TIP OF THE WEEK
Fentanyl Transdermal System -- Updated Information from the FDA
The U.S. Food and Drug Administration (FDA) issued an update on December 21, 2007 that highlights important information on appropriate prescribing, dose selection, and the safe use of the fentanyl transdermal system (patch).1 The FDA previously issued a Public Health Advisory and Information for Healthcare Professionals in July 2005 regarding the appropriate and safe use of the transdermal system.
According to the release, the agency continues to receive reports of death and life-threatening adverse events related to fentanyl overdose that have occurred when the fentanyl patch was used to treat pain in opioid-naive patients and when opioid-tolerant patients have applied more patches than prescribed, changed the patch too frequently, and exposed the patch to a heat source. The fentanyl patch is only indicated for use in patients with persistent, moderate to severe chronic pain who have been taking a regular, daily, around-the-clock narcotic pain medicine for longer than a week and are considered to be opioid-tolerant.
Patients must avoid exposing the patch to excessive heat as this promotes the release of fentanyl from the patch and increases the absorption of fentanyl through the skin, which can result in fatal overdose. Directions for prescribing and using the fentanyl patch must be followed exactly to prevent death or other serious side effects from fentanyl overdose.
RECOMMENDATIONS FOR HEALTHCARE PROFESSIONALS
The following recommendations are provided by the FDA as guidance for healthcare professionals.
- The fentanyl patch is indicated for the management of persistent, moderate to severe chronic pain in opioid-tolerant patients 2 years of age or older who require a total daily opioid dose at least equivalent to fentanyl transdermal system 25 mcg/h. Opioid-tolerant patients are those who have been taking daily, for a week or longer, at least 60 mg of morphine, 30 mg of oral oxycodone, or at least 8 mg of oral hydromorphone or an equianalgesic dose of another opioid. Fentanyl patch use in non-opioid tolerant patients has resulted in fatal respiratory depression.
- Consult the prescribing information to determine the initial fentanyl patch dose. Overestimating the dose when converting patients from another opioid analgesic can result in fatal overdose with the first dose.
- The fentanyl patch is contraindicated in the management of post-operative pain, mild pain, or intermittent pain (e.g., use on an as needed basis) because of the risk for serious or life-threatening respiratory depression. Fatalities from fentanyl overdose have occurred in these situations.
- Concomitant use of the fentanyl patch with any cytochrome P450 3A4 inhibitors (such as ketoconazole, erythromycin, nefazodone, diltiazem, or grapefruit juice) may result in an increase in fentanyl plasma concentrations, which may cause potentially fatal respiratory depression. Carefully monitor patients concomitantly taking cytochrome P450 3A4 inhibitors and using the patch for an extended period of time and adjust the fentanyl dose if necessary.2
These directions are provided in the current prescribing information and Instructions for Applying a Fentanyl Transdermal Patch and the new Medication Guide for patients: http://www.fda.gov/cder/foi/label/2005/19813s039lbl.pdf
Online courses for continuing education.
Learn something new and get free CE credit!
Fulfill your continuing education goals early in 2008 with Ohio KePRO’s online self-learning modules. These online trainings are free of charge and offer 1 hour of continuing education credits for nurses.
Benefits Improvement and Protection Act
Learn more about BIPA, fast-track appeals, and what you and your organization need to do to respond appropriately. Who should take this course: discharge planners, case managers, social workers, nurses, and administrative staff.
General Pain Principles
Review the basics in pain management including definitions, prevalence, consequences, barriers/ misconceptions, and common approaches. Who should take this course: administrators/CEOs, nurses, social workers, QI personnel, direct care staff, and educators.
General Pressure Ulcer Principles (Coming Soon)
Understand the basics in pressure ulcer management including definitions, prevalence, barriers/misconceptions, and common approaches. Who should take this course: administrators/ CEOs, nurses, social workers, and QI personnel.
To begin, go to www.ohiokepro.com/education/main.asp
RESOURCE SPOTLIGHT
Steps to Accessing CMS Enterprise Applications for Provider Organizations (PDF)
The Centers for Medicare & Medicaid Services’ (CMS) enterprise applications are those hosted and managed by CMS and do not include Fiscal Intermediary (FI)/carrier/Medicare Administrative Contractor (MAC) Internet applications. This one page guide, released December 2007, provides instructions for registering two staff members for the IACS-PC CMS online application.
IN THE NEWS
HEALTH OF PREVIOUSLY UNINSURED ADULTS AFTER ACQUIRING MEDICARE COVERAGE
December 26, 2007 -- JAMA -- A study released on Wednesday in the Journal of the American Medical Association (JAMA) reveals that the health of uninsured seniors with heart disease or diabetes improved after they became eligible to enroll in Medicare. Adults who previously had insurance upon reaching age 65 received no boost in health status. Read the abstract >>
December 20, 2007 -- FDA -- AM2 PAT, Inc., Angier, North Carolina, is initiating a nationwide recall of one lot of Pre-Filled Heparin Lock Flush Solution USP (5 mL in 12 mL Syringes), Lot # 070926H. The heparin IV flush syringes were found to be contaminated with Serratia marcescens, which resulted in patient infections. The Centers for Disease Control and Prevention (CDC) has confirmed growth of Serratia marcescens from several unopened syringes of this product. This type of bacterial infection could present a serious adverse health consequence that could lead to life-threatening injuries and/or death. Read more >>
NEW CMS E-MAIL LIST FOR FEE-FOR-SERVICE (FFS) PROVIDERS, SUPPLIERS, AND THEIR STAFF
November 8, 2007 -- CMS -- The Centers for Medicare & Medicaid Services (CMS) will be offering a new e-mail update (or listserv) service that delivers Medicare information to Fee-for-Service (FFS) providers, suppliers, and their staff's Inboxes. Visitors to www.cms.hhs.gov will be able to sign up to receive updates relevant to Medicare Fee-for-Service providers & suppliers and to receive information on related topics. This new service will allow you to choose between many audience types and subjects of information, such as the National Provider Identifier (NPI), the Physician Quality Reporting Initiative (PQRI), and Preventive Services. Subscribe here >>
INDUSTRY EVENTS
Cardiac Care Concerns Teleconference
February 21, 2008, 1:00 to 2:00 PM
Dial-in #: 1-866-206-6900 | Conference ID: 1182306
Cost: Free!
CEUs for nurses are pending.
Special Open Door Forum: Minimum Data Set, Version 3.0 (MDS 3.0)
Thursday, January 24, 2008, 1:00 p.m. to 3:00 p.m. EST
A report on the findings of a 5-year CMS Nursing Home MDS 3.0 Validation Study.
- Download the MDS 3.0 timeline for implementation
- Register online (capacity is limited)
- Recording will be available 1/30/08 to 2/29/08 on this Web page
The History and Evolution of Quality in Healthcare
Tuesday, January 8, 2008, 12:00 to 1:30 p.m. EST
A national teleconference from the Medicare Quality Improvement Organizations.
Presenter: Sharon Eloranta, MD, from the Institute of Healthcare Improvement (IHI)
Cost: Free
Medicare Learning Network:Learning resources and products for the healthcare professional.
Alzheimer’s Association Training Events
Case Western Reserve University School of Medicine Courses
Ohio Department of Health, Technical Assistance Program – New Programs
Ohio Health Care Association Events
An archive of The Nursing Home Weekly Update is available on our Web site. Click here >>
