coca production in Colombia has surged to levels not seen in two decades

Posted on July 14, 2017 by Pharmaciststeve

UN: Production of coca leaf surges in Colombia

http://www.foxnews.com/world/2017/07/14/un-production-coca-leaf-surges-in-colombia.html

BOGOTA, Colombia –  A new United Nations report shows that coca production in Colombia has surged to levels not seen in two decades, complicating the South American country’s efforts to make its vast, lawless countryside more secure following a peace deal with leftist rebels.

The report Friday confirms U.S. government findings from March that production is skyrocketing. The culprits are varied and include President Juan Manuel Santos’ decision in 2015 to stop using crop-destroying herbicides over health concerns and unintended incentives created by the peace deal for farmers to grow coca.

The amount of land where coca was cultivated last year jumped 52 percent to 146,000 hectares, the U.N. said. Potential cocaine production rose 34 percent to around 866 metric tons.

While the bumper harvest is worrisome, the U.N. said conditions for a sustained eradication campaign have improved dramatically thanks to last year’s peace deal with the Revolutionary Armed Forces of Colombia. The rebels had long funded their insurgency by levying taxes on drugs produced and transported in areas they dominate but as part of the accord to end their half-century war against the state they’ve committed to helping the government persuade farmers to voluntary eradicate the crops.

However the agreement has also provided a perverse incentive for farmers to grow coca. Those growing coca will be awarded subsidies if they agree to renounce the crop and grow products like potatoes and fruit instead. Cocaine production began increasing in 2014, after the government and FARC announced the new drug strategy that would go on to be ratified in the final accord, and has steadily risen every year since.

“The report shows a complex outlook with data that indicates a worrisome situation but also a scenario that looks propitious for a sustainable solution,” said Bo Mathiasen, the UN drug agency’s representative in Colombia.

Longer term, there’s doubts about whether the state can really assert itself in long-neglected territories. Early evidence suggests that criminal gangs are seeking to fill the void left by some 7,000 withdrawing FARC rebels.

In recognition of those risks, and increased pressure by the Trump administration to curb the flow of drugs to the U.S, Colombia is also stepping up its forced eradication program. So far this year, police and army eradication crews have destroyed by hand some 21,000 hectares of the crop — almost half of this year’s goal. Seizures of cocaine also rose 49 percent to 378 metric tons last year.

Another key finding of Friday’s report is that cocaine production is increasingly concentrated to a few lawless areas, allowing authorities to focus more sharply their eradication efforts.

Filed under: General Problems | 2 Comments »

Instead of getting drugs from Canada, we got dangerous and ineffective counterfeit pills from other countries.

Posted on July 14, 2017 by Pharmaciststeve

U.S. lawmakers should say no to drug import legislation

www.pressherald.com/2017/07/14/maine-voices-u-s-lawmakers-should-say-no-to-drug-import-legislation/

BANGOR — U.S. Sen. Bernie Sanders recently introduced a bill that would allow Americans to import prescription drugs from Canada. The legislation is intended to curb the costs of prescription drugs.

But it would come with a huge cost. Lawmakers need just look at Maine to see why.

 

 A few years ago, Maine introduced similar legislation that allowed patients to buy drugs from foreign pharmacies. We, too, wanted to provide patients with lower-cost medicines.

It proved to be a big mistake. Instead of getting drugs from Canada, we got dangerous and ineffective counterfeit pills from other countries. Maine’s disastrous experience with counterfeit Canadian drug imports should serve as a lesson to our lawmakers to say no to drug importation legislation.

The globe is awash in counterfeit drugs. The World Health Organization estimates that 10 percent of all drugs worldwide are fake, a number that rises to 30 percent in parts of Africa, Asia and Latin America. Thousands of sites sell these drugs to consumers – in 2014, more than 10,000 websites selling counterfeit drugs were shut down.

