First Digital Pill Approved By The FDA

Transcription

IN THIS ISSUE
• Proper Disposal Of Used
Fentanyl Patches
• Seasonal Influenza Vaccination
2012-2013 UPDATE
• New Drug Updates
Sleep Problems
Increase Risk For
Alzheimer’s Disease
How To Choose The
Right Vitamin D Test
Berries May Prevent
Memory Loss
Find ‘Diamond Pharmacy
Services’ on Facebook
VOLUME 9, ISSUE 4, 2012
A Diamond Pharmacy Services Publication
http://www.diamondpharmacy.com
First
Digital Pill
Approved
By The
FDA
In This Issue:
Page 4
Design Staff
Steven 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]
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in this Diamond publication, please
contact our Marketing Department
[email protected]
Diamond Pharmacy Services
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Indiana, PA 15701-3570
www.diamondpharmacy.com
1.800.882.6337
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Page 16
Page 10
Page 8
Editorial Staff
Editor: Eric Pash, R.Ph.
Associate Editors:
Denise Zahorchak, R.Ph.,
Courtney Adams
Issue 4, 2012
Clinical Briefs:
Sunlight Could Help Nighttime Wandering In Patients
With Alzheimer’s Disease
Clinical Briefs:
Sleep Problems Increase Risk For Alzheimer’s Disease
Disease Management:
How To Choose The Right Vitamin D Test
Med Supply Corner:
Diamond Joins National Health Initiative To Combat
COPD
Keeping It Safe:
Proper Disposal Of Used Fentanyl Patches
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.
Page 14
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Public Health Watch:
Seasonal Influenza Vaccination
2012-2013 UPDATE
17
Diamond Makes A Difference:
Diamond Holds 8th Annual Educational
Conference
In The News:
First Digital Pill Approved By The FDA
18
- Diamond Employees Participate In 5K
Love Of Life
- Fundraiser Updates
Adverse Drug Watch:
Ampyra® (dalfampridine) Associated With
Increased Seizure Risk
15
Adverse Drug Watch:
Sulfonylureas And Increased Mortality Risk
Vs. Metformin
16
Diamond Hosts DEA Take-Back Day
20
23
New And Noteworthy:
New Drug Updates
Health And Nutrition:
Berries May Prevent Memory Loss
Sleep Problems Increase Risk
For Alzheimer’s Disease
Sunlight Could Help Nighttime
Wandering In Patients With
Alzheimer’s Disease
DIAMOND PHARMACY SERVICES
A
A new treatment could be on the horizon to aid
patients suffering from circadian rhythm reversal
and nighttime wanderings. Researchers have
gathered information demonstrating that
patients with Alzheimer’s disease and related
dementias experience lower light levels on
a daily basis compared to healthy people.
These lower light levels may contribute to
lower activity levels throughout the day,
leading to drowsiness and frequent napping.
This discovery has caused researchers to
lean towards a new treatment strategy of light
therapy. It is proposed that perhaps patients
need to spend more time outdoors in order to
increase sun exposure from at least 15 minutes
to several hours per day, which would help
to increase daytime stimulation and improve
sleep throughout the night. Researchers also
state that patients could possibly benefit from
4
Issue 4, 2012
N
ew advancements are beginning to show
that there may be a link between sleep
problems and the risk for developing Alzheimer’s
disease later in life. According to the studies
conducted, people will need to find a balance
between too much sleep and too little sleep, as
both can increase the risk of cognitive decline
and eventually the development of Alzheimer’s.
The Nurses’ Health Study showed that in 70
year old female participants, those that received
just the right amount of sleep (seven hours a
day) had the highest scores on their cognitive
assessments. Participants that received five
hours or less and those that received nine or
more hours of sleep scored lower. The reported
score deficits correlated with the cognitive
decline occurring within two years for this age
group.
Brittany Bonneau, Pharm D Candidate 2013
s people age, they tend to sleep less and
accumulate sleep problems. This is very
true of patients with Alzheimer’s disease. Over
time, Alzheimer’s patients actually experience
a reversal of their circadian rhythm, causing
them to sleep more during the day while being
awake and restless throughout the night. Due
to this reversal, patients may become bored or
restless, which may lead to nighttime wandering
and the endangerment of the patient.
sitting in front of a blue LED light box for a
prescribed amount of time each day. Hopefully
over the next few years more studies will be
conducted to test whether or not light therapy
is as a beneficial to Alzheimer’s patients as
researchers are proposing.
References:
1. Alzheimer’s Disease and Sleep. National Sleep Foundation. http://
www.sleepfoundation.org/article/sleep-topics/alzheimers-disease-andsleep. Accessed: 20 September 2012.
2. Alzheimer’s: Managing Sleep Problems. Mayo Clinic. 4 November
2011. http://www.mayoclinic.com/health/alzheimers/AZ00030. Accessed:
20 September 2012.
3. Everyday Life with Alzheimer’s Disease – Wandering. Alzheimer’s
Disease Research. 10 January 2012. http://www.ahaf.org/alzheimers/
livingwith/everydaylife.html#wander. Accessed: 20 September 2012.
4. Sunlight treatment could help nighttime wandering in people with
Alzheimer’s. McKnight’s Long-Term Care News & Assisted Living. 27 July
2012. http://www.mcknights.com/sunlight-treatment-could-help-nighttimewandering-in-people-with-alzheimers-study-suggests/article/252101/.
Accessed: 20 September 2012.
A second study was conducted that monitored
older female patients with sleep-disordered
breathing for up to 20 years. The study leader,
Kristine Yaffe, MD, concluded that patients with
sleep-disordered breathing, increased oxygen
desaturation, or high percentages of time spent
in apnea or hypopnea were at double the risk
for eventually being diagnosed with cognitive
impairment and even dementia.
