Cannabidiol Effective and Safe at 3 Months for Epilepsy

Posted on December 1, 2016 by Pharmaciststeve

Cannabidiol Effective and Safe at 3 Months for Epilepsy

http://www.medscape.com/viewarticle/855768?

PHILADELPHIA — New open-label data from the expanded-access treatment program involving the cannabidiol Epidiolex (GW Pharma) show the median reduction in frequency of convulsive seizures after 3 months of treatment was 45% in all patients but higher in those with Dravet syndrome, among the most severe types of epilepsy.

The data are “very positive and promising,” said lead author Orrin Devinsky, MD, professor, neurology, neurosurgery and psychiatry, and director, New York University Comprehensive Epilepsy Center.

A “big caveat,” however, is that this was an open-label study, he said. Results of the first of four placebo-controlled trials of this cannabidiol product are expected early next year.

Dr Devinsky reported the findings here during the American Epilepsy (AES) 69th Annual Meeting.

Convulsive Seizures

Epidiolex is a purified cannabidiol compound in an oil base that is administered as a liquid.

The efficacy analysis included 261 patients with continuous exposure to the drug and on whom investigators had evaluable data. These patients ranged in age from 4 months to 41 years with a median of 11.8 years.

In these patients, 19% had a known cause of their epilepsy. The most common diagnoses were Dravet syndrome (17%), Lennox-Gastaut syndrome (LGS), or another rare type of epilepsy (15%).

The median number of convulsive seizures per 28 days in these patients was 31, so this was a group of children and young adults with “very frequent seizures,” commented Dr Devinsky.

Patients started cannabidiol at a dose of 2 to 5 mg/kg per day, which was gradually increased to a maximum dose of 25 mg/kg per day. They were also taking an average of three antiepileptic drugs (AEDs).

The primary outcome was change in the number of convulsive seizures, which are relatively easy to count, said Dr Devinsky.

“The seizure had to last at least 3 to 5 seconds with convulsive activity, cause the child to drop or fall to the floor or have a tonic-clonic convulsive event,” he noted. These are readily identifiable by most parents who tracked these events in seizure diaries, he said.

The median convulsive seizure frequency reduction was 45.1% in all patients and 62.7% in patients with Dravet syndrome. The median reduction of atonic seizures was 71.1% in patients with LGS.

In terms of achieving a greater than 50% reduction in seizures, this rate was 47% among all patients. During the last 4 weeks of the trial (between weeks 9 and 12), 9% of all patients and 13% of patients with Dravet syndrome were seizure-free.

“These are numbers that are much greater than what I would have predicted, and certainly would have ever predicted for a placebo response,” said Dr Devinsky.

 He stressed that the study population was “an extremely treatment-refractory group.” Such patients are at high risk for sudden unexpected death from epilepsy and status epilepticus.

Safety Data

Safety data were available on 313 treated patients. The most common adverse effects were somnolence (23%), diarrhea (23%), fatigue (17%), decreased appetite (17%), convulsion (17%), and vomiting (10%).

 Dr Devinsky stressed that only 4% of all patients stopped the study medication because of adverse effects. “For an antiepileptic drug trial, that is relatively low.”

About 12% of patients withdrew because of lack of effectiveness, which “again was relatively small” in this type of trial, said Dr Devinsky.

Serious adverse events were reported in 34% of patients and included seven deaths. “None of these were felt by investigators to be related to the study medicine,” said Dr Devinsky.

 Although these new results “add more fuel to the fire showing that this drug is likely to be effective for some people,” without a double-blind study “we are essentially blind to know what the truth is,” said Dr Devinsky.

An interesting study finding was that patients who were taking the AED clobazam had a better overall rate of treatment response (57% with a 50% or greater seizure reduction compared with 39%). This may reflect elevations in the desmethyl clobazam metabolite, he said.

“We think that some of the efficacy — and some of the toxicity — in some patients may have been related to the clobazam,” said Dr Devinsky.

 He noted, however, that there was “absolutely no difference” in the response rate between patients with Dravet syndrome and LGS taking clobazam and those not taking that drug.

Asked whether increasing the dose of clobazam in patients already receiving this drug might have resulted in the same improved treatment response, Kelly Knupp, MD, Children’s Hospital, Aurora, Colorado, said that’s “possible.”

Increased clobazam levels probably reflect “some drug-to-drug interactions that need to be sorted out,” said Dr Knupp, who treats children with epilepsy.

 

She, too, is keen to know what the placebo effect is. “The value of doing a double-blind randomized study is that it takes into account that placebo effect; we just don’t really understand it here.”

In the meantime, she said she’s “guardedly hopeful” about the new results.

