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DEAR HOSPICE LEADER – IS BIGGER ALWAYS BETTER?

Drew Mihalyo, PharmD
Thursday, 16 July 2020
Delta Care Rx

Dear Hospice Leader,

Is bigger always better?

When it comes to hospice pharmacy benefit management, we believe it is NOT.

Of the two biggest hospice PBMs, one is being sold by its venture capital
backers to venture capital-owned Humana Healthcare, the insurance giant, and the
other is and always has been a minuscule component of a huge multinational
healthcare conglomerate.

We don't think the typical community-based, mission-driven hospice can be
particularly well served when such a vital component of both quality care AND
expense management—its pharmacy benefit—is in the hands of huge corporations
whose primary focus is definitely NOT hospice and end-of-life care.

As soon as the Enclara-Humana-Kindred-Curo deal closes, one of the nation's two
largest PBMs will be owned and operated by one of the nation's largest hospice
providers (Curo/Kindred @ Home). Meanwhile, Optum, the other of the nation's two
largest PBMs, will continue to be a minuscule subsidiary of the $100 billion
United HealthCare behemoth that is first and always a managed care company.

Where does your community-based hospice fit in such a world?

For those hospices with PBM relationships with Enclara, I can think of better
strategic business decisions than sharing pharmacy spend and outcomes with Curo
Health*. But call me skeptical.

And, as someone who has dealt with health insurance companies since my first day
behind a pharmacy counter as an intern, I can think of far better strategic
decisions than putting so much of my hospice's budget and reputation for quality
care in the hands of a corporate behemoth like United's Optum.

Instead, why not partner with a PBM that understands the importance and value of
your mission, is committed to disrupting the PBM sector and can guarantee to
save you money and enhance your quality of care?

To find out more, just send me a message on LinkedIn.

And... thanks for hearing me out,

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GENUINE PARTNERSHIPS ARE THE REAL REWARD

Drew Mihalyo, PharmD
Wednesday, 19 February 2020
Delta Care Rx

When Delta Care Rx was founded in 2008, one of the promises we made as a company
was to only take on business where we felt real partnerships with our customers
could be developed. It's never been a goal of ours to be the biggest hospice
pharmacy solution in the country. Instead, we strive to have the strongest
partnerships possible with like-minded folks who also value partnerships and
mission fulfillment.

If you look in the dictionary or Google "business partnerships," you'll probably
see a description that goes something like this:

"A business partnership is a specific kind of legal relationship formed by the
agreement between two or more individuals to carry on a business as co-owners."

The partnerships we build with our clients obviously don't involve any
co-ownership. The only "co-ownership" involved concerns the dual responsibility
of Delta Care Rx and our partners in caring for and providing excellent care to
the patients we're both privileged to serve.

Looking back on 2019, it is clear that there was a whole lot of definition and
strengthening around so many of our hospice provider partnerships. We're doing
special work together with so many partners throughout the country—work on
improving symptom management and pain control, educating and supporting the
clinicians who provide hands-on care at the hospice bedside, leveraging
technology to improve outcomes and clinician efficiency, and, of course,
managing costs effectively and transparently.

In early February, I had the wonderful opportunity to spend an evening with
about 50 CEO's of mission-driven hospices. Near the end of the dinner we were
pleased to sponsor, the CEO of one of our partners in Ohio stood up and
described what it's like to work with Delta Care Rx and how he feels like we are
a "true partner." He went on to describe Delta Care Rx as an extension of their
team while being an essential component of the execution of their mission day in
and day out. For me, it was a moment that I'll never forget.

In just about 3 minutes, this busy CEO described exactly what we aspire to as
partners with community hospices. While I won't mention any specific names, it
was creatively articulated in a way only he could do.

I truly believe that a majority of the business relationships we hold also feel
this way about our partnership. And our clients (if I have to say it) do feel
like our partners (that's better).

Thank you to all of our PARTNERS for your belief in our company and for making
these wonderful feelings possible. We're your biggest fans.

Your Phavorite Pharmacist,

-Drew

https://www.linkedin.com/in/drewmihalyo/ 

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PROPOSED REGULATION REGARDING BLISTER PACKAGING OF CERTAIN IMMEDIATE-RELEASE
OPIOIDS

Mary Mihalyo B.S., PharmD, CGP, BCPS
Wednesday, 14 August 2019
Delta Care Rx

Mary Mihalyo, B.S., PharmD, BCPS, CDE
Chief Executive Officer
Delta Care Rx
264 Smith Township Road
Burgettstown, Pennsylvania 15021

Via Electronic Submission

July 30, 2019

Norman E. Sharpless, MD
Commissioner
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, Maryland 20993

Subject: Re Fixed-Quantity Unit-of-Use Blister Packaging for Certain
Immediate-Release Opioid Analgesics for Treatment of Acute Pain — (Docket No.
FDA-2019-N-1845)

Dear Dr. Sharpless:

Delta Care Rx appreciates the opportunity to share our perspective on the issue
of Fixed-Quantity Unit-of-Use Blister Packaging for Certain Immediate-Release
Opioid Analgesics for Treatment of Acute Pain.

Delta Care Rx is a pharmacist-founded, pharmacist-owned and pharmacist-operated
pharmacy benefit management company that works exclusively with and for hospice
and palliative care providers, primarily community-based, not-for-profit hospice
and palliative care organizations. We provide our pharmaceutical care through
our own mail order pharmacy and a nationwide network of highly regarded local
retail pharmacies. With a mission to transform and improve the hospice pharmacy
industry through business transparency, innovation, unyielding customer service
and community pharmacy relationships, Delta Care Rx has been privileged since
our founding in 2008 to work with some of the nation’s most highly regarded
community-based hospice providers. At Delta Care Rx, we pride ourselves on being
an industry disruptor, having created a revolutionary transparent pass-through
pricing model and having introduced a number of innovative technologies designed
to support clinicians at the bedside in delivering quality, compassionate,
cost-effective pharmaceutical care for patients with a life-limiting diagnosis.

With roots in western Pennsylvania and eastern Ohio, as pharmacists and as
citizens of the communities in which we live and work, we know all too well the
dangers and impact of widespread opioid addiction. Delta Care Rx applauds the
Food and Drug Administration’s commitment to developing innovative and
far-reaching policies to end the scourge of opioid addiction.

As a relatively young company, this is the first time we have chosen to speak
out individually on an issue before federal regulators rather than deferring
solely to our respected industry and trade representatives. We do so out of a
profound concern for the impact (intended or unintended) of any regulation that
could affect the most vulnerable among us—the 1.5-plus million Americans who
will benefit from hospice care this year.

Whatever the final outcome, we urge the FDA to consider specifically the impact
of such regulation on the provision of essential pain medications to hospice and
palliative care patients and, where appropriate, make specific exceptions in
such regulations specifically for hospice and palliative care patients.

Impact on Hospice Pharmacy Practice

As the impact of the opioid addiction crisis grows, we have seen ever-increasing
regulatory and compliance burdens placed on dispensing pharmacies that fill a
significant portion of the pain medications prescribed for hospice and
palliative care patients. Delta Care Rx recognizes the important role of local
pharmacies in ensuring quality patient care, responsive service, ethical
practices and access to essential medications particularly for geriatric
populations. We are further concerned about the increased burden on the pharmacy
community nationwide—including our own hospice mail order pharmacy service—as it
would endeavor to comply with this additional regulatory requirement.

While it’s not much of a problem in populous, prosperous suburbs, the ready
availability of Schedule II narcotics in exurban and rural areas as well as
low-income/inner-city neighborhoods is certainly a genuine problem. And it’s
getting more dire—so-called “opioid deserts” are, in fact, real.

Blister packaging will increase labor costs for retail pharmacies dispensing
immediate-release opioid analgesics. Many of these retail pharmacies operate on
very slim margins and at some point the conflict between managing a sustainable
business and meeting a community’s need for access to the broadest possible
range of prescription medications forces retail pharmacies to opt to make the
difficult decisions to stop carrying certain classes of prescription medications
simply to keep their doors open.

Impact on Hospice Providers

Blister packaging also will result in increased costs for the hospice providers
responsible for providing all medications necessary and appropriate for the care
of each patient. Blister packaging likely will increase the cost of
immediate-release opioid analgesics by as much as 20–25 percent. Hospice
providers will have no choice but to absorb those increased costs. And for
community-based, not-for-profit hospices already existing on thin margins, the
impact of such a cost increase could severely affect the long-term
sustainability and mission-fulfillment work of these hospices.

Impact on Hospice Patients and Their Caregivers

We are also concerned about the effect blister packaging will have on hospice
patients themselves and/or the loved ones caring for them. Blister packages
understandably are difficult to open. For anyone. They’re challenging for a
young person with no tactile limitations. They’re infuriatingly difficult—if not
impossible—for a geriatric population with sometimes significant tactile
limitations. We can’t imagine there are many hospice patients who could open a
blister package on their own. We’re concerned for the hospice patient without a
full-time caregiver in the home to open blister packages. We’re concerned for
the hospice patient whose full-time caregiver in the home is a spouse, sibling
or other loved one with tactile limitations who could be equally challenged in
opening a blister package. We’re used to hearing the stories of Medicaid,
Medicare and commercial insurance patients forgoing essential prescription
medications due to cost. We don’t want to start hearing stories of hospice
patients forgoing essential prescription medications because they can’t get the
pills out of the blister packaging. Patients can’t adhere to a physician’s
prescribed regimen if they can’t get the blister package open.

A Proposed Solution

We do recognize the obvious advantages for the population at large in utilizing
blister packaging for immediate-release opioid analgesics.

As pharmacists who work exclusively with hospice providers and patients, we
support a greater decision-making role for pharmacists—at the bedside, in the
weekly hospice interdisciplinary team meetings, at the administrative level. In
this case, we would like to see primary pharmacists given leeway within this
proposed regulation to utilize alternate packaging modalities. Such a solution
could range from traditional age-friendly pill bottles to individual pill pack
envelopes to bingo dispensers or bingo cards—based in large part on patient need
and the patient’s/caregiver’s ability to manage medications.

The hospice movement was founded in the United States 40+ years ago on the
steadfast commitment that patients should be supported as they die at home, in
familiar surroundings, in the presence of their loved ones, with end-of-life
symptoms managed effectively and their pain under control. Combatting the opioid
epidemic does demand a universal call to arms. We just don’t want to see the
goal of managing the pain of hospice patients become an unintended casualty in
the battle against opioid addiction.

We trust you will keep the needs and limitations of hospice patients in mind as
you formulate this modification to the Opioid Analgesic Risk Evaluation and
Mitigation Strategy.

