The International Pain and Spine Intervention Society is committed to assisting interventional pain physicians in delivering the safest care possible for patients. To achieve this, we monitor multiple government sources to identify issues of relevance
to physicians and patients. Additional links and information that may be of assistance are included below.
Local Anesthetic Shortage Advisory (January 18, 2023)
Best Practices for Interventional Pain Procedures in the Setting of a Local Anesthetic Shortage
Read the new timely and widely-accepted best practice recommendations for the performance of interventional pain procedures in the setting of
a local anesthetic shortage in Interventional Pain Medicine (IPM), the official journal of the International Pain and Spine Intervention Society
(IPSIS).
The recommendations were developed by IPSIS and are endorsed by the American Academy of Pain Medicine (AAPM), the American College of Radiology (ACR), the American Society of Neuroradiology (ASNR), the American Society of Spine Radiology
(ASSR), the North American Neuromodulation Society (NANS), the North American Spine Society (NASS), and the Society of Interventional Radiology (SIR).
Physicians should carefully weigh the risks and benefits of performing procedures without local anesthetic or using an alternative agent in the context of each unique patient's situation and should involve patients in shared decision making before proceeding.
Multisociety Contrast Media Advisory (August 1, 2022)
Best Practices for Interventional Pain Procedures in the Setting of an Iodinated Contrast Media Shortage: A Multisociety Practice Advisory
Read the new timely and widely-accepted best practice recommendations for mitigating the risks of performing interventional pain procedures when
iodinated contrast media are in short supply in Interventional Pain Medicine (IPM), the official journal of the International Pain and Spine Intervention
Society (IPSIS), published by Elsevier.
These recommendations were developed by IPSIS and the American Academy of Pain Medicine (AAPM) and are also endorsed by the American Academy of Physical Medicine and Rehabilitation (AAPMR), the American
Society of Neuroradiology (ASNR), the American Society of Spine Radiology (ASSR), the North American Neuromodulation Society (NANS), the North American Spine Society (NASS), and the Society of Interventional Radiology (SIR).
The new, expanded
practice advisory further clarifies and provides evidence in support of the recommendations designed to assist physicians who may be considering reuse of ICM vials for multiple patients, repackaging ICM vials, performing procedures without the use
of ICM, or using gadolinium-based contrast media in place of ICM.
It is critical that physicians carefully weigh the risks and benefits of performing procedures without ICM or using an alternative agent in the context of each unique patient’s situation and should involve patients in shared decision making before proceeding.
IPSIS Position Statement
Best Practices for Coping with Dexamethasone Shortages
The International Pain and Spine Intervention Society has
outlined best practice recommendations to maximize safety while performing epidural steroid injections during preservative-free dexamethasone shortages, like the one we are currently experiencing. These recommendations are designed to assist physicians
who may be considering alternative steroid preparations or different approaches to the epidural space. It is critical that physicians carefully weigh the risks and benefits of using alternative agents or approaches for epidural steroid injections and
involve each patient in the process of shared decision making before proceeding.
Centers for Disease Control and Prevention: www.cdc.gov
CDC's One & Only Campaign
We are proud to announce that the International Pain and Spine
Intervention Society has recently become a member of the One & Only Campaign, a public safety campaign to promote safe injection practices in all healthcare settings. By teaming up with the Safe Injection Practices Coalition, we're joining professional
groups, healthcare systems, provider groups, private companies and others dedicated to raising awareness of the importance of injection safety. Click here to learn more and download materials.
Injection Safety: www.cdc.gov/injectionsafety
Safe Injection Practices are a set of recommendations within Standard Precautions, which are the foundation for preventing transmission of infections during patient care in all healthcare settings including hospitals, long-term care facilities, ambulatory
care, home care and hospice. The most recent guideline outlining Standard Precautions is the Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings 2007
CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016
Deborah Dowell, MD; Tamara M. Haegerich, PhD; Roger Chou, MD.
MMWR Recomm Rep 2016;65:1–49
This guideline provides recommendations for primary care providers who are prescribing opioids for chronic pain outside of active cancer treatment, palliative care, and end-of-life care. The guideline addresses 1) when to initiate or continue opioids
for chronic pain; 2) opioid selection, dosage, duration, follow-up, and discontinuation; and 3) assessing risk and addressing harms of opioid use. This guideline is intended to improve communication between providers and patients about the risks and
benefits of opioid therapy for chronic pain, improve the safety and effectiveness of pain treatment, and reduce the risks associated with long-term opioid therapy, including abuse, dependence, overdose, and death.