 

 

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SG: addiction is a brain disease… bureaucratic answer.. NALOXONE

Posted on December 1, 2016 by Pharmaciststeve

Rising Price of Naloxone Concerns Some Addicts’ Families

http://www.emsworld.com/news/12283380/rising-price-of-naloxone-concerns-some-addicts-families

emptyheadBureaucrats have changed the status of Naloxone to OTC… which means that health insurance doesn’t have to pay for it anymore. Surgeon General recently stated that addiction is a “brain disease”…  So we – as a society – allow addicts to continue to use street drugs – some mixed with illegal drugs (acetyl fentanyl, carfentanil and others) that are basically LETHAL to those buying and using “street drugs”.  Without a clean needle program there is an increased risk of these addicts contracting HIV and Hep B&C… which has a life time therapy cost of upward of $750,000.00 per pt…. and since most of these addicts are not employed nor have health insurance… guess who gets to pick up that tab ???…. Medicaid/Medicare and the American taxpayer. Does the ready availability of Naloxone really SAVE LIVES… or just postpone a OD death to some point in the future ?  Would it be better to just “treat” this addictive brain disease with pharmaceutical grade opiates and clean needles ?  I know of no clinical evidence that reviving a OD’d addict with Naloxone causes a addict to have an epiphany that they need to get sober and change their life style.

Nov. 30–Deena Porter’s 26-year-old daughter has been addicted to pain pills and heroin for half her life, and she can’t be forced into treatment.

But Porter, 54, of McConnelsville in Morgan County, at least had some peace of mind knowing they could afford a lifesaving drug that can reverse an opioid overdose.

That is until recently when, she said, the cost of the naloxone her daughter had been buying went up to almost $50.

“We’re being priced out of the market, and I’m losing my mind,” she said, crying uncontrollably. “If I can’t keep her alive, I can’t eventually get her into recovery.”

Naloxone, which also is sold under the brand name Narcan, works by blocking the effect that painkillers and heroin have in the brain and reversing the slowed breathing and unconsciousness that come in an overdose. It can be given by an injection or nasal spray.

Until the late 1990s, naloxone, which has been around for more than four decades, could be bought for as little as a dollar a dose. Now the drug runs from a little less than $40 for a single generic dose to $3,800 for two auto-injectors that give people administering the drug voice instructions, according to an analysis of Ohio prices by HealthPlan Data Solutions.

The average wholesale cost of a dose of injectable naloxone has more than doubled since 2013, according to data by Truven Health Analytics. This is even as generic versions of naloxone still cost pennies in other countries.

“It’s not cheap. A Narcan spray kit can easily cost $135,” said Dr. Brad Lander, a psychologist and clinical director of addiction medicine at Ohio State University’s Wexner Medical Center. People might need to buy multiple kits over time. And kits have a shelf life of only 18 months to 24 months before they have to be replaced.

“I don’t know if the price increases are legitimate or not,” Lander said. “But I know people will pay whatever they have to to save their loved ones, and I wouldn’t be surprised if the drug companies are taking advantage of that.”

Drug overdoses killed a record 3,050 people in Ohio last year, more than a third of them from fentanyl, a super-potent opiate often mixed with heroin.

“Ohio loses about eight people a day to this terrible epidemic, and it would be dramatically higher if not for naloxone,” Ohio Attorney General Mike DeWine said.

Though naloxone can reverse an overdose from drugs laced with fentanyl and carfentanil, a sedative used on elephants and other large animals, higher or multiple doses of naloxone are often needed to revive patients because of the drugs’ higher potency, DeWine said.

“Tragically, there is no sign that this epidemic is going to drop any time soon,” DeWine said, which is why it is so important to make naloxone more accessible and affordable.

To that end, the state recently reached a deal with Adapt Pharm to freeze the price of its naloxone spray at $75 for two, 4-milligram doses next year to agencies serving the public interest. That’s a 40 percent discount from the business’ wholesale cost of $125.

Ohio also receives a rebate for Amphastar Pharmaceuticals of $6 for each naloxone syringe purchased through early March 2017 through an agreement reached almost two years ago.

The discounts apply to law enforcement; state, county and local government agencies; and Project Dawn community programs that provide naloxone kits and education to the public free of charge.

So far, the agreement has saved Ohioans nearly $392,000, DeWine said.

Ohio Gov. John Kasich signed a bill into law in February 2015 that allows pharmacists to dispense naloxone without a prescription.

Nearly 1,400 pharmacies in 84 of 88 counties offer the drug without a prescription, said Cameron McNamee, spokesman for the Ohio Board of Pharmacy. That’s about two-thirds of all retail pharmacies in the state, up from less than half in August.

To make naloxone more available in all 88 counties, the most recent state budget also included $500,000 to be distributed among the county health departments in fiscal 2016 and 2017. Cuyahoga County received the largest amount ($46,669 annually), followed by Franklin ($44,789) and Hamilton ($29,724).

