Chronic painer “forced” into buying street drugs… dies from overdose ?

After 7th Death, DEA Takes Over Search For Fentanyl Pills In Sacramento

SACRAMENTO (CBS13) — The Drug Enforcement Administration is taking over an investigation into how fentanyl ended up in drugs in the Sacramento area after a seventh person is believed to have been killed by the drug.

The family of Jerome Butler says he was taken off life support on Wednesday afternoon, just three days after his mother said he took a pill for chronic stomach pain he didn’t know had been laced with Fentanyl.

The drug is also believed to be responsible for 21 other hospitalizations.

CBS13 has learned recession budget cuts claimed narcotics teams in the Sacramento area who would track down drugs like Fentanyl.

Assemblyman Jim Cooper was once an undercover cop who busted drug dealers daily. He established Sacramento County’s first street narcotics team in 1988.

“It was turn and burn; you go out arrest someone, and get the next one,” he said.

His unit was dedicated to finding the guys dealing prescription pills like the ones now being blamed for multiple deaths in Sacramento County.
“It’s unfortunate, because those folks—the actual dealers selling out there right now—they’re out there unimpeded. They could do whatever they want,” he said.

The recession claimed the sheriff’s department’s team in 2008, while the Sacramento Police Department got rid of theirs in 2011. Neither has been restored.

Both agencies declined on-camera interviews, but defend their current operations. They say high-level drug task forces now pick up the slack.

“There’s lots of task forces in Sacramento, but they work on high-level drug dealers, but the street teams, they go out every night for that purpose, arresting drug dealers,” Cooper said.

He hopes the pill problem could be solved with a bill that would make locking pill bottles available to people with prescriptions, making it harder for addicts to steal the drugs.

For now, he hopes to see street teams back on the street deterring drug dealers and their deadly combinations.

“Otherwise you’re going to see more deaths with this,” he said


Over the total 78 weeks observed, there were no overdose events in the extended-release naltrexone group and seven in the usual-treatment group

Extended-Release Naltrexone to Prevent Opioid Relapse in Criminal Justice Offenders

http://www.nejm.org/doi/full/10.1056/NEJMoa1505409#t=abstract

Background

Extended-release naltrexone, a sustained-release monthly injectable formulation of the full mu-opioid receptor antagonist, is effective for the prevention of relapse to opioid dependence. Data supporting its effectiveness in U.S. criminal justice populations are limited.

 

Methods

In this five-site, open-label, randomized trial, we compared a 24-week course of extended-release naltrexone (Vivitrol) with usual treatment, consisting of brief counseling and referrals for community treatment programs, for the prevention of opioid relapse among adult criminal justice offenders (i.e., persons involved in the U.S. criminal justice system) who had a history of opioid dependence and a preference for opioid-free rather than opioid maintenance treatments and who were abstinent from opioids at the time of randomization. The primary outcome was the time to an opioid-relapse event, which was defined as 10 or more days of opioid use in a 28-day period as assessed by self-report or by testing of urine samples obtained every 2 weeks; a positive or missing sample was computed as 5 days of opioid use. Post-treatment follow-up occurred at weeks 27, 52, and 78.

 

Results

A total of 153 participants were assigned to extended-release naltrexone and 155 to usual treatment. During the 24-week treatment phase, participants assigned to extended-release naltrexone had a longer median time to relapse than did those assigned to usual treatment (10.5 vs. 5.0 weeks, P<0.001; hazard ratio, 0.49; 95% confidence interval [CI], 0.36 to 0.68), a lower rate of relapse (43% vs. 64% of participants, P<0.001; odds ratio, 0.43; 95% CI, 0.28 to 0.65), and a higher rate of opioid-negative urine samples (74% vs. 56%, P<0.001; odds ratio, 2.30; 95% CI, 1.48 to 3.54). At week 78 (approximately 1 year after the end of the treatment phase), rates of opioid-negative urine samples were equal (46% in each group, P=0.91). The rates of other prespecified secondary outcome measures — self-reported cocaine, alcohol, and intravenous drug use, unsafe sex, and reincarceration — were not significantly lower with extended-release naltrexone than with usual treatment. Over the total 78 weeks observed, there were no overdose events in the extended-release naltrexone group and seven in the usual-treatment group (P=0.02).

 

Conclusions

In this trial involving criminal justice offenders, extended-release naltrexone was associated with a rate of opioid relapse that was lower than that with usual treatment. Opioid-use prevention effects waned after treatment discontinuation. (Funded by the National Institute on Drug Abuse; ClinicalTrials.gov number, NCT00781898.)

 

WV: 3,000 doses Naloxone administered, which hopefully saved 3,000 lives… we don’t know ?

