How to stop opiates....

[ventana]

https://www.fda.gov/Drugs/DrugSafety/ucm635038.htm

 

FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering

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Safety Announcement

[4-9-2019] The U.S. Food and Drug Administration (FDA) has received reports of serious harm in patients who are physically dependent on opioid pain medicines suddenly having these medicines discontinued or the dose rapidly decreased. These include serious withdrawal symptoms, uncontrolled pain, psychological distress, and suicide.

While we continue to track this safety concern as part of our ongoing monitoring of risks associated with opioid pain medicines, we are requiring changes to the prescribing information for these medicines that are intended for use in the outpatient setting. These changes will provide expanded guidance to health care professionals on how to safely decrease the dose in patients who are physically dependent on opioid pain medicines when the dose is to be decreased or the medicine is to be discontinued.

Rapid discontinuation can result in uncontrolled pain or withdrawal symptoms. In turn, these symptoms can lead patients to seek other sources of opioid pain medicines, which may be confused with drug-seeking for abuse. Patients may attempt to treat their pain or withdrawal symptoms with illicit opioids, such as heroin, and other substances.

Opioids are a class of powerful prescription medicines that are used to manage pain when other treatments and medicines cannot be taken or are not able to provide enough pain relief. They have serious risks, including abuse, addiction, overdose, and death. Examples of common opioids include codeine, fentanyl, hydrocodone, hydromorphone, morphine, oxycodone, and oxymorphone.

Health care professionals should not abruptly discontinue opioids in a patient who is physically dependent. When you and your patient have agreed to taper the dose of opioid analgesic, consider a variety of factors, including the dose of the drug, the duration of treatment, the type of pain being treated, and the physical and psychological attributes of the patient. No standard opioid tapering schedule exists that is suitable for all patients. Create a patient-specific plan to gradually taper the dose of the opioid and ensure ongoing monitoring and support, as needed, to avoid serious withdrawal symptoms, worsening of the patient’s pain, or psychological distress (For tapering and additional recommendations, see Additional Information for Health Care Professionals).

Patients taking opioid pain medicines long-term should not suddenly stop taking your medicine without first discussing with your health care professional a plan for how to slowly decrease the dose of the opioid and continue to manage your pain. Even when the opioid dose is decreased gradually, you may experience symptoms of withdrawal (See Additional Information for Patients). Contact your health care professional if you experience increased pain, withdrawal symptoms, changes in your mood, or thoughts of suicide.

We are continuing to monitor this safety concern and will update the public if we have new information. Because we are constantly monitoring the safety of opioid pain medicines, we are also including new prescribing information on other side effects including central sleep apnea and drug interactions. We are also updating information on proper storage and disposal of these medicines that is currently available on our
Disposal of Unused Medicines webpage.

To help FDA track safety issues with medicines, we urge patients and health care professionals to report side effects involving opioids or other medicines to the FDA Me

 

Additional Information for Health Care Professionals

• Do not abruptly discontinue opioid analgesics in patients physically dependent on opioids. Counsel patients not to discontinue their opioids without first discussing the need for a gradual tapering regimen.
• Abrupt or inappropriately rapid discontinuation of opioids in patients who are physically dependent has been associated with serious withdrawal symptoms, uncontrolled pain, and suicide. Abrupt or rapid discontinuation has also been associated with attempts to find other sources of opioid analgesics, which may be confused with drug-seeking for abuse. Patients may also attempt to treat their pain or withdrawal symptoms with illicit opioids, such as heroin, and other substances.
• It is important to ensure ongoing care of the patient and to agree on an appropriate tapering schedule and follow-up plan so that patient and provider goals and expectations are clear and realistic.
• When deciding how to discontinue or decrease therapy in an opioid-dependent patient, consider a variety of factors, including the dose of the opioid analgesic the patient has been taking, the duration of treatment, the type of pain being treated, and the physical and psychological attributes of the patient.
• There are no standard opioid tapering schedules that are suitable for all patients. A patient-specific plan should be used to taper the dose of the opioid gradually.
• In general, for patients who are physically dependent on opioids, taper by an increment of no more than 10 percent to 25 percent every 2 to 4 weeks. It may be necessary to provide the patient with lower dosage strengths to accomplish a successful taper.
• If the patient is experiencing increased pain or serious withdrawal symptoms, it may be necessary to pause the taper for a period of time, raise the opioid analgesic to the previous dose, and then once stable, proceed with a more gradual taper.
• When managing patients taking opioid analgesics, particularly those who have been treated for a long duration and/or with high doses for chronic pain, ensure that a multimodal approach to pain management, including mental health support (if needed), is in place prior to initiating an opioid analgesic taper. A multimodal approach to pain management may optimize the treatment of chronic pain, as well as assist with the successful tapering of the opioid analgesic.
• Patients who have been taking opioids for shorter time periods may tolerate a more rapid taper.
• Frequent follow-up with patients is important. Reassess the patient regularly to manage pain and withdrawal symptoms that emerge. Common withdrawal symptoms include:
  • Restlessness
  • Lacrimation
  • Rhinorrhea
  • Yawning
  • Perspiration
  • Chills
  • Myalgia
• Other symptoms also may develop, including:
  • Irritability
  • Anxiety
  • Insomnia
  • Backache
  • Joint pain
  • Weakness
  • Abdominal cramps
  • Anorexia
  • Nausea
  • Vomiting
  • Diarrhea
  • Increased blood pressure or heart rate
  • Increased breathing rate
• Patients should also be monitored for suicidal thoughts, use of other substances, or any changes in mood.
• When opioid analgesics are being discontinued due to a suspected substance use disorder, evaluate and treat the patient, or refer him/her for evaluation and treatment of the substance use disorder. Treatment should include evidence-based approaches such as medication assisted treatment of opioid use disorder. Complex patients with comorbid pain and substance use disorders may benefit from referral to a specialist.
• To help FDA track safety issues with medicines, report adverse events involving opioids or other medicines to the FDA MedWatch program, using the information in the "Contact FDA" box at the bottom of this page.

