By: Preethi Samuel, PharmD Candidate c/o 2021, Aisa Mrkulic, PharmD. Candidate c/o 2022
Opioid use disorder (OUD) is a chronic illness involving misuse of opioids, both prescribed and non-prescribed, as well as the use of illicitly obtained heroin. OUD carries a risk of fatal overdose, preceded by the following triad: pinpoint pupils, respiratory depression, and unconsciousness.Pharmacologic treatments of OUD, which include buprenorphine, methadone, and naltrexone, reduce the likelihood of relapse. Access to care has been challenged by social-distancing protocols in response to the ongoing pandemic. In light of this public health crisis, the Substance Abuse and Mental Health Services Administration (SAMHSA) set forth guidance for OUD treatment made possible by present-day technologies.1
Federal and state regulations governing the use of telehealth have been relaxed, acknowledging, “the declaration of a national emergency.” 2 Telehealth, as defined by the U.S. Department of Health and Human Services (HHS), “is the consensual use of digital patient information and telecommunication technologies for the provision of remote healthcare services and health-related education”.3 Video conferencing is the most popular platform for telehealth services, but text messaging can be used as an alternative. Telehealth is to be conducted in private settings, ensuring only the participation of intended parties.3 Lowered voices and speakerphone avoidance are reasonable precautions, just to name a few.
Stigma persists as a barrier to a world where telehealth is the norm. However, the benefits of using telehealth are undeniable. Time and time again, telehealth services are cited as most valuable to rural communities.4 Remote healthcare services provide passive support for the practice of social distancing, which in turn, minimizes the spread of the virus. Patients with COVID-19 are able to continue with their treatment. Similarly, clinicians who have tested positive for COVID-19 may carry on in the provision of much-needed healthcare services.2 Remote patient monitoring is no longer of the future, but rather the present!
How does the Health Insurance Portability and Accountability Act (HIPAA) restrict telemedicine? Well, desperate times call for desperate measures and a national, public health emergency surely qualifies as one. Telemedicine technologies may not fully comply with HIPAA. The Office of Civil Rights (OCR) at HHS announced that the, “good faith provision of telehealth” would be permitted for the duration of the pandemic.5 Under these circumstances, clinicians, including pharmacists, need not fear penalties for failing to abide by HIPAA.5 The imposition of a penalty for noncompliance with HIPAA will, moving forward, remain unheard of, so long as providers, “enable all available encryption and privacy modes” during remote interactions.5 Notably, when private or semi-private settings are not accessible to patients seeking care, it is the responsibility of providers to implement “reasonable HIPAA safeguards, the goal of which is limited protected health information (PHI) disclosure”.3
Opioid treatment programs (OTP) are healthcare facilities that have been deemed essential amidst the present-day COVID-19 crisis.6 Normally, under federal law, any new patient admitted to an OTP for OUD is required to undergo a complete physical evaluation and cannot be seen via telehealth.7 However, in these unprecedented times, SAMHSA has the authority to grant exceptions to otherwise non-negotiable OTP regulations.7 For the duration of the pandemic, any new patients in an OTP may be prescribed buprenorphine, so long as an adequate evaluation can be completed using telehealth.7 Evaluations of the patient should be performed with the same level of care as would be done in a face-to-face encounter. Simply put, a comprehensive history of substance use, episodes of overdose, and medical history is the expectation in both scenarios.6 Contrastingly, all new patients starting methadone for OUD are required to be evaluated in person.7 Methadone requires more careful dose titration as compared to buprenorphine. For this reason, it is not ideal to prescribe methadone via telehealth for first-time patients. Additionally, close follow-up and medical assessment are necessary during initiation so as to minimize adverse events, including overdose.6 Existing patients can be prescribed either methadone or buprenorphine with telehealth.7 In order to help aid clinicians, the Addiction Treatment Needs Assessment Tool was created by the American Society of Addiction Medicine (ASAM), Shatterproof, and OpenBeds.8 This 13-question assessment inquires about substance-related behaviors and environment to guide the level of care or type of treatment needed to optimize OUD treatment.8
Effective March 19, 2020, all stable OTP patients are entitled to up to a 28-day supply of take-home OUD medications.9 A clinician’s professional judgement is the deciding factor for patient eligibility. For patients who are deemed less stable, states may request to limit to a 14-day supply, if believed by the OTP that the patient can safely handle take-home medications.9 A caveat to extended take-home doses is the inability for patients initiated on methadone to lawfully receive escalating doses for self-administration.7 Dispensing such doses runs the risk of inadequate dosing, attributed to the opioid’s sensitive titration schedule.7 Pertaining to extended take-home doses, patient stability should be reassessed before making a plan. Factors which should be taken into consideration are the use of other CNS depressants, home environment—including availability of a responsible adult-member of the household, and COVID-19 risk.7 Options range from having the patient come in every other day instead of daily, to giving the full 14 or 28 days, or anything in between.7 Most importantly, each and every patient should be given unimpeded access to naloxone rescue kits, with instructions from either the OTP or a local pharmacy.7
Through a chain of custody protocol, the Drug Enforcement Agency (DEA) has authorized a delivery option for those patients who are quarantined at home from COVID-19.6 Documentation proving that a patient has been medically ordered to self-isolate is required before delivery can be pursued.Identification of a patient-specified, trustworthy, uninfected member of the household to deliver medications to should be kept on record.If no specified, trustworthy member of the household exists, doorstep delivery, with an approved lockbox, by designated staff, law enforcement, or the National Guard, is permitted. Prior to delivery, the OTP should communicate in advance with the patient to guarantee the designee is available on the date of delivery.After arrival to the destined location, a second phone call is made to notify the patient. Delivery personnel must maintain a distance of 6-feet from the doorstep and remain until the designee accepts the medication. He or she should ensure to document the exchange before departure.If the designated person is absent from the location, another attempt should be made to reach them.Failure to arrive within a reasonable amount of time requires the documented return of medication to the OTP.Such is the process of DEA-authorized delivery.10
Dr. Ebtesam Ahmed, PharmD, M.S, Clinical Professor at St. John’s University’s College of Pharmacy and Health Sciences, had this to say, “In times of the COVID-19 pandemic crisis, the present regulations that exist in the SUD treatment world highlight the barriers that already exist for patients because of the excessive regulation and policies in the U.S. Currently, healthcare providers have been challenged to address the needs of patients with opioid use disorder in the setting of long-standing regulations around medications such as buprenorphine and methadone. Pharmacists have a role in dispelling misinformation about medications that may be ineffective or could even exacerbate coronavirus disease. They stand ready with colleagues from other disciplines to lead variation in techniques that will remove barriers to treatment for patients with OUD.” In conjugation with her faculty appointment, Dr. Ahmed is the Director of Pharmacy Internships of the MJHS Institute for Innovation in Palliative Care. Additionally, she proudly serves as a member of the Board of Directors for the International Association for Hospice and Palliative Care.
