DEA to Allow Huge Increase in Marijuana Production to Meet Research Demands

Posted on June 16, 2015 by Pharmaciststeve

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DEA to Allow Huge Increase in Marijuana Production to Meet Research Demands

http://www.raps.org/Regulatory-Focus/News/2015/06/16/22702/DEA-to-Allow-Huge-Increase-in-Marijuana-Production-to-Meet-Research-Demands/

The US Drug Enforcement Administration (DEA) has proposed a massive increase in the amount of marijuana it will allow to be produced this year in the hopes of meeting the demand of researchers studying new medicinal uses for the drug, it has announced.

Background

In the US, the manufacture and production of marijuana is controlled by the DEA, whose authority to do so stems from the Controlled Substances Act (CSA)—a law which categorizes drugs in accordance with their risk of abuse and medical benefit.

For example, drugs regulated by DEA under Schedule II of the CSA may have a recognized benefit, but also a substantial risk of misuse or abuse. A Schedule V drug, meanwhile, may have a recognized medical benefit and a very small risk of misuse or abuse.

And then there are Schedule I drugs like cocaine and marijuana—drugs which DEA claims have no recognized medicinal purpose as well as a high risk of misuse or abuse.

But while these drugs might not have the approval of the US Food and Drug Administration (FDA) or DEA, that doesn’t mean they are totally banned in the US. Under the CSA, DEA controls the production of schedule I and II drugs, including for research purposes.

As a result, even drugs like cocaine are allowed to be manufactured and distributed under DEA’s Aggregate Production Quotas (APQs). Such quotas determine the exact amount of each drug that is permitted to (legally) be produced in the US each year for research or other official purposes.

Marijuana Production Quotas

In September 2014, DEA released its Established Aggregate Production Quotas for Schedule I and II Controlled Substancesin the Federal Register. The document details the exact amount of each schedule I and II drug that can be produced in the US during 2015.

Among the drug substances included in DEA’s initial 2015 APQ is marijuana—spelled marihuana in the document—which is set at a production quota of 125,000 grams.

Then, in April 2015, DEA proposed a further and substantial increase for the APQ for marijuana, which it said should be increased to 400,000 grams.

The increase, DEA said, was in response to an elevated demand for cannabidiol, an active ingredient in marijuana, for research purposes.

“Since the establishment of the initial 2015 aggregate production quotas, the DEA has received notification from DEA registered manufacturers that research and product development involving cannabidiol, is increasing beyond that previously anticipated for 2015,” DEA explained in its notice. “The associated product development activities are related to process validation and commercialization activities, including qualification activities related to potential FDA submission support.”

In plain terms, several companies have been trying to obtain supplies of cannabidiol to test its medicinal properties. For example, two companies, Insys Therapeutics and GW Pharma, are seeking FDA approval for drugs to treat different types of epilepsy. Dozens of other studies are hoping to determine if the ingredient is helpful in treating schizophrenia, graft versus host disease, Dravet syndrome and more.

The boost in demand is also due, in part, to increased interest from the government. DEA said the National Institute on Drug Abuse (NIDA) has requested “Additional supplies of marijuana to be manufactured in 2015 to provide for ongoing and anticipated research efforts involving marijuana.”

Further Increase

But even a three-fold increase in the APQ is apparently not enough. DEA is now proposing to increase its production quota for marijuana even further.

In a Federal Register posting on 16 June 2015, the agency said upon further review of the quota, and in consideration of comments received from the public, it will increase the production quota for marijuana to 658,000 grams—more than five times the amount permitted previously.

The new quota amount applies to all of fiscal year 2015, DEA said.

– See more at: http://www.raps.org/Regulatory-Focus/News/2015/06/16/22702/DEA-to-Allow-Huge-Increase-in-Marijuana-Production-to-Meet-Research-Demands/#sthash.s3cXCLbh.dpuf

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CVS playing the 21st century version of PACMAN ?

Posted on June 15, 2015 by Pharmaciststeve

CVS buys Omnicare for $12.7B to expand senior care business

CVS buys Target pharm biz for $1.9B

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Local Pharmacist working on personal opinions and not facts… gets shot down ?

