Opportunities for Collaboration
The following is a sampling of drugs, drug classes or therapeutic areas that could benefit from stakeholder collaboration.
- Acetaminophen toxicity
- Antipsychotic use in elderly with dementia-related psychosis
- Benzocaine gels, liquids and topical sprays and the risk of methemoglobinemia
- Epidural steroid injections
- Fentanyl transdermal system “patches”: safe disposal
- Health literacy
- Long-acting beta agonists (LABA)
- Medication adherence
- Mitoxantrone (Novantrone) monitoring for cardiac function
- Nonsteroidal anti-inflammatory drugs (NSAIDs) for the treatment of pain in geriatric patients
- Opioid patient-prescriber agreement
- Psychotropic medications in pediatric populations
- Safe disposal of needles and other sharps used outside of healthcare settings
- Safe injection practices
- Surgical fires
- Unintentional medication overdoses in children
- Vincristine administration
Acetaminophen, used for treating pain and fever, is an active ingredient in over 600 prescription and over-the-counter medications. Daily dosing in excess of the recommended maximum labeled dose has been associated with serious liver injury and death. Despite efforts (since the early 1990s) to reduce acetaminophen-related liver injury, acetaminophen overdose remains the most common cause of drug-induced liver injury leading to liver transplant in the United States. FDA has an ongoing public education campaign, is participating in education coalitions, and has taken and is considering new regulatory actions.
FDA’s Safe Use Initiative and a broad group of stakeholders, under the leadership of the National Council for Prescription Drug Programs (NCPDP), produced a white paper with recommendations intended to provide consistency in labeling across all acetaminophen-containing medicines. Safe Use will continue to work with stakeholders to encourage adoption, implementation and adherence to these recommendations, address existing barriers and encourage education and communication. Safe Use serves as advisors to the Acetaminophen Awareness Coalition’s “Know Your Dose” campaign. We will continue to initiate and participate in other collaborative efforts and alternative strategies to help decrease unintentional overdose of acetaminophen-containing medicines. Please see: Acetaminophen Toxicity.
Antipsychotic use in elderly with dementia-related psychosis
Both conventional and atypical antipsychotics are associated with an increased risk of mortality in elderly patients treated for dementia-related psychosis.
The Safe Use Initiative has teamed up with Centers for Medicare and Medicaid Services (CMS) and Acumen to review CMS's claims data for elderly patients with dementia to see if CMS data reinforces this association. The Safe Use Initiative will collaborate with healthcare professionals, state and federal agencies, consumer organizations and others to promote safe prescribing practices and the safe use of these medications in our nation's elderly.
Benzocaine gels, liquids and topical sprays and the risk of methemoglobinemia
Over-the-counter gels and liquids containing benzocaine are used by consumers to relieve pain from teething, canker sores, and irritation of the mouth and gums. Benzocaine is also contained in topical sprays used by healthcare professionals to numb the mucous membranes of patients' mouths and throats during medical procedures. Because of the risk of a rare but serious and potentially life-threatening adverse event, called methemoglobinemia, which has been associated with the use of oral products containing benzocaine, in April 2011 the FDA issued two drug safety communications—one to consumers about the gels and liquid medications, and a second to healthcare professionals about the topical sprays. To further awareness of this serious risk and improve the safe use of these medications, the Safe Use Initiative has teamed up with CDER's Office of Communications to broadly disseminate important risk information through consumer and healthcare professional organizations, internet health sites, professional journals and newsletters. Safe Use will continue to look for opportunities to collaborate with the healthcare community on this issue. Please see: Benzocaine.
Epidural steroid injections
The FDA’s Safe Use Initiative is collaborating with a working group of clinical experts concerned about the safety of epidural steroid injections (ESIs), including medical professionals, members of academia, and representatives of professional pain management societies and organizations. The ESI working group is developing recommendations for healthcare professionals who administer ESIs as a treatment for spine pain. To facilitate the development of those recommendations, FDA’s Safe Use Initiative provided the ESI working group with a forum for their discussions regarding epidural steroid injections.
