Atypical antipsychotic medication use in pediatric populations
Compounded oral liquid medications
Epidural steroid injections
Nonsteroidal anti-inflammatory drugs for the treatment of pain in geriatric patients
Opioid misuse and abuse
Opioid patient-prescriber agreement
Opioid safe prescribing
Preventing surgical fires
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 is teaming up with the Centers for Medicare and Medicaid Services (CMS), Acumen, LLC and researchers from the University of Maryland School of Pharmacy Department of Pharmaceutical Health Services Research to study regional, diagnostic, racial, age- and gender-related variation in antipsychotic utilization among pediatric Medicaid beneficiaries.
For more information on atypical antipsychotic medications, please see FDA’s page, Atypical Antipsychotic Drugs Information.
Impact of the unapproved drug initiative on colchicine use
FDA put its Unapproved Drug Initiative in place to guarantee marketed drugs are safe and effective. The unapproved formulations of colchicine were phased out of the market as a result of the approval of Colcrys in 2009. Stanford University conducted a project that uses data retrieved from the Stanford Translational Research Integrated Database Environment (STRIDE) to compare the utilization pattern of colchicine, its dosing and the associated adverse outcomes before and after the approval of Colcrys. To get an idea of the lag between the approval of Colcrys and a change in the clinical practice, the project prospectively determined the prevalence and risk factors of the inappropriate use of the unapproved colchicine formulations using the Stanford University Rheumatic Disease Registry and the Stanford Gout Database.
For more information on the FDA Unapproved Drug Initiative, please see FDA’s page, Unapproved Prescription Drugs: Drugs Marketed in the United States That Do Not Have Required FDA Approval.
Statewide pediatric safety collaboration to standardize compounded oral liquids
The University of Michigan and the Michigan Pharmacists Association joined in a collaboration to improve the safety of compounded oral liquid medications prepared for pediatric patients in Michigan. The collaborators gathered information on the current practices regarding the preparation of oral liquid medications in pharmacies across the state of Michigan, and then developed a set of voluntary standard concentrations prescribers and pharmacists can use in compounding these medications to reduce the potential risk of errors when patients change pharmacies or at transitions of care. Standardization lowers the risk of delivering the wrong dose because of confusion over the concentration of the drug in the oral liquid medication.
This initiative’s several phases involved surveying pharmacists across Michigan to gain a better understanding of compounding practices for oral liquids, collaborating with healthcare providers to determine standard concentrations and creating a Web site to disseminate information on those concentrations. In August 2014, University of Michigan published an abstract and article, “Variability in Compounding of Oral Liquids for Pediatric Patients: A Patient Safety Concern,” in the Journal of the American Pharmacists Association. For more information, please see the project’s page, State-Wide Initiative to Standardize the Compounding of Oral Liquids in Pediatrics.
Experts in the practice of epidural steroid injections (ESIs) approached FDA to help them address the issue of rare, serious neurologic events observed in association with ESIs. Talks led to the formation of a multi-disciplinary panel of experts who conducted research in the area of ESI safety. To understand the root causes of these events and identify strategies to minimize their risk, FDA’s Safe Use Initiative provided the panel of clinical experts with a forum for their discussions about ESIs, their safety and effectiveness and the practices that potentially can minimize the associated risk. The panel members assented to develop recommendations for healthcare professionals who administer ESIs as a treatment for spine pain and send them to representatives of national pain organizations for review and input.
The ultimate goal of the panel of experts and representatives of the participating national pain organizations is to minimize the risk of ESI-related neurologic injuries, to the extent these injuries are related to clinical administration procedures and techniques. With this goal in mind, the panel of experts and representatives of the national pain organizations agreed on the breadth, content, and specificity of the recommendations and plan to publish the recommendations in a reference document for healthcare professionals who administer ESIs as a treatment for spine pain.
As part of FDA’s ongoing effort to investigate this issue, the agency is convening a two day advisory committee meeting of external experts on November 24-25. 2014. The Anesthetic and Analgesic Drug Products Advisory Committee Meeting will discuss the risk of serious neurologic adverse reactions associated with ESIs administered to reduce inflammation for pain management. The committee will also consider the efficacy of ESIs and the overall risk benefit balance of injecting steroids in the epidural space to treat pain. These considerations will assist the Agency in our discussions of possible regulatory options, including but not limited to changes to the product labeling. For more information, please see FDA’s page, FDA requires label changes to warn of rare but serious neurologic problems after epidural corticosteroid injections for pain.
Improving the safe use of isotretinoin
Isotretinoin is used to treat severe skin disease, such as acne, which has not responded to other treatments.
Because isotretinoin can cause serious side effects, including fetal injury and severe birth defects if a woman becomes pregnant during treatment, FDA approved isotretinoin for marketing under a special, restricted distribution program (called a Risk Evaluation and Mitigation Strategy, or REMS). The REMS requires women of childbearing potential use effective contraception.
This project developed and evaluated a contraceptive informational sheet for women who are considering using isotretinoin. The sheet provides clear recommendations about the most effective contraceptive methods available to avoid pregnancy before, during and after drug therapy. In April 2014, University of Pittsburgh published an abstract and article “Women’s Experiences with Isotretinoin Risk Reduction Counseling,” in the Journal of the American Medical Association Dermatology.
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.
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
- Revise the PPA based on the results of the pilot testing
- Post the final model PPA on FDA Web site
- 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.
If your organization is interested in testing this Opioid PPA, we welcome your collaboration. Please contact us at firstname.lastname@example.org or 301-796-7600.
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.
An estimated 550 to 650 fires occur per year in inpatient and outpatient surgical settings.1 This number is small compared to the number of surgical procedures performed every year in the United States, but 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 develop tools, implement strategies, and conduct education and outreach efforts to reduce the risk of fires. To supplement FDA's regulatory and non-regulatory efforts and highlight the efforts of FDA’s partners, in October 2011 the Safe Use Initiative, CDER, and CDRH launched an initiative and several Web pages. Safe Use continues 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. For more information on preventing surgical fires, please see FDA’s page, Preventing Surgical Fires.
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.