all medical error that is preventable, is the fourth leading cause of death in our country in 2016

Posted on March 22, 2016 by Pharmaciststeve

TV-6 Investigates: QCA lacks public medical mistake databases

http://kwqc.com/2016/03/21/tv-6-investigates-qca-lacks-public-medical-mistake-databases/

DAVENPORT, Iowa. (KWQC) – Wrong site surgeries are what doctors call never events, they should never happen. But it’s tough for patients in the Q.C.A. to find out if their hospital had any. Earlier this month TV-6 investigates revealed a state inspection citing Genesis Health System for failing to protect patients from wrong site surgeries at its hospitals. Genesis has since submitted a plan of corrections to fix what the inspector found. But patients have no way to find out how common wrong site surgeries are at any Iowa or Illinois hospital.

Half of the states across the country have some type of public reporting system for never events. These systems typically gather data on wrong site surgeries, patients given the wrong medication, and patients with tools left in their body after surgery. Illinois created a reporting system over a decade ago, but it’s still not operational because the state has never funded it. Iowa came close to implementing a system, but a state board never voted on it.

Patient safety expert Dr. David Nash said, “The public deserves complete and thorough transparency and accountability, from the medical system, I’m an absolute strong believer in that and always have been.”

Nash is a patient safety expert and an advocate for public reporting systems. He’s the editor in chief of the American Journal of Medical Quality. He was one of the first to publish a study comparing Philadelphia hospitals against their track records for open heart surgery. He says public data improves care.

“We also have had literally two decades of public reporting, maybe not always about wrong site surgery but certainly about the outcomes of many different types of surgery, so I firmly believe that reporting has contributed mightily to reducing wrong site surgery, reducing post operative infection,” said Nash.

State adverse event reporting systems were created in response to reports studying preventable medical errors. A Health and Human Services Inspector General study measured medical errors in Medicare patients who went to the hospital in October 2008. Of the one million Medicare patients discharged during that month, the HHS Inspector General found one in seven experienced an adverse event.

Nash said, “Medical error, all medical error that is preventable, is the fourth leading cause of death in our country in 2016, is hard to believe.”

The former director of the Iowa Department of Inspections and Appeals, Dean Lerner, tried to create a public adverse event reporting system in the state.

Lerner said, “I thought it would be a really good idea for Iowa to expose to the public in a very scientific and straightforward way one that had been approved by 20 other states, and make those kinds of events transparent.”

The Iowa Department of Inspections and Appeals inspects hospitals. Lerner believed implementing mandatory public reporting would improve health care in Iowa.

Lerner said, “If you ask any Iowan whether having this information would be valuable and important in the scheme of things in terms of their care, they will tell you yes.”

He brought his proposal to the hospital licensing board back in 2010. The minutes of two meetings show the board had a lot of questions. How would this data improve care? What had other states experienced? How would the data be used? The former chairman of the hospital licensing board Bob Miller said those were critical questions.

“It did not appear to us that there was a plan for what to do with the information to be gathered,” said Miller.

He said the board also felt a state-run public reporting system was redundant.

“We felt that there was a lot of reporting going on through the collaborative, required by CMS, and for our relicensure, Joint Commission,” said Miller.

The Iowa Healthcare Collaborative has gathered data voluntarily from all hospitals in the state since 2007. Its CEO, Dr. Tom Evans said the group publishes a report comparing hospital performance across the state.

“The never events are a starting point, they were a very popular thing to start talking about in the early 2000’s but we’ve moved so far beyond that,” said Evans.

He said the Collaborative’s report has flaws. It’s very technical, so patients in the state may not understand what is being compared and why those comparisons are important. He says they’re working on improving it.

“We want consumers to be engaged with meaningful information so we have other things, tracking infection rates and antibiotic usage and falls and pressures sore,” said Evans.

Evans believes focusing on never events like wrong site surgeries is distracting.

“I want consumers engaged, I want them looking at this information, and we want to be transparent, but we’ve got to give consumers meaningful information that they can make good healthcare decisions based upon,” said Evans.

Miller said those concerns were key in the discussion.

“Is it going to improve quality of care of is it going to penalize an error,” said Miller.

Lerner said he needed the board’s support to move forward with a state public reporting system. He planned to answer questions as they came up.

“We didn’t want to jump with both feet before we carefully analyzed everything was to take this one step at a time, and I honestly thought that would help industry to adjust and get comfortable with the change,” said Lerner.

At the meeting back in 2010, chairman Bob Miller twice called for a motion on the proposal to create a public adverse event reporting system. No one on the board made one. The idea died without anyone casting a vote.

Never events at Iowa hospitals continue to remain hidden from public view. Iowa hospitals are not required to publicly report never events to anyone. Patient safety advocate David Nash said adverse events should be public knowledge.