Respectfully submitted,

Mary Mihalyo, B.S., PharmD, BCPS, CDE
Chief Executive Officer
Delta Care Rx

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HAVE YOU CHECKED THE ORGAN DONOR BOX ON YOUR DRIVER’S LICENSE?

Cordt T. Kassner, PhD
Wednesday, 17 July 2019
Delta Care Rx

How Hospices Can Help Solve Organ and Tissue Donation Shortages

Currently there are ~120,000 people in the US waiting for organ transplants, of
whom ~8,000 die each year still waiting. The demand for organs for transplant is
~5 times the supply. One single organ and tissue donor can save and heal the
lives of more than 75 people. Yet ~50% of Americans have indicated desire to be
organ donors1 and ~50% of deaths occur in hospice2 – so why is there an organ
shortage, and how can hospices help?

Organ Donation. Solid organ donation is challenging, but not impossible, for
hospice patients. To be eligible for solid organ donation, a hospice patient
must be in a controlled environment (e.g., a hospital or an inpatient hospice
unit located in a hospital), where organ recovery can occur at the time of
death. There are examples when a hospice patient can also be an organ donor –
e.g., a patient on a ventilator, hospice patients served in an inpatient unit
located within a hospital, etc. Hospices are encouraged to contact their local
Organ Procurement Organization (OPO) regarding all patients on ventilators to
discuss details. Your local OPO can be found on the US Department of Health &
Human Services website: www.OrganDonor.gov.

In Colorado, there are ~30,000 deaths each year and ~15,000 of these deaths are
served by hospice. Over the past five years, there have been ~75,000 deaths in
Colorado hospices. However, according to Donor Alliance, there has only been one
(1) organ donor identified coming from any Colorado hospice in the past five
years.

Tissue Donation. However, tissue donation is a different matter. Tissues (e.g.,
skin, bone, heart valves, eyes, etc.) can be donated up to 24 hours following
death, and the demand for tissues is also great. A woman described how her
mother loved to read and considered it her greatest joy to share the gift of
reading with someone else by donating her eyes when she died. According to
AlloSource3 (an organization specializing in tissue donation), the tissue in
most demand is skin – and skin can be donated at any age. Some tissues, e.g.,
cartilage and patella, are age and size specific and generally require younger
donors. Hospices are encouraged to contact their local Organ Procurement
Organization (OPO) regarding all patients interested in tissue donation to
discuss details. Your local OPO can be found on the US Department of Health &
Human Services website: www.OrganDonor.gov.

Tissue donation eligibility criteria is nearly patient specific and warrants
discussion with a local OPO. Active cancers (~25% of hospice patients) exclude
most, but not all, tissue donation. Tissue donation changes peoples lives and
offers hospice patients the opportunity to help others after their own death.
Yet hospice participation in tissue donations is extremely rare.

How can hospices more actively participate in organ and tissue donations?

1. Ask the question “Have you checked the organ donor box on your driver’s
license?” as part of your admission process. This is an easy, non-invasive way
to approach the topic. If the patient (or medical durable power of attorney)
says yes, then contact your local Organ Procurement Organization.

Also, hospices might consider:

2. Include organ and tissue donation materials in the hospice admission packet
from your local Organ Procurement Organization.
3. Knowing that about half of Americans have indicated desire to be organ donors
should make the donation conversation more comfortable for everyone. Hospices
are expert in difficult end-oflife care conversations and advance care planning
discussions. However, most of these conversations focus “upstream” to bring
people into hospice. Aren’t “downstream” conversations about donation and
funeral arrangements equally important in honoring patient and family wishes?
4. Hospices serve patients of all ages, and organ and tissue donors of all ages
are needed.
5. Is it possible to include organ and tissue donation questions on POLST, MOST,
Respecting Choices, 5 Wishes, and other advance care planning documents?
6. Hospitals are required to notify the Organ Procurement Organization upon the
death of every patient. The OPO then cross-references names with an online donor
registry before talking with family members of the deceased about donation.
Could hospices participate in similar notifications when serving patients on
ventilators, in inpatient units, etc.?

 

For additional information, please contact:

Cordt T. Kassner, PhD
CEO, Hospice Analytics
CKassner@HospiceAnalytics.com
719-209-1237

 

____________________________________________

1 https://www.donoralliance.org/understanding-donation/why-donate/donation-faq/,
accessed 10/31/18. Also personal communication with Kim Robuck at Donor Alliance
on 10/31/18, 303-329-4747.
2 www.HospiceAnalytics.com/InfoMAX, accessed 11/15/18. Also, personal
communication with Cordt T. Kassner, PhD, CEO, Hospice Analytics on 11/15/18,
719-209-1237.
3 Personal communication with Colleen Kilkenny at AlloSource on 10/31/18,
720-873-0213, https://www.allosource.org/.

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WE ARE IN A RIGHT TO ACCESS PAIN MEDICATION CRISIS

Deanne Sayles RN, MN, CHPN, FPCN
Thursday, 26 April 2018
Delta Care Rx

“The crisis of people in the throes of addiction deserves the time, attention
and talents of health-care providers and legislators. But the crisis of people
in pain deserves the same.” -Anna Fuqua, former nurse living in Alabama, in the
Washington Post

The time has come to reframe the “opioid crisis” as the “right to access pain
medication” crisis. The frequently mentioned “opioid epidemic” makes me cringe,
yet this term runs rampant in our news industry. Left unchecked, it induces fear
and misunderstanding. We must define the root cause of this crisis, without
dismissing it as over-prescribing of opioid tablets, patches or suppositories.
We need to look deeper at the issue to ensure that hospice and palliative care
patients get the medications they need to ensure their symptoms and pain are
managed.

As a hospice nurse, I can share that professionals in the field currently
experience restrictions and regulations which nearly choke off access to pain
medications for our precious patients. In each case, the nurse must get a
special order. The prescription on paper is signed and provided to the pharmacy
before it can be filled.

Then, the pressure is on the pharmacy to follow specific rules and regulations
to complete dispensing. This process is cumbersome and involves many checks and
balances, from confirmation of necessary prescriber licensing to availability to
accurate dispensing.

In the case of an uncontrolled pain event, the situation becomes more complex.
If the doctor prescribes a limited amount of the opioid needed, then the patient
may be unable to get relief if the nurse is unable to obtain a new prescription
quickly thereafter. Unfortunately, refills for narcotic prescriptions are not
allowed by the DEA. For hospice patients in dire circumstances, short term
emergency verbal orders are possible, but incredibly difficult to obtain with
detailed follow-up to the dispensing pharmacist required. Thankfully, the advent
of e-prescribing technology has decreased the amount of difficulty in many
cases.

In hospice, we frequently use morphine to relieve the symptom of dyspnea,
characterized by severe shortness of breath. Though not classified as pain, I
think it deserves a spot in the severe discomfort category. On multiple
occasions in my thirty years of caring for the dying, I have had physicians tell
me “I am not comfortable prescribing such a high amount of opioid.” Or, “I have
no experience with methadone, can you ask the medical director, or hospice
physician, to manage that aspect of care?” Obviously, more education may be
required to prepare non-hospice physicians to address the symptoms and pain
arising from serious illness.

The Center for Medicare Services, or CMS, has proposed a new policy to prevent
at-risk beneficiaries from simultaneously obtaining prescription opioids from
multiple physicians or pharmacies. The plan would also limit the quantity of
opioids dispensed. We must ask how this works when the patient has been shifted
from specialist to specialist to manage specific symptoms.

And what about the pharmacy informing the hospice nurse, “We no longer carry
Oxycontin™ because we were robbed a month ago, and our supply was totally
depleted?” Some pharmacies no longer carry any type of opioid due to the risks
it poses to personal safety. In some instances, this situation adds a burden on
the nurse to locate a pharmacy in the area that will carry the inventory needed.
Better would be access to a competent pharmacy benefits manager, like Delta Care
Rx, which can ease that burden. Unfortunately, prescription drug thefts
contribute to a climate of increasing regulations, making it more difficult for
patients to access the appropriate type and amount of medication to manage their
symptoms.

Which brings me to a final point. In my experience with a leading Health
Maintenance Organization, or HMO, palliative care patients sometimes get
shuttled from doctor to doctor. However, though one might see a rheumatologist
for pain, that physician defers to the primary medical doctor to write the
prescription. Though the positive intention was avoidance of duplicative
prescriptions, the result defies logic. A patient cannot realistically request
pain medication from a physician who has not directly assessed his or her pain.
Too often, patients in chronic pain are treated like drug addicts when they ask
for a medication stronger than ibuprofen, one which affords the luxury of at
least four hours of comfort. Unfortunately, many patients with serious, terminal
illness have no choice but to be in pain and live with it, even as they are
dying.

Submitted by Deanne Sayles RN, MN, CHPN, FPCN Client Services Quality Liaison
for Delta Care Rx

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PRESENTATION: “HOW DOES HOSPICE PHARMACY PRICING REALLY WORK?” AT NHPCO
CONFERENCE IN WASHINGTON, D.C. APRIL 23

Super User
Friday, 13 April 2018
Delta Care Rx

PITTSBURGH, Pa. - As a hospice clinician or manager, chances are that you’re
highly motivated to save money, even as you and your team work to improve
patient outcomes. That’s why Delta Care Rx President and COO Drew Mihalyo,
PharmD, along with Hospice Analytics CEO Cordt Kassner, Ph.D., Colorado Springs,
Colo., will present “How Does Hospice Pharmacy Pricing Really Work?” at the
National Hospice and Palliative Care Conference in Washington, D.C., Monday,
April 23, at 1:30 p.m.

The timely presentation carries significant implications for healthcare,
hospice, and industry business ethics. Pharmacy pricing tops the national media
agenda. Simultaneously, hospice clinicians and managers are responding to these
changes by re-evaluating their pharmacy purchasing and pricing agreements.

“Our shared goal is to increase the level of transparency in the hospice
pharmacy sector,” says Mihalyo. “Each attendee will leave with the knowledge
needed to more effectively navigate current or future hospice pharmacy
agreements for the betterment of their patients’ access to creative therapies.”

Industry-wide, increasing numbers of hospices strive to meet the goal of
optimizing long term cost savings on prescriptions related to terminal diagnosis
or contributing disease states, all while improving patient care and family
satisfaction.

“We developed the presentation together based on questions I was asking Drew
about a prescription for my daughter,” Kassner says. “One pharmacy was charging
$12, while another was charging $267, for the same prescription.”