‘Ahead of the curve’: Summit shows WV’s progress on drugs

http://www.herald-dispatch.com/news/ahead-of-the-curve-summit-shows-wv-s-progress-on/article_fc4301e0-89af-51dc-be12-9a1b173ff34e.html

Naloxone can be compared to finding someone starving to death.. you give them a meal/drink and hope that they stop starving.. Apparently WV… just revives people who overdose and puts them back into the environment from which they came and hope that they “get their act together”…  Is it that they just keep count of how many doses of Naloxone they have administered and that is really all that really matters.. the NUMBERS ?

HUNTINGTON – A delegation of West Virginians who face drug addiction on a daily basis represented the state at the 2016 National Prescription Drug Abuse Summit in Atlanta this week, and what they learned is West Virginia is ahead of the curve.

More than 1,500 people, including President Barack Obama, attended the summit, the largest collaboration of professionals from areas impacted by prescription drug abuse and heroin use.

Gov. Earl Ray Tomblin; U.S. Sen. Joe Manchin, D-W.Va.; U.S. Rep. Evan Jenkins, R-W.Va.; and Huntington Deputy Fire Chief Jan Rader, who is also a member of the Mayor’s Office of Drug Control Policy, were among those who presented during the three-day summit.

Tomblin was part of the keynote address Monday, and participated in a panel discussion with Manchin and U.S. Secretary of Agriculture Tom Vilsack.

He was the only governor invited to the summit, and he said Wednesday he believed that was because of the progress West Virginia has made in the fight against the opioid epidemic.

“We are really one of the leaders in the country right now as far as the things we’ve been able to do as far as shutting down pill mills, the reporting of prescriptions filled to the Board of Pharmacy – we’ve taken a very active role in letting the licensing board know who those people are who are overprescribing,” Tomblin said.

“We’ve had the medical community learn more about prescriptions they are prescribing and the problems with those pills sometimes. We’ve got our call line in place, and I think it’s still one of the only services of its kind in the country that let those people who need help to pick up the phone and they will stay on the line with you until they get you to a person who can help you.”

Tomblin said the state has also made strides with naloxone.

Just last year, our EMS administered over 3,000 doses, which hopefully saved 3,000 lives,” he said. “Now, anybody can get it without a prescription, and plus the pharmacist will teach you how to properly administer the drug, so hopefully we will save a lot more lives in our state to give people a second chance to get the help that they need.”

Tomblin signed the bill Tuesday that made naloxone available without a prescription.

He said he also thinks West Virginia is one of the first states to change the attitude toward drug abusers.

“We used to think we could just lock them up and that would help,” Tomblin said. “It’s an illness, and we are going to treat it that way.”

Jenkins said it was an honor to share a story of progress, and he said it was an energizing experience. He was one of seven on a congressional panel.

Jenkins said he focused on three areas during the panel: the potential and power of prescription drug monitoring programs, holes in Obama’s proposed $1.1 billion plan to combat opioid abuse, and the need for more centers like Lily’s Place nationwide and removing the barriers to creating them.

He said that with the state’s more proactive monitoring program, the Board of Pharmacy has been able to search the database and send more than 8,000 letters to practitioners about patients who had received a pain medication prescription from other prescribers, a practice often called pill shopping.

“We are so far ahead of the curve in West Virginia to use that database in a very proactive, effective way,” he said.

Jenkins said the next barrier is finding a way to share this data across state borders. To do so, state confidentiality programs must match. Currently, West Virginia only matches 18 states.

Treading carefully, Jenkins said he also talked about holes in the president’s proposed budget. The proposal focuses mainly on medication-assisted treatment, but Jenkins, a member of the House Appropriations Committee, said the president is proposing cutting programs that are proven to work in his district, including Cabell County, such as drug courts and the High Intensity Drug Trafficking Area.

He also talked about centers like Lily’s Place and the regulatory challenges to replicating Lily’s Place nationwide.

“I talked about the Cradle Act, which would push the federal health regulators to put in place regulatory standards to allow Lily’s Place to be replicated,” Jenkins said. “We’ve already done it in West Virginia.”

Jan Rader represented Huntington on a panel with representatives from Camden, New Jersey, about communities’ responses to heroin.

Rader said she talked about the harm-reduction program, the involvement of the whole community and other initiatives like the expansion of drug courts. She also talked about where Huntington hoped to go, including needing more detox beds. There are only 18 in Cabell County.

“Being there a couple days brought to light we are ahead of the curve,” Rader said, echoing Tomblin and Jenkins. “We’ve been doing a lot that they are doing at national level just now. We are really making do with what we have and being creative.

