New insurer policies kick in as doctors, patients adjust to Nevada’s new opioid law

https://thenevadaindependent.com/article/new-insurer-policies-kick-in-as-doctors-patients-adjust-to-nevadas-new-opioid-law

Nevada’s new law to combat the rising number of opioid deaths has drawn a public outcry from doctors and patients who say it is styming access to necessary medications, but recent changes to insurer and pharmacy management policies have largely flown under the radar in the conversation.

Several insurance companies, responding to both public pressure to combat the opioid epidemic as well as guidelines issued by the Centers for Disease Control and Prevention, instituted changes nationwide at the beginning of the year, limiting the initial prescription of opioids for acute pain to seven days and requiring prior authorization for long-acting opioids. The biggest pharmacy benefit managers, responsible for negotiating drug prices between manufacturers, insurance companies and pharmacies, also have recently put limits on initial fills of opioid prescriptions.

The policy changes take effect amid a larger conversation in Nevada about how to balance laws and regulations aimed at preventing opioid overdoses with ensuring that patients who actually need pain medication receive it in a safe and responsible way. Proponents of the new opioid law attribute the initial pushback against it to doctors being uninformed about how to follow it, a problem that can be solved through education, while others say the law is inherently flawed and in need of fixing.

The insurance company and pharmacy benefit manager (PBM) policies are yet another method of combating opioid deaths. But they also are creating another layer of paperwork and rules for doctors to follow as they navigate compliance with the new Nevada law and can complicate things for patients.

“There are unintended consequences with these artificial restrictions,” said Dr. Jim Marx, a pain specialist in Las Vegas.

For instance, Aetna started limiting the quantity of opioids prescribed for acute pain and post-surgery to a seven-day supply starting Jan. 1. Any prescription greater than seven days requires prior authorization, to ensure providers are not overprescribing in an acute pain setting, an Aetna spokeswoman said.

“Physicians and members can always appeal denials for prescriptions, including for opioids,” said Aetna spokeswoman Anjie Coplin in an email.

Aetna also requires prior authorization for all long-acting opioids in order to ensure the medicines are being appropriately used, Coplin said. The prior authorization process takes into account whether the patient is undergoing treatment for cancer or receiving end-of-life care. Long-acting opioids can be covered for up to six months at a time for chronic pain, but lifetime coverage can be granted for end-of-life or cancer diagnoses.

Health Plan of Nevada and Sierra Health and Life, two United Healthcare subsidiaries providing insurance in Nevada, started requiring prior authorization for patients on their commercial plans taking long-acting opioids or those cumulatively taking more than 180 morphine equivalent doses starting on Jan. 1. Medicaid patients on Health Plan of Nevada have been subject to prior authorization for long-acting opioids since July.

Starting Thursday, commercial customers on the two plans and Medicaid patients on Health Plan of Nevada are now only able to receive initial prescriptions of opioids for up to seven days and no more than 49 morphine equivalent doses on their first prescription if they are new to opioid therapy. (There are no restrictions on a second prescription as long as it doesn’t meet the other criteria for prior authorization.)

Other insurance companies started rolling out limits over the last couple of years. Anthem Blue Cross Blue Shield started limiting initial prescriptions of short-acting opioids to seven days for some drugs in October 2016, and all short-acting opioids were subject to the limit in July. Anyone covered by Anthem can only receive a maximum of a 14 day supply for short-acting opioids in a 30-day period without prior authorization. The company also implemented a prior authorization process for long-acting opioids in September 2016 for initiation of therapy.

Pharmacy benefit managers have also adopted their own policies as far as the drugs they’ll cover. CVS Caremark, one of the three largest pharmacy benefit managers, started limiting initial prescriptions of opioids for acute pain for patients who are new to therapy starting Feb. 1. The new policy also limits daily dosages and requires that immediate-release formulations or drugs be given before extended-release versions are prescribed. Doctors can ask for exemptions for certain patients and employers and insurers are allowed to opt out of the new policy.

Express Scripts, another of the big three, started limiting patients new to opioid therapy to a seven-day supply on a short-acting opioid on Sept 1. OptumRx now limits members naive to opioid therapy to 49 morphine-milligram equivalent per day, with up to two seven-day fills in a 60-day timeframe starting July 2017.