Attendees will gain insider know-how and tips that hospice senior staff and
management need to:

 * Craft economical, therapeutically effective medication purchasing agreements
 * Work productively with industry specific vendors and pharmacies
 * Identify which of the commonly found purchasing arrangements works best in
   hospice situations
 * Utilize all available resources for optimizing long term cost savings on all
   medications – not only hospice! This might even benefit you personally at
   some point as a non-hospice patient.

A question and answer session will close the seminar. Additionally, nurses,
health care clinicians, physicians, and social workers are eligible for
continuing education credits (CE/CME) when they attend the session.

Click HERE to get the course info for Session 3C, "How Does Hospice Pharmacy
Pricing Really Work?"

 

To learn more about our truly pass-through model, click HERE

Share your #WhyExtra story and join the movement HERE

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FAIR ENOUGH? WHAT YOU NEED TO KNOW ABOUT COMMON HOSPICE PHARMACY PRICING MODELS

David Clapp
Monday, 29 January 2018
Delta Care Rx

Not all pharmacy benefits management (PBM) providers are created equal.

Take, for instance, changes in recent years to hospice Medicare benefits. In the
near future, Medicare changes will phase out the common “per diem” pharmacy
pricing model. Despite this, some vendors continue to tout the per diem model as
an optimal solution, usually a mail order product. For hospice leaders focused
on lowering costs while increasing quality of care, this model has built in
obsolescence.

Let’s look at the situation, and ask “what’s next?”

The Per Diem Business Model

When we look at Medicare’s recent changes, we can read the writing on the wall.
The question is not “if” the per diem pharmacy benefits management business
model is on the way out, but “when.” Hospices which have adopted PBMs or a
pharmacy solutions vendor operating on a per diem model will need to undergo a
shift. Their provider’s business pricing model will no longer be cost effective.
The resulting situation is an inconvenience at best, and an unforeseen
expenditure of time and extra money at worst.

Unfortunately, some of the largest hospice care networks in the U.S. will find
themselves in the position of weathering a storm of costly, frustrating fee
changes and administrative snafus in the year ahead as their vendor plays catch
up with Medicare.

The AWP Discount Model

PBMs and/or pharmacies which offer an average wholesale price (AWP) minus
business model to their clients will also find themselves at odds with Medicare
reimbursements and their clients’ bottom line. Right now, those companies are
offering an AWP, minus a discount percentage that’s typically in the 40-60%
range. On the surface, the discounts offered look like a fair deal. But care
providers are actually losing money. How is this possible?

Often, generics are priced much lower than the fee charged. Take for instance,
Olanzapine 5mg 30 tablets, with an AWP of $396.04. Staggering, when you consider
this medication has a acquisition price of under ten dollars for a local
pharmacy. With an AWP discount of 40%, a hospice provider would still pay
$237.63 for 30 tablets of Olanzapine 5mg. The same is true of many other
commonly prescribed hospice medications. Over the past decades, the chasm
between what a drug costs, and the amount the hospice pays, has widened
significantly.

PBMs (and many local pharmacies doing business direct with hospices) are touting
an “AWP minus a Discount” model, therefore, have no problem with the illusion
they are slashing prices. Further, their hidden margins allow for dramatic
gestures used to direct their clients’ attention where they want it to go. Once
opening a pharmacy benefits relationship in a specific location, these folks
will promise almost anything to hold on to that contract.

What’s next? If the PBM per diem model is obsolescent and the non-transparent
fee for service model pads prices at the expense of their clients’ economic
health, what might hospice leaders consider instead? We’ve asked that question a
lot at Delta Care Rx, and we’ve come up with a viable alternative: the
cost-effective pass through model. Let’s take a look at it here.

The Pass-Through Model

Pioneered here at Delta Care Rx, the pass-through PBM purchasing model called
“Hospice Taper™” has proven something of an industry disruptor. That’s because
the level of transparency the client receives regarding pharmaceutical costs is
unprecedented in hospice pharmacy. Just how transparent is it? In a fiduciary
and truly pass-through purchasing model, the client retains the ability to audit
the hospice pharmacy provider at any time. Plus, the contract between the client
and the PBM specifies the actual pass-through rates. Such is not left undefined
or identified in a vague manner. No fees or revenue sources are hidden, and the
value provided to the client is agreed upon in advance.

With three different types of business models, how does one make sense of the
offers advanced by potential pharmacy vendors? We suggest a cost comparison
breakdown, like the one shared here. An apples-to-apples comparison of a
hospice’s most commonly prescribed pharmaceuticals should reveal what may
otherwise be hidden.

David Clapp is National Director of Business Development at Delta Care Rx.

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TOP 3 TIPS FOR MANAGING COMPLIANCE CHANGES IN E-PRESCRIBING IN 2018

Helen New
Friday, 17 November 2017
Delta Care Rx

As we look ahead to 2018, we’re sure to see fast paced changes to e-prescribing
regulations in the hospice pharmacy specialty.

Recently, I’ve begun hearing from clients that they’re already thinking about
those compliance changes. I asked my team for common sense approaches to help
our hospice partners get ready for the new requirements. After discussion, we
condensed our thoughts into these resulting top 3 “need to know” tips.

As 2017 counts down, we hope these straightforward strategies will help prepare
you for the compliance changes expected in 2018. (You’ll also want to watch our
blog in January 2018, as Delta Care Rx will speak directly to those compliance
changes as they relate to e-prescribing.)

Feel free to help us add to this list.

 1. Identify a “point person.”

A point person on the team is aware of the required changes. In smaller hospice
organizations, this role is fulfilled by the CEO, and in larger hospice
settings, by a compliance officer. This person monitors changes as they occur,
educates staff, and helps make changes to keep e-prescribers in alignment with
the regulatory guidelines set by the state.

The point person typically manages the aspects of change inside the hospice
organization. They’re responsible for the built-in accountability, or “paper
trail,” that changing regulations often require. With e-prescribing practices,
we recommend documenting the formal process and ensuring replicability with
staff developed check-sheets and protocols.

 2. Monitor changes for your state.

Minimally, monitoring industry briefs, such as those by the National Hospice and
Palliative Care Organization, or NHPCO, ensures an efficient way to monitor
changes and share relevant information with staff.

Other ways to stay informed include talking with regulatory compliance educators
at state or national conferences, or sending representatives to hospice
coalition meetings to see what’s changing and who’s managing that change.

Setting Google “alerts” to monitor online posts and breaking news can also be
helpful. Set the alert using keywords such as your state, hospice, pharmacy,
e-prescribers, etc. Have the alerts delivered to your inbox weekly and scan for
pertinent information.

As you monitor emergent changes, encourage your team to commit to early
adoption. This reduces workplace stress, increases quality of care, and
establishes your leadership among peers.

 3. Use a good e-prescribe integration with knowledgeable support team in place.

A good integration for pharmaceutical benefits management systems includes
access to skilled professionals who are trained to do e-prescribing, and do it
well.

What you don’t want in the midst of regulatory changes? To call state regulators
and ask questions that make it obvious there’s confusion on your end. Or to
realize that peers and colleagues have already made the requisite changes, and
you’re behind the curve. Using a third party vendor for e-prescribing also adds
a layer of potential obfuscation, complication, and time delays.

To meet these challenges, opt for direct integration of e-prescribing options
into your system. At Delta Care Rx, the SureScripts integration answers this
need in ways that make sense, increase efficiencies, and keep e-prescriptions in
the hands of professionals. We’ve found that one system with dual entry
capability is much more effective than third party alternatives. The process is
simplified, e-prescriptions are processed in real time and within your direct
control.

Escalating medication pricing and new e-prescribing regulations require changes
at a rapid rate. We hope these tips will serve hospice leaders, physicians, and
nurse practitioners well as the new year approaches.

Best wishes for a joyful holiday season,

Helen

Helen New is National Director of Client Strategies for Delta Care Rx.

 

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DEPRESCRIBING: QUALITY OF CARE, COMFORT, AND THE DEMISE OF POLYPHARMACY IN
HOSPICE SETTINGS

Michelle Mikus, PharmD
Tuesday, 12 September 2017
Delta Care Rx

From a hospice pharmacy perspective, end of life care is really all about
comfort and the palliation of symptoms. That shift in priority often comes with
a de-escalation of medication, a practice called “deprescribing.”

The choice to deprescribe medications is one every pharmacy benefits manager
should be prepared to support. Deprescribing offsets the potential harm to the
patient’s quality of life caused by polypharmacy practices, which is defined as
the prescription of as many as 5-10 pharmaceuticals to a single individual.
 During the last stage of a loved one's life, patient and family/caregiver goals
switch to focus on side effects and increasing comfort.

In hospice pharmacy benefits management, deprescribing is increasingly common
and particularly seen at times of transition during the patient’s care. At the
transition to hospice, aggressive treatment of a particular illness is
necessarily replaced with pain management and monitoring. Reducing the number of
prescriptions and therefore eliminating any potentially resulting side effects
can increase comfort as terminal illness progresses toward the end stage of
disease.

When that day comes

When the day comes that a hospice practitioner makes a home visit and suggests
that the medications a patient planned to take for the rest of his or her life
are no longer needed, it’s a difficult conversation to hold at an already
emotional time. Delta Care Rx provides its clients with tools to assist the
nurse and caregiver with deprescribing discussions. These tools outline how to
broach the topic of deprescribing with the patient from an evidence-based
perspective. For example, certain pharmaceuticals may no longer be indicated due
to the terminal prognosis, or in some cases one drug might be preferred over
another due to side effect profile.  Sometimes we can even use side effects to
our advantage in hospice.  For example, a medication that can improve mood might
also help the patient sleep at night and improve their appetite

The business of deprescribing

In the hospice pharmacy world, there is a necessary spotlight on the overall
"per patient day" cost of a patient’s care. Quite simply, fewer medications
reduce the cost of care, and at times the benefits of deprescribing in relation
to the comfort of the patient can be extensive.

The idea of deprescribing isn’t always popular. Direct to consumer
advertisements of prescription medications is legal in the United States, and
we’re exposed every time we go to the doctor, turn on the TV, open a magazine,
or read a medical article. Patients often go to the doctor knowing what
medications they want before they arrive. Over time, doctors continue to write
prescriptions often unknowing what the patient may have already been prescribed
by other practitioners

Unfortunately few guidelines and protocols exist for pharmacists and
practitioners related to deprescribing. Future work in this regard needs to
include discussions of end stage disease, side effect profiles, and how our
approach to pharmacotherapy needs to be altered at end of life.

Michelle J. Mikus-Rachwal, Pharm D, is pharmacy manager at Delta Care Rx.