“If we’re going to have consumer engagement in health care and consumers having more skin in the game with higher deductibles, they have every right to be able to connect the dots between what hospital is in my network and what are the outcomes of care for procedures that I may need, or family members may need in those institutions,” said Nash.

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“ADDICTED” to campaign contributions?

Posted on March 22, 2016 by Pharmaciststeve

Florida Attorney General Pam Bondi listens to a report of the investigation of Dozier reform school during a cabinet meeting at the state Capitol, Thursday, Jan. 21, 2016, in Tallahassee, Fla. (AP Photo/Steve Cannon)

Florida Attorney General Pam Bondi becomes latest victim of the Trump Curse.

http://www.redstate.com/moe_lane/2016/03/21/pam-bondi-trump-foundation-crew-irs-nonprofit-justice-for-all/

Executive summary: Florida Attorney General Pam Bondi in 2013 was considering joining in a lawsuit against Trump University.  Shortly thereafter, a check for $25,000 was sent to Bondi’s campaign political action committee [electioneering communications organization] “And Justice For All” by the Trump Foundation. AG Bondi (who has since endorsed Trump) ended up not joining in on the Trump University lawsuit.  So far, so bad: but here’s the wrinkle: the left-wing government transparency group CREW (Citizens for Responsibility and Ethics in Washington) today noted that the Trump Foundation is a 501(c)(3) nonprofit organization, and is thus not permitted to make campaign contributions*. Nobody noticed at the time because while the Trump Foundation reported the contribution properly on Florida campaign finance disclosure forms, it reported it to the IRS as a contribution to “Justice For All,” which is a non-political, pro-life group out of Kansas.  Justice for All has confirmed that they never got that money; CREW has now lodged a formal complaint with the IRS.

Now, I have a powerful advantage over many people when it comes to this sort of thing: a very smart, aggressively apolitical, and nigh-infinitely sensible wife.  I often use her as a check on my enthusiasms; she has accurately forecast the limits to many a political scandal that I have pitched to her, over the years.  But when I described this one to her, she looked at me as if either I was joking, or I had left something out, or both.  But no, I had not. The bottom line is, the Trump Foundation shouldn’t have offered that contribution and Bondi’s PAC ECO shouldn’t have taken it.  And it looks really, really bad that it just happens that the IRS got told wrong information that just happened to keep the IRS’s own internal watchdogs from independently starting an investigation into a potential violation of campaign finance law**.

Whether or not Donald Trump survives this one is, alas, open to debate: after all, the man routinely survives worse.  But it really doesn’t look good for AG Pam Bondi.  I mean, why did her PAC ECO take a campaign contribution from a 501(c)(3) nonprofit? Did they figure that it wouldn’t get noticed? – Although, to be fair: if Trump hadn’t run for President, it might not have…

*Exact text is “Organizations that are exempt from income tax under section 501(a) of the Internal Revenue Code as organizations described in section 501(c)(3) may not participate in, or intervene in (including the publishing or distributing of statements), any political campaign on behalf of (or in opposition to) any candidate for public office.”

**There’s a certain karma here, given that this entire affair was made possible by a bad law created in large part by Senator John McCain. Still, bad law or no: one should never give the impression that one is trying to flaunt [that you’re breaking] the rules.

[Some mild editing, after the fact. Most pertinently, Bondi used an Electioneering Communications Organization {ECO}, not a PAC; it can coordinate with the candidate, but has a more limited scope and cannot operate at certain times during the election cycle. It is definitely not a Super PAC. – ML]

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FDA:We are going to be dealing with opioids every day

Posted on March 21, 2016 by Pharmaciststeve

Dr. Robert Califf, President Barack Obama's choice to lead the Food and Drug Administration (FDA), testifies on Capitol Hill in Washington, Tuesday, Nov. 17, 2015, before the Senate Health, Education, Labor and Pensions Committee hearing on his nomination. (AP Photo/Pablo Martinez Monsivais)

The Senate last month confirmed Dr. Robert Califf to run one of the world’s most influential health agencies, the U.S. Food and Drug Administration. The 89-4 vote followed a delay by a handful of lawmakers who had turned President Obama’s nomination into a proxy fight over the FDA’s willingness to approve opioid pain-killers, despite a growing problem with addiction nationwide. Opioid addiction will be a major priority, Califf says, but it is just one of the items on his to-do list. As commissioner of the FDA, his responsibilities extend from the safety of the U.S. food supply to the regulation of drugs, some produced through scientific advances that were unimaginable even a few years ago.

Prior to his appointment, Califf was professor of cardiology at Duke University School of Medicine and has led numerous landmark clinical trials and served on many pivotal committees, including one charged with developing recommendations for identifying and preventing medication errors.

In his first in-depth interview since taking office, Califf spoke with U.S. News about his agency’s efforts to fight the opioid epidemic, the future of cancer research and other priorities. Excerpts:

Your nomination was held up by senators concerned about the opioid epidemic. How is FDA responding to their concerns?