The policy changes come as a reaction to guidelines issued by the CDC in 2016 as far as appropriate prescribing of opioids for both acute and chronic pain. They also come amid increased focus on the role that insurance companies and pharmacy benefit managers have played in the opioid crisis.

The limits on opioids seem like a good idea at face value, Marx said, but don’t always work out the way you think they’re going to in practice.

Marx gave the example of a chronic pain patient who takes 200 morphine milligram equivalents (MME) a day. Because patients who take higher amounts of opioids at one time are more likely to become addicted, doctors like to use as low a dose as possible as many times a day that a patient requires it. However, he said he’s run into situations where pharmacy benefit managers will approve two 100 MME doses but not four 50 MME ones.

“They want the patient to take one big pill, presenting a situation where the patients are presented with larger doses of medication, less times a day, and more likely to develop a liking for that medication,” Marx said.

Prescribers also have to be cognizant of the fact that although Nevada’s new opioid law allows them to write initial prescriptions for up to 14 days, a patient’s insurance may only pay for seven days.

Larry Pinson, executive secretary of the Board of Pharmacy, said that he hasn’t heard of issues between insurance companies, PBMs and pharmacists in response to the new policies because whether or not the prescription can be filled is usually decided right on the spot in the pharmacy. But he said it makes sense for insurers to set their own policies on opioids.

“I think in the long run, if you look at it empirically, it makes sense for insurance companies to look at those sorts of things,” Pinson said. “What good is it going to do to pay for narcotics for forever if someone gets addicted?”

Chronic, Noncancer Pain Boosts Suicide Risk

Chronic, Noncancer Pain Boosts Suicide Risk

https://www.medscape.com/viewarticle/804832

Certain types of noncancer pain conditions are associated with an increased risk for suicide, a new study suggests.

A study conducted by investigators at the University of Michigan in Ann Arbor showed that psychogenic pain, back pain, and migraine, but not arthritis or neuropathy, were associated with an increased risk for suicide.

Although some of this risk appears to be due to co-occurring mental health problems, there may be something about the experience of pain that also contributes directly to suicide risk, lead author Mark A. Ilgen, PhD, told Medscape Medical News.

“Treatment providers, particularly those who work in pain treatment settings, should be aware of these risks and consider mental health and suicide risk assessments in their patients,” Dr. Ilgen said.

 

Previous research suggests that individuals with pain may be at increased risk for suicidal thoughts and behaviors, but it is likely that “not all pain is created equal” in terms of its association with suicide, and that the association between pain and suicide could vary, depending on the type of pain patients experience, Dr. Ilgen said.

The study was published online May 22 in JAMA Psychiatry.

Arthritis Most Common Dx

In the current study, the investigators sought to understand the degree to which specific pain conditions related to suicide risk. The investigators also wanted to understand whether pain remained an important predictor of suicide, even after controlling for other mental health conditions that are associated with both pain and suicide risk.

The team looked at treatment records of all patients (n = 4,863,036) who were seen in the Veterans Health Administration system in fiscal year 2005 and who were alive at the start of fiscal year 2006.

They then examined the association between baseline clinical diagnoses of the following pain-related conditions: arthritis, back pain, migraine, neuropathy, headache or tension headache, fibromyalgia, and psychogenic pain, as well as the extent to which each of these conditions predicted risk for suicide in fiscal years 2006 to 2008.

Arthritis was the most common diagnosis, occurring in 2,076,514 patients (42.7%), followed by back pain, in 1,111,187 (22.8%). Psychogenic pain was the least frequent diagnosis, occurring 18,145 patients (0.4%). Suicide occurred in 4823 (0.01%) in the subsequent fiscal years.

After controlling for demographic and other factors, including age, sex, and Charlson score, the researchers found that except for arthritis and neuropathy, each pain condition was associated with an elevated risk for suicide.

 

Psychogenic pain was associated with the greatest risk for suicide death (hazard ratio [HR], 2.61; 95% confidence interval [CI], 1.82 – 3.74).

 

Back pain was associated with a 33% increased risk for suicide death (HR, 1.33; 95% CI, 1.22 – 1.45), migraine with a 68% increased risk (HR, 1.68; 95% CI, 1.28 – 2.20), headache or tension headache with a 38% increased risk (HR, 1.38; 95% CI, 1.17 – 1.64), and fibromyalgia with a 45% increased risk (HR, 1.45; 95% CI, 1.16 – 1.81).

