Medications are imperfect … FDA turning a blind eye to some known imperfection ?

Posted on May 6, 2016 by Pharmaciststeve

The FDA Is Hiding Reports Linking Psych Drugs to Homicides

http://www.madinamerica.com/2016/05/the-fda-is-hiding-reports-linking-psych-drugs-to-homicides/

In my wildest dreams, I could never have imagined being drawn into a story of intrigue involving my own government’s efforts to hide, from the public, reports of psychiatric drugs associated with cases of murder, including homicides committed by youth on the drugs. But that is precisely the intrigue I now find myself enmeshed in.

The saga began several years ago. My child had the misfortune of being born during the last month of eligibility for kindergarten, and was subsequently labeled with A.D.H.D. – which stands for August Date Hikes Diagnosis. While other Americans with the same chronological impairment such as Man Ray and Robert Ringling managed to make something of themselves despite being born in the month of August, it seemed my child was doomed to failure from the get-go, unless provided lifesaving stimulant medication.

With an abiding uneasiness about both the alleged disorder and its miracle remedy, as they were presented to me, I set out to understand as much as I could about stimulant medications, prescribed disproportionately to the youngest children in the class.

It wasn’t long before I stumbled upon the FDA Adverse Event Reporting System (FAERS), also referred to as MedWatch. The FDA publishes quarterly FAERS data files on its website containing hundreds of thousands of reports of various drug adverse events. Though unencrypted, the FAERS files might as well be, as the data appear hieroglyphic to the average person who is not a database expert, including myself at the time.

With the aid of the internet and with a lot of trial and error, I taught myself to write Structured Query Language (SQL) code to decipher the FAERS files. I first plumbed the depths of the adverse event data searching for reports of pediatric fatalities associated with stimulant medications, and found hundreds of them. Expanding my queries to include all psychotropic medications, I eventually identified nearly 2,000 pediatric fatalities. (More on the pediatric psychotropic fatalities in a future post.)

As I contemplated the gravity and the scale of the human tragedy, I began to wonder what drug side effects these children experienced at the time of their deaths. The FAERS data files yielded answers: cardiac arrest, respiratory arrest, hepatoxicity, multi-organ failure, Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, Neuroleptic Malignant Syndrome, completed suicide, homicide . . . Wait, what?  Homicide, as a drug side effect? Then I saw it again: Murder.

The light bulb went off. I performed a query for homicide or murder as a drug side effect. To my astonishment, there were over 700 reports in FAERS of homicides linked to psychotropic medications.

In October 2014, I submitted a Freedom of Information Act (FOIA) request to the FDA to obtain copies of the FAERS homicide reports. After ten months of “Foot Dragging and Alibis,” which is what Rep. Joe Barton (R-TX) once suggested the agency’s acronym stood for, the FDA still had not produced a single report. Frustrated with the FDA’s stonewalling, I filed a federal lawsuit in August 2015. Within three months of filing the FOIA lawsuit, the FDA coughed up over 3,000 pages of FAERS reports.

However, hundreds of pages were completely redacted, while many hundreds more were heavily redacted. A letter from Deputy Director of Information Disclosure Policy Howard Philips attested that the records were redacted in accordance with the FOIA statute, and other applicable laws. The FDA claimed that the redaction of information was justified under FOIA’s privacy exemption.

To add some perspective, according to the HHS Freedom of Information Annual Report, among 10,145 FOIA requests the FDA processed during fiscal year 2015, the privacy exemption was applied only 24 times. Federal regulations require the FDA to “make the fullest possible disclosure of records to the public” in response to FOIA requests.

All but the case numbers were redacted in forty-seven of the FAERS homicide reports that the FDA released. The FDA had suppressed all of the report information for these cases: age, gender, drug name(s), reported drug reaction(s), case narrative, etc. The wholesale censorship of entire FAERS reports turned out to be an untenable action on the part of the FDA.

Pursuant to 21 CFR 20.81, the FDA cannot properly withhold any record that contains data or information that have been previously disclosed in a lawful manner to a member of the public. The age, gender, drug name(s), and reported drug reaction(s) had already been publicly disclosed in FAERS data files available on the FDA’s website. It was based on this publicly available information that I was able to ascertain and request the case reports involving homicide in the first place.

I fired off a letter to then-Acting Commissioner Stephen Ostroff, protesting the FDA’s improper withholding of public information, citing the federal regulation prohibiting such conduct. A month later, I received a second production of records totaling over 3,000 pages. The agency did not acknowledge any wrongdoing, or even explain what was different about the new document dump. This time around, though, the FDA had not redacted age, gender, drug name(s), and reported drug reaction(s), but the case narratives remained entirely redacted.

Insofar as the FDA had released the case narratives of hundreds of the other FAERS homicide reports, albeit heavily redacted at times, I surmised that the case narratives of these 47 reports in particular must contain information that was damaging either to the pharmaceutical companies, the FDA, or both.

Here are four examples of medication-linked homicide case narratives that were being withheld.

Case 10213469

The narrative in this case report, when it was initially sent to me, was completely redacted by the FDA. This is what I received:

10213469

However,  I knew from the FAERS data files that the case involved a 10-year-old taking Vyvanse (lisdexamfetamine), a stimulant drug prescribed to a million children in the U.S for ADHD. The girl had reportedly experienced a drug reaction that led her to commit homicide. The FDA would eventually send me a lesser-redacted version of the report, confirming the information in the FAERS data files, but the case narrative was still completely redacted.

Then, on April 12th of this year, the FDA presented a Vyvanse pediatric safety review to the Pediatric Advisory Committee. In advance of the meeting, the FDA’s “Pediatric Postmarketing Pharmacovigilance and Drug Utilization Review” was made public as part of the briefing materials posted on the agency’s website. The safety review contained a bombshell case narrative summary.

Homicide (n=1) 

Case # 10213468, USA, 2014: A 3-month-old female infant was left alone with a babysitter’s 10-year-old daughter. Lisdexamfetamine was prescribed to the 10-year-old daughter of the babysitter; the 10-year old girl had ADHD, ODD, and attachment disorder. The infant sustained various injuries. The autopsy reported the cause of death was “asphyxia and suffocation,” as the result of “homicide.” Additionally, the infant’s blood contained traces of amphetamine (lisdexamfetamine).

In an appendix, I noticed that one of  the FAERS’ reports that I had requested (10213469), which had been completely redacted, was only one digit off from the FAERS report quoted in the Vyvanse pediatric safety review, and was also listed as a duplicate report.  And then I put one and one together:  The FDA had represented to the Court handling my FOIA lawsuit that the case narrative of the FAERS homicide report I had requested—number 10213469—was exempt from disclosure under a FOI request for privacy reasons, yet now the FDA had publicly disclosed the case!

