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PostScript
A Newsletter from UniCare, Inc. |
September 2004
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Weathering the Storm
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All of us at UniCare want
to thank you for your understanding and cooperation during Hurricane Ivan
last week and the aftermath. We hope
that all is well at your nursing home now.
It took all of us working together as a team to make sure your
residents received their medication when they needed it and we truly
appreciate your part. Speaking of storms. . . Medicaid has one that
we’ll all have to weather regarding the latest additions to the PDLs
beginning in October. |
Roy Pickering, RPh, whose
statement “Hang on; it’s going to be a bumpy ride,” is not referring to a
storm but to the following additions to the Medicaid Preferred Drug List: *Older insulins (Humulin/Novolin
N, R, 70/30,etc.) will be preferred over newer ones (Humalog/Novolog),
Lantus. *Exelon will be preferred
over Aricept and Reminyl. *Doing without will be
preferred over Namenda. *Glyburide/Glipizide will
be preferred over Amaryl. |
*Starlix
is preferred over Prandin. *Glyset
preferred over Precose *Avandia
is preferred over Actos. *Omeprazole,
Prevacid and Protonix will be preferred over Aciphex and Nexium. The
October PDL also addresses certain topical agents, including steroids and
antifungals. It’s mostly a story of
generics preferred over brands.
Santyl is nonpreffered; Accuzyme and Xenaderm are acceptable. Generic Bactroban (regular ointment only,
at present) is preferred over the branded cream. Bactroban Nasal is nonpreferred. |
Inside
this Issue:
OTC Cholesterol
Drug
Lipitor Prevents
Cardiovascular Disease
Acetaminophen &
Decline in Renal Function
Flu
Season 2004-2005 CDC Recommendations
Role of Anitviral
Agents
Preferred and
Non-prefered Antiviral treatment
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2 2 2 3 4 5 5 |
Medicaid PDLs and Your Facility
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If you haven’t already,
your facility should soon receive a letter explaining the insulin products
with a list of residents currently receiving them. All other categories will be handled with a PAL (Physician
Approval Letter) which we will generate and send to the doctors. The insulin is too individualized to
handle this way. |
UniCare has been way ahead of the PDL issue since its
beginning. We have worked behind the
scenes on Prior Authorizations and getting approval to make changes to CAID
covered drugs from your doctors. We
have internal staff assigned to this process which involves tons of paperwork
and phone calls to either get the medication |
changed
or the criteria submitted to Medicaid for Prior Approval of a non-covered
drug. |
Annual Survey Information Requested
As your time permits,
please e-mail Sallie Reynolds the date of your last annual survey. Her address is sallie.reynolds |
NEW
DRUGS/FORMULARY INFO
First
OTC Cholesterol Drug Launched in Britain
Britain became the first
country in the world to sell a cholesterol-lowering drug without a prescription
on Thursday when a low-dose "over-the-counter" (OTC) form of Merck
& Co Inc's Zocor was launched.The new version of
Zocor (simvastatin) will be marketed by Johnson & Johnson MSD under the
brand name Zocor Heart-Pro.
In a
ground-breaking move in May, the British government approved the switch from
prescription to over-the-counter status, arguing that easier access would allow
more people to protect themselves from the risk of coronary heart disease.
The
10-milligram daily pill is designed for people at moderate risk of heart
disease, defined as those with a 10% to 15% risk of a heart attack in the next
10 years. Pharmacists will be able to sell Zocor Heart-Pro to customers after
asking about their situation and offering various health tests to ensure it is safe
to give them the drug. A cholesterol test will be offered but is not
compulsory.
In the United
States, Zocor has patent protection until 2006 and Merck is focusing there on
seeking OTC status for an older statin called Mevacor.
http://mp.medscape.com/cgi-bin1/DM/y/eiZC0HfjHF0D2W0F7Gp0AO
DRUG INDICATIONS /
WARNINGS
FDA Approves Atorvastatin (Lipitor) to Prevent
Cardiovascular Disease
The Food and Drug Administration approved Pfizer
Inc.'s cholesterol drug Lipitor (atorvastatin calcium) to be used to reduce the
risks of heart attack, chest pain and revascularization procedures in people
with normal to mildly elevated levels of cholesterol who have other risk
factors for heart
disease.
Regulators based their decision on a trial involving
more than 10,300 patients who had normal or borderline cholesterol and no prior
history of heart disease, but who had high blood pressure and at least three
other known risk factors for heart disease, such as family history, age older
than
55 years, smoking and diabetes.
