Ohio Board Of Pharmacy Recommends Ban On Kratom

https://www.prnewswire.com/news-releases/ohio-board-of-pharmacy-recommends-ban-on-kratom-300723130.html

WASHINGTON, Oct. 2, 2018 /PRNewswire/ — Dave Herman, Chairman of the American Kratom Association, strongly denounced the action by the State Board of Pharmacy on October 1, 2018 to commence the process to schedule kratom as a Schedule I controlled substance in Ohio.

“The findings of the Ohio Board of Pharmacy today parrot the false propaganda of the US Food and Drug Administration (FDA) in their crusade to ban kratom. The FDA attempted the same scheduling process in 2016, and that recommendation was rejected by the Drug Enforcement Administration (DEA) because the FDA data failed to meet the required standards for the scheduling of kratom at the federal level,” Herman stated.

“Since their failure in 2016, the FDA has launched a broad-based campaign to demonize this natural plant by consistently misstating the science and the actual pharmacologic activity of kratom,”

continued Herman. “The FDA has flooded state regulators, including the Ohio Board of Pharmacy with false claims and disinformation about the addiction profile and safety of this safe botanical plant.”

The FDA Commissioner, Scott Gottlieb, has repeatedly stated that kratom is an opioid, but credible scientists strongly dispute that statement showing that kratom’s pharmacologic activity is distinctly different than classic opioids where the respiratory system of the user shuts down and leads to overdoses that have created the opioid crisis that we are in today.

Commissioner Gottlieb also claims that there are 44 deaths associated with the use of kratom. Independent analysis of those claims have shown that the FDA conclusions are flat wrong and appeared to be deliberate manipulations of the data in order to convince the DEA and state regulatory agencies to enact bans on kratom because they simply do not have the scientific evidence that is statutorily required for such bans.

“The FDA has ignored credible science that clearly demonstrates that kratom has a very low potential for abuse and poses no risk to the public health for the citizens of Ohio or any other state,” Herman continued. “The AKA provided detailed reports and data to the Board of Pharmacy staff that show the scientific evidence, including new peer-reviewed and published research that shows conclusively that kratom has a very low addiction profile, and any deaths associated with kratom are from adulterated or contaminated kratom products, not the natural plant.”

There has never been a scheduling of any substance in the United States because it was adulterated with a toxic or dangerous chemical. The FDA has broad statutory authority to seize any adulterated product that poses a danger to the public, and they can provide the evidence to the Department of Justice to prosecute any individual or company who produces or distributes a dangerous adulterated kratom product.

The AKA is looking forward to working with the Ohio Board of Pharmacy to provide the compelling evidence that directly contradicts the conclusions found in their scheduling proposal for kratom. The nearly 5 million kratom consumers who safely consume kratom as a part of their health and well-being regimen should not have that freedom infringed upon by any regulation that is premised on bad science, inaccurate data provided by the FDA, and a deliberate attempt to manipulate the scheduling process by a federal agency.

ABOUT AKA

The American Kratom Association (AKA), a consumer-based non-profit organization, advocates to protect the freedom of consumers to safely consume natural kratom as a part of their personal health and well-being regimen.  AKA represents the nearly 5 million Americans who consume kratom safely each year. www.americankratom.org

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Survey: 42% of Physicians Report Burnout, Some Cite Depression

Physician Burnout: Throwing a Lifeline to Overburdened Physicians

www.mdsyncnet.com/throwing-lifeline-overburdened-physicians/

The Affordable Care Act triggered a revolution that continues to impact everyone along the healthcare spectrum, from the patient to the provider to the administrator.

The goal of better health outcomes at lower costs has fueled myriad trends. Increased responsibility for copays and premiums has driven the increased expectations of patients-as-consumers. Complex regulations have motivated smaller physician groups to sell their practices to larger healthcare organizations. New reimbursement models like bundled payments have spurred administrators to create innovative ways to mitigate risk among stakeholders.