A third study conducted in France followed
almost 5,000 patients 65 years of age or older for
10 years. The patients were questioned about
their sleep issues such as trouble falling asleep,
staying asleep, and if they felt sleepy during the
day. The patients also had to complete the MiniMental State Examination in order to have their
cognitive ability measured. Results show that
cognitive decline may correlate with specific
sleep issues. The highest cognitive decline was
demonstrated in patients that suffered from
frequent sleepiness during the day, although it
was not stated whether or not the patient also
suffered sleep problems at night.
Overall, there appears to be a correlation
between sleep problems and cognitive decline,
but an absolute statement of cause cannot be
drawn. The data collected from these studies
was obtained so from mostly or all female
subjects, so the results do not truly exemplify
the overall population. However, since all
three studies still came to roughly the same
conclusion, the correlations are probably worth
looking into in order to further the research
and understanding of how Alzheimer’s disease
may develop. Perhaps these findings will lead
to sleep and circadian rhythm-based methods
for reducing a patient’s risk for developing
Alzheimer’s disease.
References:
1. Bad Sleep Tied to Cognitive Decline. Med Page Today. 19 July 2012.
http://www.medpagetoday.com/MeetingCoverage/AAIC/33820. Accessed
19 September 2012.
2. Sleep Problems Up Risk of Alzheimer’s Says Study. ALFA. 24 July
2012.
http://www.alfa.org/News/2618/Sleep-Problems-Up-Risk-of-AlzheimersSays-Study. Accessed 19 September 2012.
3. Sleep Problems Appear to Raise Alzheimer’s Risk. Psychiatric News
Alert. 17 July 2012.
http://alert.psychiatricnews.org/2012/07/sleep-problems-appear-to-raise.
html. Accessed 19 September 2012.
5
How To Choose The Right
Vitamin D Test
Lauren Lichtenfels, Pharm D Candidate 2014
V
itamin D is essential in the management of
calcium and phosphate levels in the blood,
permitting normal bone formation, assisting
in osteoblast and osteoclast growth, and
remodeling. In the event of vitamin D deficiency,
the mineral levels in the blood may also be
deficient, causing the bones to release stores
of calcium and phosphate to compensate,
consequently resulting in the bones becoming
thin, soft, or misshapen, as seen in children
with rickets or the elderly having osteoporosis.
On the other hand, excessive vitamin D in the
blood can lead to calcification of blood vessels
and tissues. Vitamin D also partly serves in
the modulation of cell growth, proliferation,
and differentiation, as well as playing roles in
inflammation reduction among other immune
functions. For this reason, vitamin D deficiency
is currently being researched for its implication
in cancer causation. This is the basis for Vitamin
D supplementation being studied for its role in
the possible prevention and treatment of cancer.
Vitamin D exists in two forms: D2, or
ergocalciferol, which may be obtained only
exogenously through plant sources, fish oils,
and supplementation, and D3, or cholecalciferol,
which may be endogenously synthesized in
the skin upon exposure to ultraviolet sunlight
or exogenously through animal sources and
supplementation. D3 is generally the preferred
6
Issue 4, 2012
choice because it prolongs blood levels of
vitamin D versus D2, although both may be
used for supplementation. Vitamin D, a fat
soluble vitamin, is absorbed from the intestines
as biologically inert vitamin D2 or D3. Before it
can be used by the body, it must undergo two
hydroxylations to be converted to its active form,
the first of which occurs in the liver to make
precursor 25-hydroxyvitamin D, or calcidiol
(which chiefly circulates through the blood),
while the second hydroxylation occurs primarily
in the kidneys, releasing the active form 1,
25-dihydroxyvitamin D, or calcitriol.
With this knowledge, when faced with the
choice between 25-hydroxyvitamin D and
1,25-dihydroxyvitamin D tests, most doctors opt
for the latter to measure the amount of active
vitamin D. However, this may not always be the
best choice.
Administered
via
blood
test,
1,
25-dihydroxyvitamin D is a radioimmunoassay
that is both difficult and expensive to complete
and requires two to four days to process the
results. The reference range is between 15-75
ng/mL. 1, 25-dihydroxyvitamin D test should
only be used in certain situations, such as
in suspected hypervitaminosis D (excessive
vitamin D) or vitamin D toxicity. This is a
relatively rare occurrence and generally is only
seen in patients who are prescribed vitamin D
therapy. Symptoms are generally nonspecific
including polyuria, anorexia, weight loss,
and heart arrhythmias. When vitamin D is
elevated, calcium levels can also be elevated or
potentially dangerous hypercalcemia can occur,
which could cause damage to the kidneys,
heart, and blood vessels. If hypercalcemia is
suspected, a 1, 25-dihydroxyvitamin D test
could be ordered. Other situations in which
a 1, 25-dihydroxyvitamin D test would be
appropriate is in suspected sarcoidosis or in
forms of lymphoma, two conditions that could
cause excess vitamin D. In some cases, a 1,
25-dihydroxyvitamin D test may be ordered to
monitor 1-alphahydroxylase abnormalities or
problems with the parathyroid, as vitamin D is
required for both the function of both. All of these
conditions would demonstrate higher results.
On the other hand, this test could be used to
test for kidney failure. The kidney’s inability to
perform the second hydroxylation would deplete
the amount of 1, 25-dihydroxyvitamin D in the
blood and produce low results.
1, 25-dihydroxyvitamin D should not be used
to measure suspected vitamin D deficiency. In
a vitamin D deficient patient, the parathyroid
hormone actually drives the production of 1,
25-dihydroxyvitamin D, which increases the
concentration in the blood, thus giving misleading
results when tested. 1, 25-dihydroxyvitamin
D only becomes significantly decreased in
individuals that are severely vitamin D deficient,
because all substrate needed to convert to the
active form has been depleted. Results may
also be skewed because 1, 25-dihydroxyvitamin
D is generated intracellularly as an immune
response, such as to suppress the cancer cell
proliferation or to ward off tuberculosis infection.