The trial results showed Lipitor, given at its lowest
dose of 10 mg, reduced the relative risk of heart attack by 36 percent compared
with placebo. The trial was halted two years ahead of schedule "because of
the significant benefits seen with Lipitor early in the trial," Pfizer
said in a press release.
Sever PS, et al. Prevention of coronary and stroke
events with atorvastatin in hypertensive patients who have average or
lower-than-average cholesterol concentrations, in the Anglo-Scandinavian
Cardiac Outcomes Trial – Lipid Lowering Arm (ASCOT-LLA): a multicentre
randomized controlled trial. The Lancet 2003 at http://image.thelancet.com/extras/03art3046web.pdf
Acetaminophen
Linked to Slight Decline in Renal Function 
Lifetime use of aspirin or
nonsteroidal anti-inflammatory drugs (NSAIDs) did not cause a decline in renal
function, but acetaminophen slightly increased risk, according to the results
of an analysis from the Nurses' Health Study published in the July 26 issue of
the Archives of Internal Medicine.
A
total of 1,697 women enrolled in the Nurses' Health Study completed a
questionnaire in 1999 about lifetime use of acetaminophen, aspirin, and NSAIDs
and provided blood samples in 1989 and 2000. Multivariate logistic regression
was used to determine the odds of developing the main outcome of change in
estimated glomerular filtration rate, or creatinine clearance, (GFR) for 11
years, based on lifetime analgesic intake.
Mean
estimated GFR decreased from 88 + 17 mL/minute per 1.73 m2 in 1989
to 79 + 17 mL/minute per 1.73 m2 in 2000.
At baseline or after 11 years, there were no substantial differences in the
unadjusted or estimated GFR levels among the categories of lifetime intake for
the three analgesic groups.
Aspirin
and NSAID use were not associated with an increased risk of GFR decline.
However, acetaminophen use was associated with an increased risk of GFR decline
of at least 30 mL/minute per 1.73 m2 (P
for trend = .01) and of a GFR decline of 30% or more (P for trend <
.001). For women consuming more than 3,000 g of acetaminophen,
multivariate-adjusted odds ratio for a decline in GFR of at least 30 mL/minute
per 1.73 m2 was 2.04 (95% confidence interval, 1.28 to 3.24)
compared with women consuming less than 100 g.
Arch
Intern Med. 2004;164:1519-1524
Ciclopirox
Shampoo for Treating Seborrheic Dermatitis
Seborrheic dermatitis is a common inflammatory
skin disease, affecting between 1% and 3% of immunocompetent adults. While its
cause is unknown, a number of predisposing factors have been reported,
including the implications of Malassezia yeasts. Various treatment
options are available, such as ciclopirox shampoo, which combines anti-Malassezia
activity with an anti-inflammatory action. This agent has been shown to be an
effective and safe treatment for seborrheic dermatitis of the scalp.
Clinically, seborrheic dermatitis presents as
red, flaking, slightly greasy-looking patches, which are located primarily on
the scalp, nasolabial folds, ears, eyebrows and chest. Due to the fact that
there is an increased prevalence of seborrheic dermatitis in HIV-positive and
AIDS patients, it is thought that the disease may be caused by an abnormal
immune response to Malassezia.
The two main classes of treatment for seborrheic
dermatitis are topical corticosteroids and antifungal agents. Corticosteroids
reduce inflammation, thus resulting in clinical improvement of seborrheic
dermatitis. Because of the adverse effects associated with topical steroids,
there has been a shift in treatment strategies for seborrheic dermatitis with
an increased interest in antifungal agents.
Ciclopirox shampoo 1% is an antifungal
agent with antibacterial and anti-inflammatory properties. In
placebo-controlled trials, ciclopirox has been shown to reduce signs and symptoms of
erythema, scaling, and pruritus in 93% of the ciclopirox shampoo-treated
patients compared to 41% in the placebo group (P<0.00001). It is a
colorless, translucent solution, which has been used in the treatment of
seborrheic dermatitis that is applied after wetting hair. Treatment should be repeated
twice per week for 4 weeks, with a minimum of 3 days between each application.
A. K. Gupta MD, PhD, FRCPC; R. Bluhm BSc
(Hons), BA, MA Skin Therapy Lett 9(6):4-5, 2004.
