July 1, 2013
Volume 77, Number 7
Practice Management: ASA Partners With FDA’s Safe Use Initiative to Reduce Preventable Medication Harm
Brian J. Cammarata, M.D.
Carol J. Peairs, M.D.
Lisa Pearlstein, J.D.
ASA has partnered with the Food and Drug Administration’s (FDA’s) Safe Use Initiative on two major initiatives to improve the safe use of medications and reduce preventable harm from medication misuse, abuse and errors. The rate of medication errors and preventable harmful events is still a serious cause for concern. The 2007 Institute of Medicine report Preventing Medication Errors estimated that at least 1.5 million preventable adverse drug events occur in the United States each year.1 The Centers for Disease Control and Prevention (CDC) reported that in 2008, more than 36,000 people died from drug overdoses, and most of these deaths were caused by prescription drugs.2
To complement the agency’s regulatory mission of approving safe and effective medications, the FDA launched the Safe Use Initiative in 2009. The Safe Use Initiative supports collaborative, non-regulatory efforts between the FDA and health care stakeholders to reduce preventable medication harm. The Safe Use Initiative addresses a wide range of medication risks such as acetaminophen toxicity, medication adherence and safe injection practices. ASA has partnered with the FDA on two initiatives that focus on patient safety concerns particularly relevant to anesthesiologists: the Preventing Surgical Fires Initiative and the Opioid Patient Prescriber Agreement Working Group.
Preventing Surgical Fires Initiative
The FDA, ASA and other health care stakeholders launched the Preventing Surgical Fires Initiative in 2011 to increase awareness of surgical fire risks, disseminate surgical fire prevention tools and promote the adoption of risk-reduction practices. Even though the root causes of surgical fires are well understood, 550-650 surgical fires occur in the United States each year and can cause serious injury, disfigurement and even death.3
On the Preventing Surgical Fires website, the Safe Use Initiative has made available multiple resources for physicians, including educational videos (CME and non-CME), reference articles and advisories, fire risk assessment tools, and educational posters to minimize and fight surgical fires. The FDA publicized ASA’s “Practice Advisory for the Prevention and Management of Operating Room Fires,” which identifies the situations conducive to fire and the elements of a fire response protocol, and advises anesthesiologists on how to prevent the occurrence of and reduce adverse outcomes associated with surgical fires. In recognition of ASA’s leadership in launching the Preventing Surgical Fires Initiative, the FDA selected ASA to receive the “Group Recognition Award for superior achievement of the Agency’s mission through teamwork, partnership, shared responsibility or collaboration to achieve FDA goals.”
Anesthesiologists interested in learning more about preventing surgical fires should attend the “Surgical Safety Hot Topics” panel at the ANESTHESIOLOGY™ 2013 annual meeting, which will report on the Preventing Surgical Fires Initiative, common patient safety concerns and mishaps that occur in the perioperative setting, and the Council on Surgical and Perioperative Safety’s (CSPS’) safe surgery principles. Anesthesiologists should also visit the Preventing Surgical Fires Initiative’s webpage www.fda.gov/preventingsurgicalfires and ASA’s webpage on surgical fires www.lifelinetomodernmedicine.com/Anesthesia-Topics/Operating-Room-Fires.aspx.
Opioid Patient Prescriber Agreement Working Group
In response to the prescription drug abuse epidemic, the
Safe Use Initiative formed the Opioid Patient Prescriber Agreement Working Group (PPA Working Group) to develop a model Patient Prescriber Agreement (PPA) for physicians to use with their patients when discussing an opioid treatment plan. Chronic pain and prescription drug abuse are both enormous public health concerns. According to the Institute of Medicine report Relieving Pain in America, more than 100 million Americans suffer from chronic pain with an annual national economic cost of $560-635 billion.4 The CDC reported that nearly 15,000 people in the United States died from opioid pain reliever overdoses in 2008, which is more than three times the number of people who died from these drugs in 1999.5
The Safe Use Initiative convened patients, patient advocates, pain medicine specialists, addiction specialists, primary care physicians, pharmacists, medical malpractice representatives and other health care stakeholders to develop a model PPA. The initial template of the PPA has been created and will be implemented on a trial basis at select participating institutions. In this trial stage, physicians and patients will provide input on whether the PPA helped facilitate communication between physicians and their patients, made physicians and patients more mindful about the drugs that are being prescribed, addressed the risks and benefits of opioids, and highlighted the responsibilities of the physician and patient in the management of opioids. Once finalized, the model PPA will be made publicly available and could potentially replace the variety of PPAs currently in use in some settings.
Physicians can play a significant role in efforts to reduce prescription drug abuse. They can encourage participation in CME offerings on opioid prescribing that are part of the FDA Risk Evaluation and Mitigation Strategy (REMS) on long-acting and extended-release opioids. This FDA REMS is a plan that manages serious risks associated with opioids, and the centerpiece of the REMS is an education program on safe and effective opioid prescribing. Anesthesiologists can also get involved in ASA’s efforts to reduce prescription drug abuse. One major effort at ASA was our collaboration with the Partnership at DRUGFREE.org on the Medicine Abuse Project, a public awareness campaign that encourages parents and the public to: 1) talk to their kids about the dangers of medicine abuse, and
2) safeguard and properly dispose of unused medications. Physicians can also educate patients about the dangers of medicine abuse and the importance of safeguarding and properly disposing of unused medications.
To learn more about reducing preventable medication harm, visit the FDA Safe Use Initiative webpage www.fda.gov/safeuseinitiative.
Brian J. Cammarata, M.D. is Partner
and Director of Risk Management,
Old Pueblo Anesthesia; Chief Medical Information Officer, Tucson Medical
Center; Clinical Assistant Professor,
Department of Anesthesiology,
University of Arizona, Tucson.
Carol J. Peairs, M.D. is Chief of
Pain Medicine Services, Department of Surgery, Phoenix VA Health Care System, Phoenix, and Clinical
Associate Professor, University
of Arizona College of Medicine, Phoenix.
Lisa Pearlstein, J.D. is ASA Pain
Medicine and Regulatory Lobbyist.
1. Aspden P, Wolcott JA, Bootman L, Cronenwett LR, eds.; Institute of Medicine, Committee on Identifying and Preventing Medication Errors; Board on Health Care Services. Preventing Medication Errors. Washington, DC: National Academies Press; 2007:5-6.
2. National Center for Injury Prevention and Control, Division of Unintentional Injury Prevention. Policy impact: prescription painkiller overdoses. Centers for Disease Control and Prevention website. http://www.cdc.gov/homeandrecreationalsafety/rxbrief/. Updated November 29, 2012. Accessed May 2, 2013.
3. ECRI Institute. New clinical guide to surgical fire prevention. Health Devices. 2009;38(10):314-332.
4. Institute of Medicine, Committee on Advancing Pain Research, Care, and Education; Board on Health Sciences Policy. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. Washington, D.C.: National Academies Press; 2011.
5. National Center for Injury Prevention and Control, Division of Unintentional Injury Prevention. Prescription painkiller overdoses in the US. Centers for Disease Control and Prevention website. http://www.cdc.gov/vitalsigns/PainkillerOverdoses/index.html. Updated November 1, 2011. Accessed May 2, 2013.