Therefore, the 25-hydroxyvitamin D test is the
most accurate way to measure the amount of
vitamin D in the body and should be the go-to test
for vitamin D deficiency; in fact, some doctors
will not prescribe medications for osteoporosis
unless this test is completed. The amount of
25-hydroxyvitamin D in the blood reflects the
vitamin D received from either endogenous
or exogenous sources. With a longer half-life
than 1, 25-dihydroxyvitamin D that makes it
more useful for assessment, 25-hydroxyvitamin
D is the predominant form that circulates
through the blood. Administered via blood test,
25-hydroxyvitamin D test is a chemiluminescent
immunoassay, and results can be produced
within 24 hours. The reference range is 30 to 57
ng/mL; readings below 20 ng/mL are indicative
of deficiency in both children and adults.
Gathering evidence supports that vitamin D
deficiency is more common than previously
thought. Vitamin D deficiency can stem from
inadequate dietary vitamin D intake, lack
of sunlight exposure, diseases of the liver
and kidney, poor intestinal absorption, and
the use of certain medications such as antiseizure drugs. With that in mind, susceptible
populations
include
infants
exclusively
breastfed, the elderly, housebound individuals,
populations having darker skin, those with fat
malabsorption diseases, obese patients, and
those who have had gastric bypass surgery.
Severe cases of vitamin D deficiency presents
as bone weakness, softness, and deformation
as Ricketts in children and osteomalacia or
osteoporosis in adults.
Overall, the 1, 25-dihydroxyvitamin D test is
harder to complete, takes longer to process,
costs more, and is less accurate than the
25-hydroxyvitamin D test when testing for
vitamin D deficiency, though it may be more
effective for other vitamin D-related pathologies.
Generally, 25-hydroxyvitamin D test should
be used more often than its counterpart, due
to the higher incidence of deficiency versus
the relatively rare hypervitaminosis. However,
when faced with which vitamin D test to select,
first decide whether too little or too much is the
issue, whereupon it will be apparent whether
1,25-dihydroxyvitamin D is the test to be used
or not.
References:
1. “25-Hydroxy Vitamin D Test.” MedlinePlus. 13 Aug 2010.
Accessed at www.nlm.nih.gov.
2. Ott, Susan. “Vitamin D.” University of Washington. 30 Aug
2011. Accessed at http://courses.washington.edu.
3. “Vitamin D, 1,25-Dihydroxy and Vitamin D, 25-Hydroxy.” ARUP
Laboratories. May 2011. Accessed at www.aruplab.com.
4. “Vitamin D, 25-Hydroxy, LC/MS/MS.” Quest Diagnostics. 2012.
Accessed at www.questdiagnostics.com.
5. “Vitamin D.” Lab Tests Online. 15 May 2012. Accessed at
www.labtestsonline.org.
6. “Vitamin D.” NIH Office of Dietary Supplements. 24 Jun 2011.
Accessed at http://ods.od.nih.gov.
7
Diamond Joins National Health
Initiative To Combat COPD
Judy Tomayko, RRT
Proper Disposal Of Used
Fentanyl Patches
I
n celebrating Respiratory Care Week October 21-27,
Diamond Drugs, Inc. has joined DRIVE4COPD to
help find the “Missing Millions.”
Diamond has partnered with DRIVE4COPD, a national
health initiative that aims to raise awareness of and
promotes screening of risk factors for developing
COPD, a disease that kills one person every four
minutes in the U.S. COPD stands for chronic obstructive
pulmonary disease and can include chronic bronchitis,
emphysema, or both. COPD gradually robs people of
their ability to breathe.
It is estimated that half of the 24 million people in
the United States who may have COPD remain
undiagnosed. Because many of the symptoms,
including shortness of breath, are confused with normal
signs of aging, many people delay seeing a healthcare
professional for proper diagnosis. By the time patients
do become diagnosed, most have already lost more
than 50% of their lung function.
Over time, COPD impacts a person’s ability to breathe
and, by extension, the ability to live his or her life.
It’s important for people to know if they have COPD
so that they can take steps to help manage it. That’s
why we’ve joined DRIVE4COPD. If you are a current
or former smoker and age 35 or older, you may be at
risk for developing COPD. Our respiratory therapists
encourage individuals to take a brief, five-question
screener at DRIVE4COPD.ORG. This screening can
heighten awareness of their risks for developing COPD
and provides printable results that can be shared
with one’s healthcare professional. It’s important
to diagnose COPD as soon as possible, as this is a
progressive disease. Once lung function is lost, it
cannot be regained.
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Issue 4, 2012
The following are some noteworthy COPD statistics:
• COPD may affect as many as 24 million Americans,
but half of them don’t know they have it.
• Smoking just 100 cigarettes in a lifetime puts people
at risk, even those who stopped smoking years ago.
• COPD kills one person every four minutes in the
U.S., which is more than breast cancer and diabetes
combined.
• COPD is the only leading cause of death in the U.S.
that is on the rise.
• Most people are not diagnosed with COPD until they
have lost half or more of their lung function.
Through education and screening, Diamond aims to
help our employees and their families recognize the
symptoms early on and encourages them to talk to their
healthcare professional before critical lung function
has been lost. Our respiratory therapists at Diamond
Medical Supply have successfully completed a course
offered by the American Association of Respiratory
Care and are Certified COPD Educators.
COPD education is an area of expanding opportunities,
and with a growing COPD population, it is important
to discuss issues with patients. Through this course,
our therapists are knowledgeable about diagnosis,
assessment, treatment, oxygen therapy, medication,
and disease management, as well as how to educate
patients about COPD and motivate them to control it.
For more information about the DRIVE4COPD
program, please contact our Certified COPD
Educators at Diamond Medical Supply Respiratory
Department at 1-888-520-2500 or via email to RRT@
diamondpharmacy.com.
Chuck Plazio, Account Executive, Assisted Living Facilities
T
he number of fentanyl-related deaths has
risen significantly over the past several
years. Fentanyl is 80 times stronger than
morphine and has made its mark in the illegal
drug market. Many people are injecting or
drinking the medication from fentanyl patches,
causing accidental overdoses. More disturbing
is the fact that there have been many confirmed
accidental deaths in children who have visited
a long-term care or skilled facility.
