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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
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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
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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
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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
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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
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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
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