 

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HOSPICE NURSE FELLOW SPOTLIGHT: DEANNE SAYLES, R.N., MN, CHPN, FPCN

Mary Mihalyo B.S., PharmD, CGP, BCPS
Tuesday, 20 June 2017
Delta Care Rx

Recently, I enjoyed reconnecting with colleague Deanne Sayles, R.N., and
learning of her receipt of the honor of Hospice Nurse Fellow from the Hospice
and Palliative Nurses Association. Deanne and I created a presentation called
“Interdisciplinary Medication Management for Hospice” for the 2013 NHPCO
Clinical Team Conference and a webinar for our Brainy Brunch series in 2012 on
Pediatric Hospice and Palliative Care. She’s an exceptional collaborative
partner, with particular insights about the provision of hospice pharmaceutical
care from the nursing perspective. This article features highlights drawn from a
recent conversation about the importance of collaboration between pharmacists
and nurses when caring for patients.

Deanne, why would you say this designation is important to the hospice nurse
profession?

The recognition is important within a team or in a company, as it means they are
selective and that there’s someone on their team who has achieved the highest
honor in hospice and palliative nursing. You see the importance of that kind of
thinking every day, Mary, in Delta Care Rx’s commitment to have excellent, high
quality nurses working alongside excellent, high quality pharmacists.

So you see pharmacists and nurses as care team partners?

Yes. The knowledge a hospice and palliative care nurse offers to the team
includes caring for patients across care settings, whether at home or in
inpatient settings such as nursing homes. That insight helps the Delta Care Rx
pharmacist understand what it’s like to be at the bedside when someone on the
team reaches out for assistance.

Delta Care Rx offers continuing education training to hospice and palliative
care nurses. Why should nurses consider pharmaceutical care related topics for
furthering their knowledge?

You’ll find that the bulk of education and product training aimed at nurses
focuses on delivering care and administering medications to the patient. When
patients are cared for at home, those medication teachings sometimes need to be
supplemented by the expertise of the Delta Care Rx pharmacist during a
consultation or webinar education.

What are some of the greatest challenges hospice and palliative care nurses face
while working in the field?

When patients live a great distance from town, and pharmacies can’t deliver…
Delta Care Rx, for example, overcomes this barrier to care by shipping
medications quickly and without non-transparent added costs. But in severe pain
cases, or during severe weather such as a blizzard in mountainous regions, the
nurse may need to ensure the medication gets there by other creative means.
That’s a situation that occurs rarely, but nurses are committed to finding
solutions for their patients. Another great challenge is the rigorous,
frequently changing regulatory scrutiny hospices experience. The documentation
requirements put a lot of pressure on nurses to deliver care quickly and
efficiently. Additionally, compassion fatigue and lack of self-care drain the
nurses’ empathy banks. We need to address the continual “giving” burden that
nurses experience by identifying and using ways to re-charge.

You are a nurse, but also a consultant. How did you find your niche?

Quality client services require a certain level of expertise in hospice and
palliative learning. When I help other nurses acquire those skills, they can
offer the best support to patients and families. That’s my focus: helping nurses
give the best quality care to their patients. I also focus on helping hospice
agencies train and educate their staff on best clinical practices in hospice and
palliative care.

What about nurses who are new to hospice care?

Nurses need to carefully prepare for each visit, which includes a thorough
review of the medications listed on the patient profile. I strongly recommend
they have a mentor with whom they debrief, at least monthly. This work is very
intense. Most of us need to bounce patient cases off someone else to help deal
with our own feelings. We are unable to help people manage grief, unless we’ve
dealt with our own.

From this perspective, how should hospice nurses best work with pharmacists in
patient care?

It’s incumbent upon the nurse to study medications, know what medications are
and what they do, to discuss and observe side effects with patients and
families. The nurse manages medications, notes side effects, and requires ready
access to a medication management expert. The pharmacist is that expert. Having
a hospice PBM on board with consulting availability is ideal; the nurse can be
at the bedside of a patient and consult a pharmacist while observing symptoms.

How would you explain this relationship to a pharmacist or nurse new to the
field?

It works like this: Nurses pick up the phone and reach out to pharmacists as
needed. With a new patient, the medications get organized; with an existing
patient, the nurse knows when medications change. It’s his or her job to monitor
patients for therapeutic responses to medications and adverse experiences. In
turn, the pharmacist provides recommendations and expertise in medication
management so that care can be delivered safely and effectively.

The nurse brings those recommendations to the hospice physician and
interdisciplinary team. Ultimately, it is the responsibility of the hospice
physician to use the information provided to make a decision in prescribing.
This is how pain and symptom management issues get resolved.

How do you feel about receiving the hospice nurse fellow recognition?

It was absolutely mind-blowing to be in the room. The board of directors held a
reception for the 11 new fellows. One of the nurses was someone I had worked
with in AIDS care back in the 1980s. There was a wide range of expertise. We’re
functioning as a mini-team now, setting up phone conferences and brainstorming
about how we wish to contribute to the Hospice and Palliative Nurses Association
and the future of the profession.

Mary Mihalyo, PharmD, is the CEO of Delta Care Rx.

About Deanne Sayles, R.N.

Deanne Sayles, R.N., received Hospice Nurse Fellow recognition in January 2017.
She has cared for the terminally ill since 1979, experiencing life-limiting
disease across care settings, and managed protocols for both curative and
palliative pharmaceuticals at a large pharmaceutical company for 7 years. In
2010, she founded the first local chapter of the Hospice and Palliative Nursing
Association. Since 2003, her consultancy focuses on elevating patient and family
experiences through quality hospice and palliative care nursing.

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NOTES FROM THE @AAHPM #TWITTER BOARD: A PHARMACIST’S REFLECTIONS ON #HPM17

Drew Mihalyo, PharmD
Monday, 10 April 2017
Delta Care Rx

Self-reflection is a powerful tool for integrating the experiences and messages
of the spring conference of the American Academy of Hospice and Palliative Care.
As President & COO of Delta Care Rx, I met a lot of people, many of whom I hope
to speak with again at the National Hospice and Palliative Care Organization’s
32nd Annual Management & Leadership Conference in April.

Here is my “Top 5” idea list, supported by the wise words of a range of
colleagues who said it best on the event’s public Twitter Board using #hhpm17. I
look forward to learning more in the days ahead.

#1 – We’re educating “Policymakers” every day

The clinicians attending – doctors, nurses, pharmacists, and advanced students –
offer vital contributions to a nation with a rapidly aging population. Hospice
care made its debut almost half a century ago, but we may at times find we’re
still educating policymakers about palliative care, hospice, and professional
practice.

End of life care issues have gained new traction due to recent political
rhetoric. I recently cut through the noise of the Aid In Dying debate to suggest
proactive approaches for pharmacists. Here, Andi Chatburn shares a statement by
Mark Ganz, responding to public remarks made by Senator Paul Cruz:





Thoxbee Me replaces it with a simple message and clear defining characteristic,
which supersedes politics.



The practitioner versus clinician debate is tied directly to the way
professionals are perceived by the public and lawmakers. Thomas W. LeBlanc and
Drew Rosielle hone in on a possible strategy for the way professionals might
choose to refer to themselves and their roles.



#2 – Effective, affordable pain management is integral to palliative care and
patient quality of life.

A lot of the conversation coming out of the conference focused on the use of
opioids and dose tapering. As a pharmacist, this was a topic that I certainly
found interesting. At Delta Care Rx, colleagues and I are part of this
discussion with Physicians and Nurses who utilize our On Demand Pharmacist
Services (ODPS). These services supplement an interdisciplinary approach
regarding Conditions of Participation, or complaint medication management.

Colleague Sarah Scott Dietz kindly provided a photo of the summary on opioids
presented at the conference, and it provides context for the discussion around
these specific class of medications, as listed below.



Admittedly, I’m relatively new to Twitter as a live platform for sharing
information across the discipline. I’ll share a few of those posts that had
relevance for me here. The first set of responses focused on pain management
options in a positive vein.

Methadone: “I love methadone” most common phrase heard at our exhibit. (Virtual
Hospice)

Midazolam: “Intranasal and buccal midazolam – safe, effective and inexpensive in
treating seizures! Better than lorazepam/diazepam,” (Armida Parala Metz)

Levorphanol: “treatment for phantom pain” (Marvin Delgado-Guay); “can you even
get levorphanol? I tried 1 or 2 years ago. Got blanked,” from Dr. The Frog, aka
Skip Bidder. Akhila Reddy MD notes “Levorphanol available now but have to
pre-order it, expect pharmacy to take 2 to 3 days to get it.” Levorphanol is a
“forgotten opioid” (Marvin Delgado-Guay) and “more education and research
needed.”

Cannibis: "I do know that no one dies of a marijuana overdose because there are
no cannabanoid receptors in the brainstem." (Courtney Simmons)

Naloxene kit: “If your patient is on opioid & benzo consider ordering a naloxone
kit-will need PA may have to pay out of pocket, talk with their pharm.”
(Kimberly Curseen)

Other pain management options were treated with more skepticism, with posts of
the Pharm Ladies seminar by attendee Courtney Simmons.

Codeine: “We should just vote codeine off the island.”

Sufentanil: “…not impressed with sufentanil, think best use may be on the
battlefield or other places we can’t give parenteral.”

Amtiza: “Post marketing warning for syncope and hypotension. …warning of high
cost & not much better efficacy.”

Kratom: “Can produce opioid effect with abuse, being rescheduled as C-1.
Currently an herbal.” (a relative of the coffee plant)

Documentation processes were found to be critical for success. Being able to
collect prescribing data is a must when defining a path forward. While many
organizations have access to reports that help with this documentation or
tracking of patterns, often the actual prescribing information is lacking
granularity that can be instead accessed on the front end (of the ordering
process) when e-Prescribing technology is utilized to the fullest extent.
Shireen Heidari expressed the need for thorough documentation at a GIP level,
saying:



#3:Starting with the telephone call, possible transition to tele-health
technology or telemedicine options are the way of the future in some care
scenarios.


 





LeBlanc offered a caution that the way ahead for #palliativecare is patient
needs, not prognosis. Shirley Otis-Green and Kyle Edmonds suggest the need for
data-driven decision making within the field.





#4. Inter-professional education for pharmacists, nurses, and care teams will
develop communicative leaders offering patients a range of skill sets and
abilities.

Socialization, mentoring, internships, curriculum design, and human sources of
inspiration will fuel professional commitment within the growing field.



