Have we spilled the beans on opioids?

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Guest Blogger Dr. Jessica E Geiger-Hayes, together with several of her palliative care colleagues offered to share some insight on how the national opioid panic has effected their patients.  How could I refuse?  Here’s what Dr. Geiger-Hayes had to share…

When I was a kid, I used to play a game called “Don’t Spill the Beans.” Where you take turns placing a bean on a suspended container, being careful not to cause them to spill in one direction or the other.  The person that causes the container to tilt too far and spill the beans, loses the game.

I was thinking about this game as I was contemplating my guest blog post content.  In my mind, we have been adding more and more anti-opioid beans (or should I say poppy seeds) to the container, some of them carefully placed with noble intent, and some that are just thrown on the top with no forethought to potential adverse outcomes. The container starts to lean and gets closer and closer to tipping as more beans are thrown on.

Just throwing additional beans (or legislation, or insurance rules etc.) onto an already unstable situation could be a recipe for disaster.  The CDC wrote guidelines for chronic pain, and did include exceptions for hospice patients, patients with a cancer diagnosis, or palliative care to treat pain with opioids when all other options have been exhausted. Notwithstanding, legislation that has been implemented after these guidelines were released which have made it exceedingly difficult for physicians and other prescribers to adequately care for the patients that fall under the categories. Then you add the layer of insurance companies using these guidelines as hard stops for requiring prior authorizations or refusing to pay, despite that fact that the guidelines clearly exclude patients with cancer and pain specialty clinics.

Several pharmacists from various practice settings shared examples below of how the new legislation and subsequent insurance requirements have affected care of their patients who qualify for and require opioids to manage their pain.

Let’s start with the legislation. Many states have implemented maximum morphine equivalent daily dose, or MEDD, and day supply limits. Lawmakers either don’t understand or have ignored the fact that MEDD is based on equivalent efficacy, not toxicity, and that such comparisons do not consider individual patient characteristics as outlined in The MEDD myth: the impact of pseudoscience on pain research and prescribing-guideline development. They do allow exceptions for certain patients (i.e. palliative care, hospice, cancer diagnosis), but the physicians writing the prescriptions are often not comfortable utilizing such exceptions because they feel as though a DEA target is painted on their backs.  The end result is that patients are frequently sent home with a fraction of what they need in either number of tablets/capsules or overall dosage. For example, a patient requires 200mg of morphine per day to adequately control their pain and is currently hospitalized. They are out of their medication at home and do not have a follow up appointment scheduled with their oncologist for another 3 weeks. They are discharged with a prescription for only 100mg of morphine total per day (even though they came in on a different dose) and only given a 1-week supply.  What kind of position does this leave the patient in? They leave the hospital knowing they will have uncontrolled pain, probable opioid withdrawal and wondering how they will get the medication required to manage their pain so they can make it to their follow-up.  This also leaves the door open for a potential re-admission to the hospital due to uncontrolled pain.  If this happens enough times, these patient’s get labelled as having drug seeking behavior, when in reality it is behavior related to seeking adequate pain control.

In response to legislation, insurance companies and various community pharmacy chains have also begun to implement new processes for patients to utilize their prescription benefits in order to obtain medications that have been deemed appropriate.  Some are requiring that only certain limited abuse deterrent medications be utilized, but then also requiring a prior authorization for those medications to be dispensed. While some of the ADF formulary selections may be appropriate and even most desirable, more often than not it is based solely on cost or the amount a pharmaceutical manufacturer is willing to pay the PBM to place their drug on formulary – that was addressed recently in PBM Clawbacks – The Hidden Fees That Hurt Both Pharmacists and Patients and previously here, Wee Outliers versus We Out Liars. This delays pain management in the outpatient setting.  It also has the potential to delay discharge from the hospital if we have the luxury of finding this information out before they go home.

Other insurance companies have recently implemented policies to deny coverage for extended release or long acting (ERLA) medications except for a specific formulation of long acting morphine, tramadol. The patient who encountered this barrier had an allergy to morphine and the other covered medications were not good options for them.  A good regimen was put into place while the patient was hospitalized, only to have it all fall apart immediately following discharge.  They were sent home on only short acting, immediate release medications.  These formulations can be quite burdensome as they generally have to be scheduled every four hours, which means you would have to wake up overnight in order to keep the medication in your system. But, does the insurance carrier care – NO!