When these analyses were further controlled for concomitant psychiatric conditions, these associations between pain conditions and suicide death were reduced.

 

However, significant associations remained for back pain (HR, 1.13; 95% CI, 1.03 – 1.24), migraine (HR, 1.34; 95% CI 1.02 – 1.77), and psychogenic pain (HR, 1.58; 95% CI, 1.11 – 2.26).

 

Controversial Diagnosis

 

“Psychogenic pain is listed within the ICD-9 [International Classification of Diseases, Ninth Revision] coding system and characterizes pain that is caused by psychological instead of purely physical factors,” Dr. Ilgen explained.

Dr. Mark Ilgen

“This is a diagnosis that is used relatively infrequently within the VA, and there is considerable disagreement among pain and mental health professionals about the validity and utility of this diagnosis,” he said.

 

Because of the type of data that were analyzed in this study, it is impossible to tell what treatment providers were thinking when they used the diagnosis of psychogenic pain, Dr. Ilgen added.

 

“Still, this diagnosis had the strongest association with suicide of any of the pain disorders that we examined. It is my guess that a diagnosis of psychogenic pain is given to patients with pain that is poorly understood and that may be particularly difficult to treat. Also, there is the possibility that patients with this diagnosis are particularly frustrated with their care and hopeless about the resolution of their pain condition. I do not interpret our findings to indicate that ‘psychogenic pain,’ as it is defined in the ICD-9, is directly causing suicide, rather, that there is something about being diagnosed with this condition that is associated with a particularly poor prognosis.”

 

Need for Screening and Treatment

 

Commenting on this study for Medscape Medical News, Colonel (retired) Elspeth Cameron Ritchie, MD, chief medical officer for Washington, DC, Department of Mental Health and an expert on suicide in the military and veterans population, called it important, although not a surprise.

 

“It’s not a revelation because anecdotally, we have known that pain is a risk factor for depression and for suicide. But it is looking at a very large population, and this adds to its importance,” she said.

 

Dr. Ritchie, who retired from the army 2 years ago, said she saw this firsthand.

 

“Pain was a major risk factor. Many service members, after 12 or 20 years of service, have a lot of aches and pains. So in the military, pain is a risk factor.”

 

She added that for her, the “take-home message” is that clinicians should be evaluating suicide risk in all patients with pain.

 

“The standard questions for evaluating risk for suicide are, ‘Have you given away your possessions?’ and ‘Have you made a will?,’ but it’s not a standardized question in the psychiatric setting to ask about pain, and it absolutely should be.”

 

Also, asking about pain is not enough. Clinicians should make sure that patients with pain are getting appropriate treatment, she added.

 

The study was sponsored by the Veterans Health Administration. Dr. Ilgen and Dr. Ritchie report no relevant financial relationships.

 

JAMA Psychiatry. Published online May 22, 2013. Abstract

FDA: PROP’s request on high dose opiates – PUT ON HOLD ?

 

Opinion: Medicare Considering Opioid Restrictions – Comment on Docket by Monday 3/5

www.nationalpainreport.com/opinion-medicare-considering-opioid-restrictions-comment-on-docket-by-monday-3-5-8835679.html

Most of us knew this had been coming; however, it doesn’t make it any easier to swallow.  This is probably one of the most important tasks you will be asked to do as a chronic pain patient or for pain patients.  We know there have been literally hundreds of ‘Calls to Action’ over the years, but this is it.  Medicare is considering limiting coverage for opioid dosages over 90 MME and putting a 3, 5, or 7-day cap on new prescriptions for acute pain.  There is a proposed 7-day supply to be provided while you seek an exemption to an over 90 MME prescription.  Medicare is also proposing adding extra flags for Gabapentin, Lyrica and Benzos in combination with opioids.  Final approval is given to your insurance carrier, not your doctor.  We must ask for a legacy exemption for those already stabilized above 90 MME.

We have until Monday to badger as many people as we can to comment on the federal docket.  Pain patients are now joining their State Pain Advocacy Groups, created several months ago for direct action and advocacy.  These groups are a little different than your typical advocacy groups, as they discourage personal stories, memes, medical talk and surgical photos.  We are focusing on the collective and not individual experiences, though they are the most important part of this.  We will comment on federal dockets, attend legislative hearings, talk with reporters/policy makers and even protest at the nationwide ‘Don’t Punish Pain’ rallies on April 7, 2018.

