Jeffrey Fudin, PharmD, DAIPM, FCCP, FASHP
Jeffrey Fudin, PharmD, DAIPM, FCCP, FASHP
Dr. Jeff Fudin graduated from Albany College of Pharmacy & Health Sciences with a BS and PharmD. He is a Diplomate to the Academy of Integrative Pain Management, a Fellow to ACCP and ASHP, and a member of several other professional organizations. He is President and Director, Scientific and Clinical Affairs for Remitigate, LLC (remitigate.com), a software platform for interpreting urine drug screens (Urintel) and risk for opioid-induced respiratory depression (Naloxotel). Dr. Fudin is a section editor for Pain Medicine and serves on the editorial board for Practical Pain Management. He practices as a clinical pharmacy specialist (WOC) and director of PGY-2 pharmacy pain residency programs at the Stratton Veterans Administration Medical Center in Albany, New York and has academic affiliations with Western New England University and Albany Colleges of Pharmacy.

Considerations in Expanded Buprenorphine Access for Opioid Abuse Disorder

NOVEMBER 16, 2016
America is in the midst of four clinical conundrums: poorly controlled pain for those suffering with daily chronic pain, inadequate pain education in almost every professional school nationwide (medicine, pharmacy, nursing), an opioid epidemic, and insufficient resources to help those with opioid abuse disorder. 
 
Recovery from an opioid use disorder should incorporate a multifaceted approach including detoxification, 12 step programs, psychological counseling, and medication-assisted treatment.1 Medication-assisted treatments use methadone, buprenorphine, and/or short or long acting naltrexone for the treatment of opioid use disorder.1 Buprenorphine is one of the most commonly prescribed medications to treat opioid addiction. In 2014, about 60-65% of Americans using medication-assisted treatment received buprenorphine.2
 
Buprenorphine acts as a partial agonist at mu-opioid receptors and an antagonist at kappa receptors.3 Because of this mixed partial agonist/antagonist activity, buprenorphine carries a lower risk for abuse, producing less euphoria and physical dependence than methadone. In both short-term and long-term studies, medication-assisted treatment has proven to be the most effective treatment for opioid use disorder.4,5 Particularly, outpatient buprenorphine therapy, alone or as a combination product with naloxone, has demonstrated success in helping patients abstain from opioids.1 These demonstrated benefits are why buprenorphine has gained popularity in the addiction medication realm. Buprenorphine is currently available as a generic agent in a sublingual tablet (with or without naloxone). For a review on all the branded products, see A Brief Review of Buprenorphine Products.


Expanding Access
On July 6, 2016, the Department of Health and Human Services (HHS) announced that it will raise the limit on the number of patients that can receive the addiction medicine buprenorphine to 275 patients per qualified provider.2 Previously, physicians were limited to treatment of 100 patients. It was estimated in 2014 that nearly 21.1 million Americans needed treatment for substance use disorder.6 Of these 21.1 million Americans; only 2.5 million patients actually received the treatment they needed.

NPR recently released a news article describing the role that insurance companies play in addiction treatment.7 Many of these third party insurance companies will only cover addiction medications after a clinician completes a prior authorization.7 Prior authorizations can take days to weeks to obtain approval, which leaves the patient without medication. In 2013, Medicaid in 48 states required a prior authorization for buprenorphine.7
 
One bill alone will not fix the problem, but is certainly a step in the right direction to removing some barriers and allowing more patients to get the treatment they need. With expansion there is bound to be an increased cost. HHS estimates that, with the expansion of buprenorphine access, the cost will be between $43.5 million and $313 million in the first year.8

The Comprehensive Addiction and Recovery Act (CARA), recently passed in the senate will authorize $181 million in federal money to curb the opioid and heroin epidemic.9 Additionally, this bill will allow increased access to naloxone and allow more health care providers, such as nurse practitioners and physician assistants, to prescribe buprenorphine for opioid addiction treatment.9
 
