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IN THIS ISSUE
• Fundraisers Contribute To Relay
For Life Cause
• Use Of Sliding Scale Insulin In
Long-Term Care Facilities
• New Drug Updates
Short Cycle Dispensing
Requirements In The
Long-Term Care Setting
Multivitamins And
Cancer In Men
Transitioning To
eMARs
Follow ‘Diamond Pharmacy
Services’ on Facebook
VOLUME 10, ISSUE 1, 2013
A Diamond Pharmacy Services Publication
http://www.diamondpharmacy.com
“Brain Pacemaker”
Offers Promise To
Alzheimer’s Patients
In This Issue:
Issue 1, 2013
Page 5
Page 4
Editorial Staff
Editor: Eric Pash, R.Ph.
Associate Editors:
Denise Zahorchak, R.Ph.,
Rachael Houllion
Design Staff
Steve Heidenthal
Nick McFerron
Reader Information
If you have any questions or
comments regarding this publication,
please contact our Diamond editors
1.800.882.6337 or via e-mail:
[email protected]
[email protected]
If your company is interested in
advertising your product or service
in this Diamond publication, please
contact our Marketing Department
Page 8
Page 6
4
5
Journal Watch:
An Alternative To Antibiotic Prophylaxis For
Recurrent UTIs?
On The Radar:
Experimental Immunotherapy Shows Promise For The
Treatment Of Alzheimer’s Disease
6
Regulatory Update:
Updates To The Rules And Regulations For
Pennsylvania LPNs and IV Therapies
8
Diamond Makes A Difference:
Fundraisers Contribute To Relay For Life Cause
[email protected]
Diamond Pharmacy Services
645 Kolter Drive
Indiana, PA 15701-3570
www.diamondpharmacy.com
1.800.882.6337
Diamond will not be held responsible for the content within the paid advertisements, nor do we endorse any advertised products or services. Organizations providing financial support do
not participate in the editorial process or otherwise influence editorial decisions. Every effort is made to ensure the accuracy of the information published. Since the standards of care
change rapidly, the authors and editors will not in any way be held liable for the timeliness of information or for errors, omissions, or inaccuracies in this publication. Clinical judgement
must guide each professional. Consult complete prescribing information before administering any medication.
9
10
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Page 9
Medication Management:
Short Cycle Dispensing Requirements In
The Long-Term Care Setting
In The News:
Multivitamins And Cancer In Men
In The News:
“Brain Pacemaker” Offers Promise To
Alzheimer’s Patients
Keeping It Safe:
Reducing The Use Of Antipsychotic
Medications In Long-Term Care Settings
13
14
Keeping It Safe:
Ask The Joint Commission Experts
16
18
What’s New At Diamond:
Transitioning To eMARs
Diabetes Corner:
Use Of Sliding Scale Insulin In Long-Term
Care Facilities
New And Noteworthy:
New Drug Updates
• AUBAGIO®
• OXTELLAR XR®
• FYCOMPA®
Experimental Immunotherapy
An Alternative To Antibiotic
Prophylaxis For Recurrent UTIs? Shows Promise For The Treatment
Of Alzheimer’s Disease
Susan Rugh, Pharm D Candidate 2013
DIAMOND PHARMACY SERVICES
S
tudy results were recently published in the
Archives of Internal Medicine comparing
the efficacy of sulfamethoxazole-trimethoprim
400mg/80mg (Bactrim SS®) once daily to
109 CFUs of Lactobacillus rhamnosus and
Lactobacillus reuteri twice daily as prophylaxis
against recurrent urinary tract infections (rUTIs).
The goal of the study was to find a reasonable
alternative prophylaxis treatment against rUTIs
which would not contribute to bacterial resistance
in the population.
The authors conducted a double-blind, doubledummy, randomized trial of 252 postmenopausal
women with rUTIs to determine if Lactobacillus
was
not
inferior
to
sulfamethoxazoletrimethoprim.
After monitoring the women
for 12 months, researchers compared the
percent of women with at least one UTI, the
median time until the presentation of the first
UTI, the average number of UTIs, the number
of complicated vs. uncomplicated UTIs, and
the rate of resistance to common antibiotics
(sulfamethoxazole-trimethoprim, nitrofurantoin,
amoxicillin, amoxicillin with clavulonic acid,
gentamicin, ciprofloxacin, and norfloxacin) within
the detected E. coli for each of the two treatment
groups.
Researchers also monitored the
nugent score for each woman over the course
of treatment to determine if Lactobacillus could
promote recolonization of normal vaginal flora in
postmenopausal women.
4
Issue 1, 2013
At the study’s conclusion, the difference between
the groups was not able to support the author’s
hypothesis that Lactobacillus is as good as (or
not inferior to) the current recommended UTI
prophylaxis of sulfamethoxazole-trimethoprim.
Women in the Lactobacillus group were more likely
to contract a UTI (14% more women contracted
a UTI in the Lactobacillus group), contracted
a UTI more quickly (three vs. six months at
onset), and had a higher number of UTIs than
women randomized to the sulfamethoxazoletrimethoprim group. Lactobacillus treatment
was also unable to stimulate the recolonization
of normal vaginal flora in the test group.