We are going to be dealing with opioids every day, until everyone’s convinced that the tide has turned and the problem is receding significantly. It’s a very big problem and we’re going to stay hyperaware and focused on it.

160321_report.fda_quote

pilingon1We are working in conjunction with [the U.S. Centers for Disease Control and Prevention] to support their guidelines. The fundamental issue right now is over-prescribing and FDA has a major role to play. The guidelines say prescribe fewer opioids. Don’t neglect people in significant and chronic pain, but prescribe fewer opioids

You’ve advocated the development of abuse-deterrent forms of pain-killers that make it more difficult for abusers to crush pills so that they can inject the medicine. Critics say this won’t solve the problem. What’s your response?

We completely agree that if you take an abuse-deterrent formulation, it doesn’t change the risk that you could get addicted. But formulations that work may still prevent some forms of abuse. It’s early days. There’s a lot of technology development to do. It’s a very high priority for us to work with industry to come up with effective abuse- deterrent formulations.

What is at the top of your agenda for FDA?

The workforce. We have a tremendous workforce that has done a pretty amazing job across the ecosystem from agriculture to medical products. We’re going to need to reinforce that by hiring really good people and creating the best possible environment to retain the really great people that we have. The expertise you need to be great at FDA is the same expertise needed in cutting-edge companies that are developing new medical products or health related information technology – or figuring out ways to get higher yields in agriculture with better nutrition.

You’ve long been an advocate of rethinking the studies that we use to approve drugs and draw conclusions about public health. How do you see these changing?

In the way we generate [scientif

ic] evidence. The FDA does really well when it has high quality evidence. It’s really good at making decisions that benefit the public health. When decisions have to be made without the highest quality evidence, it’s not ideal. What’s really great now is that – with over $50 billion invested in electronic health records and with multiple other sources of data, from social media to high-end computation to devices that are implanted or wearable – we’ve got an amazing opportunity to increase the evidence that will drive good decisions.

[RELATED: CDC Issues Guidance on Prescription Painkillers]

Another way to think abou

t this is that we’ve been very dependent on clinical [drug] trials as one key source of information. Clinical trials are very expensive; as we learn to use existing data sources better, the cost of clinical trials can come way down. This is also pertinent to food safety… If you think of the vast diversity and complexity of agriculture, there’s no way you can inspect every product, one product at a time. But when you use high-end analytics, one can [target] the more detailed inspections to where the problems are.

What about clinical trials specifically, the hugely expensive studies that examine the risks and benefits of medication?

In this era, genetic and genomic information have given us the opportunity to develop targeted therapy and treat rare diseases in ways that wouldn’t have been imaginable before. This also affects clinical trial design. In some cases, [involving rare diseases,] clinical trials may actually be a lot smaller and more targeted [than in the past]. In other cases, when therapy might be administered to millions of people on a global basis, they may need to be much larger and more inclusive.

How much influence does FDA have when it comes to shaping the design of these trials?

FDA gets to see all the trials before they’re started, if they’re done with the goal of gaining approval or changing the label. This is a very powerful position to be in, with a lot of responsibility. As you might imagine, people don’t want to do a trial that the FDA doesn’t like, if they need FDA’s approval when the trial’s completed.

After decades of relativ

e drought, there are dozens of cancer drugs in the pipeline. Have we turned a corner in cancer treatment ?

You’re right, if you went back a couple of decades, there was a lot of worry that cancer was an area where progress was slow. It was hard to find highly effective therapies. That’s totally reversed. The ability to implement targeted chemotherapy and immunotherapy appears to be revolutionary. But it appears that it is not a magic bullet.

[Cancer researcher Dr.] Bert Vogelstein at Johns Hopkins [University School of Medicine] has a tremendous lecture on this. He makes the point that we really are at war with cancer: We fire our salvo in terms of therapy, and the cancer responds by adapting and changing its tactics. Then we have to go after it again. For many kinds of cancer, we n

ow, for the first time, have effective treatments. But…many people need additional treatment as time goes on.

Our growing understanding of the human genome makes it possible to come up with precisely targeted therapies for many diseases, not just cancer. What does the precision medicine revolution look like from your perspective?

[PHOTOS: The Big Picture – March 2016]

It’s useful to think about precision medicine and the cancer “moonshot” [Vice-President Joseph Biden’s effort to accelerate research to find a cure] as being tightly integrated and overlapping. To me, of course, [the power of] genetics and genomics to help us understand the molecular basis of disease is crucial for being able to target therapies better than we could before. But it goes beyond genetics. If you look at the Precision Medicine Initiative [the White House plan to study one million people and precisely target therapies] the emerging use of wearable technology and social media allows us to understand things like patient prefere

nces and continuously record data that we couldn’t monitor before.

