March 2017, Issue 11

Inside This Issue

New Definition of Epilepsy May Improve Treatment

Popular Heartburn Medication Linked to Increased Stroke

Marijuana Ingredient Shows Promise in Seizure Reduction

Technology & Innovation: Tweaked DNA as Electrical Switches?

Government Relations: Wandering Poses Challenges for New Medicaid Waiver Rules

Clinical

The Post Script

New Definition of Epilepsy May Improve Treatment

The definition of epilepsy has recently changed to help physicians and

healthcare professionals treating patients with suspected epilepsy to improve

the timeliness of diagnostic and treatment options.

Before the revision, the guideline was for physicians to wait until 2 spontane-

ous seizures occurred before treating a patient with suspected epilepsy. How-

ever, this raises questions such as “Is it necessary or appropriate to put off

treatment until 2 seizures have been experienced?” and “If it is known that

epilepsy has developed, should physicians still wait to initiate treatment?”

The revised definition removes any burden on physicians to determine the risk of a second seizure for each patient.

Physicians are now trying to diagnose epilepsy after the first sei-

zure, as long as the necessary evidence is present.

In the article “A Practical Clinical Definition of Epilepsy,” which

updated the definition of the disease, epilepsy is considered to be

present if there are 2 unprovoked seizures within 24 hours or if

the probability of additional seizures after the first is similar to

the general recurrence risk of 60%.

In addition, the new definition says that if there is enough infor-

mation to diagnose an epilepsy syndrome without the presence

of seizures, a patient can be given a diagnosis of epilepsy.

Although the definition has changed and may speed up diagnosis,

treatment may not be an immediate decision, according to the

session. Time to treatment varies depending on the uncertainty

present after 1 seizure because there is no concrete diagnostic

test for determining the risk of another seizure.

The Post Script | 2

Clinical

March 2017 | Issue 11

Popular Heartburn Medication Linked to Increased Stroke Proton pump inhibitors (PPIs) — used widely to reduce stomach acid and treat heartburn — have been linked to

an increased risk for ischemic stroke in a new study.

The Danish nationwide observational study, presented at the recent American Heart Association (AHA) 2016 Sci-

entific Sessions, showed a dose-related increased risk for ischemic stroke with all four PPIs investigated, but no

increased risk with histamine-2 (H2) blockers, which are used for similar indications.

Researchers say the evidence is not yet strong enough to support stopping use of PPI drugs if they are needed.

However, they would recommend that people should not take these

drugs unless there is a clear indication for them, many people are

taking them unnecessarily or they are continuing to take them long-

term when they don't need to. They would urge doctors to review

their patients on PPIs and look at why they are taking these drugs

and consider whether they really need them or if they could take a

lower dose.

Additionally researchers pointed out that PPIs are available over the

counter in many countries and many patients take them off label,

which "is a concern."

Researchers also concluded that prescriptions of PPIs have increased

rapidly during the past decade and the prevalence of PPI use is high

in the general population, although many patients are taking these

drugs with no obvious indication.

While many states across our nation are engaged in political battles over the recreational use of marijuana, research-

ers have been busy studying the medical benefits of cannabidiol (CBD) for seizures and the results look promising.

Cannabidiol, one of at least 60 cannabinoids contained in the marijuana plant, is a non-psychoactive molecule that

has been considered for a variety of potential clinical uses. New studies, recently released at the annual American Epi-

lepsy Society (AES) meeting in Houston, showed significant benefits over placebo in patients with Dravet syndrome

(DS) and Lennox-Gastaut syndrome (LGS).

Epidiolex®, the name given to this concentrated form of CBD being developed by GW Pharmaceuticals, is an exciting

breakthrough and offers hope to thousands of potential patients.

Adverse effects, while common, were generally mild and well tolerated. These included symptoms such as drowsi-

ness, decreased appetite, diarrhea, fever, vomiting and upper respiratory infection. More serious treatment-related

adverse effects occurred approximately 8.2% of the time in patients compared to a rate of 5.1% for placebo.

While we don’t have any guesses as to if or when a CBD treatment for these rare and debilitating seizures for children

will be widely available as an FDA-approved treatment, expanded access programs are making it easier for physicians

to treat some of their patients right now.