Counterfeit drugs can be deadly. Sometimes, they contain dangerous ingredients that kill, but far more often, fake drugs contain no active ingredients at all. Patients take these duds expecting them to have positive effects. But instead, patients only grow sicker. Worldwide, officials estimate that counterfeit drugs kill more than 700,000 people each year.

The United States bans most prescription imports in order to prevent smugglers and counterfeiters from shipping unapproved, unsafe products to American patients and pharmacies. In the early 2000s, the Food and Drug Administration stepped up enforcement of the ban after finding that nearly 90 percent of drug shipments to the United States were not up to par. Many of these illicit shipments contained medications that hadn’t been approved by the FDA. Others had not been shipped at the proper temperatures to prevent spoilage.

Despite law enforcement’s best efforts, some counterfeit drugs still wind up in our drug supply. The FDA warns that medical professionals have injected hundreds of patients with counterfeit cosmetics in recent years. Fake treatments for HIV and cancer also have turned up hundreds of times at American medical practices.

And when counterfeit blood thinners from China made their way into the U.S. drug supply in 2008, as many as 81 people lost their lives.

Mainers experienced these hazards firsthand in 2013. That’s when state lawmakers legalized drug importation from developed countries such as Australia, Canada, the United Kingdom and New Zealand.

Many of the drugs that entered our state were not legitimate. To show how unreliable imports could be, Kenneth McCall, then president of the Maine Pharmacy Association, ordered drugs from Canada Drug Center, an online pharmacy claiming to be Canadian. McCall found that the drugs actually had been manufactured in facilities in Turkey and India. Lab testing found that the supposed “Canadian” medications contained “only a tiny percentage of the active ingredient.”

Worse, some of the imported drugs contained dangerous ingredients. The generic blood thinner Clopidogrel, for instance, was contaminated. It most likely contained methyl chloride, which can damage genetic material and even cause cancer.

There is simply no way to ensure the safety of drugs reportedly coming from Canada. Indeed, Bernie Sanders’ proposed law has no mechanism to stop counterfeiters from shipping fake drugs from developing nations, through a Canadian check station, and then on to America. FDA officials have repeatedly warned that they cannot vouch for the safety of drugs that cross the border. And making matters worse, Canadian officials have said that they would not inspect drugs that pass through Canada en route to America. They only monitor the safety of medicines that are prescribed to Canadian citizens.

Americans would be wise to learn from Maine’s mistake. Drug importation is not a worth risk taking, for in the quest for “cheap” foreign drugs, patients could pay with their lives.

Filed under: General Problems | 1 Comment »

Healthcare DISCRIMINATION… some “classes of people” get to sue ?

Posted on July 14, 2017 by Pharmaciststeve

Lawsuit claims discrimination against millions of Medi-Cal patients, especially Latinos

http://www.dailynews.com/general-news/20170712/lawsuit-claims-discrimination-against-millions-of-medi-cal-patients-especially-latinos

California’s Medicaid patients lack access to health care and are therefore facing discrimination, because doctors are not being paid enough to take them. That’s the charge in a lawsuit filed Wednesday against state regulators.

The suit, filed in Alameda County by the Mexican American Legal Defense and Educational Fund, or MALDEF, among others, alleges that the state’s Department of Health Care Services has failed to monitor the problem. The issue has created a system of discrimination, especially against Latinos, according to the lawsuit.

Latinos make up roughly half of the 13.5 million Californians enrolled in Medi-Cal, the state’s version of Medicaid, according to state data. In their lawsuit, MALDEF said that as the number of Latinos enrolled into the program rose over the years, reimbursement rates to physicians who accepted the insurance fell by 20 percent. California ranks 48th in the nation in reimbursement rates, said Thomas Saenz, MALDEF president and general counsel.

Because there are so few Medi-Cal providers, Latinos and others can’t get primary or speciality care in a timely manner, said Saenz and others who filed the lawsuit.

“We must ensure that Medi-Cal is administered in a fair and non-discriminatory manner that serves the healthcare needs of Latinos and all others enrolled in the program,” Saenz said in a statement.

