Patient Safety Information and Resources

The Spine Intervention Society is committed to assisting spine care providers in delivering the safest care possible for patients. To this end, we monitor multiple government sources to identify issues of relevance to interventional spine care providers and patients. Additional links and information that may be of assistance are included below.


Centers for Disease Control and Prevention: www.cdc.gov

CDC's One & Only Campaign

We are proud to announce that the 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.

One Needle, One Syringe, Only One Time. Safe Injection Practices Coalition.

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: www.ama-assn.org/go/endopioidabuse

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

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