Physicians are Drowning

Amid this sea change, some physicians feel as though they’re drowning. While physician employment is up, physician engagement is down. A Mayo Clinic study found that the “clerical” work demanded by electronic health records (EHR) and computerized physician order entries is correlated with physician burnout. A literature review in the Lancet noted that physician burnout has topped 50%.

The Startling Consequences of Burnout

Burnout has real consequences. It causes medical errors. It leads to car crashes. And it’s estimated that, each year, more than 400 doctors commit suicide, in part because of the stigma attached to and repercussions of seeking burnout-related mental health treatment. Yet researchers have found that even relatively small decreases in burnout scores – as little as one point – translate into significant decreases in negative outcomes.

Creating Change

Healthcare organizations can take a number of steps – some small, some systemic – to create a working environment that inspires collegiality while still hitting targeted health outcomes and lowered costs.

1. A Gathering Place

In a recent survey of physicians at a small hospital, almost 60 percent yearned for something that was de rigueur in the not-so-distant past: a gathering place for physicians. “We have no place to eat lunch or sit and talk with fellow providers,” noted one respondent. “A physician lounge that is open to all physicians, not just surgeons, would be a welcome addition,” wrote another. A third summed it up this way: “Since so few docs go to the hospital anymore due to hospitalists, there is a loss of camaraderie in our community.”

2. Mindfulness

A literature review published in the Journal of the American Medical Association found that mindfulness programs helped to alleviate burnout among physicians. One study documented an improvement following a program that supplemented weekly mindfulness exercises with presentations about stress-related topics and group discussions. Another relied on weekly sessions that taught mindfulness meditation techniques to physicians and allied health professionals. It’s important to note that both interventions were physician-directed.

3. Communications Training

Burnout increases when physicians talk past each other; ineffectively convey information to residents, nurses, and other care team members; or avoid interacting with other staff members. Intensive communications training, when combined with stress management training, can ramp up physician skills and potentially tamp down burnout.

4. Small Group Discussions

First and foremost, physicians are people. Like all people, they gather comfort and strength from talking to their peers. A study tested a 19-week intervention with facilitated discussion groups that incorporated reflection, shared experience, and small group learning. The result? A substantial decrease in burnout, emotional exhaustion, and depersonalization.

5. Changes to Scheduling

A promising pilot study compared two different types of shift work scheduling for ICU intensivists. The standard staffing model, where one intensivist worked for seven days and was on call at night, was compared to 24/7 intensivist coverage, where one intensivist was scheduled for seven day shifts and two other intensivists alternated working night shifts. The intensivists experienced significantly less burnout. Another study found that two-week inpatient attending physician rotations improved burnout rates when compared to four-week rotations. Taken together, these studies open up the possibility that hospitals should re-examine how they schedule physicians.

6. Treating Physicians as Stakeholders

Physician lounges, mindfulness workshops, and communication trainings are small but important steps in acknowledging doctors as both professionals and people. Another critical measure is recognizing that physicians are stakeholders in the organization and then creating partnerships with them.

True Collaboration

A true partnership involves taking the time to explain the “why” behind the “what” and collaborating with doctors in developing short- and long-term strategies to alleviate burnout. Nurturing physician leaders who are then able to communicate with other doctors results in increased buy-in for organizational initiatives.

In this changing healthcare landscape, physicians needn’t be left behind. Ensure that physicians become more engaged partners in meeting today’s challenges and embracing tomorrow’s trends.

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http://www.ncpanet.org/home/find-your-local-pharmacy

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www.cawnation.com

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Combat veteran Ross F. is about to have his 2nd back surgery and after taking his Rx to the pharmacy at Walmart in Deerfield Beach they would not fill his Rx for post op pain, which surgery is scheduled in 2 days. Ross is an avid herbalist and advocate for kratom. He is also father, husband, disabled combat veterans and a psychotherapist. He said “They want to know why we use kratom, this is why!” He said he’s not even in recovery and now he knows what his patients feel. He said with the level pain he understands why going to buy dope is a viable option being treated and profiled like a drug seeker seems like a viable option. This is why military veterans sought kratom and other healing herbs. This is why educating and protecting safe access to kratom is so much more important now more than ever.