An additional example is a patient who was seen by an inpatient palliative care service.  This patient had a new diagnosis of lung cancer with bone metastases, a past medical history that included bipolar disorder and remote illicit drug abuse.  They had been tapered off methadone for medication assisted therapy with methadone at 6 months prior to admission and the patient was already on gabapentin 800mg three times daily.  While in the hospital, IV hydromorphone was used to manage pain and was then converted to oral oxycodone.  After investigating insurance options for the patient, it was discovered that the insurance would not cover long acting oxycodone without having clinical failure of 3 other long acting medications on the formulary (morphine ER, fentanyl patch, Xtamza, or Zohydro).  This patient was then converted to extended release morphine. Even though the process was followed of using a preferred agent (extended release morphine), the insurance company still required a prior authorization for the medication. The day after discharge, the patient and left voicemail message that they were very concerned about how they were going to get the insurance to cover the prescriptions provided at hospital discharge. Because of the time required to obtain the prior authorization, the patient used more of his immediate release morphine as needed (PRN) dose, ran out early and suffered uncontrolled pain.  The prior authorization was sent on the day of discharge, on day 12 after discharge the patient ran out of all of the pain medications and presented back to the hospital on day 14 after discharge due to uncontrolled pain. The patient was never able to fill the extended release morphine due to insurance issues. The emergency department staff gave the patient new prescriptions for immediate release morphine and provided authorization to the retail pharmacy to fill the prescriptions early. The palliative care team saw the patient 1-month after discharge and converted the pain medication to methadone. The prior authorization for methadone was faxed in and finally approved 7-days later after a 1-hour long peer to peer review completed by the prescribing physician. One week later the patient required an increase in the methadone and PRN immediate release morphine.  The insurance company required yet another prior authorization due to quantity limits of the morphine tablets as well as exceeding the insurance company’s MEDD.

The biggest challenge these insurance barriers have caused is that they also affect patients that have been on well-established pain regimens.  They either experience a delay in their treatment, or they have to go through the process of converting to a different medication that may or may not work as well as what was controlling their pain previously.

In addition to the legislation and insurance, we also have to battle all the negative press that is splattered ubiquitously in the news and Internet surrounding an opioid epidemic that focuses largely on prescription opioids, when we clearly have an illicit fentanyl and heroin epidemic – in fact, some may argue that a prescription opioid epidemic no longer exists, as outlined in Fentanyl: Separating Fact from Fiction. And because of this, we are encountering more and more patients and caregivers that are afraid to utilize medications that could benefit them.  They voice concerns that they will become addicted if they utilize opioids for pain control.  Some even state that they would rather be in pain than use medications that could cause them to become addicted.  Most of this is based promulgated by news and alternative facts.

Some colleagues are seeing increased frequency of pharmacists/pharmacies that are refusing to dispense opioids for emergency verbal order or via fax and requiring additional documentation.  This is seen more often as states roll out slightly different requirements for access/dispensing of controlled substances.

General confusion still exists about what hospices are required to do, or if hospice/palliative care/cancer diagnosis is in fact an exclusion to the various opioid legislation. Non-hospice/palliative care clinicians are increasingly hesitant and questioning of opioid prescriptions. This again causes delay in care for patients that are appropriate for opioid therapy which can lead to increased suffering.

These additional barriers, or beans will eventually cause the container to spill and the placement of the last bean causes patients, caregivers, and clinicians to lose the game while politicians claim victory. The questions is, victory over what?  In the end, it is our patients that lose, as they are smothered by beans and unrelenting pain.

Jessica E Geiger-Hayes is a palliative care pharmacist at OhioHealth where she is actively involved in pain and symptom management for patients with cancer and other chronic disease states. She presents locally, at the state level, and nationally on pain management and palliative care.

Drs. Geiger-Hayes and Fudin wish to acknowledge input from colleagues listed below:
Natalie Malone, PharmD
Pamela Moore, PharmD, BCPS
Tanya J. Uritsky, PharmD, BCPS, CPE
Bridget McCrate Protus, PharmD, MLIS, BCGP, CDP

As always, comments are welcome!

 

 

16 thoughts on “Have we spilled the beans on opioids?

  1. I don’t understand how politicians and pharmacies can live with themselves. Politicians won’t even have the decency to reply to an email. I’ve written them the last 3 years and if I get a reply it says thank you for writing about the opioid crisis we are in or the health care crisis we are in and has nothing to do with what was wrote. This has been going on for 3 years in Texas. Such horrible treatment, discrimination and inhumane treatment to allow a human to suffer and what makes it worse is they put you in a category of being a criminal seeking drugs and pain sufferers should be ashamed of themselves. All I can do is pray God hears my prayers for help.
    Try this again

  2. I don’t understand how politicians and pharmacies can live with themselves. Politicians won’t even have the decency to reply to an email. I’ve written them the last 3 years and if I get a reply it says thank you for writing about the opioid crisis we are in or the health care crisis we are in and has nothing to do with what was wrote. This has been going on for 3 years in Texas. Such horrible treatment, discrimination and inhumane treatment to allow a human to suffer and what makes it worse is they put you in a category of being a criminal seeking drugs and pain sufferers should be ashamed of themselves. All I can do is pray God hears my prayers for help.

  3. Oh there’s lots more nonsense you all missed. There are possibly hundreds of opioids to choose from, I just know from taking morphine about MSContin, Kadian, Avinza (no longer manufactured), various generics, and then all the dosages those come in, and that’s only long acting. Well guess what? The pharmacy doesn’t carry all of these, nor all the different dosages. That leaves you in a bind if you’re being tapered or titrated (yeah, as if). Because your doctor will date the prescription 1-2 days before you need it, but it takes the pharmacist 4-6 days to order and get it in.

