PHARMACIST STEVE

www.edsinfo.wordpress.com/2018/05/15/the-lethal-success-of-pain-pill-restrictions/

In a speech on Monday, Attorney General Jeff Sessions said the Justice Department is striving to “bring down” both “opioid prescriptions” and “overdose deaths.”

A study published the following day suggests those two goals may be at odds with each other, highlighting the potentially perverse consequences of trying to stop people from getting the drugs they want.  

Columbia University epidemiologist David Fink and his colleagues systematically reviewed research on the impact of prescription drug monitoring programs (PDMPs), which all 50 states have established in an effort to prevent nonmedical use of opioid analgesics and other psychoactive pharmaceuticals

The review covers 17 studies, 10 of which looked at the relationship between PDMPs and deaths involving narcotic pain relievers. Three studies “reported a decrease,” six “reported no change,” and one “reported an increase in overdose deaths.”

The picture looks worse when you take into account deaths involving illegally produced drugs, which now account for a large majority of opioid-related fatalities. Fink et al. found six studies that included heroin overdoses, half of which reported a statistically significant association between adoption of PDMPs and increases in such incidents.

Restricting access to pain pills also seems to be increasing the percentage of opioid users who begin with heroin. A 2015 survey of people entering treatment for opioid use disorder found 33 percent had started with heroin, up from 9 percent in 2005.

If the aim is preventing drug-related deaths, this shift is counterproductive, to say the least. Because their purity and potency are inconsistent and unpredictable, illegally produced opioids are much more dangerous than pain pills.

Comparing deaths counted by the federal government to its estimates of users suggests that heroin is more than 10 times as lethal as prescription opioids.

Policies that drive people toward more dangerous drugs help explain why deaths involving heroin and illicit fentanyl have skyrocketed in recent years, even as opioid prescriptions have declined.

That trend includes a 252 percent increase in heroin-related deaths and an astonishing 628 percent increase in deaths involving the opioid category that consists mainly of fentanyl and its analogues.

Final CDC figures for 2017 are not available yet, but the provisional numbers indicate there will be more increases.

In addition to magnifying the risks that nonmedical users face, the crackdown on pain pills is hurting patients.

Many people who have successfully used opioids to treat severe chronic pain for years now find it difficult or impossible to obtain the medication they need to maintain a decent quality of life.

The article below is of the same tone: ridiculing a government immune to facts, which persistently prosecutes a non-problem (use of pain medication) to solve a problem (addiction).

New Research Reinforces Earlier Studies Suggesting PDMPs Are Adding to Opioid Overdose Rate – May 9, 2018 – By Jeffrey A. Singer

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http://www.centralillinoisproud.com/news/local-news/special-report-the-other-side-of-the-opioid-epidemic/1164359700

We often hear about the opioid epidemic from the perspective of those who are addicted But what about the other side of the coin, people who use prescription opioids as a means of treating chronic pain?

Jennifer Bowersock lives her life day to day.

“I am never out of pain, I am in pain from the second I wake up to the second I fall asleep.” Bowersock explains.

Open heart surgery put her on a painful road to recovery.

“Some days I’m good, I can get out of bed, function normally. Then, other days it’s very depressing, you just can’t move, I can’t get out of bed.” Bowersock says.

She takes prescription opioids to take the edge off and help her sleep. Three years later, she can’t imagine life without them.

“I probably wouldn’t be able to function at all.”

For Shari Burdick it was a diagnosis with Degenerative Disc Disease 10 years ago. Debilitating pain put her out of her longtime job in the school cafeteria.

“I have a new normal, it’s not the normal I used to have.” Burdick says.

Physical therapy and injections didn’t help with the crippling pain. Prescription opioids help her do more of the things she loves, like cooking and spending time with her grandkids.

Shari has been on her medication for 5 years and in that time, has seen changes with every trip to the pharmacy.

“You don’t get as much in one prescription as you used to, they cut it back. You can’t get it early, I mean if you pick up your prescription on a certain day it’s exactly a month later that you can get it. Not a day sooner. They’re very strict with it.” Burdick explains.