The ESI working group’s ultimate goal is to minimize the risk of ESI-related neurologic injuries, to the extent these injuries may be related to clinical administration procedures and techniques. As a first step toward this goal, the ESI working group has compiled a preliminary list of ESI administration strategies to be discussed by pain management experts and representatives of pain management societies and organizations.
The ESI working group intends to present its final recommendations at a national meeting of healthcare professionals. The working group plans to publish the recommendations in a reference document for healthcare professionals who administer ESI as a treatment for spine pain.
Fentanyl Transdermal System “Patches”: Safe Disposal
The fentanyl transdermal system “patch” (Duragesic and its generics) is one of a small number of potent medications that, if accidentally or inappropriately used, can be fatal in just a single dose. New patches contain a 3-day supply of fentanyl. Used patches still contain enough fentanyl to harm or cause death in a child. Only patients prescribed fentanyl patches (or their caregivers) should have access to the patches and used patches must be disposed of safely.
From 1997 to 2012, there have been 26 reported cases of accidental fentanyl patch poisonings in young children; 10 of these children died. These poisonings have occurred at home as well as in healthcare settings where children have accompanied adults to visit patients. In spite of multiple FDA advisories, fentanyl patch poisonings continue to occur.
The Safe Use Initiative is leading a broad-based collaborative effort to augment continuing activities for improving the safe use and safe disposal of fentanyl patches. You can learn more about this effort in our stakeholder letter (PDF - 101KB) in which we invite you to join us in exploring a wide range of ideas and perspectives and implementing new fentanyl patch safety strategies.
For more information please see Fentanyl Transdermal System (marketed as Duragesic) Information and Disposal of Unused Medicines: What You Should Know.
Health literacy skills are needed to navigate every aspect of the healthcare system—for dialogue and discussion, reading health information, interpreting charts, making decisions about participating in research studies, using medical tools for personal and family health care, calculating timing or dosage of a medication, and voting on health or environmental issues.1 Cumulative and consistent findings suggest a causal connection between limited health literacy and negative health outcomes. Stakeholder collaboration can lend support for health literacy research and other health literacy efforts. Please see “The Safe Use Initiative and Health Literacy-A Workshop,” held by the Institute of Medicine (IOM)’s Roundtable on Health Literacy.
Long-acting beta agonists (LABA)
Some patients who take long-acting beta agonists (LABAs) as monotherapy for asthma experience exacerbations of asthma symptoms, which can result in hospitalizations and death. On June 2, 2010, FDA announced revisions to the prescribing information for LABA labels to improve their safety. Under the Safe Use Initiative, partnerships with Centers for Medicaid and Medicare Services (CMS), Horizon Blue Cross/Blue Shield of New Jersey, and the Department of Defense are underway to study patterns of LABA use from their databases. If we identify suboptimal LABA prescribing and use practices, Safe Use hopes to develop interventions with these groups and with other collaborators that will improve prescribing practices. Please see: Long-Acting Beta Agonist (LABA) Information.
The National Consumers League (NCL) leads “Script Your Future,” a nationwide multimedia campaign to improve public health by raising consumer awareness of the importance of good medication adherence. Separate websites for consumers and health care professionals provide tools to improve communication between consumers and their health care professionals and tools to help consumers manage their medicines. The Safe Use Initiative has joined other FDA offices and HHS agencies in supporting the efforts of this broad cross-section of public and private stakeholders.
Mitoxantrone (Novantrone) monitoring for cardiac function
- Patient messaging , to increase MS patient awareness about the need for cardiac monitoring because the risk of cardiac toxicity can occur during mitoxantrone treatment or years after its completion, and that treatment is available which can prevent or at least slow cardiac function deterioration and progression to heart failure;
- Healthcare provider messaging, to increase awareness about the importance of cardiac function monitoring in MS patients who are or were treated with mitoxantrone;
- Health plans to voluntarily send annual reminders of cardiac monitoring to MS patients and their healthcare provider(s).
