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Down The Rabbit Hole
Posted on August 11, 2018 by Pharmaciststeve
Down The Rabbit Hole
By: Suzanne Stewart
(8-11-18)
I want to inform the pain community about my situation because this is happening to many chronic pain patients. I’ve been a voice in the pain community and now I too, am going “down the rabbit hole”! Before I become possibly incapacitated; I want you to know what is happening. For those who believe that we should “get beyond the pill bottle”; I say, unless or until you are in my shoes and live with my experiences, stop saying silly things like “pain acceptance”, will help. It cannot help all of my pain conditions combined. Stop acting like you are better, mightier or stronger than me because you might feel better from “grounding” (which is in essence, touching the earth with your feet, being “one with the ground/nature”, to make your pain lessen or disappear). The bottom of my feet are covered with open sores due to the stage of CRPS that I live with. This has become insane, while there are individual cases in which opioids are the preferred treatment and they do continue to reduce our pain.
*A bit of history if you want it: I won’t start at the very beginning because that would be much too long. I will tell you that I’ve been on SSDI since 1999 and initially for PTSD (*they said that I was the “worst case of childhood trauma/abuse they’d seen in 36 years) and kidney failure. Then I was hit by a car that ran through a red light. One minute my husband & I were sipping lemonade at an art fair. The next minute, (as we travelled through a green light to have dinner afterwards) he was really bruised & shaken and I was unconscious & strapped to a back board, on route to the hospital. That experience is a story for another day. The entire auto insurance bullying and fear mongering was another traumatic debacle. These experiences have continued, one after another; which brings me to today and this article.
After our accident in 2002 and upon being discharged from the hospital; I was sent to doctor after doctor. I was also sent to TBI rehabilitation, PT/OT and also to Tri-County pain clinic in MI. I was totally new at all of this & it was my first experience with this type of physical pain. Although, I have had 2 C-sections and I’ve lived through childhood, ex-spousal & other abuse throughout my entire life. At the pain clinic, I received various epidural nerve blocks, trigger point, cortisone and other injections. I also saw a Pain Psychologist, did Biofeedback and did many other types of therapies. The Pain Psychologist wrote in his report, by the way, that I “do not fit the profile for an addictive personality.” He attached me to an EMG type of machine where he can “see” your pain spiking via a red line going upward. Mine went off the charts. This was prior to my diagnosis’ of: systemic CRPS, EDS-4/vascular (aka Polyneuropathy in Collagen Vascular Disease), R.A., Dysatuonomia/POTs, Gastroparesis, S.I.B.O., Chiari and more. At that time though, I was diagnosed after the auto accident with: many physical injuries and a TBI. I went through 8 surgeries, 2 screws in my left shoulder, metal in my jaw, 2 AFO’s, prisms in my glasses, 2 hearing aids, a dual chamber pacemaker and a hospital bed in my home. I have a walker, loft-strand crutches, wheelchair, motorized scooter, leg braces and also knee, neck, hand and shoulder type of braces.
After going through all of the “hoops” at the pain clinic, I was found not to be a candidate for an SCS (spinal cord stimulator) nor a pain pump (intrathecal). I was diagnosed with CVID or “Combined Immune Deficiency” disease. They informed me that I would be sent back to my primary dr. because they could not give me the medication that I needed. In 2005, they were already saying that they could not prescribe pain medications (which they felt I needed) because they had to “stay under the radar of the DEA”. I went back to my PCP and for the next 10 years he prescribed pain medications. Until one day in December of 2014, I arrived at my PCP’s office and was told that it was his last day working there. I received no other information and I was terrified because I did not know where to go or what to do. Dr. Pete Bullach, Jr., MD, promised me that he would personally make a call to my former pain clinic and Dr. Dennis Dobritt, my former pain physician. He also promised me that my treatment would remain the same under his partner. I returned the next month to see his partner and was teased, put down, called names and told that “all of the other dr’s patients were “drug addicts”, “drug seekers” and unworthy people seeking pain medications. He promised to see me for a couple of months because he had known me “to be a good person” since my children were small. But over the next 6 months I had to put up with derogatory remarks.
I sought out a pain physician and found one near my home. He told me that if I could take myself off of the medication that had been prescribed to me since 2005, that he would “accept me as his patient”. I was very ill for about 11 days and for up to 6 months, I was not feeling well aside from the pain issues. But I got through it and would not ever want my worst enemy to go through that experience. I did it with my loving husband by my side because I was not addicted to it. My mind did not care at all, but my body was dependent. When that ordeal was over, I saw my current pain dr; the one I still see today. Things had been going well and I have had some semblance of a life. He had told me that I was a “complicated patient” and that I did not have to worry about my medication being stopped.
