- ONS Congress (http://dev-voice.ons.org/conferences/ons-congress)
- U.S. Food and Drug Administration (FDA) (http://dev-voice.ons.org/topic/us-food-and-drug-administration-fda)
- Targeted Therapy (http://dev-voice.ons.org/topic/targeted-therapy)
- Oncology Clinical Trials (http://dev-voice.ons.org/topic/oncology-clinical-trials)
Nurses Must Be Pharmacovigilant With Emerging Cancer Treatments
The field of cancer care is changing and evolving like never before. In 2018, the U.S. Food and Drug Administration (FDA) approved a number of new (https://www.cancer.org/latest-news/2018-in-review-new-cancer-drug-approvals.html) biosimilars, targeted agents, and agents that target certain mutations regardless of tumor site. New requirements for accreditation and reimbursement mean oncology nurses are being used in a growing number of new or developing roles including navigation and survivorship. On Thursday, April 11, 2019, Kathleen Wiley, RN, MSN, AOCNS®, addressed these emerging trends and more in a clinical chat at the ONS 44th Annual Congress in Anaheim, CA (https://congress.ons.org/).
Nurses have an increasing role in pharmacovigilance in such a revolving treatment environment, Wiley explained. With so many new treatments coming to market so quickly, nurses may find themselves in a position where they are looking up new drugs and reading drug labels and administration considerations at the point of care immediately prior to administration. Wiley added that nurses continue to play a role after drug administration, keeping watch for short- and long-term effects.
Drug Labeling
FDA drug labels are an important source of information for nursing practice, and Wiley identified key sections for nurses. The highlights section provides high-level, critical information pertaining to the drug. Section 5 describes dose modifying warning and precautions, and section 14 displays the results of clinical trials involving the agents for nurses to understand outcomes.
ONS is involved in work with FDA to understand the challenges healthcare teams face in a setting where drugs are receiving expedited approvals. Wiley explained that one component of the work is to elevate nursing considerations when developing literature that supports new drug approvals. ONS is launching a webinar later in 2019 with FDA staff involved in the development of FDA drug labels and sorting through MedWatch data.
Clinical Trials
The rigor of the clinical trial setting includes strictly adhering to protocols and dosing requirements and reporting mild and severe adverse events. But how are we collecting data in the postmarket setting after FDA approval? Wiley said that in a clinical trial environment, patient population is controlled, adverse events are tracked, and data are shared. In comparison, the postmarket setting has far less transparency in patient experiences across settings, and it’s difficult to track adverse event incidence without a known denominator of patients receiving an agent.
Nurses play a vital role in pharmacovigilance to ensure that clinicians managing patients receiving agents outside of a clinical trial understand the full scope of adverse events, chronic issues, and late effects. Electronic health records are critical for documenting adverse events and attributability to the agent in question. The responsibility lies with the healthcare team to determine the need to share observed events with FDA.
Oral agents represent a fair percentage of the newly approved indications and play a growing role in cancer treatment plans. Consequently, patients receive care in a variety of different settings other than inpatient areas and ambulatory clinics. Nurses need to ensure seamless integration of oral antineoplastic therapy in the home setting, communicate safety considerations to family members, and develop strategies to personalize adherence assessments, Wiley concluded.