Bulletin Today

The delayed oral arguments in Rutledge v Pharmaceutical Care Management Association (PCMA) were finally heard by the Supreme Court of the United States (SCOTUS) via telephone on October 6. PCMA won a challenge to an Arkansas state law regulating PBMs’ pharmacy reimbursement rates in the Eighth Circuit Court of the United States, and Arkansas Attorney General Leslie Rutledge appealed to bring the case to SCOTUS. 

Arkansas’s Act 900 sought to require that PBMs reimburse pharmacies at or above the wholesale costs of generic drugs. This act addressed the PBM practices that caused some pharmacies to lose money on the prescriptions they filled, threatening their business and patients’ access to their services. Act 900 also forbid PBMs from reimbursing affiliated pharmacies more than they paid others (e.g., CVS Health comprises the PBM CVS Caremark and the CVS pharmacy chain) and created an avenue for pharmacies to appeal reimbursements lower than wholesale acquisition cost. 

SCOTUS’s eight remaining justices—Justice Ruth Bader Ginsburg passed away about 2 weeks before arguments began—were asked to decide whether Act 900 is preempted, or prevented, by the federal law ERISA. Rutledge and Arkansas say it is not. The Court has previously ruled that rate regulation laws like Act 900 are not preempted by ERISA and are therefore lawful. ERISA, or the Employee Retirement Income Security Act of 1974, is intended to provide nationwide, consistent standards and requirements for employee retirement and health plans by preempting states from passing laws and regulations affecting employee retirement and health plans. 

Forty-five other states have some kind of law that regulates PBMs, so the case could have a big impact on how states, pharmacies, and PBMs interact. To read a primer on the case, visit apha.us/RutledgePrimer. 

Five justices must side with Arkansas to win the case and proceed with regulating PBM reimbursement. Tiffany Wright, a litigation expert who clerked with Supreme Court Justice Sonia Sotomayor and with Justice Neil Gorsuch when he was a Circuit Court judge, believes that five of the justices may side with Arkansas based on their rulings in similar cases and other writings. You can view her analysis and case debrief with APhA, the National Community Pharmacy Association, the Arkansas Pharmacists Association, and the National Alliance of State Pharmacy Associations at apha.us/RutledgeAnalysis. 

To hear the arguments and read a transcript, visit apha.us/Rutledge
Transcript. 

The decision likely will not be issued until spring 2021. 

Poison control centers report more calls about phenibut

A new MMWR report from CDC finds that calls to local U.S. poison control centers about the unregulated drug, phenibut  (b-phenyl-g-aminobutyric acid), have increased in the past decade. The drug, which was developed in Russia in the 1960s for use as an anti-anxiety medication with cognitive enhancement properties, has a growing presence online, where retailers claim it can aid in anxiety, relaxation, and sleep.

According to regional poison control center data, roughtly 1300 phenibut exposures were reported in the U.S. from 2009 to 2019, with most calls originating from health care facilities. Most exposures occurred in men aged 18 to 34 years.

The number of cases increased sharply after 2015 when regional poison control centers were first able to use the term phenibut to capture the exposures. Common adverse effects included drowsiness, agitation, tachycardia, and confusion. Nearly 13% of exposures were life-threatening or resulted in major disability or disfigurement, and three deaths were reported.

FDA: Clinicians need to provide patients with instructions for personal collection of COVID-19 nasal samples

On October 7, FDA advised health care personnel, including pharmacists and pharmacy technicians, to provide patients with clear instructions on collecting their own nasal swab samples for on-site COVID-19 testing.

In addition to verbal instruction, FDA said health care personnel should provide visual step-by-step instructions to patients as well. FDA included examples of each.

Written instructions are available from CDC or Audere’s HealthPulse communication. (Audere, a Washington State nonprofit, has granted a general right of reference to any organization who wishes to access and use these instructions for lower nasal swabs administered at a testing site.) Video or animated instruction is also available from Audere’s HealthPulse communication.

Patients should be instructed to place the entire tip of the swab (usually 1/2 to 3/4 of an inch) inside the nose, and the side of the swab tip should be rubbed with moderate pressure against as much of the wall of the anterior nares region as possible, moving the tip through a large circular path inside the nose. At least four of these sweeping circles should be performed in each nostril using the same swab. This should take approximately 10 to 15 seconds per nostril.

Nasal swab samples have their benefits—including feeling more comfortable for patients than other upper respiratory specimen collection—but only if they are done correctly.

Without clear instruction, FDA said “patients who, in a health care setting, are self-collecting anterior nares (nasal) samples may not collect an adequate sample for testing, which may decrease the sensitivity of the test. Health care providers have a critical role in helping patients perform self-collection
accurately.”

Healthy vitamin D levels may lower risk of severe COVID-19

Patients with healthy vitamin D levels may have a lower risk of developing and dying from severe COVID-19, according to a study published in PLOS One on September 25.

In the study, Maghbooli and colleagues analyzed the data of 235 patients with COVID-19 who had laboratory documentation of their 25(OH)D level at the time of hospitalization in Sina Hospital in Tehran, Iran. The average age of the study participants was 58.7 years, and 37.4% were aged 65 years or older.

Among the participants, 74% had severe COVID-19 disease, and 32.8% were vitamin D sufficient, with 25(OH)D levels at or above 30 ng/mL. The researchers found that patients with healthy vitamin D levels had lower risks of becoming unconscious and hypoxic; significantly lower levels of serum C-reactive protein (CRP), an inflammatory marker; and higher total blood lymphocyte counts. No one younger than 40 years died from COVID-19 in the study. However, of the 206 patients aged 40 years and older, 16.3% succumbed to the disease. Of those who died, only 9.7% had sufficient vitamin D levels compared with 20% who had insufficient levels below 30 ng/mL.

These results suggest that healthy vitamin D levels improved patients’ immune response by “reducing risk for cytokine storm in response to this viral infection,” wrote the authors. They also noted that 6.3% of the patients who died had 25(OH)D levels of 40 ng/mL or higher, so “a blood level of at least 40 ng/mL may be optimal for vitamin D’s immunomodulatory effect.”

More studies are needed to understand the role of vitamin D status on the risk of acquiring COVID-19 and developing severe disease. However, based on the available literature and this study’s results, the authors wrote that “it is reasonable to recommend vitamin D supplementation” to improve vitamin D status in the general population and possibly reduce the risk of acquiring COVID-19. Vitamin D supplementation may also reduce the risk of severe disease in patients who already have COVID-19, especially those who are hospitalized, they wrote.

The COVID-19 crisis continues to evolve rapidly. For the most up-to-date information and resources, visit the APhA Pharmacist’s Guide to Coronavirus at www.pharmacist.com/coronavirus.