PACC 2016 Guidelines

Guideline Creation Process

Strength of Evidence and Consensus

The United States Preventative Services Task Force (USPSTF) created hierarchies of studies and degrees of recommendations based on evidence rankings.

Reprinted from American Journal of Preventive Medicine, Vol 20, Issue 3, Supplement 1, Russell P. Harris, Mark Helfand, Steven H. Woolf, Kathleen N. Lohr, Cynthia D. Mulrow, Steven M. Teutsch, David Atkins. ‘Current methods of the U.S. Preventive Services Task Force A review of the process’. Pages 21-35, Copyright 2001, with permission from American Journal of Preventive Medicine.

Consensus determination was performed with a quorum of 80% of contributing authors determining strength of evidence. Consensus rankings were determined to be strong if there was greater than 80% consensus, moderate if 50%-79% of authors agreed on the evidence, and weak if less than 49% of authors agreed on the recommendation.

Recommendations for IT Therapy Compared to Neurostimulation Using USPSTF Criteria

Along with neurostimulation, IT therapy should play an important role in the pain treatment continuum. The table below represents the strongest consensus recommendations comparing IT therapy vs. neurostimulation.

Reprinted from Neuromodulation: Technology at the Neural Interface, Vol 20 / Issue 2, Timothy R Deer, Jason E Pope, Salim M Hayek, Anjum Bux, Eric Buchser, Sam Eldabe, Jose A De Andrés, Michael Erdek, Dennis Patin, Jay S Grider, Daniel M Doleys, Marilyn S Jacobs, Tony L Yaksh, Lawrence Poree, Mark S Wallace, Joshua Prager, Richard Rauck, Oscar DeLeon, Sudhir Diwan, Steven M Falowski, Helena M Gazelka, Philip Kim, Michael Leong, Robert M Levy, Gladstone McDowell II, Porter McRoberts, Ramana Naidu, Samir Narouze, Christophe Perruchoud, Steven M Rosen, William S Rosenberg, Michael Saulino, Peter Staats, Lisa J Stearns, Dean Willis, Elliot Krames, Marc Huntoon, Nagy Mekhail, The Polyanalgesic Consensus Conference (PACC): Recommendations on Intrathecal Drug Infusion Systems Best Practices and Guidelines, Pages 96-132, Copyright (2017), with permission from the International Neuromodulation Society.

The evidence-base is not as strong supporting the application of IT therapy compared to neurostimulation in the following situations.

Reprinted from Neuromodulation: Technology at the Neural Interface, Vol 20 / Issue 2, Timothy R Deer, Jason E Pope, Salim M Hayek, Anjum Bux, Eric Buchser, Sam Eldabe, Jose A De Andrés, Michael Erdek, Dennis Patin, Jay S Grider, Daniel M Doleys, Marilyn S Jacobs, Tony L Yaksh, Lawrence Poree, Mark S Wallace, Joshua Prager, Richard Rauck, Oscar DeLeon, Sudhir Diwan, Steven M Falowski, Helena M Gazelka, Philip Kim, Michael Leong, Robert M Levy, Gladstone McDowell II, Porter McRoberts, Ramana Naidu, Samir Narouze, Christophe Perruchoud, Steven M Rosen, William S Rosenberg, Michael Saulino, Peter Staats, Lisa J Stearns, Dean Willis, Elliot Krames, Marc Huntoon, Nagy Mekhail, The Polyanalgesic Consensus Conference (PACC): Recommendations on Intrathecal Drug Infusion Systems Best Practices and Guidelines, Pages 96-132, Copyright (2017), with permission from the International Neuromodulation Society.

Patient Selection

Recommendations for Patient Selection Criteria for IT Therapy by the PACC Using USPSTF Criteria

Reprinted from Neuromodulation: Technology at the Neural Interface, Vol 20 / Issue 2, Timothy R Deer, Jason E Pope, Salim M Hayek, Anjum Bux, Eric Buchser, Sam Eldabe, Jose A De Andrés, Michael Erdek, Dennis Patin, Jay S Grider, Daniel M Doleys, Marilyn S Jacobs, Tony L Yaksh, Lawrence Poree, Mark S Wallace, Joshua Prager, Richard Rauck, Oscar DeLeon, Sudhir Diwan, Steven M Falowski, Helena M Gazelka, Philip Kim, Michael Leong, Robert M Levy, Gladstone McDowell II, Porter McRoberts, Ramana Naidu, Samir Narouze, Christophe Perruchoud, Steven M Rosen, William S Rosenberg, Michael Saulino, Peter Staats, Lisa J Stearns, Dean Willis, Elliot Krames, Marc Huntoon, Nagy Mekhail, The Polyanalgesic Consensus Conference (PACC): Recommendations on Intrathecal Drug Infusion Systems Best Practices and Guidelines, Pages 96-132, Copyright (2017), with permission from the International Neuromodulation Society.