If anyone understands why new guidelines are being put in place to limit the supply of opioids available, it’s Burdick.

“My younger brother died from an overdose of opioids so yes I can see both sides of it.” Burdick says.

“Most people don’t realize the other side of the coin, that legitimate pain patients are getting caught up in the hysteria over the opioids.” Pharmacist, Mike Minesinger, says.

Minesinger is owner and pharmacist at Alwan Pharmacy. He says if prescriptions are going to be cut back, it needs to be done gradually and humanely.

“I’m just seeing reports of people who are being suddenly taken off of them. You know, their suicide rate goes up or you know, alternatively, they switch to street drugs because they can’t get the prescription anymore.” Minesinger explains.

Dr. Dennis McManus is Director of the Central Illinois Pain Clinic. When it comes to prescribing to his patients at the clinic, he takes a tough stance, telling them it’s the medicine contributing to their pain.

“We’re having a lot of people dying, more people than died in the Vietnam War, more people dying than the height of the AIDS epidemic, people are dying and the question is what’s going on? My stand point is there’s just no good evidence for the use of chronic opioids in chronic pain.” Dr. McManus explains.

Dr. McManus says the evidence shows long-term opioid use actually increases our sensitivity to pain.

“The best way to avoid the problem is not to create the problem in the first place.”

The Centers for Disease Control published a guideline for prescribing opioids for chronic pain in 2017. In it, the CDC says clinicians should prescribe the lowest effective dosage and should prescribe no greater quantity than for the expected duration of pain severe enough to require it. The CDC goes on to say 3 days of less will often be sufficient, more than 7 days is rarely needed.

If the benefits don’t outweigh the harms, the CDC recommends physicians try other therapies and work with patients to taper opioids to lower dosages or discontinuation.

Still, for patients like Bowersock and Burdick, they wish they didn’t need the treatment they call life-changing.

“Try living a day in our life to take them and somebody that doesn’t need them, you’re making it that much harder for the people that actually do need them.” Bowersock says.

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https://www.medpagetoday.com/resource-centers/contemporary-fibromyalgia-approaches/fibromyalgia-brain-signature/884

Fibromyalgia currently lacks a clear-cut, objective method to confirm its diagnosis, complicating clinicians’ jobs and frustrating patients. However, researchers may be getting much closer to identifying neurophysiological markers that are diagnostic of fibromyalgia.

Patients with fibromyalgia experience widespread pain, altered cognition, fatigue, and sleep dysfunction. On top of these burdensome symptoms, it often takes several years, several doctors, a few misdiagnoses, and numerous tests before a diagnosis of fibromyalgia is confirmed. What’s worse, these patients might have to fight an uphill battle to convince clinicians, family, friends, and coworkers that their condition is a “real” one.

To provide an objective diagnostic marker for fibromyalgia, researchers recently used a multisensory approach to identify a brain signature that distinguishes individuals with fibromyalgia from individuals without it.

^The other 35 were healthy controls matched for age, education status, and handedness (all were right-handed).^\

Participants were exposed to visual and auditory stimulation and were asked to perform a finger opposition task.

A functional magnetic resonance imaging (fMRI) based neurologic pain signature (NPS) (previously validated to predict experimental pain and discriminate it from other unpleasant/arousing emotional experiences) was applied to the subjects during pain processing.

In addition, researchers discriminated patients with fibromyalgia from healthy controls using activation patterns during painful pressure (FM-pain) and during nonpainful multisensory stimulation.

Patients with fibromyalgia experienced greater NPS than healthy participants when exposed to the same painful stimuli. Furthermore, when pattern response values were combined for the NPS, FM pain, and multisensory patterns using logistic regression, this combined classifier was able to discriminate patients from healthy participants with 92% sensitivity (confidence interval [CI], 84% – 98%) and 94% specificity (CI, 87% – 100%).

Tor Wager, PhD, director of the cognitive and affective neuroscience laboratory and professor in the department of psychology and neuroscience and the Institute for Cognitive Science at the University of Colorado, Boulder, and author of the study, said, “Abnormal responses to multisensory events was the strongest individual predictor of whether a person had fibromyalgia. This suggests it is a systemic, rather than pain specific, neurological disorder.”