Posted on June 15, 2015 by Pharmaciststeve

Dr Mark Ibsen (MTN News photo)

Examiner: no action recommended against Helena physician for pain pill prescriptions

http://www.kxlh.com/story/29326510/examiner-no-action-recommended-against-helena-physician-for-pain-pill-prescriptions

HELENA – Nearly two years after the Montana Board of Medical Examiners first brought the action, a state hearing examiner says the board “did not meet its burden of proof” that longtime Helena doctor Mark Ibsen over-prescribed pain medication to nine patients. 

Ibsen, owner of Urgent Care Plus and a former emergency department doctor at St. Peter’s Hospital, failed to meet standards of care in his record keeping, according to the hearing examiner with Montana Department of Labor & Industry, David Scrimm. 

He proposed that the board put Ibsen’s license on probation for 180 days, and take various measures to improve his record keeping. 

But on the more serious matter of failing to meet standards of care for the patients, the examiner found insufficient evidence. 

The order, issued late Friday, is just a one step in a process that began for Ibsen as a board action in July 2013, concerning allegations by a former employee that Ibsen over-prescribed medication to nine patients. A board screening panel narrowed the allegations to the care of five patients. 

The investigation then expanded to include 21 additional patients who sought his care after the board and the U.S. Drug Enforcement Administration raided and shut down the office of Dr. Chris Christensen in Florence in April 2014. But Scrimm found no evidence of unprofessional conduct by Ibsen with those patients either. 

Along the way, agent of the U.S Drug Enforcement Administration visiting his office suggested he could face criminal charges. 

According to the proposed order, in July 2014, a DEA agent told Ibsen, “You are not only risking you’re license by prescribing to these folks, you are risking your freedom.” 

When Ibsen asked how, then, he should ensure he was doing things right, the agent replied, “I can’t tell you. We’re not doctors.” 

Scrim wrote that he went through 5,000 pages of documents, including more than 800 pages of just one patient’s medical record. 

The 49-page proposed order describes in detail the efforts by Ibsen to examine the situation of each patient and prevent abuses such as doctor shopping. It notes that some of the patients reduced or eliminated their use of opioids under Ibsen’s care. 

The proposed order also takes several jabs at the board’s case, calling out its attempts to paint Ibsen as mentally unstable and casting doubt on the reliability of some witnesses. 

One local pharmacist, the proposed order notes, “took it upon himself” to ensure Ibsen was weaning patients as he claimed, and enlisted other pharmacists in his effort; the examiner said such judgments were beyond the scope of that pharmacist’s training. 

Michael Fanning, a lawyer for the board, said it Monday morning it was too early to say whether the board would file many exceptions. Ibsen declined comment, pending consultation with his attorney. 

Once fully briefed, the case will then go to the board’s adjudication panel, which will review the entire record — which Fanning called a “monumental task.” 

The panel’s final order could come in a few months — at which time either side could appeal it to District Court. 

Ibsen meanwhile has held weekly group pain therapy sessions, where patients discuss their issues including the runaround some say they get when seeking medications. The sessions include plenty of Ibsen’s opinions on the way pain patients are treated, along with some discussion of the cultural context of pain. 

Some of his patients have said they were turned away from other doctors and came to Ibsen because he alone prescribed the medications they said they need to simply live a functional life. 

Ibsen has described pain — and the anticipation of pain — as “terroristic,” crippling people with the fear of pain. At one such session in May, he discussed the different way pain patients are treated compared to, for example, cancer patients. 

“The families of people in pain are busy criticizing the pain patient,” he said. “Until you have pain, you don’t understand pain. Until you get pain, you don’t get pain. You don’t get it.”

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State courts applies Federal rules.. what Constitution and states’ rights ?

Posted on June 15, 2015 by Pharmaciststeve

FILE - In this April 25, 2013, file photo, attorney

FILE – In this April 25, 2013, file photo, attorney Michael Evans, left, listens in his office in Denver, as his client Brandon Coats talks about the Colorado Court of Appeals ruling that upheld Coats being fired from his job after testing positive for the use of medical marijuana

Pot may be legal in Colorado, but using it can still get you fired

Quadriplegic Brandon Coats is a medical marijuana user who worked for Dish Network until he was fired in 2010 for flunking a random drug test. The company cited its zero-tolerance drug policy but acknowledged there was no evidence that Coats was high on the job. In Colorado, marijuana is legal (although against federal law). So Coats took his case to court — and the Colorado Supreme Court ruled Monday against him. The case is important for pot smokers and their employers in states where use has been legalized. Colorado became the first state to legalize recreational use of the drug in 2012. Monday’s ruling makes it at least the fourth state in which courts have ruled against medical marijuana patients who are fired for using pot.

