An Interview with Jeffrey Fudin, BS, PharmD, FCCP
Kevin L. Zacharoff, M.D.:
Thank you for agreeing to this interview with PainEDU. We are speaking with you on the initiative you began in August 2012, Professionals for Rational Opioid Monitoring & PharmacoTherapy (PROMPT) which was formed in response to the Physicians for Responsible Opioid Prescribing (PROP) petition sent to the FDA in July 2012. Please share with us the primary goals of PROMPT.
Jeffrey Fudin, BS, PharmD, FCCP: I think that the most important message that I would want people to know about PROMPT’s goal is that we feel that it takes a “whole neighborhood” to treat pain. PROMPT is a multidisciplinary group of clinical and research professionals invested in best practices for pain care in the U.S., ranging from psychologists and addictionologists to physicians, and all disciplines in between. The diversity of our group allows for a high degree of focus, as well.
I would cite four major goals for PROMPT:
- To carefully identify the exact problems with respect to opioids and their role in chronic pain management, and to figure out safe and effective solutions to those problems
- To take a rational, evidence-based approach to those problems and their solutions
- To promote provider education, preferably mandatory, as a primary approach to safe and effective pain care
- To promote risk stratification schematics as a standard of care for chronic pain care management
KZ: Specifically, what aspects of the Physicians for Responsible Opioid Prescribing (PROP) petition inspired you to take action by sending a response letter, in the form of a docket submission, to the FDA?
JF: First and foremost, PROP’s approach seems to overlook the multi-drug responsibility for many of the unintended deaths that occur related to opioids. More often than not, a number of confounding substances are identified in the bodies of these people.
Second, two portions of the PROP petition specifically pushed PROMPT to write a response: the request for a label change to a maximum 100mg daily morphine-equivalent dose, and the request for a 90-day maximum treatment limit for noncancer pain patients.
There is no one accepted definition of morphine equivalency to use as a standard, and to complicate matters, the varying pharmacokinetics of opioid analgesics make equivalency precision nearly impossible to measure in an entire population. One has to ask, whose definition of an “equianalgesic dose” would the FDA use?
The 90-day limit is not feasible, as it wouldn’t really be 90 days. You can’t just stop someone on the 90th day – what about withdrawal? Time is needed to taper these medications. Would that mean beginning a taper at day 75 to conclude by day 90? Additionally, there are individuals with severe, noncancer pain that clinically don’t fit a 90-day limit. One example that comes to mind is of a woman who had been hit by a bus in New York and had severe injury-related pain that lasted significantly longer than 90 days.
PROP has stated that these label changes would not affect practice, as providers may prescribe off-label as they wish – but not every provider working with a person in pain is ready to prescribe that way. “Off-label” very often carries a stigma associated with it, and while off-label prescribing may be defended as a standard of care and practice in certain situations, there are instances where prescribers have charges brought against them and the expense of the defense process is a thorn in the side. Also, the frequency of off-label prescribing may draw additional regulatory scrutiny, particularly in the charged atmosphere of pain management.
PROP also cited four observational studies that looked at dose-related overdose risk, but that did not separate substance abusers and chronic pain patients. This number contrasts with the American Pain Society/American Academy of Pain Medicine 2009 Guidelines that reviewed over 8,000 studies to provide an evidence basis for its dosage recommendations. PROMPT is concerned by the lack of quality evidence used to support PROP’s request for a label change that, if accepted by the FDA, could adversely affect many people with chronic, noncancer pain.
KZ: Please detail the key aspects of the PROMPT docket submission to the FDA.
JF: We wanted to communicate the following to the FDA as they consider the PROP petition:
- PROMPT has serious concerns about chronic opioid use and favors mitigating risks by employing reasonable and validated interventions on behalf of patient care and public safety.
- PROMPT’s membership includes a multidisciplinary group of clinicians, researchers, and academicians from across the spectrum of expertise (e.g., addiction, anesthesiology, nursing, pain, pharmacy, primary care, psychiatry, and psychology).
- PROMPT advocates for clinician education, proactive risk stratification, and appropriate therapeutic monitoring.
- PROMPT seeks to underscore the FDA’s responsibility to exercise its oversight responsibilities and authority as representatives of the people of the U.S., including the protection of chronic pain patients while mitigating risks.