Food and Drug Administration: www.fda.gov
Health Care Professionals: www.fda.gov/ForHealthProfessionals/default.htm
Information of interest to health care professionals.
MedWatch: www.fda.gov/Safety/MedWatch/default.htm
Your FDA gateway for clinically important safety information and reporting serious problems with human
medical products.
Know Your Source: http://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm389121.htm
"Know Your Source" is an educational
program advising health care professionals and practice administrators to only purchase prescription drugs from wholesale drug distributors licensed in your state to protect your patients from unsafe and ineffective drugs.
Drug Information Update- FDA Takes Important Step to Increase the Development of, and Access to, Abuse-Deterrent Opioids
On March 24, 2016, the U.S. Food and Drug Administration issued a draft guidance intended to support industry
in their development of generic versions of approved opioids with abuse-deterrent formulations (ADF) while ensuring that generic ADF opioids are no less abuse-deterrent than the brand-name drug. Today’s actions are among a number of steps the agency
recently outlined in an action plan to reassess its approach to opioid medications. The plan is focused on policies aimed at reversing the epidemic, while still providing patients in pain access to effective relief.
For more information, please visit: abuse- deterrent opioids.
FDA Calls for Sweeping Review of Opioids Policies
In response to the opioid abuse epidemic, on February 4, 2016, Dr. Robert Califf, the FDA’s Deputy Commissioner for Medical Products and Tobacco, along with other FDA leaders, called
for a far-reaching action plan to reassess the agency’s approach to opioid medications. The plan aims at reversing the epidemic, while still providing patients in pain access to effective relief.
The FDA will:
- Re-examine the risk-benefit paradigm for opioids and ensure that the agency considers their wider public health effects
- Convene an expert advisory committee before approving any new drug application for an opioid that does not have abuse-deterrent properties;
- Assemble and consult with the Pediatric Advisory Committee regarding a framework for pediatric opioid labeling before any new labeling is approved;
- Develop changes to immediate-release opioid labeling, including additional warnings and safety information that incorporate elements similar to the extended-release/long-acting (ER/LA) opioid analgesics labeling that is currently required;
- Update Risk Evaluation and Mitigation Strategy requirements for opioids after considering advisory committee recommendations and review of existing requirements;
- Expand access to, and encourage the development of, abuse-deterrent formulations of opioid products;
- Improve access to naloxone and medication-assisted treatment options for patients with opioid use disorders; and
- Support better pain management options, including alternative treatments.
As one of the cornerstones of this plan, the FDA will seek guidance from outside experts in the fields of pain management and drug abuse. For example, the FDA has already asked the National Academy of Medicine to help develop a framework for opioid review,
approval, and monitoring that balances individual need for pain control with considerations of the broader public health consequences of opioid misuse and abuse.
In addition, the FDA will convene independent advisory committees made up
of physicians and other experts when considering for approval any new opioid drugs that do not contain abuse-deterrent properties.
The FDA is also strengthening the requirements for drug companies to generate postmarket data on the long-term
impact of using ER/LA opioids. The agency expects this to result in the most comprehensive data ever collected in the field of pain medicine and treatments for opioid use disorder. The data will further the understanding of the known serious risks
of opioid misuse, abuse, overdose and death.
For more information, please visit: Opioids
AMA Task Force to Reduce Opioid Abuse
The American Medical Association has formed the AMA Task Force to Reduce Opioid Abuse to help coordinate, develop, and implement specific recommendations to ensure effective pain management practices and evidence-based prescribing of opioids; promote
appropriate referrals and access to care for patients with opioid use disorders; and take necessary steps needed to reduce opioid-related harm. The Task Force has launched a web-based resource (www.ama-assn.org/go/endopioidabuse) and will soon begin a national ad campaign to increase physicians’ registration and use of prescription drug monitoring programs as well as promote enhanced education and training to ensure that
physicians take the lead in becoming educated about evidence-based care and appropriate prescribing practices. The new website offers courses and educational materials offered by the American Osteopathic Association, American Dental Association, 55
state and specialty medical societies, and other key stakeholders. Resources include:
- State-specific information and links to prescription drug monitoring programs
- CME courses and webinars on preventing opioid abuse and safe opioid prescribing
- Safe and effective use of opioids for treatment of chronic pain and opioid use disorder: Resources from the Providers' Clinical Support System for Opioid Therapies
- Resources for patients
- Educational resources by state and specialty society