The most significant finding of the study showed
a large increase for antibiotic resistance in
women on antibiotic prophylaxis (up to 80-95%),
not only towards sulfamethoxazole-trimethoprim,
but towards the other antibiotics tested as well.
Women in the sulfamethoxazole-trimethoprim
test group had a higher rate of complicated UTIs
(resistant to sulfamethoxazole-trimethoprim and
amoxicillin) than those taking Lactobacillus. As
demonstrating this increase in resistance was
one of the primary purposes of the study, the
authors hope this will educate prescribers to use
caution when recommending long-term antibiotic
treatment as prophylaxis against rUTIs.
References available upon request
A
lzheimer’s disease is a progressive,
degenerative disorder in which the neurons
in the brain lose the ability to communicate and
atrophy. Insoluble, sticky protein fragments,
known as amyloid-beta (Aβ) plaques, accumulate
around the neurons in the brain. These plaques
block the neurotransmitters (acetylcholine),
which prevents communication between
neurons. As these neuronal cells atrophy and
die, patients experience dementia and loss of
intellectual functioning.
Currently, therapeutic research for Alzheimer’s
disease has focused on preventing the
accumulation of, and promoting the removal of,
these insoluble amyloid deposits. Until recently,
the use of antibodies against amyloid plaques
has been unsuccessful. Antibodies quickly
became saturated by soluble Aβ proteins and
were ineffective in reaching the existing insoluble
Aβ protein deposits. These non-selective antiAβ antibodies were also associated with a high
risk of micro-hemorrhages in patients.
In December, Eli Lilly released a study showing
the effects of an engineered anti-Aβ murine
monoclonal antibody specific for the treatment of
the insoluble amyloid deposits already present.
The Aβp3-42 antibodies easily crossed the blood
brain barrier to attach to the plaque deposits but
did not show the same micro-hemorrhages seen
in previous Alzheimer’s immunotherapy. The
Aβp3-42 - specific antibodies were able to clear and
significantly reduce the amount of existing Aβ
plaque deposits in mice. Similar findings were
identified in subsequent tests and appear to be
directly related to the dose of the medication.
Eli Lilly believes results of their study may help
explain why the Alzheimer’s drug bapineuzumab
was unsuccessful for treating existing plaque
deposits in patients during clinical trials.
Bapineuzumab binds to both soluble and
insoluble Aβ proteins and becomes saturated
before reaching plaque deposits in the brain.
Findings from the Eli Lilly study will allow a more
targeted approach to the removal of plaque
deposits and holds promise for the future of
Alzheimer’s pharmacotherapy.
5
Updates To The Rules And
Regulations For Pennsylvania
LPNs And IV Therapies
Trina Plazio, RN, CRNI
O
n August 25, 2012 the Pennsylvania State Board
of Nursing released amendments to the Licensed
Practical Nurse (LPN) Rules and Regulations. The
following is a brief overview of the changes:
The regulation changes further define the LPN’s role
in IV therapy. The entire regulation can be viewed
at www.pabulletin.com Volume 42, Number 34.
Following is an excerpt pertaining to the Function of
the LPN and IV therapy:
An LPN who has met the education and training
requirements of § 21.145b (relating to IV therapy
curriculum requirements) may perform the following
IV therapy functions, except as limited under
§ 21.145a and only under supervision as required
under subsection (f):
1. Adjustment of the flow rate on IV infusions.
2. Observation and reporting of subjective and
objective signs of adverse reactions to any
IV administration and initiation of appropriate
interventions.
3. Administration of IV fluids and medications.
4. Observation of the IV insertion site and
performance of insertion site care.
5. Performance of maintenance. Maintenance
includes dressing changes, IV tubing changes,
and saline or heparin flushes.
6. Discontinuance of a medication or fluid infusion,
including infusion devices.
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Issue 1, 2013
7. Conversion of a continuous infusion to an
intermittent infusion.
8. Insertion or removal of a peripheral short
catheter.
9. Maintenance, monitoring, and discontinuance of
blood, blood components, and plasma volume
expanders.
10.Administration of solutions to maintain patency
of an IV access device via direct push or bolus
route.
11.Maintenance and discontinuance of IV
medications and fluids given via a patientcontrolled administration system.
12.Administration, maintenance, and
discontinuance of parenteral nutrition and fat
emulsion solutions.
13.Collection of blood specimens from an IV access
device.
Italicized above are the new functions the LPN may perform if the
education and training requirements are met.
Below is the list of prohibited acts under the Function
of the LPN section:
§ 21.145a. Prohibited acts.
An LPN may not perform the following IV therapy
functions:
1. Initiate administration of blood, blood
components, and plasma volume expanders.
2. Administer tissue plasminogen activators,
immunoglobulins, antineoplastic agents, or
investigational drugs.
3. Access a central venous route access device
used for hemodynamic monitoring.
4. Administer medications or fluids via arterial lines.
5. Administer medications via push or bolus route.
6. Administer fibrinolytic or thrombolytic agents to
declot any IV access device.
7. Administer medications requiring titration.
8. Insert or remove any IV access device, except a
peripheral short catheter.
9. Access or program an implanted IV infusion
pump.
10.Administer IV medications for the purpose of
procedural sedation or anesthesia.