 

I read with particular interest the discussion of curriculum for interns,
fellows, and other clinicians entering the field. Delta Care Rx offers a
comprehensive internship program for pharmacists in our Pittsburgh, PA area
offices via our Delta Campus educational program. We have also support the next
generation of both nurses and pharmacists via collaborative efforts with clients
of ours in their local communities.



The curriculum in each case offers exposure to the very important
 interdisciplinary care team and student-mentor approach. We see a continuous
call to action for these types of learning initiatives from AAHPM members. Last
year, we partnered with Four Seasons Compassion for Life in North Carolina to
develop a similar curriculum for nurses entering hospice and palliative care
professions. You can learn more online about that in our news release and a
magazine feature.







Once operating in our profession, the next generation is inspired by leaders in
the field and their interests are encouraged in special interests groups.







#5. Palliative Care professionals require self-nurturance for long term success.

The best “medicine” for caregivers does not come in a bottle, but instead: time
in nature, inner work, the desire to transform, self-awareness, cultural
reflection, and self-care.

 









Finally, we welcome the feeling of satisfaction that comes from learning/growing
personally and professionally (while celebrating the lives we touch).

--------------------------------------------------------------------------------

Drew Mihalyo, PharmD is Founder, President, and COO at Delta Care.

About Delta Care:
Delta Care – http://www.deltacarerx.com/, transforms and improves the hospice
pharmacy industry through business transparency, innovation, extreme customer
service, and the maintenance of vital community-pharmacy relationships. As a
pharmacist owned, privately held provider, Delta Care sets the industry
benchmark for pharmacy benefit management, on-demand pharmacist services, and
hospice tailored electronic prescribing. Additionally, Delta Care offers tools
and technologies to simplify essential workflow and ordering processes within
hospice settings.















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WHAT DO YOU NEED TO KNOW ABOUT STATE OPT-OUT PROVISIONS, ACCESS AND COSTS?

Drew Mihalyo, PharmD
Monday, 20 February 2017
Delta Care Rx

A January 2017 article in the New York Times suggests concerns for pharmacists
in the hospice care sector concerned with “aid in dying” impacts on practice and
care

Last month, the New York Times ran an article, “Physician Aid in Dying Gains
Acceptance in the U.S.” It outlines the current “Aid in Dying” debate among
hospice and palliative care physicians and providers. Questions raised through
this debate create ethical, legal, and professional issues for pharmacists and
pharmaceutical companies.

The goal here is not to discuss the moral or ethical dilemmas each of us
necessarily considers deeply and personally. For those who would like to do so,
a 2011 article in “American Journal of Health System Pharmacy” may prove useful.
Also, “Aid-In-Dying Practice in the United States Legal and Ethical Perspectives
for Pharmacy,” was published in Research in Social and Administration Pharmacy
(Summer 2016). The JAMA Journal from January 2016 focused on diverse issues
clinicians face in death, dying, and end of life.

Additionally, clinicians may also wish to refer to position statements on the
issues issued by American Academy of Hospice and Palliative Medicine (AAHPM) and
Hospice and Palliative Nurses Association (HPNA).

Here, we’ll focus on implications of mainstream coverage in the January 2017 New
York Times article. Specifically, this piece will address two issues with
relevance to pharmaceuticals: state opt-out provisions, access and costs.

Issue 1: State Opt-Out Provisions
The New York Times article states that in the U.S. states that have opt out
provisions for hospice physicians: “State opt-out provisions allow any
individual or institution to decline to provide prescriptions.” It follows
logically that pharmaceutical industry professionals would have a similar
ability to decline to provide prescriptions.
Opt out provisions are determined at the state level. State laws impact
pharmaceutical professionals, informing practices and procedures. State
legislatures determine laws regarding professional pharmaceutical practice and
govern access to particular types of medical procedures. Statutes differ from
state to state, and may or may not resemble industry policy. We have a
responsibility to remain current in our area of expertise.

Issue 2: Access and Costs
The article also delineates cost and access concerns of patients who would
choose to end their pain and suffering by ending their lives. Less than one
percent of hospice and palliative care patients in the four U.S. states with
“Aid in Dying” provisions ever choose to exercise those rights. Those few
hospice patients require access to a pharmacist willing to fill their
prescriptions. Then, cost becomes a factor.

The New York Times notes the increase in cost for barbiturates from a couple of
hundred dollars in years past, to $3-4,000 after insurance. The article reveals
that Valeant Pharmaceuticals acquired Seconal, a commonly prescribed
barbiturate, in advance of California’s 2015 legislation. Then, the company
deliberately “spiked the price.”

Apart from ethics concerns, we are left with more questions than answers.
• Should pharmaceutical companies inflate costs for formerly affordable
prescription drugs?
• How should price be determined?
• What mark-up can consumers realistically expect to pay for a prescription?

These types of questions have both broad and situational implications within
pharmaceutical professions. We might also ask if intended usage of the drug
should determine market price, or if substitutions are appropriate in terminal
cases.

Without doubt, informed hospice pharmacists remain critical to pain and symptom
management teams for those with serious illness or at end of life.

--------------------------------------------------------------------------------

Drew Mihalyo is founder and president of Delta Care Rx.

About Delta Care Rx:
Delta Care Rx – http://www.deltacarerx.com/ – transforms and improves the
hospice pharmacy industry through business transparency, innovation, extreme
customer service, and the maintenance of vital community-pharmacy relationships.
As a pharmacist owned, privately held provider, Delta Care Rx sets the industry
benchmark for pharmacy benefit management, on-demand pharmacist services, and
hospice tailored electronic prescribing.

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ACUTE MYOCARDIAL INFARCTION IN WOMEN

Holly Lassila, DrPH, MSEd, MPH, RPh
Monday, 07 November 2016
Delta Care Rx

The American Heart Association recently released a scientific statement
concerning Acute Myocardial Infarction in Women.1 Cardiovascular disease is
still the leading cause of death in women in the United States and globally and
of the 2.7 million women with a history of an (myocardial infarction) MI, more
than 53,000 have died of an MI, and an estimated 262,000 were hospitalized for
AMI and unstable angina. The differences in the clinical presentation between
men and women have consequences for timely identification of symptoms,
appropriate triage, diagnostic testing and treatment. Compared with men women
are more likely to have pain in the upper back, arm, neck, and jaw as well as
unusual fatigue, flu-like symptoms, dyspnea, indigestion, nausea/vomiting,
palpitations, weakness, and a sense of dread and anxiety feeling.

Mehta LS, et al reported the top ten things to know about acute myocardial
infarction in women:

1. Although there has been a reduction in cardiovascular mortality death in
women in the US, there has not been a substantial decline in acute MI event
rates or MI deaths in young women. 

2. Compared with older women, younger women are trending with worse risk factor
profiles and higher mortality.

3. Plaque characteristics differ for women, and recent data have suggested a
greater role of microvascular disease in the pathophysiology of coronary events
among women even though epicardial coronary artery atherosclerotic disease
remains the basic cause of acute MI in both men and women.

4. Date from autopsy studies have shown that women have an increased prevalence
of plaque erosion compared to men, and that MI without obstruction coronary
artery disease (CAD) is more common at younger ages and among women.

5. Any young woman who presents with an acute coronary syndrome without typical
atherosclerotic risk factors should be suspected of having spontaneous coronary
artery dissection (SCAD). This is a very rare condition and occurs more
frequently in women. The clinical presentation of SCAD can be unstable angina,
MI, ventricular arrhythmias, and sudden cardiac death.

6. Recent evidence suggests that depression in women is a powerful predictor of
early-onset MI, showing a strong association with MI and cardiac death in young
and middle-aged women than in men of similar ages. In the general population,
depression is 2 times more prevalent in women than in men.

7. Women with risk factors such as high blood pressure and diabetes have an
increased risk of heart attack compared to men.

8. As mentioned above, women are more likely to present with pain in the upper
back, arm, neck, and jaw, as well as unusual fatigue, dyspnea, indigestion,
nausea/ vomiting, palpitations, weakness, and a sense of dread, compared with
men who present with central chest pain.

9. Research suggests that women are delayed in seeking treatment for acute MI
compared to men. Reasons for the delay include living alone, interpreting
symptoms as non urgent and temporary, consulting with a physician or family
member and fear and embarrassment.

10. Women, compared to men, tend to be undertreated and are less likely to
participate in cardiac rehabilitation after a heart attack.

--------------------------------------------------------------------------------

 Submitted by: Holly Lassila, DrPH, MSEd, MPH, RPh; Hospice Clinical Pharmacist
at Delta Care Rx

--------------------------------------------------------------------------------

 References:
1. Mehta LS, et al; on behalf of the American Heart Association Cardiovascular
Disease in Women and Special Populations Committee of the Council on Clinical
Cardiology, Council on Epidemiology and Prevention, Council on Cardiovascular
and Stroke Nursing, and Council on Quality of Care and Outcomes Research. Acute
myocardial infarction in women: a scientific statement from the American Heart
Association [published online ahead of print January 25, 2016]. Circulation.
doi: 10.1161/CIR.0000000000000351.

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HAART AND PALLIATIVE CARE: A COMBINED APPROACH

Sydney Janusey, PharmD
Monday, 03 October 2016
Delta Care Rx

Drug therapies continue to evolve so often that the goals of their intended care
for certain disease states also change. A classic example of this shift would be
the medications used to treat HIV and AIDS. Less than a few decades ago the
medications for HIV/AIDS were purely thought as palliative and were used to keep
patients from suffering near the end of life. Now with highly active
antiretroviral therapy (HAART) as a first line treatment option, patients are
living without an imminent threat to their health status. However, there are a
few points to consider when looking at HAART and patients at the end of their
life in need of symptom management and palliation. The drugs used to treat
HIV/AIDS come with a lot of side-effects and drug interactions, particularly
interactions with medications used in palliative care. Palliative care in
HIV/AIDS does not always have to be an alternative treatment, but one that can
be combined with disease-state focused therapy1.