We must bombard Capitol Hill with calls, faxes, Tweets and emails and meet with them if we can.  Not only do we need to let them know how medically fragile and chronically ill we are, and that we depend on these medications for our very existence, but we have to PROVE to them we are not functioning addicts.  They must see us speaking as one, with clear speech and clear eyes.  We must be rational, calm, cool and collected – not an easy thing to be when you are fighting for your life along with daily fatigue, illness and disability.

Please comment on the federal docket that closes on Monday, March 5th, 2018.  Use these steps as a guide, but please do not copy them verbatim, as Medicare will disregard duplicate comments.  Join your state pain advocacy group – it’s your state name and ‘Pain Advocacy Group’ on Facebook – the website is under construction.  We will never ask for money from chronically ill pain patients, as most don’t have any to spare.  Ask how you can help in your state group, as there’s so much to be done.  We are just at the beginning of what we fear will be a very long battle.  It’s way past time for us to be advocating together – if we wait until our pain relief has been completely taken away, it could be nearly impossible to fight.  Please know that we are all just one appointment away from losing access to pain medication – whether it’s your doctor unwilling or unable to prescribe, your insurance denying coverage or your pharmacist being out of supply or refusing to fill.  It’s happening and it’s real.  Come join us – we need you now!

Here are some tips on how to comment on the federal regulations:

  1. https://www.regulations.gov/document?D=CMS-2017-0163-0007
  2. Click Blue Box ‘COMMENT NOW’
  3. You may want to write your comment in a document and then copy/paste in case the site glitches or it’s too long and you need to attach it as a doc – ‘Choose files’ – if you need to upload it.
  4. Name/City/Sate/Zip/Country/email or submitting on behalf of 3rd party – we can submit your comment anon for you/CONTINUE.
  5. I am a Medicare/Medicaid patient or future patient – or have a private insurer which often follows Medicare policies.
  6. I am a pain patient diagnosed with (diagnosis) for (how many?) years. I tried( ______ ) – list all the non-opioids (n-saids, Tricyclic anti-depressants, SSRIs, SNRIs, Steroids, anti-epileptics, etc.) you tried BEFORE opioids and include all the different therapies/treatment/surgeries (i.e., PT, OT, Aqua T, Chiro, Osteo, injections, devices, procedures, CBT/mindfulness, acupuncture, acupressure, massage, biofeedback, Medical Cannabis, creams, TENs, MENS, natural remedies, etc.) but they all failed to heal/help or adequately control my pain, so I require opioid pain medications. Opioids help me by managing my pain and (_____) – talk about improved function that opioids help with – working, chores, childcare, travel, entertainment, etc.
  7. If Medicare/Medicaid/private insurer refuses to pay and if I do not have access to my medication over 90 MME/any dosage I will (____) – explain how your life will change – lose your job, income, home, car, entertainment, not be able to care for family/house, etc.
  8. Explain you have been a model, compliant patient, and if you have a pain contract – include how often you have UAs, pill counts, secure you medications and if you use one pharmacy, avoid alcohol, cannabis, etc. Mention it is unlikely your condition will improve and the effects of time and aging will make things worse. Opioids and pain management were a last resort option.
  9. Proposed policies are not supported by proven studies, everyone genetically metabolizes medications differently, the CDC guidelines were written outside the rules by non-pain management physicians, some who may have professionally or personally profited from the outcome.
  10. These policies could: create more chronic pain by not treating acute pain, scare more doctors out of pain treatment, create more demand for urgent care, increase the rate of expensive and possibly dangerous procedures, more disability claims/unemployment, and need for social services.
  11. Force involuntary tapers, withdrawals, risk of suicide, high blood pressure, stroke risk, and cardiac issues.
  12. I am disabled, NOT over 65 and pain medication helps me PREVENT falls by stabilizing my pain.
  13. My medical care and decision making should be left to my doctor, who understands my complicated and complex case, not CMS/Medicare.
  14. A 7-day supply while seeking an exemption to 90MME would cause extreme stress, paperwork burden for my doctor, extra copays at pharmacy/doctor, plus another trip to doctor/pharmacy when you are in pain.
  15. A 7-day limit on prescriptions for new patients would be a physical and financial hardship – doesn’t take into account injury, size, metabolizing, genetics or other factors.
  16. I take _____ (Benzos, Gabapentin, Lyrica) safely – I do not mix them with alcohol, other substances and use as directed.  Explain what might happen if these were to be discontinued.
  17. Prescribing has been going down for over 5 years while ODs to illicit heroin/Fentanyl coming in from Mexico/China is skyrocketing – deaths will continue to rise, as this crisis is NOT an over prescribing issue.