“We don’t deal with egos. We work together. A lot of communities are up against political battles, people not cooperating. We aren’t dealing with that. Huntington and Cabell have come together as a community to do the right thing.”

She said one thing Camden is doing that she would like to see happen here is training police in the academy how to deal with someone with addiction and how to administer naloxone. She said she would like to see fire and EMS responders receive the same training as well.

Rader said she was honored to represent Huntington, and reiterated what Mayor Steve Williams frequently says: Huntington will be known as the place that helped.

“We have a problem, but we will help turn it around,” she said.

Andrea Darr, director of the West Virginia Center for Children’s Justice; Kristi Justice, executive director for Kanawha Communities that Care; and Chad Napier, prevention and education coordinator for Appalachia HIDTA in West Virginia and Virginia, also presented during the summit.

Follow reporter Taylor Stuck on Twitter @TaylorStuckHD.

unintended consequences from bureaucrats interfering with the healthcare system

Doctors resist new painkiller prescribing procedures

http://www.cbsnews.com/news/doctors-resist-new-painkiller-prescribing-procedures/

It has been reported that only 47% of prescribers are ready/capable of sending electronic control medications Rxs. Whereas 95% of the pharmacies are able to accept electronic controlled Rxs. Using averages, for every million people population there are 11,000 pts that need to get a controlled Rx filled EVERYDAY. If only 47% of prescribers are capable of generating electronic controlled Rxs… how many pts are going to be thrown into cold turkey withdrawal every day going forward ? How many are going to suffer from a hypertensive crisis… resulting in a stroke or death ?

Unintended consequences:

prescriber sends a C-II to a pharmacy that is out of inventory or Pharmacist is “not comfortable”… the C-II Rx becomes DOA. It can’t be transferred to another pharmacy.. the prescriber could be drug into participating into the “pharmacy crawl” trying to find a pharmacy that has or is comfortable filling a C-II. If the Rx is C-III -C-V… will the pharmacy/Pharmacist be willing to participate in the “pharmacy crawl” to find another pharmacy to fill the Rx ? Technically, the prescription is the property of the pt, but now in NY… the pt never receives a written Rx and remains in the possession of the pharmacy it was first transmitted to. What is the obligation of the receiving Pharmacist to help assure the pt gets the medication that the prescriber intended for the pt to get?

WASHINGTON –The nation’s top health officials are stepping up calls to require doctors to log in to pill-tracking databases before prescribing painkillers and other high-risk drugs.

The move is part of a multi-pronged strategy by the Obama administration to tame an epidemic of abuse and death tied to opioid painkillers like Vicodin and OxyContin.

But physician groups see a requirement to check databases before prescribing popular drugs for pain, anxiety and other ailments as being overly burdensome.

Helping push the administration’s effort forward is an unusual, multi-million lobbying campaign funded by a former corporate executive who has turned his attention to fighting addiction.

“Their role is to say what needs to be done, my role is to get it done,” says Gary Mendell, CEO of the non-profit Shatterproof, which is lobbying in state capitals to tighten prescribing standards for addictive drugs.

Mendell founded the group in 2011, after his son committed suicide following years of addiction to painkillers. Previously, Mendell was CEO of HEI Hotels and Resorts, which operates upscale hotels. To date, Mendell has invested $4.1 million of his own money in the group to hire lobbyists, public relations experts and 12 full-time staffers.

A new report from Shatterproof lays out key recommendations to improve prescription monitoring systems, which are currently used in 49 states.

The systems collect data on prescriptions for high-risk drugs that can be viewed by doctors and government officials to spot suspicious patterns. The aim is to stop “doctor shopping,” where patients rack up multiple prescriptions from different doctors, either to satisfy their own drug addiction or to sell on the black market. But in most states, doctors are not required to check the databases before writing prescriptions.

Last week, the White House sent letters to all 50 U.S. governors recommending that they require doctors to check the databases and require pharmacists to upload drug dispensing data on a daily basis.

The databases are “a proven tool for reducing prescription drug misuse and diversion,” said Michael Botticelli, National Drug Control Policy Director, in a statement.

But government health officials say virtually all state systems need improvements, including more up-to-date information.

“There isn’t yet a single state in the country that has an optimal prescription drug monitoring program that works in real time, actively managing every prescription,” said Dr. Tom Frieden, director of the Centers for Disease Control and Prevention, in a press conference last week.

Physicians warn about the unintended consequences of mandating use of programs that can be slow and difficult to use. Patients may face longer waits and less time with their physicians, says Dr. Steven Sacks, president of the American Medical Association.

“There really is a patient safety and quality-of-care cost when you mandate the use of tools that are not easy to use,” Sacks said.

The report from Shatterproof highlights the gaps in current prescribing systems. When doctors are not required to log in, they generally only do so 14 percent of the time, according to data from Brandeis University.