In 2016, 8,190 kits were distributed and 2,311 lives were saved through overdose reversals, thanks to the investment, according to Eric Wandersleben, spokesman for the Ohio Department of Mental Health and Addiction Services.

The state also set aside another $200,000 for emergency naloxone needs in 2017, he said.

Since April, the Mount Carmel Health System has distributed more than 100 naloxone kits free of charge through its mobile medical coach and at forums held throughout Franklin County to raise awareness about the growing heroin problem, said Brian Pierson, Mount Carmel’s regional director of outreach population.

“If I had a child at home or someone close to me who was addicted, I can say with 100 percent certainty that I would have a kit,” Pierson said.

In September, Columbus Public Health and the Columbus City Council teamed up with Equitas Health to buy naloxone for people who don’t have insurance or can’t afford it. The $20,000 grants will buy about 400 doses of the drug, which officials say probably won’t even last a year.

“If I had a crystal ball, I would say we haven’t even hit the peak of the epidemic yet,” said Peggy Anderson, chief operating officer at Equitas Health. “I don’t know what we’ll do once those doses are gone.”

To find a list of Ohio pharmacies carrying naloxone or Project Dawn sites, go to stopoverdoses.ohio.gov. Because retail prices vary greatly, people should call around before making their purchase.

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A deep dive into kratom, the herb that helps with opioid withdrawal

Posted on December 1, 2016 by Pharmaciststeve

kratom_treeA deep dive into kratom, the herb that helps with opioid withdrawal

https://boingboing.net/2016/12/01/a-deep-dive-into-kratom-the-h.html

Kratom (previously) is a widely used herb that has been very effective in treating opioid withdrawal and other chronic, hard-to-treat conditions — it also became very controversial this year because the DEA decided, without evidence, to class it as a dangerous drug, and then changed its mind (unprecedented!) after a mass-scale petition that included interventions from members of Congress.

Wired has done an excellent, deep dive into kratom, and its past and future — which may include a degree of regulation, but also guarantees of quality. The DEA reprieve is only temporary, and kratom could end up back on Schedule 1 as a dangerous drug, depending on who Trump appoints and what they do.

All that research costs money. Which is kratom’s catch-22: The DEA wants to schedule the drug because they think it might pose a danger to public health, but the only way to confirm (or refute) the DEA’s worries is with more research—which will be next to impossible should the DEA follow through on its promise to schedule.

One of the few scientists studying kratom is the University of Florida’s Oliver Grundmann, who is finishing up an online survey of nearly 10,000 users. And the data (preliminary, though Grundmann plans to publish a paper in the coming months) reveals a different profile of kratom users than you’d expect from an “illicit” recreational drug.

“The age range is more geared toward an older population,” says Grundmann, “which is more likely to experience work related injuries or acute or chronic pain from another medical condition.” Over half of users are between the ages of 31 and 50. Eighty-two percent completed at least some college. Nearly 30 percent of respondents pull in a household income of over $75,000 a year. Not quite the party drug demographic. And the public comments on the DEA’s scheduling notice reflect that population. Many of those folks are using kratom to either wean themselves off prescription opioids or use the drug alone to treat pain.

 

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Insulin prices skyrocket, putting many diabetics in a bind

Posted on November 30, 2016 by Pharmaciststeve

InsulinInsulin prices skyrocket, putting many diabetics in a bind

http://www.chicagotribune.com/lifestyles/health/sc-anger-over-high-insulin-prices-health-1207-20161130-story.html

Insulin, a life-saving medication used to treat diabetes, was discovered nearly 100 years ago, yet the price of the drug has now spiked by 700 percent in just two decades.

In early November, U.S. Sen. Bernie Sanders, the Vermont independent, pointed out that certain insulins had risen from $21 a vial in 1996 to $255 a vial in 2016.

Some have likened the insulin price boosts to the recent price hikes for EpiPen — the lifesaving medication needed when someone has a serious allergic reaction.

Edith Prentiss, 64, of New York City, knows all too well what the rising cost of insulin means. She needs insulin to treat her diabetes and stay alive, yet living on a fixed income has forced her to make tough choices on which drug she can afford.

“I have other medications I’ve been on for years, and as they became generic, they got cheaper. Insulin has never gotten any cheaper,” she said.

Others have taken notice of these increases too. In mid-November, the American Diabetes Association (ADA) issued a call for Congress to investigate insulin pricing and come up with solutions so that people with diabetes aren’t facing financial hardship when purchasing the medication they need to stay alive.

The ADA said that in many areas in Europe, insulin costs one-sixth of what it does in the United States.

“Insulin is not a luxury,” said Dr. Desmond Schatz, president of medicine and science for the ADA. “The current situation is unacceptable. We have to make sure there is access for everyone, and that’s why we’re calling on Congress to hold hearings to identify why there’s been such a dramatic increase in insulin prices.”