The identification of a fibromyalgia-specific brain signature has the potential to launch the medical community far ahead of the past notion that the condition was in patients’ heads. According to Daniel G. Arkfeld, MD, associate professor of clinical medicine at the Keck School of Medicine of the University of Southern California (USC), and director of rheumatological education at the Keck Hospital of USC, “It is an old idea that fibromyalgia is a made-up disorder and doesn’t exist. Results of studies such as this, as well as others that have shown high levels of substance P [a pain-promoting or algesic neurotransmitter] in the spinal fluid of patients within fibromyalgia,

^Show that there is a neuropathophysiologic basis for the unique syndrome of fibromyalgia.”

The use of such a brain signature has implications beyond improving fibromyalgia diagnosis. “There is a need for objective measures in fibromyalgia. This research may help point toward appropriate targets for a more directed approach in treating fibromyalgia,” said Dr. Arkfeld. Dr. Wager concurred, “We need to diagnose patients and group them based on the underlying neuropathology. Then we have a better chance of finding the best treatments based on an individual’s biology.”

In other words, the use of fMRI technology to observe brain patterns in real time when patients with fibromyalgia are experiencing pain and multisensory stimulation may allow patients to be diagnosed using objective measures, and may also lead to advances in fibromyalgia treatment due to the enhanced understanding of the disorder it affords. There may come a time in the not-so-distant future when fibromyalgia enters its own era of targeted medicine, with therapies tailored to individual disease characteristics such as those included in the brain signature.

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www.fibrowomen.com/fda-warns-about-dangers-of-epidural-steroid-injections-for-back-pain/

The Food and Drug Administration has just issued what’s called a “Medwatch Alert” warning that Epidural steroid injections or “ESIs” for back and neck pain can be extremely dangerous.

The alert says: “Injection of corticosteroids into the epidural space of the spine may result in rare but serious adverse events, including loss of vision, stroke, paralysis, and death.”

Epidural steroid injections – and catastrophic injuries from them – were the subject of my debut investigation for The Dr. Oz Show almost exactly a year ago. (You can watch the video here and read the web article here.) The epidural space is an area between the spinal cord and the bony structure of the spine.

Our investigation revealed that the steroids – called corticosteroids – used for epidural injections are not even FDA approved for this purpose and yet ESIs are done nearly 9 million times a year, according to an analysis by Dr. Laxmaiah Manchikanti.

In addition to informing the public via its Medwatch Alert, the FDA said, “We are requiring the addition of a Warning to the drug labels of injectable corticosteroids to describe these risks.”  Injectable corticosteroids include methylprednisolone, hydrocortisone, triamcinolone, betamethasone, and dexamethasone.

The new warning will be a more prominent reminder to doctors that injecting steroids into the epidural space, just outside the spinal cord, has risks. But the warning failed to list all of the possible adverse reactions. Those reactions are named in the fine print of current drug labels, and include: “arachnoiditis, bowel/bladder dysfunction, headache, meningitis, parapareisis/paraplegia, seizures, sensory disturbances.”

In 2009, the FDA convened a group to study the safety of some types of epidural steroid injections. In its new notice, the FDA said that group’s recommendations still are not ready and will be released when they are.

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Dennis Capolongo of the EDNC, a group that has been campaigning against epidural steroid injections for years, called the FDA’s new warning “bitter sweet” because it did not go further.  Capolongo wants the FDA to go beyond telling doctors that injecting steroids into the epidural space COULD have severe side effects and instead state that they MUST NOT do it.

In February of this year, Australian and New Zealand health authorities came out with exactly that stronger language, stating that steroids like this, “MUST NOT be used by the intrathecal, epidural, intravenous or any other unspecified routes.” The South African government issued similar warnings, according to Capolongo.

Since the FDA is still actively studying these procedures, it will be interesting to see if the agency takes any further steps. If and when it does, you can bet I’ll pass the information along.