For several days prior to these appointments, I became very apprehensive, nervous and had many of the PTSD symptoms recurring monthly. Then his attitude towards me changed from a mutual respect to him being the “Wizard with a magic wand” and Me being a peasant “needing his magic”. Thats the only metaphor I can come up with. It was bazaar. I had a routine urine drug screen test in April 2018 and he knew before I left his office that something was not “right” with it, but he failed to inform me prior to leaving. At my next appointment he informed me that I had had a positive urine test and so he sent it into a lab for more testing. It came back as a “false positive” because of the migraine medication that HE KNEW WAS PRESCRIBED to me for many years. I take very little, but he knew it was in my records; he knows that I take it. In the end, we got stuck with a $265.00 bill for testing that I did not agree to pay for. We got stuck with this large bill for something that I did not do and would never have done. It was his mistake, not mine that he forgot the medications that I am taking and that it can show up as something else, as he explained later.
He has had an “edge” to his treatment of me since that date. I am literally ill prior to each monthly appointment. Nothing changes in 30 days anyways? Why in the world do we need to go so often? This is ridiculous. Just as a person with diplopia or myopia needs glasses; just as a diabetic needs insulin and a depressed person needs anti-depressants; I am a chronic intractable pain patient and I need pain medications. I’ve never done anything wrong as far as I always pick up my meds on time, I’m never late for my appointments and I’ve never been a “no-show”. But I showed up on July 9th, 2018; and was suddenly without explanation, cut down to 75% of my LA/ER pain medication. He was going to stop it abruptly that day, but I did not get hysterical. I reasoned with him, adult to adult. I reminded him of my prior heart attack, the CVA (stroke) and my complicated medical history with multiple co-morbidities. He agreed reluctantly to taper me a bit. He informed me that he was doing this to get me “psychologically ready” and that next month I would get zero. I’m not “Psychologically addicted” so that made no sense at all, but I went with it for my own comfort and safety. He went on to tell me that suddenly the patch is now “only for cancer patients”, which he does not treat. He also told me that I was “not heavy enough” for the patch and “I was probably only really getting 30% of the medication”. I did not say a word as I was prescribed down from 100 mcg per hour, every 48 hours (due to hyper metabolizing), to 75 mcg every 72 hours. So not only 25% less medication, but now being stretched out a full 24 hours longer each patch. The first few days were difficult as I had a few withdrawal symptoms. But the rest of the month, I’ve had increased pain, exacerbation of my CRPS, and fatigue. Also, every 3rd day I was in bed, very ill. We all know that for especially those of us who hyper-metabolize (due to the types of pain illnesses that we have), the patch never works on the 3rd day!
I have a loving, supportive husband and my support “team” online which consists of a few people who have been there for me throughout this ordeal. I had websites, stories and ideas sent, all in an effort to help me reason with my pain dr. On 8-10-18, I showed up well prepared. I had with me, the 2013 FDA’s response to Andrew Kolodny, when he wanted Fentanyl labelling changed for non-cancer pain. They told him this, in their 2013 letter (Docket No. FDA-2012-P-0818): “It is FDA’s view that a patient without cancer, like a patient with cancer, may suffer from chronic pain, and PROP has not provided scientific support for why labeling should recommend different treatment for such patients. In addition, FDA knows of no physiological or pharmacological basis upon which to differentiate the treatment of chronic pain in a cancer setting or patient from the treatment of chronic pain in the absence of cancer, and comments to the Petition docket reflect similar concerns. FDA therefore declines to make a distinction between cancer and non-cancer chronic pain in opioid labeling”. My dr responded that “this was not about Fentanyl” and that I am educated and should be able to find out about this?
Next, I brought to his attention, a letter that I received a copy of, from a good friend of mine on LinkedIn. He had written to the CDC and asked about the horrific state of affairs within the chronic pain community. We covered his name and I showed this to my dr as well. This letter, which is directly from the CDC and dated 4-8-18, states these things:
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chronic pain patients deserve safe and effective pain management
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physicians should continue to use their clinical judgment and base their treatment on what they know about their patients. That includes the use of opioids if they are determined to be the best course of treatment.
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The Guideline does not support involuntary tapering.
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Obtaining patient buy-in before tapering is critical to successful dose reduction.
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The Guideline is not a rule, regulation , or law.
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The Guideline is not intended to deny access to opioid pain medication as an option for. pain management.
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The Guideline is a set of voluntary recommendations intended to guide primary care providers as they work in consultation with their patients to address chronic pain.
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The Guidelines are not intended to take away physician discretion and decision-making.