Valorie Hawk lives in Washington and has experience working with Congress. She can be reached by Email: C-50painadvocacygroups@outlook.com and you can follow her on Twitter   @C50painadvocacy

President Trump says drug dealers may deserve ‘ultimate penalty’

http://www.wpxi.com/news/national/president-trump-says-drug-dealers-may-deserve-ultimate-penalty/709651660

WASHINGTON (AP)President Donald Trump said Thursday the “ultimate penalty” may be in order for drug dealers because the nation’s drug problem will never be solved without a show of strength and toughness.

The comments were Trump’s most explicit on the matter to date. He previously has alluded to death for drug dealers by noting that some countries are “very harsh” with drug dealers. Trump also has said he knows the answer to the drug crisis, but he isn’t sure the country is “ready for it yet.”

In remarks Thursday at a White House summit on the opioid epidemic, Trump said drug dealers and pushers kill hundreds of people but that that most don’t go to jail.

“You know, if you shoot one person, they give you life, they give you the death penalty. These people can kill 2,000, 3,000 people and nothing happens to them,” he said, referring to drug dealers.

“Some countries have a very, very tough penalty – the ultimate penalty. And, by the way, they have much less of a drug problem than we do,” Trump continued. “So we’re going to have to be very strong on penalties.”

Trump also held out the possibility of initiating federal lawsuits against opioid makers and distributors. He also said his administration will be “rolling out a policy” on opioids in the coming weeks that will be “very, very strong.” Neither he nor his aides provided any details.

Trump said he had spoken with Attorney General Jeff Sessions about suing opioid makers. Sessions announced this week that the Justice Department will support local officials in hundreds of lawsuits against opioid makers and distributors.

Addressing potential federal litigation, Trump said: “I think it’s very important because a lot of states are doing it, but I keep saying, if states are doing it, ‘Why isn’t the federal government doing it?’ So that will happen. So that will happen.”

Trump’s wife, Melania, opened the summit. She said many people are grieving loved ones lost to the opioid crisis and “we need to change that.”

She read from a letter from Betty Henderson, a Florida woman who lost her 29-year-old son, Billy, to drugs last September. Henderson appealed to Mrs. Trump for help “in claiming these lost souls before drugs take them from this earth.”

Opioids, including prescription opioids, heroin and fentanyl, killed more than 42,000 people in this country in 2016, more than any year on record, according to the Centers for Disease Control and Prevention. Trump has declared that fighting the opioid epidemic is a priority for the administration but critics say the effort has fallen short.

Trump in the past has addressed the issue of tough penalties for drug dealers and pushers.

In January, Trump said: “We’ve never had a problem with drugs like we do, whether it’s opioid or drugs in the traditional sense. It’s never been like it is.

“And we are going to do everything we can. It’s a very difficult situation, difficult for many countries,” Trump said. “Not so difficult for some, believe it or not. They take it very seriously and they’re very harsh. And those are the ones that have much less difficulty. “

Trump raised the issue later that month as he signed legislation giving Customs and Border Protection agents new resources to stop the illicit drug flow. He suggested that he’d like to take a more aggressive approach to the drug crisis – but said the country isn’t ready for what he has in mind.

“So we’re going to sign this. And it’s a step. And it feels like a very giant step, but unfortunately it’s not going to be a giant step, because no matter what you do, this is something that keeps pouring in,” he said.

“And we’re going to find the answer. There is an answer. I think I actually know the answer, but I’m not sure the country’s ready for it yet,” he added. “Does anybody know what I mean? I think so.”

Pres Trump, when it comes to the opiate crisis and the war on drugs.. is so out of his league and he is depending on the advice of that numb-nuts AG Sessions who is still in the 70’s or 80’s in trying to fight the war on drugs… nothing like trying to deal with 21st century crooks with 20th century policies and processes.