A spokeswoman from the Department of Health Care Services said the agency won’t comment on the lawsuit. DHCS is required by law to monitor patient access to services. But no systematic problems have been identified, according to the spokeswoman.

MALDEF has raised concerns about discrimination in the past. In 2015, MALDEF, with the Civil Rights Education and Enforcement Center, sent a letter to the state listing the same complaints. In their response, the DHCS said they found no evidence of discrimination.

“You have not alleged and we are not aware of any evidence that Latino beneficiaries are being treated differently than other beneficiaries under the Medi-Cal program,” DHCS said in a 2016 response. “Indeed, Medi-Cal rates are uniform for all providers and patients and they do not discriminate in any way on the basis of race, color, national origin or any other protected category.”

A glance through data provided by DHCS show that almost 50 percent of all grievances compiled quarterly in 2016 had to do with accessibility issues. Latinos filed about a third of those grievances. White Medi-Cal recipients filed another 30 percent.

“In the past, when Medi-Cal was a predominantly white program, access was better because the reimbursement rates were closer to other insurance reimbursement rates,” said Bill Lann Lee, senior counsel of the Civil Rights Education and Enforcement Center. “That changed when the Medi-Cal program became increasingly Latino and then majority Latino. That is discrimination.”

Given the recent discussions surrounding the Senate’s plan to repeal and replace the Affordable Care Act, Saenz said Medi-Cal is still worth fighting for, but it needs to be improved, not scrapped.

Anthony Wright, executive director for Health Access, a California-based consumer advocacy group, said people who have private insurance also can face obstacles to care, but he said those with public insurance struggle more.

Still, it’s worth saving, Wright added.

“Even though there is an issue of access, Medi-Cal is still far better than being uninsured,” Wright said. “There’s data that show Medi-Cal does provide a lot of good services and care.”

Filed under: General Problems | Leave a Comment »

The Death of Pharmacist’s Professional Judgement

Posted on July 14, 2017 by Pharmaciststeve

The Death of  Pharmacist’s Professional Judgement

In the immortal words of Korben Dallas, “I am a meat popsicle”. This answer shall suffice in response to any question concerning a pharmacist’s job responsibilities.
Why?
Pharmacy schools (apparently) no longer teach “professional judgement” or companies have basically policied it out of existence. The new mantra is: “Don’t Think For Yourself!”.

CP: Why can’t I just use my professional judgement, that with which I was naturally blessed as well as professionally paid to have attuned, to make a decision?
ME: Because you’re not allowed anymore.
CP: Why am I not?
ME: Policies. You are a meat popsicle. You are a button pusher. You do not get paid to think.
CP: In what dystopian novel did I just awake?
ME: None. It is the era of Big Brother. It is the era of micromanaging. It is the era of fear of lawsuits. It is a direct result of ISIS and terror threats.
CP: Huh? How can you associate my using my collegiately enhanced brain and years of experience to make a professional decision to that of terror threats?
ME: What are you trying to accomplish?
CP: I wish to change an e-script from Proair to Ventolin because this patient’s State Medicaid plan changed and they have a new formulary.
ME: Not allowed. They are totally different.
CP: Okay. How about Amoxicillin or Doxycycline? The insurance only cover tablets as opposed to the capsules, or vice versa. I simply wish to change the dosage form and provide service to my patients.
ME: No can do. That’s practising medicine. Prescribers are infallible and there must be a reason they selected the exact option they did on their e-script software.
CP: You mean the software that doesn’t make them choose Doxy Mono or Doxy Hyclate?
ME: The same.
CP: You mean the prescribers that have become so irritated with whiny pharmacists wasting their time over the last 5 years that they have changed their prescribing habits on their electronic devices?
ME: How so?
CP: Now we receive what would pass as passive-aggressive threats on any social media.
“Doxycycline 100mg, don’t care what salt form or if it’s tabs or caps. I just want the patient to have what’s covered. Don’t call me unless all forms of Doxy are not covered and rather expensive. Again, I. Don’t. Care! Stop calling me.”

or . . .

