In response to Insurance Business America's May 14 opinion piece by International Academy of Compounding Pharmacists CEO David G. Miller, which offers an alternative view Joe Paduda’s April 3 article featuring a CompPharma report on potential dangers in using compounded medications in workers' compensation, Paduda has provided the following responses to the questions raised by Miller.
David Miller asked me several questions in his May 14 opinion piece regarding CompPharma’s research paper on compound medications in workers’ compensation. Here is my response.
First, Miller said, “Paduda is clearly watching a bottom line in relation to worker compensation costs, he is missing the big picture: the goal of worker compensation programs is to get workers back to work, and compounded medications – like commercially manufactured medications – play a role in returning these individuals to health and to work.”
He must not have read the research paper, which clearly noted the purpose of workers’ compensation, cited the importance of importance of quality of care and patient safety.
I’d also note that, as with the rest of his comments, Miller didn’t cite any research, quote any studies, note any published papers, or reference any articles. Unlike the meticulously researched and carefully vetted paper authored by a half-dozen pharmacists and government affairs professionals, Miller cited no outside sources, relying solely on his opinion.
On to Mr. Miller’s questions.
“Which drugs does Mr. Paduda want to restrict? Chemotherapy for the oncology patient whose commercially manufactured medication is unavailable? Liquid medications for patients on feeding tubes who cannot swallow oral medications? We are eager to know.”
Cancer claims, while rare, do exist in workers' compensation—and may increase as more and more states adopt cancer presumption laws. This research paper did not in any way imply that there is an objection to the extemporaneous compounding of FDA-approved drugs, just as it did not object to the compounding of hospital admixtures, radionuclides or any other area where the delivery of FDA-approved products requires such activity. Second, the paper clearly noted that compound medications are indeed appropriate for patients who cannot swallow and where the medication cannot be put into liquid form.
Second, Miller asks, “Regarding Mr. Paduda’s comments on safety, where is the source that forms the basis of his opinion? He relates the story of New England Compounding Center, which we all know now to have been a drug manufacturer masquerading as a pharmacy and whose problems were known to, but ignored by, both state and federal regulators.”
Well, the New England Compounding Center did make drugs that were used in epidural steroid injections, a procedure far-too-commonly used in workers’ compensation. I don’t understand how Miller would think this isn’t relevant; it certainly is to the individuals harmed and the families of those killed by NECC.
Mr. Miller wrote: “Compounded pain medications, for instance, are non-addictive. So as our nation faces a staggering human and fiscal cost relating to abuse of opioids, compounded pain gels and creams offer a safe alternative. Yet increasingly, insurers won’t cover this cost, and instead pay exponentially more as a result of abuse and diversion of Oxycodone and similar drugs.”
CompPharma has been addressing the opioid abuse/overuse problem for years, and many enlightened insurers have implemented programs—many provided by our member PBMs—to identify opioid overuse on claims and intervene to create an appropriate drug regimen.
However, the suggestion that topical compounds are somehow comparable to Oxycontin is just ludicrous. We looked for peer-reviewed evidence that topical compounds can decrease the need for opioids and could not find any. Instead, insurance payers see compounds as merely adding unnecessary costs rather than eliminating problematic therapies.
Instead of dispensing hugely expensive custom compounds using mostly the same ingredients as over-the-counter creams, doctors should first prescribe those OTC creams plus generic NSAIDs or FDA approved topical preparations that are proven to work, then if the patient fails, move to other medications.
Finally, it is instructive to discern what Miller did not take issue with: the complete lack of research supporting the efficacy or safety of compounded topical medications
that was clearly described in CompPharma’s research paper. To that, he chose not to take issue.
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