Link below will help you find a independent pharmacy – that WON’T PLAY GAMES WITH PT’S MEDICAL NEEDS

http://www.ncpanet.org/home/find-your-local-pharmacy

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Health professionals for patients in pain

https://healthprofessionalsforpatientsinpain.org/

Health Professionals Call on the CDC to Address Misapplication of its Guideline on Opioids for Chronic Pain through Public Clarification and Impact Evaluation

Authors: Health Professionals for Patients in Pain (HP3)

Date: September 24, 2018

Any professional who cares for patients, including physicians, pharmacists, nurses, psychologists and social workers, is invited to sign on to this letter, as are any professional organizations that wish to endorse formally. 

I. In 2016, the Centers for Disease Control and Prevention, CDC, issued a Guideline for Prescribing Opioids for Chronic Pain for primary care physicians. Its laudable goals were to improve communication between clinicians and patients about the risks and benefits of opioid therapy for chronic pain, improve the safety and effectiveness of pain treatment, and reduce the risks associated with long-term opioid therapy. The Guideline reflected the work of appointed experts who achieved consensus on the matter of opioid use in chronic pain.

Among its recommendations are that opioids should rarely be a first option for chronic pain, that clinicians must carefully weigh the risks and benefits of maintaining opioids in patients already on them, and that established or transferring patients should be offered the opportunity to re-evaluate their continued use at high dosages (i.e., > 90 MME, morphine milligram equivalents). 

In light of evidence that prescribed dose may pose risks for adverse patient events, clinicians and patients may choose to consider dose reductions, when they can be accomplished without adverse effect, and with possible benefit, according to some trial data. 

Nonetheless, it is imperative that healthcare professionals and administrators realize that the Guideline does not endorse mandated involuntary dose reduction or discontinuation, as data to support the efficacy and safety of this practice are lacking. 

II. Within a year of Guideline publication, there was evidence of widespread misapplication of some of the Guideline recommendations. Notably, many doctors and regulators incorrectly believed that the CDC established a threshold of 90 MME as a de facto daily dose limit. Soon, clinicians prescribing higher doses, pharmacists dispensing them, and patients taking them came under suspicion. 

Actions that followed included payer–imposed payment barriers, pharmacy chain demands for the medical chart, or explicit taper plans as a precondition for filling prescriptions, high-stakes metrics imposed by quality agencies, and legal or professional risks for physicians, often based on invocation of the CDC’s authority. Taken in combination, these actions have led many health care providers to perceive a significant category of vulnerable patients as institutional and professional liabilities to be contained or eliminated, rather than as people needing care. 

III. Adverse experiences for these patients are documented predominantly in anecdotal form, but they are concerning. Patients with chronic pain, who are stable and, arguably, benefiting from long-term opioids, face draconian and often rapid involuntary dose reductions. Often, alternative pain care options are not offered, not covered by insurers, or not accessible. Others are pushed to undergo addiction treatment or invasive procedures (such as spinal injections), regardless of whether clinically appropriate. 

Consequently, patients have endured not only unnecessary suffering, but some have turned to suicide or illicit substance use. Others have experienced preventable hospitalizations or medical deterioration in part because insurers, regulators and other parties have deployed the 90 MME threshold as a both a professional standard and a threshold for professional suspicion. Under such pressure, care decisions are not always based on the best interests of the patient.

lV. Action is Required: The 2016 Guideline specifically states, “the CDC is committed to evaluating the guideline to identify the impact of the recommendations on clinician and patient outcomes, both intended and unintended, and revising the recommendations in future updates when warranted”. The CDC has a moral imperative to uphold its avowed goals and to protect patients. 

Therefore, we call upon the CDC to take action:

1. We urge the CDC to follow through with its commitment to evaluate impact by consulting directly with a wide range of patients and caregivers, and by engaging epidemiologic experts to investigate reported suicides, increases in illicit opioid use and, to the extent possible, expressions of suicidal ideation following involuntary opioid taper or discontinuation.