“Albuterol inhaler. They’re all the same. I don’t care what the package inserts say. So the patient switched insurance. Fine. Then they can switch inhalers. Albuterol is Albuterol. I. Don’t. Care! Just stop calling me!”

or . . .

“Amoxicillin 500mg tabs to take 1 capsule 3 times a day. Look, if I were to hand write this prescription, I’d not put tabs or caps anywhere on it. It’s not my phault the software makes me pick one and for some reason the sig does not match. Unless the patient has a gelatin allergy, I don’t care. And you’d probably know more about that than I.”

or . . .

“Prednisone tapers. Look, I tried to quickly figure out how many I would need to prescribe but my math skills suck and they make us use the computers for everything. Just give the patients what they need and we can all be happy. I Love You! You are the most helpful, underrated profession and we need to thank you more for saving our asses.”

ME: So what’s the real problem?
CP: New(er) pharmacists are so worried about everything that they cannot think for themselves. (I had an e-rx for a cream with directions to “apply 1 tube twice a day” and another for FeSO4 325mg with directions to “take 1 milligram once a day”. A real life pharmacist refused to approve them when I corrected them to “apply twice a day” and “take 1 tablet once a day”, respectively.) I have offsite pharmacists, that’s PHARMACISTS (people with licenses like mine), that refuse to check or approve prescriptions like this. I see comments from pharmacists on my posts every day that echo the fear factor present in our profession. Too many times have I read “I have to call” or “I’d call on that” instead of “My alma mater and past preceptors trained me to use my brain and make this decision all on my own. It’s my license and I earned it and I am damn well going to use it”.
(Obviously, there are instances where we HAVE to call. Our educated brains tell us to do so. But not for many of the more trifling, petty situations I see all too often.)
ME: So …?
CP: So we bitch and moan about being treated as equals; as peers; as knowledgeable professionals all the while calling and asking stupid questions.
ME: But won’t your stupid questions cause the prescribers to change their habits?
CP: Yes. They now write notes telling us not to call. Rather than solving the serious problems, we annoyed them with petty grievances and now they don’t take us seriously.
ME: What do you want?
CP: I want my profession to grow back its spine. Document your actions and thoughts and calculations on the hard copy then fill it accordingly. We are so afraid of an error, an inspection, a policy violation, an audit that we forget how to actually do our job. You didn’t go to college to live in fear. You went to be a respected professional. Now grow up and be one.
ME: Tough words.
CP: Tough Profession. We fight everyone else; it makes no sense to fight ourselves.
ME: I think I love you CP.
CP: I know.

Filed under: General Problems | 2 Comments »

Federal planned GENOCIDE 2.0 ?

Posted on July 13, 2017 by Pharmaciststeve

Opioids under attack: Government now is on the offensive

http://www.post-gazette.com/opinion/editorials/2017/07/13/Opioids-under-attack-Government-now-is-on-the-offensive/stories/201707310015

Two announcements from the federal government represent progress in the fight against opioids. On Monday, the Food and Drug Administration said it will require drug manufacturers to better educate physicians about the painkillers. On Tuesday, the Justice Department announced a $35 million settlement with Mallinckrodt Pharmaceuticals, a company charged with looking the other way when it had reason to believe some of its opioids were landing on the black market.

If the tide of the epidemic has not been turned, the battle at least is joined. In addition to the contributions of federal agencies, the states and local governments are becoming increasingly aggressive against drug dealers, manufacturers and the insurance companies that limit treatment for substance abuse. Pennsylvania Attorney General Josh Shapiro has been calling on insurers to make sure they adequately cover addiction treatment, make it easy for people to access that treatment and better cover alternatives, such as physical therapy, that can reduce the need for painkillers.

Ohio and other states have sued drug companies, alleging they fueled the epidemic by underplaying or misrepresenting the drugs’ danger. There’s more to come. Mr. Shapiro last month said he is part of a bipartisan coalition of attorneys general that is using “investigative tools, including subpoenas for documents and testimony, to determine the appropriate course of action.”