In one case, a six year old child was found
unconscious several hours after visiting a
relative in a facility. The child was taken to the
emergency room where they found what they
thought was a piece of “tape” in the back of
his throat. Toxicology confirmed it was a used
fentanyl patch. The parents claim the child
was playing with a toy truck on the floor at the
facility and picked up the patch there.
Numerous other fatal cases have been noted
from children taking discarded fentanyl patches
out of the garbage and either eating them or
applying them to themselves as Band-Aids or
stickers. In some cases, children have actually
removed the patches from sleeping residents.
As healthcare providers, we must always think
of the safety and well-being of not only our
patients, but that of their families and friends
who visit our facilities. Please take a moment
to review the FDA warning below and make
sure your staff follows an appropriate protocol
when managing fentanyl patches.
FDA Warning For Used Fentanyl Patches:
Used patches should be folded so that the adhesive side of the patch adheres to itself, then
the patch should be flushed down the toilet immediately upon removal. Patients should
dispose of any patches remaining from a prescription as soon as they are no longer needed.
Unused patches should be removed from their pouches, folded so that the adhesive side of
the patch adheres to itself, and flushed down the toilet.
9
Seasonal Influenza Vaccination
2012-2013 UPDATE
Your Opinion
Matters!
Deborah Yackuboskey CRNP, MSN
T
he Centers for Disease Control and Prevention
(CDC) each year makes recommendations
regarding the upcoming flu season. As in past years,
they again have determined that the most effective
way for preventing seasonal influenza virus infections
and complications is to receive the seasonal influenza
vaccination. Based upon the recommendations of
the World Health Organization (WHO), the 2012-2013
seasonal influenza vaccine contains the following
three vaccine viruses for the Northern Hemisphere:
• an A/California/7/2009 (H1N1)pdmo9-like virus;
• an A/Victoria/361/2011 (H3N2)-like virus; and
• a B/Wisconsin/1/2010-like virus (from the B/
Yamagata lineage of viruses).
Currently, there are two types of flu vaccines which are
licensed by the Food and Drug Administration (FDA)
for use in the United States: trivalent inactivated
influenza vaccine (TIV) and live, attenuated influenza
vaccine (LAIV). TIV is typically known as “the flu shot”.
It is administered intramuscularly (usually injected
into the muscle of the upper arm) and is approved
for use in people six months of age and older. It can
also be used in those with chronic medical conditions
and women who are pregnant. During the 20112012 influenza season, a new TIV product became
available which uses a microinjection system having
an ultra-fine needle that is 90% shorter than the typical
needle. This system allows for intradermal delivery
rather than intramuscular. The intradermal delivery
system is recommended for adults 18 through 64
years of age.
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Issue 4, 2012
LAIV is given as a nasal spray. This vaccine is made
with live, weakened flu viruses. Contrary to popular
belief, the viruses in the nasal spray vaccine do not
cause influenza. LAIV is approved for use in healthy
people 2-49 years of age who are not pregnant.
It is recommended that administration of the flu
vaccination begin in September (or as soon as
available) and continue throughout the flu season.
The height of flu season usually is during the months
of January and February. Antibodies to protect
against seasonal influenza virus infection take about
two weeks to develop after receiving the flu vaccine.
Precautions to protect yourself from exposure to
seasonal influenza viruses should be taken while
antibodies are developing.
Seasonal influenza vaccines do have some risks
associated. However, serious side effects upon
receiving the vaccine are rare. The most frequent
adverse events reported in children and adults who are
administered the TIV include pain and other injectionsite reactions. Fever, malaise, and other systemic
reactions that can occur most often affect persons
who have had no previous exposure to the vaccine.
The most common adverse effects noted with use of
the LAIV are runny nose or nasal congestion in all
age groups, fever >100ºF in children 2-6 years of age,
and sore throats in adults.
It is the recommendation of the CDC that everyone
six months and older receive a seasonal influenza
vaccine each year. Additional information regarding
the flu vaccine or flu may be accessed at www.cdc.
gov/flu.
At Diamond Pharmacy, your feedback is very important
to us as we strive to provide our customers with the best
possible experience in customer service. Please take a
few moments to fill out our survey provided to you in your
next order.
Fill out our survey online
today!
http://www.surveymonkey.com/s/
dps_customer_satisfaction_survey
Courtney Adams, Administration
T
First
Digital
Pill
Approved
By The
FDA
12
Issue 4, 2012
he FDA recently approved a “smart pill”
created by Proteus Digital Health. The
device is a small silicon chip, no larger than
a grain of sand, and contains small amounts
of copper and magnesium. The chip has no
battery and is powered solely by the human
body. After ingestion, the chip will interact
with digestive fluids producing voltage that
can be read via a detector patch placed on the
skin. Once the voltage reaches the detector
patch, it sends a signal to the respective
prescriber’s mobile phone to alert him/her
that the pill has been taken. Physicians
are then able to monitor heart rate and
amount of physical activity to better assist
in determining whether therapy is working,
needs adjusted, or should be discontinued.
“People live busy and complex lives, and as
a result
often don’t take their medicines correctly,”
stated Andrew Thompson, co-founder and
CEO of Proteus. “We wanted to develop
a solution that would help make existing
medicines more effective in real life.”
Currently, Proteus is working with the
manufacturers of metformin, a diabetes
medication, which is the most prescribed
drug in the world. Eventually, they would
like to add a wireless glucose monitor to
their device and also work on digitalizing
medications used to treat neurological
disorders.
“We are thrilled to have achieved this
important milestone to market our ingestible
sensor in the United States now, as well as in
Europe,” commented Dr. George M. Savage,
co-founder and Chief Medical Officer of
Proteus. “We are very much looking
forward to bringing the benefits of
our ingestible sensor to the
American public in the
form of innovative
product offerings.”