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Specifically, the Guideline includes a recommendation to taper or reduce dosage only when patient harm outweighs patient benefit of opioid therapy.
In the end, none of the information that I presented, made any difference to my pain dr.. He just kept repeating “the guidelines, the guidelines, the guidelines”. He told me that in all reality, I was not worth saving, because if I look at his waiting room, he has all of those other people to serve, who also live with pain. If he helps me, he risks losing his practice and then he would not be able to help all of them. He informed me that “everyone is looking at him the same way” and they are also “pleading with him” for their medications. I told him that he’s told me that I am “different” and that I am a “very complicated case with multiple co-morbidities”. I told him that I researched Michigan Law and that there are no changes in the care or plans for chronic pain, only acute pain. None of this mattered because he just looked at me, after I showed him the letter from my G.I. dr.. A letter written by him on my behalf, states that “Suzanne has been stable while she received the fentanyl patch”. It goes on to say that I have “RSD and severe Gastroparesis and this could “exacerbate the illness of a patient who was difficult to stabilize” due to Q-T prolongation, her allergies and intolerance for oral medications”. He said that “he strongly recommends that my pain management not be altered unless there is a strong medical reason.”
My pain dr looked at me and said “This is bullshit! His license is not any better than mine! If he wants you to have the fentanyl patch then let him prescribe it for you. You’re also welcome to find another dr and get a 2nd opinion. I won’t be upset if you do that, although Im not kicking you out or anything.” He repeated that “the CDC guidelines are specific for fentanyl” and there was no way in hell I was ever getting that from him ever again, an neither is anyone else; no matter what! He pretty much told me if there was an exception, I would be it, but there are no exceptions. He repeated to me that I am educated, and have access to the internet. If I do my research, I will know that what he’s saying is true. I have done a ton of research and I know that what he’s saying is not true. He is violating his Hippocratic oath “to do no harm”. Many other physicians are also doing this instead of defending the fragile people who need them during this opioid hysteria
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How to SUE the VA
Posted on August 11, 2018 by Pharmaciststeve
https://youtu.be/WTKfFeg11ng
This is the first in a series depending on the response this one receives. If people do these steps and are interested in the addresses needed to serve subpoenas on the VA and DOJ, I’ll make part II. In the second part, I will also include the language needed to make your case(s) the strongest possible by eliminating what the defense attorneys can use in their motions to dismiss. Together, we will destroy these policies of DENY till DEAD. Thank you, take care and may God bless you in all your endeavors to the right the wrongs being done to veterans each day we are silent. SF-95 CLAIM FOR DAMAGE, INJURY, OR DEATH https://www.va.gov/OGC/docs/SF-95.pdf
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I originally posted this almost THREE YEARS AGO – time to look at it again ?
Posted on August 11, 2018 by Pharmaciststeve
Compensating The Spouse and Family of The Injured: Loss of Consortium Claims
In a personal injury or wrongful death case, the family members of the injured person — spouse/partner, children and parents — can file a lawsuit for their own loss.
Talk to a local personal injury lawyer:
Most states permit spouses or family members of the injured person to recover damages for loss of consortium against the defendant in a personal injury case. Loss of consortium is meant to compensate the spouse or family member of a person who has been injured or killed because of the negligence or otherwise wrongful act of the defendant. This article will explain the legal elements of a loss of consortium claim.
What is Loss of Consortium?
Loss of consortium is a claim for damages suffered by the spouse or family member of a person who has been injured or killed as a result of the defendant’s negligent or intentional, or otherwise wrongful acts.
But what are those damages exactly? The concept is that, as a result of the defendant’s actions, the person who was injured or killed cannot provide his or her spouse or family member with the same love, affection, companionship, comfort, society, or sexual relations that were provided before the accident. So, the spouse or family member of the person injured has a claim against the third party for those losses.
Typically, claims for loss of consortium are not awarded unless the person injured dies or suffers a severe and enduring injury — such as paralysis, amputation, or incontinence.
How is the Loss Calculated?
Loss of consortium is a type of harm that falls under the category of general damages. General damages are non-economic damages, meaning they are losses for which money is only a rough substitute. Other examples of general damages include:
- physical pain and suffering
- humiliation and embarrassment
- shock and mental anguish
- loss of reputation
- loss of society and companionship, and
- emotional distress
Typically, this type of an award is left to the discretion of the judge or jury. However, since this type of damage is difficult to quantify, you will likely have to retain an expert to provide a more precise monetary value for a loss of consortium claim.
Who Can Bring a Loss of Consortium Claim?
