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HEALTHLINE September 2006 Title: Focus on Seasonal Influenza 2006-2007 NEW DRUGS/INDICATIONS Ionsys Iontophoretic Transdermal System (fentanyl iontophoretic transdermal system): The FDA has approved Ionsys for the short-term management of acute post-operative pain in adult patients requiring opioid analgesia during hospitalization. Ionsys is the first needle-free, patientactivated analgesic system. The system uses a process in which a low-intensity electric field, which is generally imperceptible to the patient, is used to rapidly transport fentanyl across the skin and into the circulatory system of the body. Ionsys securely adheres to the upper outer arm or chest, and provides patients an on-demand dose of fentanyl. Ionsys is not intended for home use and is, therefore, inappropriate for use in patients once they have been discharged from the hospital. It is not recommended for patients under the age of 18. Fentanyl is an opioid analgesic that has been used in the management of pain for more than 40 years. Ionsys differs from other methods of administering pain medications after surgery because it is compact, self-contained, and needle-free. When pain medication is needed, the patient double-clicks the dosing button, which delivers a pre-programmed, 40mcg dose of fentanyl through the skin. Each dose is delivered over a 10-minute period. Ionsys should be applied to intact, non-irritated and nonirradiated skin on the chest or upper outer arm. Opana ER and Opana Tablets (oxymorphone hydrochloride): The FDA has approved Opana ER (oxymorphone HCl extended- release) and Opana (oxymorphone HCl immediate-release) for the relief of moderate-to-severe pain. Prior to Opana ER and Opana, oxymorphone has only been available in the USA as an injection or suppository. Opana ER is a new oral extended-release opioid analgesic indicated for the relief of moderate-to-severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time. Opana ER is available in 5mg, 10mg, 20mg, and 40mg tablets and is not intended to be used on an as-needed basis. The most common adverse drug reactions reported for Opana ER were nausea, constipation, dizziness, vomiting, pruritus, somnolence, headache, increased sweating, and sedation. Alcoholic beverages or medications containing alcohol must not be consumed, while on Opana ER therapy. The co-ingestion of alcohol with Opana ER may result in increased plasma levels and a potentially fatal overdose of oxymorphone. Opana immediate-release is indicated for the relief of moderate-to-severe acute pain where the use of an opioid is appropriate. Opana is available in 5mg and 10mg tablets. The most common adverse drug reactions reported for Opana were nausea and pyrexia. Respiratory depression is the principal hazard of Opana ER and Opana, especially in elderly or debilitated patients. DP WARNINGS AND ADVERSE EFFECTS Solid Oral Potassium Chloride and Anticholinergics Added as New Interaction Pair First DataBank’s Drug-Drug Interaction Module (DDIM), used by Omnicare’s operating systems, has added solid oral potassium chloride/anticholinergics as a new interaction pair. This interaction was added because the FDA-approved prescribing information for K-Dur states the following: "All solid oral dosage forms of potassium chloride are contraindicated in any patient in whom there is structural, pathological (e.g., diabetic gastroparesis), or pharmacologic (use of anticholinergic agents or other agents with anticholinergic properties at sufficient doses to exert anticholinergic effects) cause for arrest or delay in tablet passage through the gastrointestinal tract." The interaction is not linked to oral effervescent tablets, oral powders, oral liquids, or injectables. Therefore, effervescent and liquid formulations of potassium supplements are Copyright 2006 All Rights Reserved Published by Omnicare, Inc. distributed by PBM Plus, Inc. Page - 1 HEALTHLINE September 2006 recommended to avoid the drug interaction potential and assure therapeutic benefit is obtained from KCL supplementation. REGULATORY UPDATE Annual Update of ICD-9-CM Codes A MLN article MM5142 titled " Medicare Contractor Annual Update of the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM)" has been posted on the What's New Intermediary at:http://www.adminastar.com/News/IntermediaryNews/files/AP06_1243.pdf. Medicare has issued the annual update of the ICD-9-CM to Medicare contractors. This annual update will apply to claims with service dates or discharges on or after October 1, 2006, for institutional providers. Joint Commission Adopts Standard on Influenza Vaccination The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) has announced the approval of an infection control standard that requires accredited organizations to offer influenza vaccinations to staff, including volunteers, and licensed independent practitioners with close patient contact. The standard will take effect January 1, 2007, for the Critical Access Hospital, Hospital, and Long Term Care accreditation programs. JCAHO developed the standard in response to recommendations by the U.S. Centers for Disease Control (CDC) making the reduction of influenza transmission from health care professionals to patients a top priority. While CDC has urged annual