The prescribing of controlled substances has remained a subject of debate within the world of healthcare. To curb misuse, legislation dictates, or rather restricts, both the prescribing and dispensing of these drugs. So where do pharmacists fit into this picture? They often serve as the bridge between patient and provider; therefore, the implication of a rise in telehealth is an increased demand of these healthcare professionals. More patient contact provides drug experts with a platform for the justification of their value. Pharmacists are already the most accessible of healthcare providers, and telemedicine would only add to patients’ access to care – just think of the potential impact on medication adherence! In aworld of OUD, interruptions in treatment are alarming. Relapse is a real fear clinicians have for their patients. Ultimately, addiction is a disease of isolation, and it is with telehealth, that patients stand a chance against the least favorable of circumstances.
- Strain, E., MD. Opioid Use Disorder: Epidemiology, Pharmacology, Clinical Manifestations, Course, Screening, Assessment and Diagnosis. Up-to-Date website. https://www-uptodate-com.jerome.stjohns.edu/contents/opioid-use-disorder-epidemiology-pharmacology-clinical-manifestations-course-screening-assessment-and-diagnosis?search=OUD%20treatment&source=search_result&selectedTitle=4~150&usage_type=default&display_rank=4#H1. Updated February 11, 2020. Accessed July 3, 2020.
- COVID-19 Supporting Access to Telehealth. American Society of Addiction Medicine (ASAM) website. https://www.asam.org/Quality-Science/covid-19-coronavirus/access-to-telehealth#Telehealth”. Updated April 14, 2020. Accessed July 1, 2020.
- U.S. Department of Health and Human Services (HHS) Office of Civil Rights (OCR). FAQs on Telehealth and HIPAA during the COVID-19 Nationwide Public Health Emergency. https://www.hhs.gov/sites/default/files/telehealth-faqs-508.pdf. Accessed July 1, 2020.
- Gershman J.,PharmD, CPh. Telehealth Offers Myriad Unique Opportunities for Pharmacists. Pharmacy Times Website. https://www.pharmacytimes.com/publications/issue/2020/April2020/telehealth-offers-myriad-unique-opportunities-for-pharmacists. Published April 29, 2020. Accessed July 2, 2020.
- Notification of Enforcement Discretion for Telehealth Remote Communications during COVID-19 Nationwide Public Health Emergency. U.S. Department of Health and Human Services website. https://www.hhs.gov/hipaa/for-professionals/special-topics/emergency-preparedness/notification-enforcement-discretion-telehealth/index.html Human. Updated March 30, 2020. Accessed July 2, 2020.
- Ensuring Access to Care in Opioid Treatment Programs. American Society of Addiction Medicine Website. https://www.asam.org/Quality-Science/covid-19-coronavirus/access-to-care-in-opioid-treatment-program. Updated June 30, 2020. Accessed July 1, 2020.
- Substance Abuse and Mental Health Services Administration (SAMHSA). FAQS: Provision of methadone and buprenorphine for the treatment of Opioid Use Disorder in the COVID- 19 emergency. https://www.samhsa.gov/sites/default/files/faqs-for-oud-prescribing-and-dispensing.pdf.Updated April 21, 2020. Accessed July 1, 2020.
- ASAM Staff. With COVID-19 Pandemic Making Access to Addiction Treatment Services More Challenging, New Free Online Addiction Treatment Needs Assessment Available. American Society of Addiction Medicine Website. https://www.asam.org/Quality-Science/publications/magazine/read/article/2020/06/29/with-covid-19-pandemic-making-access-to-addiction-treatment-services-more-challenging-new-free-online-addiction-treatment-needs-assessment-available. Published June 29, 2020. Accessed July 1, 2020.
- Substace Abuse and Mental Health Services Administration. Opioid Treatment Program (OTP) Guidance. https://www.samhsa.gov/sites/default/files/otp-guidance-20200316.pdf Published March 16, 2020. Updated March 19, 2020. Accessed July 1, 2020.
- Substance Abuse and Mental Health Services Administration (SAMHSA). OTP Guidance for Patients Quarantined at Home with Coronavirus. https://www.samhsa.gov/sites/default/files/otp-covid-implementation-guidance.pdfhttps://. Updated March 30, 2020. Accessed July 2, 2020.