Spouses and Partners
Historically, only spouses could bring a claim for loss of consortium. Many states, however, have recently relaxed this requirement and permit committed partners or same-sex couples to file a lawsuit alleging loss of consortium. The rules are different in each state.
Children and Parents
Some states also permit a child or parent to file a loss of consortium claim. In such a circumstance, the child or parent would argue that his or her injured parent or child is no longer able to provide the same level of care, nurturing, and affection as he or she provided prior to the injury. In this situation, the child or parent would have to show that the parent/child relationship was irrevocably altered by the physical injury.
Limitations on Loss of Consortium
Your loss of consortium claim may be limited by your state’s laws (or by an insurance policy if you’re making a claim).
Legal Limitations
Each state has its own limitations on the availability of loss of consortium claims. In most jurisdictions, for example, in order to bring a claim for loss of consortium, you will need to show that a valid marriage exists. So, if the couple divorced prior to the trial, the amount of damages awarded will be negatively affected.
Other states, as discussed above, may allow same-sex couples to bring loss of consortium claims, even in states where same-sex marriage is prohibited.
Insurance Policy Limitations
Most liability policies include “single injury” limitations. This means that there is a cap on the amount covered by the insurance company per accident. In order to determine whether or not there is a policy limit, you will need to read the insurance policy. Unless the defendant is wealthy or has some significant assets, it’s usually not possible to collect more compensation than the insurance policy allows.
What to Consider Before Making a Loss of Consortium Claim
By bringing a loss of consortium claim, the private and intimate aspects of your marriage will be put at issue. So, you should consider whether you are willing to withstand the rigorous questioning — during deposition and trial — that the defense attorney will likely bring.
If the marriage suffered through any hardships or tribulations prior to the injury such as infidelity, separation, criminal charges, or abuse — the circumstances surrounding those problems will likely be discussed ad nauseum in front of the judge and jury, and will be a part of the public record.
This is probably the last thing that a prescriber would be expecting.. is being sued by a spouse and kids over one spouse having their pain meds cut and end up being house/bed/chair confined… basically under “house arrest” … in the worse sort of way.
I am no attorney, but the spouse having an attorney send a letter informing the prescriber that unless the chronic pain spouse’s pain management is restored to previous levels – where their pain management was optimized and they were much more functional… the spouse is going to sue the prescriber… the attorney might also wish to include a warning that if the prescriber discharges the chronic painer that the chronic painer will be suing for pt abandonment and retaliation because of the legal letter received from the chronic painer’s spouse.
The prescribe may have “painted” themselves into a corner… and he/she might find it acceptable to make this one exception to treat this one pt… because if a lawsuit is filed… how many more chronic painers in the practice and their spouses could follow the same path ?
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police sergeant: choses SUICIDE over going to JAIL ?
Posted on August 11, 2018 by Pharmaciststeve
UPDATE: Hagerstown police sergeant who faced drug charges dies by suicide
https://www.heraldmailmedia.com/news/local/update-hagerstown-police-sergeant-who-faced-drug-charges-dies-by/article_6f199e52-9c0f-11e8-87f2-a740ab07e8ed.html
A Hagerstown police sergeant scheduled to be in court next week on charges that he stole drugs on multiple occasions has died by suicide, according to Police Chief Paul Kifer.
Sgt. Christopher Barnett, 45, of Three Springs, Pa., was charged in February with taking three pills from a disabled woman at Potomac Towers on Jan. 30, according to court documents. The theft allegedly took place when Barnett went to her apartment to inquire about another person.
Barnett was later charged in a 10-count indictment with other criminal offenses.
“I see this as another tragedy of the opioid crisis,” Kifer said Thursday. “Chris was a valued and highly respected officer during his time here. Unfortunately, he fell victim to an opioid addiction, which caused him to make some poor decisions.”
Kifer said he did not have many details regarding Barnett’s death. The department generally does not comment on suicides, and this one happened in another jurisdiction, he said.
Barnett’s attorney and the coroner’s office in Huntingdon County, Pa., couldn’t be reached for comment on Wednesday and Thursday. Pennsylvania State Police in Huntingdon County had no additional information on Wednesday when word began to spread about Barnett’s death.
A member of the department since 2002, Barnett was promoted to sergeant in 2012, Kifer said. Barnett was on unpaid administrative leave at the time of his death.
Barnett was initially charged in February after the woman at Potomac Towers discovered some of her pills were missing after Barnett left, and called police. Barnett later showed up at the woman’s apartment, offering her four pills of a higher dosage and $30.
Barnett’s effort to replace the drugs and buy the woman’s silence was caught on a video camera set up by a friend in the woman’s apartment, authorities have said. It was later turned over to the police.