One part of precision medicine would be to say, “We understand you have gene that’s putting you at risk and we have developed a treatment.” Another would be to say, “Now that we can look at your blood pressure [24 hours a day, seven days a week] we understand you have a pattern that’s different. You need a treatment that is different.” Or, “We have three different treatments for your problem, and now that we can communicate with you about your preferences, we can make the treatment more precise to achieve the risk-benefit trade-off that’ s important to you.”

If you look at the Precision Medicine [million-person study] – the initial funding is underway now – it will be built along the whole spectrum from genes to patient preferences.

How does this affect FDA?

As you can imagine, this has major implications for FDA. As precision medicine therapies are developed, they still, like everything else, have to meet evidentiary standards to be put on the market and made available.

Do you have to create thes

e new standards out of whole cloth?

In many cases, they will be less different than people think. If we were restricted by paper records, as we used to be, we might say, “Gee if you’ve got a targeted therapy that pertains to a small part of the population you can’t possibly do a [large] clinical trial. But when everybody has an electronic health record and people can sign up on the web to be part of the Precision Medicine Initiative [research study] we may not be limited by the kinds of things that kept us from getting high-level evidence before.

In other cases?

There are areas that are entirely novel. One that’s getting a lot of our attention now is next-generation sequencing. Up until now, one worked in a lab [and developed one test at a time]. Next-ge

neration sequencing allows [us to decode] the entire genome all at once. Each one of us has three billion base pairs in our genome. You could say it’s like doing 3 billion tests at one time on each individual person.

It’s obvious we can’t regulate that one test at a time. We’re working closely with the National Institutes of Health and others to develop…what’s called a data commons. You put the [sequence] data in a big database—which, by the way, would have been impossible three years ago, because you need cloud computing to do it. We can look at the database and see which tests are working and which aren’t. And we can label the tests appropriately, so that, when a doctor orders a test, there’s a much higher chance of understanding what the result means when the test comes back. It’s a whole new away of thinking about regulation, made possible by this amazing change in technology.

Everyone’s concerned about the high cost of drugs. Can FDA do anything about it?

The fact that over 90 percent of prescriptions are now [lower-cost] generics is a major victory. it’s critical for us to keep the pipeline of generics healthy.

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Converting a BRIBE into a CAMPAIGN CONTRIBUTION

Posted on March 20, 2016 by Pharmaciststeve

Filed under: General Problems | 1 Comment »

Congress continues to be in denial that drug abuse is a DISEASE ?

Posted on March 20, 2016 by Pharmaciststeve

Senate passes Ensuring Patient Access and Effective Drug Enforcement Act

http://www.drugstorenews.com/article/senate-passes-ensuring-patient-access-and-effective-drug-enforcement-act#.Vuy–4I1Vjw.blogger

WASHINGTON — The Senate this week unanimously passed the Ensuring Patient Access and Effective Drug Enforcement Act to help ensure that prescription drugs land in the hands of patients and not those who would abuse them.  
 
The bill, authored by Sens. Orrin Hatch, R-Utah, and Sheldon Whitehouse, D-R.I. and advocated by the National Association of Chain Drug Stores, would clarify the standards companies must meet when protecting prescription drugs from being diverted toward improper uses and help protect patients from dangerous disruptions in the production and delivery of their prescription drugs.  
 
The U.S. House of Representatives passed its largely similar version of the bill (H.R. 471) in April 2015. Congressional leaders will need to determine the best path to achieving passage of the exact same legislative language in both chambers, so the bill can advance to the President.
 
“Prescription drug abuse is a complicated and troubling trend that requires better coordination between drug manufacturers and law enforcement,” Hatch said. “The fact that prescription drugs can be abused should not prevent patients from receiving the medications they need. This bill takes a balanced approach to the problem of prescription drug abuse by clarifying penalties for manufacturing or dispensing outside approved procedures while helping to ensure that supply chains to legitimate users remain intact.”
 
“By offering better guidance for companies in the prescription drug supply chain, and by promoting better communication between those companies and federal regulators, this bill can help fight drug abuse and ensure that patients have access to their prescriptions,” Whitehouse added.  
 
In late February, NACDS sent a letter to members of the U.S. Senate, urging the passage that was achieved yesterday. “NACDS appreciates the diligence that has brought this legislation to the brink of enactment,” commented Steven Anderson, NACDS president and CEO. “Throughout, NACDS has emphasized pharmacy’s commitment to a zero-tolerance for abuse and diversion, and a 100% commitment to patient care. This legislation will help to deliver on that vision.”
 
“The passage of S. 483, coupled with Senate’s approval of the Comprehensive Addiction and Recovery Act (S. 524), substantially enhances the range of tools now available to regulators, supply chain stakeholders and the broader healthcare community to effectively address the prescription drug abuse epidemic,” added John Gray, president and CEO of the Healthcare Distribution Management Association.
 
NACDS and HDMA have both expressed strong support for this legislation. 
 