On April 13th, the day after the Pediatric Advisory Committee met and considered the FDA’s Vyvanse pediatric safety and drug utilization review, I fired off an email to the Assistant U.S. Attorney on the case, copying the FDA’s Assistant Chief Counsel, demanding a lesser-redacted version of FAERS report 10213469, pursuant to 21 CFR 20.81, since the agency had publicly released a summary of the case narrative of a duplicate report.

I figured that the FDA would now have to cough up the report.

The next day, on April 14th, Shire submitted a New Drug Application (NDA) for a chewable formulation of Vyvanse, as if following a script written long before the Pediatric Advisory Committee meeting. The company wrote in its press release that the Vyvanse chewable tablets are intended for patients “who may have difficulty swallowing or opening a capsule,” which is likely targeting very young children.

A day later, on April 15th, the Assistant US attorney sent me an email, indicating that rather than provide me a lesser-redacted version of FAERS report 10213469, the FDA had instead decided to remove the case summary detailing the homicide from its drug safety review on its website.   Just like that, Uncle Sam had covered up the homicide of a 3-month-old infant girl, by an amphetamine-addled child, as if the baby had never existed. Now you see the homicide, now you don’t.

Apparently, we can’t have a story made public about a 10-year-old girl on Vyvanse who forced the ADHD drug down a baby girl’s throat before suffocating her to death. That would be bad for business. Especially even as Vyvanse chewable tablets are being approved for the market.

There is one more part to this story of homicide linked to ADHD drugs. Earlier, after I had filed my FOIA lawsuit concerning the FAERS homicide cases, the FDA approved Adzenys XR-ODT, the first orally disintegrating amphetamine tablet approved for kids with ADHD.  Without fanfare, a homicidal ideation warning was added to the label of Adzenys XR-ODT: “Anxiety, psychosis, hostility, aggression, suicidal or homicidal ideation have also been observed.”

Adzenys XR-ODT was approved as a bioequivalent of Adderall XR, another Shire-manufactured amphetamine drug that was formerly the most prescribed drug for ADHD prior to Vyvanse. Oddly, at this writing, Adderall XR does not have a homicidal ideation warning on its label, whereas its bioequivalent Adzenys XR-ODT does. I’ve emailed the FDA Division of Drug Information for an explanation of the inconsistent homicidal ideation label warnings for these bioequivalent drugs, and was told that a Subject Matter Expert (SME) had to be consulted before the agency could respond. Of similar interest, a homicidal ideation warning was added to the Vyvanse label as well.

Case 7979016

This case involves a 16-year-old male from Canada taking Prozac, who experienced the reported drug reaction of “homicide.”  The FDA initially released a completely redacted version of this report, claiming in effect that public disclosure of any information whatsoever would constitute an unwarranted invasion of personal privacy. Once I reminded the FDA of 21 CFR 20.81, the agency produced a lesser-redacted version. This time, the FDA did not redact age, gender, nationality, drug name, or drug reactions disclosed in the FAERS data files, yet persisted with the redaction of the entire case narrative.

As it so happens, I had requested FAERS 7979016 twice, so the FDA produced yet another version of the report. This time, much of the case narrative could be read, and it contained a bombshell:

The reporting psychiatrist assessed the homicide, self-injurious behavior, manic symptoms, and worsening of his condition as related to fluoxetine, it drove him over the edge and it contributed to his actions.

Under the pretext of a phony privacy claim, the FDA had, in its previous redactions,  deliberately kept hidden a psychiatrist’s damaging causality assessment linking a popular antidepressant to homicide.

Case 8464514

This case involves a 35-year-old female from Australia, who took the antidepressant nortriptyline and killed her daughter. In one version of the report, the FDA as I subsequently learned, had completely redacted the following narrative:

My husband was drinking. I took small doses of valerian for a month and had weird dreams and premonitions. When I took nortriptyline, I immediately wanted to kill myself, talked myself out of it. I’d never had thoughts like that before. My husband was angry, shouting. I walked outside a lot, with palpitations, trouble breathing, and became more depressed. My smoking went up to 25 a day, no alcohol. I didn’t sleep for two nights, dreamt, then slept maybe three hours, felt awful. I dreamt that my daughter had dark teeth and I saw a black halo around her head, a spear hanging over it. I felt like a zombie. I believed I had to help my daughter, that a bad spirit possessed her. I picked up a knife and stabbed her and woke up. I was not myself. I was looking on from the outside, controlled by dark forces. She said, “Mum, what are you doing here?” I realized what I’d done. I asked my husband to kill me. He called the police. I felt better in the police cells without the pills, but the pills started again, and thoughts of killing myself returned.

The FDA–and this is almost hard to believe–had redacted signs or symptoms of medication-induced suicidal ideation (“When I took nortriptyline, I immediately wanted to kill myself. I’d never had thoughts like that before” and “I asked my husband to kill me”); parasomnia or hallucinations (“I dreamt that my daughter had dark teeth and I saw a black halo around her head, a spear hanging over it”); delusions (“I believed I had to help my daughter, that a bad spirit possessed her); automatism: (“I felt like a zombie”); homicide, somnambulism, and parasomnia (“I picked up a knife and stabbed her and woke up”); dissociation (“I was not myself”); depersonalization (“I was looking on from the outside”); paranoia (“controlled by dark forces”); as well as positive dechallenge (“I felt better in the police cells without the pills”); and positive rechallenge – considered the gold standard with regard to causality (“but the pills started again and thoughts of killing myself returned.”)

The FDA then provided another version of the report to me, this time with bits and pieces of the above testimonial unredacted, yet with much of the passage still missing. However, this version contained another gem:

Ranbaxy medical reviewers comment: The case is deemed serious. Medical Reviewer considered the case to be possibly related to suspect drug due to its temporal association as per WHO UMC system for standardized causality assessment.

The FDA understood that there was likely a causal link to homicide. This was the finding that the FDA did not want to make public.

Case 6179785

This case report describes a 47-year-old male prescribed Prozac (fluoxetine), lithium, temazepam, and trazodone who committed homicide. The FDA redacted the type of place he entered, as well as whom or what he shot, but did reveal that the subject ultimately shot himself.  Only the report cited a BMJ article  entitled “FDA to review ‘missing’ drug company documents,” which contained the following passage:

The documents received by the BMJ reportedly went missing during the 1994 Wesbecker case that grew out of a lawsuit filed on behalf of victims of a work-place shooting in 1989. Joseph Wesbecker, armed with an AK-47, shot eight people dead and wounded another 12. He then shot and killed himself. Mr Wesbecker, who had a long history of depression, had been placed on fluoxetine one month before the shootings.

This is a well-known case, dating back to 1989, which has been the subject of a book, The Power to Harm, by John Cornwall. The survivors and relatives of the dead sued Eli Lilly, the manufacturer of Prozac. The jury ruled in favor of Eli Lilly, which–as this was the first such case to be tried in court over whether an SSRI could stir homicidal actions–proved to be a boon to the company. Its drug had been cleared, and Lilly’s stock price soared. However, as Cornwall later revealed, Eli Lilly had made a secret deal with the plaintiffs during the trial, paying them a huge sum of money to deliberately lose the case.