References:
1. Forbes
2. CBS News
13
Sulfonylureas And Increased
Mortality Risk Vs. Metformin
Ampyra (dalfampridine) Associated
With Increased Seizure Risk
®
mpyra® is an FDA-approved medication
indicated to improve walking speed in
multiple sclerosis patients. Ampyra® is a
broad spectrum potassium channel blocker
which has been shown to increase the
conduction of action potentials via inhibition
of potassium channels in animal studies.
A
Recently, a new FDA warning was issued
stating that Ampyra® has an increased
seizure risk in those patients starting
the medication. Also, patients who have
experienced seizures had no past history
of seizures. Seizures are already a known
adverse effect for Ampyra®, but evidence is
demonstrating that the majority of seizures
are occurring days to weeks
upon starting therapy and in
patients that have no record
of past seizures. Due to
this seizure risk, patients
with a history
of seizures should not receive Ampyra®. Also,
patients having reduced renal function (CrCl
50 mL/min or less) should not use Ampyra®
due to drug concentrations reaching too high
of levels and thereby increasing seizure
risk in these patients. Patients should be
instructed to not double up on doses if a prior
dose is missed, due to an increased seizure
risk. Patients are also being advised to stop
taking Ampyra® and to contact their doctor if
they experience a seizure while taking the
medication.
References:
1. Ampyra® package insert. DailyMed, July 2012. Accessed
20 August 2012. http://dailymed.nlm.nih.gov/dailymed/
lookup.cfm?setid=550eb76a-e4a6-4fa1-ad65-c0fd8b0ce783.
2. FDA Drug Safety Communication: Seizure risk for multiple
sclerosis patients who take Ampyra® (dalfampridine). US
Food and Drug Administration, 23 July 2012. Accessed
20 August 2012. http://www.fda.gov/Drugs/DrugSafety/
ucm312846.htm.
One out of every five health care dollars
is spent caring for someone diagnosed
with diabetes, while one in 10 health care
dollars is attributed directly to diabetes.
retrospective
cohort
study
analyzing
electronic health records from outpatient
clinics found an increased risk of mortality in
patients taking sulfonylureas versus metformin
in a population of patients with type 2 diabetes.
While biguanide metformin (Glucophage®) is
generally the preferred first-line type 2 diabetes
drug therapy treatment, sulfonylureas such as
glyburide (DiaBeta®), glimepiride (Amaryl®), or
glipizide (Glucotrol®) are considered secondline treatment if desired goals are not met with
metformin. Sulfonylureas act on pancreatic betacells, stimulating insulin release by inhibiting the
ATP-sensitive potassium channels on the betacell’s membrane closing the potassium channels
and opening calcium channels, which allows
the entry of calcium and the secretion of insulin.
Simultaneously, sulfonylureas sensitize peripheral
tissues to the released insulin through an outside
pancreatic mechanism. Sulfonylureas were
previously thought to demonstrate similar safety
and efficacy as metformin.
A
(4,325), glyburide (4,279), and lastly glimepiride
(2,537). The Social Security Death Index verified
2,546 patient deaths of the records analyzed. In
comparison to metformin, glipizide demonstrated
a 64% mortality increase, while glyburide ranked
lowest at 59% and glimepiride the highest at 68%,
combining for an overall 1.50 mortality hazard
ratio versus metformin.
Researchers also analyzed a subgroup of patients
with coronary artery disease (CAD) due to recent
concerns surrounding sulfonylureas and possible
risk in cardiac patients. Of the 2,721 records
produced, the Social Security Death Index
verified 419 deaths. Compared to metformin,
glyburide was associated with a 38% increase in
mortality, while glipizide notched 41%. However,
the risk with glimepiride was negligible compared
to metformin. These results suggest that in type
2 diabetic patients with known CAD, glimepiride
is the safest sulfonylurea choice if second-line
antidiabetic drug therapy is required.
This study, spearheaded by Dr. Kevin Pantalone,
DO, of Western Reserve Hospital in Cuyahoga
Falls, Ohio, looked at patients from the Cleveland
Clinic involved in monotherapy treatment for type 2
diabetes, excluding those on multiple antidiabetic
drug regimens, as well as those using insulin or
other injectable diabetes medications. Cost did not
factor in due to availability of relatively inexpensive
generics. Of the 23,915 patients
fitting the criteria, over half were
taking metformin (12,774),
followed by glipizide
The results of this study were presented at a
meeting of the Endocrine Society in Houston,
Texas, on June 25, 2012, and have yet to be
published in a peer-reviewed medical journal.
References:
1. “Drug Class Overview: Sulfonylureas.” Clinical Pharmacology. 2012. Accessed at http://
clincalpharmacology.com.
2. “Drugs for Type 2 Diabetes.” The Medical Letter. Issue 108. Published 1 Aug 2011.
Updated 3 Mar 2012. P 47.
3. “Glimepiride.” Micromedex. 2012. Accessed at www.thomashc.com.
4. “Glipizide.” Micromedex. 2012. Accessed at www.thomashc.com.
5. “Glyburide.” Micromedex. 2012. Accessed at www.thomashc.com.
6. Pantalone, Kevin M, and et al. “Increased Risk of Overall Mortality in Patients with Type
2 Diabetes Receiving Glipizide, Glyburide, and Glimepiride vs. Metformin. A Retrospective
Analysis.”
7. “Sulfonylureas Increase Mortality by 50 Percent.” DiabetesInControl.com. 29 Jun 2012.
Accessed at www.diabetesincontrol.com.
8. Weiss, Daniel. “Sulfonylureas Associated with Increased Risk of Death.” Pharmacy
Times. 10 July 2012. Accessed at www.pharmacytimes.com.
Source: American Diabetes Association
14
Issue 4, 2012
15
we intend to continue to participate in,“ stated Joan
Zilner, owner and president of Diamond Drugs, Inc.
