Abstract

More than 35 states have reported increases in opioid-related mortality since the COVID-19 crisis began, according to the American Medical Association. While the hard data is still forthcoming about the reported escalations in opioid overdose deaths, experts believe the pandemic is exacerbating many of the conditions that contributed to the rise of the opioid epidemic in the first place. “All the issues we see ordinarily are amplified during the pandemic,” said Bethany DiPaula, PharmD, BCPP, FASHP, during a July 23 APhA webinar on how pharmacists can continue to address the opioid epidemic during the COVID-19 crisis. “A lot of it circles around access to care,” said DiPaula, who is a professor of pharmacy practice and science at the University of Maryland School of Pharmacy. Many recent regulatory changes have been put in place to address some of the access issues for patients with opioid use disorder during this time and decrease barriers to care. COVID-19 made it more difficult for patients—who are already reluctant to seek treatment—to access care. Most treatment programs, which are normally community and group based, had to be reduced. Some treatment centers had to close completely, according to DiPaula. “I think another big piece is the lack of socialization with some of the stay-at-home orders and the triggers and life stressors that have come with this,” said Chris Herndon, PharmD, BCACP, FASHP, professor at Southern Illinois University Edwardsville School of Pharmacy and another speaker on the webinar. Bradlee Rea, PharmD, outpatient pain management clinical pharmacist at Kaweah Delta Health Care in Visalia, CA, who was not associated with the webinar, said there is a strong correlation between anxiety, depression, pain, and opioid use disorder. “Maintaining social relationships are paramount to many individuals being able to continue living their best and healthiest life. When the social anchor helping to maintain sobriety and reduce patients’ perceptions of pain is taken away, as COVID-19 has done for so many of us, the associated risk of relapse and pain exacerbations drastically increases,” said Rea. DiPaula added that fentanyl continues to be an issue and is a huge contributor to overdose deaths right now. “Fentanyl is being mixed into everything.” The U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) along with the Drug Enforcement Agency (DEA) loosened many of the restrictions around providing buprenorphine and methadone to patients with opioid use disorder. Obtaining controlled substances for medication-assisted treatment is extremely restricted in the United States. Pharmacotherapy for opioid use disorder normally combines FDA-approved medications like buprenorphine and naltrexone with behavioral therapy. Buprenorphine prescriptions require a provider to have a Drug Addiction Treatment Act [DATA] waiver number, sometimes referred to as an X-waiver. DATA waivers are the first step in allowing health care practitioners to prescribe Schedule II/III medications for the treatment of opioid use disorder. Once a health care practitioner receives one, the DEA assigns a unique number starting with the letter X to designate them as a provider who can prescribe medications for opioid use disorder. Health care practitioners have built-in limitations for the number of patients who can be treated with medications for opioid use disorder. Another issue is the significant shortage of DATA-waived practitioners. Although pharmacists can develop treatment plans, monitor patients, and provide other services for patients who are being treated with medications for opioid use disorder, they cannot obtain DATA waivers. Even if a pharmacist practices in one of the eight states where they have been granted authority to prescribe controlled substances—normally with a collaborative practice agreement in place—the option to prescribe these medications does not exist. To make it easier for patients to access these vital medications during the pandemic, the administration allowed physicians to use telehealth to virtually prescribe medications for opioid use disorder. “The initiation and use of telehealth is an incredible step in the right direction because there aren’t enough treatment programs for easy access and there aren’t enough DATA-waived practitioners in communities,” said Daniel Ventricelli, PharmD, MPH, assistant professor of clinical pharmacy with the Philadelphia College of Pharmacy at the University of the Sciences. The relaxed restrictions have allowed patients on methadone to receive up to 28 days of medication instead of requiring a daily visit to a clinic. SAMHSA and DEA also collaborated to further decrease patient barriers for those who are authorized to self-administer methadone while in their home. Opioid treatment programs are allowed to set up temporary off-site locations where patients can pick up their take-home doses of methadone without having to separately register the site with DEA. In late April, this regulation expanded to include at-home buprenorphine. SAMHSA and DEA granted further flexibility for providers to initiate buprenorphine to new and existing patients with opioid use disorder via telephone, not requiring an in-person or two-way audio-visual interview. If the patient has been seen previously by the provider, then a follow-up evaluation is allowed to be conducted by any method—in-person, over the phone, or virtually—prior to issuing a new controlled substance prescription. Ventricelli said there are still limitations under the loosened regulations, however. He said finding a DATA-waived prescriber virtually could still be difficult, and even if a patient has found one, they need to make sure there’s a pharmacy in their community that has the medications in stock and can fill their prescription consistently. DiPaula points out there are still many patients in this population who do not always have access to the internet, a computer, or a phone to access telehealth. The same is true for connecting to the support and recovery groups that have shifted online. Buprenorphine and naloxone tend to be coprescribed, but many pharmacists who are experts in pain management think that more needs to be done to reduce the stigma of buprenorphine for opioid use disorder. “We really started to push the use of buprenorphine for those who require opioid therapy for severe pain as a more reasonable and likely safer approach to treating their pain even for those who don’t have a substance use disorder,” said Herndon. Because of the medication’s safety profile, he said that in his practice, they promote buprenorphine as an analgesic before going to a drug like hydrocodone. During the webinar, he reminded pharmacists that they don’t need an X DEA number to dispense buprenorphine, even suboxone, if it’s being used for an indication of pain. For the treatment of opioid use disorder, health care practitioners need the X DEA number. DiPaula said pharmacists should be aware of what their state laws are around transmitting (electronically prescribing, faxing, calling in, etc.) prescriptions for Schedule III drugs. Pharmacists have a critical role in providing access to buprenorphine, an evidence-based treatment for opioid use disorder. Ventricelli believes there are a few actions pharmacists can take during this time to help patients. They can maintain an adequate supply of buprenorphine-containing medication and naloxone to reduce the risk of a patient resuming substance use or having a recurrence of their opioid use disorder symptoms while waiting for their prescription medications to be filled if the medication was not in stock. Pharmacists can also talk to patients about naloxone and how it works, but also educate them on how to stay healthy against the coronavirus. He said pharmacists can also provide patients with access to sterile syringes and support other harm reduction efforts. Going forward, he thinks it’s important for the regulatory changes related to medications for opioid use disorder to stay put. “My concern would be having people start a medication, stabilize, and then experience barriers to remaining engaged with their new treatment provider if these regulations are not maintained moving forward. That could have a negative impact on their long-term recovery,” he said. While the relaxed regulations are only temporary through the public health emergency, legislation has been introduced to make certain emergency actions permanent, like boosting telehealth access for opioid use disorder.

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