According to the Senators, the Controlled Substances Act currently does not make clear which factors the Drug Enforcement Agency should consider when deciding whether to register a company applying to manufacture or distribute prescription drugs. Hatch and Whitehouse’s legislation directs the DEA to use findings Congress compiled while drafting the CSA to define those factors.  
 
The bill also describes the circumstances under which the Attorney General can suspend a company’s registration. Finally, it allows companies that violate the CSA an opportunity to work with the DEA to correct the violation before having their registration revoked. 
 
NACDS has noted that the steady progress of the legislation in the Congress can be considered to be highly consistent with public attitudes. In an opinion study commissioned by NACDS last summer, likely voters who are engaged and aware when it comes to current events indicated through their responses an appreciation for the need to address drug abuse and drug access in a complementary manner.
 
Nearly 8-in-10 respondents agreed with the statement: “Pharmacies have a dual role when it comes to battling prescription drug abuse: They have to be part of the solution by working with law enforcement officials to stop prescription drug abuse, but they also have to maintain their responsibilities to patients by making sure they receive the medications they legitimately need.”

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Family members search for answers after suicide at beachside rehab house

Posted on March 20, 2016 by Pharmaciststeve

Delray Beach: Xanax, addiction and death

http://thecoastalstar.ning.com/profiles/blogs/delray-beach-xanax-addiction-and-death

Family members search for answers after suicide at beachside rehab house

  Tod Abrams’ last act, in a life that included a once-thriving career as a Hollywood film executive and fathering a son whom he said he adored, was to tie a pair of bathrobe cords together, loop them around his neck and fix a knot below his left ear. Then he hanged himself from a metal rod in a closet.
“The anguish, anxiety and nightmares were unbearable,” the 52-year-old Abrams had written in a note to his family. Police found it on a dresser in his room on Aug. 30 last year, after he had been dead for a few hours. It was only a month after he had sought help with his addiction to Xanax, a sedative used to treat anxiety, at a $60,000-a-month residential facility run by Caron Treatment Centers in an upscale oceanside neighborhood in Delray Beach.
    “I haven’t slept in 4 days and I’m probably beginning to hallucinate,” his note went on. “The people here were very kind but the program was too rigorous, too difficult. I’m too fatigued to proceed on. I don’t have the strength.”
With his death, Abrams joined the hundreds — perhaps thousands — of people suffering from substance use disorders who in recent years have succumbed to their disease in Florida. In Palm Beach County alone, at least 377 people died last year from drug overdoses, according to Pamela Cavender, the records custodian for the county’s medical examiner, citing statistics that are still being assembled. The problem, Cavender said, is “out of control.”
While the level of commitment to battling drug abuse varies widely, the success rate of treatment is exemplified not only by the almost ceaseless procession of deaths — whether by overdose, suicide or other means — but by the parade of addicts going in and out of rehabilitation centers and so-called sober homes in Delray Beach and other towns in South Florida.
Distraught addicts who announce their intention to kill themselves are routinely taken for evaluation to the South County Mental Health Center and other institutions under the terms of the Baker Act, which provides for involuntary commitment of people deemed a danger to themselves or others.
“Any time a kid says, ‘I’m going to kill myself,’ he gets Baker Acted,” said a Delray Beach firefighter-paramedic who asked not to be named and who has often transported such patients. “We’re doing 10 of those a week.”
In the wake of Abrams’ death, his younger sister, Jill, and other relatives have been left to wonder why no such action was taken in his case, especially since he took part in regular counseling sessions at the Caron facility and, according to his family, often discussed his state of mind with anyone who would listen. It remains unclear whether he actually brought up the subject of suicide while at Caron, and officials of its parent organization declined to comment on his time there.
Still, two days before her brother left for Delray Beach, Jill Abrams said, he told her he wanted to end it all. “ ‘The meds tell me to kill myself,’ ” she recalled him saying, and described him as “panicking and bouncing off the walls, crying hysterically.”
“We all knew as a family that my brother was suicidal,” she said, and asked why it might not have been equally apparent to the caregivers at Caron. “He was there to be weaned off drugs, but I assumed that in all these counseling sessions they were also going to deal with his suicidal feelings.”
Six months before he died, however, Abrams suggested in a blog that he had come to terms with ending his addiction to Xanax, which he said he had begun taking only to help him sleep.
“I am truly heartbroken today as I have to break up with the great love of my life,” he wrote. “I love Xanax. Of course my doctor never told me that Xanax is highly addictive.”
He wrote that, as with heroin, a Xanax addict cannot simply go “cold turkey”: suddenly and completely ceasing the use of a drug. Such a shock, he went on, would result in full “meltdown” and leave him “blubbering and incoherent.”
Abrams, who had held executive positions at New Line Cinema and Fine Line Features, founded Alternative Marketing Solutions, produced several independent films and accumulated considerable wealth, asked his blog readers to pray for him, “for I have lost the greatest love I have ever known and his name is Xanax, Xanax, Xanax.”
Before traveling last summer from his home in Los Angeles to Delray Beach, Abrams had tried to detoxify for eight days in Long Beach, Calif., but his effort foundered and he went back to taking the drug, according to a family member. After he had arrived at Caron’s residence at 1232 Seaspray Ave., the task was to wean him off his dependence on Xanax and transition him to lesser narcotics.
But things apparently began to go wrong very quickly. On Aug. 16, after having been there only two weeks, Abrams wrote in his journal that he had already attempted suicide and “was quite serious about killing myself.” He went on: “I planned to hang myself and nearly completed the task.”
The following day, his caretakers diagnosed him with bipolar disorder and schizophrenia and put him on Zyprexa, an antipsychotic medication. According to his medical records, Abrams also had been prescribed Zofran, to combat toxic side effects that were making him vomit; Inderal, which is used to treat tremors, chest pain and high blood pressure; and Xopenex, which addresses lung problems such as asthma and chronic obstructive pulmonary disease.

