Safe Use Initiative - Current Projects
- Atypical antipsychotic medication use in pediatric populations
- Medication adherence
- Nonsteroidal anti-inflammatory drugs for the treatment of pain in geriatric patients
- Opioid misuse and abuse
- Opioid patient-prescriber agreement
- Opioid safe prescribing
- Safe injection practices
- Unintentional medication overdoses in children
Improving prescription container labels for acetaminophen-containing medicines
Acetaminophen, used for treating pain and fever, is one of the most common active ingredients in the United States. When acetaminophen medicines are used according to the label directions, acetaminophen has a well-established record of safety and efficacy. Although acetaminophen overdose is rare in the context of its broad usage, overdose can be toxic and lead to acute liver failure. Liver injury from acetaminophen overdose remains a serious public health problem despite ongoing regulatory and educational efforts over the past several years to improve the safe use of medicines that contain acetaminophen. Patients can take too much if they take more than the labeled dose of one acetaminophen medicine or if they take more than one medicine containing acetaminophen (for example, an over-the-counter [OTC] medicine that contains acetaminophen with a prescription medicine that contains acetaminophen).
To prevent acetaminophen overdose, consumers need to be able to read labels and recognize when their medicines contain acetaminophen. The active ingredients in OTC medicines are clearly listed on the label, but the container labels on prescription medicines that contain acetaminophen may not clearly identify acetaminophen as an active ingredient.
Under the leadership of the National Council for Prescription Drug Programs (NCPDP ), FDA’s Safe Use Initiative and a broad group of stakeholders came together in 2011 to form the Acetaminophen Best Practices Task Group. The Task Group produced Version 1.0 of a White Paper and an update, “NCPDP Recommendations for Improved Prescription Container Labels for Medicines Containing Acetaminophen, Version 1.1. (PDF - 834KB).” Posted January 2013, the update provides additional guidance for stakeholders who have not been able to fully implement the recommendations, a progress report on the industry response to the recommendations and a resource list to facilitate the efforts of healthcare professionals to educate their patients. (For the resources, see Section 10.4, Appendix D of the white paper.)
The recommendations put forth in the white paper are intended to make it easier for consumers to: 1) identify when their prescription pain reliever contains acetaminophen, 2) compare active ingredients on their prescription and over-the-counter labels and 3) take action to avoid taking two medicines with acetaminophen. Implementation of the recommendations harmonizes prescription container labeling with the labeling that already exists for OTC medicines that contain acetaminophen, providing consistency in labeling across all acetaminophen-containing medicines.
The white paper recommends:
- complete spelling of acetaminophen and all other active ingredients on the pharmacy labels of all acetaminophen-containing prescription medicine, eliminating the use of abbreviations, acronyms, or other shortened versions for active ingredients
- a standardized concomitant use and liver warning label for these medicines applied on the pharmacy container
- formatting and wording on pharmacy container labels consistent with plain language and health literacy principles
- a stakeholder call to action - to adopt, implement, adhere, communicate and educate
FDA has an ongoing public education campaign and Safe Use and CDER’s Office of Communications serve as advisors to the Acetaminophen Awareness Coalition’s “Know Your Dose” campaign and to other partners’ educational campaigns on the safe use of acetaminophen.
For more information on acetaminophen, please see FDA's page, Acetaminophen Information.
The growing use of atypical antipsychotics in children, coupled with the mounting evidence these drugs are associated with weight gain, metabolic syndrome and diabetes, raises questions about the appropriate and safe use in pediatric populations.
The Safe Use Initiative participated for FDA in a collaboration that developed a companion resource to a 2012 guide for youth in foster care. Led by the Children’s Bureau, the collaborative effort included other federal agencies; national organizations; healthcare professionals, including physicians and psychiatrists; and youth representatives. The 2015 guide, “Supporting Youth in Foster Care in Making Healthy Choices: A Guide for Caregivers and Caseworkers on Trauma, Treatment, and Psychotropic Medications,” is available in English and Spanish, and includes a message from youth as well as information on seeking help for youth, monitoring treatment, and supporting progress. See also the original guide, “Making Healthy Choices: A Guide on Psychotropic Medications for Youth in Foster Care,” (2012).
For more information on atypical antipsychotic medications, please see FDA’s page, Atypical Antipsychotic Drugs 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 Web sites 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 medications. The Safe Use Initiative joins other FDA offices and HHS agencies in participating in and supporting the efforts of this broad cross-section of public and private stakeholders.
