January 2019 Newsletter
News
GSHP 2019  Spring Meeting  
March 8-10, 2019
Marriott Riverfront
Savannah, GA

Call for Poster Presenters at the GSHP Spring Meeting 2019

 This is your opportunity to share your results with pharmacy colleagues from around Georgia at the GSHP Spring Meeting Poster Session in Savannah on Saturday, March 9, 2019. Posters highlighting innovative services, evaluations and pharmacy practice model change initiatives are especially encouraged. Encore presentations from national meetings (ASHP, ACCP, etc.) are accepted.  Presenting a peer-reviewed poster is an ideal professional development activity for preceptors, both seasoned and new practitioners, residents and students. The primary (first) poster presenter must be a GSHP member and results must be included on abstract to be accepted.  Research-in-progress abstracts with background and methods only will not be accepted for the poster awards but can present.  Pharmacy students and residents are especially encouraged to participate.   Students and residents presenting posters will receive free meeting registration if they are the primary (first author) on the poster.  Please let us know if you are able to attend the entire program or Saturday only). 

The GSHP Education Committee will be evaluating ALL posters submitted for recognition and designation as "Outstanding GSHP Poster".   There will be three categories recognized: 1) Best Pharmacy Student Poster; 2) Best Pharmacy Resident Poster; 3) Best Pharmacy Practitioner Poster based on the credentials of the primary (first) author.  One student, one resident, and one practitioner poster will each win an award based on the highest combined abstract and poster scores. Winners will each receive a plaque and $200.

The scoring rubric by which the posters will be judged will be available on the GSHP website.    
 
The deadline for submission of abstracts is at 12:00 Noon on February 15. 

To submit your poster abstract, or for questions, contact Marjorie Phillips, GSHP Poster Session Coordinator at: mphillip@augusta.edu 

Each abstract email submission must be entered on the abstract form (abstract example) and contain the following:
1)    Brief descriptive title (use title case)
2)    Author information. Include full name, professional credentials and institutional affiliation (i.e., health care organization or college name) author(s), email address for corresponding author/presenter.
3)    Body of the abstract with the following headings: Purpose, Methods, Results and Conclusions.  
4)   The submitted abstract must fit on the attached form and be no more than 300 words.
5)    Abstract should be written using calibri font and should be 11-point font.  Do not include tables, graphs, or illustrations in abstract.  Spell out all pharmaceutical acronyms and special symbols (e.g., < or >).  
6)    Include which poster category applies (should be based only on first author's credentials)
  • Pharmacy Student Poster
  • Pharmacy Resident Poster
  • Pharmacy Practitioner Poster
7)    Include submission type
  • Descriptive report - describes new, improved, or innovative roles or services in pharmacy practice, or case report.
  • Evaluative study report - describes original research including clinical research, drug effects in humans, drug use evaluations, and evaluations of clinical pharmacy services
Webinar-  Thursday, February 14, 2019 - 12 noon-1:00 pm
Opioid Stewardship Strategies
Pharmacist Learning Objectives
By the end of this program the learner will be able to:
  • ·         Calculate morphine equivalent daily dose (MEDD) and identify MEDD thresholds for increased risk of opioid-induced respiratory depression
  • ·         Screen opioid orders for high-risk characteristics
  • ·         Use a validated tool to identify patients at risk factor for opioid induced over-sedation and respiratory depression
  •  
Pharmacy Technician Learning Objectives
By the end of this program the learner will be able to:
  • ·         Calculate morphine equivalent daily dose (MEDD)
  • ·         Identify high risk opioid therapies
  • ·         Identify patient risk factors for opioid induced over-sedation and respiratory depression
 
Jasmine Jones, PharmD, CGP
Wellstar Health System
 
Georgia Society of Health-System Pharmacists is accredited by the Accreditation Council for Pha
rmacy Education (ACPE) as a provider of continuing pharmacy education. This program is approved for 1 hour (0.1 CEUs) of continuing pharmacy education credit.  Proof of participation will be posted to your NABP CPE profile within 4 to 6 weeks. Participants must participate in the entire presentation and complete the course evaluation to receive continuing pharmacy education credit.  UAN # 0228-0000-19-012-L01-P; 0228-0000-19-012-L01-T

This is a member service of GSHP.  There is no charge for members to attend.   Dues must be current to receive CE credit.