A grand jury indicted Barnett on 10 counts, including five counts of malfeasance in office, theft of $100 to $1,500, obtaining the property of a vulnerable adult, two counts of possession of Oxycodone and one count of distribution of Oxycodone.
The indictment included allegations that Barnett on Dec. 18, 2017, took 20 morphine tablets from a department “take-back box to offer for trade to a third party.” The box is for people to drop off unused and potentially dangerous medications, former Police Chief Victor Brito said earlier this year.
The indictment further alleged that Barnett, on the same day, offered to trade a bag of suspected crack cocaine “recovered during the course of his police duties” to a third party, although the trade did not take place.
The indictment also charges Barnett with obtaining a controlled dangerous substance from a person while on duty on Jan. 9.
Kifer said Barnett might have become addicted to prescription pain medications as a result of a back injury and a subsequent hand injury, both of which occurred several years ago.
The criminal accusations against Barnett should not erase people’s memories of the good Barnett did for the city, Kifer said.
“Chris was the kind of person who would literally pay money out of his own pocket to put a homeless family up in a hotel” or buy a meal for someone, he said. He knew of several such instances when Barnett stepped in to help someone in need.
“That’s the kind of guy Chris was,” Kifer said. “The entire HPD family is saddened by his death.”
Among his duties, Kifer said, Barnett ran the department’s Civil Disorder Unit, which was deployed to Baltimore during the riots following the death of Freddie Gray.
“Chris was a really good officer and his heart was in the right place,” the chief said. The criminal charges shocked the department.
“Our condolences go out to Chris’s family and his friends,” Kifer said.
Barnett was scheduled to be in circuit court on Tuesday for a trial, according to online court records.
“We anticipate at this point moving to abate or dismiss the charges,” State’s Attorney Charles P. Strong said.
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pained lives matters
Posted on August 11, 2018 by Pharmaciststeve
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Suit: Woman killed herself after Olathe doctor got her hooked on opioids, cut her off
Posted on August 11, 2018 by Pharmaciststeve
Suit: Woman killed herself after Olathe doctor got her hooked on opioids, cut her off
https://www.kansascity.com/news/business/health-care/article216457440.html
Some time around Jan. 19, Jacquelyn Spicer sent one last email to her Olathe doctor, the man who had treated her back pain with opioids for a decade before he suddenly stopped, according to court documents.
Then she killed herself.
In a lawsuit filed Thursday in Johnson County court, Spicer’s family accuses Douglas Brooks of getting her hooked on pain medicine and then leaving her with no way to get off it safely after the Kansas medical board ordered him to stop treating chronic pain patients because of his dangerous prescribing patterns.
Brooks didn’t respond to a phone message left Friday at his Olathe clinic, Brooks Family Care. An attorney who represented him before the Kansas medical board didn’t either.
The order issued by the Kansas Board of Healing Arts in October stated that Brooks, a primary care doctor, was supposed to refer all of his chronic pain patients to specialists “without abandoning the patient in need of care.”
But according to the lawsuit, Brooks didn’t do that for Spicer.
Instead, he allegedly cut her off cold turkey, and ignored her requests for a referral to a methadone clinic or other provider who could help with withdrawal symptoms. The lawsuit says Spicer warned him that she was very concerned about withdrawal and contemplating suicide.
“I have had several patients get off high doses very quickly without issues so don’t predetermine your outcome,” Brooks responded on Jan. 13, according to the suit. “It won’t be as bad as you can imagine.”
About six days later, after sending Brooks a final email, Spicer committed suicide.
According to his website, Brooks was the chairman of the department of obstetrics and pediatrics at Olathe Medical Center from 2004 to 2006, before starting a primary care practice.
The suit brought by Spicer’s family says she started seeing Brooks in 2007. From then until the end of 2017 he prescribed her between 240 and 450 tablets of 60-milligram morphine sulfate every month.
The family’s lawyers wrote that Spicer showed signs of opioid addiction and, at one point in 2016, told Brooks she wanted to get off the painkillers. But he didn’t refer her to an addiction specialist and kept prescribing the morphine.
According to the suit, the staff at Brooks’ clinic called him “The Candy Man” because of his “history of freely prescribing addictive controlled medications.”
Last year the Kansas medical board said that an investigation revealed Brooks was negligent or grossly negligent in his treatment of five chronic pain patients.
“He improperly and inappropriately prescribed and refilled excessive doses of opioid/controlled medications, failed to properly monitor the patients’ adherence to treatment, failed to address the red flags for opioid/controlled medications abuse, failed to properly treat/modify his treatment plan, failed to refer to appropriate specialists, failed to address a patient’s presenting illness and failed to properly document within the patients’ medical record(s),” the board’s attorney wrote.