    Paradoxically, his sister said, Abrams appears to have been on more medications at the end of his month at Caron than when he arrived.
    Abrams’ relatives and friends remain perplexed as to whether his caretakers were fully aware of the depth of his despair.
    Did no one at Caron — which claims on its website to have attendants on duty around the clock — learn that Abrams continued to have severe anxiety and insomnia, and that when he did manage to sleep he had raging nightmares?
    Two days before he died, Abrams was reported to have been vomiting profusely. Why was he not taken to an emergency room, especially since he was so ill that someone at Caron canceled a visit by Abrams’ father?
    Why was he allowed to have belts, the kind of item often used in suicides?
    Why would a rehab facility take Abrams and a few other patients out to see a violent film like Straight Outta Compton on what turned out to be Abrams’ penultimate night alive?
    After Abrams’ death, his toxicology report showed a significant amount of caffeine in his system. Why was he allowed to consume coffee or caffeinated drinks, especially since the mix of caffeine and powerful drugs might have been contributing to his chronic sleeplessness?
    Those questions and others were posed to Karen Pasternack, a spokeswoman for Caron, which sent two grief counselors to the home of Abrams’ mother after his death.
    In an email message to The Coastal Star, Pasternack declined to address any issues related to Abrams or his care.
“The law and Caron’s own high ethical standards forbid our employees from discussing even the smallest of details about any patient, including confirming the identity of current or former patients,” wrote Pasternack, who said she represented the views of Bradley F. Sorte, the executive director of Caron’s facilities in Delray and Boca Raton, which are licensed by Florida’s Department of Children and Families to provide rehabilitation services.
    “We will never violate federal or state laws or breach our patients’ sacred trust,” she went on. “We can proudly state that many Caron alumni, who have returned to their communities in Florida, Pennsylvania and elsewhere, know firsthand the strength of our programs. Caron fully complies with the law and adheres to the highest medical and psychological best practices with a focused commitment to transforming the lives of individuals and families impacted by addiction.”
    Some years before Abrams’ death, a doctor in Beverly Hills, Calif., began prescribing a daily dose of Xanax to help fight his insomnia, according to Jill Abrams, who spoke from her home in Los Angeles. She said her brother was not told that the drug could have a permanent and negative effect on the chemistry of his brain.
    When she spoke with her brother by phone about halfway through his stay in Delray Beach, he told her he “wanted to run away” from the residence, and that he had been going for 10-mile walks on the beach almost every day.
    “That was not a good thing, because he was already so thin,” Jill Abrams said of her 5-foot, 8-inch-tall brother, who weighed 127 pounds when he died. “I can’t understand why he had such freedom. I thought it was a lock-down facility. In the rehab places in California, the patients don’t walk off on their own. They really watch them.”
    In any case, she said, the death of her brother has left her not only deeply saddened but remorseful. “I feel incredible guilt,” she said, “for not hospitalizing him here in Los Angeles when he told me he was suicidal.”
    In a blog, Jill Abrams wrote about the drug that bore perhaps more direct responsibility for her brother’s demise. “I am left feeling that we need to understand why this insidious drug is as prevalently over-prescribed as it is,” she wrote. “In rehab, Tod began working on his ideas for a foundation to educate and lobby for more transparency with prescription drugs like Xanax. Let my brother’s unexpected death put a spotlight on this dire epidemic in America.”
    After Tod Abrams’ suicide, criticism of his treatment at Caron prompted a defense of the company by John Lehman, president of the Florida Association of Recovery Residences, which seeks to improve industry standards.
    “I remain confident that this particular organization strives to serve their clients with the highest level of professionalism,” he wrote in an email, referring to Caron. “In point of fact, were the remainder of the Florida provider group as committed to delivery of quality services, there would be significantly less demand for oversight.”
    Lehman — who dismissed as “absurd” the persistent allegations from Delray Beach residents that recovering and relapsed addicts had committed crimes and caused other problems in their neighborhoods — extended his condolences to the Abrams family.
“As is evidenced by this tragic story, a highly accomplished, creative and well-respected artist lost his battle to an insidious brain disease that robbed him of hope,” Lehman said. “May he rest in peace.”