The report points to positive results in seven states that have mandated database usage: Kentucky, New York, Tennessee, Connecticut, Ohio, Wisconsin and Massachusetts. In Kentucky, deaths linked to prescription opioids fell 25 percent after the state required log-ins in 2012, along with other steps designed to curb inappropriate prescribing.

The same information can be used to prevent deadly drug interactions between opioids and other common medications, including anti-anxiety drugs like Valium of Xanax.

Opioids are highly addictive drugs that include both prescription painkillers like codeine and morphine, as well as illegal narcotics, like heroin. Deaths linked to opioid misuse and abuse have increased fourfold since 1999 to more than 29,000 in 2014, the highest figure on record, according to the CDC.

Earlier this month, the CDC released the first-ever national guidelines for prescribing opioids, urging doctors to try non-opioid painkillers, physical therapy and other methods for treating chronic pain.

But pain specialists fear requiring pill-tracking databases will discourage doctors from prescribing the drugs even when appropriate, leaving patients in pain. Dr. Gregory Terman says it takes him three minutes to log in to the system used in his home state of Washington.

“If it was easier to use, more people would use it,” said Terman, who is president of the American Pain Society, a group which accepts money from pain drugmakers. Like many physicians, Terman says he supports the technology but doesn’t think it should be required.

Last week, two states targeted by Shatterproof signed into law database-checking requirements: Massachusetts and Wisconsin. Mendell says his staffers are lobbying now in California and Maryland.

“I don’t think we can afford to wait decades for this to slowly get implemented into the system,” he says. “I think we need to take action now.”

Study involving 21 pts … produces valid conclusion/outcome ?

lmaoOne Month of Opioid Use Causes Gray Matter Loss, New Study Confirms

http://www.painmedicinenews.com/Science-Technology/Article/03-16/One-Month-of-Opioid-Use-Causes-Gray-Matter-Loss-New-Study-Confirms/35476/ses=ogst

Scientists from the United States and Australia have confirmed there is reduced gray matter volume in several areas of the brains of people who take opioids for more than a few days (Pain Med 2015 Dec 26. [Epub ahead of print]).

The researchers randomly assigned 11 people with low back pain to receive morphine daily for a month and another 10 to receive placebo. Subsequent imaging identified loss of gray matter in several reward- and pain-related regions of the brain in the morphine group but not the placebo group. There were no appreciable gray matter losses in the placebo group despite significant pain reduction.

The changes observed by the investigators corroborate evidence from an earlier study they published that showed alterations in the brain’s reward-related networks after one month of daily morphine use (Pain 2011;152:1803-1810).
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“It’s disturbing to learn that in as little as one month, daily use of opioids can alter brain morphology. And it’s even more disturbing to learn that despite the harm caused to the subjects in the morphine arm, their pain wasn’t any better controlled than the patients receiving placebo,” commented Andrew Kolodny, MD, chief medical officer, Phoenix House; executive director, Physicians for Responsible Opioid Prescribing; and senior scientist, Heller School for Social Policy and Management, Brandeis University, Waltham, Mass. “This is strong evidence that for many patients, the risks of long-term opioids clearly outweigh potential benefit.”

However, lead investigator Joanne C. Lin, PhD, postdoctoral research fellow in the Department of Psychology at the University of Alabama at Birmingham, and her co-investigators from The University of Alabama; Stanford University, in California; and Monash University, in Victoria, Australia, said the study was small and that its clinical implications remain to be seen.

“It is important to note that brain changes do not necessarily mean that something bad has happened. The next step is to carefully monitor patients taking opioids to see what happens when the brain changes,” Dr. Lin said in an email to Pain Medicine News. “Are the brain changes associated with good (e.g., pain relief) or bad (e.g., addiction) outcomes? It is important that we answer that question before we start suggesting that this research should change how physicians treat pain.”

The patients’ average ages were 39 years in the morphine group and 45 years in the placebo group (P=0.178), and the average duration of pain was 11.1 years in the morphine group and 5.2 years in the placebo group (P=0.115). There was a 29.9% reduction in pain in the morphine group over the month of the study and a 33.3% reduction in the placebo group.

Magnetic resonance imaging revealed significantly reduced gray matter with morphine in the left inferior orbitofrontal cortex, right gyrus rectus, bilateral presupplementary motor areas and left dorsal posterior cingulate. There also was significant volume loss in the superficial subregions of the bilateral amygdala, left insula, two regions of the left superior temporal gyrus, right precentral gyrus, right superior frontal gyrus, right inferior temporal gyrus and right rolandic operculum. Several of these overlapped with decreases documented in earlier studies. There also were gray matter volume increases in some areas such as the bilateral insula and right hippocampus. There were no significant volume changes in placebo patients.