State court upholds FEDERAL LAW..  I thought that states had RIGHTS ?  Maybe we have become a FEDERATIONS OF LEMMINGS ?

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CATCH-22 … FDA & DEA mandates… Part D won’t pay for ?

Posted on June 15, 2015 by Pharmaciststeve

Report: Medicare Part D plans less apt to cover opioids with abuse deterrents

https://drugstorenewsce.com/editorial-news-item/3/6090

Despite high-profile efforts to implement abuse-deterrent labels and properties on brand-name opioids, advisory company Avalere Health’s latest research notes a key blind spot in the efforts — accessibility. In particular, the research shows that Medicare Part D plans cover generic opioids that lack abuse-deterrent features at a higher rate than it covers branded opioids. 
 
“While there has been significant attention on the development and approval of new abuse-deterrent drug products, there has been noticeably less consideration of access to such products,” Avalere CEO Dan Mendelson said.
 
Particularly with regard to oxycodone hydrochloride, the brand-name OxyContin received approval from the Food and Drug Administration in 2013 for abuse-deterrent labeling, but since 2012, Part D plan coverage for it has dropped from 61% to 46%. On the other hand, every Part D plan covers generic oxycodone hydrochloride. As a result, seniors have less access to safer opioids.
 
“While prescription opioid abuse continues to be a priority for public health experts and lawmakers, coverage for these products by Part D plans is limited and plans are increasingly favoring lower-cost generic products on their formularies,” Avalere SVP Caroline Pearson said. “Policymakers seeking to limit opioid abuse will have to balance the desire for greater access to abuse-deterrent opioids with the increased costs of such medications to public programs and private payers.”

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Audio files from FL BOP committee meeting on pain meds

Posted on June 15, 2015 by Pharmaciststeve

(1)Introductions

(2)Discussion

(3)Issues Identified

http://ww10.doh.state.fl.us/pub/bop/Audio/Controlled_Substance_Standards_Committee_06092015/Controlled%20Committee/

Because Lois Lerner of the IRS lost emails and  Hillary Clinton lost emails and Richard Nixon had sections “go blank” on the oval office recording system. I copied these files down to my computer… for safe keeping 🙂

readingbetween If you listen to the introduction by the committee chair.. this committee was created a couple of years ago.. and “hasn’t done much”… does that suggest how much interest the BOP has concerning the denial of care of chronic pain pts in Florida ? Or does this suggest that investigative reporter Matt Grant and other FL TV channels have given this issue so much coverage of late… that they felt that were compelled to do something. And something was to limit everyone from the audience wanting to make a statement was limited to 3 minutes.. except the representative of NACDS (National Association of Chain Drug Stores) who was allowed to read his entire prepared statement.

I also found it rather STRANGE .. each of the members of the special committee was allowed to make sometimes lengthy statements and there was not time allotted for questions from the audience… concerning their statements or seeking clarifications.

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Taking away a person’s driver’s license because they see a particular prescriber ?

Posted on June 15, 2015 by Pharmaciststeve

Taking away a person’s driver’s license because they see a particular prescriber ?

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When you need to look for a reason to JUST SAY NO.. you will find it ?

Posted on June 15, 2015 by Pharmaciststeve

It would appear that the state’s PMP ( Prescription Monitoring Program) has been down – not working – for one or more days and this prescriber is talking to a local pharmacist about a pt’s Rx and getting it filled for a controlled substance. In this particular state the data in the PMP can be as much as 7 days out… ..but.. this particular pharmacist after six years of education and unknown period of experience in a community pharmacy… can’t make a decision without being able to pull a PMP report and apparently could care less if the pt is thrown into withdrawal and elevated pain.. because the state’s PMP system is not working …  just another reason to “JUST SAY NO “?

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Too many middlemen’s cost and not enough direct pt care ?

Posted on June 14, 2015 by Pharmaciststeve

spiderweb

http://www.usatoday.com/longform/news/2015/06/05/medicare-costs-seniors-sick-chronic-conditions/27390925/

This article is a very scary article.. because the youngest baby boomer is now turning 51 this year… and the oldest is turning 69… For the last 3-4 decades we have been creating this infrastructure to help our health system to save money.. while attempting to assure some sort of positive health outcomes..