 

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“This is really the first time CDC has waded into the water of giving prescribers advice on how to practice medicine,”

Posted on March 20, 2016 by Pharmaciststeve

Centers for Disease Control releases controversial opioid guidelines

http://www.kmtv.com/news/national/centers-for-disease-control-releases-controversial-opioid-guidelines

AURORA, Colo. — The Centers for Disease Control released new guidelines for opioid prescriptions Tuesday in an effort to fight the disturbing trend of abuse and prescription drug deaths.

The move is a first in the medical world, with the CDC telling doctors to stop writing opioid prescriptions for patients, when possible. The new recommendation is “start low, go slow.”

It’s no secret opioids, such as Oxycontin and Vicodin are highly addictive. But, the CDC seems to think even doctors need a reminder.

“This is really the first time CDC has waded into the water of giving prescribers advice on how to practice medicine,” said Robert Valuck, PhD, RPh, a professor at the University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences. “So, that’s very controversial.”

Primary care physicians prescribe almost half of all opiates. There is no legal obligation for them to follow the new recommendation.
       
“They are not laws and they are not regulations, so doctors don’t have to do it,” said Valuck. “But, the guidelines kind of become standard of practice.”

Valuck, who coordinates the Colorado Consortium and has testified in front of Congress about prescription drugs, says he agrees that opiates are only safe to take for a few days before patients can develop an addiction.

Right now, forty Americans die from opioid overdoses every day, and nearly two million people abuse the drugs or are dependent on them.

 

 

Valuck says opioids are not effective for all pain, and patients who are prescribed them should not expect pain to go away entirely. He advises the public to ask doctors about alternatives before filling an opioid prescription.

There are some exceptions in the new CDC guidelines, mainly for cancer treatments and end-of-life care.

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One year after the Obama Administration came to power.. interpretation of the law(s) changed ?

Posted on March 20, 2016 by Pharmaciststeve

Why are federal Inspectors General not allowed to do their job?

http://weartv.com/news/nation-world/why-are-federal-inspectors-general-not-allowed-to-do-their-job

When DEA agents last year were accused of having sex parties with prostitutes paid for by drug cartels, an investigation by the Inspectors General of the Department of Justice was immediately launched.

In their concluding report, they noted getting access to information was met with repeated delays and difficulties.

Michael Horwitz was the author of that report and says it was just one on a long list of examples of IGs being told they can’t get the documents or resources they need.

Michael Horwitz, Inspector General, Dept. of Justice said, “Up until 2010 the law was quite clear and everyone operated under the law which was that we get, as IGs, access to all information.”

Here’s the thing – the law never changed – just the interpretation of it starting in about 2010.

He says IGs for dozens of other agencies noticed as well and called for action in a letter signed by 68 of them.

“These decisions are being made by agency counsel to limit our access in a way that’s not transparent and not accountable.”

Kristine: it seems that’s not the way the system was set up

Michael: well it can’t be how the system was set up. If you need to go to the folks that you’re overseeing to ask permission to get access to records about potentially very serious misconduct there is always the potential that we don’t get all the records we need and of course we don’t know what we don’t know”

There is bipartisan legislation on cap hill right now to try to fix this problem, spelling out that access to all information means all information. So far that bill is stalled in both the House and the Senate.

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We’ve come out a little strong at this point in time about the risks of NSAIDs in older people

Posted on March 20, 2016 by Pharmaciststeve

 INSERT DESCRIPTIONExperts Warn Against Long-Term Use of Common Pain Pills

http://newoldage.blogs.nytimes.com/2009/05/06/experts-warn-against-long-term-use-of-common-pain-pills/?_r=1

Aspirin and ibuprofen are staples in just about every medicine chest and first aid kit. They’re sold over the counter, and they’re not expensive. Most people don’t think twice about taking them.

But they should — especially if they’re elderly.

Last week, an expert panel of American Geriatrics Society pretty much bumped all non-steroidal anti-inflammatory drugs, or NSAIDs, off the list of medicines recommended for adults ages 75 and older with chronic, persistent pain. Long-term use of drugs like ibuprofen, naproxen and high-dose aspirin is so dangerous, the panelists said, that elderly people who can’t get relief from alternatives like acetaminophen may be better off taking opiates, like codeine or even morphine.

All this despite the fact that NSAIDs are known to be effective for chronic pain conditions that often plague older adults — and despite the fact that opiates can be addictive.

“We’ve come out a little strong at this point in time about the risks of NSAIDs in older people,” said Dr. Bruce Ferrell, chair of the panel that made the recommendations and a professor of geriatrics at the University of California, Los Angeles. “We hate to throw the baby out with the bathwater — they do work for some people — but it is fairly high risk when these drugs are given in moderate to high doses, especially if given over time.”

