lot numbers, and expiration dates. It also obtains, tracks, and supplies commercial agents for clinical trials and for laboratory use by Rutgers Cancer Institute members.

Storage and Security

All investigational agents are stored in the shared resource area, which is double locked at all times, and is accessible only by licensed staff members. There is adequate, room-temperature storage space, refrigeration, and freezers (one -30oC and two -86oC). Monitoring of these temperatures occurs every ten minutes and is documented with SmartVue™, a wireless remote temperature monitoring system with daily backup to the Rutgers Cancer Institute’s server.

Dispensing

Research Pharmacists directly oversee the handling of investigational agents and ensure that preparation of agents is performed according to the respective protocol and accordance with FDA and NCI guidelines for investigational drug use. The staff is responsible for verifying study agents are dispensed only for patients on IRB-approved clinical trials, the most up-to-date informed consent is signed by both the patient and an approved investigator, patient eligibility and has been enrolled by OHRS via Oncore®. The pharmacy staff in collaboration with OHRS develops CPOE order-entry for each protocol. All medication orders are cross-referenced to the protocol for verification of dosing, dosing modification, laboratory data, toxicity information.

Drug Accountability

Drug accountability is performed as outlined in the NCI Drug Accountability guidelines. The Department recently expanded to incorporate Vestigo® for drug accountability documentation and are in the process of roll-out across the Health-System.

Expert Consultation for Clinical Trial Development

Occurs during the development of clinical trials. The staff focuses on the development of exclusion criteria for concomitant medications that may interact with the protocol agent, dose modifications for renal, pulmonary, liver or cardiac function based on the preclinical toxicity profile of a new agent for a phase I trial and collaborate on the sequence of administration of protocol agents in the treatment plan. Supportive care medications on investigator-initiated trials are developed and weekly Phase I Group meetings and in protocol activation meetings to continuously and prospectively address these issues.

Drug Formulation

The shared resource has the capacity to formulate and handle new agents including biologicals (e.g., Coxsackievirus A21, talimogene laherparepvec, PANVAC, fowlpox vaccines) and natural products (e.g., tocopherols). The shared resource staff works with OHRS and sponsoring regulatory agencies to achieve approval of new formulations. It also works with institutional safety committees to make sure that each potentially hazardous compound or agent is handled and dispensed in compliance with Good Clinical Practice (GCP) and in concordance with all safety procedures for the agent.

Quality Assurance

The shared resource is responsible for ensuring that all study agents are dispensed only for patients on IRB-approved clinical trials and only after the most recently IRB-approved consent form has been signed by both the patient and an approved investigator. Staff also verifies that a signed and dated consent form is in the chart, re-verifies patient eligibility, and confirms with OHRS that the patient is enrolled onto a study before dispensing a protocol agent. Additionally, a pharmacist obtains a comprehensive medication history from the patient to minimize the risk of adverse drug interactions.

All the IRB-approved investigator-initiated clinical trials are first translated into the EMR by the OHRS Clinical Trials Informatics Specialist and then all investigational agents are inputted by the Informatics Pharmacist and verified by the shared resource.

For randomized, investigator-initiated clinical trials, the shared resource obtains the randomization schema from the Biometrics shared resource. It also performs the randomization and maintains the randomization codes for possible decoding in the event of a medical emergency.

Research Pharmacy Services for Multicenter Investigator-Initiated Clinical Trials: For network trials conducted at network institutions, the shared resource is responsible for inspecting the pharmacy at these sites and training their staff.