This year’s National Rx Drug Abuse and Heroin Summit attracted a lot of Federal, State, Healthcare, and Workers’ Compensation dignitaries. In my day to day work reality, I have the privilege of learning from and interacting with the brightest minds in Healthcare and WorkComp. The Summit allowed me an opportunity to sit and listen to two well-respected thought-leaders in WorkComp on the subject of drug formularies, Joe Paduda and Mark Pew.
The format of the 3-way discussion (between Paduda, Pew, and the audience) was less presentation and more interactive, a very welcome respite from a PowerPoint-intensive week. The dialog flow and subject-matter was malleable by audience inquiry/commentary and loosely guided by questions from the moderator (Michelle Landers, JD).
Among numerous topics that were covered relative to drug formularies, both presenters had very interesting comments on the question, what formulary model is “better” – the binary Y/N model, or the newly available condition-based model.
The general consensus between Paduda and Pew on the question was in sync:
Pew qualified that while the binary Y/N model was easy to use and easy to implement, this format typically delegates the selection of drug classification (either Y/N; included or excluded) to non-clinical professionals, such as bureaucrats, instead of clinically trained professionals. Pew shared an experience where he witnessed doctors asking bureaucrats what drugs they should use/prescribe during a recent hearing/meeting he attended. This scenario demonstrates that a binary Y/N option can be counter-productive to a medically sound process. My summation of Mark Pew’s comments on this topic is that aY/N approach is quick and easy, but is not the most clinically responsible option.
Paduda echoed Pew on the binary Y/N model being easy to implement and added that the model was “wrong” and medically inappropriate. “People are not binary,” Paduda continued. In the case of the 50% of individuals who are genetically predisposed to addiction, it could be a costly mistake to prescribe a pharmaceutical agent that has been classified as a Y drug for a completely inappropriate medical condition without consideration to the phase of care (acute or chronic). Paduda also shared concerns about back-flow issues to WorkComp systems caused by retrospective denial of payment for scrips filled for inappropriate medical conditions. My interpretation of Joe Paduda’s comments on the issue is that the easy/overly simplistic model presents serious concerns with the well-being of injured workers and potential back-flow to WorkComp systems.
Both presenters stated that jurisdictions should carefully consider their vision for implementation and clearly define their measurement of success before selecting the model that best fits their system.
Paduda and Pew also addressed the most important principles/attributes to look for in a drug formulary/formulary adoption:
Pew identified that a successful formulary adoption hinges on a dispute resolution process. The process by which a doctor requests a variance from the formulary must be easy and efficient minimizing needed administrative activity. The key is to avoid the delay of important pharmaceutical therapy due to an overly complex dispute resolution process.
Pew added that the formulary must be founded in evidence-based medicine(EBM) and an implementation should be supported by key stakeholders (Healthcare, Payers, Employers, Legal, and Government Agencies, etc.) through active participation in the education and adoption process in their jurisdictions.
Paduda identified a principle often overlooked and rarely discussed in the formulary review/implementation process – the accounting of functionality, or return to function. A member of the audience, a Pain Specialist, offered commentary on the subject. He explained that physicians are being providedPDMPs (Prescription Drug Monitoring Programs), formularies, and numerous other technical tools. He expressed that a very useful/fundamental tool physicians can/should use is the measurement of functional improvement. For example, if a physician prescribes an opioid (deemed appropriate by EBM for the diagnosed medical condition) and functional improvement is experienced then it is appropriate to cautiously continue with the short-term prescription as defined by sound EBM protocol. However, if functional improvement is absent, then an “exit strategy” should be devised immediately. In WorkComp, functionality, or the measurement of functional improvement, is ultimately measured by return-to-work (modified duty, or full duty).
Paduda touched on another very important principle that is often overlooked when considering a formulary. The resource’s development should be transparent per the IOM’s (Institute Of Medicine) standards for EBM. The term EBM is used too frequently and without qualification; it is in danger of becoming “white noise”. The term is frequently associated with solutions, content sources, services, that do not meet the objective criteria of EBM. I liken the industry’s use of the label to Healthcare’s Big Data movement; many claim to have big data without truly having the qualified resources. The alignment with the IOM standards ensures that the formulary is truly rooted in a process that is transparent, reproducible, researched and developed by qualified professionals, and deemed accurate/appropriate by non-interested external review.
When asked about THE outcome that demonstrates a successful adoption and implementation of a formulary, Paduda and Pew suggested that it depends on the original goals set forth by the jurisdiction. Paduda spoke to Texas’ successful reduction of opioid prescriptions. The reduction of prescriptions in and of itself is a “good thing.” However, can anyone explain what is happening with the individuals previously being prescribed opioids and no longer have access to the scrips in the State of Texas? With 75% of heroin users reporting their substance abuse started with opioids, it is a very real concern that these individuals may turn to the black market if addiction is a factor (8% of individuals prescribed opioids will become addicted; Nora Volkow, MD, National Institute on Drug Abuse). With this in mind, a reduction in prescriptions, may not be the ultimate measurement of success.
The State of Texas is often used as an example of a successful implementation of a drug formulary, so it is fitting that it would be a theme that Paduda and Pew parked on for discussion.
Pew explained that Texas saw a need for a drug formulary long before they actually implemented one. They took time to research, communicate, plan and rally key stakeholders in the State to maximize support of the adoption. HB7 in Texas laid the proper foundation for enforcing compliance once the formulary was ready for implementation. While the reduction in the prescription of opioids is undeniable, there is still cause for concern with the format they’ve adopted. As previously mentioned, the binary Y/N format is not medically appropriate and creates back-flow issues for the State. Exposure to the State and to its injured employees is compounded by the fact that prescription drugs are being prescribed and filled with the qualification of medical appropriateness being done on the back-end, and likely by a non-clinical professional.
Pew was gracious in explaining that Texas was a “leader” in the area of formulary adoption and implementation. Pew stated, “You can always pick out a leader. They are the ones with arrows in their back”. The statement implies that leaders are willing to travel unexplored roads and paths. As a result of having no roadmap to follow or experiences to learn from, they “don’t know what they don’t know” and grow/improve through “unintentional consequences.”
Tying a bow on the theme of Texas, Paduda and Pew both agreed that Texas was a good start. The format that was adopted was the only format available at the time. However, States can now learn from Texas’ unintended consequences and solve for them in their endeavor to adopt and implement a medically sound, patient-centric, and EBM drug formulary.
The session with Paduda and Pew was ended by the moderator due to time constraints (the time really flew by). The dialog on the whole was engaging and informative. Experience and expertise from both speakers was plentiful; the information provided was insightful and offered new areas of consideration for the numerous States/jurisdictions looking to adopt a drug formulary.
Thank you to Joe Paduda and Mark Pew for an excellent discussion on a very important topic!