ONS President Addresses FDA
Monday, July 26, 2010
PITTSBURGH, PA – July 26, 2010 – Oncology Nursing Society (ONS) President Carlton Brown, RN, PhD, AOCN®, recently testified before a Food and Drug Administration (FDA) committee in Washington, DC, regarding the proposed Risk Evaluation and Mitigation Strategies (REMS) for Extended-Release and Long-Acting Opioid Analgesics, which seeks to address the issue of opioid misuse and abuse. Brown, representing the more than 36,000 members of ONS, highlighted ONS’s top concerns and recommendations regarding the proposal.
“Any opioid REMS should be reasonable and evidence-based, ensuring that patients with legitimate need have access to the opioid pain therapies that they and their healthcare providers deem most appropriate,” said Brown. “We urge the FDA to develop systems for the safe disposal or return of unused opioids for patients and caregivers. Such a program, combined with patient education, should decrease the number of unused opioids remaining in people’s homes, where they can be accessed by non-legitimate users.”
Brown assured the FDA committee members that ONS stands ready to work with them to develop and implement reasonable and evidence-based policies and programs that give patients with legitimate need access to the appropriate opioid pain therapies, while ensuring that the drugs are not abused. ONS believes that additional research should be conducted and urges the FDA to reconsider a pilot to determine the validity and appropriateness of various interventions. The FDA will then be able to modify and improve the REMS before it is instituted on a large scale, which will help make certain that the final national REMS employs evidence-based interventions found to decrease abuse without adversely impacting patients who require the regular use of opioids to improve their quality of life.
“Pain control needs of patients with cancer-related pain cannot be overlooked,” said Brown. “Piloting a new system and more research will help the FDA to achieve its goal of ensuring that the benefits of these drugs continue to outweigh the risks.”
The Oncology Nursing Society (ONS) is a professional organization of more than 36,000 registered nurses and other healthcare professionals committed to excellence in oncology nursing and to leading the transformation of cancer care by initiating and actively supporting educational, legislative, and public awareness efforts to improve the care of people with cancer. ONS provides nurses and healthcare professionals with access to the highest quality educational programs, cancer care resources, research opportunities, and networks for peer support. Learn more at www.ons.org.