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By Federal Drug Administration Friday, October 28, 2024

Opportunities for Collaboration

The following is a sampling of drugs, drug classes or therapeutic areas that could benefit from stakeholder collaboration.

• Acetaminophen toxicity
• Benzocaine gels, liquids and topical sprays and the risk of methemoglobinemia
• Health literacy
• Long-acting beta agonists (LABA)
• Medication adherence
• Nonsteroidal anti-inflammatory drugs (NSAIDs) for the treatment of pain in geriatric patients
• Prescription opioids
• Safe injection practices
• Surgical Fires
• Unintentional medication overdoses in children 

Acetaminophen toxicity
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.

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.

Health literacy
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.

Medication adherence
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.

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.

Prescription opioids
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. Informational errors in the prescribing and use of opioid analgesics can increase risk and lead to serious harm, including death. The harm caused by these and other informational errors is preventable harm.

To increase the safe use of opioid analgesics, the Safe Use Initiative formed the Opioids Patient Prescriber Pain Treatment Agreement Working Group. The working group is a collaborative of thought leaders from patient advocacy organizations, pain management specialists, safe prescribing advocates, health literacy experts, and others; and it is part of a larger, multipronged, multi-Agency effort to address the public health concerns around the inappropriate use, misuse and abuse of opioid analgesics. The working group’s charge is to develop tools for patients and prescribers when opioid analgesics are under consideration, such as a model Patient Prescriber Pain Treatment Document(s) and/or an opioid analgesic treatment checklist. These tools can replace the variety of opioid treatment contracts or agreements currently in use in some settings.  The intent of the to-be-developed document(s) is/are to:

• Replace the currently used opioid treatment agreement documents with a model document that provides consistent and accurate information regarding the use of opioids to treat pain,
• Facilitate an open dialogue between the prescriber and patient around the choice to use prescription opioid analgesics to treat pain,
• Create mindfulness on both the part of the prescriber and patient about the nature of the drugs they are choosing to use to treat pain. 
• Address both the risks and benefits of using opioid analgesics; and,
• Highlight the responsibilities of the patient and prescriber in the management of opioid analgesics as part of pain treatment.

Once developed, prescribers and healthcare entities can choose to use these documents.  In addition, because information on the utility and efficacy of the currently available patient prescriber agreement documents is considered limited or poor, future plans for the Safe Use opioid project includes defining outcomes to measure how use of the documents influences opioid prescribing practices and overall patient understanding.

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 .

Surgical Fires
An estimated 550 to 650 fires occur per year in inpatient and outpatient surgical settings.³ 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. Historically the focus of the coalition has been to develop strategies to reduce unintentional overdoses from OTC medications, but plans are underway for a second coalition, called PROTECT Rx, that will develop strategies to reduce unintentional overdoses from prescription medications. The Safe Use Initiative participates in the activities of both of CDC’s PROTECT Initiatives . 

References

¹IOM (Institute of Medicine). 2004. Health Literacy: A Prescription to End Confusion. Washington, D.C.: National Academy Press.

² IOM. 2011. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. Washington, D.C.: National Academy Press.

³International Academy of Cosmetic Dermatology, Fire in the Operating Room , accessed October 27, 2009; and ECRI Institute, Surgical Fire Prevention , accessed October 27, 2009.

SOURCE