2. We urge the CDC to issue a bold clarification about the 2016 Guideline – what it says and what it does not say, particularly on the matters of opioid taper and discontinuation. 

Signatories here represent their own views, and do not purport to reflect formal positions of their employing agencies, governmental or otherwise. For questions regarding the letter please contact Stefan G. Kertesz, MD, Professor of Medicine at University of Alabama at Birmingham School of Medicine (skertesz@uabmc.edu)

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RM Alert: Medication Misadventure – Stevens-Johnson Syndrome

Background

Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are a group of hypersensitivity reactions that are very rare, serious and potentially fatal. Carbamazepine is the drug most commonly associated with the disease although some antiretroviral drugs, sulphonamides, penicillins, fluoroquinolones, and NSAIDs have also been known to cause the reaction.

The initial symptoms of the reaction are fever, muscle aches, and general weakness for one to three days. Subsequently, the skin develops painful open blisters. If the rash develops, the medication must be stopped immediately. Treatment is much like that of a burn victim including fluid replacement, infection prevention, and pain management. Treatment can last up to a year and many times permanent scaring results.

Lessons
• Carbamazepine is associated with Stevens-Johnson syndrome/toxic epidermal necrolysis in carriers of the human leucocyte antigen (HLA) B*1502 gene.
• The HLA B*1502 gene is most frequently found in Asian populations (Indians, Han Chinese, Thais and Malays). This population has a 10 times greater risk of developing SJS/TEN than Caucasians exposed to carbamazepine.
• The HLA A*3101 allele has been associated with reactions in Northern European populations.
• In 2007, the FDA recommended genetic screening of individuals of Asian ancestry prior to the start of carbamazepine.
Recommendations
• Ensure screening in genetically at-risk populations prior to initiating therapy.
• Review all signs and symptoms of SJS/TEN with all new prescriptions for carbamazepine.
Other insights

The increased use of carbamazepine, especially for control of pain, may be the reason for the increased incidence of SJS/TEN with it.

Awareness of such drugs implicated in life-threatening drug reactions will help physicians in preventing them by judicious use of the drugs.

For patients who are HLA-B*15:02 and HLA-A*31:01 positive, oxcarbazepine, phenytoin, fosphenytoin, eslicarbazepine acetate, and lamotrigine may also be associated with drug-associated cutaneous adverse reactions so these medications may need to be avoided as well.

For Tools & Resources to help you manage risk, members can access the Pharmacists Mutual Risk Management Center (RMC) from the Pharmacists Mutual Member Portal. Visit www.phmic.com, click on “My Account” & follow the on-screen prompts to set-up your free account.

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LANCASTER, Pa. (WHTM) – Inside Pet Pantry of Lancaster County, there is a logbook for every time a doctor has to use opioids.

“We do use a lot of opioids such as fentanyl and some other things in hospital as anesthetic agents for these immediate operating times,” said Dr. Bryan Langlois, the clinic’s medical director.

Langlois is also the president of Pennsylvania’s Veterinary Medical Association. He said because of the opioid epidemic, drug companies are making less of the drugs and veterinarians are getting less of them.

“The human hospitals are getting the first crack at things,” he said. “We in the veterinary profession are left trying to get what we can.”

The issue is creating a supply and demand problem, which is turning into higher bills for pet care.

“Some prices are going to go up through distributors to be able to get those products,” Langlois said.

Prices aren’t skyrocketing, but some veterinarians are changing their protocols and seeking other options.

Langlois said that’s an issue because he believes opioids work best for pets.

“These drugs are some of the safest ones out there for us to do these procedures with,” he said. “We want to be able, for people’s pet safety, we want to provide the best and safest option that’s out

Where is PETA and ASCPA   aren’t they suppose to stand up for the abuse/mistreatment of animals.  Neither of these organizations have a DEA license.. thus the DEA has no lethal authority to threaten their existence – like they do prescribers who have DEA licenses if they stand up to the abuse by them.

ACLU   seems to also be reluctant to take a stand for the hundred of millions of chronic pain pts that are being denied adequate pain management.

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