The DEA holds this program twice a year in order
to provide a means for convenient and proper
Diamond Hosts DEA Take-Back Day
disposal for the American people. This is the first
time Diamond has participated in the national
event, and the response received indicates that
there is a true need for programs of this nature.
Diamond Holds 8th Annual
Educational Conference
Rachael Houllion, Administration
ON LEFT: A portion of the
56.57 pounds of medication
collected from the Indiana,
PA community
ON RIGHT: Sheriff Robert
Fyock taking custody of any
unwanted and/or expired
medications
O
n Saturday, September 29, Diamond’s retail
pharmacy located at 670 Philadelphia Street
in Indiana, PA, served as a drop-off location for
the DEA’s Fifth National Prescription Drug TakeBack Day. Robert Fyock, Indiana County Sheriff,
was there to take custody of any unwanted and/
or expired medications, and Courtney Hankinson,
Prevention Specialist with the Armstrong, Indiana,
and Clarion Drug and Alcohol Commission, was
there to provide literature and educate about the
harmful effects of drug misuse.
“We are proud to partner with local law enforcement
and the local drug and alcohol commission to help
educate and bring awareness to an issue we all
feel very strongly about. Diamond is thrilled about
what was achieved today, and we are committed to
helping to make a difference within our community
through this and similar programs,” commented
Eric Pash, pharmacy manager at Diamond’s 670
Philadelphia Street store and host of the day’s
event.
16
Issue 4, 2012
During the four hour event, Diamond collected
56.57 pounds of medications from the community,
which was then added to make an overall Indiana
County total of 93 pounds. Nationwide, 244 tons
of medications were collected on September 29.
The DEA started this free, anonymous service two
years ago, as they recognized that prescription
drug abuse was on the rise due to how easily
accessible these medications are on the market.
In 2011, the Substance Abuse and Mental Health
Services Administration’s National Survey on Drug
Use and Health (NSDUH) reported that over six
million Americans misuse prescription drugs,
and more than 70% of those had received the
medications from family or friends.
“Diamond is pleased to have participated in the
DEA Take-Back Day. We received 56.57 pounds
of drugs that will not be left in medicine cabinets
for children to have access to or to be flushed into
our water system. This is a worthwhile cause that
O
n Wednesday, October 17, 2012 our
Educational Conference planning committee
held a Hawaiian Luau-themed seminar for
attendees at the Kovalchick Convention and
Athletic Complex in Indiana, PA as part of its 8th
Annual Educational Conference. Along with the
Association of Personal Care Administrators
(APCA) and AseraCare Hospice, Diamond
Pharmacy sponsored a Personal Care (PC)
Home administrator and staff conference in
conjunction with a Skilled Nursing Facility (SNF)
staff conference. Overall, we had 99 attendees at
this year’s event: 78 representing PC and 21 SNF
participants.
Diagnosed Eye Disorders, and Eric Pash, R.Ph. of
Diamond, discussed Coronary Heart Disease and
High Cholesterol.
PC administrators were offered six continuing
education (CE) credits. There was a three-hour
class on the Occupational Safety and Health
Administration (OSHA)’s Consulting Program in
Pennsylvania, presented by Bryan Brougher, CSP
Consultant. There were three additional one-hour
sessions offered: Wendy Faust, RN, PTR from
AseraCare, reviewed Hydration and Nutrition,
Diamond’s Debbie Yackuboskey, CRNP, MSN,
RN Consultant, gave a presentation on Commonly
Diamond would like to thank all of our guests
and sponsors who participated; without you the
conference would have not been a success. We
hope that you enjoyed this year’s event and that
it was worthwhile. We would also like to thank all
the Diamond employees who worked effortlessly
to make this year’s conference once again a
success. We look forward to seeing you again
next year!
SNF staff attendees also had the opportunity
to earn six CE credits. Jarrod Deavor, PTR and
Heather Malay, RN from AseraCare, moderated a
one-hour class on Hydration and Nutrition and a
one-hour class on Understanding Burnout for the
RN. Trina Plazio, RN CRNI and Steve Jablunovsky,
RN CRNI, both of Diamond, reviewed current IV
practice guidelines in a four-hour course entitled
Advanced IV Therapy for the RN: A Review of the
Revised INS Standards of Practice 2011.
Diamond would like to extend a special thank you to the
participating vendors in attendance:
•Amgen
•Boehringer Ingelheim
•Cubist
•Healthpoint
•Novartis
•Covidien
•Philips Respironics
•Optimer
•AseraCare Hospice
•Biocodex USA
17
Diamond Employees Participate
In 5K Love Of Life
Nick McFerron, Marketing
A total of 397 runners and walkers
participated this year, helping to raise
an estimated $10,000. The participants
consisted of current and surviving
patients of breast cancer as well as
their friends and family, and anyone
who is interested in helping to raise
money. One very notable participant
was a ninety year old man who
successfully completed the race. The
event organizers are very proud of the
turnout this year and they look towards
the future for many more successful
Love Of Life 5Ks.
We are pleased to announce that
Diamond employees Chuck Schiefer,
Eric Pash, Timmy Welsh, Lisa
Berezansky, Joseph Kennedy, Tammy
e
Ag
on
nin
w
Congratulations to all who participated in the event and
thanks for helping in the fight against breast cancer!
D
Conroy, Diane Bell, Rebecca Fetzer, Jill Conrad, Angel
Claypool, Becky Pfronger, Brianna Greene, Angela
McAfoose, and Michelle Kishlock all completed the
run/walk.
The
O
n October 13th, several of Diamond’s employees
participated in the 2nd annual Love Of Life 5K
Run/Walk. This event was in effort to raise money
for the fight against breast cancer. The proceeds for
the event went to the IRMC M. Dorcas Clark, MD,
Women’s Imaging Center and will help to advance
mammography care to all women in the area.
TM
gO
e
N
fA
The Doff N’ Donner is used to help
put on or take off compression
garments easily and without
complications. Some of its benefits
include:
Only
$36.35
*Prices subject to change
• The ability to put a garment on
over any size or shape of leg.