“I hope the authors report back on how these patients do over time. It will be important to learn if the brain changes are reversible after opioids are discontinued,” said Dr. Kolodny.

I’m from the government and here to help you !

adaletter govworker

You will have to click on image to enlarge and make readable.

This is a letter that a chronic painer received from the Federal ADA agency, after filing a complaint against Humana Mail Order Pharmacy for refusing to fill a C-II for a pt having Humana Medicare Advantage program.

The ADA agency – part of the Dept of Justice – after reviewing the complaint, could not even provide an OPINION as to the validity of the complaint. Of course, the ADA is under the same Cabinet position .. Dept of Justice (DOJ)… the same as the DEA. So is the ADA unwilling to pursue this denial of care issue is being caused by actions of the DEA and it is unheard of one Federal agency “going after” another Federal agency particularly under the same Cabinet position ?

It would appear that the ADA staffers are so lazy… they provide a list of organizations serving the complainant’s area… BUT.. CANNOT GUARANTEE that the listings are current and/or accurate.

Here is a list of actions taken by the ADA against various entities http://www.ada.gov/enforce_activities.htm

Looking at their actions, could it be that the ADA is discriminating against certain groups they are suppose to be representing ?

 

 

 

End global war on drugs, bring in decriminalization to protect human rights

End global war on drugs, bring in decriminalization to protect human rights, says report

https://www.rt.com/uk/337648-war-drugs-human-rights/

The global war on drugs has failed, eroding public health and human rights, and must be scrapped in favor of decriminalization, a report commissioned by a leading medical journal says.

Anti-narcotics efforts have had little impact on global patterns of supply and demand and cannot be defended on public health or scientific grounds, according to academics who worked on a hard-hitting study jointly commissioned by the Lancet and America’s Johns Hopkins Ivy League University.

The report uncovers compelling evidence that EU states such as the Czech Republic and Portugal have achieved positive results from decriminalizing non-violent, minor drug offenses. Portugal, in particular, decriminalized the personal use of drugs such as cannabis, cocaine, and heroin in 2001.

Benefits reportedly include improved public health, lower rates of imprisonment, money saving and “no significant increase in problematic drug use,” the report’s authors say.

After examining evidence from across the globe, the study concluded that drug laws often discriminate against ethnic and racial minorities and women and have undercut basic human rights. The report also highlights prison terms for those who commit minor drug offenses as the biggest contributor to increased infection rates of HIV and hepatitis C among drug users.

The study’s authors are calling on the US and the UK to consider introducing regulated markets for the sale of cannabis similar to those found in Uruguay and the US states of Washington, Colorado, Oregon and Alaska.

 Dr Chris Beyrer of Johns Hopkins’ Bloomberg School of Public Health says prohibition has been the foundation of national drug laws. Beyrer also argued counter-narcotics policies across Europe and America focus on ideas relating to drug use and dependence that have no scientific grounding.

“The global ‘war on drugs’ has harmed public health, human rights and development,” he said.

“It’s time for us to rethink our approach to global drug policies, and put scientific evidence and public health at the heart of drug policy discussions.”

The report marks yet another drive for changes to UK drug laws, a move which has been put forward by ex-Liberal Democrat leader Nick Clegg and British billionaire, businessman Richard Branson. Experts suggest that legalizing cannabis in Britain could rake in up to £1 billion in taxes.

increased in patient adverse events, including higher mortality rates and hospitalizations

Medicare Competitive Bidding Program Under Fire

http://www.medpagetoday.com/PrimaryCare/Diabetes/57018?xid=NL_breakingnews_2016-03-30&eun=g578717d0r

WASHINGTON — A new Medicare competitive bidding program for durable medical equipment has made it more difficult for diabetic beneficiaries to get the supplies they need, according to endocrinologists and diabetes advocates.

“As implemented, Medicare has used the Competitive Bidding Program to significantly reduce the cost of diabetes testing supplies by restricting access to improved technology devices and limiting choice for patients and healthcare professionals based primarily on cost,” George Grunberger, MD, president of the American Association of Clinical Endocrinologists, wrote in a letter to senators Orrin Hatch (R-Utah) and Ron Wyden (D-Ore.) leaders of the Senate Finance Committee. “The result has been an increase in patient adverse events, including higher mortality rates and hospitalizations, which ironically have led to overall higher Medicare costs.”

“The goal of competitive bidding was to reduce costs for both patients and the American taxpayer and to ensure access to quality products and services,” wrote members of the National Diabetes Volunteer Leadership Council, a group of former board members of the American Diabetes Association, in a letter to Andy Slavitt, acting administrator of the Centers for Medicare and Medicaid Services (CMS). “For diabetes testing supplies, the program has failed on both of its objectives.”