Insulin is a naturally occurring hormone that’s necessary for the body to use the sugars found in foods as fuel. People with Type 1 diabetes don’t make enough insulin to survive and must inject insulin multiple times a day to stay alive, according to the ADA.

In Type 2 diabetes — the more common form of the disease — the body’s cells become increasingly resistant to insulin. People with Type 2 diabetes sometimes also need to take insulin injections, the ADA says.

Insulin was discovered in 1921 by orthopedic surgeon Dr. Frederick Banting and medical student Charles Best, from the University of Toronto. The pair later sold the patent for insulin to the university for $1.

But the university couldn’t produce enough insulin for the number of people who needed it. So it teamed up with pharmaceutical companies in the United States and abroad. Part of the deal was that drugmakers could take U.S. patents on any manufacturing process improvements.

And, since that time, there have been some improvements in insulin. The companies making insulin went from beef or pork insulin to human insulin to synthetic analog insulins, according to the ADA and Lilly Diabetes, a branch of insulin manufacturer Eli Lilly & Co. Each new insulin class acted a bit differently from the others, and some caused fewer complications, such as low blood sugar (hypoglycemia).

But, there’s no one insulin that’s right for everyone, according to Schatz. “Every patient is different. Individualized care is paramount. There’s no ‘one-shoe-fits-all,’ and insurance companies should not be dictating what insulin we can and cannot use based on formularies,” he said.

Which brings up the pricing issues. What’s most important, said Schatz, is that there be a transparency in the process that’s currently lacking.

The list price of insulin — and other drugs, too — is what the pharmaceutical companies say their product costs. However, insurance companies and pharmacy benefit managers, who administer prescription drug programs for private and government insurers, don’t pay that price. They negotiate discounts.

But for people who don’t have insurance or those with high-deductible health insurance plans who haven’t yet met the deductible, that list price may be what they’re stuck paying.

Pharmacy benefit managers and health insurance plans also set a “formulary,” or a list of covered drugs. Consumers typically pay the least for generics, more for “preferred” brand-name drugs and even more for “nonpreferred” medications. Finally, retail pharmacies may mark up the drug’s price.

Insurers and pharmaceutical companies, therefore, may not know exactly who is charging what. And, that’s why the ADA is asking all of these players to come together before Congress to increase transparency in pricing for the patient.

Prentiss’ current situation illustrates how confusing drug pricing can be.

She’s chosen to use an older, cheaper version of insulin because it’s all she can afford. Prentiss said she has more debilitating low blood sugar episodes on this type of insulin. But on a fixed income, she feels it’s the best — maybe only — option for her.

When she goes to the pharmacy to pick up her prescription, she said, she has to make sure it doesn’t run the prescription through her Medicare Part D insurance. If it does, a vial of her insulin would cost $105. But, if it doesn’t use her insurance, a vial costs her $25, she said.

“I would love to understand the logic behind that,” Prentiss said.

Insulin manufacturers realize there is a problem.

“Reasonable access to insulin has become a problem for some people with diabetes. This needs to change, and we are committed to doing our part to improve access,” said a statement from Lilly Diabetes.

The company said it is exploring different ways to help patients who need the most assistance, particularly those with high-deductible health plans.

Another insulin manufacturer, Sanofi, described the problem another way.

The company said in a written statement that the list price for its insulin drug Lantus hasn’t increased since November 2014. “In fact, the net price of Lantus over the cumulative period of the last five years has decreased because of efforts to remain included on formularies at a favorable tier, which helps to reduce the out-of-pocket costs to patients,” the Sanofi statement said.

The statement added, “Sanofi is disappointed by recent decisions to exclude Lantus from formulary coverage. Health care professionals and patients should have a choice regarding their treatment and access to the right therapy to meet individual patient needs.”

 

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If ADDICTION is a disease… how can prescribed opiates cause it ?

Posted on November 30, 2016 by Pharmaciststeve

hypocracySG: addiction is a DISEASE.. Republican’s health plan: doesn’t even mention treating addiction and mental health

The surgeon general, backed by overwhelming medical research, rejected that notion. “Research on alcohol and drug use, and addiction, has led to an increase of knowledge and to one clear conclusion: Addiction to alcohol or drugs is a chronic but treatable brain disease that requires medical intervention, not moral judgment,” the report states.

If addiction to opiates/alcohol/nicotine is a BRAIN DISEASE… then how can a pt being prescribed a opiate or controlled substance CAUSE THIS ?