11.Administer fluids or medications via an epidural,
intrathecal, intraosseous, or umbilical route, or
via a ventricular reservoir.
12.Administer medications or fluids via an
arteriovenous fistula or graft, except for dialysis.
13.Perform repair of a central venous route access
device or PICC.
14.Perform therapeutic phlebotomy.
15.Direct access of implantable devices.
program, they have the option to determine their need
to complete an entire Board – approved IV therapy
course or those components necessary.
Diamond Pharmacy offers a Pennsylvania State
Board of Nursing - approved LPN IV Therapy
Certification Program. This course has been updated
to offer all the components listed under the Function
of the LPN. In addition to this complete course, we
are offering a supplemental course that addresses
the maintenance of central vascular access devices
(CVAD) including flushing, dressing changes, and
blood draws.
We hope you find this information most helpful. If you
have any questions or concerns about the updated
regulations, we will be happy to assist and guide you
in the right direction. You can also contact our IV
Department using the email link below if you would
like more information pertaining to our offered LPN
courses and/or costs of the program.
Questions or comments:
Trina Plazio RN, CRNI
[email protected]
As stated on the Pennsylvania State Board of
Nursing website as Special Notice -LPN IV Therapy
Regulations – Final:
“§21.148(a)(1) of the LPN Regulations (related to
standards of nursing conduct) states, “A licensed
practical nurse shall: (1) Undertake a specific
practice only if the licensed practical nurse has the
necessary knowledge, preparation, experience, and
competency to properly execute the practice.” LPNs
can determine their need to complete an entire
Board-approved IV therapy course or only those
components needed to meet regulatory changes.”
If individuals have previously completed a Board
- approved program or received it in their nursing
DID YOU KNOW?
An estimated 5.4 million Americans suffer from Alzheimer’s
Disease (AD), and most people with AD develop it after
age 60. It is estimated that nearly half (43%) of adults
age 85 and older may have the disease. Almost twothirds of AD patients are women. The estimated annual
government cost for this disease is $183 billion, and this
cost is projected to increase to $1.1 trillion by 2050.
Sources: www.annalsoflongtermcare.com; www.clinicalgeriatrics.com
7
Fundraisers Contribute To
Relay For Life Cause
Short Cycle Dispensing
Requirements In The
Long-Term Care Setting
Steve Heidenthal, Marketing
D
iamond’s Relay For Life team finished the
2012 year off strong with two successful
fundraisers to benefit the American Cancer
Society. Once again, a Pie Shoppe fundraiser
was held during the holiday season to give
employees an opportunity to enjoy some
delicious pies and to contribute to such
a great cause. Through many generous
donations, the Pie Shoppe fundraiser was
able to raise nearly $200 for the Relay For
Life team.
Diamond’s Relay For Life team hopes to
continue to make an impact for the American
Cancer Society in 2013.
With several
fundraisers already planned, be sure to read
upcoming Diamond Quarterly Newsletters to
stay updated on their success.
The team also held a basket raffle fundraiser
during the month of December. Over 27
themed baskets were kindly donated by
Diamond employees to be raffled off. Some
of the themes this year included “Kitchen For
The Cure” basket, “Camo” basket, “Breakfast”
basket, “Fun In The Sun” basket, “Steelers/
Penguins” basket, “Lottery Tree,” and many
more. This fundraiser has become one of the
largest earnings for Diamond’s Relay For Life
team and raised over $3,900, which is nearly
$1,800 more than last year!
8
Issue 1, 2013
E
ffective January 1, 2013 a regulation
authorized by section 3310 of the
Affordable Care Act (ACA) of 2010 requires
certain medications dispensed to Medicare
Part D beneficiaries in nursing facilities or
skilled nursing facilities to be dispensed in
quantities of 14 days or less.
The final version of this rule was published
in the Federal Register on April 15, 2011. In
summary, the regulation is enforced by the
Centers for Medicare and Medicaid Services
(CMS) and is intended to achieve cost savings
by reducing the quantity of medications
dispensed but not consumed by Medicare
Part D beneficiaries residing in nursing
and skilled nursing facilities. CMS expects
this requirement to reduce the amount of
prescription drug waste associated with 30
day cycle fills.
RELAY FOR LIFE
Basket Raffle
Paul Daisley, R.Ph., Director of Skilled Nursing Facilities
Linda, a Diamond employee for over
six years, was the winner of the “Soups
ON” basket that included a crockpot
filled with soups and a bread mix.
The ACA regulation covers solid oral
brand name drugs and some generic
drugs dispensed to any Medicare Part D
beneficiary residing in a nursing home facility
from any pharmacy including closed door,
community, and mail order pharmacies. Solid
oral brand name controlled substances and
some generics will also be subjected to the
14-days-or-less dispensing requirement.