Medicare’s competitive bidding program was established under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. Round 2 of the program, which included a mail-order component for diabetes supplies, was fully implemented in July 2013 after several years of testing.

“Importantly, the program has maintained beneficiary access to quality products from accredited suppliers in all competitive bidding areas,” CMS said in a press release issued March 15th. “Extensive real-time monitoring data have shown successful implementation with very few beneficiary complaints and no negative impact on beneficiary health status based on measures such as hospitalizations, length of hospital stay, and number of emergency room visits compared to non-competitive bidding areas.”

But that’s not the conclusion reached by Christopher Parkin, MS, of CGParkin Communications, in Boulder City, Nev., and colleagues. They published results from a 4-year, retrospective, longitudinal study which examined 2009-2012 data on nearly 530,000 Medicare beneficiaries who were insulin users. The study appeared online March 18th in Diabetes Care.

The authors noted that Medicare reimburses for the acquisition of three glucose test strips per day for insulin-dependent beneficiaries.

“Based on that reimbursement schedule, full procurement of self-monitoring blood glucose supplies is defined here as the purchase of diabetes testing strips so that, from the date of the first purchase, the beneficiary continued to acquire testing supplies, resulting in their purchasing enough blood glucose testing supplies to allow them to test their blood glucose three times per day more than 80% of the year,” they explained.

“Any beneficiary who scored 80% or higher on this … scale was considered full [supply] acquisition; any beneficiary who scored less than 80% was defined as partial/no [supply] acquisition.”

The study found that use of the competitive bidding system in nine test markets resulted in a 23% increase in beneficiaries getting partial or no diabetes supplies, as opposed to a 1.7% increase among the beneficiaries in the nontest markets. In addition, “4-year survival was negatively associated” with partial or no supply acquisition among both groups (P<0.0001), the investigators said.

“The results indicate that the system implemented to reduce cost was associated with a disruption of acquisition of [diabetes] supplies,” the authors wrote. “These findings are particularly concerning, given the predominant use of short-acting insulin and rapid-acting insulin analogs by Medicare beneficiaries, who are at significantly greater risk for hypoglycemia than younger individuals with insulin-treated diabetes.”

“Based on our findings,” they continued, “policy makers should consider suspending the competitive bidding program until CMS can demonstrate its ability to effectively monitor the effects of the program and ensure that Medicare beneficiaries, a population that is most vulnerable to both the acute and chronic complications of diabetes, are protected from harm.”

Howard Lando, MD, a member of the AACE board of directors and chair of the association’s Legislative and Regulatory Committee, agreed that the program has caused problems for diabetes patients. “The unintended consequences of the competitive bidding program are restricted access to improved technology devices — e.g. high-quality brand-name blood glucose meters — and limited choice of monitors and test strips for patients and healthcare professionals,” he said in an email to MedPage Today.

“Patients have received meters and strips different from those they used prior to the competitive bidding program’s implementation that did not have user instructions, which led to the inability to download or read data,” wrote Lando, an endocrinologist in Alexandria, Va. “Alarmingly, neither the patients nor their physicians neither approved nor were notified of these switches in advance. Furthermore, lower quality non-branded devices can provide inaccurate or inconsistent readings, which have led to patients experiencing adverse medical events, such as hypoglycemia.”

The competitive bidding program should be suspended for diabetes testing supplies “until it can be determined that patient safety is not at risk,” he continued. “AACE is also advocating for passage of H.R. 771, ‘Protecting Access to Diabetes Supplies Act of 2015,’ legislation that will enhance patient protections by strengthening and enforcing program safeguards that, as currently implemented, have been ineffective in protecting patient access to preferred diabetes testing supplies.”

CMS was contacted for this story but declined to comment.

More bureaucrats creating new medical practicing laws/rules/regulations?

Four Distinct Federal and State Policies Addressing Prescription Opioid Abuse

http://www.lexology.com/library/detail.aspx?g=23c0c774-0136-4bc3-9239-0e894838379f

USA March 29 2016

The first quarter of 2016 has witnessed a great deal of attention in government to the problem of opioid-related overdose and death in the United States. In just the past few weeks, the Senate passed prescription drug treatment and abuse prevention legislation—the Federal Comprehensive Addiction and Recovery Act (CARA), Senate Bill 524—while two states—Massachusetts and Wisconsin—enacted legislation establishing new rules and procedures for the prescribing, use, and disposal of controlled substances. The Centers for Disease Control and Prevention (CDC), meanwhile, published the long-awaited CDC Guideline for Prescribing Opioids for Chronic Pain (the Guideline) to assist primary care clinicians in outpatient settings outside of end-of-life or palliative care. The interplay between these new legislative and regulatory actions and public attitudes about opioid addiction paint a complex picture of the future of pain care.