Important goals of palliative care include treating pain, fatigue, weight loss,
nausea, vomiting, and depression. Here are some examples of medications
appropriate for treating these signs.
1. For the symptom of fatigue, consider managing with prednisone, dexamethasone,
or methylphenidate.2

2. For the symptom of weight loss, consider managing with prednisone,
dexamethasone, or megestrol acetate (non-preferred).2
3. For the symptom of nausea and vomiting, consider managing with
metoclopramide, haloperidol, prochlorperazine, promethazine, lorazepam, or
corticosteroids.2
4. For the symptom of depression, consider managing with methylphenidate,
prednisone, or dexamethasone.2

As medications are added to a patient’s care plan it is very important to
consider a few crucial interactions between HAART and commonly used palliative
care medications.2 The protease inhibitors ritonavir, indinavir, nelfinavir,
saquinavir and amprenavir as well as non-nucleoside reverse transcriptase
inhibitor (NNRTI) delavirdine interact with commonly used antidepressants
including fluoxetine, paroxetine and sertraline. The NNRTIs efavirenz and
nevirapine interact with anticonvulsants carbamazepine, phenytoin, and
phenobarbital. In addition to these interactions on the basis of the cytochrome
P450 enzyme the following medications should also be used with caution:
meperidine, methadone, codeine, morphine, fentanyl, dronabinol, benzodiazepines
and zolpidem.2

Inevitably there will come a time when discontinuation of HAART is warranted.2
With this discussion comes the question of benefit versus. risk of therapy.2 The
benefit is based on the patient’s prognosis and treatment goals for their end of
life care. The benefits of continuing therapy include protection against
encephalopathy or dementia, relief of constitutional symptoms and a
psychological benefit from comfort that treatment is being maintained.2 The risk
includes the continued build up of adverse effects from medications no longer
truly working, patient comfort, and complication of end of life care and advance
planning.2

As palliative care services continue to grow and play a greater role the trend
is shifting towards palliation of symptoms.2 These medications should be given
much earlier in care allowing patients to be comfortable for a longer period of
time than just at the end of life.2 Eventually, however, removing HAART with a
heavy side-effect profile and focusing on symptom palliation will lead to the
most comfort for the patient and ideal treatment for their last days.1

--------------------------------------------------------------------------------

 Submitted by: Sydney Janusey, PharmD; Hospice Clinical Pharmacist at Delta Care
Rx

--------------------------------------------------------------------------------

References:
1. O’Neill, Joseph F et al. A Clinical Guide to Supportive and Palliative Care
for HIV/AIDS. US Department of Health and Human Services. Health Resources and
Services Administration. HIV/AIDS Bureau. 2003. Accessed February 28, 2016.

2. Selwyn, Peter A; Forstein, Marshall. Overcoming the False Dichotomy of
Curative vs Palliative Care for Late-Stage HIV/AIDS. JAMA, Vol 290, No 6. August
13, 2003.Accessed February 16, 2016.

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PURPLE IS NOT THE NEW YELLOW: A CLINICAL LOOK AT PURPLE URINE BAGS

Michelle Mikus, PharmD
Thursday, 01 September 2016
Delta Care Rx

From orange to red and all shades of yellow, most clinicians can list reasons
for discolored urine. When urine appears purple, however, both patients and
clinicians are taken off guard. Interestingly enough, Purple Urine Bag Syndrome
(PUBS) is a very real however rare clinical phenomenon that cannot go unnoticed.

Purple urine bags are just that -the bags themselves appear to have a purple
tint. The urine itself is not discolored. This happens when gram-negative
bacteria that produce two specific enzymes (phosphatase and sulfatase) are
present in the urine and react with PVC urinary catheters and bags. While
urinary tract infections are common, especially among patients in long term care
facilities, PUBS is not common since it is dependent on bacteria producing those
specific enzymes.

Patients that present with PUBS are often geriatric females with a history of
constipation and are catheterized. Patients most often have multiple comorbid
conditions, however this could be coincidental due to the age and environment of
care of the patient population from many case studies. Alkaline urine plays an
important role as does dehydration. Constipation allows for an overgrowth of
bacteria which introduces more potential pathogens to the body (including E.
Coli). The final component of the purple color is the presence of tryptophan in
the body, which when in the presence of sulfatase and phosphatase in an alkaline
environment is converted to indigo (blue) and indirubin (red). When indigo and
indirubin combine, they appear purple to the eye.

A purple urine bag is very apparent indication of a urinary tract infection that
needs treated. If not treated quickly, septicemia can occur and outcomes can be
fatal, especially considering the population this most often occurs in. By
treating the underlying infection and therefore eliminating the presence of
phosphatase and sulfatase in the urine, the urine bag for a catheterized patient
will no longer turn purple in color when replaced.

--------------------------------------------------------------------------------

 Submitted by: Michelle Mikus, PharmD; Hospice Clinical Pharmacist at Delta Care
Rx; Pharmacy Manager at ProCure Pharmaceutical Services

--------------------------------------------------------------------------------

 References:

 1. Lin CH. Huang HT. Chien CC, et al. Purple urine bag syndrome in nursing
    homes: ten elderly case reports and a literature review. Clin Interv Aging.
    3:729-34. 2008

 2. Harun NS, Nainar SK, Chong VH. Purple urine bag syndrome: a rare and
    interesting phenomenon. South Med J. 100:1048-50. 2007

 

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LACK OF E-PRESCRIBING CONTROLLED SUBSTANCES BY DOCTORS

Delta Campus Pharmacy Student
Monday, 22 August 2016
Delta Care Rx

A recent article in USA Today discussed the fact that although electronic
prescribing of prescriptions, specifically controlled substances, would be a
great way to cut down on abuse and fraud the majority of the United States is
not utilizing this system. Only 7% of doctors are electronically prescribing
controlled substances today. Currently only three states actually require that
controlled substances be e-prescribed, however, only two of these three actually
enforce this law. The three states that require controlled substances to be
e-prescribed include Minnesota, New York and Maine.

Minnesota was the first state to require e-prescribing of controlled substances,
although they do not allow physicians to be penalized for not doing so. New York
requires physicians to check the online database to see if patients are getting
controlled substances elsewhere before prescribing. They are then required to
e-prescribe these prescriptions or they could face legal action. Maine became
the third state to require e-prescribing of controlled substances in April 2016
and starting January 2017 physicians could face fines and/or jail time for not
doing so.

Opioid abuse is one of the leading causes of death in the country currently,
much of the abuse stemming from prescription painkillers. Physicians e-prescribe
non-controlled medications on a regular basis and now that they have the ability
to electronically send prescriptions to pharmacies for controlled substances
they should be utilizing this software. Eliminating paper prescriptions can
ensure that the patient is not altering the prescription in anyway, it would
lessen the chance of patients ‘doctor-shopping’ to get multiple prescriptions,
and it could prevent the chance of physician prescription pads being stolen
which we see in the news all too often. Some people are afraid that although
e-prescribing may make it harder for drug users to get their hands on controlled
substances it could lead to these individuals turning to heroin to get their fix
instead. Either way you look at the issue it is amazing that so few physicians
are taking advantage of this new technology simply as an easier way to keep
records if nothing else.

Hospices utilizing e-prescribe technology automatically meet federal and state
regulations regarding how prescriptions are issued for controlled substances.
Delta Care Rx is the only hospice pharmacy benefit manager in the United States
that has developed their own proprietary e-prescribing platform for hospice
clients. Currently, more than 250 clinicians use the Delta Care Rx e-prescribing
tool. The number of hospice clinicians utilizing the Delta Care Rx e-prescribing
technology is expected to quadruple by 2017 says Drew Mihalyo, PharmD who is the
President and COO of Delta Care Rx.

--------------------------------------------------------------------------------

Submitted by: Stephanie Stuparitz, PharmD Candidate 2017, Duquesne University

--------------------------------------------------------------------------------

Reference:
O’Donnell J. Most doctors don’t use e-prescribing for opioids. USA Today. May
19, 2016: 3A.

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REVIEW OF ADDISON’S DIEASE

Lori Osso-Connor, PharmD, CGP
Monday, 01 August 2016
Delta Care Rx

Addison’s disease or adrenal insufficiency is a very rare hormonal disorder. It
is so rare that this condition is often not discussed in end of life care. It
can be useful to understand Addison’s disease and the management of this
condition as many of these patients are on steroid therapy that may overlap with
the hospice plan of care. This highlights importance of obtaining a complete and
accurate medical history on admission to ensure that we have a full
understanding of why the patient is on a current medication therapy.

Addison’s disease is a result of a hormanal change in the adrenal glands. The
adrenal glands are walnut sized organs that sit on top of the kidneys. Their
function is to produce cortisol, aldosterone, and DHEA (dehydroepiandrosterone)
which are necessary for many functions in the body. There are two types of
adrenal insufficiency: primary adrenal insufficiency and secondary adrenal
insufficiency. Primary adrenal insufficiency occurs when the adrenals cannot
produce enough cortisol and/or aldosterone due to some type of damage to the
adrenals caused by an infection, virus, or autoimmunity. Approximately 80% of
Addison’s disease is caused by an autoimmune disorder. This is when the body’s
immune system attacks its own organs. Secondary adrenal insufficiency occurs
when the pituitary in the brain fails to produce ACTH (adrenocortisotropin).
Secondary adrenal insufficiency may be caused by the abrupt discontinuation of
high doses of steroids, surgical removal of pituitary tumor, or a change in the
pituitary gland function. ACTH is needed to stimulate the production of
cortisol. If the ACTH is low, the cortisol will also be low.

The HPA axis (hypothalamic-pituitary-adrenal axis) is a negative feedback
mechanism which functions to control cortisol levels. In the brain, the
hypothalamus releases corticotrophin releasing hormone(CRH) which then signals
the pituitary to release ACTH. ACTH signals the adrenals to make cortisol. When
cortisol levels peak, there is a negative feedback that tells the hypothalamus
to stop releasing CRH and thus the pituitary to stop making ACTH.

Cortisol, a glucocorticoid, aldosterone, a mineralcorticoid, and DHEA, sex
hormones, have many functions in the human body. Cortisol helps to maintain
blood pressure, regulate metabolism, and slows the inflammatory response.
Aldosterone works to maintain blood pressure and balance sodium and potassium.
If aldosterone is low, sodium is decreased and potassium is increased. DHEA
makes the sex hormones androgen and estrogen.

The symptoms of adrenal insufficiency include: weight loss, fatigue, abdominal
pain, muscle weakness, nausea and vomiting, hypotension, dizziness,
hypoglycemia, and salt craving. Additionally, hyperpigmentation can occur in
primary adrenal insufficiency. This is due to the high ACTH stimulation the
melanocytes in the skin especially in the skin folds, elbows, knees, and palms
of the hands.

The primary treatment for adrenal insufficiency is the replacement of oral
hydrocortisone (a glucocorticoid) plus or minus fludrocortisone (a
mineralcorticoid). If the patient becomes ill or has an accident and is unable
to swallow, the injectable form of hydrocortisone must be administered. Events
such as surgery or pregnancy would also cause those with adrenal insufficiency
to be managed with the injectable formulation instead of oral. When a patient
becomes ill, they must follow a stress dosing plan by doubling or tripling the
steroid doses dependent on the numerical value of the fever as the body requires
more cortisol to deal with the acute illness.