Non-members will be charged $20.
 
Non-member registration:  https://gshp.wildapricot.org/event-3233814

GSHP Leadership Profile
Lori Duke, PharmD
What is your current leadership position in GSHP?
 
My position on the Board of Directors is as the faculty liaison for the UGA College of Pharmacy.
 
What benefits do you see in being active in a professional association such as GSHP?  
 
Professional organizations have been so important to me throughout my career. Aside from the obvious networking and continuing education opportunities, the professional development and growth offerings have been invaluable to me. Through my involvement in several national professional organizations, I was appointed to my current position on the ACPE Board of Directors and was selected to complete a national leadership fellows program.
 
What initially motivated you to get involved in GSHP?
 
As a health-system pharmacist, I have always been involved in the ASHP state chapter where I resided. So, when I moved to Georgia, GSHP was a natural home for me to stay involved in health-system practice and meet pharmacists throughout the state.
 
Where did you go to pharmacy school?
 
University of North Carolina at Chapel Hill
 
Where have you trained or worked?  
 
I completed a specialized residency in critical care at Medical College of Virginia Hospitals / Virginia Commonwealth University followed by a 2 year fellowship in critical care at Virginia Commonwealth University. For the first 5 years of my career, I was a Clinical Assistant Professor at the University of Texas College of Pharmacy at the branch campus located in San Antonio and practiced at University Hospital within the Coronary and Medical ICUs. I have been on faculty for the past 21 years at the University of Georgia College of Pharmacy.
 
Describe your current area of practice and practice setting:
 
I currently serve as the Assistant Dean for Experience Programs at the University of Georgia College of Pharmacy. Although I do not have a practice site as part of my position, I precept students on various introductory pharmacy practice experiences.
 
What advice would you give to student pharmacists?
 
While in pharmacy school, it is so important to make sure that you focus on learning the curricular material rather than merely studying for the test to ensure you will be able to correctly apply the material later. In terms of career advice, think about the longevity of your career and what additional training you may need now in order to open doors later in life. A small investment now can pay great dividends in the future.
 
What pharmacy related issues keep you up at night?
 
As a profession, I am concerned we are often too fractionated so that our voice is not heard and our true worth is not fully appreciated. It is imperative that all pharmacists become advocates for the profession at both the state and national levels to ensure we are recognized as providers.
 
Do you have any special interests or hobbies outside of work?
 
Aside from traveling both within and outside the US, I enjoy gardening.
 
What is your favorite place to vacation?
 
Traveling is my passion. I think we can learn much from understanding all types of cultures.
 
What 3 adjectives would people use to best describe you?
 
Adventurous, Confident, Determined
 

Basaglar for the Treatment of Diabetes
 
Authors: Franklin Reeves, Pharm.D.* and Kendra Manigault, PharmD., BCPS, BCACP, CDE
*pharmacy student at the time of writing
 
Mercer University College of Pharmacy
Corresponding author:
Kendra Manigault, Pharm.D., BCPS, BCACP, CDE
Clinical Assistant Professor
Email: manigaukr@gmail.com
 