What has happened?

On March 10, CARA passed the Senate by a vote of 94 to 1. It provides a multi-pronged approach to tackling record levels of prescription drug addiction, from mandating the development of best practices for prescribing opioids to authorizing grants for drug education, prevention, and treatment programs. CARA directs the Secretary of the U.S. Department of Health and Human Services (HHS) to convene a Pain Management Best Practices Interagency Task Force—composed of representatives of HHS, the Department of Veterans Affairs, Drug Enforcement Administration, CDC, addiction treatment organizations, and other stakeholder communities—to review, modify, and update best practices for managing pain (including chronic pain) and prescribing pain medication. CARA authorizes HHS, in consultation with the President’s Office of National Drug Control Policy, to make grants to entities suffering from “drug crises” (those experiencing above average rates of drug abuse for extended periods or sudden spikes) to implement community-wide abuse prevention strategies. The law also would expand disposal sites for unwanted prescription medications, the availability of naloxone to law enforcement agencies and other first responders, educational efforts to prevent opioid and heroin abuse, and promote drug treatment and recovery.

CARA reflects strong public support for increased government spending on treatment programs. In a recent Harvard School of Public Health-Stat poll, 41% of American adults surveyed responded that the amount of money the government currently spends on such programs is too low.

Within a week of CARA’s passage, CDC published the Guideline, which sets forth 12 recommendations for determining when and how to initiate or continue opioid therapy for chronic pain. According to CDC Director Tom Frieden,

[t]he guideline is designed to help clinicians and patients together assess the risks and benefits of opioid use and identify the best treatment option . . . based on three key principles. First, non-opioid therapy is preferred for chronic pain outside of active cancer, palliative and end of life care. . . . Second, when opioids are used start low and go slow. . . . Third, always use caution when prescribing opioids and monitor every patient closely.

In addition to the Senate and CDC, state legislatures have focused on stemming the opioid health crisis locally. On March 9, Massachusetts lawmakers introduced House Bill No. 4056, entitled An Act relative to substance abuse, treatment, education and prevention. The Massachusetts House and Senate unanimously approved the first-in-the-nation bill, which was signed into law five days later on March 14.

The Massachusetts bill affects doctors, patients, public health agencies, and pharmaceutical manufacturers in different ways. First, and most notably, the bill prohibits “a practitioner [from] issu[ing] a prescription for more than a 7-day supply . . . [w]hen issuing a prescription for an opiate to an adult patient for outpatient use for the first time [or] to a minor,” the first such limitation legislatively imposed by any state. If, however,

in the professional medical judgment of a practitioner, more than a 7-day supply of an opiate is required to treat the adult or minor patient’s acute medical condition or is necessary for the treatment of chronic pain management . . . then the practitioner may issue a prescription for the quantity needed to treat such acute medical condition [or] chronic pain . . . .

To reduce the prevalence of unused medications, the Massachusetts bill requires that manufacturers of Schedule II or III controlled substances (including opioids) participate in a “drug stewardship program” to “collect, secure, transport and safely dispose of unwanted drugs.” Manufacturers must engage in public outreach and education about the program and pay the operational and administrative costs associated with it, which by law cannot be passed through to consumers. Participation is required for any manufacturer selling or distributing a “covered drug” in Massachusetts, directly or through a wholesaler or retailer. Retail pharmacies may but are not required to participate in the drug stewardship program, which takes effect January 1, 2017.

Eight days after Massachusetts made national headlines, Wisconsin’s governor signed into law eight pieces of legislation as part of his Heroin Opioid Prevention and Education (H.O.P.E.) tour. The H.O.P.E. laws require that, before prescribing any “monitored prescription drug,” i.e., any Schedule II, III, IV, or V controlled substance or other “drug identified by the board by rule as having a substantial potential for abuse,” Wis. Stat. § 961.385(1)(ag), dispensers report and review patient and dispensing information using the Wisconsin Prescription Drug Monitoring Program. To root out so-called “pill mills,” pain clinics and programs treating addiction with the use of narcotics, e.g., methadone, must register with and be certified by the Wisconsin Department of Health Services (WDHS).