The board ordered Brooks to hand off his chronic pain patients to specialists, submit monthly reports of his narcotic prescribing for a year, complete continuing education courses on proper prescribing and medical record-keeping and pay some of the costs the board incurred in hearing his case.
Brooks’ current clinic advertises itself as a direct primary care practice, a model in which the medical provider doesn’t take insurance but instead charges patients directly.
Unlike some other direct primary care practices, though, Brooks’ website says that his patients are bound to 12-month contracts, rather than being able to opt out of membership on a monthly basis.
According to the lawsuit, Brooks’ patients were charged by the minute. That’s also different from most direct primary care practices, which charge a flat monthly rate for unlimited office visits.
The suit also names Price Chopper Pharmacy as a defendant, alleging that staff at the Price Chopper at 2101 E. Santa Fe St. in Olathe was negligent in continuing to fill and refill Spicer’s prescriptions without warning her of the risks of addiction or notifying authorities about the “excessive opioid/controlled medications” Brooks was prescribing her.
Staff at that Price Chopper pharmacy declined to comment, citing medical privacy laws.
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For those voting in the FL primary this Aug for Republican candidates – where is what I found
Posted on August 10, 2018 by Pharmaciststeve
5 Questions for Florida Attorney General Candidate Ashley Moody
Attorney General Bondi has made opioids and human trafficking key issues of her office. From a legal stance, what is the biggest issue right now facing the state? I wish I could say that we’re at a point where the attorney general coming in will no longer have to focus on the opioid epidemic or will no longer have to focus on human trafficking. The sad reality is, despite the amazing accomplishments of Attorney General Pam Bondi, we’re still dealing with 15 deaths a day. My biggest fear is that we as a state get tired of talking about opioids — because it’s been such an issue for so long — and we lose energy and focus to attack it. And so, what I’d like to do when I come in is immediately put together a state force, a statewide task force, or use maybe our grand jury system to bring in experts to figure out where we need to go and direct our resources. A mistake we can make if we’re not careful is we pump a bunch of money towards a specific issue and we don’t do it in an effective way. So, I want to make sure we’re good stewards of the taxpayer money and we do invest resources, and I don’t just mean money, I also mean human resources, sheriffs’ investigations, prosecutors, that we’re doing it in a way that we’re going to reduce the numbers. I’m a numbers person. I was trained in accounting. At the end of four years, being attorney general, I want to make sure I have the numbers to show I’ve been working to address this.
The Plant City native is familiar with Bay County, her mother born and raised in Panama City. Moody is a former federal prosecutor and judge married to a DEA agent. She plans to fight opioid epidemic by continuing the conversation and focusing on synthetic drugs like fentanyl.
5 Questions for GOP Attorney General Candidate Frank White
What reforms or improvements do you see as needed within the Attorney General’s Office?
I think Attorney General Bondi has done a fantastic job. She has done a wonderful job. She’s saved lives, particularly in the opioid crisis. I think there are some areas where we disagree. One I’d point [to] would be the identity of Jane Doe in the NRA’s lawsuit against the state. It’s just a difference of opinion where I think Jane Doe’s identity should remain anonymous. I think it’s really a difference in terms of emphasis. One important part of it [the job] will be government accountability, making sure politicians are held accountable. That’s just one area where I particularly want to focus on immediately.
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FDA seeks to tailor length of opioid prescriptions to patient conditions
Posted on August 10, 2018 by Pharmaciststeve
FDA seeks to tailor length of opioid prescriptions to patient conditions
https://www.bendbulletin.com/health/6432868-151/fda-seeks-to-tailor-length-of-opioid-prescriptions
The Food and Drug Administration is developing new opioid prescribing guidelines that would tailor the duration of the prescriptions to specific patient conditions.
Speaking at a provider roundtable with Rep. Greg Walden, R-Hood River, on Tuesday in Bend, FDA Commissioner Dr. Scott Gottlieb said the agency was working with provider groups and the National Academy of Medicine to determine what amount of prescription pain medication would be appropriate after various surgeries and procedures, instead of relying on the current one-size-fits-all approach.
Prescribing guidelines from the Centers for Disease Control and Prevention, for example, say that three days or less of opioids are often sufficient and that more than seven days will rarely be needed, but do not differentiate based on condition.
“From my perspective, one of the concerns about the five-day, seven-day sort of limit is the 14 days becomes seven days, but the two days becomes seven days,” Gottlieb said. “So you’re going to be bringing some prescriptions down to a more appropriate duration, but you’re also going to be bringing prescriptions that are shorter to a longer duration.”