EXCLUSIONS
The regulation does not apply to:
• Drugs that are difficult to dispense
• Drugs for acute illness
• Liquids
• Drugs that must be dispensed in the
original container according to the FDA
• Ear drops, eye drops, inhalation drugs,
nasal sprays, parenteral drugs, and
topical drugs
This regulation also excludes beneficiaries in
these settings:
• Assisted living
• Group homes
• ICF-MR’s
• Facilities operated by Indian Health
Service or Tribal or Urban Indian
organizations
9
Multivitamins And Cancer
In Men
T
he Physicians’ Health Study II (PHS
II) is a large, double-blind, randomized
controlled study testing the potential
benefits of taking a daily multivitamin for the
prevention of cancer, heart disease, cognitive
decline, and eye disease in men. The
statistical analysis on cancer was recently
published in the Journal of the American
Medical Association. PHS II hoped to give
a definitive answer to the question of how
beneficial multivitamins are to the prevention
of common chronic diseases.
number of total cancer incidents (only first
cancer incidents were included) among
multivitamin users compared with placebo
(1.7 vs. 1.83 per 100 respectively). While
this finding was statistically significant (HR,
0.92; 95% CI, 0.86-0.998; P = .04), the
clinical significance is unclear, as the actual
difference in cancer incidents is 0.0013%
(1.83-1.7/100). The noted reduction in cancer
rates was reportedly more pronounced in
men with a prior history of cancer and for
men with epithelial cell cancers.
Researchers
followed
14,641
male
physicians in the United States, aged 50 or
older, from early 1997 until June 2011. They
primarily looked at epithelial cell cancer,
the number of total cancers (including and
excluding the number of prostate cancers),
and the amount of cancer mortality for this
portion of the study. Men were randomized
to one of several groups: receiving Centrum
Silver® multivitamin, vitamin E, vitamin C, and
beta carotene or the equivalent placebos.
Researchers recognize the limitations in
generalizing the results of this study to
younger men and women. Studies on the
relationship between multivitamin use and
cancer have had mixed results, and it is
difficult to confirm the benefits of multivitamin
therapy when their mechanism in cancer
prevention is unknown. Further research on
this topic is warranted. The PHS II results
for cardiovascular disease, cognitive decline,
and eye disease are scheduled to be released
separately.
The results of the PHS II showed the use of
a daily multivitamin did not change the rate
of prostate cancer, colorectal cancer, other
site-specific cancers, or the amount of time
until the development of cancer compared to
patients who received placebos. There was
also no difference in cancer-related mortality
between the multivitamin study group and
the placebo groups.
The only significant finding was in association
to the rates of total cancer. The PHS II
demonstrated a modest reduction in the
10
Issue 1, 2013
“Brain Pacemaker” Offers
Promise To Alzheimer’s Patients
Courtney Adams, Administration
R
esearchers at Johns Hopkins University
believe that a brain pacemaker, similar
to that used to treat Parkinson’s disease
patients, may offer great benefit to those
suffering with Alzheimer’s disease.
“You put two wires in the brain, in the part of the
brain that we know is involved in memory…it
looks like a pacemaker, it’s a little battery that
fits under your shoulder blade,” explained Dr.
Paul Rosenberg, lead researcher at Johns
Hopkins. “It puts electricity through these
wires, these wires run along the natural
wires of the brain, which feed your memory
and they actually stimulate those parts of the
brain,” he added.
In a pilot clinical trial in Canada, where
the treatment was tested on six patients,
the patients “did somewhat better with
their memory”, but “did great with brain
metabolism,” stated Rosenberg.
Brain
metabolism normally degenerates in
Alzheimer’s patients, but in this trial it actually
improved.
In the United States, neurologists at Ohio
State’s Wexner Medical Center implanted
the brain pacemaker into Kathy Sanford last
October and will be monitoring her through
2015. Sanford is one of 10 patients enrolled
in the FDA-approved study and is the first
American to receive the procedure. The
study participants have mild or early-stage
Alzheimer’s disease and will be monitored for
improvement trends in behavioral, cognitive,
and functional deficits.
“If the early findings that we’re seeing continue
to be robust and progressive, then I think that
will be very promising and encouraging for
us,” said Dr. Ali Rezai, director of the Center
for Neuromodulation at Ohio State. “But so
far we are cautiously optimistic.”
While the procedure may intimidate
individuals, experts state it is not that
invasive, however it does require the drilling
of a couple holes into the patient’s skull.
Additionally, they note that this procedure
would not be used as replacement therapy
for medication, but can be used along with it.
For Alzheimer’s patients like Sanford, who
was thrilled with the chance to participate in
the study, the future seems bright. “I’m just
trying to make the world a better place,” she
commented. “That’s all I’m trying to do.”
11
Reducing The Use Of Antipsychotic
Medications In Long-Term Care Settings
Denise Zahorchak, R.Ph.
T
he use of antipsychotic medications in longterm care facilities has been receiving renewed
attention recently, especially with those residents who
are given these medications without an appropriate
corresponding diagnosis.
In 2012, the Centers for Medicare and Medicaid
Services (CMS) added two new quality measures
related to the use of antipsychotic medications in longterm care residents. The new measures that will be
posted on the Nursing Home Compare (NHC) website
assess the percentage of short-stay residents who are
started on an antipsychotic medication after they have
been admitted to the facility and also measure the
prevalence of long-stay residents that are receiving an
antipsychotic medication. These statistics will exclude
residents who are taking an antipsychotic medication
and also have a diagnosis of schizophrenia, Tourette’s,
or Huntington’s disease. The initial goal that CMS had
set for the end of 2012 was a 15% reduction in the
off-label use of antipsychotic medications in the longterm care setting. Off-label usage of an antipsychotic
medication would include using these medications to
control dementia-related behaviors.