Nonsteroidal anti-inflammatory drugs (NSAIDs) for the treatment of pain in geriatric patients
Pain is a prevalent condition in older adults. According to some estimates, more than 50% of individuals aged 65 and older have daily pain. Without proper management, patients may be undertreated or they may use pain medications inappropriately. In late September 2010, the Safe Use Initiative staff initiated collaborative efforts to address these issues by bringing together experts in geriatric care, pain management and medication safety, and representatives of public and private healthcare delivery systems. Please see: Expert Roundtable on Pain Management in Older Adults.
The Safe Use Initiative, in collaboration with the Association for Chronic Pain Patients (ACPP), is undertaking a project to identify, collate, and disseminate best practices for NSAID use in older adults. A collaboration initiated with Medscape will evaluate the utility of an established cardiovascular risk assessment tool in predicting NSAID related serious cardiovascular events. If the tool is shown to have predictive value, a second phase will assess its value as a personalized communication tool for the risk of NSAID-related cardiovascular adverse effects. Under consideration is a project that involves establishment of a web-based community for patients and prescribers that provides evidence-based information on the safe use of NSAIDs.
Opioid patient-prescriber agreement
Pain affects the lives of more than a hundred million Americans.2 As part of a pain treatment regimen, patients may be prescribed opioid analgesics. Opioids, like all drugs, have risks. Prescribing errors and inappropriate use of opioid anaslgesics increase risk and can lead to serious harm, including death. This harm is preventable.
To increase the safe use of opioid analgesics, the Safe Use Initiative convened a collaborative working group, including patients, patient advocacy organizations, pain management specialists, health literacy experts, addiction specialists, primary care providers and others. The working group’s charge was to develop tools for patients and prescribers to use when they are considering opioids for the treatment of pain. In 2012, the working group developed a model Opioid Patient-Prescriber Agreement (PPA) that is patient-centric by incorporating the patients’ perspective and including the patient as an active participant of their treatment for pain. This document tool can replace the variety of opioid treatment contracts or agreements currently in use in some settings. Many of the agreements currently available are inconsistent in the information they provide about the safe use of opioids and their risks and benefits, are written at too high a reading level for most patients, and are derogatory in tone. Please see: Opioid Patient-Prescriber Agreement: A Tool for Shared Decision-Making in the Treatment of Pain.
Psychotropic medications in pediatric populations
The use of psychotropic medications has been on the rise in the past ten years, particularly the second generation, or so called atypical antipsychotic, drugs.3 The growing use of these drugs in children, coupled with the mounting evidence that these drugs are associated with weight gain, metabolic syndrome and diabetes, raises questions about the appropriate and safe use in pediatric populations.4
The Safe Use Initiative has teamed up with Centers for Medicare and Medicaid Services (CMS) and Acumen to review CMS's claims data to study the patterns of antipsychotic medication use among Medicaid beneficiaries. The goal is to determine whether there is an identifiable subpopulation of Medicare beneficiaries at high risk of antipsychotic metabolic side effects. If the data indicate an identifiable subgroup, then as part of a second phase, Safe Use Initiative, in conjunction with CMS, other healthcare professionals, state and federal agencies, consumer organizations and others will determine if we can identify and promote interventions that will improve patient monitoring and ultimately reduce the incidence of metabolic side effects.
The Safe Use Initiative has also been involved with The Administration for Children and Families (ACF) in their efforts to facilitate and promote the health and welfare of children in foster care. The Safe Use Initiative is working with ACF to develop a user-friendly guide for adolescents who have reached the age of 18 and are exiting foster care. The guide will help the youth better understand the benefits and side effects of these medications and will enhance their safe and appropriate use.