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Hi Steve, just wanted to let you know that it happened to me now too – got a letter from my dr and he is stopping prescribing any opiates here in Ohio. Here’s what the letter he sent me reads: As your ongoing primary care provider I deeply value your trust and reliance on me. Being a dedicated professional, I am committed to delivering excellent care to my patients. As you may be aware, the opioid crisis is significantly impacting our community. The Ohio State Medical Board and Ohio Board of Pharmacy have recently issued additional rules regarding controlled medication prescribing, aimed to enhance patient safety and reduce the risk of unintentional overdose and death. Accordingly, UH(University Hospital) is taking a strict stand with regard to patient safety and the usage of controlled medications, including pain medications and anxiety medications (e.g. opioids and benzodiazepines).(Note I do not take any anxiety meds) Given the importance of optimal symptom management, along with challenges in complying with the new regulatory requirements, I will no longer be prescribing controlled medications. As a result, I would like to refer you to a provider who specializes in the treatment of your symptoms, and can reevaluate and potentially establish a new plan of care. Since I would like to discuss specific referrals with you, please call the office to make an appointment at your earliest convenience. I look forward to continuing as your primary care physician for all of your general medical needs, and I look forward to seeing you soon.

I think you are probably right – however my dr has been being pressured by DEA for almost 2 years now – he wasn’t keeping records as good as he should have been initially and got that squared away but they kept coming back – he’s 3 years away from retirement and now Ohio just instituted new laws making it even more restrictive so knowing all of this I honestly can’t blame my doc for making this change so he can finish out his last couple years and then retire. But sadly 2 months ago he told me he wasn’t going to leave me high and dry but now he’s gone back on his word. I don’t have the money to be a test patient with laws though I am disabled and could file against the laws Ohio is setting up.

Sure sounds like to me that this is another hospital/corporation that has decided to CYA themselves and mandate all their employee/prescribers to stop prescribing all controlled substances.  To me.. that sounds like practicing medicine without a license and since the vast majority of pts taking controlled substances are dealing with a protect class under the Americans with Disability Act.  One would suspect that the hospital/corporation has “deep pockets” and I suspect that there are other state/fed laws that are being violating and who knows if the laws/regulations that Gov Kasich and the bureaucrats have enacted are actually constitutional ?

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https://www.painnewsnetwork.org/stories/2018/5/7/breakthrough-blood-test-shows-the-color-of-pain#

Hutchinson and his colleagues discovered molecular changes in the immune cells of chronic pain patients. These pain biomarkers can be instantly identified through hyperspectral imaging, giving doctors the ability to measure a patient’s pain tolerance and sensitivity.

The test could potentially provide physicians with the first biology-based test to measure pain as the “5th vital sign” and to justify prescribing pain medication or other therapies.

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http://sacramento.cbslocal.com/2018/05/15/pills-prescriptions-kill-us/

DALLAS (KTVT) – The investigative team at KTVT-TV has learned there are more than 2.3 million prescription drug dispensing errors made every year in pharmacies across the United States.

About 100,000 patients die every year because of a pharmaceutical mistake according to reports published by the National Center for Biotechnology Information.

PHARMACY DISPENSING ERRORS

Lake Towakoni resident Linda Lilley thought she was taking her pain medication Gabapentin, but she says her bottle contained Gemfibrozil- a cholesterol medication which looked very similar to Gabapentin.

The bottle had a correct manufacturer label but she says the pharmacist put the wrong label on it.

She got so sick she says she eventually could not move. She needed help doing day-to-day chores.

“I felt nauseated,” she said. “By the third day, I was debilitated.”

The pills looked so similar that Lilley did not suspect anything was wrong. Finally, one morning, she looked at the bottle closely and discovered the mistake. She immediately stopped taking the medication; however, by that time, she had taken the wrong drug for 12 days, three times a day.

EFFECTS OF MEDICATION MISTAKES

Since 2016, KTVT learned the State of Texas has disciplined nearly 200 pharmacists for making errors. The documents obtained by KTVT show some striking examples of dispensing mistakes.

