Ongoing Opioid Guideline Issues

Authors of the 2016 opioid guideline are now bringing more heat to medical professionals. The Centers for Disease Control and Prevention’s (CDC) recently clarified the opioid guideline, but the authors said in a new paper that medical professionals had misapplied the recommendation they had made.

Deborah Dowell, M.D. wrote, “unfortunately, some policies and practices purportedly derived from the guideline have in fact been inconsistent with, and often go beyond its recommendations.” Basically saying that medical professionals have been doing the wrong thing. But, this seems to be more of a cover-up for their poorly made guideline. And as we’ve covered in past blogs, many doctors have been forced by payers to leave their hurting patients untreated because of this guideline. Physicians know all too well how often their opinions get ignored by insurance companies.

However, the American Medical Association (AMA) is still welcoming the CDC’s revised guideline, as it has been much needed and will help things move in the right direction.

Patrice A. Harris, M.D., the president-elect of the AMA and chair of the Opioid Task Force, had this to say, “The AMA appreciates that the CDC recognizes that patients in pain require individualized care and that the agency’s 2016 guidelines on opioids have been widely misapplied. The guidelines have been treated as hard and fast rules, leaving physicians unable to offer the best care for their patients.”

The AMA is the voice for physicians all around the nation and is causing the CDC to listen more intently. The first step still won’t be giving opioids to a patient. However, providing opioids to patients who can responsibly use them, and need them to better their lives, should be a more accessibly available course of action for medical professionals. Also, being able to help patients with methods other than opioids should be easier as well.

“The guidelines have been misapplied so widely that it will be a challenge to undo the damage,” Harris adds that the AMA is urging a detailed review of the formulary and benefit design by payers and pharmacy benefit managers to ensure patients have access to both pharmacologic and non-pharmacologic treatments. The CDC made sure to clarify that the guideline was not meant to limit access to pain management for patients with cancer or sickle cell disease. The guideline was put it into play because prescription opioids could turn into opioid addiction. The CDC also said that more than 200,000 people have died from opioid overdose since the crisis began in the late ’90s.

When problems surface, making it more difficult to give their patients the care they need, medical professionals need to be heard. The AMA has provided that voice within this ongoing struggle. Locally, we here at Emerald Coast Medical Association can help you be heard too. A perk available to our physicians is the Emerald Coast Medical Association member meetings. In these meetings, you will hear new information, meet fellow medical professionals, and have the ability to offer your own opinions. Additionally, our Board of Governors routinely takes time to advocate for our members and their patients at the local, state, and federal levels of government.


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The “War on Opioids” Needs to End

“With the first cut of the scalpel, excruciating pain exploded in my foot, and I was shocked speechless. I froze, paralyzed, terrified that any movement would jostle that knife digging into my flesh.” Angelika Byczkowski, a patient suffering from Ehlers-Danlos Syndrome (EDS) has felt multiple surgeries through anesthetics.

The unforgettable recollection above was from a procedure that was done on her foot to remove a plantar wart. She also felt pain when she received stitches, which had anesthetics applied. Her doctor told her it was impossible that she was feeling pain, so she stuck to it and all the while, feeling extreme amounts of pain run through her body, she sat there quietly because she did not want to question authority. She thought she was going crazy. However, once she was 54 years old, she was finally diagnosed with EDS. EDS in many patients has brought them pain even after being numbed through local anesthetics. However, now that the medical world has gotten more advanced, we can help people with EDS with what is called by many a last resort: Opioids.

There is a four-step procedure to be taken before providers prescribe opioids:

Step 1: Initial Assessment

An Evaluation of the patient’s pain, which should include; location of pain, duration of pain, characteristic of pain, what relieves the pain, and what time of day the pain occurs. There should also be a check on how the patient’s past treatments and medication have worked out. A look at the patients personal and family history of alcohol or substance abuse should be taken into precaution.

Step 2: Informed Consent and Treatment Agreement

Before prescribing opioids for the treatment of chronic pain, a practitioner should obtain an informed consent agreement and a treatment agreement.

Step 3: Initiating and Monitoring Treatment

Once the decision has been made to initiate the opioid treatment, it should start as a therapeutic trial for a defined period (not to exceed 30 days). The patient should know that the trail will be carefully monitored to assess the benefits and harm that may occur and to evaluate the level of and change in pain.

Step 4: Red Flags and Aberrant/Diversionary Behavior

There is no exhaustive list of behaviors that might be considered red flags. However, it is a must for practitioners to recognize such behaviors and to document them in the medical record as well as what actions have been taking, including discontinuance of opioid treatment or discharging the patient.

With all of that in mind, opioids are there to help the patient try to function normally in day to day life. It should not be the medical professional’s fault for the patient’s actions. The war on opioids is not helping anyone in this situation because it can cause more problems for the patient by not giving them the drug sooner. Medical professionals are doing everything they can to help their patients; it’s their job, and most often their passion. The war on opioids has been causing more problems than solutions in the medical field and has even led to medical professionals to be questioned.