Safe disposal of needles and other sharps used outside of healthcare settings
The U.S. Environmental Protection Agency (EPA) estimates that approximately 9 million people use needles and other "sharps" to manage their medical conditions at home, at work or on travel. Often consumers and their caregivers and healthcare professionals don't know how to dispose of sharps safely in these settings. Needle sticks, cuts or punctures from sharps that are not disposed of safely can lead to community exposure to blood-borne viruses, such as Hepatitis B (HBV), Hepatitis C (HCV), and Human Immunodeficiency Virus (HIV). Recognizing the need to address the risks, CDRH is leading an FDA collaboration that includes CVM, CBER and CDER’s Safe Use Initiative to develop interventions to reduce the public health risks posed by improper disposal of sharps. Please see: Safe Disposal of Needles and Other Sharps Used Outside of Health Care Settings
Safe injection practices
Many injectable medications come packaged in vials of various sizes and strengths. In order to minimize preventable harm, everyone who draws up or administers medications that come in vials must follow appropriate injection practices. When inappropriate injection practices are employed, patients are at risk for serious bacterial and/or blood borne infections. FDA can work with partners, such as professionals who use these products, infection control personnel and standard setting organizations to identify the factors that lead to unsafe practices and to develop effective strategies to reduce the risks of inappropriate injection practices. The Safe Use Initiative serves as an advisor to the Safe Injection Practices Coalition and supports the activities of the coalition's One and Only Campaign .
In December 2012 the Safe Injection Practices Coalition posted new materials to make it easier for doctors, nurses, and other healthcare providers to learn about and follow safe injection practices.
An estimated 550 to 650 fires occur per year in inpatient and outpatient surgical settings.5 Although this number is small compared to the number of surgical procedures performed every year in the United States, a surgical fire can have serious consequences to patients. Surgical fires are preventable medical errors, but despite the fact that the root causes are well understood, surgical fires still happen. Many healthcare organizations have developed tools, implemented strategies, and conducted education and outreach efforts to reduce the risk of fires. To supplement FDA regulatory efforts and highlight the efforts of FDA’s partners, in October 2011 the Safe Use Initiative, CDER and CDRH launched an initiative and a website. Safe Use will continue to work with private and public partners to increase awareness of the factors that contribute to surgical fires and to promote adoption of risk reduction practices. Please see: Preventing Surgical Fires.
Unintentional medication overdoses in children
Children are especially vulnerable to unintentional overdoses from over-the-counter and prescription medicines used for consumers of all ages. Most of these overdoses are preventable. The Centers for Disease Control and Prevention’s (CDC) PROTECT Initiative is a collaboration of national experts in patient safety and health literacy, health professional societies, consumer and patient advocates, public health agencies, and private sector companies. PROTECT Initiative has launched its Up and Away and Out of Sight educational program to encourage parents to follow a few simple steps to protect their children from unintentional overdoses from OTC medications. PROTECT Rx held an inaugural meeting in fall 2011 and is building on the experiences from PROTECT and applying them towards the prevention of unintentional overdoses from prescription medications in children. The Safe Use Initiative participates in the activities of both of CDC’s PROTECT Initiatives .
Vincristine is a chemotherapeutic agent that should only be given intravenously. Severe neurological damage, paralysis or death result when vincrisitine is inadvertently administered into the spinal canal. FDA is analyzing adverse event data to determine the root causes of this serious medication error that occurs in healthcare settings. By convening the relevant stakeholders, such as oncology healthcare professional groups, other healthcare entities, and medication safety, accreditation and licensing organizations, the Safe Use Initiative can augment FDA's regulatory actions and recommendations to improve the safe use of vincristine.
1IOM (Institute of Medicine). 2004. Health Literacy: A Prescription to End Confusion. Washington, D.C.: National Academy Press.
2IOM. 2011. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. Washington, D.C.: National Academy Press.
3Alexander, GC, Gallagher, AS, Mascola A, Moloney RM, Stafford, RS. Increasing off-label use of antipsychotic medications in the United States, 1995-2008. Pharmacoepidemiology and Drug Safety 2011 20:177-184
4Almandil, NB, Wong IC. Review on the Current Use of Antipsychotic Drugs in Children and Adolescents. Arch Dis Child Educ Pract. Ed. 2011 Oct 96(5) (abstract)
Safe Use Initiative: Related Information
Expert Roundtable on Pain Management in Older Adults
FDA-Sponsored Stakeholder Meeting on Surgical Fire Prevention
October 22, 2010
- Safe Use Initiative: Public Workshop [ARCHIVED]
November 16-17, 2010