Everyone who has three brain cells holding hands that when you take out a drug dealer… there are two or three waiting in the wings to step up and take over selling the product to meet the demands for the product in the general population of our society.

We already have the highest percent of our population in jails/prisons of any civilized society on the globe… most for non-violent drug offenses…  Perhaps Trump and Sessions need to be given an abbreviate education in Economics 101 and the law of supply and demand.

Is it time for a valid THIRD POLITICAL PARTY ?

 

 

 

West Virginia AG says new opioid directive came from his DEA lawsuit

http://www.whsv.com/content/news/West-Virginia-AG-says-new-opioid-directive-came-from-his-DEA-lawsuit-475689823.html

According to Attorney General Patrick Morrisey, his December 2017 lawsuit was the cause behind Attorney General Jeff Sessions’ new directive for the DEA to change its regulation establishing how many opioid pills can be manufactured each year.

The announcement came just hours before a key deadline in Morrisey’s lawsuit, which sought greater transparency and broader input in the process the DEA uses to establish those limits.

He says evidence of diversion has been ignored for years in setting those limits, and he moved to suspend his lawsuit Thursday after getting the federal directive.

“The era of unlimited supply must end,” Attorney General Morrisey said. “We are losing too many neighbors, too many friends, too many sons and too many daughters to senseless death.

“The DEA’s quota system is fundamentally broken,” Morrisey said. “For far too long, it served the industry’s wants, instead of the patients’ needs, inexcusably neglecting evidence of diversion to rely on a formula that continues to kill hundreds each day. This must stop.”

Morrisey says the new process should require the DEA to formally seek input from the Department of Health and Human Services, Food and Drug Administration, Centers for Disease Control and Prevention, as well as every state.

He says that would be “a reversal from years of reckless oversight and abject failure.”

“I heartily applaud Attorney General Sessions for the major step he is taking and for his continued collaboration with our office to protect West Virginians from this deadly scourge of opioid excess,” Attorney General Morrisey said. “I am also appreciative of President Trump’s dedication to addressing the opioid problem, as it represents such a stark departure from the past.”

You can read Morrisey’s lawsuit here, Sessions’ directive here, and Morrisey’s motion to suspend the suit here.

legal opiate prescriptions in 2016 was less than 2006 and DEA cut opiate prescription manufacturing quotas in 2016.. again in 2017 and again in 2018… many opiates production quotas are abt 50% of what they were in 2015. .. and this numb-nuts attorney wants a larger cut… because the citizens of his state because of genetics, or socioeconomic reasons they have decided to abuse and/or be diverters of controlled substances.

Unnecessary Use of Fluoroquinolone Antibiotics Prompts New CDC Warning

www.rxinjuryhelp.com/news/2018/03/02/unnecessary-use-of-fluoroquinolone-antibiotics-prompts-new-cdc-warning/

The U.S. Centers for Disease Control (CDC) is now warning doctors to prescribe fluoroquinolone antibiotics – a class of drugs that includes Levaquin, Avelox and Cipro – only when “absolutely necessary” because of their potential to cause serious adverse events.

Fluoroquinolones Often Prescribed for Uncomplicated UTIs, Viral Respiratory Conditions

The CDC warning follows the release of data suggesting that the drugs are often used to treat conditions that do not require antibiotic treatment or those with a different recommended first-line therapy,

According to a report published in Clinical Infectious Diseases, 1.5 million fluoroquinolones were prescribed to adults during ambulatory care visits in 2014. Genitourinary conditions (24.5%) and respiratory conditions (21.6%) accounted for the majority of these prescriptions.

Nearly 20% of fluoroquinolone prescriptions were written for patients with uncomplicated urinary tract infections or viral respiratory infections and bronchitis that don’t require antibiotic treatment. What’s more, fluoroquinolones were the MOST COMMONLY prescribed antibiotic for uncomplicated UTIs (40.3%) and the third most commonly prescribed antibiotic for respiratory conditions.