• Safe and effortless removal of
garment increases longevity
by limiting wear and tear.
*Diamond employees with family and friends at 5K Love Of Life Run/Walk. Photo courtesy of Jackie Fairman.
Fundraiser Updates
• No struggle to apply garments
over legs that are wet, slippery
with lotion, or bandaged.
• Plus MORE!
Product #2BDOFDON
Steve Heidenthal, Marketing
D
iamond Pharmacy’s Relay For Life team has been
busy once again this quarter working effortlessly to
raise much needed funds to save lives against cancer.
Over the past few months, the Diamond community has
pulled together to raise over $1000 through numerous
fundraisers. These fundraisers include:
• A Sarris candy bar sale that raised over $500
• A Pie Shoppe sale that raised over $125
18
Issue 4, 2012
• A Marianna’s Hoagie and Pizza sale that brought
in over $440
Diamond’s Relay For Life team will continue to work to
raise money for this great cause. Our annual basket
raffle will take place in December, and we anticipate
tremendous results. Thanks to everyone who has
been so generous to help in the fight against cancer.
Available Through
639 Kolter Drive
Indiana, PA, 15701
1.888.520.2500
www.diamondpharmacy.com
19
limitation in thick and inflamed lungs, COPD is a common
respiratory disease that is progressive and debilitating in
nature. With 90% of cases caused by tobacco smoke, COPD
affects 64 million people worldwide and is responsible for
over three million deaths each year. While it is already the
third leading cause of death in the United States, COPD is
expected to be the third leading cause of death worldwide
by 2030.
NEW DRUG UPDATES
TUDORZA
Figure 1
®
(aclidinium)
Following a three-month delay in approval, international
pharmaceutical manufacturer and marketer Forest
Laboratories, Inc. and the Spain-based pharmaceutical
innovator Almirall, announced on July 23, 2012, the FDA
approval of the product aclidinium bromide, marketed
as Tudorza® Pressair®. Tudorza® is a novel, easy-touse, multidose dry powder inhaler (MDPI) indicated for
the maintenance treatment of bronchospasms related to
chronic obstructive pulmonary disease (COPD), including
both emphysema and chronic bronchitis. Tudorza® is not
indicated for acute bronchospasms and should not be used
as a rescue inhaler.
Tudorza® is a long-acting muscarinic receptor antagonist,
highly selective at M3 receptors and weakly selective at
M2 receptors, that mediates bronchodilation by preventing
airway smooth muscle contraction when inhaled in patients
suffering from COPD. Increased residence time at the M3
receptor allows convenient dosing of one inhalation of
400 mcg twice daily, a retreat from multiple times a day
dosing from rival product and COPD standard ipratropium
bromide. Ipratropium bromide (marketed as Atrovent® or in
combination with salbutamol as Combivent® by Boehringer
Ingelheim) and tiotropium bromide (jointly marketed by
Boehringer Ingelheim and Pfizer as Spiriva®) are currently
the only other two anticholinergic agents available on the
market for COPD, and although Tudorza® is in the same
long-acting class as Spiriva®, both products work by different
mechanisms. A combination product containing aclidinium
and the long-acting beta-agonist, formoterol, is also presently
being studied.
The innovative Pressair® DPI design is made for ease-ofuse administration as well as optimal patient safety. After
removing the cap and pressing and releasing the green
button, the colored control window shows green whenever
20
Issue 4, 2012
a dose is ready to be inhaled (see figure 1). Completely
breathing out and then placing lips around the mouthpiece, a
clicking mechanism signifies completion of an inhaled dose
and the colored control window shifts to red. A dose indicator
reminds a patient how many of the 60 available doses per
inhaler remain. When all doses are completed and the dose
indicator reads “0,” a built-in end-of-dose lock prevents
further use and the inhaler should be discarded. Pressair®
is only good for 45 days once it has been removed from its
sealed packaging.
The most common side effects associated with Tudorza®
include cold-like symptoms such as cough, headache, and
nasopharyngitis. Development or worsening of narrowangle glaucoma or urinary retention may also occur with
the use of Tudorza® and should be monitored. Tudorza®
should be used with caution in patients having severe
hypersensitivity to milk protein, as the aclidinium bromide
is distributed in a lactose monohydrate carrier. In case of
paradoxical bronchospasm which may occur with the use
of inhaled medications, Tudorza® should be discontinued
and alternative treatments considered. Because COPD is a
progressive disease, it does not often occur in children, and
thus Tudorza® has not been studied in pediatric populations.
Characterized by shortness of breath, wheezing, chronic
cough, and increased sputum production resultant of airflow
MYRBETRIQ®
(mirabegron extended-release)
Myrbetriq® is new FDA-approved medication that is
manufactured by Astellas Pharma Inc. Myrbetriq® is
indicated for the treatment of overactive bladder when the
symptoms of urge urinary incontinence, urgency, and urinary
frequency are present. These symptoms cause patients to
feel the instant urge to urinate or to urinate without meaning
to. Patients also experience frequent urination at any time
of day.
Myrbetriq® is a beta-3 adrenergic receptor agonist that
causes the detrusor muscle to relax during urine storage and
increase storage capacity. The most common adverse effects
observed in clinical trials were hypertension, nasopharyngitis,
urinary tract infection, headache, and upper respiratory
tract infection. There are no contraindications to taking
Myrbetriq®, however warnings and precautions of increased
blood pressure and urinary retention in patients with bladder
outlet obstruction or who are taking anti-muscarinic agents
do exist. Also, Myrbetriq® is a moderate CYP2D6 inhibitor,
so increased levels of metoprolol and desipramine can be
observed. Co-administration with narrow therapeutic index
drugs such as thioridazine, flecainide, and propafenone
should be monitored and may require dosing adjustments.
