On The Cover
APhA Staff
After more than 6 years, CDC is updating its opioid prescribing guidelines. With public feedback, officials are fine-tuning 12 new recommendations in the proposed guidelines, in what will be the first overhaul since 2016.
“It’s an improvement over the 2016 guidelines and does things those guidelines don’t,” said Bradlee R. Rea, PharmD.
When opioid use is unavoidable, the revised recommendations direct prescribers to use their best judgment guided by individual patient-centered decision making, whereas earlier guidance outlined set limits on opioid dosages patients could receive.
“My overall reaction is appreciation [that] they have removed many of the rigid numbers that were unfortunately overemphasized in the previous 2016 version,” said Chris Herndon, PharmD, BCACP, FASHP, FCCP, professor at Southern Illinois University Edwardsville School of Pharmacy.
Rea, who is an outpatient pain management clinical pharmacist at Kaweah Delta Health Care in Visalia, CA, said the new guidelines appropriately put the decision on the provider.
“The doctors own autonomy over opioid prescribing,” he said. This is particularly important with pain patients for whom care is often complex but who generally have established relationships with providers who can individually assess their unique needs and circumstances.
The 2016 CDC guidelines—which were simply intended to “guide” therapy—turned into policies and practices that, for example, encouraged hard limits and resulted in abrupt tapering of opioid drug doses in some cases.
“These new guidelines are not absolutes—that’s what got us in trouble with the 2016 guidelines. They took those and made them absolutes,” said Rea.
From the get-go, CDC said the 2016 guidelines were simply that: a series of suggestions to improve prescribing practices, not a regulation. However, insurance companies, states, provinces, and other government groups used the guidelines as an opportunity to create hard-and-fast rules. Insurance companies, for instance, may have coverage restrictions in place for opioid prescriptions above a certain morphine milligram equivalent per day.
Rea said the new CDC guidelines do not reverse the hard limits that insurance companies and others have put in place, however.
“Turning back laws and policies can be extremely difficult,” said Anne Burns, RPh, vice president of professional affairs at APhA, who was the only pharmacist on the workgroup that reviewed the guidelines.
Overall, Burns said she was pleased with the approach CDC took with these new guidelines—pushing for a patient-centered focus, for example, and placing an emphasis on social determinants of health and health equity.
The new guidance from CDC also encourages nonopioid therapies like prescription gabapentin and OTC nonsteroidal anti-inflammatory medications as well as nonpharmacologic strategies such as physical therapy, massage, and acupuncture.
“The guidelines attempt to provide direction on nonopioid and nonpharmacologic modalities, although the authors do not hold all treatment options to the same standard in terms of level of evidence,” said Herndon. “Many of the recommendations continue to be clinically intuitive, with recommendations focusing on avoiding opioids for first line therapy for most chronic pain syndromes as well as some acute pain conditions.”
The new guidelines are intended for primary care clinicians—including physicians, nurse practitioners, and physician assistants—as well as for outpatient clinicians in other specialties such as those managing dental and postsurgical pain and ED clinicians. The guideline authors have added sickle cell disease pain to the exclusion recommendations along with palliative and end-of-life care.
A final version of the proposed CDC opioid prescribing guidelines is expected by the end of 2022, and compliance with the recommendations is not mandatory.
Current snapshot of opioid epidemic
The new CDC opioid prescribing guidelines are released as overdose deaths reach record highs in the United States.
CDC estimates that during the COVID-19 pandemic the number of deaths from drug overdoses totaled 100,000 nationwide in over a year. Approximately three-quarters of those deaths were linked to opioid analgesics, primarily synthetic ones such as fentanyl.
“The opioid epidemic has transitioned almost entirely to illicit fentanyl,” said Herndon. “While I agree prescription opioid over-prescribing likely lit the match that started the fire, these guidelines—along with continued regulatory, corporate, and payer efforts—are continuing to focus on limiting prescription opioid use despite declining prescribing since 2012.”
The new CDC guidelines strive for a balance between protecting patients against the risks of opioid exposure and ensuring availability of opioids to manage severe or chronic pain.
Rea said it seems that the pendulum has swung back into the direction of opioids being appropriate and acceptable for certain patients experiencing pain.
“When monitored and used correctly, opioids can get people back to work,” said Rea.
According to provisional data released by CDC in March 2022, an estimated 105,752 Americans died from overdoses in the 12 months ending in October 2021, the highest number of overdose deaths recorded in the country in a single 12-month period. The total number of overdose deaths in 2020 was the highest ever at the time. Overdose deaths increased in 46 states compared with the year before, with Alaska having the largest yearly increase of 78% from October 2020. Only Hawaii, Wyoming, Delaware, and New Hampshire experienced year-over-year decreases in overdose deaths.