In 1914 Congress passed the Harrison Narcotic Act https://en.wikipedia.org/wiki/Harrison_Narcotics_Tax_Act

and in 1917 this act caused our judicial system to determine that opiate addiction was a CRIME and not a DISEASE… thus making it illegal for a prescriber to treat/maintain a addict

The act appears to be concerned about the marketing of opiates. However a clause applying to doctors allowed distribution “in the course of his professional practice only.” This clause was interpreted after 1917 to mean that a doctor could not prescribe opiates to an addict, since addiction was not considered a disease. A number of doctors were arrested and some were imprisoned. The medical profession quickly learned not to supply opiates to addicts. In United States v. Doremus, 249 U.S. 86 (1919), the Supreme Court ruled that the Harrison Act was constitutional, and in Webb v. United States, 249 U.S. 96, 99 (1919) that physicians could not prescribe narcotics solely for maintenance.[14]

Does the Surgeon General have the authority to declare that a judicial decision is illegal/unconstitutional ?

If addiction is a “brain disease” why did the CDC bring out opiate dosing guidelines and putting daily mg limits on therapy ?  Are different agencies not communicating with one another and just going about willy-nilly creating guidelines and/or interpretation of laws without concern of what other Federal agencies are doing? Meaning various agencies are generating conflicting policies and at the same time compromising/harming the quality of life of millions of our citizens ?

 

 

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Providing highest quality of care to Medicare Advantage pts ??? NOT ???

Posted on November 30, 2016 by Pharmaciststeve

Cures Act would give pass to lowest-quality Medicare Advantage plans

http://www.modernhealthcare.com/article/20161129/NEWS/161129920?

If Congress passes the 21st Century Cures Act, the federal government would be barred from axing the worst performers in Medicare Advantage through 2018.

The provision, Section 17001 in the 996-page bill being floated in Congress this week, flexes the lobbying muscle of private health insurers that could face the chopping block if their Medicare Advantage quality ratings falter. The Cures legislation essentially would ensure the CMS stays on the sidelines.

“It’s a stay of execution for crappy plans, and that’s just bad policy,” said John Gorman, a former CMS official who now is a health insurance consultant in Washington. “This program works a lot better when there’s a level playing field.”

Current law allows the CMS to boot out Medicare Advantage plans—the private managed-care alternative to traditional Medicare—if those plans don’t attain at least three stars just once in three consecutive years. The system grades companies on a variety of clinical and care-management measures and dishes out a star rating ranging from one to five. Plans with four or more stars get bonus payments.

Nabbing three stars is a relatively low bar for insurers. Roughly 99% of the 18 million Medicare Advantage enrollees are in plans with three or more stars for 2017, according to CMS data.

In fall 2015, the CMS published its star ratings for 2016, and it said there were three plan contracts that were eligible for termination at the end of 2016. Those three plans were Windsor Health Plan, owned by WellCare Health Plans; Sierra Health and Life Insurance Co., owned by UnitedHealth Group; and Cuatro, a small plan based in New York City’s Queens borough.

In April, the CMS sent a letter to Cuatro CEO Dr. Juan Estevez notifying him the insurer was getting tossed out of the Medicare Advantage program because it “failed to achieve a … rating of at least three stars” in 2014, 2015 and 2016.

However, UnitedHealth and WellCare received no such letters, based on publicly available records. The latest Medicare Advantage data from the CMS show both plans had stable enrollment as of Nov. 1. The UnitedHealth contract in question has 3,426 members, and WellCare’s low-performing contract had more than 46,000 members—representing millions of dollars in Medicare revenue for those companies. Medicare’s annual enrollment ends Dec. 7.

However, a CMS spokesperson said in a statement that “none of the three plans mentioned will be operating in 2017.” UnitedHealth and WellCare, both publicly traded companies, did not immediately respond to interview requests.

Many lower-rated plans contend they have higher proportions of sicker, complex patients with socio-economic issues that are not easily resolved. But experts say lax or nonexistent enforcement on Medicare Advantage star ratings fails to hold insurers accountable, allowing them to skirt penalties and continue to gain financial rewards.

“If you’re below four stars, the incentives are exactly the same,” said Gretchen Jacobson, an associate director at the Kaiser Family Foundation who studies Medicare. She added that the government also wants to give plans enough time to turn their quality ratings around.

The Medicare Advantage provision embedded in the latest Cures legislation was not part of last year’s original bill. However, many other members of Congress previously introduced separate legislation that would delay the CMS’ authority to terminate poorly performing plans. Legislators on both sides of the aisle have framed the issue as preserving seniors’ access to their Medicare Advantage plans.

Including the provision in a growing bill that was primarily focused on reforms to regulatory approval of drugs and devices indicates Medicare Advantage insurers can “buy the best lobbyists ‘Gucci Gulch’ has to offer,” Gorman said.

“I just find it shocking that a Republican Congress that prides itself on competition in healthcare markets wants to issue squirt guns to Medicare’s firing squad for quality,” he said.