So here it is twenty-five years later, and the FDA, in its case report of this fluoxetine-related homicide, which was the subject of a book, redacted some of the pertinent information. And this leads to the obvious question: has the FDA attempted to hide, from the public, links between psychotropic medications and mass shootings? More on that subject in a future post.

Now the FDA Wants Some Case Reports Back

Besides antidepressants and homicide, the three preceding FAERS reports and many others like them share two additional commonalities: 1) The cases were widely publicized in news and scholarly publications; and 2) The FDA now wants the versions that spilled some of the narrative details back from me. Much like the FDA removed the evidence of a 3-month-old girl murdered by a ten-year-old on Vyvanse from its Vyvanse pediatric safety review, the FDA, in its efforts to get these documents back, apparently wants to conceal the details about other homicides linked to psychotropics.

It is doubtful that the legislators who passed the Freedom of Information Act intended for government redactors to be censoring media reports and scholarly publications.

Last week, consumer advocacy group Public Citizen also sued the FDA, alleging the agency has arbitrarily and capriciously redacted public information from the curricula vitae of advisory committee members, thus obscuring their ties to pharmaceutical companies. It seems as though the FDA views the redaction process as thwarting the intentions of the FOIA act, and keeping secret information that might damage commercial interests.

I’ll end with a prediction: more homicidal ideation warnings are coming to psychotropic drug labels. Pharmaceutical companies will need to protect themselves from failure-to-warn lawsuits, and the FDA will no longer stand in their way from doing so, like when they wouldn’t allow Wyeth to place a suicidal ideation warning on Effexor. Tellingly, a homicidal ideation warning was also added to the Effexor label in the premarketing evaluation adverse events section, i.e.,  the company received reports of homicidal ideation before the drug was even approved.

More reports linking psychotropic drugs to homicides can be found here.

Andrew ThibaultAndrew Thibault is an extremely curious, inconvenient parent.  He is Co-Founder of Parents Against Pharmaceutical Abuse (PAPA), a parent movement opposed to over-diagnosis and over-medication of children.  A frequent guest of The Justice Hour on South Florida’s Health Talk Radio, he has also been quoted and his research has appeared in the Orlando Sentinel, Tampa Tribune, Tampa Bay Times, and Christian Science Monitor.

Filed under: General Problems | 4 Comments »

So you think that the CDC/FDA listens to your comment on proposed issues ?

Posted on May 6, 2016 by Pharmaciststeve

https://youtu.be/FFroMQlKiag?t=15s

If you look at the most recent comment period on the CDC proposal on limits on opium prescribing as typical of what goes on in Washington DC.  First of all you are dealing with UN-ELECTED BUREAUCRATS/REGULATORS… their ONLY job is to create regulations from the 300 odd new laws that Congress pass every year and/or re-interpret existing regulations and/or expand existing regulations.

Before that CDC comment period, it has been reported that the CDC included in the advisory committee a fair share of so called “experts” with a vested interest in the opiate rehab/recovery industry and/or just plain anti-opiate mindset.  They had “closed door meetings”… which is against the law… and to the best of what was divulged about the committee… there was NO INPUT from the chronic pain community and/or chronic pain experts.

They were FORCED to have a open line comment period… which was limited to 3 minutes per person and total comment period was ONE HOUR or so.. no questions could be asked… nor would they be answered…

In the final outcome…. the CDC final publication of “guidelines” were pretty much the same as before any comments made by the public. You can place your own value the CDC placed on comments made by the public that was being directly affected by these new guidelines.

Did anyone in Congress or this Administration know or care about what the CDC was doing and how they were doing it ? If they did, they apparently agreed with what they were doing  or decided to turn a “blind eye” to what was going on. Either way, those in the chronic pain community is going to get SCREWED… while those in charge were not about to get involved ?

It was recently reported that the Federal government took in the MOST REVENUE EVER and yet Congress spent 500 BILLION more than they took in… all that money goes to allow these un-elected … unbridled bureaucrats/regulators continue to impose their belief system – via Federal regulations – on 330 million people in our country.

The only way that these regulators can be reigned in.. is for Congress to start cutting the budgets of these agencies.. they can’t continue to create “boat loads” of new regulations if their budgets/staffing numbers are CUT.

There are 435 House members and 31 Senators running for re-election… they all will have Face Book pages, Websites, Twitter accounts… plus the two Presidential candidates. Also there are highly visible reporters in every major TV market which may be able to be reached via the same internet resources.

You DO NOTHING… you SAY NOTHING…. you GET NOTHING…  Pain never killed anyone.. UNTREATED PAIN.. is causing pts to DROP LIKE FLIES… and the number are only going to increase… will you be one of the CAUSALITIES ?

 

Filed under: General Problems | 4 Comments »

How much is your vote worth ?

Posted on May 6, 2016 by Pharmaciststeve

Using the last Presidential election as a gauge… where 126 million votes were cast and 106 million eligible voters — DID NOT VOTE ! .. and FIVE MILLION votes separated the winner from the loser..

It is estimated that this Presidential election that there were be 2.5 billion dollars will be spent to win a four year term that pays 400,000/yr salary..

Presuming that the same number will vote..  that would put the cost of getting one vote at abt $20.00

Let’s admit it… some people would vote a straight Democratic or Republican ticket.. even if  Goofy was at the “top of the ticket”.  For some, it isn’t about what is right or wrong for the country and its citizens.. it is all about politics.

When you really look at the numbers… the 5 million votes.. between winner and loser are only the votes that really mattered… in fact… if half of the votes had changed their votes… the outcome of the election would have been different…

So when it come down to the bottom line .. the 2.5 million votes that really determine the outcome of the election cost abt $1000 EACH..

There are 106 million chronic painers… not to count the number of others with subjective diseases that are being SCREWED WITH… not to mention all the healthcare providers that DEA/CDC/FDA are SCREWING WITH…  If those could UNITE and become their own VOTING BLOCK…  the politicians could spend the ENTIRE FEDERAL BUDGET (abt FOUR TRILLION) and could not be enough to change the outcome of the election that did not match the wishes of the “pained lives matter” voting block..cryingeyevote

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Chronic pain kills. It killed Prince. It’s time to talk about it

Posted on May 6, 2016 by Pharmaciststeve

Prince did not die from pain pills — he died from chronic pain

http://www.rawstory.com/2016/05/prince-did-not-die-from-pain-pills-he-died-from-chronic-pain

The media can’t seem to get its stories about Prince right. As the news feed overflows with stories with the word “Prince” and “addiction” in them, very few of them feature the word “chronic pain.” Multiple reports mention that Prince had suffered from years with pain in his hips due to injuries racked up during his performances. His body wracked with pain, Prince relied on opiate pain medications to provide him some relief. And yet, even today, the stately New York Times features a long article about Prince seeking “help” with an “addiction.”