Non-steroidal anti-inflammatory drugs (NSAIDs) carry the risk of gastrointestinal bleeding that can be serious and life-threatening and dose-related risks of cardiovascular, renal and hematological adverse events. In late September 2010, the Safe Use Staff initiated collaborative efforts to understand and address the safety of pain medications in geriatric patients by bringing together experts in geriatric care, pain management and medication safety, and representatives of public and private healthcare delivery systems. Please see FDA's page, Expert Roundtable on Pain Management in Older Adults.
The Association for Chronic Pain Patients (ACPP) undertook the leadership of the effort that led to BEACON (Best Practices of Safe NSAID Use), a comprehensive integration of cutting edge information and practices to help guide practitioners through safe prescribing practices and help guide patients seeking up-to-date information on the safe use of NSAIDs. The leaders on this effort identified other thought leaders and parties interested in working on identifying, collating and disseminating state-of-the-art and evidence-based information and best practices for NSAID use in older adults. The outcome of this effort will be published in a series of articles in a peer-reviewed journal.
FDA held an advisory committee meeting in February 2014 to review data relevant to the risk of cardiovascular thrombotic risk associated with NSAIDs. For more information, please see FDA’s page, Joint Meeting of the Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee Meeting.
Opioid misuse and abuse
Reducing prescription opioid misuse and abuse with urine drug testing
The long-term goal of this project is to ensure the safe use of and reduce the preventable harm from prescription opioid medications. The project employs mixed research methods to study urine drug testing (UDT) and methods for managing patients who abuse prescription opioids. Researchers at the Oregon Health and Science University aim to (1) estimate the incidence of UDT and identify variables associated with the use of UDT from a national sample of patients, (2) conduct qualitative interviews with clinicians to explore perceptions of barriers to UDT and methods for managing patients with aberrant UDT results and (3) describe current clinical practice following an aberrant UDT result. These results can inform the development of a larger implementation study designed to increase the use of UDTs and assist providers in managing patients who have abnormal UDT results.
For more information on opioids, please see FDA’s page, Opioid Medications.
A tool for shared decision-making in the treatment of pain
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 analgesics increase risk and can lead to serious harm, including death. This harm is preventable.
In April 2011, FDA Safe Use Initiative convened the Safe Use Initiative Opioid Patient-Prescriber Agreement Working Group. The multidisciplinary working group includes pain specialists, addiction specialists, and primary care providers; research institutes; professional organizations; government agencies; plain language and health literacy experts; and patients and patient advocacy groups. The working group’s charge is 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-focused. This tool can replace the variety of opioid treatment contracts or agreements currently in use in some healthcare settings.
The Opioid Patient-Prescriber Agreement is intended 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
- Increase prescriber and patient awareness of the nature of the drugs they choose to treat pain
- Address both the risks and benefits of using opioid analgesics
- Highlight the responsibilities of the patient and prescriber in the management of opioid analgesics as part of pain treatment
- Opioid PPA completed by the working group
- Opioid PPA survey completed by FDA employees
- Pilot documents developed by the working group
- Opioid PPA usability testing by FDA employees completed
- New York University volunteered to lead the pilot effort for the Opioid PPA working group
- New York University received Institutional Review Board (IRB) approval and began recruitment of providers and piloting in October
Updates from 2014
- New York University completed the pilot study and feedback from the pilot effort was collected for revisions
- In October 2014, FDA published an abstract and article, “Developing and Initiating Validation of a Model Opioid Patient-Prescriber Agreement as a Tool for Patient-Centered Pain Treatment,” in The Patient – Patient Centered Outcomes Research
In April 2017, members of the Safe Use Initiative Opioid Patient-Prescriber Agreement Working Group published an abstract and article , “A Multicentre Evaluation of an Opioid Patient-Provider Agreement,” in Postgraduate Medicine Journal on the follow-up pilot study using the model Opioid PPA with patients in medical facilities in the USA.
A multicentre evaluation of an opioid patient-provider agreement
The role of the patient-provider agreement (PPA) is to set forth respective roles and responsibilities for opioid therapy with the goal of improving outcomes, reducing risks, and improving patient education. The Food and Drug Administration (FDA) Safe Use Initiative Opioid PPA Working Group convened to develop a PPA and test it for acceptability as an educational and shared decision-making tool in opioid therapy. This multicentre study evaluated the utility of the PPA, how readily patients understood it, its ability to educate patients in an unbiased way about opioid treatment and the feasibility of incorporating a PPA in clinical practice. A total of 117 patients and 14 providers at urban centres were included (mean patient age: 56 years) with 85% of patients treated for pain for >3 months. Most patients reported the PPA to be 'somewhat helpful' or 'very helpful' in deciding a course of treatment (96%) and 'easy to understand' (97%). Both patients and prescribers (89% and 92%, respectively) found the PPA was neutral in terms of presenting opioid therapy. Most centres found the PPA could be administered in ≤10 min and 72% of prescribers said this PPA could be readily incorporated into their practice. This PPA was perceived by both patients and prescribers as helpful in deciding a course of treatment and unbiased in terms of presentation of the risks and benefits of opioid therapy.