[Click here to view PROMT’s response letter (includes the AAPM response letter sent to FDA)]
KZ: Specifically, in addition to responding to the PROP petition, what impact is PROMPT hoping to have on the landscape of chronic opioid therapy?
JF: We seek to be a voice for safe and effective pain management. Our mission statement is: “To advance a universal interdisciplinary, multi-modal approach in striving for effective pain management, including but not limited to, medically necessary opioids for chronic noncancer and palliative pain management and to advocate for appropriate Federal and State legislative strategies that improve outcomes and mitigate risks throughout the United States for all chronic pain sufferers.”
We seek to be a trusted advisory group on matters related to pain management for local, state, and federal regulatory agencies. We would like to contribute to rigorous study design to answer the unanswered questions on best practices for pain management.
KZ: What is PROMPT’s position with respect to the “crisis” of abuse, misuse, and unintended opioid-related deaths in the U.S.?
JF: We feel there needs to be involvement of key regulatory agencies over the long term, at both the state and federal levels. This involvement should be inclusive, not exclusive, and should include PROP representation. This collaboration should work together towards design and encouragement of studies to answer the unanswered questions.
A shorter-term strategy is to mandate prescriber education on the use of chronic opioid therapy, and include education about risk stratification. There should be encouragement for and support of prescription drug monitoring programs (PDMPs), not only within states, but between states. There should also be national sharing of data gathered from PDMPs, whereby military hospitals/clinics and Veteran’s Administration (VA) databases are included to get a fuller view of abuse, misuse, and unintended opioid related deaths. We need to work with the PDMPs to have the data available in real time; there is usually a 30-90 day lag and that is sub-optimal.
Over the long term, we also advocate for incorporating core pain management education, right from the beginning of healthcare education, into all programs that are training healthcare providers – the goal is to build competency and capacity to meet chronic pain care challenges. This education should span from schools of medicine and nursing to schools of dentistry, psychology, pharmacy, and other specialties, including podiatry. All providers with prescriptive privileges absolutely need training; this training should help them determine when they’re in over their heads and need to refer to a pain specialist.
To summarize, we need an approach that is proactive, not retroactive.
KZ: What do you anticipate the FDA’s response will be regarding the PROP petition?
JF: I believe it will not be accepted. The FDA is aware that there is a problem. We have a Risk Evaluation and Mitigation Strategy (REMS) class-wide for opioids that is just getting underway, with the provider education available in March 2013. I believe the FDA will want to see the impact of that effort as they undertake other measures to increase safe and effective use of opioids, and to minimize harm from misuse, abuse, and diversion. I think the FDA will use a due process approach.
KZ: Do you anticipate an FDA response to PROMPT’s docket submission?
JF: I don’t believe they will respond specifically to us; we are just one voice that accepted the invitation to comment and respond. If they responded to us, they would have to respond to all docket submissions. But, we are more than willing to work with them in any capacity that can ultimately improve patient outcomes.
KZ: Do the members of PROMPT see changes ahead with respect to the utilization of opioids to treat chronic noncancer pain?
JF: A couple of things come to mind. If the FDA were to allow any part of the PROP petition to happen, a number of patients with chronic pain could suffer for any of a number of reasons. There is a huge subset of patients requiring long-term therapy with opioids that are not being discussed. There are medically complex patients with comorbidities that make opioids their only choice for pain management. I see this in my practice setting daily. There is also the complexity of chronic pain with comorbid histories of substance abuse. These are tough choices to make – to prescribe analgesics with side effect profiles that are not safe for certain patients when those same patients may have substance abuse concerns. The reclassification of hydrocodone to a more restricted schedule (currently under consideration) could create challenges to getting optimal care by patients with chronic pain. On the one hand, this could reduce inappropriate prescribing, but on the other hand, it could promote more NSAID use – the result of which could be poor outcomes in terms of kidney dysfunction, heart disease, and GI bleeding. The needs of these medically complex patients must be considered, and I would say that opioid therapy may be the lesser of two evils as providers work to alleviate suffering.
KZ: What is the long-term vision for PROMPT?
JF: We plan to be together for the long term; we are not a short-term group. We have our finger on the pulse of regulations that affect patient care. We are a group of experts nation-wide that have a common interest in things being done right and ensuring that patients aren’t harmed. We are available to offer our opinion on policies that affect pain management. What we’re really looking for is good discussions to take place that ultimately benefit patients.