Updated: The story has been updated to reflect CMS’ response and the fact the three low-performing plans from 2016 will no longer be operating in 2017.

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OIG/DOJ : Oversight of DEA’s Confidential Source Program Report

Posted on November 30, 2016 by Pharmaciststeve

Image result for graphic thumbs downOversight of DEA’s Confidential Source Program

 

 

 

Oversight of DEA’s Confidential Source Program

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Palliative Care: The Role of the Pharmacist

Posted on November 30, 2016 by Pharmaciststeve

Palliative Care: The Role of the Pharmacist

http://www.pharmacytimes.com/publications/health-system-edition/2016/november2016/palliative-care-the-pharmacists-role

NOVEMBER 22, 2016
Jerry Barbee, Jr, PharmD, BCPS, CPh; Suzanne Kelley, BPharm, CPh; Jessica Andrews, 2017 PharmD candidate; Amanda Harman, 2017 PharmD candidate
Palliative care is defined as “an approach that improves the quality of life of patients and their families facing the problem associated with life-threatening illness, through the prevention and relief of suffering by means of early identification and impeccable assessment and treatment of pain and other problems—physical, psychosocial, and spiritual.”1
 
Pharmacists are essential in developing an individualized treatment regimen for each patient. A treatment plan requires specific patient goals with pharmacologic and nonpharmacologic management to improve quality of life while reducing costs and unnecessary medications. Effective utilization of pharmaceutical options optimizes the care of active disease states, enhances individualized dosing regimens, and assists in reducing the adverse effects (AEs) of medications.2

Excessive Medication
Excessive medication use can lead to polypharmacy and AEs. In palliative care patients, AEs can be avoided by discontinuing inappropriate medications. Examples of interventions pharmacists can use to prevent and reduce polypharmacy include medication reconciliation, patient education, geriatrics consultation, and multidisciplinary team consults.3 In addition, resources such as the Beers List Criteria4 can be used as a guide for effective and appropriate medication de-escalation in elderly patients.

Nontraditional Administration Routes
Alternative administration routes for palliative care are vital to providing effective patient care. Many commonly prescribed drugs (eg, promethazine, morphine sulfate) may be used in nontraditional routes.5 Topical gels containing lorazepam, diphenhydramine, or metoclopramide can be effective for patients with refractory nausea and vomiting.6 Various dosage forms, including transdermal patches of scopolamine and depot injections of octreotide, are used to treat specific needs of individual patients.7 Many medications not manufactured in parenteral or suppository formulations can pose administration challenges in patients with an interruption in oral access. Commonly prescribed medications can have nontraditional uses and rectal bioavailability, such as carbamazepine tablets or suspension for convulsions; rectal use may allow rapid absorption and partially avoid first-pass metabolism.8 If necessary, drugs can be compounded into parenterals, solutions, creams, ointments, and transdermal dosage formulations to improve patient adherence and ameliorate AEs, such as constipation, nausea, gastrointestinal issues, and sedation.9
 
Individualized Care
Because palliative care regimens are highly individualized to meet each patient’s needs, integrating a pharmacist into the interdisciplinary team is vital to achieving a patient’s care goals. Body kinetics and volume of distribution are altered in patients in end-of-life care. Pharmacists have a unique knowledge base for optimizing patient care while reducing AEs and toxicity.10 Specific characteristics of a patient affect his or her pain. Patients in palliative care typically require higher doses of opioids. This results in greater stimulation of mu-receptors and, in turn, increases activation of delta and kappa receptors, contributing to increased AEs. In addition, fentanyl patches in patients with cachexia may provide less pain relief due to protein binding and low subcutaneous fat stores.11

Gastrointestinal Issues
Gastrointestinal issues may develop secondary to many chronic conditions (eg, advanced cancer, neurologic disorders).12 Constipation is one of the most common problems patients experience at the end of life. The cause can be as simple as dietary alterations or the inability to ambulate or exercise. Severe discomfort and pain from constipation may cascade into an unrelenting decline in a patient’s quality of life, requiring pharmacologic intervention.13 Privacy issues during toileting and the inability to complete defecation without assistance may progress as a chronic disease worsens.
 
Pharmacists can play an important part in preventing and managing the symptoms of constipation, such as bowel obstruction, dehydration, loss of appetite, mobility issues, and medication AEs.12 Many nonpharmacologic approaches (eg, dietary changes, avoidance of negative environmental stimuli, behavioral measures such as relaxation) may assist patients without adding to the pharmacologic burden.
 
Nausea and vomiting are frequently reported because medications and chronic illnesses stimulate different mechanisms and receptors in the body7 (Table 17,14).
 