Antipsychotic medications can be split into two general
categories: typical (aka conventional or first generation)
and atypical (aka second generation).
Typical
antipsychotics were the first group of these medications
to be approved and used in the US. Whenever the
atypical antipsychotics were first released, they were
more expensive than the typical agents, yet they
were thought to be safer and have fewer side effects.
However, later studies showed that both classes of these
medications can be extremely dangerous when used in
the elderly for treating dementia-related behaviors. In
12
Issue 1, 2013
2005, the FDA issued a Black Box Warning for atypical
antipsychotics when used in elderly patients having
dementia, and in 2008 they expanded the warning to
include the first generation typical antipsychotics. This
Black Box Warning was the result of studies showing
an increased risk of death in the elderly when taking
these medications. Although the causes of death
were varied among the patients in the studies, most
of them appeared to be either cardiovascular (ie. heart
failure or sudden death) or infectious (ie. pneumonia).
When deciding to use these medications in the elderly
population, one must weigh the risks vs. the benefits.
Numerous studies have shown these medications to
have very modest results when used in the elderly
having dementia, with only 20-30% showing even
marginal improvements in behaviors and function.
When considering the increased risks of death and
side effects that accompany antipsychotics, reducing
the utilization of this group of medications in the elderly
with dementia becomes a worthwhile goal.
The Office of the Inspector General (OIG) May 2011
report (based on January-June 2007 data) reviewed
claims that were submitted for Medicare Part B and
D reimbursement. This data showed that 14% of
elderly nursing home residents had claims for atypical
antipsychotics, and 83% of these claims were for offlabel use. CMS analysis of MDS 3.0 data from the 4th
quarter of 2011 shows the national average of off-label
usage of antipsychotic medications to be 24%. The
CMS target goal was to reduce that number by 15% by
the end of 2012, which would result in the total number
of atypicals used off-label dropping to about 20%.
F-Tag 329 addresses the use of unnecessary drugs in
long-term care. This tag states that residents should
have drug regimens that are free of unnecessary drugs,
which are defined as: excessive doses or duplicate
therapy, excessive duration of therapy, inadequate
monitoring of the drug or inadequate indication for
the drug, adverse consequences of using the drug, or
any combination of these factors. There are specific
conditions for antipsychotic drugs within this tag. The
facility must ensure that residents who have not used
antipsychotic drugs before are not started on these
medications unless it is absolutely necessary to treat
a specific condition which has been diagnosed and
documented in the clinical record. Also, residents
who are using antipsychotic medications must receive
gradual dose reduction attempts and behavioral
interventions in an attempt to discontinue these drugs,
unless it is clinically contraindicated.
There are several methods that can be used to help
facilities reduce the number of residents who are
taking antipsychotic medications. The consulting
pharmacist can assist the facility in identifying
residents who are taking antipsychotic medications for
off-label uses and requesting gradual dose reductions
for these medications. It may be helpful to initially
target antipsychotic medications that are being given
as needed and those that are being given at very low
doses or at bedtime to assist with sleep. Antipsychotic
medications given under these conditions are often
easily replaced by other medications that do not carry
the same risk factors. The biggest challenge that
facilities may face will be educating family and staff
about dementia-related behaviors and the lack of
effectiveness of antipsychotic medications when used
for this problem. Education of staff is vital to help them
understand behaviors associated with dementia and
learn non-pharmacologic strategies to help manage
individuals with these behaviors. Inter-disciplinary
teams within the facility can be very helpful in looking at
all aspects of the resident’s life, such as how different
situations or surroundings may trigger behaviors.
There are many resources available to help educate
family and caregivers about how to deal with dementiarelated behaviors, which can ultimately help to
decrease the off-label usage of antipsychotics. The
National Institutes of Health (NIH) website (nih.gov)
has a list of many references and books on this topic,
the Alzheimer’s Association website (alz.org) has an
online brochure that focuses on how to respond to
dementia-related behaviors, and the CMS website
(cms.gov) can be used to review the most current
regulations regarding these medications.
The reduction of off-label use of antipsychotic
medications in the geriatric population is a worthwhile
goal, but this will require proper education,
reinforcement, and a collaborative effort by the entire
healthcare team.
Ask The Joint Commission Experts
Rick Bartlebaugh, CSP
W
hat emergency management protocols does
Diamond have in place for Long-Term Care
Facilities to follow in the event of an emergency or
natural disaster in order to maintain the highest level
of resident care?
• In the event that an emergency occurs at a
nursing facility: Notify Diamond Pharmacy of the
extent of the emergency by dialing 800-882-6337.
Continue faxing daily orders to 888-284-3784. If
applicable:
• Request replacement medications
• Request copies of MAR forms
• Request additional medical equipment and
supplies
If patients have been displaced to an alternative nursing
facility (s), please provide the temporary address,
phone number, and contact information.
• In the event that an emergency occurs at
Diamond Pharmacy: Nursing Home Administrators
and Directors of Nursing will be contacted and
notified of the extent of the emergency. Critical
orders will be sorted and processed through
alternative locations. Backup pharmacies will be
notified of the emergency and utilized to fill orders
as needed.