Pharmaceutical companies should regard the Justice Department’s settlement with Mallinckrodt as a shot across the bow. The agreement, described as the first with a manufacturer tied to the opioid crisis, carried more than a stiff financial cost. It  requires the company to begin tracking its drugs as they move through the supply chain into the hands of consumers. That obligation, if required of other manufacturers and suppliers as well, should help to dampen what seems to be a free flow of drugs.

Physicians represent another potential choke point. If people aren’t prescribed opioids, they can’t become addicted and move on to related drugs, such as heroin. Last year, Pennsylvania restricted the prescription of opioids in emergency departments and to juveniles and ramped up physician training. The FDA’s expanded education mandate is another welcome step.

The FDA already requires drugmakers to provide training to physicians about extended-release opioids. Now, they’ll have to offer the training about fast-acting opioids, too, and provide information about pain management and non-drug therapies (some of the same ones that Mr. Shapiro wants insurance companies to cover).  Physicians don’t have to accept the training, but they should. One wonders why physicians don’t learn enough about the dangers of opioids in medical school.  Addiction, as Greensburg Bishop Edward Malesic has said, is not a moral failing. The failing would be if government and other parties did not marshal all available resources against the scourge. Increasingly, we are seeing what Mr. Shapiro has called a “multidisciplinary  approach.”

Filed under: General Problems | 3 Comments »

FDA Struggles with Sizing Up Abuse-Deterrent Opioids

Posted on July 13, 2017 by Pharmaciststeve

FDA Struggles with Sizing Up Abuse-Deterrent Opioids

https://www.medpagetoday.com/PublicHealthPolicy/FDAGeneral/66563

During a two-day meeting convened by the FDA, experts discussed strategies for determining whether abuse-deterrent opioids are having a real-world impact on misuse, abuse, addiction, overdose, and death.

Getting a handle on the issue has been a challenge, given that the available data sources and methodologies for assessing these outcomes are imperfect, according to Judy Staffa, PhD, RPh, director of the agency’s division of epidemiology, who led the meeting.

That’s been the main reason that none of the 10 “abuse-deterrent” opioids approved by FDA to date have labeling that the drugs reduce abuse — they are only “expected” to do so.

Indeed, one such product, Opana ER, was just removed from the market because it led to an increase in injection abuse, which was tied to an outbreak of HIV and hepatitis C in Indiana, as well as cases of thrombotic thrombocytopenic purpura (TTP) across the country.

The new formulation of Opana was harder to crush, which made it more difficult to snort, but those determined to abuse it found a way to cook it down and inject it instead.

Opana ER was never officially given any abuse-deterrent labeling by FDA, but the company went to great lengths to paint it as an abuse-deterrent formulation.

Other drugmakers have also stumbled in this realm: In 2015, Purdue Pharma nixed a supplemental New Drug Application related to the ability of abuse-deterrent OxyContin to diminish abuse in the real world. It did so just 1 day before the agency was going to release its evaluation of the application.

To avoid similar problems with other abuse-deterrent formulations, the FDA invited a wide range of experts with diverse perspectives — from expertise in drug abuse and addiction treatment to those who have conducted surveillance on other public health problems — to the hearing.

While the first day focused on improving the use of existing data sources, such as poison control center data, population-based surveys, and claims data, day 2 focused on developing and using new data sources, including building on established national surveys, and designing studies that assess exposure and outcomes in the same individuals over time.

Staffa said the path forward will likely involve a “mosaic” approach that incorporates data from multiple imperfect sources.

During several public comment periods, industry representatives noted that many insurers are refusing to cover the drugs because they haven’t been shown to reduce abuse in the real world. That, in turn, is driving down the number of patients on abuse-deterrent formulations, which isn’t making it any easier to study outcomes, they argued.

Staffa noted that abuse-deterrent opioid prescriptions have fallen from 5.6 million in 2011 — the year after the first formulation was approved — to 4.3 million in 2016.