Psychological Issues
As patients cope with their illness and chronic pain, anxiety and depression are often comorbid conditions. Distinguishing between grief and depression is essential in determining appropriate pharmacotherapy. Many pharmacologic options (eg, benzodiazepines, anxiolytics, antihistamines, antidepressants) are available to assist with symptoms of anxiety and depression. By carefully interviewing patients, pharmacists can delineate the most appropriate therapeutic class to use. Evaluation of life expectancy is critical because some medications take many weeks of use to produce the desired therapeutic effect, possibly resulting in minimal patient benefit.

The Interdisciplinary Team
In collaboration with the interdisciplinary team, the pharmacist must assess the needs of each patient, including family dynamics and spirituality, to select the best method of treatment.15 This team may include a spiritual counselor, nurses, physicians, caregivers, and volunteers.16
 
Tapering or Discontinuing Medications
Appropriateness of therapy should be evaluated in regard to a patient’s anticipated life expectancy.17 Research shows that discontinuing certain medications in elderly patients and those in palliative care does not worsen outcomes, but can actually reduce the risk of AEs and decrease patients’ overall costs.18 Pharmacists can de-escalate medications by eliminating long-term medications that do not show immediate benefit to elderly patients and those in palliative care. As treatments centered on comfort and quality of life become a greater priority, many common long-term medication therapies may require reevaluation for patients in palliative care 3 (Table 23,19). Antihypertensive medications, for example, can be lifesaving; however, for patients receiving palliative care, the AEs (ie, fatigue and orthostatic hypotension) should be considered on an individual basis. It may be more appropriate to taper or discontinue these medications than to continue them.19
 
Counseling by pharmacists can bridge the knowledge gap for patients and caregivers to prepare them for possible discontinuation of long-term medications. Pharmacists within the interdisciplinary team can help patients and their families understand the risks and potential dangers of these medications. Some drugs may not be beneficial for sustaining life or providing comfort at the end of life, but may increase AEs.
 
End Note
Improving patients’ quality of life during the transition into palliative care is an essential goal of the interdisciplinary team. As the pharmacist’s palliative care role continues to evolve, pharmacists need to step out of their comfort zone. Patients need to be assessed and treated appropriately, which may require using dosages and medications to which pharmacists are unaccustomed.
 
Each patient’s dignity and comfort are always at the center of any care plan. As pharmacists, we should do what we can to make the last days of our patients lives as good as possible. There is never a more pressing time for palliative care pharmacists to advocate for their patients.
 

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Cigna Prescription Drug Fee Lawsuit Alleges Overcharging Scheme

Posted on November 30, 2016 by Pharmaciststeve

Cigna Prescription Drug Fee Lawsuit Alleges Overcharging Scheme

topclassactions.com/lawsuit-settlements/lawsuit-news/349864-cigna-prescription-drug-fee-lawsuit-alleges-overcharging-scheme/

A woman has filed a class action Cigna prescription drug fee lawsuit over allegations the health insurance company overcharged for medications.

Cigna is accused of collecting “clawback fees,” which are amounts collected by the insurance company when the insurance company requires pharmacies to charge a co-pay for a drug that could be purchased for less money directly from the pharmacy without using insurance.

The difference between the co-pay amount and lesser cost of the drug is “clawed back” to the insurance company, which reaps the profit.

For example, a patient paid a $20 co-pay to a pharmacy to purchase a prescription drug, which was 1,042 percent more than the fee paid by Cigna to the pharmacy. Cigna contracted to pay the pharmacy $1.75 for the prescription, but told the pharmacy to collect the $20 “co-pay” from the insured. Cigna then pocketed the $18.25 difference.

According to the Cigna prescription drug fee lawsuit, “The secret payment of the ‘spread’ to the Defendants and/or their agents is known as a ‘clawback.’”

When an insured person pays a co-pay, the co-pay should never be more than the amount paid the insurance company paid the pharmacy for that prescription.

Oftentimes, the pharmacy is contractually banned from informing customers that there are cheaper alternatives to paying the co-pays that enable clawbacks.

In some instances, pharmacists are unaware of the clawbacks until monthly reconciliations show evidence of these clawbacks after the drugs have already been dispensed to customers who have paid the inflated co-pay prices.

Cigna Prescription Drug Fee Lawsuit Alleges Fraudulent Activity

According to the Cigna prescription drug fee lawsuit, Cigna has secretly taken clawbacks from customers, an action opposed in its own policies.

In one quote taken from Cigna policies, the line states “In no event will the… Coinsurance for the Prescription Drug or Related Supply exceed the amount paid by the plan to the Pharmacy, or the Pharmacy’s Usual and Customary (U&C) charge.”

The U&C charge is defined as the pharmacy’s retail cash price, “less all applicable customer discounts that Pharmacy usually applies to its customers regardless of the customer’s payment source.”

Many patients don’t realize their insurance companies are obtaining clawbacks because the patients are unaware of the drug’s cost without insurance. Most patients pay the co-pay, unaware it could be more than the cost of the medication without insurance.