Prince was not addicted to pain medication. Prince had a medical condition — chronic pain — which is criminally under-treated. It is also a medical problem that is more likely to be reacted to with stigma and condescension, even challenges about the patient’s moral character, or, if male, masculinity. Pain is still the condition that we treat by telling its sufferers to just “suck it up,” or “maintain a stiff upper lip,” or to stop acting like a “wuss.” And yet, when someone dies from complications of the disease — for that is what chronic pain is — we react with shock and pity and anger that the person died from a drug overdose. Some outlets make money off our confusion about overdose and medications and our fascination with drugs.

 

As early as 2009, reports surfaced that Prince was in chronic, debilitating pain. His friends reported that he was taking pain medication to try to control the constant, excruciating pain from damaged hips. The supposed conflict between Prince’ conversion to the Jehovah’s Witnesses and his ability to accept a blood transfusion — should the need arise during hip replacement surgery — was bandied about by the vultures who pose as gossip reporters. The idea that Prince would forego surgery in order to serve his faith contributed to the undercurrent that Prince was “weird.” Nevertheless, at least some news outlets report that Prince did have the double hip replacement surgery in 2010.

But it’s not just about how the media doesn’t understand how chronic pain works. They are also ignoring the realities of the impact of race upon the practice of medicine.

Into the mix must surely be added the element of race. Prince was a black man. Strong racial disparities in how doctors and other medical staff respond to pain in the emergency room has been documented. For example, a recent study published in one of the most prestigious pediatrics journals studied the treatment of appendicitis, a condition that is often initially suspected after a “chandelier test.” In medical slang, if a doctor places her hand on the pain point in the lower abdomen affected by the pain of an inflamed appendix, the patient will try to jump up into the metaphoric chandelier on the ceiling above their head.

And yet, even here, black kids cannot get a break. 

 

“Our findings suggest that there are racial disparities in opioid administration to children with appendicitis,” wrote one of the lead researchers, Dr. Monika Goyal.

“Our findings suggest that although clinicians may recognize pain equally across racial groups, they may be reacting to the pain differently by treating black patients with nonopioid analgesia, such as ibuprofen and acetaminophen, while treating white patients with opioid analgesia for similar pain.”

Similar studies have documented that African Americans’ chest pain is less likely to be diagnosed correctly as a heart attack. Other studies have attempted to measure whether African Americans have a “lower pain threshold.” Similar studies about why women’s pain is not taken seriously in emergency rooms have also been produced.

Surgeries can fail to repair the issues that trigger intense pain. And they fail often.  In medical conditions in which pain has been long-standing, scientific evidence suggests that the brain’s pain receptors “short out.” After a while, regardless of even whether the painful part of the body has been removed — as in amputations — the brain’s pain receptors continue to process signals that the body is under attack. Phantom limbs can cause severe pain. It does not make the pain fake. It is the brain that feels pain. And the brain can continue to experience pain even after surgery has been performed.

And yet, despite the evidence that Prince was being given Percocet for documented pain, the media narrative has shifted to a story in which Prince died of an overdose. An overdose is a self-inflicted wound. It’s a moral judgment. That’s how we react to it. “He was such a talented actor. Why overdose?” Or, “She had such a powerful voice. But she was a demon for drugs.” That story allows us to distance ourselves, to see it as the fault of a weak personality, an “addictive” personality. It’s part of the mythos we create around talented folks. The idea that the truly gifted are also the ones in the worse psychological pain, and their psychological “weaknesses” make them ripe for drug addiction.

Prince is being pushed toward that precipice over which we have pushed Amy Winehouse, Whitney Houston, Philip Seymour Hoffman, Michael Jackson and every other artist who has died from drugs in the past century — especially those who succumbed to heroin. But heroin and pain medication are not the same thing. Undoubtedly, some will gain fame for their discussions of the “abuse” of pain medication.

Chronic pain management requires, in most cases, the taking of strong, often-opiate based medications. ANY patient who takes these drugs on a daily basis will become “physically dependent” in a short time. Physical dependence is not addiction. Diabetics are physically dependent on insulin, and yet we do not call insulin an addictive drug. Without it, diabetics would die. Stopping pain medication that has been used for chronic pain can kill you if it’s done abruptly. Under a doctor’s care, a change in pain medication is handled on a strict schedule in which the body is weaned off one drug in order to either start a new medication, or to determine whether the body is reacting in a different way to the condition causing the pain.

I am not Prince. And yet, I know chronic pain from the inside. And I know how it is treated by cynical doctors who suspect that everyone is just trying to score.

My own experiences in hospital emergency rooms have involved being willing to go through several treatment options before being given the IV opiate medication that I need when I have a cluster headache. Cluster headaches are nicknamed “suicide headaches” by doctors, for good reason. The pain of cluster headaches has caused me to hallucinate, to have trouble breathing, and, of course, to wish for death. And yet, in the midst of a cluster headache, or its cousin, migraine, I have been interrogated by emergency room physicians who want to get me to admit that I am faking my symptoms while on a “drug-seeking” mission.

Prior to moving to the state of Florida in January, I had spent 23 years living in New York state. For the past nine years, I have suffered with migraines and clusters. During that time, I have been hospitalized for more than 24-hours seven separate times. I have had every diagnostic test available that might reveal why my head hurts so much. I have tried nearly every prophylactic treatment available. I have changed my diet. I avoid “triggers” that may cause a headache. I exercise, try to eat right, and wear prescription eyeglasses to make certain that it’s not eyestrain that make my migraines feel as if someone has inserted a bottle opener under my orbital bone and is trying to pry it out.

In New York, after all other treatments had failed, I was prescribed opiates. Yet, when I moved to Florida—which in a moral panic about its reputation as a state where it was easy to score drugs—has passed laws that make it near impossible for a family doctor to prescribe strong pain medications. Instead, I had to wait nearly two months to get in to see a specialist—in my case, a neurologist, who prescribes what I need. Triptans, the most common and effective way to treat migraine pain, are also expensive. My insurance company limits my triptans so that I can only use one of my pills for every three headaches I experience. Opiates are cheap. Guess which one my insurance company prefers to pay for?

Before the media narrative of the tortured genius who abused drugs takes over the story, there needs to be a pushback. Chronic pain patients should step forward and speak of their own experiences of living with the condition, and the constant barriers that are being thrown up to treatment. The latest obsession with white kids using heroin is stigmatizing those with chronic pain.

Chronic pain kills. It killed Prince. It’s time to talk about it

Filed under: General Problems | 3 Comments »

Are some medicare part D (PDP) programs PLAYING GAMES ?

Posted on May 5, 2016 by Pharmaciststeve

robotwarningOur PDP (Prescription Drug Program) Silver Scripts … part of CVS Health … that we have used since Jan 1, 2006… IMO.. is starting to “play games” with how medications are classified in the various pricing “TIERS”.

Apparently with the 2016 formulary and tiers.. there was a lot of upward shifting of most generic medications in the pricing tiers.