PATIENT CARE
INFORMATION
Flu Season 2004-2005 Strategy
The Centers for Disease
Control and Prevention (CDC) has released the 2004-2005 recommendations for
influenza immunization, prevention, and treatment (http://www.cdc.gov/mmwr/preview/mmwrhtml/rr53e430a1.htm). Most of the recommendations are consistent
with those outlined in 2003. The
primary target groups recommended for annual vaccination are 1) persons at
increased risk for influenza-related complication (e.g. those ³ 65 years, children aged 6 – 23 months, pregnant
women, and persons of any age with certain chronic medical conditions), 2)
persons 54-64 years because this group has an elevated prevalence of certain
chronic medical conditions, and 3) persons who live with or care for persons at
high risk, including health care workers and family members. Influenza vaccination is associated with
reductions in respiratory illness and physician visits among all age groups,
hospitalizations and death among persons at high risk, otitis media among
children, and work absenteeism among adults.
Influenza vaccination remains the cornerstone for the control and
treatment of influenza illness. Optimal
vaccination time is October and November, however the flu season can last
through March and adults develop peak antibody protection against influenza
infection 2 weeks after vaccination. Antiviral medications play a role in
selected populations and circumstances.
Primary Changes and Updates in the
2004-2005 CDC Recommendations
1.
Healthy
children aged 6-23 months and close contacts of children in those ages, should
be vaccinated against influenza.
2.
Inactivated vaccine is
preferred over live, attenuated influenza vaccine (LAIV, i.e. FluMist) for
vaccinating household members, health-care workers, and others who have close
contact with severely immunosuppressed persons during periods when such persons
require care in a protected environment. Recipients of LAIV should refrain from
contact with immunosuppressed persons for 7 days following receipt of the
vaccine.
3.
Severely
immunocompromised individuals should not administer LAIV.
4.
The 2004-2005 trivalent
vaccine virus strains are
·
A/Fujian/411/2002(H3N2)-like,
·
A/NewCaledonia/20/99
(H1N1)-like, and
·
B/Shanghai
361/2002-like antigens.
Manufacturers
may substitute A/Wyoming/3/2003 for A/Fujian and B/Jilin/20/2003 or
B/Jiangsu/10/2003 for B/Shanghai strains.
Considerations for Adults Aged ³ 65 Years
Persons ³ 65 years of age should all receive
inactivated influenza vaccine. Older persons and persons with certain chronic
conditions might develop lower postvaccination antibody titers than healthy
young adults and thus can remain susceptible to influenza-related upper
respiratory tract infection. A randomized controlled trial among
noninstitutionalized persons greater than or equal to 60 years of age reported
a vaccine efficacy of 58% against influenza respiratory illness, but indicated
that efficacy might be lower among those aged ³ 70 years. Among elderly persons not
living in nursing homes, influenza vaccine is 30 – 70% effective in
preventing hospitalization for pneumonia and influenza. Among older persons who do reside in
nursing homes, influenza vaccination is most effective in preventing severe
illness, secondary complications, and death. In nursing home residents, the
vaccine can be 50 – 60% effective in preventing hospitalization or pneumonia,
and 80% effective in preventing death, although the effectiveness in preventing
influenza illness often ranges from 30 – 40%.
LAIV is not indicated for use in persons older than 50 years.
Antiviral agents
are effective for treatment of influenza infection and chemoprophylaxis of
exposed persons, including those ³ 65 years of age. However, dosage reductions are recommended for nursing home
residents and those with renal impairment (table).
The Role of
Antiviral Agents for Treatment
Amantadine and rimantadine
are adamantanes with activity against influenza A but not B viruses. The
neuraminidase inhibitors zanamivir (Relenza) and oseltamivir (Tamiflu) are
effective for treatment of uncomplicated infections of both influenza A and B
viruses. When administered within 2
days of illness onset to otherwise healthy adults antiviral drugs can reduce
the duration of uncomplicated influenza illness by approximately 1 day,
compared to placebo.
Data are limited
regarding the effectiveness of the four antiviral agents in preventing serious
influenza-related complications. Oseltamivir (Tamiflu) treatment of influenza
illness has been shown to reduce antibiotic use and lower respiratory tract
complications such as bronchitis and pneumonia in otherwise healthy young adults
and those at risk due to underlying conditions and/or age greater than 65 years
(Kaiser et al. Arch Intern Med 2003;163:1667-72).
The Role of
Antiviral Agents for Chemoprophylaxis Following Exposure
Chemoprophylaxis
is not a replacement for vaccination. Amantadine and rimantadine are 70-90%
effective in preventing illness from influenza A but not influenza B infection.
The adamantanes can prevent or blunt clinical illness while permitting the
development of protective antibodies to circulating influenza viruses. Both
drugs have been shown to decrease nursing home outbreaks of influenza A. As many as one third of influenza A strains
are resistant to adamantanes.