By definition, a co-pay should be a fraction of the true cost of the drug, not a charge that exceeds the true cost of the medication.

More than 80 million Americans might be victims of such prescription drug fraud by insurance companies overcharging for medications. The Cigna prescription drug fee lawsuit is only the tip of the iceberg.

If you have been overcharged for a prescription drug, denied coverage or overcharged for a service, you could be eligible for compensation through a legal claim.

The Cigna Prescription Drug Fee Lawsuit is Case No. 16-cv-1702 in the U.S. District Court District of Connecticut.

Join a Free Health Insurance Fraud Class Action Lawsuit Investigation

If you or a loved one were overcharged for a prescription drug, denied coverage or overcharged for a medical service, you may qualify to participate in a health insurance fraud class action lawsuit investigation. It’s absolutely free to participate, so act now!

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Has the DEA shifted “the blame” of rescheduling Kratom on the FDA ?

Posted on November 30, 2016 by Pharmaciststeve

The Stakes Are High As DEA Reconsiders Waging War On The Herb Kratom

http://www.huffingtonpost.com/entry/kratom-dea_us_583d8a66e4b04b66c01bb424

The FDA works – makes decisions – from clinical trials which takes 10+ yrs.  Will the FDA not recommend rescheduling Kratom….BUT… say that it can no longer be classified as a supplement and in order to be sold, will have to go thru clinical trials. Basically, still making Kratom UNAVAILABLE for OTC sale as long as clinical trials moves forward at a “snail’s pace” and will be giving BIG PHARMAS their next “cash cow” ?

Seven weeks after the U.S. Drug Enforcement Administration officially withdrew its plan to ban kratom, the federal government is once again set to decide the fate of the herb and the people who rely on it for pain relief and other treatment.

The DEA had initially planned to use its emergency scheduling power to push through the ban without input from the public, despite concerns from lawmakers and scientists ― as well as kratom users ― that the move would do more harm than good. In October, however, the DEA opened a public comment period allowing individuals to weigh in on the agency’s decision to place mitragynine and 7-hydroxymitragynine, two active compounds in kratom, in Schedule I. Substances in this category include heroin and LSD and are considered to have no known medical benefit and a high potential for abuse.

With the comment period set to close on Thursday, the DEA will now have to take into account the nearly 9,000 submissions from people who wanted to voice their opinions about this proposed expansion of the war on drugs.

But kratom isn’t in the clear yet. The DEA is currently awaiting the results of a U.S. Food and Drug Administration analysis on the potential harms and health benefits of the herb, which will determine if kratom truly poses an “imminent hazard to the public safety,” as the agency initially claimed in August.

The DEA doesn’t know when it will get the results of the FDA’s review, Russell Baer, a spokesperson for the agency, told The Huffington Post.

“We’ve asked the FDA to expedite their analysis, but they’ve not given us any indication as to when that may be done, other than as soon as practical,” said Baer. “They’re involved in an exhaustive scientific review and evaluation, so these things do take time.”

Although Baer said he expects the DEA to wait for the FDA’s analysis before deciding on an appropriate schedule for kratom ― or whether it should be scheduled at all ― he noted that the agency could still proceed with emergency scheduling even in the absence of more concrete scientific evidence.

The DEA’s next steps will have huge implications for people like Joshua Levy. In the video above, Levy explains that he turned to kratom after struggling with dependence on the opioid painkillers he’d been prescribed following a hit-and-run accident. Like many kratom users, he says the herb gave him back the life that had been taken from him by addiction and other side-effects of narcotic painkillers.

“Since I started taking kratom, since I had gotten off of the pain pills, my life has basically opened up dramatically,” Levy told HuffPost. “I got a new job. I’m building a friendship up with my sister that I haven’t had in a long time. I’m not lazy anymore. I don’t want to isolate myself. I want to go out, I want to be out of the house.”

The kratom community is full of success stories like Levy’s. But together, they form only anecdotal evidence of the herb’s benefits, which is not enough to support a more official confirmation of its medicinal value.

Experts like Andrew Kruegel, an associate research scientist at Columbia University, hope the DEA will allow kratom to remain legal so they can keep working to unlock the herb’s potential.

Kruegel’s studies have shown that kratom can be used to alleviate mild pain, and that the plant’s negative side effects are relatively minor.

“As a scientist, I try to be as objective as possible and not overstate the promise of kratom,” said Kruegel. “We just don’t know that much about the plant yet.”

But Kruegel also has bigger hopes for kratom, which he believes can be used to aid in the development of safer alternatives to the prescription opioids that claimed more than 18,000 lives in the U.S. in 2014 due to overdose.

“Of course, if it’s in Schedule I, historically that greatly limits the ability to do research on it,” he said.

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