“Fluoroquinolones’ side effects can involve tendons, muscles, joints, nerves and the central nervous system, or could lead to life-threatening Clostridium difficile infection, which causes diarrhea that can lead to severe colon damage and death,” the CDC said in a statement responding to the report. “Because of these serious side effects, in 2016, the [U.S. Food & Drug Administration (FDA)] issued a warning advising health care providers to not use fluoroquinolones for conditions for which alternative and effective treatment is available and when the potential risks outweigh the benefits.”

Fluoroquinolone Side Effects

The FDA warning followed an agency review that suggested fluoroquinolone antibiotics could cause potentially permanent side effects involving the tendons, muscles, joints, nerves and central nervous system. At the time, the FDA required fluoroquinolone manufacturers to add this information to the Black Box Warning included with the drugs’ prescribing information. A Black Box Warning is the most urgent type of safety notice.

That warning was only the most recent FDA alert to focus on fluoroquinolone antibiotics. In August 2013, the agency ordered the drugs’ manufacturers to modify label information regarding their potential to cause a serious nerve disorder called peripheral neuropathy. While mention of the condition had been added to the prescribing information in 2004, the FDA determined that the labels did not reflect the possible rapid onset of the condition, or the potential for permanence.

In 2008, information regarding the potential for tendon damage – including ruptures and tears of the Achilles tendon – was added to the drugs’ Black Box Label.

Fluoroquinolone Antibiotic Lawsuits

Hundreds of people are currently pursuing peripheral neuropathy lawsuits against the manufacturers of Cipro, Levaquin and Avelox. Among other things, plaintiffs accuse the drug companies of downplaying this risk and failing to provide doctors and patients with adequate safety warnings.

Claims have also been filed on behalf of patients who suffered aortic injuries – including  aortic aneurysm and aortic dissection – allegedly associated with the use of Cipro, Avelox and Levaquin.

Story line starts out abt illegal Heroin and transitions to being about legal opiates ? no more “fair and balance” bullshit at FOX !

It is amazing how the media can start down one story path and end up with prescribers and legal opiates being the problem..  Here is a kid that is suppose to be the 16th best hockey player in the USA.  Apparently a over achiever, nothing wrong with that… but apparently accepted a offer from someone before a game to “take the edge off” and it was a opiate (Heroin) … and he never played another competitive game without his “little helper”… I believe, in athletics that is considered “doping/cheating”…  But those illegal acts by this kid – using a illegal substance and taking an illegal substance to help him win in a competitive team sport not part of this media’s message.

Mrs Kruczek and Ainsley headed directly to about prescribers … OVER PRESCRIBING… as the cause of all of these deaths. In this particular case it would appear that this kid’s “gateway drug” … was directly from the street and no prescriber was ever involved in giving him a prescription opiate.

 

https://www.nytimes.com/2017/06/14/business/media/fox-news-fair-and-balanced.html

Apparently this article explains a lot 

Fox News Drops ‘Fair and Balanced’ Motto

www.nytimes.com/2017/06/14/business/media/fox-news-fair-and-balanced.html

Fox News is “Fair and Balanced” no more.

In the latest sign of change at the cable news network, the “Fair and Balanced” motto that has long been a rallying cry for Fox News fans — and a finger in the eye of critics — is gone. The channel confirmed on Wednesday that slogan and network have parted ways.

“The shift has nothing to do with programming or editorial decisions,” the network said in a statement. Instead, the slogan was dropped in part because of its close association with Roger Ailes, a network founder, former chairman and the originator of the phrase, who was fired in August in a sexual harassment scandal.

The network said that “Fair and Balanced” was shelved as a marketing tool after Mr. Ailes’s departure. In its place is a new motto: “Most Watched, Most Trusted.”

Another Fox slogan, “We Report, You Decide,” has also been retired, although the network said that it returned occasionally.

Some viewers may be surprised. Several Fox News personalities still toss the phrase “fair and balanced” into on-air conversation, though it no longer appears in graphics. Gabriel Sherman, longtime Fox News chronicler, reported on New York magazine’s website that the motto was gone for good.

The new motto, “Most Watched, Most Trusted,” mimics the firm cadence of the previous slogans, but does not have their Ailes-tinged tone of defiance.

For conservative-leaning viewers, “Fair and Balanced” was a blunt signal that Fox News planned to counteract what Mr. Ailes and many others viewed as a liberal bias ingrained in television coverage by establishment news networks.