influenza vaccination for health care workers since 1981, vaccination rates have remained low (typically below 40%), and the agency has issued a report calling for stronger steps. Health care-associated transmission of influenza has been documented in a variety of clinical settings, and infections have been linked epidemiologically to unvaccinated health care workers. The new Joint Commission standard requires organizations to: Establish an annual influenza vaccination program that includes at least staff and licensed independent practitioners; Provide access to influenza vaccinations on-site; Educate staff and licensed independent practitioners about flu vaccination; non-vaccine control measures (such as the use of appropriate precautions); and diagnosis, transmission and potential impact of influenza; Annually evaluate vaccination rates and reasons for non-participation in the organization's immunization program; and Implement enhancements to the program to increase participation. To view JCAHO’s news release on this, go to http://www.JointCommission.org/NewsRoom/NewsReleases/nr_06_13_06.htm. Quick Reference Information: Medicare Immunization Billing This two-sided job aid gives Medicare fee-for-service physicians, providers, suppliers, and other health care professionals’ quick information to assist with filing claims for the influenza, pneumococcal, and hepatitis B vaccines and their administration. This product is available to view, download, and print from the CMS Medicare Learning Network Preventive Services Copyright 2006 All Rights Reserved Published by Omnicare, Inc. distributed by PBM Plus, Inc. Page - 2 HEALTHLINE September 2006 Educational Products web page located at http://www.cms.hhs.gov/MLNProducts/35_PreventiveServices.asp on the CMS website. Print copies will be available in early Fall, 2006. IoM Releases Preventing Medication Errors The Institute of Medicine (IoM) recently released Preventing Medication Errors, its latest offering in its Quality Chasm Series. It sets forth an agenda for improving the safety of medication use. The book provides an overview of the systems for drug development, regulation, distribution, and use. It also examines the peer-reviewed literature on the incidence and the cost of medication errors and the effectiveness of error-prevention strategies. Action agendas are outlined, detailing the measures needed to improve the safety of medication use in both the short and long term. To order a copy or to read more about this publication, go to http://www.nap.edu/catalog/11623.html. New DAVE 2 Website CMS has created a new website for the second phase of the Data Assessment and Verification (DAVE2) program, designed to assure accuracy and reliability of Minimum Data set (MDS) assessment data. The data drives Medicare Part A payment, public reported quality measures (QMs) and quality indicators (QIs) and in some states, Medicaid case mix payment systems. To access the DAVE2 website go to www.cms.hhs.gov/NursingHomeQualityInits/30_NHQIDAVE2.asp KM PATIENT CARE Flu Season 2006-2007 In the United States, epidemics of influenza typically occur during the winter months and have been associated with an average of approximately 36,000 deaths per year between 1990-1999 in the U.S. Influenza viruses cause disease among all age groups. Rates of infection are highest among children, but rates of serious illness and death are highest among persons age ≥65 years, children aged < 2 years, and persons of any age who have medical conditions that place them at increased risk for complications from influenza. The new guidelines update the 2005 ACIP recommendations regarding the use of influenza vaccine and antiviral agents. Based on new and updated information, the 2006 recommendations contain several changes, including: Children aged 24 to 59 months and their household contacts and out-of-home caregivers should be vaccinated against influenza. Children aged 6 months to younger than 9 years who were unvaccinated previously should receive 2 doses of influenza vaccine. Healthcare providers, those planning organized campaigns, and state and local public health agencies should develop plans for expanding outreach and infrastructure to vaccinate more persons than during 2005, and they should Copyright 2006 All Rights Reserved Published by Omnicare, Inc. distributed by PBM Plus, Inc. Page - 3 HEALTHLINE September 2006 develop contingency plans for the timing and prioritization of administering influenza vaccine, if the supply of vaccine is delayed and/or reduced. Providers should routinely offer influenza vaccine to patients throughout the influenza season. Until evidence of susceptibility to amantadine or rimantadine has been reestablished among circulating influenza A viruses, neither of these antiviral medications should be used for the treatment or chemoprophylaxis of influenza A in the United States. The 2006-2007 trivalent influenza vaccine virus strains should be used: A/New Caledonia/20/1999 (H1N1)-like, A/Wisconsin/67/2005 (H3N2)-like, and B/Malaysia/2506/2004-like antigens. For the A/Wisconsin/67/2005 (H3N2)-like antigen, the makers may use the antigenically equivalent A/Hiroshima/52/2005 virus, and for the B/Malaysia/2506/2004-like antigen, the makers may use the antigenically equivalent B/Ohio/1/2005 