In addition, more research is surfacing on the surging racial disparities in the overdose crisis in the United States. Whereas previously the opioid epidemic was perceived as a “white” problem, a paper published February 2022 in the American Journal of Psychiatry found that overdose mortality per capita among non-Hispanic Black individuals tripled between 2010 and 2019. By 2019, Black mortality exceeded that of white individuals in 23 of the 40 states covered in the study. The authors said these shifts were largely driven by elevated rates of overdoses involving fentanyl and its analogs.
Overdose rates among non-Hispanic American Indian or Alaska Native individuals also jumped during this time period, mainly driven by increases in methamphetamine-related overdoses.
“As the 4-decade long overdose crisis enters its ‘fourth wave’—characterized by polysubstance use of potent, illicitly manufactured synthetic opioids, psychostimulants, and other drugs,” the authors of the study wrote. “Renewed attention is warranted to trends stratified by race and ethnicity.”
They said this new data paint a “stark picture” of the worsening burden of overdose on minority and ethnic communities.
Naloxone access and distribution
As the drug crisis only worsens, there’s one tool all health care professionals need to be comfortable with: naloxone.
“Everyone should have this,” said Rea. “Having Narcan everywhere will help get us through this crisis.”
A new study published in The Lancet Public Health is the first to estimate naloxone need for each U.S. state. Researchers found significant gaps in access to and distribution of naloxone, with areas like the East Coast—which are heavily affected by fentanyl use—to have the highest need compared to other regions.
“I think the findings show a path forward for the volume of naloxone across the country to saturate communities with access,” said Traci C. Green, PhD, MSc, senior author of the study and a professor at Brandeis University.
While there are many paths to obtain naloxone, the team modeled data from community naloxone distribution programs and community pharmacies and found that community-based and pharmacy-initiated naloxone distribution were more efficient in averting opioid overdose deaths than prescriber-based approaches only.
Unlike most community organizations, pharmacies are more easily accessible and are open longer hours. They also dispense prescription pain and opioid treatment medications; additionally, many sell nonprescription syringes.
“It’s a critical partnership,” said Green. “Our study shows that few states are putting enough naloxone in the hands of those who need it most—people at risk of experiencing or witnessing overdose. Naloxone provision is harm reduction and fundamentally patient safety. The model is clear there are many more lives that could be saved with improved access to naloxone at the pharmacy. Now we need to make it easy for patients to ask for it and for pharmacists to provide it.”
Green hopes that by answering the “how much naloxone do we need?” question, companies will know how much to manufacture, governments will know how much to budget for, and community leaders will know how many organizations will need to distribute the medication.
What Green and her colleagues did not model, however, was stigma. This remains a barrier to naloxone access and distribution in many places, and this is especially applicable to pharmacists. On the state level, adopted pharmacy-based naloxone laws allow pharmacists to dispense the opioid overdose antidote without a prescription. All states give pharmacists this authority through either statewide protocols, standing orders, or direct prescriptive authority (see map).
“Pharmacists can dispense naloxone, but they are not embracing that,” said Laura Palombi, PharmD, MPH, an associate professor at the University of Minnesota College of Pharmacy. “We are actually part of the problem.”
“There’s still a negative association of Narcan with opioid drug use,” said Rea. “But you can take opioids as prescribed and still have a breathing emergency.”
“We need to get educated on why this is a disease state and not a moral problem,” said Palombi. “People with substance use disorder may need naloxone just like someone with asthma may need an inhaler.”
“Opioid use disorder is stigmatized more than depression, even though I see these [both as] mental health disorders,” said Rea.
Even if a pharmacist is comfortable stocking naloxone, some only see a financial loss due to product reimbursement that does not cover product cost.
“When you look at the pharmacy side of [product] reimbursement for naloxone, it’s a loss to the pharmacy when you are trying to maintain a business,” said Thomas S. Franko, PharmD, associate professor of pharmacy practice at Wilkes University in Pennsylvania. Pharmacists want to help their patients, he said, but they tend to be placed into a precarious situation when dispensing naloxone at a loss.
“The inability for insurers to provide appropriate payment is hamstringing pharmacists, especially those in at-risk communities,” said Franko. “If those pharmacies unfortunately close, that will place the local community at increased risk of harm from limited health care access.”
Pharmacy organizations should continue to advocate around these issues, said Franko. He also sees training as a step toward removing some of the hesitation and discomfort pharmacists have with naloxone. A good place to start, according to Franko, is the APhA Institute on Substance Use Disorders, which is held each year in Salt Lake City.
Alabama, Alaska, California, Colorado, Illinois, Iowa, New Mexico, South Carolina, and Tennessee have a training component for pharmacists in their naloxone standing order or statewide protocol.
“There are things we can control and things we can’t control—we can control our comfort around naloxone,” said Franko. ■