13
Types of Insulin and Their Pharmacokinetics
Category
Rapid Acting
Insulin
Analogues
Use Of Sliding Scale Insulin In
Long-Term Care Facilities
I
The most common form of diabetes in the longterm care (LTC) setting is type 2 diabetes, which is
caused by a combination of insulin resistance and the
inability of the pancreas to secrete enough insulin to
compensate for the insulin resistance. This results in
chronic elevations of blood sugar which is associated
with multiple organ dysfunction, especially affecting the
eyes, kidneys, nerves, heart, and blood vessels.
LTC residents with diabetes are more likely to suffer
with co-morbid conditions, and hyperglycemia may
impair cognition and contribute to further functional
decline in patients with dementia. Hyperglycemia may
also decrease pain thresholds, impair vision, interfere
with wound healing, and can increase the risk of falls.
Elderly patients with diabetes may also be more likely
to experience hypoglycemia, which can also contribute
to falls or accelerate cognitive decline. Hypoglycemia
may also be mistaken for dementia, psychosis,
behavior changes, or other conditions and thus may
be treated inappropriately.
The goal of treatment for diabetes should be to improve
14
Issue 1, 2013
Onset of
Actions
Peak Action
Duration of
Effect
Maximal
Duration
Comments
Lispro (Humalog “H”)
5 - 15min
1/2 - 2h
2 - 4h
3 - 5h
Must be given just before or within 20min
after eating
Insulin Aspart (Novolog)
10 - 20min
1 - 3h
3 - 5h
5h
Must be given before eating
Insulin Gluisine (Apidra)
<15 - 20min
1/2 - 2h
3h
3h
Must be given just before or within 20min
after eating
1/2 - 1h
2 - 4h
3 - 7h
up to
12h
Normally dosed 30min before a meal.
Available in fixed combinations with NPH
(e.g., 70/30)
1 - 4h
4 - 12h
up to 24h
24h
Normally dosed 30 - 60min before a meal
1 - 4h
4 - 12h
10 - 24h
24h
4 - 6h
no pronounced
peak
24h
24+h
3 - 4h
Relatively Flat
5.7 - 23h (Dose
Dependent)
24h
30min
4.2h
up to 24h
24
10 - 20min
2.4h
up to 24h
24h
Insulin Type
Insulin Regular
Intermediate NPH Insulin
Acting
Lente Insulin
Insulin Glargine (Lantus)
Long Acting
Insulin Delemir (Levemir)
Denise Zahorchak, R.Ph.
n the United States, approximately 26 million people
have diabetes mellitus, 11 million of whom are aged
65 or older. There has been a 26% increase in the
number of patients discharged from hospitals with a
primary diagnosis of diabetes over the last decade.
The costs related to the care of the diabetic patient
place an enormous burden on the healthcare system.
Healthcare costs for diabetic patients are normally
two to three times higher than non-diabetics. Good
glycemic control can help to keep these costs down by
reducing the micro-vascular damage that leads to the
long-term complications of the disease.
Short Acting
TABLE 1
Never mix with other insulins
Rotate injection sites
Premixed combination Insulins
blood glucose control, decrease cardiovascular
risk factors, and minimize complications, while also
adjusting treatment based on patient preferences, life
expectancy, and quality of life. While good glycemic
control is a desired goal of therapy, not all elderly or
frail patients are able to tolerate tight glycemic control
and the hypoglycemia that may sometimes accompany
it. It may be desirable to set more modest goals in
individuals who have a poor prognosis, have anorexia,
malignancy, or severe dementia, or a life expectance of
less than five years.
Both oral medications and insulins are used to treat
diabetes mellitus. There are a variety of insulins
available, which may be used together in many
different combinations. Ultra short-acting, short-acting,
intermediate, long-acting, and several combination
insulin products are made (see Table 1). Intermediate
or long-acting insulin, also known as basal insulin, helps
to maintain consistent insulin levels and suppresses
hepatic glucose production between meals. Prandial
or bolus insulin (ultra short or short-acting insulin) limits
hyperglycemia after meals. Treatment with insulin
needs to be individualized based on the patient’s blood
glucose levels, prognosis, and treatment goals.
Sliding scale insulin (SSI) administration involves
the use of short-acting insulin based on immediate
blood sugar levels that are measured several times a
day. If the patient’s blood sugar is elevated, then a
pre-determined dose of insulin is given based on the
blood sugar reading. SSI is widely used in hospitals
and LTC facilities, but its prolonged use is generally
not recommended. Many studies have shown that it
is not an effective method of meeting physiological
needs. A SSI may be ordered for short-term use due
Standard
Humulin or Novolin
Combination
Analog
Novolog 70/30
Combination Lispro 75/25
to an acute illness, but it is often not discontinued
whenever the illness has resolved. Widespread use of
SSI results in greater patient discomfort and increased
nursing time spent measuring the blood glucose and
administering the insulin. There is also an increased
risk of hypoglycemia with SSI use. Thus, the patient’s
quality of life and level of activity may be compromised.
The American Medical Directors Association (AMDA)
has recommended against long-term use of SSI, and
the American Geriatrics Society (AGS) has added SSI
to the Beer’s List of medications that are potentially
inappropriate for use in the elderly.