Patients must be very compliant or they could end up in an Addisonian crisis
which could lead to shock and death. Symptoms of an adrenal crisis include: low
blood pressure, low blood sodium, low blood glucose, and high blood potassium.

Adrenal insufficiency is diagnosed through blood and urine tests. This will help
to determine the cortisol level. If the cortisol level is low, an ACTH
stimulation test will be done. The patient will be given an IV injection of
synthetic ACTH and samples of blood, urine or both are taken before and after
the injection. If the cortisol rises in response to the ACTH, Addison’s can be
ruled out. A little or no increase indicates adrenal insufficiency. If the ACTH
test is abnormal, a CRH stimulation test can be done to determine the cause of
the adrenal insufficiency. A patient is injected with synthetic CRH and blood is
taken before, 30, 60, 90, 120 minutes after the injection. Addison’s patients
will produce a high ACTH with no cortisol response. Those with secondary adrenal
insufficiency will fail to produce ACTH or it is delayed. If it is delayed, the
hypothalamus is the cause. If no ACTH is produced, the pituitary is the cause.
Other tests may include an ultrasound of the abdomen to see if there are
structural abnormalities in the adrenals, a tuberculin test, and antibody blood
tests.

Those with adrenal insufficiency should always wear a medic alert bracelet to
indicate that they are cortisol dependant. They also need to always carry the
injectable form of the corticosteroid in the event of an emergency.

There is still a lot to learn with adrenal insufficiency. The recent article,
The Diagnosis and Treatment of Primary Adrenal Insufficiency in the Journal of
Clinical Endocrinology acknowledges that diagnostic procedures and treatment
strategies are far from optimal. They also state that the validity of the
adrenal function tests are questionable. Salivary cortisol testing which has
been done by functional medicine for many years is only recently being
acknowledged in the medical world as a biomarker. Liquid chromatography testing
is also being studied as a diagnostic test. Additionally, replacing cortisol has
no effect on the HPA axis and ACTH levels remain high. Drugs such as rituximab
and tetracosactide has resulted in regeneration of cortisol production.
Immunomodulatory treatment to stop the autoimmune response may eventually be the
treatment for those with autoimmune adrenal insufficiency. They have also
documented a successful adrenal transplantation. As you can see, much work needs
done so that adrenal insufficiency can have a cure and not just a treatment.

--------------------------------------------------------------------------------

References:
1. Bornstein, SR, Bruno A, Wiebke A, Andreas B, Don-Wauchope A, Hammer GD, et
al. "Diagnosis and Treatment of Primary Adrenal Insufficiency: An Endocrine
Society Clinical Practice Guideline." The Journal of Clinical Endocrinology &
Metabolism 101.2 (2016): 364-89. Web.
2. Loechner, K. "Adrenal Insufficiency and Addison's Disease." N.p., May 2014.
Web. 12 Feb. 2016.

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MANAGEMENT AND TREATMENT OF GOUT

Irene Petrides, PharmD
Friday, 15 July 2016
Delta Care Rx

Gout is a syndrome of acute or chronic recurrent arthritis and pain. The
incidence of this condition continues to rise with increasing age. Therefore,
this condition is a common comorbidity for many hospice patients. Reviewing the
characteristics of gout and how to most appropriately manage this condition can
help us to also best manage our hospice patients.  

Gout is characterized by having chronic hyperuricemia. Hyperuricemia is defined
as having urate levels greater than 6.8 mg/dl which is considered the level at
which the physiological saturation threshold is exceeded.5 Hyperuricemia is the
result of overproduction or underexcretion of uric acid. Increased production of
uric acid is less common but is seen in myeloproliferative disorders or
lymphoproliferative disorders.1 The risk of developing gout can be associated
with medications, renal disease, obesity, and hypothyroidism.2 Medication that
are most frequently associated with gout are thiazide and loop diuretics.
Stress, trauma or alcohol ingestion may also result in an acute gout attack. Due
to multiple comorbid conditions with combination of medication use, the elderly
have an increased occurrence of developing gout.5

The clinical presentation of an acute gouty attack includes the abrupt onset of
joint inflammation causing pain and swelling. This can occur at any time of the
day be seems to present most often during the night. Gout commonly affects the
first metatarsophalangeal joint and can also affect the feet, ankles, heels,
knees wrist, fingers, and elbows. Symptoms include fever, chills, warmth,
swelling, erythema, and intense pain of the involved joint.2 An untreated, mild
gout attack will usually subside within 3 to 10 days. However, nephrolithiasis,
nephropathy, or urate deposits in affected joints can occur in severe cases.1
Treatment of an acute gout attack should start immediately following symptoms
and include the use of nonsteroidal anti-inflammatory drugs (NSAIDs),
colchicine, and/or corticosteroids.2

Due to excellent efficacy NSAIDs are considered first line therapy for gout
management. Indomethacin, naproxen, and sulindac are approved for labeling by
the Food and Drug administration for the treatment of gout. Note other NSAIDs
can be used in the treatment of gout but they do not all have the labeled
indication for treating gout. Therapeutic success is based on how quickly the
drug is initiated. High dose therapy should be initiated and continued for 24
hours after complete resolution of gout and then taper down over 2 to 3 days.
After initiating therapy, resolution of gout should occur within 5 to 8 days.2
NSAIDs should be monitored closely or avoided in patients with cardiovascular
disease, severe chronic kidney disease, and peptic ulcer disease. Common adverse
effects include gastrointestinal intolerance and worsening of renal function.

Colchicine is a medication which is highly effective at treating an acute gout
attack and produces a response within hours of administration. Colchicine should
be reserved for patients who are unable to take NSAID therapy. However, if
colchicine is not administered within the first 48 hours of onset of an acute
attack, then efficacy is substantially diminished.  Abdominal cramping and
diarrhea may be reported with colchicine therapy. Recommendation include to
start colchicine therapy at initial dose of 1.2mg followed 1 hour later by
another 0.6mg and not to exceed 1.8mg on the first day of therapy. Therapy with
continue at a dose of 0.6mg daily or twice daily until gout attack resolves.2
Due to multiple drug interactions including lipid lower agents, colchicine
should be used with extreme caution due to risk of toxicity. Therefore,
colchicine should be avoided in patients with renal or hepatic disease and would
not be the drug of choice.

Corticosteroids are reserved for patients where NSAID therapy and colchicine
therapy are contraindicated or in patients who do not have clinical response to
NSAIDs or colchicine.1,4 Patients with gout in multiple joints may benefit from
the use of an oral corticosteroid.2 High dose therapy is initiated at onset of
gout for 3 to 5 days and then should be tapered gradually over 10 to 14 days in
order to avoid a rebound attack. Although most patients tolerate oral
corticosteroids, common adverse effects may include mood changes, flood
retention, hyperglycemia and increased blood pressure.5

Allopurinol is indicated for prophylactic therapy. Allopurinol is usually
initiated after the first gout attack or after the passage of the first renal
stone. If the first gout attack was mild and quickly responded to therapy,
allopurinol does not need to be initiated.2 Initial dose of allopurinol is 100mg
per day and titrated up 100mg per week to achieve a uric acid level of 6 mg/dL
or less with a maximum dose of 800mg per day. Adverse effects include skin rash,
leukopenia, gastrointestinal problems, headache and urticarial.4

When treating gout, a comprehensive treatment strategy is required. This
includes lifestyle changes including a restricted diet. Comorbidity and
medication use need to be taken into account. Initiate immediate treatment of
acute gout flares with NSAIDS, colchicine or corticosteroids. When indicated,
initiate uric acid lowering therapy (allopurinol) at the proper time usually
weeks after an acute flare is subsided. Recognizing the signs and symptoms of
gout in a timely manner is the primary contributing factor to a desired
therapeutic outcome. The goal of therapy is to reduce pain and disability with
minimal adverse effects.

--------------------------------------------------------------------------------

References

 1. Khanna D, Fitzgerald JD, Khanna PP, Bae S, Singh MK, Neogi, T. Terkeltaub,
    R. (2012). 2012 American College of Rheumatology guidelines for management
    of gout. Part 1: Systematic nonpharmacologic and pharmacologic therapeutic
    approaches to hyperuricemia. Arthritis Care Res Arthritis Care & Research,
    64(10), 1431-1446.

 2. Khanna D, Khanna PP, Fitzgerald JD, Singh MK, Bae S, Neogi T, Terkeltaub, R.
    (2012). 2012 American College of Rheumatology guidelines for management of
    gout. Part 2: Therapy and antiinflammatory prophylaxis of acute gouty
    arthritis. Arthritis Care Res Arthritis Care & Research, 64(10), 1447-1461.

 3. Edwards N, Sundy J, Forsythe A, Blume S, Pan F, Becker M. (2010). Work
    productivity loss due to flares in patients with chronic gout refractory to
    conventional therapy. Journal of Medical Economics, 14(1), 10-15.

 4. Edwards N, Sundy J, Forsythe A, Blume S, Pan F, Becker M. (2010). Work
    productivity loss due to flares in patients with chronic gout refractory to
    conventional therapy. Journal of Medical Economics, 14(1), 10-15.

 5. Mandell, BF. (2008). Clinical manifestations of hyperuricemia and gout.
    Cleveland Clinic Journal of Medicine, 75(Suppl_5).





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MANAGEMENT OF ORTHOSTATIC HYPOTENTION

Guest
Wednesday, 01 June 2016
Delta Care Rx

Orthostatic hypotension affects 20-30% of the population over 65.1 Orthostatic
hypotension or postural hypotension is a form of low blood pressure that occurs
when you stand up from a sitting or lying down position. It is defined as a drop
in systolic blood pressure by ≥20 mmHg and ≥10 mmHg for diastolic blood
pressure. Normal individuals only have a 5-10 mmHg drop in their systolic blood
pressure when standing. There are many pharmacologic and nonpharmacologic
therapies used to treat orthostatic hypotension. Examples of pharmacologic
therapy include midodrine and fludrocortisone, whereas nonpharmacologic
therapies involve body manipulation, postural changes and diet. Note that the
use of fludrocortisone in the management of orthostatic hypotension is
considered an off-label use of this medication.