Myrbetriq® is an extended-release tablet that comes in two
strengths, 25 mg and 50 mg. The daily dose is one 25 mg
tablet per day with or without food, which may be increased to
50 mg per day if the patient can tolerate. Patient populations
in renal impairment (CrCl 15-29 mL/min) and in moderate
hepatic impairment should not exceed a daily dose of
25 mg. Patients with end stage renal disease or severe
hepatic impairment should not use Myrbetriq®. Patients are
instructed to take Myrbetriq® with water and swallow the
tablet whole.
RAYOS®
(prednisone delayed-release)
Rayos® is a new FDA-approved medication manufactured
by Horizon Pharma. Rayos® is indicated to treat a wide
array of inflammatory diseases such as rheumatoid
arthritis, psoriatic arthritis, and asthma by acting as an antiinflammatory or immunosuppressive agent. In the case of
rheumatoid arthritis, patients feel joint stiffness and pain in
the joints of the wrists, fingers, knees, feet, and ankles. As
time passes, patients will lose their range of motion, and the
joints can become deformed. Patients can also experience
other symptoms such as chest pain, dry eyes and mouth,
irritated eyes, skin nodules, sleep problems, and numbness,
tingling, and burning of the hands and feet.
Rayos® is a synthetic adrenocortical steroid which acts mostly
as a corticosteroid to inhibit the inflammatory process and
end stages of wound healing. The production of eosinophils
and lymphocytes is also impaired, while erythropoiesis and
polymorphonuclear leukocyte production is stimulated. The
only contraindication listed for Rayos® is for any patients
having a history of hypersensitivity when taking prednisone.
There are numerous warnings and precautions for Rayos®
such as Cushing’s syndrome, hyperglycemia, increased risk
of infection, increased blood pressure, mood disturbances,
decreased bone density, cataracts, glaucoma, and fetal
harm. Along with these warnings and precautions, additional
adverse effects have also been observed in patients such
as anaphylaxis, cardiovascular problems, skin issues,
abnormal fat deposits, edema, electrolyte imbalance,
increased appetite, and weight gain. Due to corticosteroids
having so many metabolic effects, patients’ medications
should always be monitored due to the possibility of drug
interactions, which may require dose adjustments.
Rayos® is a delayed-release tablet that is available in three
strengths: 1mg, 2mg, and 5mg. The initial dose of Rayos®
can range between 5mg and 60mg per day, depending on the
severity of the disease treated and response of the patient.
During clinical trials, Rayos® was administered at 10pm
each evening in order to reduce nighttime inflammatory
mediators. In order to realize the full clinical effect of Rayos®,
this medication should always be taken with food. Monitoring
of blood pressure, chest x-rays, body weight, and routine lab
work is highly recommended when including Rayos® in any
treatment regimen.
References:
1. “Aclidinium Bromide.” Clinical Pharmacology. Accessed at www.clinicalpharmacology-ip.com.
2. “Aclidinium Bromide.” Micromedex 2012. Accessed at www.thomsonhc.com.
3. “Briefing Book – aclidinium bromide.” Forest Research Insititute, Inc. Accessed at www.fda.gov.
4. “Forest Laboratories and Almirall Announce FDA Approval of Tudorza® Pressair® For the LongTerm Maintenance Treatment of COPD.” Forest Laboratories, Inc. www.news.frx.com. 23 July
2012.
5. “Forest Laboratories, Inc. Reports Fiscal Year Fourth Quarter 2012 Earnings Per Share of $0.72
Including $0.06 Per Share of Acquisition Amortization.” Forest Laboratories, Inc. www.news.frx.
com. 17 April 2012.
6. Tudorza® Pressair® Prescribing Information. Accessed at www.tudorza.com.
7. “Value Through Innovation: Chronic Obstructive Pulmonary Disease.” Boehringer Ingelheim.
2012. Accessed at www.boehringer-ingelheim.com.
8. Myrbetriq® package insert. DailyMed, June 2012. Accessed 17 August 2012. http://dailymed.nlm.
nih.gov/dailymed/lookup.cfm?setid=ba9e9e15-e666-4c56-9271-2e24739cfa2d.
9. Prednisone delayed-release tablets approved for rheumatology indications. Drug Topics, 27
July 2012. http://drugtopics.modernmedicine.com/drugtopics/article/articleDetail.jsp?id=783123.
10. Rayos® [package insert]. DailyMed, August 2012.
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=281ab967-7565-4bef-9c0c-a646589c671e.
11. Rheumatoid Arthritis. PubMed Health, 2 February 2012. http://www.ncbi.nlm.nih.gov/
pubmedhealth/PMH0001467/. Accessed: 13 September 2012.
21
Berries May Prevent
Memory Loss
A
ccording to a recent Nurses’ Health Study
of more than 16,000 women, consuming
berries at least once a week could prevent
age-related memory loss.
for developing memory impairment as opposed
to those who ate few to no berries. Overall,
researchers determined the difference to be
approximately two and a half years of aging.
On average, women eating berries during the
study consumed one half cup of blueberries or
two half cup servings of strawberries per week.
Researchers then measured mental functioning
by conducting three interviews with each study
participant. The interviews took place every two
years via telephone call. Researchers had the
women listen to
a paragraph and
then recall details
from what they
had just heard or
to remember the
order of words or
numbers in a list.
“This is pretty compelling evidence to suggest
that berries do appear to have memory
benefits,” stated Elizabeth E. Devore, ScD,
researcher and instructor of medicine at
Bringham and Women’s Hospital in Boston.
References:
1. WebMD
2. Huffington Post
It was found that
women who ate
more blueberries
and strawberries
had a slower rate
Alzheimer’s disease is the most common form of dementia
and the 6th leading cause of death in the United States
Source: Alzheimer’s Disease Research, www.ahaf.org/alzheimers
22
Issue 4, 2012
23
Efficient. Paperless. Smart.
For more information, please contact
a Sapphire representative today,
1.877.532.2345
or visit
www.sapphire-health.com
*For correctional facilities only

First Digital Pill Approved By The FDA

Transcription

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