The commissioner said the guidelines will focus initially on acute care conditions where over prescribing has been rampant. Agency data suggests that patients often need opioids for only one or two days after laparoscopic gallbladder or hernia surgeries, but may need pain killers for a week or more after a heart bypass or orthopedic procedures.
Gottlieb is also leading a joint effort with cancer groups to develop better guidelines for opioid use to treat cancer pain, but the agency will not be looking at new guidelines for chronic pain conditions at this time.
Gottlieb spoke just two days before an Oregon committee plans to begin reviewing a proposal that would limit Medicaid coverage for five broad chronic pain conditions to 90 days of opioid pain relievers and would force patients who have been taking opioids for longer to be tapered off those medications within a year. Oregon implemented a similar strategy for low back pain two years ago.
While Gottlieb said the agency wasn’t focused on what states were doing with respect to opioid limits, he spoke about the need to balance efforts to address over prescribing and give doctors the flexibility to prescribe opioids for those who need them.
“There are certain patients for whom chronic use is appropriate,” Gottlieb said. “We need to recognize that and allow for that.”
Rick Treleaven, director of Redmond-based BestCare Treatment Services, expressed concerns that after years of promoting opioid use, the pendulum was swinging too far the other way at both the federal and the state level.
“We’re getting so tight again with the pain medication, that it’s inhumane,” he said at the round table. “We’ve got to find that middle ground.”
The wide-ranging discussion with local Central Oregon health officials, held at the Oregon State University, Cascades campus, touched on a number of opioid-related topics.
• Walden touted the 57 separate opioid measures passed by the House Energy and Commerce committee he chairs and rolled into H.R. 6, passed by the House in June. Senate leaders are now working on their own version of the opioid bill, which will then have to be reconciled with the House version.
“Hopefully, in September, we hope to get it on the president’s desk,” Walden said. “I don’t anticipate major changes.”
• Included in the House bill was a measure to allow providers treating patients with addiction to coordinate care with those patients’ other medical providers. Doctors have complained that a privacy measure last updated in 1987 was preventing better integration of their care.
• Gottlieb reiterated the agency’s commitment to developing new abuse-deterrent formulations of pain medications. Some attempts by drug makers to produce abuse-deterrent drugs have run into hurdles, causing the manufacturers to withdraw from the approval process. But Gottlieb said there were new technologies and novel approaches that had merit.
“I think they can be potentially very effective,” he said.
• The FDA issued new rules on Monday that would allow drug makers to get approval for addiction treatments without having to prove they could get patients with addictions completely off of opioids.
“That was a high threshold to hit,” Gottlieb said. “If you could have a treatment, for example, that cuts down the risk of overdose or cuts down on craving, that might be an important adjunct to an overall approach to care.”
• Gottlieb said that while the U.S. has made progress in reducing over prescribing of opioids, the progress has been more than offset by the increase in illicit opioids, such as fentanyl, flowing into the country.
“The amount of illicit drugs is dramatically more than the reduction that we’ve seen,” he said. “It’s being backfilled with fentanyl.”
• The agency has received new authority and funding to ramp up efforts to intercept illicit substances and unapproved drugs coming into the U.S. by mail. Gottlieb said more than 800 million packages were mailed to the U.S. last year, and this year, the number could exceed 1 trillion. That provides a gap through which illicit substances such as fentanyl can be shipped into the U.S. “What we’re trying to do,” he said, “is plug those gaps.”
• Crook County Health Director Muriel Delavergne-Brown raised concerns about the rising cost of and difficulty of obtaining Narcan, the drug used to reverse opioid overdoses. The county health department supplies the Prineville Police Department and the Crook County sheriff’s deputies with the medication but is facing challenges in acquiring sufficient supply.
• Several providers at the round table raised concerns over the continued prescribing of opiods and benzodiazepines, a combination that has been shown to dramatically increase the risk of overdose.
“It’s kind of the shadow epidemic to the opioid epidemic,” said Kim Swanson, chair of the Central Oregon Pain Standards task force. “And it’s not been hit as hard with education or guidelines.”
—Reporter: 541-633-2162, mhawryluk@bendbulletin.com
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‘Middlemen’ Account for One Third of US Drug Costs
Posted on August 9, 2018 by Pharmaciststeve
‘Middlemen’ Account for One Third of US Drug Costs
https://www.medscape.com/viewarticle/900505
About one third of drug spending in the United States goes to pharmacies, pharmacy benefit managers (PBMs), and hospitals or clinics that dispense drugs, according to an analysis published by Health Affairs.
