Understanding the PACC Guidelines
December 2nd, 2022 Education, Government Regulations and Compliance, Understanding Intrathecal Therapy
Guiding the Path of Chronic Pain Treatment
If you treat patients living with chronic pain, you’ve probably heard of The Polyanalgesic Consensus Conference (PACC) Guidelines as you considered treatment options, such as intrathecal (IT) therapy.
What exactly are the PACC Guidelines? What do they do and why are they necessary? Let’s take a look at what they are and why they are so important to the intrathecal therapy landscape.
What is The Polyanalgesic Consensus Conference?
The PACC was formed in 2000 by the International Neuromodulation Society and is made up of 37 members. The members are MDs or PhDs with numerous years of experience and a high level of expertise in pain management and treatment.1
The International Neuromodulation Society formed PACC as a way to guide the practice of IT therapy, including how MITIGO™ is used, and address both innovations and deficiencies in treatment.1
What Does The PACC Do?
The goal of the PACC is to improve the safety and efficacy of intrathecal therapy. Research hasn’t kept pace with industry developments and changes, and as a result, clinical decision-making has relied on expert opinion. With 80% of IT therapy in the US being off-label, navigation around informed IT therapy decisions is needed.1
Essentially, the PACC looks at what is currently happening in the intrathecal landscape to make recommendations that promote safe, efficacious evidence-based care, help practitioners identify patients for intrathecal therapy, determine what diagnoses and diseases are treatable, and provide guidance on best practices. The guidelines were last updated in 2017 but are expected to be updated again in the near future.
Additional Information
For more in-depth information about the 2017 guidelines, check out this neurology publication’s take on the updates.
You can also read the full guidelines and best practices here.
MITIGO™: Intrathecal Therapy Treatment for Chronic Pain
Learn more about how MITIGO (morphine sulfate injection) can provide relief to your chronic pain patients.
Have more questions? Contact Us.
Sources:
1The National Library of Medicine.
*Note: Piramal Critical Care is not affiliated or partnered with the Neurology Advisor or Cal Spine Pain, whose resources are shared here.
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Important Risk Information
INDICATIONS AND USAGE
MITIGO™ (Morphine Sulfate Injection, USP – Preservative-free) is an opioid agonist, for use in continuous microinfusion devices and indicated only for intrathecal or epidural infusion in the management of intractable chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
IMPORTANT RISK INFORMATION
WARNING: RISKS WITH NEURAXIAL ADMINISTRATION; LIFE-THREATENING RESPIRATORY DEPRESSION; RISK OF ADDICTION, ABUSE, AND MISUSE; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
See full prescribing information for complete boxed warning.
- Single-dose neuraxial administration may result in acute or delayed respiratory depression up to 24 hours. Because of the risk of severe adverse reactions when MITIGO is administered by the epidural or intrathecal route of administration, patients must be observed in a fully equipped and staffed environment for at least 24 hours after the initial dose.
- Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. Patients must be observed in a fully equipped and staffed environment for at least 24 hours after each test dose and, as indicated, for the first several days after surgery.
- MITIGO exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient’s risk before prescribing and monitor regularly for these behaviors and conditions.
- Prolonged use of MITIGO during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If prolonged opioid use is required in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
- Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation.
CONTRAINDICATIONS
- Significant respiratory depression
- Acute or severe bronchial asthma in an unmonitored setting in absence of resuscitative equipment
- Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days
- Known or suspected gastrointestinal obstruction, including paralytic ileus
- Hypersensitivity or intolerance to morphine
Neuraxial administration of MITIGO is contraindicated in patients with:
- Infection at the injection microinfusion site
- Concomitant anticoagulant therapy
- Uncontrolled bleeding diathesis
- The presence of any other concomitant therapy or medical condition which would render epidural or intrathecal administration of medication especially hazardous.
WARNINGS AND PRECAUTIONS
- Risk of Inflammatory Masses: Monitor patients receiving continuous infusion of MITIGO via indwelling intrathecal catheter for new signs or symptoms of neurologic impairment.
- Risk of Tolerance and Myoclonic Activity: Monitor patients for unusual acceleration of neuraxial morphine, which may cause myoclonic-like spasm of lower extremities. Detoxification may be required.
- Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients: Monitor closely, particularly during initiation and titration.
- Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid.
- Severe Hypotension: Monitor during dosage initiation and titration. Avoid use of MITIGO in patients with circulatory shock.
- Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness: Monitor for sedation and respiratory depression. Avoid use of MITIGO in patients with impaired consciousness or coma.
ADVERSE REACTIONS
Most serious adverse reactions were respiratory depression, apnea, circulatory depression, respiratory arrest, shock, and cardiac arrest. Other common frequently observed adverse reactions include: sedation, lightheadedness, dizziness, nausea, vomiting, and constipation.
USE IN SPECIFIC POPULATIONS
- Pregnancy: May cause fetal harm.
- Hepatic and Renal Impairment: May affect the metabolism and excretion of MITIGO.
To report SUSPECTED ADVERSE REACTIONS, contact Piramal Critical Care, Inc. at 1-888-822-8431 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
For additional Important Risk Information, including boxed warning, see enclosed Full Prescribing Information.
INDICATIONS AND USAGE
MITIGO™ (Morphine Sulfate Injection, USP – Preservative-free) is an opioid agonist, for use in continuous microinfusion devices and indicated only for intrathecal or epidural infusion in the management of intractable chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
IMPORTANT RISK INFORMATION
WARNING: RISKS WITH NEURAXIAL ADMINISTRATION; LIFE-THREATENING RESPIRATORY DEPRESSION; RISK OF ADDICTION, ABUSE, AND MISUSE; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
See full prescribing information for complete boxed warning.
- Single-dose neuraxial administration may result in acute or delayed respiratory depression up to 24 hours. Because of the risk of severe adverse reactions when MITIGO is administered by the epidural or intrathecal route of administration, patients must be observed in a fully equipped and staffed environment for at least 24 hours after the initial dose.
- Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. Patients must be observed in a fully equipped and staffed environment for at least 24 hours after each test dose and, as indicated, for the first several days after surgery.
- MITIGO exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient’s risk before prescribing and monitor regularly for these behaviors and conditions.
- Prolonged use of MITIGO during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If prolonged opioid use is required in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
- Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation.
CONTRAINDICATIONS
- Significant respiratory depression
- Acute or severe bronchial asthma in an unmonitored setting in absence of resuscitative equipment
- Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days
- Known or suspected gastrointestinal obstruction, including paralytic ileus
- Hypersensitivity or intolerance to morphine
Neuraxial administration of MITIGO is contraindicated in patients with:
- Infection at the injection microinfusion site
- Concomitant anticoagulant therapy
- Uncontrolled bleeding diathesis
- The presence of any other concomitant therapy or medical condition which would render epidural or intrathecal administration of medication especially hazardous.
WARNINGS AND PRECAUTIONS
- Risk of Inflammatory Masses: Monitor patients receiving continuous infusion of MITIGO via indwelling intrathecal catheter for new signs or symptoms of neurologic impairment.
- Risk of Tolerance and Myoclonic Activity: Monitor patients for unusual acceleration of neuraxial morphine, which may cause myoclonic-like spasm of lower extremities. Detoxification may be required.
- Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients: Monitor closely, particularly during initiation and titration.
- Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid.
- Severe Hypotension: Monitor during dosage initiation and titration. Avoid use of MITIGO in patients with circulatory shock.
- Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness: Monitor for sedation and respiratory depression. Avoid use of MITIGO in patients with impaired consciousness or coma.
ADVERSE REACTIONS
Most serious adverse reactions were respiratory depression, apnea, circulatory depression, respiratory arrest, shock, and cardiac arrest. Other common frequently observed adverse reactions include: sedation, lightheadedness, dizziness, nausea, vomiting, and constipation.
USE IN SPECIFIC POPULATIONS
- Pregnancy: May cause fetal harm.
- Hepatic and Renal Impairment: May affect the metabolism and excretion of MITIGO.
To report SUSPECTED ADVERSE REACTIONS, contact Piramal Critical Care, Inc. at 1-888-822-8431 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
For additional Important Risk Information, including boxed warning, see enclosed Full Prescribing Information.