Because Barb is on a lot of medications, the copays that I get hit with at the pharmacy counter can at times exceed $1000.00.  I have become jaded to the $$$ that exchange hands at the pharmacy counter. We are fortunate to be in the 8% of families where the disease and/or cost of treating the disease doesn’t have a adverse financial impact on our family.

To be honest, I have never really paid much attention to the EOM (Explanation of Benefits) that they send out monthly/quarterly. Until this year… I had put them aside and one day recently I started going thru them… before putting them in the shredder and noticed that about 75% of the meds for both of us… WE PAID A LOT and SILVER SCRIPTS PAID NOTHING on a lot of the Rxs that we had filled.

I starting going thru LINE BY LINE… and found one generic medication that we both take and Barb was charged $80 for a 90 days supply and I was charged $12 for a 90 days supply.. WTF  ??  Looking at it.. Barb was given TABLETS and I was given CAPSULES… same generic medication, same strength… I called up Silver Scripts and they told me that CAPSULES were CHEAPER than TABLETS…  WRONG !!! commercial production of capsules is a semi-automated process… tablets is a fully automated process…  Come to find out that the capsules are a TIER ONE drug (preferred generics) and the tablets are a TIER THREE (Brand name & non-preferred generics).   So someone who has trouble swallowing LARGE capsules would have to pay abt $300/yr more to get small swallowable tablets.

So I went to www.goodrx.com and checked retail prices.. and GUESS WHAT… capsules are abt 50% MORE EXPENSIVE than tablets..

I got a new Rx from my doc this week.. another generic… and a 30 days supply was $33… This medication is a combination of two existing generics… so back to Silver Scripts formulary.. and another generic that is in TIER 3… and they PAID NOTHING…

Digging a little deeper… each of the two medications in this medication… individually are TIER ONE … and if the doc had written TWO PRESCRIPTIONS… one for each.. my cost would have been $6 and back to www.goodrx.com .. I could have purchased the medication I paid a $33 copay for…. $10 retail/cash..

There is an estimate 4+ million Medicare folks enrolled in Silver Scripts..  making them the second or third largest Medicare Part D PDP.

Paying them a monthly premium gets us what… paying more than cash paying customers are paying for the same medication… paying up to SIX TIMES the price for the same medication depending if my doctor writes for tablets or capsules ?

Just this past week.. Silver Scripts parent company CVS HEALTH… reported a 20% INCREASE in revenue… for first quarter of 2016… I wonder where all those extra dollars came from… how about from the pockets of Medicare folks ?  Many who have trouble making ends meet and often have to decide between paying for food and medicine…

Other Medicare Part D PDP programs may be doing the same thing to others on Medicare… I don’t know… but if you have a Part D medicare program.. maybe it would be in your best interest to check out what you are paying and what  they are paying…  maybe some should call their Congressman..and suggest that there be an investigation of such tactics.

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The new “CANDID CAMERA” to catch drug diversion ?

Posted on May 5, 2016 by Pharmaciststeve

Does Patient Privacy Trump Hospital Security?

http://www.medpagetoday.com/HospitalBasedMedicine/RiskManagement/57723?xid=NL_breakingnews_2016-05-05&eun=g578717d0r

A San Diego Hospital’s hidden cameras may have captured too much information

by Cheryl Clark
Contributing Writer, MedPage Today

Surveillance cameras track people scurrying along urban sidewalks, driving on highways, and shopping in convenience stores, but what about hidden cameras in operating rooms? A San Diego area hospital is now grappling with that question and the unforeseen sequelae of its plan to “catch” the person or persons responsible for missing drugs.

In 2012 Sharp Grossmont Hospital, a sprawling healthcare facility located in La Mesa, a community east of San Diego, installed cameras inside computer monitors attached to anesthesia machines used in three operating rooms at the hospital’s Women’s Health Center. The goal, according to hospital officials, was to catch a thief. The result, court documents charge, was multiple violations of patients’ privacy.

An attorney representing a doctor who has been accused of taking the drugs from an anesthesia cart and putting them in his shirt pocket claims the hospital’s “shocking” and “secret” surveillance, which went on for nearly a year starting July 17, 2012, violated the privacy rights of hundreds of patients.

“Essentially, every patient who had surgery or had their baby delivered by C-section or had a tubal ligation during that time, from July 2012 to June of 2013, would have had their images taken at some point,” said Duane Admire, attorney for the accused physician, Adam Dorin, MD. Admire said he does not believe the patients consented to have their surgeries recorded on video.

Healthcare workers’ theft of drugs intended for patients has been an increasing problem nationally. Doctors and employees who steal drugs may be feeding their own addictions, potentially endangering patient care. The Centers for Disease Control and Prevention has made this a special focus.

Attorneys interviewed nationally said it’s unclear whether boilerplate consent forms that patients sign cover video surveillance as a component of monitoring quality of care. However, many said hospitals should make such activities clear, with special language in separate consents.

Medical Board

The controversy is playing out with the Medical Board of California, which last September filed an accusation against Dorin based in part on a 2013 letter from the hospital to the board. A hearing on the action against Dorin’s license to practice is scheduled for October before an administrative law judge.

Admire provided inewsource/MedPage Today with documents Sharp filed with the board, but which are not available on the board’s website. The documents detail the content of the videos.

According to those documents, the surveillance captured 6,966 video clips, some depicting “female patients in their most vulnerable state, under anesthesia, exposed, and undergoing medical procedures.”

One of the documents, a declaration by Carlisle “Ky” C. Lewis III, Sharp HealthCare’s senior vice president and general counsel, said the cameras “would capture images whenever someone entered the room.”

The documents offer details of the clips that implicate Dorin.

The video clips and their depiction of patients undergoing surgery are the centerpiece of the legal action between the hospital and Dorin. Admire has filed a subpoena with the medical board for all 6,966 clips, saying they will show Dorin subsequently taking the drugs out of his shirt pocket and using them on patients or replacing them in anesthesia carts.

Admire said they will also show other anesthesiologists doing the same thing to make sure they had the anesthetic propofol for a patient in an emergency. Additionally, Admire said that the yearlong surveillance operation showed his client removing “a total of 12 bottles of propofol.”

Dorin “has always maintained that he only took drugs out of the carts for proper patient care,” Admire said.

Sharp opposes releasing the video clips to Dorin and his legal team.

“I have explained the concern, that it would invade the most crucial privacy rights of Sharp HealthCare and SGH’s patients, often in their most vulnerable state, under anesthesia and exposed on the operating room table,” Lewis said in his declaration to the medical board. Lewis added that relinquishing the videos would also “invade the privacy rights of Sharp HealthCare and SGH’s other physicians and healthcare providers, employees, and other persons.”

Patient Privacy

It is unclear how many images of patients were captured in those clips because the cameras turned on when they detected motion in the room. Admire estimates that during the 12-month surveillance, some 14,000 to 15,000 video clips may have captured images that patients “have an expectation would be private.”