Mr. Ailes, who died in May, created the slogan with both purposes in mind. He coined the phrase when he and Rupert Murdoch founded Fox News in 1996, and it stuck.

Executives at Fox News acknowledge that it is rebuilding.

This year, Fox News has continued its yearslong streak as the top-rated cable news station over all, beating its rivals MSNBC and CNN in total viewership.

But the loss of the anchors Megyn Kelly and Bill O’Reilly has taken a toll in prime time. In May, MSNBC was the highest-rated network in a key industry category, weeknight viewers 25 through 54, for the first time in nearly 17 years.

On Wednesday, executives at Fox News played down the shedding of “Fair and Balanced,” saying that the move was strictly a marketing decision and that the network’s approach to news coverage had not changed.

One senior network official emphasized that the slogan was officially dropped last August and virtually no one had noticed.

 

 

I’ve been asked to pass this information along

KY: tax opiate Rxs to fill in state’s budget shortfall

Kentucky House votes to tax opioids to close budget gap

http://abcnews.go.com/US/wireStory/kentucky-house-votes-tax-opioids-close-budget-gap-53447557

For six years, a pharmaceutical distributor sent more than 50 million doses of prescription opioids to five eastern Kentucky counties, enough for every person there to have 417 pills each.

Kentucky’s attorney general has sued that company and others like it. Thursday, state lawmakers voted to tax them.

In a state with the fifth highest drug overdose death rate in the country, Kentucky’s Republican-controlled House of Representatives approved a tax on prescription opioids Thursday. If approved by the state Senate, Kentucky could become the first state in the country to tax the addictive prescription painkillers that have spurred a wave of addiction across the country.

Lawmakers say the goal is to reduce the number of opioids available in Kentucky. But they won’t use the money from the tax specifically for drug treatment, instead using it to fund public education and other services.

“These pills are profiting the big pharmaceutical drug companies billions and billions and billions of dollars a year. You know how much our state budget gets? Zero,” Democratic Rep. James Kay said.

As the opioid epidemic rages across the country, state and local governments have filed hundreds of lawsuits against pharmaceutical companies and distributors to recoup some of the costs to their health care systems.

Kentucky’s proposal is a step in the other direction, using taxes to fill sparse state coffers while discouraging aggressive prescription of the drugs.

“I think it could help reduce aggressive prescribing,” said Dr. Andrew Kolodny, director of opioid policy research at Brandeis University and an expert advising the court in lawsuits against pharmaceutical companies. “Right now it is too cheap and easy to give a patient a narcotic when they have a pain problem.

Kentucky is one of at least 13 states with pending legislation to tax opioids, according to the National Conference of State Legislatures. None of those proposals have been enacted.

The Kentucky proposal would tax each dose of opioids 25 cents.

State officials say it would generate about $70 million per year. In Minnesota, Gov. Mark Dayton has proposed a “penny a pill” tax on narcotic medications to raise about $20 million to pay for drug treatment programs.

Kentucky’s opioid tax revenue would not be set aside for drug treatment, instead going to fill a budget gap caused by the state’s struggling pension system.

“I think that’s a mistake,” Kolodny said. “States (need) to be investing and building out a treatment system that doesn’t really exist yet. This is a very sensible place to get that money.”

Some Kentucky lawmakers complained that the opioid tax, coupled with an accompanying 50-cent tax hike on cigarettes, disproportionately affects poor people.

But the proposal gives Kentucky’s attorney general authority to prosecute drug companies that pass the tax along to their customers.

That might not be legal, according to Nick McGee, spokesman for the Pharmaceutical Research and Manufacturers of America. He said that idea, plus the tax itself, have “some serious legal and policy questions.”

“Taxing prescribed medicines that people legitimately rely on to raise revenue for a budget shortfall is a pretty problematic precedent,” McGee said.

It’s unclear how the proposal will fair in the state Senate, a smaller legislative body that is dominated by Republicans. Senate President Robert Stivers said it would be “difficult” to pass any tax increase without a comprehensive reform of the tax code.

Republican Gov. Matt Bevin told WSON radio he would “reserve my thoughts” on the opioid tax. But later in the interview, he indicated he would not favor raising taxes just to balance the state budget.

“They are trying to put certain monies back in certain areas based on certain political pressure, when I think we need to have a collective effort in Kentucky,” Bevin said.