 

 

 

[ventana]

The above is from the FDA yesterday (4-9-19)

 

This is a huge shift away from the "just stop all opiates" mantra that hurts so many people.  

It is no longer acceptable to force withdrawal on your patients.... 

[CAAdmission]

Seriously, what morons ever thought you could just stop?

Have we become so stupid we need mommy government to guide us in everything we do? We have become a helpless society, and the fools who run things - from both parties - are only making it worse. 

 

[sas5814]

Even back in the "just stop" days that followed pain as the 5th vital sign (*sigh*) I was discussing plans to taper my opioid patients off. The vast majority simply stopped seeing me because they were terrified of stopping. I had several taper off successfully and one accelerated his own discontinuation sans my recommendation but succeeded.

I guess I was lucky. I had a bad motorcycle accident and ended up on Norco QID for years. A friend who was also my PCP told me it was time to do something else. I basically just stopped. I had no withdrawal...no desire to start again. However a host of side effects I wasn't even aware of faded away. One in a million luck I suppose.

[wilso2ar]

Working in pain management this happens all to often.  I get people showing up on our doorstep after just running out of their high dose opioids and now I'm left to deal with them.  Their previous prescriber who made the mess refuses to properly wean them. Since the CDC guidelines came out, medical providers are so scared to prescribe that they just refuse and don't care what happens to the patient.  A local large hospital system won't allow their primary care to manage any chronic opioids regardless of the dose.  We are seeing the effects of the pendulum swinging too far. 

[sas5814]

yup...this is what happens when politics gets messed in with medicine. Don't react....over react!

 

[rev ronin]

12 hours ago, wilso2ar said:

Since the CDC guidelines came out, medical providers are so scared to prescribe that they just refuse and don't care as much about what happens to the patient as they do their own malpractice and liability risk.

Fixed that for you.

I mean, I get that that's what it looks like from your perspective, but Washington State has been sending quarterly reports to every prescribing provider cataloguing all the times we've been "bad"--such as me providing Oxy and psych providing a benzo: that counts against both of us.  No credit for the formerly-stupidly-high MEDs I've brought under 50, of course.  I discuss these openly with my SP, who is very understanding, but it's still an imperfect report card from the agency that licenses me.

So I am in the intentional process of making all those "bad" numbers go away.  If  patient can't get off benzos or down below 50 MED, they need to go to pain management.  My visits are paid for by L&I and pain management's aren't?  That's an affordability/access problem, and while I might feel bad about it, it's not worth risking my family's livelihood to practice outside my scope.

Of course, I inherited all these patients anyways.  I've never, not once in 6.5 years of practice, taken a patient to above 50 MED for chronic noncancer pain, nor have I ever started anyone on scheduled benzos--prn absolutely for appropriate issues, but not scheduled.

[CAdamsPAC]

On 4/10/2019 at 10:00 PM, rev ronin said:

Fixed that for you.

I mean, I get that that's what it looks like from your perspective, but Washington State has been sending quarterly reports to every prescribing provider cataloguing all the times we've been "bad"--such as me providing Oxy and psych providing a benzo: that counts against both of us.  No credit for the formerly-stupidly-high MEDs I've brought under 50, of course.  I discuss these openly with my SP, who is very understanding, but it's still an imperfect report card from the agency that licenses me.

So I am in the intentional process of making all those "bad" numbers go away.  If  patient can't get off benzos or down below 50 MED, they need to go to pain management.  My visits are paid for by L&I and pain management's aren't?  That's an affordability/access problem, and while I might feel bad about it, it's not worth risking my family's livelihood to practice outside my scope.

Of course, I inherited all these patients anyways.  I've never, not once in 6.5 years of practice, taken a patient to above 50 MED for chronic noncancer pain, nor have I ever started anyone on scheduled benzos--prn absolutely for appropriate issues, but not scheduled.

As Ronald Reagan once said" the most frightening words ever spoken are" I'm from the government and I'm here to help."

[ventana]

To be clear -  this was intended to be a good thing - this FDA post

 

We now can simply say the FDA says this should be done this way to all the non-medical/admin types that try to unduly influence our prescribing.  How can a state BOM say you are doing it wrong when the FDA says it might take up to a year to taper someone off IF it is clinically indicated.....  it provides protection to us to do the jobs we are trained to do.