“That’s our shocking problem with it, that if you ever have a reasonable expectation of privacy, it’s when you’re with your doctor, and exposed,” Admire said.

He added that he’s convinced the hospital’s video surveillance broke the laws on privacy.

“It violates both the U.S. Constitution and the California Constitution, … and there’s no question that if you’re going to violate someone’s right to privacy, you should get their consent.”

Admire said he’s not asking for public release of the videos, only for access to them because he says they will prove his client used the drugs on patients or restored them to the carts.

The attorney said he hadn’t seen consent forms that patients signed before the videos were taken. “But I would be shocked if they were asked, if they were given proper legal consent. Who would do that? Why would they do that?”

Sharp HealthCare’s vice president for public relations, John Cihomsky, declined to say whether the patients were asked to give consent for their surgeries to be recorded, or explain what laws or regulations authorized the surveillance operation with the use of video cameras that captured patients’ images.

He provided a statement that acknowledged the surveillance operation and said, “Each video camera was ‘motion activated’ and situated in a manner so as to limit its view to the area in front of the anesthesia cart,” and that “when the investigation was complete, the video cameras were removed.”

He added, “While images of patients were occasionally recorded, the focus of the investigation was on times the operating rooms were not being used for patient care.

“Sharp has retained the video in a secured environment during the pendency of the disputes involving Dr. Dorin. Sharp will destroy all the video when those matters have been concluded. Sharp will continue to refuse to produce any video that contains images of patients or protected health information, just as we protect patient information in all other formats.”

The Big Picture

Privacy and drug abuse surveillance experts around the country had varied opinions about whether Sharp Grossmont’s use of video surveillance to catch someone removing medications was appropriate.

“I have two concerns,” said Kimberly New, a Knoxville-based attorney who specializes in preventing and detecting drug abuse and drug theft in healthcare settings.

“There are video voyeurism laws that prohibit such filming without consent,” New said, adding that Medicare’s requirements for hospitals to be reimbursed, called conditions of participation, “also prohibit such filming without explicit patient consent.”

“In my opinion, boilerplate language in a consent for admission would not satisfy either standard,” New said.

Keith Berge, MD, an anesthesiologist at the Mayo Clinic in Rochester, Minnesota, who has led efforts to detect drug theft among healthcare workers there and nationally, said Sharp should have made “every effort … to aim (the camera) in such a way that the activity can be monitored while keeping the likelihood of showing a patient to an absolute minimum. They made this harder than it needed to be by not attending to that detail.”

The hospital compromised patient privacy, said Julianne D’Angelo Fellmeth, an attorney specializing in physician licensing and discipline and administrative director for San Diego’s Center for Public Interest Law. But, she said, there are colliding interests at stake.

“You’re trying to go after the diversion of powerful and highly addictive narcotics from a hospital, which are only supposed to be used in an operating room and not any place else. I don’t know that’s the best way they should have done this, but it was probably, to them, a reliable way.”

Robert Gellman, an attorney and privacy consultant in Washington agreed that it’s a messy situation. But, he said, he has a hard time understanding “why it’s OK for the hospital to take these photographs, and use them against the doctor, but when the doctor turns around to say I need more photographs to show I’m innocent, all of a sudden this is some terrible invasion of privacy. It seems like the hospital is talking out of both sides of their mouth, and this is just a fight among lawyers.”

Dorin resigned from the hospital in October 2013, and now provides anesthesia services under contract at Palmdale Regional Medical Center, a private hospital outside of Los Angeles.

Last September, more than 2 years after Dorin was told he was seen on video taking propofol, the state board filed an accusation against him. The document notes he “was observed on camera on multiple occasions, entering one or more of the operating rooms … and removing items from the drug carts, including propofol, and placing the items into his shirt pocket.”

On April 4, during an interview with investigators, Dorin “denied taking propofol from anesthesia carts.” Later, “confronted with video evidence to the contrary, (Dorin) admitted removing items from the drug carts, including propofol and placing the items in his shirt pocket.”

Admire said his client denies the allegations.

He explained that propofol was at that time in short supply, and that the hospital has a vendetta against his client for calling attention to “lax control of drugs” at the Sharp Grossmont.

Admire said that two other anesthesiologists told hospital officials and a peer review committee that taking drugs from anesthesia carts was common practice.

Additionally, Admire said, Dorin initially thought investigators were asking him if he took the propofol out of the hospital. He said no, because he had not, Admire said.

In July 2014 , Dorin filed a lawsuit in San Diego Superior Court against the Medical Board of California objecting to its investigation and saying that it had no legal foundation. He claimed that the hospital had an “axe to grind” against him because of his whistle-blower activities against the hospital. One of those involved Dorin’s now-acknowledged leak that resulted in a 2008 San Diego Union-Tribune article in that revealed Sharp Grossmont Hospital was under investigation for a medical error that resulted in a prominent New York man’s death, and a resulting lawsuit.

“[Dorin] complained, and, as a result, was made a scapegoat — thus, the Sharp investigation,” the lawsuit said. Admire said that Dorin’s case against the medical board has been dismissed.

Cihomsky was asked how many surgeries or patients were captured by the video cameras, and why after Dorin was confronted in April he continued providing anesthesia services at Sharp Grossmont until October 2013.

Cihomsky responded, “since this is an active case, we believe our statement is sufficient at this time.”

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23,000 die annually from infections resistant to all antibiotics – a EPIDEMIC ?

Posted on May 5, 2016 by Pharmaciststeve

CDC: At least 30% of antibiotic scripts unnecessary

http://www.drugstorenews.com/article/cdc-least-0-antibiotic-scripts-unnecessary?tp=i-H55-Q5U-ba-L7hf-1v-164o-1c-9Yw-L5sV-1ZC9V2&utm_campaign=Daily&utm_source=Experian&utm_medium=email&cid=2330&mid=5034503

ATLANTA — The Centers for Disease Control and Prevention, according to new data published Tuesday in the Journal of the American Medical Association that at least 1-in-3 antibiotic prescriptions are unnecessary. The study looks at antibiotic use in doctors’ offices and emergency rooms nationwide, finding that some 47 million excess antibiotic prescriptions are written for viral respiratory conditions. 
 
“Antibiotics are lifesaving drugs, and if we continue down the road of inappropriate use we’ll lose the most powerful tool we have to fight life-threatening infections,” CDC director Dr. Tom Frieden. “Losing these antibiotics would undermine our ability to treat patients with deadly infections, cancer, provide organ transplants, and save victims of burns and trauma.”
 
The news comes as the National Action Plan for Combating Antibiotic-Resistant Bacteria (CARB) seeks to reduce the number of antibiotic prescriptions by 15% by 2020. Congress has allotted $160 million toward funding for the CDC to implement the CARB plan by accelerating outbreak detection and prevention state-by-state, supporting research to identify knowledge gaps and informing providers and the public about antibiotic resistance and appropriate use, among other initiatives. 
 