virus. Annual influenza vaccination is now recommended for persons at high risk for influenzarelated complications and severe disease, including children aged 6 to 59 months, pregnant women, those older than 50 years, those of any age with certain chronic medical conditions; and those who live with or care for persons at high risk, including household contacts who have frequent contact with persons at high risk and who can transmit influenza to those persons at high risk, and healthcare workers. Vaccination with inactivated influenza vaccine is recommended for the following groups at increased risk for severe complications from influenza: Children aged 6 to 23 months; Children and adolescents, aged 6 months to 18 years, who are receiving longterm aspirin therapy and might therefore be at risk for Reye syndrome after influenza virus infection; Women who will be pregnant during the influenza season; Adults and children with chronic pulmonary or cardiovascular disorders, including asthma but not hypertension; Adults and children who have required regular medical follow-up or hospitalization during the preceding year because of chronic metabolic diseases, including diabetes mellitus, renal dysfunction, hemoglobinopathies, or immunodeficiency, (including immunodeficiency caused by medications or by HIV); Adults and children with any condition that can compromise respiratory function or the handling of respiratory secretions or that can increase the risk for Copyright 2006 All Rights Reserved Published by Omnicare, Inc. distributed by PBM Plus, Inc. Page - 4 HEALTHLINE September 2006 aspiration, including cognitive dysfunction, spinal cord injuries, seizure disorders, or other neuromuscular disorders; Residents of nursing homes and other chronic-care facilities for persons of any age who have chronic medical conditions; and Persons aged older than 65 years. Vaccination with inactivated influenza vaccine is also recommended for children aged 24 to 59 months and persons aged 50 to 64 years at increased risk for influenza-associated clinic, emergency department, or hospital visits, particularly if they have a high-risk medical condition. Vaccination with live attenuated vaccine (FluMist) can occur in healthy persons aged 5 – 49 years and can be administered to individuals in close contact and family members of immunocompromised persons. If antiviral treatment of influenza is indicated, oseltamivir (Tamiflu) or zanamivir (Relenza) can be prescribed. These agents are both neuraminidase inhibitors with demonstrated activity against both influenza A and B viruses. Oseltamivir is approved for treatment of persons older than 1 year, and zanamivir is approved for treatment of persons older than 7 years. For chemoprophylaxis of influenza, oseltamivir is licensed for use in persons aged older than 1 year, and zanamivir is licensed for use in persons aged older than 5 years. A recommended dosage table is provided for these medications. Because of the risk for serious adverse respiratory events and because efficacy has not been demonstrated in patients with underlying airway disease, zanamivir is not recommended for treatment of this population. Adverse effects of oseltamivir may include nausea and vomiting, which might be less severe if it is taken with food. Viral resistance to adamantanes can emerge rapidly during treatment because a single point mutation can result in cross-resistance to both amantadine and rimantadine. During treatment with either of these agents, drug-resistant viruses can emerge in approximately one third of patients. In contrast, development of viral resistance to zanamivir and oseltamivir during treatment has been identified but does not appear to be frequent. Diagnostic tests available for influenza include viral culture, serology, rapid antigen testing, polymerase chain reaction, and immunofluorescence assays. The sensitivity and specificity of these tests may vary based on the laboratory that performs the test, the type of test used, the type of specimen tested, and the timing of specimen collection. Nasopharyngeal specimens are typically more effective than throat swab specimens for viral isolation or rapid detection. As with other diagnostic tests, the findings should be evaluated in the context of other available clinical and epidemiologic information. BZ Morbid Mortal Wkly Rep. 2006;55:1-41 Copyright 2006 All Rights Reserved Published by Omnicare, Inc. distributed by PBM Plus, Inc. Page - 5 HEALTHLINE September 2006 Contributing Authors for This Issue: Susan J. Klem, BS Pharm., CGP, FASCP Regional Clinical Director Great Lakes and Great Plains Regions Kelli Marsh, RHIA, RAC-C Vice President of Support Services Omnicare Pharmacies of Northern and Central Ohio David Pregizer, RPh Area Clinical Manager NeighborCare Allentown Barbara J. Zarowitz, PharmD, CGP, BCPS, FCCP Chief Clinical Officer, Vice President of Professional Services Editorial Board Karen Burton, R. Ph., GCP, FASCP Mark Coggins, Pharm. D., GCP, FASCP Kelly Hollenack, Pharm. D. CGP Philip King, Pharm. D., GCP, FASCP Susan Kleim, B.S., Pharm., GCP, FASCP Terry O’Shea, Pharm. D., GCP, FASCP Elmer Schmidt, Pharm. D., GCP, FASCP Barbara J. Zarowitz, Pharm. D., GCP, FASCP Copyright 2006 All Rights Reserved Published by Omnicare, Inc. distributed by PBM Plus, Inc. Page - 6