As modern medicine advances, new and innovative therapies are coming to the market. Follow-on biologics and biosimilars are treatment options which provide new options for patients in need of biologics. Biosimilars were specifically defined in the Biologics Price Competition and Innovation act of 2009 (BPCIA), a statute under the Affordable Care Act (ACA). 1 In the BPCIA, biosimilars were designated as being "highly similar" to a formerly FDA approved biologic drug, hence the name biosimilar. The advantages of incorporating biosimilars into the marketplace include increasing patient access to biological therapies and incorporating a higher degree of competition within the drug marketplace.2,3 A biological product, Basaglar ® (insulin glargine), was approved as a "follow-on" biologic to Lantus ® for use in patients requiring long-acting insulin therapy.4 While designated as a "follow-on" biologic due to a difference in its approval process, the "follow on" designation has often become synonymous with the term biosimilar.5
According to the U.S. Food and Drug Administration (FDA), biologics are drug products that are typically more substantial and more complex than small molecules, produced in living systems, and are sensitive to environmental changes.6 Due to the complexity and special production requirements, it has become a daunting task to make them cost-effective. As such, access and availability may be limited for patients in need due to cost concerns.3 The BPCIA created an abbreviated approval pathway for biological products, very similar to the Abbreviated New Drug Application (ANDA) created for small molecule generic drugs. In the case of the ANDA, manufacturers of generic drugs are able to submit less clinical data and require no animal safety/toxicity studies or extensive human trials to expedite the approval process.7 Comparatively, biosimilar products require less clinical trials and/or data but must demonstrate biosimilarity to the reference biologic, "notwithstanding minor differences in clinically inactive components . . . safety, purity and potency."1 Basaglar® (insulin glargine) was approved as a follow-on biologic in December of 2016.4 Biological products are designated as a follow-on or biosimilar product based on the regulatory pathway in which it is approved. Insulin products that differ from the original biologic product but may still be considered similar, such as Basaglar®, gain approval under section 505 (b)(2) of the Federal Drug and Cosmetic Act (FDC). As a result, these products and other biological products regulated by the FD&C are termed follow-on biologics.5
In a summary review from the Center for Drug Evaluation and Research (CDER), it was determined that the analytical studies performed justified the composition, strength, and presentation of Basaglar® and its similarity to Lantus®.8 In addition, studies were performed to determine Basaglar's® differences in clinical efficacy outcomes (i.e., HbA1c), and provide comparative clinical safety data after repeated and chronic dosing.8 A randomized, open-label clinical trial, ELEMENT 1, was designed to compare the safety and efficacy in Type 1 diabetics.9 In this study, two treatment groups utilized a once daily basal, either Basaglar® or Lantus®, with mealtime bolus regimen of Humalog® (insulin lispro). The study concluded Basaglar® to be non-inferior to Lantus® as both had similar and significant mean decrease in HbA1c from baseline by 52 weeks (p <0.001).9 Another study, including Type 2 diabetics using oral anti-hyperglycemic medications, was performed in the ELEMENT 2 trial.10 The patients included were either insulin naive or had utilized Lantus ® prior to entering the study. In addition, they had to be on at least two oral medications for diabetes. By study completion, it was concluded that Basaglar ® was non-inferior to Lantus ® , as both treatment groups saw a similar and significant decrease in HbA1c from baseline (p < 0.001) after 24 weeks.10 Other studies the CDER utilized to confirm its similarity to Lantus® included chemistry manufacturing and controls (CMC), nonclinical pharmacology/toxicology, clinical pharmacology/biopharmaceutics, and clinical microbiology.8
The Basaglar® KwikPen allows efficient glycogen and fatty acid synthesis in the liver and adipose tissue. In addition, it aids in uptake of blood glucose, amino acids, and other essential nutrients into cells. These combined mechanisms lower extracellular blood glucose to allow for better glycemic control in both Type 1 and Type 2 diabetics.11 When converting from once-daily Lantus® to Basaglar®, a 1:1 unit conversion may be performed.11 The main adverse event associated with the use of Basaglar® is hypoglycemia, which can commonly manifest as nervousness, sweating, and increased appetite.12 Severe hypoglycemia episodes have been reported with Basaglar® and resulted in seizures and even death. To prevent these from occurring, patient education, self-monitoring of glucose, and clinician education about the different types of insulin is vital. 12
Follow-on biologics and biosimilar products may improve accessibility and cost through increased competition among biological products. Continued innovations in biological products has the potential to make significant contributions in the management of chronic disease states.
 