 

The FDA said it’s accepting comments on means of assessing real-world outcomes with abuse-deterrent drugs through Sept. 11, 2017.

FDA Commissioner Scott Gottlieb, MD, opened the first day of the meeting by announcing that the FDA will now include immediate-release opioids in its risk evaluation and mitigation strategy (REMS) for opioids. Previously, the REMS had focused on extended-release and long-acting products, but Gottlieb noted that 90% of the 200 million opioid prescriptions written each year in the U.S. are for these fast-acting products.

The education that comes with the REMS program, however, will continue to be voluntary, not mandatory. It will be expanded to include modules for nurses, pharmacists, and other practitioners who prescribe opioids, Gottlieb said.

The agency is also still considering whether to make education mandatory, he added.

An updated draft blueprint for that education expands the amount of information focused on pain management, including non-pharmacologic treatment for pain and non-opioid alternatives, and on opioid use disorders.

The agency is also initiating a study to better understand exactly how prescribers perceive the term “abuse-deterrent” and whether their perceptions “match clinical realities.”

 

Filed under: General Problems | 4 Comments »

AG Sessions: wants DARE back , panned by many as failing to achieve any meaningful results.

Posted on July 13, 2017 by Pharmaciststeve

Justice Department announces ‘largest heathcare fraud takedown in American history’

http://www.washingtonexaminer.com/justice-department-announces-largest-heathcare-fraud-takedown-in-american-history/article/2628514

The Department of Justice on Thursday announced what Attorney General Jeff Sessions called the “largest healthcare fraud takedown operation in American history.”By working with inner Justice Department offices and the Department of Health and Human Services, the federal government charged 412 defendants accused of defrauding taxpayers of roughly $1.3 billion. The charges included 56 doctors, Session said.Acting FBI Director Andrew McCabe said at a press conference Thursday that 29 bureau field offices around the country were involved, with an assist from more than 300 agents.“The nation is in the midst of a crisis. Opioid abuse destroys lives,” he said.

At least 120 of those charged were charged for their roles in “prescribing and distributing opioids and other dangerous narcotics.”

 “Last year, an estimated 59,000 Americans died from a drug overdose, many linked to the misuse of prescription drugs. This is, quite simply, an epidemic,” said Acting Drug Enforcement Administration Administrator Chuck Rosenberg.

In talking to reporters, Sessions echoed his message from a speech earlier in the week, citing the government’s prior so-called “War on Drugs.”

According to Sessions, working together and “prevention” are the keys to stopping the drug epidemic.

“This rising drug use — crime is rising with it — […] at a rate we’ve never ever seen before,” he said, later adding. “Preventing addiction is the most important thing we can do.”

“We need to have a reinforced message to stay away from these drugs,” Sessions said, alluding to the drug war of the 1980s and 90s, which he added worked.

In a speech Tuesday, Sessions touted the decades-old Drug Abuse Resistance Education program, or DARE, even though it has been panned by many as failing to achieve any meaningful results. He also again connected a rise in crime to the current drug problems sweeping the country

Filed under: General Problems | 2 Comments »

Federal officer or employee may NOT exercise any supervision or control over the practice of medicine

Posted on July 13, 2017 by Pharmaciststeve

42 U.S. Code § 1395 – Prohibition against any Federal interference

https://www.law.cornell.edu/uscode/text/42/1395?qt-us_code_temp_noupdates=3#qt-us_code_temp_noupdates

Nothing in this subchapter shall be construed to authorize any Federal officer or employee to exercise any supervision or control over the practice of medicine or the manner in which medical services are provided, or over the selection, tenure, or compensation of any officer or employee of any institution, agency, or person providing health services; or to exercise any supervision or control over the administration or operation of any such institution, agency, or person.