“Setting a national target to reduce unnecessary antibiotic use in outpatient settings is a critical first step to improve antibiotic use and protect patients,” said Lauri Hicks, director of the CDC’s Office of Antibiotic Stewardship. “We must continue to work together across the entire health care continuum to make sure that antibiotics are prescribed only when needed, and when an antibiotic is needed that the right antibiotic, dose, and duration are selected.”

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80 percent of first-time heroin users reported that they started with legal prescribed drugs — although many stole, bought or were given drugs that weren’t prescribed to them

Posted on May 5, 2016 by Pharmaciststeve

DEA agent: Public needs wake-up call on opioids

https://www.indianagazette.com/news/indiana-news/dea-agent-public-needs-wakeup-call-on-opioids,24154319/

ELDERTON — The real trouble with opioids is that people don’t recognize the trouble with opioids.

A federal investigator said Wednesday that there are few allies in the fight against the growing rate of addiction to heroin and painkilling drugs in America.

“It’s someone else’s problem,” is what people think.

David Battiste, of the U.S. Drug Enforcement Administration, had a like-minded audience of about 100 at the monthly meeting of the Armstrong-Indiana Drug Free Communities Coalition held Wednesday at Towne Hall. The coalition brought together law enforcement, justice system, emergency services, mental health, medical, education and media representatives from the region.

Battiste, the assistant special agent in charge at DEA’s Pittsburgh District Office, spelled out goals of the “360 Strategy” program to combat prescription drug abuse, heroin trafficking and related violent crime.

Pittsburgh is one of four cities chosen in November to pilot the program.

360 Strategy aims to fast-track drug investigations, capitalize on local officials’ work and bring services to communities where agents put a dent in drug trade, Battiste said.

And Battiste pledged that the government would bring the fight to every one of the 25 counties served by the Pittsburgh office.

The fight might be easier if people understood its scope, he said.

The U.S. has 5 percent of the world’s population but Americans use 99 percent of the world’s opioids.

He said 80 percent of first-time heroin users reported that they started with legal prescribed drugs — although many stole, bought or were given drugs that weren’t prescribed to them. And recreational use wasn’t what many users originally had in mind.

“Many start not realizing the effect” and how easily addictions start, Battiste said. For example: Athletes who use painkillers to get over injuries.

“Most of us just can’t imagine how taking a pill leads to putting a needle in our arm,” Battiste said.

The Pittsburgh region recorded 743 deaths from opioid overdoses in 2014, and the 2015 figures, not final, should be in the same range. And he believes the numbers also are under-reported, “so it is more catastrophic than that,” Battiste said.

“If it was anything else — Ebola, anthrax, airplane crashes — if it were anything else causing that many deaths every year, we would have the National Guard out here and we would have a lot of assistance from everyone,” Battiste said. “But since it’s heroin … and the old stigma of putting it in the closet and saying it’s someone else’s problem, that is why this is an epidemic.

“We have to educate, we have to get it out there. And because there’s a legal feeder system causing this problem, we can’t turn out backs on it and we can’t wait until another 1,000 folks get addicted and go through the process.”

Battiste said 360 Strategy has led to intensive investigations into a recent wave of deaths of people who, perhaps unknowingly, used heroin laced with fentanyl.

“It produces the same effect but it is many times stronger and it kills. That compounds the problem,” Battiste said. “We can’t allow folks to sell that stuff to continue to sell with impunity.

“We will continue to arrest, and find and trace the heroin back to its source, because the DEA’s mission is to arrest the biggest and baddest dealers domestically and globally. That’s what we do. But we cannot turn our back on the local communities that we serve. That’s why we’re here.”

360 Strategy, Battiste said, shortens investigations from months to weeks. “We do this so two or three deaths doesn’t become 15 to 20 deaths,” Battiste said.

Indiana County District Attorney Patrick Dougherty said DEA joined the investigation of a series of heroin deaths in late March in Indiana County. The deaths were tied by the discovery of heroin packages with similar markings, investigators said.

“Within one week, an arrest was made,” Dougherty said. “That’s because of our positive relationship with the DEA. We are getting our share (of the federal resources). Indiana is not forgotten.”

Battiste said 360 Strategy works on the root of painkiller abuse by studying doctors, medical clinics and pharmacies’ records and weeding out those who are enabling and feeding addictions.

“Most doctors and pharmacists are law-abiding citizens, but there are some exceptions,” Battiste said. DEA begins by pressuring suspected providers to voluntarily surrender their registrations.

He said DEA has helped organize and promote prescription drug take-back programs in communities, where people have brought in 12,500 pounds of unwanted medications.

Battiste said 360 Strategy also works to bring together local communities services following DEA enforcement actions.

“We call it a roundup. We go into a community, we buy heroin from a lot of folks, and we arrest all of those people. Then we try to come back with ‘wraparound services,’” Battiste said. “When we arrest all those dealers and take them off the street, we understand there’s a user problem that will be looking for a fix or to get drugs to sustain their habit.

“For us, that’s an opportunity. We want to get the word out for the local services and partner with them … to let folks know where they can get help. It’s a good time to do that and help the addict community.”

A program participant questioned whether DEA would monitor low-level dealers to find higher-level suppliers.

Not when heroin with fentanyl is in circulation, Battiste said.

“We can’t sit back and let this guy sell,” he said. “If this guy has fentanyl, it’s all over. We won’t let people die to further an investigation.”

The Drug Free Communities Coalition is a project of the Armstrong-Indiana-Clarion Drug and Alcohol Commission. The group meets monthly to update partner members on local initiatives and to promote training and education programs.

Organizers of the Reality Tour in Blairsville reported that the program, which simulates the effects of drug abuse on users and their families, drew 34 participants in 2014-15 but attracted 296 so far in 2015-16. The program has added a presentation on Wednesday to its announced schedule.

The coalition also heard reports on local medication take-back programs, a contest that awarded prizes to area school students for writing radio public-service announcements, and met to reorganize an Overdose Task Force panel.

In addition to Battiste’s presentation on the DEA’s work, the coalition also welcomed faculty and student participants in the “Remembering Adam” substance abuse prevention program at Blairsville High School and Blairsville Middle School.

“Remembering Adam” was founded in Cambria County by the parents of an 18-year-old college student from Carrolltown who died of a heroin overdose in 1998. The family’s foundation aims to bring awareness of drug abuse in rural communities and supports school groups to promote healthy decisions and behaviors by students.

Students told coalition members that the program helps them withstand peer pressure and find alternatives that reduce their interest in tobacco, alcohol and drugs.

Middle school teacher Stacy Faulk said 54 percent of the high school student body and 86 percent of middle school students have signed up for Remembering Adam.

The program uses grants from the Drug and Alcohol Commission and the Pennsylvania Office of Attorney General and donations from community supporters — such as WyoTech, the VFW and American Legion — to organize activities and provide incentives for students who successfully maintain a drug free lifestyle.

Students taking part in the program agree to undergo random drug testing.