While buprenorphine carries a lower risk for abuse, it does not come without any risk for abuse and diversion. HHS does state that the increase in access to treatment could cause “unintended consequences” such as diversion.8 Buprenorphine is commonly used as a street drug by addicts to ease withdrawal symptoms.8 Additionally, it carries a street value to white collar professionals which chose to treat their addiction disorder while avoiding legal access through a bona fide medical provider.10 According to the Dawn Report presented by the Substance Abuse and Mental Health Services Administration (SAMHSA) in 2013, emergency department (ED) visits involving buprenorphine increased substantially from 3,161 in 2005 to 30,135 visits in 2010. Of these hospitalizations, over half were for non-medical use of buprenorphine followed by patients seeking detoxification or substance abuse treatment.11

Patients or Profits?
Addiction clinics have already become a lucrative business for some. In an article published by Pain News Network, Dr. Jack Woodside commented on the buprenorphine clinics reporting, “In northeast Tennessee, I am not aware of any buprenorphine provider that accepts insurance. Here buprenorphine clinics charge $100 cash at the time of service and require weekly visits for refills.”8 He goes on to say, “From the provider's perspective, collecting $5,000 yearly from 100 patients amounts to an annual gross income of $500,000, with low overhead and no costs associated with billing insurance.”8 When considering these startling numbers, it begs the question whether this is patient driven or mainly a financial incentive. Part of this is due to the restrictions on prescribing buprenorphine, creating more demand and opportunity for physicians to charge whatever they feel necessary. This seeming exploitation of a vulnerable population is just the tip of the iceberg. It was reported nationally that 1,350 of the 12,780 buprenorphine doctors have been punished for offenses such as insurance fraud, sexual misconduct, practicing medicine while impaired, and writing excessive prescriptions for opioids.8
 
Opportunity for Pharmacists
Pharmacists are essential health care providers who are trained to recognize opioid over-dose, opioid-use disorder, and withdrawal symptoms. A pilot study conducted in Maryland investigated a collaborative practice agreement between physicians and pharmacists for the treatment of opioid-dependent patients.  The goal of the pilot program was to increase access to buprenorphine. Results of the study showed high program retention rates and increased adherence to buprenorphine.12 Pharmacists were in charge of the intake and follow-up of the patients. Additionally, they provided medication adherence education, monitored medication outcomes, and assisted in diversion prevention.12 The program had a 91% attendance rate, 100% 6-month retention rate, and a 73% 12-month retention rate. A total of 12 patients completed full intakes with 135 follow-up appointments which equated to an estimated cost savings of $22,000.12 Due to these successful results, this led to the establishment of a permanent program and first-state approved collaborative practice agreement related to addiction medicine.
 
Patients with substance use disorder have been suffering for years. While the debate goes on about the pros and cons of treating addiction, the Opioid Use Disorder Treatment Expansion and Modernization Act will expand access to therapy that is sorely needed by many American’s. Studies demonstrate that expanding access to buprenorphine and cognitive behavior therapy can significantly reduce heroin overdose deaths.13 Pharmacists will now have an opportunity to educate more patients about the pharmacologic therapies available in addiction medication and overdose prevention strategies. With more than 250 million people entering a pharmacy every week and increased access to buprenorphine, pharmacists are in a unique position to take an active role in the recovery efforts of our country.14,15
 
This article was collaboratively written with Lisa Dragic, PharmD and Erica L. Wegrzyn, B.A., B.S., PharmD.

Dr. Dragic received her PharmD from Temple University School of Pharmacy. Dr. Dragic is currently a PGY-1 pharmacy resident at the Samuel S. Stratton VA Medical Center in Albany, New York, with a concentration in pain management and palliative care. Upon completion of the PGY-1 residency, Dr. Dragic hopes to complete a PGY-2 in Pain Management and Palliative care.

Dr. Wegryzn is currently completing a PGY-2 Pain and Palliative Care residency at the Stratton VA Medical Center, Albany NY. Dr. Wegrzyn received her PharmD from Western New England University College of Pharmacy, Springfield MA and completed a PGY-1 residency at MaineGeneral Medical Center, Augusta ME. 