At Emerald Coast Medical Association, we always have your back. Our Board of Governors routinely take their time to advocate for patients and physicians at the local, state, and federal level. Why wait when you can join today?

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Easing Restriction on Medication-Assisted Addiction Treatment

The Department of Health and Human Services and the Drug Enforcement Administration have recently been working together to increase access to medication-assisted addiction treatment (MAT). The HHS and DEA are aware that doctors able to prescribe these medications are in short supply, which is one of the reasons they are looking to ease restrictions on MAT.
Due to these restrictions being mitigated, doctors are now able to prescribe buprenorphine through a virtual platform. Along with this new rule, if a clinician is present, including practice providers who are not doctors, the waivered provider is legally allowed to prescribe buprenorphine even though they are not present. Late last year the White House’s opioid commission issued a slew of recommendations, one of which being that MAT becomes more accessible.

Although the waiver adjustments to MAT were made earlier this year, HHS is now making sure that providers are aware of the telemedicine options for opioid treatment. Once the HHS realized that steps were being taken to address the opioid crisis, they decided to be proactive about making the public aware. According to the Substance Abuse and Mental Health Services Administration, in 2017, there was a decline in people abusing opioids and more people got into treatment for opioid use disorder. However, the report also stated that more than 11 million Americans abused opioids in 2017.

HHS has made it one of their top priorities to tackle the opioid crisis. The secretary of the HHS, Alex Azar, has also made it one of his central agenda items. The HHS has released $1 billion in grants to approach this impending epidemic.

For the HHS to have an impact on this crisis, it is necessary not only for the HHS to be involved, but also the Department of Justice, the Department of Housing and Urban Development, and the Department of State, among many others. The Trump administration must take a multi-agency approach to this issue, which is why so many departments are involved. These steps being taken are a significant advancement towards defeating this terrible epidemic.

Emerald Coast Medical Association keeps it a priority to update our community on legal changes that impact the medical community. If you haven’t already, please consider joining us for a host of benefits, including government representation, group health, and medical malpractice protection.

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Senate Passes Bill in Response to Opioid Crisis

Emerald Coast Medical Association is dedicated to keeping our members up to date on any legal changes going on in the medical community. The most recent one being a massive package of measures in response to the ongoing opioid crisis. This package includes over 70 bills, each of which makes a significant impact on how the opioid crisis is handled.

The package was passed with the majority of Senators voting yes and only one Senator voting no. This bill will go on to the House of Representatives before advancing on to President Donald Trump. The House of Representatives had previously passed a similar package, so this one should go through with little trouble. One Senator, Lamar Alexander, described opioids as being the “most serious public health epidemic.” This statement further proved to the rest of the Senate the importance of this package of bills.
One bill included in the package is the STOP Act, which is put in place to stop illegal drugs at the border. Another is Jessie’s law; this bill was named after a Michigan woman that overdosed on opioids and died. Jessie’s law ensures that doctors can access patients’ prior addiction history, with consent, so that they can make informed decisions when treating an addict.

A bill called the Patient Right to Know Act had strong support from Senator Alexander. Certain contracts bar pharmacists from informing patients when their insurance causes a prescription to cost more than if they paid for it out of their pocket. This bill voids these contracts and allows pharmacists to make patients aware of when they are in this situation.

This package of bills would provide various benefits and an added layer of protection to Americans everywhere. Banning pharmacy gag clauses will benefit many people, patients, and pharmacists alone. As of right now, this package of bills is moving up to The House of Representatives and is expected to make it even further. There are far more bills listed in the package than just the ones mentioned in this article. Find the full list here.

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Prescription Limits Are Not The Answer

What do we do about the opiate crisis? Everywhere you look, you see a lot of hand-wringing and concern regarding this question. And with good reason! Opiate overdose and death rates continue to soar, and while the rate of prescribing has come down, the rate of consumption has not appeared to change.

As doctors, we are on the front lines of this epidemic and often feel helpless to make a change. Meanwhile, legislators are patting themselves on the back for implementing guidelines like prescription limits that tie our hands, do little to help those in chronic pain and may even harm patients already caught in addiction’s grip.

For example, in 2014, Hydrocodone was rescheduled in an effort to curb the prescriptions being written for this addictive pain medication. The DEA’s policy was revised to limit prescriptions to a 90 day supply and only allowed physically written prescriptions, handed to the patient, rather than allowing them to be phoned or faxed into the pharmacy.

Researchers at the University of Michigan were able to study almost 22,000 patients in Michigan who had undergone one of 19 elective surgeries, such as a hip replacement, both before and after the policy was updated. Surprisingly, their data showed that there was an immediate rise in the number of opioid prescriptions filled after the schedule change.