A wrong dose of medication sent a 3-month-old to ICU for five days. The infant was given 100 times the prescribed amount.

Another example indicated a wrong strength of a drug rushed a 7-year-old to the ER with heart problems.

A wrong drug left another patient with an increased risk of cancer.

A patient was prescribed “cyclosporine” but instead, the pharmacist filled “Cyclophosphamide.”

WHAT IS GOING ON?

The similarity in names is one of the biggest causes for confusion, experts told KTVT.

Dr. Marv Shepard, the former Chairman of the Pharmacy Administration Division of the College of Pharmacy at the University of Texas in Austin, says errors typically occur because pharmacists are overworked.

“They’re having trouble because of the pressures of the environment,” he told KTVT. Dr. Shepherd says the stress of staying open 24 hours can be overwhelming.

He says the typical pharmacy stocks up to 5,000 drugs, dispenses 300 prescriptions daily and makes two to four mistakes every day.

Dr. Shepard believes it results in about 100,000 deaths in the U.S. “It’s huge, it’s a big problem,” he added.

He says the two most common drugs involved in dispensing errors are insulin and anti-coagulants. And most of these occur in just about every well-known pharmacy you can think of. KTVT reached out to some of the pharmacies listed in disciplinary actions by the State of Texas.

CVS PHARMACY STATEMENT

The health and well-being of our patients is our number one priority and we have comprehensive policies and procedures in place to ensure prescription safety.  We regularly seek out new technology and innovations to improve our systems, we engage with industry experts for independent evaluations of our dispensing procedures, and we are committed to continually improving our processes to help ensure that prescriptions are dispensed safely and accurately.  Prescription errors are a very rare occurrence, but if one does happen, we do everything we can to learn from it in order to continuously improve quality and patient safety. 

WALGREENS PHARMACY STATEMENT

The quality and safety of our pharmacy services is the top priority for Walgreens, and we take any prescription error very seriously. That’s one reason we have a multi-step prescription filling process with numerous safety checks in the process to minimize the chance of human error. We also encourage patients to check with our pharmacists or their health care providers if they have a question or concern about their medications. Together, we can help ensure our patients get the best care.

WALMART STATEMENT

We work hard every day to ensure we live up to the high standards we set for ourselves and that our customers expect. We have quality control measures in place to help ensure that any medications we provide our customers are the medications prescribed.

Despite the stacks of disciplinary actions KTVT received from the state, Dr. Shepherd says most errors are never reported.

MANUFACTURER’S MISTAKE

KTVT learned it is not just pharmacies making mistakes. While it is rare, drug manufacturers have also put the wrong medicine in a sealed bottle and then sent the bottle to pharmacies.

That is exactly what happened to Karin Bollinger.

For 30 days, Bollinger, a Dallas resident, thought she was taking Clopidogrel, her prescribed blood thinner. But instead, the bottle contained Simvastatin, a cholesterol drug. She too suffered serious side effects.

”I had lost about 17 pounds in 12 days,” she said. “I had a horrible rash, blisters, and ulcerations across my chest.”

Bollinger eventually received a recall letter from the maker warning her about the mix-up in the manufacturing process, but that was months later.

“The drug mistake had been made,” Bollinger said.

The KTVT asked the manufacturer, International Labs, to respond to the error but it did not want to comment on the case.

READ FDA RECALL LETTER HERE

WHAT IS BEING DONE

Experts say the industry is cracking down on errors at the manufacturer and pharmacy level. The FDA has created a commission to change the names of similar sounding drugs. Electronic prescriptions have helped with handwriting mishaps. In addition, barcode technology has also helped lower dispensing errors.

bad handwriting prescription

Both Bollinger and Lilley say their experiences have taught them to always double check their prescriptions.

“We all need to be aware of it. Look at your medications,” Lilley said. That is the only way to stay safe she added.

“This has taught me to check every one of my medications,” Bollinger said.

WHAT CAN YOU DO?

When you leave the pharmacy and tear the insert off of the bag containing your medicine, make sure you check the description of the drug on the insert and compare it to what is in the bottle.

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