SSI therapy has come under scrutiny for being a
reactive therapy instead of a proactive one. Doses are
often given before a meal based solely on current blood
sugar levels, without considering the amount of food
about to be consumed, the patient’s weight, and other
factors. This approach may lead to hypoglycemia and
the complications that accompany it. Blood sugars are
measured by doing a finger stick up to four times a day,
which expends a significant amount of nursing time,
interferes with patient quality of life, and increases the
possibility of administration errors. This four-timesa-day regimen may result in the patient experiencing
very high blood glucose levels for several hours prior to
the next dose of insulin being given. Instead of being
“reactive” and treating a hyperglycemic event that
has already occurred, a better approach would be to
prevent the hyperglycemia from happening by adding
or increasing the basal level of insulin through the use
Normally dosed just before a meal
of long-acting insulin.
Practice guidelines now recommend the use of
structured insulin regimens with three components:
basal insulin, nutritional insulin, and correctional insulin.
Combining these three components has been shown
to decrease fluctuations in blood glucose levels. Basal
insulin (long-acting) should be given routinely to meet
the patient’s basal metabolic requirements and prevent
the liver from overproducing glucose, which can lead to
hyperglycemia. This has been shown to exhibit better
glycemic control in comparison with SSI. Nutritional
(rapid-acting) insulin is given to cover insulin needs
at mealtime. This most closely mimics normal insulin
production in the body and controls blood glucose
more effectively. Correctional insulin is given based on
pre-prandial blood glucose levels, but it is dosed based
on the patient’s insulin sensitivity, their weight, and the
amount of food about to be consumed.
In general, it is recommended in LTC facilities that a
patient on SSI be evaluated and converted to fixed
daily insulin doses that minimize the need for corrective
doses. It has been shown in LTC that blood glucose
control can be achieved with single or multiple fixed daily
doses, while having fewer episodes of hypoglycemia,
decreased nursing administration time, and increased
patient quality of life.
15
Transitioning To eMARS
Chuck Plazio, Account Executive, Assisted Living Facilities
W
ith all of the challenges of providing quality
care while remaining compliant with
countless state and federal regulations, Personal
Care Homes, Assisted Living Facilities, and Skilled
Nursing Facilities are turning to electronic medical
administration records, also known as eMARs, to
help with their recordkeeping. There are many
advantages to using eMARs:
• They are easier to read than most paper MARs
• They help reduce medication errors
• They increase communication with your
pharmacy by allowing you to view orders in
“real time”
• They have been shown to reduce medication
pass times by 30%
• They offer a host of functional reporting options
With this being said, the Pennsylvania Bureau of
Human Services Licensing (BHSL) has issued their
expectations for facilities utilizing an eMAR system:
Procedures for Electronic Recordkeeping
Electronic recordkeeping is permissible if all of the
following conditions are met:
1. The electronic record is immediately accessible
to BHSL licensing staff in electronic or paper
format
2. The electronic format conforms to the
requirements of all applicable federal and state
laws including, but not limited to, the Electronic
Transactions Act (73 P.S. § 2260.304)
3. The medium used to produce the electronic
records is able to produce paper copies of
16
Issue 1, 2013
records if requested by BHSL or any other
oversight agency
4. The medium used maintains a record of any
deletion, change, or manipulation of a document
and shows the original and altered versions,
dates of creation, and the creator
Use of Electronic Signatures
Electronic signatures may be used in lieu of penand-ink signatures on any document required by
regulation to be signed by the licensed setting,
the consumer receiving services from the setting,
or any other individual who may or must sign the
document.
Program Office Requirements
This document sets for BHSL’s expectations
only. Facilities and agencies are responsible
for understanding and applying any additional
requirements established by federal, state, and
local human services programs. BHSL is not
responsible for any sanctions imposed by such
programs if the facility or agency does not
meet the program’s requirements.
To inquire more about electronic medical
records and how they can benefit your
facility, contact a Diamond Pharmacy
Account Executive by dialing
1-800-882-6337.
17
Rebif® (interferon beta-1a), an injectable medication
which has been shown to be superior to Aubagio®
in reducing the exacerbation and progression of
RMS; however, Aubagio® allows an alternative oral
medication for those who do not wish to continue
treatment with injections.
Nikolas McFerron, Marketing
NEW DRUG UPDATES
AUBAGIO®
(teriflunomide)
Aubagio® is an oral immunomodulatory pyrimidine
synthesis
inhibitor
having
anti-inflammatory
characteristics produced by Genzyme, a subsidiary
of the Sanofi SA. Aubagio® was approved in August
2012 by the FDA for the treatment of remitting
multiple sclerosis (RMS).
Multiple sclerosis occurs when the immune system
attacks the myelin sheaths which surround the nerve
fibers of the brain, spinal cord, and optic nerve.
The scar tissue (sclerosis) along the myelin sheath
causes distortion of the signals which travel between
the central nervous system and the rest of the body.
This distortion can result in debilitating, progressive
spasms, numbness, paralysis, or visual impairment.
Other symptoms include vertigo, loss of balance,
cognitive dysfunction, depression, and loss of control
over the bladder or bowel.