References:
  1. U.S. Food and Drug Administration. Implementation of the Biologics Price and Competition Act of 2009. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/ucm215089.htm Accessed January 23, 2017.
  2. Olech E. Biosimilars: Rationale and current regulatory landscape. Semin Arthritis Rheum. 2016;45(5 Suppl):S1-10.
  3. Lucio SD, Stevenson JG, Hoffman JM. Biosimilars: Implications for health-system pharmacists. Am J Health Syst Pharm. 2013;70(22):2004-17.
  4. U.S. Food and Drug Administration. FDA approves Basaglar, the first "follow-on" insulin glargine product to treat diabetes. Updated December 21, 2015. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm477734.htm.
  5. Johnson J. FDA Regulation of Follow-On Biologics. https://primaryimmune.org/advocacy_center/pdfs/health_care_reform/Biosimilars_Congressional_Research_Service_Report.pdf. Accessed January 24, 2017
  6. http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm133077.htm. Accessed January 23, 2017
  7. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/. Accessed January 23, 2017.
  8. U.S. Food and Drug Administration. Center for Drug Evaluation and Research. Summary Review. http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205692Orig1s000SumR.pdf. Accessed January 24, 2017.
  9. Blevins TC, Dahl D, Rosenstock J, et al. Efficacy and safety of LY2963016 insulin glargine compared with insulin glargine (Lantus®) in patients with type 1 diabetes in a randomized controlled trial: the ELEMENT 1 study. Diabetes Obes Metab. 2015;17(8):726-33.
  10. Rosenstock J, Hollander P, Bhargava A, et al. Similar efficacy and safety of LY2963016 insulin glargine and insulin glargine (Lantus®) in patients with type 2 diabetes who were insulin-naïve or previously treated with insulin glargine: a randomized, double-blind controlled trial (the ELEMENT 2 study). Diabetes Obes Metab. 2015;17(8):734-41.
  11. Lexi-Comp Online. Insulin glargine. Lexi-Drugs Online. Hudson, Ohio: Lexi-Comp, Inc. https://online-lexi-com.proxy-s.mercer.edu/lco/action/doc/retrieve/docid/patch_f/320047. Accessed January 23, 2017.
  12. Basaglar [package insert]. Indianapolis, IN: Eli Lilly & Co; 2016.
 Liraglutide and Empagliflozin and Cardiovascular Outcomes in Type 2 Diabetes

 

Authors: Sapna Charania, Pharm.D.* and Kendra Manigault, PharmD., BCPS, BCACP, CDE

*pharmacy student at the time of writing

 

Mercer University College of Pharmacy

Corresponding author:

Kendra Manigault, Pharm.D., BCPS, BCACP, CDE

Clinical Assistant Professor

Email: manigaukr@gmail.com

 

 

Type 2 diabetes mellitus (T2DM) is a disorder characterized by hyperglycemia resulting from insulin resistance and deficiency. Chronic hyperglycemia can lead to multiorgan damage and serious complications.1 Of note, cardiovascular disease (CVD) is the leading cause of death and complications in patients with T2DM.2 In 2008, the FDA mandated demonstration of cardiovascular safety for the approval of all new antihyperglycemic medications.3 These recommendations were motivated by the high prevalence of CVD in diabetes and, in part, by concerns about a signal of potentially increased cardiovascular risk seen with an antihyperglycemic medication, rosiglitazone.4 Furthermore, there is concern that intensive glucose lowering or the use of specific glucose-lowering drugs may be associated with adverse cardiovascular outcomes.5  This article will discuss the cardiovascular benefits associated with two emerging antihyperglycemic medications, liraglutide and empagliflozin.

 

In January 2010, the FDA approved liraglutide (Victoza®) a glucagon-like peptide -1 (GLP-1) receptor agonist, as an adjunct to diet and exercise to improve glycemic control in adults with T2DM.6,7  In addition to activating the GLP-1 receptor, liraglutide increases intracellular cyclic AMP (cAMP), which leads to insulin release in the presence of elevated glucose concentrations. Liraglutide also decreases glucagon secretion in a glucose-dependent manner, and causes a delay in gastric emptying. 7 It is recommended that liraglutide be initiated at a dose of 0.6 mg subcutaneously per day to reduce gastrointestinal symptoms. The liraglutide dose is subsequently increased to 1.2 mg or 1.8 mg, depending upon glycemic response. The most common adverse reactions associated with liraglutide are headache, nausea, diarrhea and anti-liraglutide antibody formation. Liraglutide is contraindicated in patients with a personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2.7

 

The Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results (LEADER) Trial was a multicenter, double-blind, placebo-controlled trial in which 4,668 patients were randomly assigned to receive liraglutide while 4,672 received placebo.8 Patients ≥ 50 years old with T2DM, HbA1c > 7%, and high cardiovascular risk (i.e. coronary heart disease, peripheral vascular disease, New York Heart Association class II or III chronic heart failure) were included in the study. The objective of this trial was to assess the long-term effects of liraglutide on cardiovascular outcomes. Patients were randomly assigned in a 1:1 ratio to receive the maximum tolerated dose of liraglutide or matching placebo once daily as a subcutaneous injection in addition to standard care.8 Primary outcome was defined as first occurrence of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke. The primary outcome occurred in fewer patients in the liraglutide group (13.0%) than in the placebo group (14.9%) (hazard ratio, 0.87; 95% confidence interval [CI], 0.78 to 0.97). Death from cardiovascular causes occurred in fewer patients in the liraglutide group (4.7%) compared to the placebo group (6.0%) (hazard ratio, 0.78; 95% CI, 0.66 to 0.93; P=0.007). The rate of death from any cause was also lower in the liraglutide group (8.2%) than in the placebo group (9.6%) (hazard ratio, 0.85; 95% CI, 0.74 to 0.97; P=0.02). The frequencies of nonfatal myocardial infarction and nonfatal stroke were lower in the liraglutide group than in the placebo group, although the differences were not significant.8

 

In August 2014, the FDA approved empagliflozin (Jardiance®), a sodium-glucose co-transporter 2 (SGLT2) inhibitor, as an adjunct to diet and exercise to improve glycemic control in adults with T2DM.9,10  By inhibiting SGLT2, empagliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, thereby increasing urinary glucose excretion. The recommended dose of empagliflozin is 10 mg once daily in the morning. The dose may be increased to 25 mg once daily. The most common adverse reactions associated with empagliflozin are urinary tract infections and female genital mycotic infections. Empagliflozin is contraindicated in patients with severe renal impairment (eGFR <30 mL/minute/1.73 m2), end-stage renal disease, or dialysis.10

 

The EMPA-REG OUTCOME trial was a randomized, double-blind, placebo-controlled trial in which 4,687 patients were randomly assigned to receive empagliflozin and 2,333 were randomly assigned to receive placebo.11 Patients with T2DM who were adults (≥18 years of age) with a body-mass index of 45 or less and an estimated glomerular filtration rate (eGFR) of at least 30 ml per minute per 1.73 m2 of body-surface area, according to the Modification of Diet in Renal Disease criteria were included in the study. All patients had established CVD and either received no glucose-lowering agents for at least 12 weeks before randomization with a HbA1c ≥7.0%and ≤9.0% or received antihyperglycemic therapy for at least 12 weeks before randomization with a HbA1c ≥7.0% and ≤10.0%. Patients were randomized in a 1:1:1 ratio to receive once-daily empagliflozin 10 mg, empagliflozin 25 mg or placebo. The primary outcome in the time-to-event analysis was the first occurrence of death from cardiovascular causes, nonfatal (including silent) myocardial infarction, or nonfatal stroke. The primary outcome occurred in a significantly lower number of patients in the empagliflozin group (10.5%) than in the placebo group (12.1%) (hazard ratio in the empagliflozin group, 0.86; 95.02% confidence interval [CI], 0.74 to 0.99). As compared with placebo, empagliflozin resulted in a significantly lower risk of death from cardiovascular causes (hazard ratio, 0.62; 95% CI, 0.49 to 0.77), death from any cause (hazard ratio, 0.68; 95% CI, 0.57 to 0.82) and hospitalization for heart failure (hazard ratio, 0.65; 95% CI, 0.50 to 0.85; P=0.002)  .11

 

Both LEADER and EMPA-REG OUTCOME trials show potential cardiovascular benefits in the management of diabetic patients with poorly controlled hyperglycemia and CVD. The FDA approved a new indication for empagliflozin and liraglutide to reduce the risk of cardiovascular death in adult patients with T2DM and CVD as a result of these clinical trials.12,13 Cardiovascular risk factor reduction may offer a compelling rationale to incorporate liraglutide or empagliflozin early in the management of diabetes mellitus in patients at risk for CVD.

 

References

 

1.      American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care. 2014 Jan;37 Suppl 1:S81-90 full-text.

2.      Matheus AS, Tannus LR, Cobas RA, Palma CC, Negrato CA, Gomes MB. Impact of diabetes on cardiovascular disease: an update. Int J Hypertens 2013; 2013:653789-653789.

3.      Evaluating the Cardiovascular Safety of New Medications for Type 2 Diabetes. Available at: http://www.medscape.com/viewarticle/862488. Accessed November 21, 2016.

4.      Hiatt WR, Kaul S, Smith RJ. The cardiovascular safety of diabetes drugs-insights from the rosiglitazone experience. N Engl J Med 2013;369:1285-1287.