Midodrine targets the alpha adrenergic receptors on the vasculature, but does
not target the central nervous system therefore this medication is not
associated with central nervous side effects because it does not cross the blood
brain barrier. Midodrine is often dosed 2-3 times daily at a starting dose of
2.5mg with peak effect at 25-30 minutes. Doses are often increased rapidly until
response is achieved with a maximum of 30mg per day.2 Potential adverse effects
include uterine contractions, tachycardia, headaches, palpitations and arterial
hypertension, especially in supine position.2 Final doses of midodrine should be
taken 4 hours prior to bedtime in order to reduce supine hypertension.

Fludrocortisone is a mineralocorticoid. This medication stimulates the release
of salt into the bloodstream. By increasing blood volume there is a rise blood
pressure. Therapy is initiated at 0.1mg per day. Peak effect occurs in 1-2 weeks
therefore dosing should be increased at weekly or biweekly intervals. Most
patients obtain optimal blood pressure control at 0.3-0.4mg per day. Potential
adverse effects include hypokalemia and hypomagnesemia, supine hypertension, and
headache.3 In addition, the patient may gain up to 8 pounds in weight when
maximal effect of therapy is achieved.3

Nonpharmacologic therapy in orthostatic hypotension can provide an integral role
in reducing a blood pressure drop upon standing. Therapies include an addition
of salt to the diet or salt tablets in order to correct salt depletion due to
polyuria and poor oral intake. Moderate physical exercise has been shown to
improve orthostatic tolerance. Compression stockings and abdominal binders have
been shown to be effective, although if patient can tolerate, abdominal binders
have been shown to be more effective. Physical maneuvers such as crossing the
legs or bending forward can help raise blood pressure. Another approach to a
nonpharmacologic treatment for orthostatic hypotension is sleeping in the head
up position. Although, the efficacy of head tilt has not been determined. It is
important to have the patient stand up slowly from the supine position. Also,
prolonged exposure to heat can exacerbate orthostatic hypotension. Therefore,
reducing exposure can limit complications.4

In concluding, a combination of pharmacological and nonpharmacological therapies
should be considered in treating orthostatic hypotension. The methods summarized
in this article can provide beneficial outcomes. Using these methods, it is
possible to reduce undesired issues with orthostatic hypotension such as falls,
loss of consciousness and even broken bones.

Submitted by: Irene Petrides, PharmD, Hospice Clinical Pharmacist at Delta Care
Rx

--------------------------------------------------------------------------------

References:
1. Rutan G, Hermanson B, Bild D, Kittner S, LaBaw F, Tell G. Orthostatic
hypotension in older adults. The Cardiovascular Health Study. CHS Collaborative
Research Group. Hypertension. 1992;19(6_Pt_1):508-519.
doi:10.1161/01.hyp.19.6.508..

2. Doyle. Midodrine: use and current status in the treatment of hypotension. Br
J Cardiol. 2012;19(1). doi:10.5837/bjc.2012.007.

3. Medow M, Stewart J, Sanyal S, Mumtaz A, Sica D, Frishman W. Pathophysiology,
Diagnosis, and Treatment of Orthostatic Hypotension and Vasovagal Syncope.
Cardiology in Review. 2008;16(1):4-20. doi:10.1097/crd.0b013e31815c8032.

4. Thompson, P., Wright, J., & Rajkumar, C. (2011). Non-pharmacological
treatments for orthostatic hypotension. Age and ageing, 40(3), 292-293.

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ESTIMATING RISK FOR THROMBOEMBOLISM IN ATRIAL FIBRILLATION: THE ATRIA RISK SCORE

Shane Donnelly, PharmD
Wednesday, 01 June 2016
Delta Care Rx

Atrial fibrillation, or Afib, is essentially a temporary, semi-permanent, or
permanent change in the electrophysiology of the atria of the heart. Afib is the
abnormal rapid contraction of the atria, resulting in an irregular
atrioventricular contraction rhythm. This decreases the heart’s ability to eject
blood through the body efficiently (decreased cardiac output), thus increasing
stasis of pooled blood within the chambers of the heart. Patients with atrial
fibrillation are at an increased risk for arterial thromboembolic events because
of the procoagulant effect of hemostasis.

The most common arterial thromboembolic event correlated with atrial
fibrillation is ischemic stroke. Determining the risk for thromboembolism in
these patients is multifactorial and risk factors such as concurrent valvular
heart disease (i.e. mitral valve stenosis, prosthetic valves etc.),
significantly increase the risk for thromboembolism.1 In patients with valvular
heart disease, the risk for thromboembolism high and anticoagulation or
antiplatelet therapy should be utilized, barring significant contraindications
to either warfarin (Coumadin) or aspirin. Hospice patients with prosthetic
valves, mechanical valves, or significant valvular stenosis should maintain
anticoagulation or antiplatelet therapy until the patient loses the ability to
swallow, or a bleeding diathesis poses a greater risk to the patient and family
than the benefit of preventing an ischemic stroke.

In patients with non-valvular atrial fibrillation, the risk of stroke is less
significant and warrants an investigation into the patient’s risk of having an
ischemic event. There are several modalities by which to estimate risk for
thromboembolism in patients with non-valvular atrial fibrillation. The CHADS2
and CHA2DS2-VASc scores are the most common scoring tools utilized by
clinicians. Each scoring system is briefly described below.2

CHADS2 - Assigns points to patients based upon risk factors proven in various
trials to increase the risk for ischemic stroke in patients with atrial
fibrillation. Does not take into account previous history of arterial vascular
disease (aortic plaque, myocardial infarction, peripheral arterial disease,
etc.) or sex. Assigns 1 point for: congestive heart failure, hypertension, age
greater than 74, or the presence of diabetes mellitus. Assigns 2 points to
patients with a history of stroke/TIA. In this scoring system, patients with a
score of 0 are considered low risk, a score of 1 equates to a moderate risk, and
2 or greater indicates a high risk patient.

CHA2DS2-VASc - Broadens stroke risk assessment for patients between the ages of
65-74, adds increased risk points for age greater than 74, and includes history
of arterial vascular disease and female sex as additional risk factors. Assigns
1 point for: congestive heart failure, hypertension, presence of diabetes
mellitus, arterial vascular disease, age between 65-74, or female sex. Assigns 2
points for an age greater than 74 years and history of stroke/TIA. This risk
estimation system utilizes the same risk score-based anticoagulation parameters
as CHADS2.

The 2014 AHA/ACC/HRS guidelines recommends utilizing vitamin K antagonists (i.e.
warfarin) or novel oral anticoagulants (rivaroxaban [Xarelto ®] or apixaban
[Eliquis ®]) with a CHADS2 or CHA2DS2-VASc score of 2 or greater (moderate-high
risk).3 The downfall to utilizing these risk assessments is the underestimation
of low risk in patients who fit parameters for high risk of stroke.

The ATRIA (Anticoagulation and Risk Factors in Atrial Fibrillation) risk score
is a novel tool designed to more accurately define high risk versus low risk
patients.4 The ATRIA score includes risk factors addressed with
CHADS2/CHA2DS2-VASc and adds the presence of renal dysfunction as an additional
risk factor (eGFR < 45 mL/min or ESRD and proteinuria). The ATRIA risk score,
however, stratifies patients into two categories based on the presence/absence
of stroke/TIA in the past medical history. This unique feature of ATRIA may
provide additional clinical significance in avoiding anticoagulation when it may
actually not be clinically necessary.

In hospice patients, the need for anticoagulation is a clinical conundrum that
frequently leaves clinicians wondering if anticoagulation is necessary. Patients
may or may not be able to swallow, which complicates matters further. The ATRIA
risk score may provide hospice clinicians a better picture as to whether
anticoagulation is necessary. The scoring system is more time-intensive in
comparison to the CHADS2/CHA2DS2-VASc stroke risk scores, but in the end may be
able to help prevent adverse bleeding events and can become a cost-effective
approach to anticoagulation in hospice patients. The scoring system is as
follows:4

Risk Factor Points without prior stroke Points with prior stroke Age (years)    
        85 or greater 6 9                75-84 5 7                65-74 3 7    
             Less than 65 0 8 Female 1 1 Diabetes 1 1 CHF 1 1 Hypertension 1 1
Proteinuria 1 1 eGFR less than 45 mL/min 1 1

In patients with an ATRIA risk score of 6 or below, the risk of stroke per 100
patient years is approximately that of a CHADS2/CHA2DS2-VASc stroke risk score
or 0-1.2 In patients scoring above a 6, the benefits of stroke prevention most
likely outweigh the risk of major bleeding with anticoagulation. In patients
with a score less than 6, it may be feasible to discontinue anticoagulation or
downgrade the intensity of anticoagulation. Downgrading anticoagulation could
include discontinuing warfarin or the novel oral anticoagulants, discontinuing
clopidogrel, and switching the patient to low-dose aspirin (81 mg orally once
daily). If the patient’s ATRIA scores are as low as 2, anticoagulation is most
likely unnecessary.

Most clinicians are familiar with the CHADS2/CHA2DS2-VASc stroke risk scores.
Some hospice patients may require a more rigorous assessment of stroke risk, and
the benefits of anticoagulation should be weighed versus the risks of adverse
bleeding events, drug interactions, and the evolving issue of polypharmacy. It
may be advantageous to consider utilizing the ATRIA risk score to assist with
anticoagulation decision making at the end-of-life in patients with non-valvular
atrial fibrillation. Populations that may particularly benefit from an ATRIA
risk assessment include patients with no history of stroke/TIA and those at an
older age without renal dysfunction or other significant comorbidities.

--------------------------------------------------------------------------------

References:
1. Nishimura R, Otto C, Bonow R et al. 2014 AHA/ACC Guideline for the Management
of Patients With Valvular Heart Disease: Executive Summary: A Report of the
American College of Cardiology/American Heart Association Task Force on Practice
Guidelines. Circulation. 2014;129(23):2440-2492. Accessed December 14th 2015.
2. Friberg L, Rosenqvist M, Lip G. Evaluation of risk stratification schemes for
ischaemic stroke and bleeding in 182 678 patients with atrial fibrillation: the
Swedish Atrial Fibrillation cohort study. European Heart Journal.
2012;33(12):1500-1510. Accessed December 14th 2015.
3. January C, Wann L, Alpert J et al. 2014 AHA/ACC/HRS Guideline for the
Management of Patients With Atrial Fibrillation: Executive Summary.Journal of
the American College of Cardiology. 2014;64(21):2246-2280. Accessed December
15th 2015.
4. Singer D, Chang Y, Borowsky L et al. A New Risk Scheme to Predict Ischemic
Stroke and Other Thromboembolism in Atrial Fibrillation: The ATRIA Study Stroke
Risk Score. Journal of the American Heart Association.
2013;2(3):e000250-e000250. Accessed December 17th 2015.

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