“It looks like patients would be safer on these opioids than on high doses of NSAIDs for long periods of time,” he said, adding that for most elderly, the risk of addiction appears to be low. “You don’t see people in this age group stealing a car to get their next dose.”

The risks from chronic use of NSAIDs are myriad. They can cause life-threatening ulcers and gastrointestinal bleeding, a side effect that occurs more frequently and with greater severity as people age. Some NSAIDs may increase the risk for heart attacks or strokes, and they don’t interact well with drugs used to treat heart failure. They can make high blood pressure worse, even uncontrollable, and impair kidney function. And the list of potentially hazardous interactions with other drugs is a long one, experts say.

“Physiological changes in the elderly affect the way drugs are absorbed and secreted and how the body responds to them,” said Dr. Keela Herr, a professor at the University of Iowa College of Nursing in Iowa City who researches pain management in the elderly and was involved in drafting the new guidelines. “Younger people can use this class of medicine with limited risks. In older persons, it’s a different story. Physical changes make them more sensitive.”

The geriatrics society’s new guidelines say NSAIDs should be considered “rarely” in the population of frail elderly people, and used “with extreme caution” and then only in “highly selected individuals.” For those patients with moderate to severe pain that diminishes the quality of life, opiates may be considered, the guidelines suggest, after both the patient and caregiver are screened for prior substance abuse.

It is the third revision of the guidelines, originally created in 1998 and updated in 2002. In this latest version, acetaminophen remains the top choice for chronic pain. But acetaminophen is a fairly weak analgesic, experts say.

“Opioids are, everyone agrees, probably the strongest pain medication you have,” said Dr. Roger Chou, a pain expert who was not involved in writing the new guidelines and believes decisions about opioid therapy must be made on a case-by-case basis. “The down side is the potential for abuse, and we’re seeing huge increases nationwide of reports about the misuse and diversion of prescription drugs and related deaths. . . .The concerns about opioids are very real.”

He argued that opioids must be prescribed very carefully, no matter what the age of the patient. Patients with chronic persistent pain will be on the drugs for a long time, because the pain usually does not go away, and they will also be at risk of developing other problems related to the medication, such as constipation, nausea and fatigue.

The guidelines are not meant to discourage the treatment of pain. On the contrary, chronic pain is rampant among the elderly, affecting an estimated 25 to 50 percent of elderly people living in the community and up to 85 percent of nursing home residents. Often caused by degenerative spine conditions, arthritis and cancer or cancer treatment, chronic pain takes a powerful toll on quality of life.

Untreated, chronic pain can disrupt sleep and affect mood, restrict mobility and lead to depression, anxiety and isolation, experts say. It can also contribute to falls, which lead to further complications and often death. Although non-drug treatments like physical therapy, cognitive behavioral therapy and other educational interventions are often helpful, adding drugs to the mix usually enhances treatment, experts say.

“There really continues to be a significant amount of unrecognized and untreated pain in older people, and it’s a huge problem,” Dr. Herr said. “A lot of people think that just because they’re getting older they’re going to have pain and just have to learn to live with it. That’s not the case.”

Pain cannot always be entirely eliminated, she added. “You can get to the point where it’s in the mild category — where it’s annoying but not causing such impairment that you can’t function and interact and do the things that are important.”

 

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Fibromyalgia Awareness – Short Film

Posted on March 20, 2016 by Pharmaciststeve

In case you’re wondering how qualified the Happy Seven team is to be taking on this project, take a minute to read through this update.

Writer/director Sophie Meath is an award-winning filmmaker. Her work has been honored at the Five16 Film Festival in St. Paul (Best Narrative, 2013; Best Music Video, 2014), the Intercollegiate National Religious Broadcasters (2nd Place Short Film, 2015), the Oklahoma Broadcast Education Association (1st Place and 3rd Place Long Narrative, 2015), as well as the Upper Midwest Emmy® Chapter Student Awards (1st Place College Fiction, 2015)! She has substantial directing experience and is a talented cinematographer. You can view her production reel in the video below.

The director of photography, Carsten Johnson, is also an award-winning filmmaker. He has won several first-place awards at the Five16 Film Festival and his films have been screened at the Minneapolis Underground Film Festival as well as the Inspiration Film Festival in Florida. He and Sophie have worked together for years and are very excited to be teaming up again for this production.

Ben Carlson is both a talented producer and a gifted musician. He has performed in many different venues in both North and South America as well as Taiwan. In the past few years he cowrote, recorded, and produced two albums in two separate bands. His passion for audio and sound engineering earned him several 1st place production awards from the Intercollegiate National Religious Broadcasters association, including an Award of Excellence for Best Audio Production. He has also worked on audio in several successful short films and is very excited to tackle the sound design elements in this film.

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