US healthcare spending is a critical economic and political issue, with skyrocketing drug costs reaching crisis levels. Now, Nancy Yu, BA, MBA, a biopharma industry analyst from the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center in New York City, and colleagues estimate that the United States spent $480 billion on drugs in 2016, including the profits of pharmacies and other intermediaries.
That is nearly 50% higher than the Centers for Medicare & Medicare Services’ 2016 estimate of $328 billion in US drug spending, which did not include drugs dispensed in hospitals or clinics.
The authors note that President Trump and the pharmaceutical industry “have stressed that supply chain intermediaries, or ‘middlemen,’ are capturing much of the money that is often categorized as drug spending.” Yu and colleagues crunched the numbers and found these intermediaries account for about one third of the spending.
“A clearer understanding of the total market size, as well as the revenues retained from the purchase, distribution, and payment of prescription drugs throughout the US supply chain, may be useful for policy makers as they seek reforms while working to preserve incentives for innovation and efficiency,” Yu and colleagues write in a Health Affairs blog post published July 31.
In May, President Trump announced a raft of possible initiatives to reign in drug prices, including creating tools for Medicare to negotiate some drug prices, speeding approval for over-the-counter drugs, and promoting competition between drug makers. He also said he’d like to eliminate “middlemen,” who have “become very, very rich.”
The estimates by Yu and colleagues suggest that two thirds of US drug spending ($323 billion) goes to drug manufacturers’ net revenues. Of the remaining $157 billion retained as gross profit by intermediaries in the supply chain, about half ($73 billion) goes to retail or specialty pharmacies and 20% ($35 billion) goes to hospitals or physicians’ offices. PBMs bring in $23 billion and drug wholesalers another $18 billion, together accounting for slightly more than 25%.
“Our intent is not to infer or draw conclusions on where there are outsize profits or how difficult it would be to reduce spending within the supply chain, nor do we opine on the consequences of reducing that spending,” the authors write. “But a recent policy focus on the supply chain suggests that understanding those consequences will be important.”
Allan Coukell, senior director of health programs at The Pew Charitable Trusts, called the analysis useful in detailing where in the drug chain money is being spent. He said the findings largely align with a similar analysis by Pew that has yet to be published. However, he noted that PBMs pass a portion of the profits they make back to the health plans they work for, which isn’t accounted for in Yu’s analysis.
Much of the policy debate in Washington about the potential role of “middlemen” in driving up costs has focused on the role of PBMs in drug costs, Coukell explained. But he noted that they also provide several services including paying claims, designing drug formularies, and negotiating rebates with drug manufacturers.
“In terms of turning the tide of overall drug spending, that’s not the thing driving drug spending,” Coukell said. “The evidence shows PBMs are playing an important role in keeping drug costs down.”
Instead, Coukell said most of the growth in drug spending is driven by high prices on new drugs and year-to-year increases on the prices of drugs still under patent with no competition. To reign in these costs, he suggested optimizing drug discounts for government programs, introducing competition in Medicare B, or boosting use of generics or biosimilars.
One study coauthor reports receiving personal fees from the American Society for Hospital Pharmacy, Gilead Pharmaceuticals, WebMD, Goldman Sachs, Defined Health, Vizient, Foundation Medicine, Anthem, Excellus Health Plan, Hematology Oncology Pharmacy Association, Novartis Pharmaceuticals, Janssen Pharmaceuticals, Third Rock Ventures, and JMP Securities unrelated to the study. The other authors and Coukell have disclosed no relevant financial relationships.
My first summer working in a pharmacy (1967) I got assigned a task to calculate the average Rx price for the chain store that I was working for… Back then.. there were virtually no generics… almost everything was BRAND NAME MEDS… there was no PBM/drug cards, Medicaid was in its infancy. All prescriptions were CASH and the average price was in the $4 -$5 range.
Here we are 50 yrs later and the average price is pushing $60 and there is a 85%-90% generic utilization and PBM’s collectively pay for some 80%-90% of all prescriptions…
If one applied the CPI to the average Rx price back in 1967… one would expect that today the average Rx price would be in the $35 – $45 range.. that is ignoring that we now are dispensing all of those generics.. which is suppose to save everyone money.
The two major changes in 50 yrs is the massive change from totally brand name meds to generics and PBM’s – a middleman – controlling the prices that the pharmacy get paid and what the insurance company pays for the prescriptions and the PBM’s are in the position to be able to DEMAND rebates/kickbacks/discount from the pharmas to make sure that they meds are on the PBM’s formula..
According to my calculations … there is some $15 – $25 per Rx that shouldn’t be there in the average price of prescriptions.. Guess where that extra cost is going ?
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