Marijuana Ingredient Shows Promise in Seizure Reduction

The Post Script | 3 March 2017 | Issue 11

Teensy "living" circuits based on DNA could lead to new ways

for scientists to look inside cells and even see chemical reac-

tions such as photosynthesis. However, to create such DNA de-

vices, there has to be a way to run electricity through them.

Until now, that has been a limiting factor.

But now, scientists have turned tiny snippets of DNA into mo-

lecular "on" switches that get electricity flowing on a miniscule

scale. The molecular switches act on a scale 1,000 times small-

er than a strand of hair, meaning they could be used to create tiny, cheap molecular devices, the researchers re-

port in a new study.

The secret to creating these biological electrical switches was tweaking the letters that make up the genetic

code.

The modified DNA could be used to create nanoscale electrical devices. It can also adapt the modified DNA as a

probe to measure reactions at the single-molecule level. This provides a unique way for studying important reac-

tions implicated in disease.

Technology and Innovation Tweaked DNA as Electrical Switches?

Federal officials are chiming in on how to balance independence and safety for people with

disabilities who have a tendency to wander.

In a recently-issued frequently asked questions document, the Centers for Medicare and

Medicaid Services said that there have been concerns as states work to implement new regu-

lations governing Medicaid home and community-based services waivers.

The regulations, which are set to take full effect in March 2019, establish new standards for what settings are consid-

ered community-based.

Services paid for through Medicaid home and community-based services funds cannot be provided at nursing homes,

institutions or intermediate care facilities under the rule. Moreover, settings must be integrated in the community in

places where individuals choose to live and those receiving services must be allowed to make independent choices

about their activities, physical environment and interactions with others.

Those requirements may pose special challenges when serving individuals with disa-

bilities who elope, Medicaid officials acknowledged in issuing the guidance docu-

ment.

When providing home and community-based services to individuals with a history of

bolting, Medicaid officials said that providers should rely on person-centered plan-

ning to create a customized approach to ensure integrated access to the community while guarding against injury.

Wandering Poses Challenges for New Medicaid Waiver Rules

Government Relations

The Post Script | 4 March 2017 | Issue 11

For more information For more information For more information

regarding Pharmacy Services, contact: regarding Pharmacy Services, contact: regarding Pharmacy Services, contact:

Kathleen Brown RN, CDDNKathleen Brown RN, CDDNKathleen Brown RN, CDDN

1 (866) 7431 (866) 7431 (866) 743---244324432443

If you are interested in participating in any of the above complimentary webinars, please email Nanette Wrobel at least one

week in advance @ nwrobel@palrx.com

To subscribe to our monthly newsletter, email: POSTSCRIPT@PALRX.COM

April 7-10th: DDNA Annual conference in Dallas, TX

April 10-12th: Utah Health Care Association (UHCA) in St. George, UT

April 30th-May 1st: SPADD in Augusta, GA

May 1-3rd: ANCOR in San Antonio, TX

Educational Webinars

Topic: “Asthma and COPD”

April 3rd, 2017 @ 9:00 AM CST

April 3rd, 2017 @ 11:00 AM CST

April 14th, 2017 @ 1:00 PM CST

April 14th, 2017 @ 3:00 PM CST

NEW!! New Drug Approvals: Trulance (plecanatide) The FDA announced the approval of Trulance (plecanatide), Syner-

gy’s once-daily oral treatment for chronic idiopathic constipation

(CIC) in adult patients. Those with CIC experience persistent consti-

pation without structural or biochemical explanation. Trulance works

in the upper GI tract to stimulate secretion of intestinal fluid and support regular bowel function.

The approved dosing regimen for Trulance is 3 mg taken orally, once daily, at any time of the day,

with or without food. Trulance can be swallowed whole or crushed in applesauce for those who are

unable to swallow medication.

Trulance should not be used in children less than six years of age due to the risk of serious dehydration. Trulance should be

avoided in patients six years of age to 18 years of age. The safety and effectiveness of Trulance have not been established in

patients less than 18 years of age. Trulance should not be used in patients with known or suspected mechanical gastrointes-

tinal obstruction.

The most common and serious side effect of Trulance was diarrhea. Patients may experience severe diarrhea. If severe diar-

rhea occurs, patients should stop taking Trulance and contact their health care provider.