What has evolved is a spider web of middlemen… each with their own costly overhead and make a profit motive. One of those middlemen is Express Scripts which is a PBM (prescription benefit manager)… they have about 40% of the PBM market and has a net profit of abt FOUR BILLION dollars.. meaning that this middleman.. that operates much like MasterCard, Visa, Amex charge card system.. so that suggests that just the profits from this middleman part of the industry.. takes TEN BILLION dollars out of our healthcare system that could be used to provide how much healthcare to people.

There is another middleman that negotiates discount/rebates/kickbacks from the Pharmas for the PBM industry… more overhead… more profits.. that does not go to providing healthcare.

The large part of the “health insurance industry” doesn’t actually provide insurance but just shuffles paperwork and pays the bills for large companies that are self insured… the health insurance industry extracts another 20% of our healthcare dollars to cover their overhead and net profits…

So our healthcare system may have evolved into this huge inefficient paper generating monster that is consuming 40%-50% of every healthcare dollar that has nothing to do with direct pt care.

Have we created a “cost saving healthcare system” that is going to bankrupt up.. trying to save us money ?

 

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Insincerity is the worse kind of hypocrisy ?

Posted on June 14, 2015 by Pharmaciststeve

dumbpeople

McKesson improves patient outreach with new call center

http://www.drugstorenews.com/article/mckesson-improves-patient-outreach-new-call-center?utm_term=DSN204731&utm_source=MagnetMail&utm_medium=subject&utm_term=Weekend%20Update%3A%20Top%2010%20must-read%20stories%20on%20DSN&utm_content=DSN-NLE-WeekendUpdate-06-13-15

This is one of the three major drug wholesalers that control 80%+ of the prescription medication distribution market… who claims that they are using statistical analysis to make sure that community pharmacies have the controlled meds they need to meet their pt’s needs… but … pts and Pharmacists keep stating that people are being denied their medication because the three major wholesalers have rationed what they can purchased in a particular month. But here is a article about them expanding a service in improve pt compliance with their medications..  I wonder how many chronic pain pts or those with some other subjective disease states… they will be calling… of course,  if the pharmacies are not filling these Rxs because they can’t get the inventory… who is McKesson going to call to increase compliance ?..

SCOTTSDALE, Ariz. — McKesson Patient Relationship Solutions, a division of McKesson Corporation, on Tuesday announced the expansion of its patient engagement and support capabilities with a second Contact Center near Atlanta, Ga. The new location builds on the capabilities of MPRS’ existing Contact Center at its headquarters in Scottsdale, Ariz. 
 
The expansion is designed to accommodate significant growth in demand for its Behavioral Call Campaign offering, which leverages interactive behavioral conversations with patients to help increase engagement and improve medication adherence. The expansion also supports growth in MPRS’ core co-pay savings programs as well as new innovative platforms to further advance patient adherence.
 
“This expansion is a direct result of the increasing need for our pharmaceutical and medical device manufacturer clients to uniquely connect with their patients through both inbound and outbound conversations to support patient needs,” said Jennifer Richard, director of contact center operations at MPRS. “Our continued growth allows us to leverage our expertise to consistently deliver award-winning customer service to our existing clients. In addition, it supports the implementation of innovative new campaigns that incorporate proven and sustainable patient engagement tactics that deliver positive ROI.”
 
Traditional call centers have primarily provided responses to simple questions from patients about their medications; however, the ability to create lasting behavior change was limited. Recent research commissioned by MPRS showed that patients are less interested in receiving general information about their condition and more interested in personalized communications. Specifically, 86% of patients desired live agent phone support and 83% desired face-to-face pharmacist coaching and support. With dynamic, two-way conversations, McKesson’s Contact Center agents have successfully delivered personalized and targeted messaging that improved the patient experience, medication adherence, and ultimately health outcomes.
 
“The significant growth of our Contact Center capabilities this year demonstrates that pharmaceutical and medical device brands increasingly value a two-way dialogue that is integrated with their patient support strategy,” said Derek Rago, VP/general manager, MPRS. “Leveraging both our co-pay support programs and our proven behavioral coaching platform provides our clients with an integrated brand experience and allows us to support the patient holistically, addressing behavioral as well as cost-related barriers to adherence.”

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