(Aug. 14, 1935, ch. 531, title XVIII, § 1801, as added Pub. L. 89–97, title I, § 102(a), July 30, 1965, 79 Stat. 291.)
I read a quote one time that “…we have 10 -15 million laws, rules and regulations to get us to obey the TEN COMMANDMENTS..”
The DOWN SIDE of all of these laws, rules, regulations is that unless you have those in authority that wishes to enforce them… they are nothing more than ink on paper.

Filed under: General Problems | 2 Comments »

Pharmacy ‘Clawbacks’ Targeted in Latest State Law Aimed at PBMs

Posted on July 12, 2017 by Pharmaciststeve

Pharmacy ‘Clawbacks’ Targeted in Latest State Law Aimed at PBMs

https://www.bloomberg.com/news/articles/2017-07-11/pharmacy-clawbacks-targeted-in-latest-state-law-aimed-at-pbms

A new law in Connecticut would close a drug price loophole that’s been the subject of more than a dozen lawsuits around the U.S., taking aim at a practice by pharmacy benefit managers called pharmacy clawbacks.

The law, which takes effect in January, will allow pharmacists to tell patients about the cheapest way to pay for prescription drugs they pick up at the pharmacy counter. It was passed in response to a pharmacy benefit management industry practice called clawbacks.

Read More: Secrecy Rules Gag Drugstores as Patients Overpay

Connecticut Governor Dan Malloy, a Democrat, signed the bill on Monday. In a letter to lawmakers he said he supports its “real consumer protections.”

Suits over the clawbacks have been filed against UnitedHealth Group Inc., which runs the PBM OptumRx; Cigna Corp., which contracts with OptumRx; and Humana Inc. They allege that the PBMs defrauded consumers and violated insurance laws. OptumRx and Cigna declined to comment, while Humana didn’t respond to a request for comment.

PBM Business

The Pharmaceutical Care Management Association, the Washington-based lobby group for PBMs, said in an emailed statement that “we support the patient paying the lowest price available at the pharmacy counter for the prescribed drug.”

Pharmacy benefit managers process prescriptions for insurers and large employers, and also determine which drugs are covered or whether they will carry a co-pay when the patient picks up the drug. They also work to bargain down prices with drugmakers, excluding some drugs and preferring others in return for discounts.

Connecticut joins Louisiana, Georgia, North Dakota and Maine, which have also passed legislation aimed at stopping the clawbacks, a growing concern amid high prescription costs and a national debate over drug prices. Several other states have introduced legislation related to clawbacks, which have prompted at least 16 lawsuits since October.

“Connecticut has now joined a number of states that have outlawed these secret clawback schemes since they were first exposed last year,” said Connecticut lawyer Craig Raabe, who represents people accusing companies of defrauding them. “Consumers will benefit from these overcharge bans because they should not pay more than an insurance company actually pays for a prescription medicine.”

Filed under: General Problems | Leave a Comment »

UPDATE: 16 Senators calls for less therapy for chronic pain pts ?

Posted on July 12, 2017 by Pharmaciststeve

Senators urge lower production quotas to battle opioid epidemic

http://www.wfsb.com/story/35856912/senators-urge-lower-production-quotas-to-battle-opioid-epidemic

 

UPDATE: The letter, which was drafted by Illinois Democrat Dick Durbin, was signed by 15 other Democrats and one Independent: Senators Sherrod Brown (D-Ohio), Amy Klobuchar (D-Minn.), Edward J. Markey (D-Mass.), Joe Manchin (D-W.Va.), Dianne Feinstein (D-Calif.), Claire McCaskill (D-Mo.), Patrick Leahy (D-Vt.), Tammy Baldwin (D-Wisc.), Jeanne Shaheen (D-N.H.), Kirsten Gillibrand (D-N.Y.), Catherine Cortez Masto (D-Nev.), Maggie Hassan (D-N.H.), Richard Blumenthal (D-Conn.), Al Franken (D-Minn.) and Angus King (I-Maine).

WASHINGTON (WFSB) –

More than a dozen senators from across the country, including one from Connecticut, called on the Drug Enforcement Administration to better combat prescription drug abuse.