Medication Selection

Medication Selection Recommendations & Considerations

The current PACC algorithms have been developed to help guide treatment decisions in the safe and effective use of IT therapy, however, physicians must rely on their own best judgement in making decisions for their patients.

Off-label drug monotherapy or combination therapy is not recommended until FDA-approved drugs are tried and failed, or contraindicated. Currently IT ziconotide and morphine are the only two agents approved by the FDA.

Reprinted from Neuromodulation: Technology at the Neural Interface, Vol 20 / Issue 2, Timothy R Deer, Jason E Pope, Salim M Hayek, Anjum Bux, Eric Buchser, Sam Eldabe, Jose A De Andrés, Michael Erdek, Dennis Patin, Jay S Grider, Daniel M Doleys, Marilyn S Jacobs, Tony L Yaksh, Lawrence Poree, Mark S Wallace, Joshua Prager, Richard Rauck, Oscar DeLeon, Sudhir Diwan, Steven M Falowski, Helena M Gazelka, Philip Kim, Michael Leong, Robert M Levy, Gladstone McDowell II, Porter McRoberts, Ramana Naidu, Samir Narouze, Christophe Perruchoud, Steven M Rosen, William S Rosenberg, Michael Saulino, Peter Staats, Lisa J Stearns, Dean Willis, Elliot Krames, Marc Huntoon, Nagy Mekhail, The Polyanalgesic Consensus Conference (PACC): Recommendations on Intrathecal Drug Infusion Systems Best Practices and Guidelines, Pages 96-132, Copyright (2017), with permission from the International Neuromodulation Society.

Cancer or Other Terminal Condition-Related Pain with Localized Nociceptive or Neuropathic Pain

Reprinted from Neuromodulation: Technology at the Neural Interface, Vol 20 / Issue 2, Timothy R Deer, Jason E Pope, Salim M Hayek, Anjum Bux, Eric Buchser, Sam Eldabe, Jose A De Andrés, Michael Erdek, Dennis Patin, Jay S Grider, Daniel M Doleys, Marilyn S Jacobs, Tony L Yaksh, Lawrence Poree, Mark S Wallace, Joshua Prager, Richard Rauck, Oscar DeLeon, Sudhir Diwan, Steven M Falowski, Helena M Gazelka, Philip Kim, Michael Leong, Robert M Levy, Gladstone McDowell II, Porter McRoberts, Ramana Naidu, Samir Narouze, Christophe Perruchoud, Steven M Rosen, William S Rosenberg, Michael Saulino, Peter Staats, Lisa J Stearns, Dean Willis, Elliot Krames, Marc Huntoon, Nagy Mekhail, The Polyanalgesic Consensus Conference (PACC): Recommendations on Intrathecal Drug Infusion Systems Best Practices and Guidelines, Pages 96-132, Copyright (2017), with permission from the International Neuromodulation Society.

Cancer or Other Terminal Condition-Related Pain with Diffuse Nociceptive or Neuropathic Pain

Reprinted from Neuromodulation: Technology at the Neural Interface, Vol 20 / Issue 2, Timothy R Deer, Jason E Pope, Salim M Hayek, Anjum Bux, Eric Buchser, Sam Eldabe, Jose A De Andrés, Michael Erdek, Dennis Patin, Jay S Grider, Daniel M Doleys, Marilyn S Jacobs, Tony L Yaksh, Lawrence Poree, Mark S Wallace, Joshua Prager, Richard Rauck, Oscar DeLeon, Sudhir Diwan, Steven M Falowski, Helena M Gazelka, Philip Kim, Michael Leong, Robert M Levy, Gladstone McDowell II, Porter McRoberts, Ramana Naidu, Samir Narouze, Christophe Perruchoud, Steven M Rosen, William S Rosenberg, Michael Saulino, Peter Staats, Lisa J Stearns, Dean Willis, Elliot Krames, Marc Huntoon, Nagy Mekhail, The Polyanalgesic Consensus Conference (PACC): Recommendations on Intrathecal Drug Infusion Systems Best Practices and Guidelines, Pages 96-132, Copyright (2017), with permission from the International Neuromodulation Society.