Among the
neuraminidase inhibitors, only oseltamivir (Tamiflu) has been approved for
chemoprophylaxis although in community studies both neuraminidase inhibitors
have demonstrated an efficacy rate of 82 – 84% in preventing laboratory
confirmed influenza. A six-week study in nursing home residents reported a 92%
reduction in influenza illness with the use of oseltamivir prophylaxis.
Persons at high
risk of infection who have been vaccinated should be considered for
chemoprophylaxis. During an outbreak,
persons who have NOT been vaccinated, should receive the vaccine and receive
chemoprophylaxis to cover the exposure for the two weeks before the vaccine is
effective. The table outlines dosing considerations for antiviral medications
in elderly nursing home residents.
Antiviral Chemoprophylaxis and Treatment
|
Medication |
Dosage |
Duration |
Side
Effects |
Comments |
|
Amantadine Not
Recommended |
£ 100 mg/day tablet
or syrup |
Prophylaxis:
Minimum of 2 weeks or until 1 week after the end of the outbreak Treatment:
3-5 days or 48 hours after disappearance of signs and symptoms |
Seizures Nervousness,
anxiety, insomnia, lightheadedness (13%) GI
– nausea and anorexia (1-3%) Anticholinergic
|
Dosage
reduction is required for Clcr < 50 ml/min |
|
Rimantadine Preferred |
100
mg/day tablet
or syrup |
Prophylaxis:
Minimum of 2 weeks or until 1 week after the end of the outbreak Treatment:
3-5 days or 48 hours after disappearance of signs and symptoms |
Lower
risk of seizures and CNS effects (6%) than Amantadine GI
– nausea and anorexia (1-3%) |
Less
data in the elderly compared to amatandine |
|
Oseltamivir
(Tamiflu) Preferred |
75
mg twice daily capsule
or oral suspension |
Prophylaxis: Minimum
of 2 weeks or until 1 week after the end of the outbreak Treatment:
5 days |
Rare
reports of seizures Nausea
and vomiting (10%) |
Take
with food to reduce nausea and vomiting Reduce
treatment dose to 75 mg/day for Clcr < 30 ml/min Reduce
prophylaxis dose to 75 mg every other day for Clcr< 30 ml/min |
|
Zanimivir (Relenza) Not
Recommended |
10
mg twice daily dry
powder inhalation via device |
Treatment:
5 days Not
approved for prophylaxis |
Rare
reports of seizures Bronchospasm Diarrhea,
nausea, sinusitis, bronchitis, cough, headache, dizziness |
No
dosage adjustment in renal failure |
NOTE:
RIMANTADINE AND OSELTAMIVIR (TAMIFLU) ARE OMNICARE-PREFERRED ANTIVIRAL
AGENTS. Geriatric Pharmaceutical
Care Guidelinesã, 2004.
Recommendations
1. Education regarding appropriate influenza prevention, vaccination, chemoprophylaxis and treatment should be provided in September.
2. All residents should be vaccinated against the 2004-2005 strains of influenza.
3. All employees should be vaccinated against the 2004-2005 strains of influenza.
4. If a resident develops influenza, he/she should be treated with either rimantadine or oseltamivir (Tamiflu) (see table).
5. There are no head-to-head trials comparing rimantadine to oseltamivir (Tamiflu) for treatment or chemoprophylaxis of influenza A virus.
6. Other exposed residents (same hallway, same healthcare workers) should undergo chemoprophylaxis with either rimantadine or oseltamivir (Tamiflu). Based on superior safety and equal efficacy over amantadine, rimantadine should be recommended when ONLY influenza A is suspected, or the resident is not a candidate for chemoprophylaxis or treatment with oseltamivir (Tamiflu).
7. Most influenza outbreaks are associated with strains of influenza A, however, if influenza B is suspected or documented, residents should receive treatment and/or chemoprophylaxis with oseltamivir ONLY. Rimantadine is NOT effective treatment for influenza B.
EDITORIAL BOARD
Karen Burton, Pharm.D., CGP, FASCP
Mark Coggins, Pharm.D., CGP, FASCP
Philip King, Pharm.D., CGP
Susan J. Klem, B.S. Pharm., CGP, FASCP
Terry O’Shea, Pharm.D., CGP, FASCP
Elmer Schmidt III, Pharm. D., CGP, FASCP
Barbara J. Zarowitz, Pharm.D., CGP, BCPS, FCCP