This article is the sole work of the authors and stated opinions/assertions do not reflect the opinion of employers or employee affiliates. It was not prepared as part of the author(s) duty as federal employees.

References
1.       Jackson A, Bratberg J. Part 1: Recognition and referral to enhance recovery: The pharmacist's role in managing opioid use disorder. Drug Topics. 2016. Available at: http://drugtopics.modernmedicine.com/sites/default/files/images/DrugTopics/UCONN/2016-02-CE.pdf. Accessed July 18, 2016. 
2.       Eilperin J. To battle opioid addiction, the federal health department opens medication treatment to more patients. Washington Post. 2016. Available at: https://www.washingtonpost.com/news/powerpost/wp/2016/07/06/to-battle-opiod-addiction-hhs-opens-medication-treatment-to-more-patients/. Accessed July 17, 2016.
3.       Fudin J. Chemical classes of opioids. PainDr.com. http://paindr.com/wp- content/uploads/2012/05/Opioid-Chemistry-09-2011.pdf. Published September 2011. Accessed July 17, 2016.
4.       Hser YI, Evans E, Huang D, et al. Long-term outcomes after randomization to buprenorphine/naloxone versus methadone in a multi-site trial. Addiction. 2015 Nov 24.
5.       Pierce M, Bird SM, Hickman M, et al. Impact of treatment for opioid dependence on fatal drug-related poisoning: a national cohort study in England. Addiction. 2015 Oct 9.
6.       Behavioral Health Treatments and Services | SAMHSA. Samhsagov. 2016. Available at: http://www.samhsa.gov/treatment. Accessed July 17, 2016.
7.       Insurance Rules Can Hamper Recovery From Opioid Addiction. NPRorg. 2016. Available at: http://www.npr.org/sections/healthshots/2016/08/05/485554456/insurance-rules-can-hamper-recovery-from-opioid-addiction. Accessed September 1, 2016.
8.       The Coming ‘Economic Bonanza’ in Addiction Treatment. Pain News Network. 2016. Available at: http://www.painnewsnetwork.org/stories/2016/5/25/the-coming-economic-bonanza-in-addiction-treatment. Accessed July 26, 2016.
9.       Congress approves anti-addiction bill as funding fight continues. USA TODAY. 2016. Available at: http://www.usatoday.com/story/news/politics/2016/07/13/congress-approves-anti-addiction-bill-funding-fight-continues/87040856/. Accessed July 26, 2016.
10.   Marcucci C, Fudin J, Thomas P, et al. A new pattern of buprenorphine misuse may complicate perioperative pain control. [Case Reports, Letter]. Anesth Analg 2009 Jun; 108(6):1996-7.
11.   The DAWN Report: Emergency Department Visits Involving Buprenorphine. Samhsagov. 2013. Available at: http://www.samhsa.gov/data/sites/default/files/DAWN106/DAWN106/sr106-buprenorphine.htm. Accessed July 26, 2016.
12.   DiPaula BA, Menachery E. Physician–pharmacist collaborative care model for buprenorphine-maintained opioid-dependent patients. J Am Pharm Assoc. 2015;55:187-192.
13.   Schwartz RP, Gryczynski J, O’Grady KE, et al. Opioid agonist treatments and heroin overdose deaths in Baltimore, Maryland, 1995-2009. Am J Public Health. 2013;103:917-922.
14.   Staff N. FDA Proposal to Allow Pharmacists to Prescribe Some Drugs Sparks Swift Rebuke From AAFP. Aafporg. 2016. Available at: http://www.aafp.org/news/government-medicine/20120502pharmprescribing.html. Accessed August 15, 2016.
15.   Should pharmacists prescribe birth control?. Drug Topics. 2016. Available at: http://drugtopics.modernmedicine.com/drug-topics/news/should-pharmacists-prescribe-birth-control. Accessed August 17, 2016.
 
 
 
 
 


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