Sen. Richard Blumenthal said he joined a group of 16 senators in sending a letter to the DEA in which they urged the agency to better prevent painkillers from flooding the market by setting lower opioid quotas for 2018.

The senators said last year, the DEA reduced all quotas by 25 percent or more. However, they said DEA-approved opioid production remains high, including 55 percent higher oxycodone levels in 2017 from 2007.

“As the gatekeeper for how many opioids are allowed to be sold legally every year in the United States, we commend DEA on taking initial steps last year to lower production quotas for the first time in a generation,” the senators wrote. “However, the 2017 production quota levels for numerous schedule II opioids remain dramatically higher than they were a decade ago.  Further reductions, through DEA’s existing quota-setting authority, are necessary to rein in this epidemic.” 

The group is also looking for an explanation into how the DEA comes to a decision about setting its quotas.

Here’s the letter they sent:

The Honorable Chuck Rosenberg
Acting Administrator
United States Drug Enforcement Administration
8701 Morrissette Dr.
Springfield, VA 22152

Dear Acting Administrator Rosenberg:

As our nation continues to confront the worsening prescription opioid and heroin epidemic, we write to urge the Drug Enforcement Administration (DEA) to build upon last year’s progress in reducing aggregate production quotas for schedule II opioids and further lower those levels for 2018. 

In order to effectively combat this raging crisis, stakeholders—especially our federal oversight agencies—must use every tool available to prevent the flood of addictive narcotic painkillers onto the market that can result in misuse, abuse, and diversion.  We have shared our deep concern that, for the past two decades, DEA has approved significant increases in the aggregate volume of opioids allowed to be produced for sale in the United States.  Between 1993 and 2015, DEA allowed aggregate production quotas for oxycodone to increase 39-fold, hydrocodone to increase 12-fold, hydromorphone to increase 23-fold, and fentanyl to increase 25-fold.

As the gatekeeper for how many opioids are allowed to be sold legally every year in the United States, we commend DEA on taking initial steps last year to lower production quotas for the first time in a generation.  We were pleased that DEA followed our calls to lower nearly all opioid production quotas by 25 percent or more, including reducing the quota for hydrocodone by 34 percent.  However, the 2017 production quota levels for numerous schedule II opioids remain dramatically higher than they were a decade ago.  Further reductions, through DEA’s existing quota-setting authority, are necessary to rein in this epidemic. 

We have, and will continue to, engage with the U.S. Food and Drug Administration (FDA) on ensuring they are providing your agency with the appropriate information—which takes into account the downstream public health impact of the volume of opioids authorized to come to market—to help inform DEA’s quota-setting process.  In addition, as we have stated to you in the past, we believe that DEA should use existing authorities under the Controlled Substances Act to consider the recent Centers for Disease Control and Prevention (CDC) Guideline for Prescribing Opioids for Chronic Pain and proactively adjust opioid production quotas, given this “change in the currently accepted medical use” of opioids.

Finally, as DEA issues its draft order for the 2018 production quotas, we urge the agency to foster enhanced transparency and accountability by taking the following actions:

  • Provide an analysis of the approved 2016 opioid production quotas relative to the amount that was ultimately used;
  • Provide an explanation for the draft 2018 order of the considerations DEA took into account in establishing the opioid production quotas; and if there is a proposed increase to any opioid production quota, provide a justification of why the public health benefits of increasing the quotas outweigh the consequences of having an increased volume of such substance available for sale and potential diversion in the United States; and
  • Make public the approved individual production quota for each manufacturer of schedule II opioids, including oxycodone, hydrocodone, oxymorphone, hydromorphone, and fentanyl.

We appreciate DEA’s commitment to tackling the opioid epidemic through changes to aggregate production quotas.  By continuing to use its quota-setting authority in a proactive and robust way to combat the opioid crisis, while preserving access for legitimate medical use, DEA has the opportunity to make a real and immediate difference that will benefit American communities and save lives.    

Filed under: General Problems | 6 Comments »

« Previous Page — Next Page »