Distinctions with a difference

Although they share some common characteristics, CARA, the Massachusetts law, the Wisconsin H.O.P.E. legislation, and the CDC Guideline highlight nuanced differences in strategy for combating a public health issue. CARA focuses on strengthening the network of community-based addiction prevention and treatment programs. Wisconsin has increased government oversight of potential sources of opioids, including by creating a state pain clinic registry. Massachusetts has charged manufacturers with collecting and disposing of unwanted and expired drugs to help avoid their diversion and misuse. The CDC Guideline contains recommendations for best practices for opioid therapy for chronic pain. CDC’s focus on prescriber conduct seems most in line with public opinion: nearly two in five adults believe doctors who inappropriately prescribe opioid pain relievers are “mainly responsible” for painkiller abuse. Similar proportions, 37%, blame opioid users, while only 10% fault pharmaceutical companies.

Looking ahead

The extent to which recent state and federal measures aimed at curbing opioid abuse are successful remains to be seen. The prescription, use, and misuse of opioids will remain hot-button issues for the foreseeable future, however. Just a few days ago, in fact, the U.S. Food and Drug Administration (FDA) announced safety labeling changes for immediate-release opioid pain medications, including a new “boxed warning” (FDA’s strongest risk communication) regarding the risks of opioid addiction and overdose. Two days later, FDA published draft guidance for industry recommending studies to ensure that generic opioids are sufficiently deterrent to all potential routes of abuse. More is sure to come.

Could this be their game plan.. learning from their previous mistakes

There are a lot of comparisons between alcohol prohibition by the 18th Amendment back in 1920. It created a “black market” for alcohol.. just like the Harrison Narcotic Act 1914 created a “black market” for certain opiates (Heroin & Cocaine ) and Marijuana. The 18th Amendment created the likes of Al Capone and “gangster” that “managed” the black market and the distribution of the illegal alcohol. There was untold number of “bootleggers” that created “moonshine”.  Elliott Ness and the “G-men” from the FBI was in charge of enforcing the 18th Amendment. Street violence in some areas was common place, the G-men destroyed moonshine stills and confiscated and destroyed “illegal alcohol”.

Those that wanted to get alcohol made legal again, only had to focus on getting the 18th Amendment repealed, which happened in 1933 with the 21st Amendment.

Congress basically declared “war” in 1970 against the black market that they created in 1914 with The Control Substance Act… they created the BNDD ( Bureau of Narcotics and Dangerous Drugs), which a few years latter was evolved into the DEA (Drug Enforcement Administration).  Just like the Alcohol prohibition… we have cartels instead of gangsters and we have street violence and deaths.

It would seem that unlike alcohol prohibition the number of targets it order to get the war on drugs to come to a end is multiplying like rabbits. We now have not only the DEA, but we also  have CDC, FDA and more and more state legislatures passing laws, implementing guidelines, reinterpreting existing laws, rules and regulations. What “target” do you go after ?

The CDC is not only publishing guidelines but questioning the fact that there is no long term studies that validate the effectiveness of opiate therapy for chronic pain.  The fact that there is no long term study of efficacy does not mean that efficacy does not exist.  That is like saying that just because a person has never taken a IQ test… the person does not have any intelligence. 

This week Pres Obama at the National Prescription Drug Abuse and Heroin Summit discussed about 99% of his presentation talking about “addiction” is a mental health disease. He often mentioned that “treating” addicts would save the system money.

He also stated that a person has a issue of “acute pain”… gets a Rx… becomes DEPENDENT… and turns to Heroin …. so now there is no difference between a physical dependence which will happen to anyone taking a opiate for extended period and those who have no medical need for opiates and continue to use/abuse opiates because of their mental health disease of addictive personality disorder ?

Obama and Congress have directed the DEA to leave states alone that have legalized MMJ and the CDC has put out guidelines that prescribers not test pts for MJ anymore.

Why the push for the legalization of MJ ?… to SAVE MONEY.. since no health insurance – including Obamacare/ACA – will not pay for it… why the push that there is no validation of long term use of opiates as beneficial ?  Health insurance only pays for products/services that are MEDICALLY NECESSARY… and all EXCLUDES paying for “experimental therapy”.

So are we headed for all opiates being declared to risky for short term/acute pain management and no proven clinical studies that they are beneficial for long term use…  and that MMJ/MJ is legal, but also no clinical studies proving it is beneficial in treating a number of disease states… not covered by health insurance.

A lot of health insurance companies are pulling out of Obamacare… so if this administration could remove most of the cost of treating chronic pain out of the “cost equation” of Obamacare and shift the cost to the pt.

The DEA has already came out and stated a pt – which has insurance – and wants to pay cash for a opiate Rx – BIG RED FLAG

So does this mean.. if the opiate becomes a non-covered item… is it still a RED FLAG … if the pt is forced to pay cash because their health insurance doesn’t pay for it.

Then if the FEDS are successful in making the “no proven use” in long term chronic pain stick… could the DEA then cut the production quotas/limits that it has authority over the opiate manufacturers ?