Target Audience:

Who should attend:

• Clinical faculty from the University of Pittsburgh School of Pharmacy
• Clinical staff pharmacists employed by the University of Pittsburgh Medical Center and deployed throughout the hospital campus in unit based roles and centrally in the department of pharmacy's main pharmacy
• Student pharmacy interns currently working within the department of pharmacy
• Certified Pharmacy Technicians

Abstract
Fibromyalgia is a common rheumatological condition that causes widespread muscle and joint pain along with extreme sensitivity and tenderness to touch. It also is associated with a multitude of other symptoms and disease states including depression, anxiety, fatigue, mental confusion, variable bowel habits, and migraines. The American College of Rheumatology (ACR) Guidelines outline fibromyalgia diagnosis which includes widespread pain for more than 3 months, specific tender points, and lack of inflammation. The European Alliance of Associations for Rheumatology (EULAR) Guidelines outline treatment regimens that reside on three pillars: patient education about the disease state, non-pharmacologic treatment approaches such as aerobic exercise and cognitive behavioral therapy (CBT), and pharmacologic options that include FDA approved medications such as pregabalin, duloxetine, and milnacipran along with off-label medications such as cyclobenzaprine, gabapentin, and tramadol.

Naltrexone is a pure opioid antagonist that has been hypothesized to block CNS inflammation and thus improve rheumatic disease states, namely fibromyalgia. Naltrexone is an oral or intramuscular injection medication that is known to be well tolerated, provide once daily dosing, and comes with a warning of spontaneous opioid withdrawal if used alongside opioids.

Three studies spanning from 2009 – 2020 were thoroughly reviewed. In the 2009 study published by Younger et al was a small pilot investigation study that was placebo controlled, single blind, and crossover in design. It was discovered in this study that oral naltrexone 4.5 mg daily had a significant impact on the participants fibromyalgia symptom severity, specifically daily pain, highest pain, fatigue and stress. Four years later, Younger et al then completed another study in 2013 that was a small, randomized, double-blind, placebo-controlled, crossover trial assessing daily pain levels. Once again, he found a significant reduction in pain throughout his participants. In both 2009 and 2013, naltrexone was found to be very well tolerated by participants. Lastly, in 2020 the author Bruun-Plesner et al completed an investigation into the dose-response relationship between naltrexone dose and a reduction in fibromyalgia symptoms. This study found that 50% of the participants experienced a response at the naltrexone dose of 3.88 mg daily and 95% experienced a response at the dose of 5.40 mg daily.

In conclusion, naltrexone 4.5 mg by mouth daily may provide a significant reduction in symptom severity, namely daily pain, in patients suffering from fibromyalgia.

Educational Objectives:

Upon successful completion of this continuing pharmacy education program, the participant should be able to:

• Define guideline management of fibromyalgia 
  
• Describe multiple studies examining low dose naltrexone in the treatment of fibromyalgia.
• Identify a place in therapy for naltrexone in fibromyalgia management
  

Pharmacy Continuing Education Credits In support of improving patient care, the University of Pittsburgh is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team. The assigned universal program number(s) is JA4008223-0000-23-110-H01-P This knowledge-based activity provides 1  contact hours of continuing pharmacy education credit. Disclaimer Statement:  The information presented at this activity represents the views and opinions of the individual presenters, and does not constitute the opinion or endorsement of, or promotion by, the UPMC Center for Continuing Education in the Health Sciences, UPMC / University of Pittsburgh Medical Center or Affiliates and University of Pittsburgh School of Medicine.  Reasonable efforts have been taken intending for educational subject matter to be presented in a balanced, unbiased fashion and in compliance with regulatory requirements. However, each program attendee must always use his/her own personal and professional judgment when considering further application of this information, particularly as it may relate to patient diagnostic or treatment decisions including, without limitation, FDA-approved uses and any off-label uses.

Suggested Additional Reading & Joint Accreditation Statement - Note: This Accreditation Statement Supersedes All Other Statements:

Suggested Additional Reading:

1. Macfarlane GJ, Kronisch C, Dean LE, et al. EULAR revised recommendations for the management of fibromyalgia. Annals of the Rheumatic Diseases 2017;76:318-328
2. Bhargava J, Hurley JA. Fibromyalgia. StatPearls Publishing, 2021 
3. Fibromyalgia. Centers for disease control and prevention. Last review: January 6, 2020
4. Lacasse A, Bougault P, Choiniere M. Fibromyalgia-related costs and loss of productivity: a substantial societal burden. BMC Musculoskeletal Disorders 2016; 17: 168
5. Marlowe, Karen. Treating fibromyalgia requires a multidisciplinary approach. Continuing Education 2008; 37-47
6. Azzo, Lance. Managing Fibromyalgia. PharmCon 2020; 1-24
7. Wolfe F, Clauw DJ, Fitzcharles MA, et al. The American college of rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. American College of Rheumatology 2010; 62(5) 600-610
8. Hang Pham, CC BY-SA 4.0 <https://creativecommons.org/licenses/by-sa/4.0>, via Wikimedia Commons.
9. Fibromyalgia impact questionnaire (FIQ). American Academy of Family Physicians (AAFP). FIBROMYALGIA IMPACT QUESTIONNAIRE (FIQ) (aafp.org)
10. REVIA (naltrexone hydrochloride tablets USP) 50 mg. FDA. access.fda.gov
11. Younger J, Mackey S. Fibromyalgia symptoms are reduced by low-dose naltrexone: a pilot study. Pain Medicine 2009; 10(4), 663-672
12. Younger J, Noor N, McCue R, Mackey S. Low-dose naltrexone for the treatment of fibromyalgia: findings of a small, randomized, double-blind, placebo-controlled, counterbalanced, crossover trial assessing daily pain levels. Arthritis & Rheumatism 2013; 65(2): 529-38
13. Bruun-Plesner K, Blichfeldt-Eckhardt MR, Vaegter HB, et al. Low-dose naltrexone for the treatment of fibromyalgia: investigation of dose-response relationships. Pain Medicine 2020; 21(10), 2253-2261

Joint Accreditation Statement - this statement supersedes any other statement on this pageIn support of improving patient care, the University of Pittsburgh is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

Pharmacy (CPE) - This knowledge-based activity provides 1.0 contact hours of continuing pharmacy education credit.
Other Healthcare Professionals: Other health care professionals will receive a certificate of attendance confirming the number of contact hours commensurate with the extent of participation in this activity.