Blairsville 11th-grader Austin Rodkey, whose family relocated to Indiana County from West Virginia two years ago, said Blairsville High School has a dramatically different atmosphere.

“At the other school, there was a lot of drugs going on. They didn’t have a program like this,” Rodkey said. “When I came here, it was cool to be drug free. It used to be cool to do drugs but here you’re getting rewarded for being drug free.

“It’s really easy for me to say no. In this group, it’s easy. I feel this program should be offered in every school.”

Rodkey said “Remembering Adam” has high participation by younger students but said it’s more important for older students to take part because they are more likely to face choices.

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12 Recommendations the CDC Should Have Made

Posted on May 5, 2016 by Pharmaciststeve

image12 Recommendations the CDC Should Have Made

http://www.painmedicinenews.com/Commentary/Article/05-16/12-Recommendations-the-CDC-Should-Have-Made/36074/ses=ogst.

Opioids as a treatment for chronic pain have exposed the holes in our country’s health care system in an unparalleled fashion. Now, a new guideline issued by the Centers for Disease Control and Prevention (CDC) discourages the use of opioids in treating chronic pain, excluding cancer and end-of-life care (MMWR Recomm Rep 2016;65:1-49). The CDC touts 12 recommendations targeted to primary care providers, including risk assessment, improved monitoring, avoidance of benzodiazepine–opioid combinations and choice of short- over long-acting formulations for acute pain.

Professional pain organizations have advocated for similar recommendations (Pain Med 2013;14:959-961), although it has often been like speaking to the deaf in a dark room. One major party that must open its ears is the payor community, which routinely fails to cover many safer and more effective therapies recommended by the CDC, as detailed in a 2014 position paper published by the American Academy of Pain Medicine (AAPM). Instead, the insurance system has forced a simple solution, reinforcing cookie-cutter, minimally monitored, drug-only therapy for complex medical and psychological problems in a highly diverse population.

Unfortunately, the CDC guidelines fail to challenge payors’ interests, choosing instead to push for opioid supply reduction measures that include dosing limits without regard for the necessity of individualized therapy and with very little consideration of the needs of people in pain. These needs have been urgently set forth and thoughtfully analyzed in the National Pain Strategy, which proposes a population-based approach to meeting the comprehensive, complicated care needs of people with chronic pain.

However, public statements that accompanied the release of the CDC guideline instead embraced reductionist—even superficial—views. In an interview with the Los Angeles Times, CDC Director Tom Frieden, MD, MPH, said the current opioid crisis is “doctor driven.” This partial truth is dangerous when presented so simplistically and without examination and discussion of true root causes. As far back as 2005, when the Salt Lake Tribune published a story with the headline “Fatalities Linked to Pain Pills on the Rise,” I knew that if indeed the medical profession unknowingly was contributing to the incidence of opioid overdoses, it was incumbent on the medical profession to take the lead to correct the problem. I feared that if the “epidemic” described by the newspaper was not reversed, the public would demand legal and legislative efforts to correct the problem. That fear has been realized.

Now, the CDC and others are using shortcuts and formulaic approaches that will cause people in pain more suffering. To truly reduce abuse, misuse, addiction and overdose risk from prescription opioids, clinical recommendations should acknowledge the complex challenges presented by current payor coverage, clinical reality and legislative/regulatory policy. Research into root causes of the opioid crisis indicates change can happen without worsening the lives of people with chronic pain, and payors absolutely must be part of the solution.

The following are 12 additional recommendations with a stronger evidence base than most of the CDC guidelines, and that would be far more likely to reverse the harm from opioids while not creating more suffering for people in pain. In Utah, a multipronged, state-funded program that included provider education (Pain Med 2011;12:S73-S76) with elements from the eight principles mentioned below was followed by a 28% reduction in the number of unintentional, opioid-related drug overdose deaths from 2007 to 2010, as reported by the Utah Department of Health:

  1. Apply the “Eight Principles for Safer Opioid Prescribing” endorsed by the AAPM (Pain Med 2013;14:959-961).
  2. Use abuse-deterrent formulations when an extended-release opioid is indicated.
  3. Remove the cap on the number of opioid-addicted people who can be treated for addiction with medications such as buprenorphine.
  4. Allow nurse practitioners to prescribe medication agonist therapy for opioid addiction.
  5. Recommend affordable, perhaps free, access to buprenorphine and methadone therapy in line with public policy that recognizes addiction as a disease.
  6. Push U.S. and state legislatures to issue mandates to payors demanding a minimum level of benefits for patients in pain to increase coverage for evidence-based alternatives to opioids.
  7. Remove methadone as a preferred opioid for pain from state formularies.
  8. Ask that payors require prescribers to demonstrate methadone-specific knowledge before being allowed to prescribe methadone for chronic pain.
  9. Encourage the U.S. Congress to increase funding to find safer and more-effective alternatives to opioids for the treatment of acute and chronic pain.
  10. Recommend legislation for partial prescription filling for Schedule II controlled substances to reduce the quantity of unused prescription drugs.
  11. Implement the National Pain Strategy as a top priority.
  12. Consider prescribing naloxone with all extended-release opioid prescriptions.

Lynn R. Webster, MD, is a past president of the American Academy of Pain Medicine and author of “The Painful Truth: What Pain Is Really Like and Why It Matters to Each of Us.” Dr. Webster also is a member of the Pain Medicine News editorial advisory board. Visit him online at ThePainfulTruthBook.com. He lives in Salt Lake City.

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opioid prescribing seems to be plateauing or even decreasing based on the data from 2011 to 2013.5

Posted on May 5, 2016 by Pharmaciststeve

stevemailboxFrom Pharmacists Letter
Looking at global morphine consumption from 2013, the largest consumer is Austria (203 mg per capita), followed by Canada (98 mg per capita), Denmark (86 mg per capita), and then the United States (80 mg per capita).3 In Canada, the 2012 Canadian Alcohol and Drug Use Monitoring Survey (CADUMS) reported that about 410,000 Canadians admitted abusing psychoactive pharmaceuticals in the past year, which has almost doubled in number from 2011. Opioids were the most commonly abused, with one in six Canadians reporting use in the previous year and 5% of them admitting to abuse.4
The good news is that opioid prescribing seems to be plateauing or even decreasing based on the data from 2011 to 2013.5

3. Pain and Policy Studies Group: Improving global pain relief by achieving balanced access to opioids worldwide. University of Wisconsin-Madison. http://www.painpolicy.wisc.edu/global (Accessed January 23, 2016).
4. Health Canada. Canadian Alcohol and Drug Use Monitoring Survey. April 8, 2014. http://www.hc-sc.gc.ca/hc-ps/drugs-drogues/stat/_2012/summary-sommaire-eng.php. (Accessed January 23, 2016).
5. Dart RC, Surratt HL, Cicero TJ, et al. Trends in opioid analgesic abuse and mortality in the United States. N Engl J Med 2015;372:241-8.

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