Analysis of the data suggests that doctors may be motivated to prescribe the maximum possible amount, given the restrictions, so that the patient will not have to visit a walk-in clinic or emergency room or make another trip back to the office. What’s more, the characterization of the opioid crisis as being caused by doctor-prescribed medications has been repeatedly shown to be false.

According to a 2016 national survey conducted by the Substance Abuse and Mental Health Services Administration, 87.1 million U.S. adults used some form of prescription opioid, prescribed or obtained illicitly, at some point in the previous year. But only 2% developed any kind of “pain reliever use disorder,” a blanket term that ranges from occasional overuse to outright, daily addiction.

Another study, published in Pain Medicine magazine, excluded all chronic pain patients with a history of drug abuse and found that the remaining patients who were prescribed opiate painkillers developed addiction at a rate as low as .19%. Patients who do become addicted to their prescribed medication often have other problems, depression, anxiety, existing or past substance abuse issues or alcoholism. It has also been shown that far more people misuse prescription medication that they obtain from a friend or relative or purchase from a drug dealer than medication they themselves were prescribed.

Limiting the number of pills prescribed or manufactured in the country only serves to hurt patients who need them, and limit what their doctors can do to help. As we see from the news stories, addicts will find a way to feed their addiction, legal or not. Prescription limits do more to punish those who want to follow their doctor’s advice and treat their pain legally, than those who would abuse opiate pain medication.

Emerald Coast Medical Association is committed to supporting doctors in efforts to make our voices heard in Tallahassee and Washington D.C. As a group, we can work together to influence decisions in government that impact us and our patients. If you are not yet a member, we encourage you to come to a monthly meeting and learn about the advocacy and encouragement we can provide.

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Abuse-Deterrent Drugs: Should We Believe the Hype?

How can we solve the opiate crisis? If you’re like most practitioners, you have thought about this problem and found very few helpful solutions. As the death toll rises, steps are being taken to prevent future patients from winding up addicted to opiates but how can we help those who are already taking them?

Right now, the President’s Commission is working with the FDA to promote development of abuse-deterrent opioids in order to address this pressing issue. The idea is to target common practices addicts and their use with these medications (such as snorting or injecting them) by creating pills with physical or chemical barriers to prevent such activities.  Other formulations of these abuse-deterrent drugs incorporate an opioid blocker that can reduce the effect of the drug if too much is taken, or negate the effects entirely.

Creating drugs that are harder or impossible to abuse seems like a great idea to lawmakers, but in reality, they may not be the answer we’re looking for. They don’t actually eliminate the risks inherent in the drugs themselves, and may actually cause harm by misleading patients and lulling providers into a false sense of security.

Consider the fact that this current crisis started, in large part, because Purdue touted Oxycontin as a safe, non-addictive medication in the 90s.  The FDA approved label on it read “Delayed absorption, as provided by OxyContin tablets, is believed to reduce the abuse liability of a drug.” which was very encouraging to doctors who wanted to help their patients manage pain. This led us down the path to Oxycontin being the most widely abused drug in the country, with addicted users finding ways to circumvent the supposed safeguards by crushing or dissolving the pills, leading to higher tolerance and more abuse.

There is not enough real-world evidence to support claims that abuse deterrent formulations can make enough difference to be worth the high cost. The tests conducted by the FDA take place in controlled environments without actual addictive behavior coming into play. The lack of ability to test these drugs in use by actual addicts makes it hard to justify a price-tag in excess of $200,000 to prevent one new case of opioid abuse. A study by the Institute for Clinical and Economic Review shows that, at current market prices, it would cost an additional $1.36 billion to prevent a single overdose death. The research and development money being funneled into these drugs could be better used for looking into treatment and coping strategies to assist those living with chronic pain and those already in the grips of addiction.

Another drawback of this approach is the paperwork. Prescribing these abuse-deterrent medications requires a lot of back and forth with insurance companies, who also balk at the high cost, so doctors spend time wrestling with red tape and bureaucracy that would be better spent with patients or their families.

There is no easy answer to the opiate epidemic, and thinking we can solve the problem with more drugs is short-sighted and could possibly backfire. As doctors, we need to take a more holistic approach to pain, be open minded about alternative therapies, and have honest conversations with our patients regarding the risks of all opiates, making sure they understand the pros and cons and have exhausted other avenues to deal with their pain. Spending money on public health campaigns to educate and empower the public with real knowledge regarding all the options for pain management could have a much greater and far-reaching effect than these costly specialized formulations of the drugs that got us here in the first place.

Emerald Coast Medical Association welcomes your input and feedback on this and other important issues facing doctors in Florida, the U.S.A. and around the world. We invite you to attend our monthly meetings, where you can share your opinions and thoughts with your peers.

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