    When I moved here, I had been talking Avinza, this is a 24 hour med. My doctor’s prescription said long acting morphine once a day. I tried to explain to the pharmacist that I need a 24 hour med for that. Nope, MSContin it is! So I’m getting a high dose for the first 8 hours with nothing by the end of the day. Lovely.

    Be super careful if you travel. I’m in KY, my family is mostly in CT, my husband’s family is mostly in MI. If we want to visit for any length of time, I have to be certain that the date chosen is right after I have filled my prescriptions. Very bad to run out of meds out of state, I used to be able to get them filled because I use a national chain pharmacy, they see me in their computer and that I fill the same prescriptions every month. They still see me but it doesn’t matter, “no out of state prescriptions EVER!” (Said like Joan Crawford in Mommy Dearest.)

    I’m sure I could think of more ridiculousness given time. Thanks for allowing me to vent.

  4. As I constantly say, EVERYONE is an accident or illness away from being a pain patient. Get enough legislators in that situation and the laws will be changed. While I don’t wish anything tragic on anyone, it’s the truth. Literally speaking, this truth is what will finally set the pain community free of all the battles and hassles now faced. Only by enough experiencing what each in this community does will they realize the damage they’ve done. Until then, keep fighting this good fight and keep the word out of the negative impact their bad laws have caused.

  5. I believe there is a handful or so of individuals who jump started this evil situation. I’m done however in mentioning names. It’s been a fruitless effort.

    How very sad that as a country we love dirty laundry. A great deal of money & media have cursed the ill & infirmed. Charging us with responsible for an epidemic.
    Michelle

  6. Thank you.
    Yes, this is an extremely difficult time for chronic and intractable pain sufferers / patients.
    It’s out of control insanity.
    It’s inhumane torture.

    1. I totally agree! As a patient being treated with opiates for 23 years after every possible option not working, i was finally back to society and better feeling about my lifestyle. Then down comes the hammer last year. I was tappered off them. I was no where close to an addiction and it’s been 10 months! But my pain and no relief in sight, I’m so depressed and in therapy for severe depression. I’m very angry with this whole new policy.

  7. Dear Jeff, Too bad the Pulitzer folks don’t count blogs.

    I have a question as opposed to a comment: Are you familiar with the position CMS announced it would be taking back in March of 2018? (https://www.nytimes.com/2018/03/27/health/opioids-medicare-limits.html) and from CMS: Improving Drug Utilization Review Controls in Part D (https://www.cms.gov/Medicare/Prescription-Drug-coverage/PrescriptionDrugCovContra/RxUtilization.html)

    We are as Jed Clampet used to say: We’re in a heap of trouble.

    Love to hear your thoughts.

    Best wishes,

    Mike Brennan

  8. I am dealing with this now. I have new coverage and pharmacy benefit provider. They require prior auth for a pain med I’ve been on for more than four years. My pcp is out of the office until next monday. Two days ago his assistant was supposed to submit prior auth, first by phone. I called today to find out the status. I was told she had to wait until I presented the written script at the pharmacy on 11/6, have it denied, then she could do the auth???

    I told her that was unacceptable, she is confused, doesn’t know what she’s talking about, and she did not have to wait to submit the auth until I was out of medication, and to please put in an urgent PA request. If the auth is denied, I will have to transition to a med on the formulary list. While looking it over, I see Oxymorphone ER is on the 2018 recommended formulary list. I thought that was taken off the market over a year ago??? Wasn’t it? Why would it be on the list? I have an allergy to two of the others.

    My meds are due to be refilled on 11/3. My pharmacy will not keep it in stock. They will only order it when I present the written script. Tomorrow is friday. If I don’t get the PA in time, I’m screwed, if I have to change meds I’m screwed. I can see how this is going to end. Not good for me. God help us all!

  9. I think they dumped about a dozen truckloads of explosive beans on a raging bonfire! In all seriousness, Dr. Geiger-Hayes and her colleagues did a great job explaining what a ridiculous mess we are in, now if only we can get the people who created ttyyÿy

    1. FYI, I just called my pharmacist. The Oxymorphone HCI ER is going to be taken off the market soon I was told. Opana was the brand that was banned last year.

      1. I think your pharmacist is confused. Oxymorphone is the generic version of Opana. Opana ER (Extended Release version) and Oxymorphone IR (Immediate Release version) were both removed from the market quite some time ago and is now unobtainable. The manufacturer is being fined for falsely assuring doctors that oxymorphone wasn’t as addictive as oxycodone, encouraging physicians to prescribe it and increase their revenues.

        1. Maureen,
          Opana ER was removed from the market because people were dissolving and injecting it, and that resulted in micro-angiopathies and death due to heart failure. The oxymorphone ER generic is still on the market but is close to being removed. The immediate release generic versions are still manufactured.

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