The Opioid Patient-Provider Agreement used in the study is available to anyone wishing to view or adopt it. The Opioid PPA fosters open two-way communication between patients and providers and is not a mandated document. This agreement provides information regarding the benefits and risks of opioids as well as the limitations of treatment, other treatment options, and safe storage and disposal methods. The goal of the Opioid PPA is to incorporate the patient in their treatment of pain and include them as part of the decision-making process.
Follow link to access the full text of “A multicentre evaluation of an opioid patient-provider.”
For more information on opioids, please see FDA’s page, Opioid Medications.
- Disseminate the model PPA more broadly to the working group members’ professional audiences and others
- Define outcomes for future Safe Use opioid project plans to measure how use of the document influences opioid prescribing practices and overall patient understanding.
For more information on opioids, please see FDA’s page, Opioid Medications.
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Assessing the impact of state intervention on high-risk prescribers
The inappropriate use of opioid analgesics increases the risk of adverse drug events to patients who need these medicines for the treatment of their pain and can lead to unintentional fatal overdoses. Brandeis University and the New York State Department of Health are collaborating to reduce these adverse drug events. "At-risk" opioid prescribers in New York State will be identified using data from the New York State Prescription Drug Monitoring Program (PDMP). Educational materials targeted to the prescribers will be designed to facilitate safer prescribing practices to improve patient safety. If the project is successful, it could provide a cost-efficient model for reducing preventable harm from high risk opioid prescribing practices that could be used by other states. For more information on opioids, please see FDA’s page, Opioid Medications.
If appropriate injection practices are not employed, patients are at risk for serious bacterial and/or bloodborne infections. 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. In addition, insulin pens are meant for one person and must never be shared.
The Safe Injection Practices Coalition is a public-private partnership led by the Centers for Disease Control and Prevention (CDC) and convened by the CDC Foundation. The coalition works to promote safe injection practices in healthcare settings in the United States by identifying the factors that lead to unsafe practices and developing effective strategies to reduce the risks of inappropriate injection practices. The Safe Use Initiative serves as an advisor to the coalition and supports the activities of the it's educational awareness campaign, the One and Only Campaign.
Children are especially vulnerable to unintentional overdoses from over-the-counter and prescription medications used for consumers of all ages. Most of these overdoses are preventable. The Safe Use Initiative is a leading partner in the PROTECT Initiative, a public-private partnership of national experts in patient safety and health literacy, health professional societies, consumer and patient advocates, public health agencies and private sector companies committed to developing strategies to keep children safe from unintentional medication overdoses. Safe Use is a partner in the Up and Away and Out of Sight educational program launched in 2012 to encourage parents to follow a few simple steps to protect their children from unintentional overdoses from OTC medications.
Under the leadership of the National Council for Prescription Drug Programs (NCPDP ), FDA’s Safe Use Initiative, CDC and a broad group of pharmacy system stakeholders came together to author “NCPDP Recommendations and Guidance for Standardizing the Dosing Designations on Prescription Container Labels of Oral Liquid Medication (PDF - 787KB),” posted in March 2014. A two page resource document (PDF - 417KB) provides a synopsis of the white paper recommendations, rationale and the call to action for pharmacy retailers. These recommendations and guidance are intended to improve patient safety by decreasing errors when patients and caregivers take and administer oral liquid prescription medications. The recommendations harmonize community prescribing, transcribing, labeling, and dispensing with standards used in hospital and other healthcare settings, recommendations for over-the-counter (OTC) medications, and international standards of expressing volumetric measurement.
The white paper recommendations are:
- Milliliter (mL) should be the standard unit of measure used on prescription container labels for oral liquid medications
- Dose amounts should always use leading zeros before decimal amounts less than one, and should NOT use trailing zeros after a decimal on prescription container labels for oral liquid medications
- Dosing devices with numeric graduations and units that correspond to the container labeling should be made easily and universally available each time oral liquid prescription medications are dispensed
The white paper includes a stakeholder call to action, to: adopt, implement and adhere to the recommendations in the white paper and to educate healthcare professionals, patients and caregivers on how to accurately measure and administer oral liquid medications.
The Safe Use Initiative continues to work with CDC, NCPDP and other stakeholders to encourage adoption, implementation and adherence to these recommendations, to address existing barriers, and to encourage education and communication to improve the safe use of oral liquid prescription medications. In addition, the Safe Use Initiative plans to continue to initiate and participate in collaborative efforts and alternative strategies to help decrease unintentional medication overdoses.
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