Aubagio® inhibits the mitochondrial enzyme,
dihydroorotate dehydrogenase, in the de novo
synthesis of pyrimidines. The mechanism by which
Aubagio® reduces the exacerbation and progression
of RMS is not fully understood, however it is
believed to reduce the amount of activated T and B
lymphocytes in the central nervous system.
Aubagio® is the active metabolite of leflunomide and
thus is contraindicated in patients already taking
leflunomide. Aubagio® is highly protein bound,
often distributed throughout the body attached to
breast cancer-resistant proteins (BCRP). BCRP
inhibitors may increase Aubagio® levels. Aubagio® is
an inhibitor of CYP2C8 and an inducer of CYP1A2.
18
Issue 1, 2013
Potential drug interactions include rifampin, warfarin,
ethinylestradiol or levonorgestrel, and other drugs
which affect the CYP2C8/1A2 systems. Aubagio®
should not be used in patients with severe hepatic
impairment.
Aubagio® is teratogenic and should not be used
in women who are pregnant or wish to become
pregnant. As Aubagio® can remain in the system for
up to two years following discontinuation of the drug
and is present in semen, women of childbearing age
should use appropriate barrier birth control to prevent
transmission of Aubagio® from their partner. Should
it be desired, accelerated clearance of Aubagio® can
be facilitated by the administration of cholestyramine
or activated charcoal.
Common adverse effects seen with Aubagio®
include elevated liver enzymes, alopecia, influenza,
paresthesia, and GI upset. Serious adverse effects
can occur while on Aubagio® such as major liver
failure, peripheral neuropathy, renal failure, lifethreatening skin reactions, hyperkalemia, blood
pressure elevation, and neutropenia. Six months
prior to initiation of Aubagio® therapy, a transaminase
and bilirubin level, complete CBC, and tuberculosis
test should be performed. Transaminase, bilirubin,
and blood pressure should be monitored monthly for
six months following initiation of Aubagio®. Patients
should contact the doctor if they experience signs of
liver failure, such as nausea, stomach pain, fatigue,
jaundice, or dark urine.
Aubagio® is available as 7 mg or 14 mg oral tablets,
taken once daily with or without food. Current
guidelines for RMS treatment recommend the use of
OXTELLAR XR®
(oxcarbazepine extended-release)
Approved in October of 2012, Oxtellar XR® is a
once daily formulation of oxcarbazepine, a currently
approved anti-epileptic drug used to prevent seizure
spread in the intact brain. Oxtellar XR® is specifically
indicated as adjunctive therapy of partial seizures in
adults and in children 6 years to 17 years of age.
The effectiveness of this new formulation is supported
by a multicenter, double-blind, placebo-controlled
study where all of the 366 adults enrolled had at least
three partial seizures per 28 days during an 8 week
baseline period. The primary endpoint of the study
was an average percentage change from baseline
seizure frequency during the treatment period related
to the baseline period. The results are as follows:
Oxtellar XR® 1200mg/day: -38.2 % (p=0.078),
Oxtellar XR® 2400mg/day: -42.9 % (p=0.003), and
placebo: -28.7 %.
The effectiveness of Fycompa® is based off of three
phase III studies. The studies showed that Fycompa®
greatly reduced seizure frequency in patients with
partial-onset seizures with or without secondary
generalized seizures.
The most common adverse effects seen with
Fycompa® during clinical trials were dizziness,
sleepiness, tiredness, irritability, falls, nausea,
problems with muscle coordination, problems walking
normally, vertigo, and weight gain. Serious or lifethreatening psychiatric problems were also seen
more frequently in patients treated with Fycompa®.
The recommended starting dosage of Fycompa® is
2mg taken once daily before bedtime. The dosage
can be increased by 2mg per day increments no
more frequently than once every week to a dose of
4mg to 8mg once daily, taken before bedtime. In
elderly patients, dosage increases during titration
are recommended no more frequently than once
every two weeks.
The recommended dosage
range is 8mg to 12mg once daily. A dose of 12mg
once daily resulted in somewhat greater reductions
in seizure rates than the 8mg once daily dose, but
with a substantial increase in adverse reactions. The
product is available in 2mg, 4mg, 8mg, and 12mg
strengths.
For more information, visit www.fda.gov.
The most common adverse effects associated with
Oxtellar XR® are dizziness, somnolence, headache,
balance disorder, tremor, vomiting, diplopia, asthenia,
and fatigue.
The recommended dosage of Oxtellar XR® is
1200mg to 2400mg once daily for adults, and 900mg
to 1800mg once daily for children 6 to 17 years of
age, depending on weight. The product is available
in 150mg, 300mg, and 600mg extended-release
tablets.
For more information, visit www.fda.gov.
FYCOMPA®
(perampanel)
In October of 2012, the FDA approved Fycompa®,
a once-daily oral medication used as an adjunctive
treatment for partial-onset seizures with or without
secondarily generalized seizures in patients with
epilepsy ages 12 and older. Fycompa® is also the
first FDA-approved non-competitive AMPA glutamate
receptor antagonist.
19
6 4 5 K o l t e r D r i v e • I n d i a n a , PA • 8 0 0 . 8 8 2 . 6 3 3 7 • w w w. d i a m o n d p h a r m a c y. c o m

now - Diamond Pharmacy Services

Transcription

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