Noncancer-Related Pain with Diffuse Nociceptive or Neuropathic Pain

Reprinted from Neuromodulation: Technology at the Neural Interface, Vol 20 / Issue 2, Timothy R Deer, Jason E Pope, Salim M Hayek, Anjum Bux, Eric Buchser, Sam Eldabe, Jose A De Andrés, Michael Erdek, Dennis Patin, Jay S Grider, Daniel M Doleys, Marilyn S Jacobs, Tony L Yaksh, Lawrence Poree, Mark S Wallace, Joshua Prager, Richard Rauck, Oscar DeLeon, Sudhir Diwan, Steven M Falowski, Helena M Gazelka, Philip Kim, Michael Leong, Robert M Levy, Gladstone McDowell II, Porter McRoberts, Ramana Naidu, Samir Narouze, Christophe Perruchoud, Steven M Rosen, William S Rosenberg, Michael Saulino, Peter Staats, Lisa J Stearns, Dean Willis, Elliot Krames, Marc Huntoon, Nagy Mekhail, The Polyanalgesic Consensus Conference (PACC): Recommendations on Intrathecal Drug Infusion Systems Best Practices and Guidelines, Pages 96-132, Copyright (2017), with permission from the International Neuromodulation Society.

Reprinted from Neuromodulation: Technology at the Neural Interface, Volume 20, Issue 2, Timothy R. Deer, Salim M. Hayek, Jason E. Pope, Tim J. Lamer, Maged Hamza, Jay S. Grider, Steven M. Rosen, Samir Narouze, Christophe Perruchoud, Simon Thomson, Marc Russo, Eric Grigsby, Daniel M. Doleys, Marilyn S. Jacobs, Michael Saulino, Paul Christo, Philip Kim, Elliot Marc Huntoon, Elliot Krames, Nagy Mekhail, The Polyanalgesic Consensus Conference (PACC): Recommendations for Trialing of Intrathecal Drug Delivery Infusion Therapy. Pages 133-154, Copyright (2017), with permission from the International Neuromodulation Society.

Trialing

Reprinted from Neuromodulation: Technology at the Neural Interface, Volume 20, Issue 2, Timothy R. Deer, Salim M. Hayek, Jason E. Pope, Tim J. Lamer, Maged Hamza, Jay S. Grider, Steven M. Rosen, Samir Narouze, Christophe Perruchoud, Simon Thomson, Marc Russo, Eric Grigsby, Daniel M. Doleys, Marilyn S. Jacobs, Michael Saulino, Paul Christo, Philip Kim, Elliot Marc Huntoon, Elliot Krames, Nagy Mekhail, The Polyanalgesic Consensus Conference (PACC): Recommendations for Trialing of Intrathecal Drug Delivery Infusion Therapy. Pages 133-154, Copyright (2017), with permission from the International Neuromodulation Society.

Dosing

Recommended Starting Dosage Ranges for Intrathecal Medications for Long-Term Therapy Delivery

Reprinted from Neuromodulation: Technology at the Neural Interface, Vol 20 / Issue 2, Timothy R Deer, Jason E Pope, Salim M Hayek, Anjum Bux, Eric Buchser, Sam Eldabe, Jose A De Andrés, Michael Erdek, Dennis Patin, Jay S Grider, Daniel M Doleys, Marilyn S Jacobs, Tony L Yaksh, Lawrence Poree, Mark S Wallace, Joshua Prager, Richard Rauck, Oscar DeLeon, Sudhir Diwan, Steven M Falowski, Helena M Gazelka, Philip Kim, Michael Leong, Robert M Levy, Gladstone McDowell II, Porter McRoberts, Ramana Naidu, Samir Narouze, Christophe Perruchoud, Steven M Rosen, William S Rosenberg, Michael Saulino, Peter Staats, Lisa J Stearns, Dean Willis, Elliot Krames, Marc Huntoon, Nagy Mekhail, The Polyanalgesic Consensus Conference (PACC): Recommendations on Intrathecal Drug Infusion Systems Best Practices and Guidelines, Pages 96-132, Copyright (2017), with permission from the International Neuromodulation Society.

Reprinted from Neuromodulation: Technology at the Neural Interface, Vol 20 / Issue 2, Timothy R Deer, Jason E Pope, Salim M Hayek, Anjum Bux, Eric Buchser, Sam Eldabe, Jose A De Andrés, Michael Erdek, Dennis Patin, Jay S Grider, Daniel M Doleys, Marilyn S Jacobs, Tony L Yaksh, Lawrence Poree, Mark S Wallace, Joshua Prager, Richard Rauck, Oscar DeLeon, Sudhir Diwan, Steven M Falowski, Helena M Gazelka, Philip Kim, Michael Leong, Robert M Levy, Gladstone McDowell II, Porter McRoberts, Ramana Naidu, Samir Narouze, Christophe Perruchoud, Steven M Rosen, William S Rosenberg, Michael Saulino, Peter Staats, Lisa J Stearns, Dean Willis, Elliot Krames, Marc Huntoon, Nagy Mekhail, The Polyanalgesic Consensus Conference (PACC): Recommendations on Intrathecal Drug Infusion Systems Best Practices and Guidelines, Pages 96-132, Copyright (2017), with permission from the International Neuromodulation Society.