FROM THE LAWHERN FILES:
NORMAN J CLEMENT RPH., DDS, NORMAN L.CLEMENT PHARM-TECH, MALACHI F. MACKANDAL PHARMD, BELINDA BROWN-PARKER, JOSEPH SOLVO ESQ., REV. C.T. VIVIAN, JELANI ZIMBABWE CLEMENT, BS., MBA., WILLIE GUINYARD BS., JOSEPH WEBSTER MD., MBA, SHELLEY HIGHTOWER, BS., PHARMD., LEROY BAYLOR, ADRIENNE EDMUNDSON, JAY K.JOSHI. MD., MBA., NATASHA DUVALL PHARMD., WALTER L. SMITH BS., LEROY BAYLOR, BS., MS., MS., BRAHM FISHER ESQ., MICHELE ALEXANDER, CUDJOE WILDING BS, DEBRA LYNN SHEPHERD, BERES E. MUSCHETT, STRATEGIC ADVISORS
THE NEW OPIOPHOBIA
By the early 2010s, several factors converged to suppress opioid prescribing and diversion — which occurs when medications initially prescribed by doctors to their patients end up in the hands of third parties. States began cracking down on pill mills and tightening their prescription-monitoring programs in an effort to detect patients who doctor-shopped. Many limited the number of days for which pain relievers could be prescribed. At the same time, the makers of OxyContin reformulated the product to make it more difficult to crush and thus abuse.
These changes appear to have helped, as a dwindling number of opioid-related deaths since 2011 have been linked to prescription opioids. A CDC study of 11 states participating in the agency’s Enhanced State Opioid Overdose Surveillance program, for example, found that only 17.4% of those states’ opioid-related deaths between July 2016 and June 2017 involved prescription opioids alone.
Over the same period, deaths related to illicit opioids climbed dramatically. In January 2015, the CDC reported that 5,766 drug-overdose deaths involving synthetic opioids — mostly fentanyl, an opioid between 50 and 100 times more potent than morphine — had occurred during the preceding 12 months. In January 2017, the 12-month total was 20,932 — a jump of nearly 400%. July 2020’s report more than doubled the 2017 number, reaching 48,729. These numbers suggest that the very efforts to curb abuse of prescription pain relievers pushed opioid abusers to more potent and inherently riskier drugs that are now cheaper and more abundant than prescription pain relievers.
Many physicians also began refusing to prescribe opioids and withdrawing patients from their stable opioid regimens around 2011 — approximately the same time as states launched their reform efforts. Reports of pharmacies declining to fill prescriptions — even for patients with terminal illness, cancer pain, or acute post-surgical pain — started surfacing. At that point, 10 million Americans were suffering “high impact pain,” with four in five being unable to work and a third no longer able to perform basic self-care tasks such as washing themselves and getting dressed.
Their prospects grew even more tenuous with the release of the CDC’s “Guideline for Prescribing Opioids for Chronic Pain” in 2016. The guideline, which was labeled non-binding, offered reasonable advice to primary-care doctors — for example, it recommended going slow when initiating doses and advised weighing the harms and benefits of opioids. It also imposed no cap on dosage, instead advising prescribers to “avoid increasing dosage to ≥90 MME per day.” (An MME, or morphine milligram equivalent, is a basic measure of opioid potency relative to morphine: A 15 mg tablet of morphine equals 15 MMEs; 15 mg of oxycodone converts to about 25 mg morphine.)
Yet almost overnight, the CDC guideline became a new justification for dose control, with the 90 MME threshold taking on the power of an enforceable national standard. Policymakers, insurers, health-care systems, quality-assurance agencies, pharmacies, Department of Veterans Affairs medical centers, contractors for the U.S. Centers for Medicare and Medicaid Services, and state health authorities alike employed 90 MME as either a strict daily limit or a soft goal — the latter indicating that although exceptions were possible, they could be made only after much paperwork and delay.
As a result, prescribing fell even more sharply, in terms of both dosages per capita and numbers of prescriptions written. A 2019 Quest Diagnostics survey of 500 primary-care physicians found that over 80% were reluctant to accept patients who were taking prescription opioids, while a 2018 survey of 219 primary-care clinics in Michigan found that 41% of physicians would not prescribe opioids for patients who weren’t already receiving them. Pain specialists, too, were cutting back: According to a 2019 survey conducted by the American Board of Pain Medicine, 72% said they or their patients had been required to reduce the quantity or dose of medication. In the words of Dr. Sean Mackey, director of Stanford University’s pain-management program, “[t]here’s almost a McCarthyism on this, that’s silencing so many [health professionals] who are simply scared.”
“THANK YOU AGAIN”
FOR NOW YOU ARE WITHIN