Postmarketing Surveillance for Oncology Drugs
Postmarketing Surveillance for Oncology Drugs
Adverse effects of cancer therapies may occur more than three decades after drug administration. Continued vigilance in postmarketing use of oncology agents is necessary to accurately track adverse effects, update prescribing information, and alert healthcare providers in a timely manner. This article will define the processes involved in regulatory approval of oncology agents and discuss selected oncology drugs, labeling changes, and the role of oncology nurses in postmarketing surveillance by reviewing journal articles, governmental agency Web sites, federal regulatory documents, and pharmaceutical prescribing information. Oncology nurses administer and monitor cancer therapies in outpatient and inpatient settings and routinely assess patients for side effects of therapy; therefore, maintaining awareness of short- and long-term adverse effects after drug approval is important to patient safety. Nursing leadership should initiate, maintain, and manage an incident reporting system to effectively respond to changing needs. In addition, publication of case reports and articles on the emergence and management of postmarketing, treatment-related side effects in peer-reviewed nursing and medical journals may improve patient care and outcomes.
Oncology has experienced a significant increase in new drug approvals since the late 1980s. Fewer than a dozen agents were commonly employed in the treatment of patients with cancer 25 years ago. Since 2000, more than 40 new anticancer agents and cancer-related supportive care drugs have been approved for use by the U.S. Food and Drug Administration ([FDA], 2007) (see Table 1 ). New medications may offer therapeutic benefit and improved safety profiles, leading to improved outcomes, survival, and quality of life for many patients with cancer. Approval of medications by the FDA often is a lengthy process designed to assess new agents in clinical trials for their efficacy in specific diseases and ensure that associated toxicities can be managed safely.
Although oncology nurses are well versed in the management of common toxicities (e.g., neutropenia, gastrointestinal side effects), targeted therapy agents have introduced them to new side effects, emphasizing dermatologic and other unique toxicities. However, unexpected toxicities may occur during the postapproval and postmarketing time frame with any agent. Adverse events detected during the postmarketing period for oncology drugs have included a variety of toxicities (e.g., venous thromboembolism with lenolidomide and thalidomide, psychiatric disturbances associated with interferons) (Ladewski et al., 2003). The toxicities may not have been apparent during the original controlled clinical studies because trials usually contain small sample sizes and require good organ function for eligibility, so infrequent adverse events can be difficult to detect (Trontell, 2004). For example, studies with 3,000 participants can identify only adverse reactions that occur at rates of 1 in 500 or 1 in 1,000 (Schultz, 2007). Trends often are not observed until new agents are in widespread use in the general population (Hampson & Harvey, 2002; Trontell).
Ongoing monitoring of the effects of oncology medications for treatment and supportive care performs a valuable service. Complete information regarding drug toxicity depends on pharmacovigilance, which is the observations of clinicians and oncology nurses who prescribe, administer, and monitor new therapy (Trontell, 2004). Issues noted with adverse event reporting in the literature include underreporting of low-grade and recurrent events and inconsistent or incomplete reporting of high-grade or significant events (Scharf & Colevas, 2006; Wysowski & Swartz, 2005). Oncology professionals should promptly report all unexpected toxicities of side effects to the manufacturer and the FDA with the MedWatch system (see Figure 1). Progressively more robust clinical trials during the initial drug approval process and postmarketing reporting of adverse effects are critical to continuing drug safety.
(Enlarge Image)
Figure 1.
Reporting Adverse Events to the U.S. Food and Drug Administration (FDA)
This article will define the FDA drug approval process in relation to oncology medications. Although listing every change noted in the postmarketing period for all oncology agents is not possible, selected oncology drug toxicities and side effects resulting in labeling changes will be discussed (see Table 2 ).
Adverse effects of cancer therapies may occur more than three decades after drug administration. Continued vigilance in postmarketing use of oncology agents is necessary to accurately track adverse effects, update prescribing information, and alert healthcare providers in a timely manner. This article will define the processes involved in regulatory approval of oncology agents and discuss selected oncology drugs, labeling changes, and the role of oncology nurses in postmarketing surveillance by reviewing journal articles, governmental agency Web sites, federal regulatory documents, and pharmaceutical prescribing information. Oncology nurses administer and monitor cancer therapies in outpatient and inpatient settings and routinely assess patients for side effects of therapy; therefore, maintaining awareness of short- and long-term adverse effects after drug approval is important to patient safety. Nursing leadership should initiate, maintain, and manage an incident reporting system to effectively respond to changing needs. In addition, publication of case reports and articles on the emergence and management of postmarketing, treatment-related side effects in peer-reviewed nursing and medical journals may improve patient care and outcomes.
Introduction
Oncology has experienced a significant increase in new drug approvals since the late 1980s. Fewer than a dozen agents were commonly employed in the treatment of patients with cancer 25 years ago. Since 2000, more than 40 new anticancer agents and cancer-related supportive care drugs have been approved for use by the U.S. Food and Drug Administration ([FDA], 2007) (see Table 1 ). New medications may offer therapeutic benefit and improved safety profiles, leading to improved outcomes, survival, and quality of life for many patients with cancer. Approval of medications by the FDA often is a lengthy process designed to assess new agents in clinical trials for their efficacy in specific diseases and ensure that associated toxicities can be managed safely.
Although oncology nurses are well versed in the management of common toxicities (e.g., neutropenia, gastrointestinal side effects), targeted therapy agents have introduced them to new side effects, emphasizing dermatologic and other unique toxicities. However, unexpected toxicities may occur during the postapproval and postmarketing time frame with any agent. Adverse events detected during the postmarketing period for oncology drugs have included a variety of toxicities (e.g., venous thromboembolism with lenolidomide and thalidomide, psychiatric disturbances associated with interferons) (Ladewski et al., 2003). The toxicities may not have been apparent during the original controlled clinical studies because trials usually contain small sample sizes and require good organ function for eligibility, so infrequent adverse events can be difficult to detect (Trontell, 2004). For example, studies with 3,000 participants can identify only adverse reactions that occur at rates of 1 in 500 or 1 in 1,000 (Schultz, 2007). Trends often are not observed until new agents are in widespread use in the general population (Hampson & Harvey, 2002; Trontell).
Ongoing monitoring of the effects of oncology medications for treatment and supportive care performs a valuable service. Complete information regarding drug toxicity depends on pharmacovigilance, which is the observations of clinicians and oncology nurses who prescribe, administer, and monitor new therapy (Trontell, 2004). Issues noted with adverse event reporting in the literature include underreporting of low-grade and recurrent events and inconsistent or incomplete reporting of high-grade or significant events (Scharf & Colevas, 2006; Wysowski & Swartz, 2005). Oncology professionals should promptly report all unexpected toxicities of side effects to the manufacturer and the FDA with the MedWatch system (see Figure 1). Progressively more robust clinical trials during the initial drug approval process and postmarketing reporting of adverse effects are critical to continuing drug safety.
(Enlarge Image)
Figure 1.
Reporting Adverse Events to the U.S. Food and Drug Administration (FDA)
This article will define the FDA drug approval process in relation to oncology medications. Although listing every change noted in the postmarketing period for all oncology agents is not possible, selected oncology drug toxicities and side effects resulting in labeling changes will be discussed (see Table 2 ).
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