5.      Udell JA, Cavender MA, Bhatt DL, Chatterjee S, Farkouh ME, Scirica BM. Glucose-lowering drugs or strategies and cardiovascular outcomes in patients with or at risk for type 2 diabetes: a meta-analysis of randomised controlled trials. Lancet Diabetes Endocrinol 2015;3:356-366.

6.      FDA Approves New Treatment for Type 2 Diabetes. Available at http:// www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm198638.htm. Accessed December 12,2016.

7.      Victoza (liraglutide) [prescribing information]. Plainsboro, NJ: Novo Nordisk Inc; April 2016.

8.      Marso SP, Daniels GH, Brown-Frandsen K, et al. Liraglutide and cardiovascular outcomes in type 2 diabetes. N Engl J Med 2016;375:311-322.

9.      FDA approves Jardiance to Treat Type 2 Diabetes. Available at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm531517.htm. Accessed December 12, 2016.

10.  Jardiance (empagliflozin) [prescribing information]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc; July 2016.

11.  Zinman B, Wanner C, Lachin JM, et al. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med. 2015;373(22):2117-28.

12.  FDA approves Jardiance to reduce cardiovascular death in adults with type 2 diabetes. Available at: https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm531517.htm Accessed December 5, 2016.

13.  News Release: Victoza® (liraglutide) is approved in the US as the only type 2 diabetes treatment indicated to reduce the risk of three major adverse cardiovascular events. Available at: http://press.novonordisk-us.com/2017-08-25-Victoza-R-liraglutide-is-approved-in-the-US-as-the-only-type-2-diabetes-treatment-indicated-to-reduce-the-risk-of-three-major-adverse-cardiovascular-events. Accessed August 20, 2018.

 

 
What is multimodal pain management?

Authors: Martha Hopkins, Amber Newell
 
            Multimodal pain management is a surgery-specific population-based approach to enhance pain relief by treating pain through multiple mechanisms along multiple sites of the nociceptive pathway. 1 This approach to the management of pain can be applicable in many scenarios such as spinal injuries, broken bones and acute pancreatitis to name a few. As it relates to Enhanced Recovery After Surgery (ERAS), multimodal pain management has evolved as the standard of care at many institutions regarding perioperative care as an effective means to control postsurgical pain, reduce opioid use, decrease opioid-related adverse events, enhance postsurgical recovery and decrease the length of stay. 2


Available at: http://ofirmev.com/why-ofirmev/pain-management.aspx. Accessed September 23, 2018.
            As clinicians strive to provide quality care to improve patient outcomes, our ability to leverage and utilize the unique qualities of the multidisciplinary healthcare team within institutions is key to improved outcomes and decreased hospitalization. Thus, ERAS success heavily depends on nurses, pharmacists and the ability of the multidisciplinary team to execute its standardized processes across the continuum of care. This continuum of care includes patient education, perioperative care, and post-surgical evaluation.2 Optimal pain management requires a comprehensive strategy with a multimodal approach that includes pharmacologic therapy, psychological therapy, physical and occupational therapy, and procedural treatments - an interdisciplinary approach.3
            Multimodal pain management is personalized medicine and fundamentally an individualized approach to patient care. It is a treatment plan that, may shortly be based on the genetic makeup of each patient taking into consideration the patient's sensitivity to pain and their systemic metabolism. 1 Developing the ability to affordably utilize technology in medicine will assist in supporting the efforts of healthcare providers to impart value and improve quality of care.
 
Multidisciplinary Team Inquiry: For trauma patients taking methocarbamol and tramadol, what are some of the potential drug-drug interactions?
 
Medication Name 4
Level of Interaction 4
Available Evidence 4
Drug-Drug Interaction 4
methocarbamol (Robaxin) +
tramadol (Ultram)
MAJOR Interaction
Fair
Increased risk of respiratory and CNS depression when using Robaxin and Ultram are used together
As clinicians navigate the developing territory of personalized medicine, as it relates to multimodal pain management; it will be essential to understand the potential barriers. Some barriers include but are not limited to, drug-drug interactions, how the medications interact with the body and moves through the body. For now, understanding the half-life of a pain medication equips the multidisciplinary to team with invaluable information that will allow them to develop an effective multimodal pain management plan. In the case of methocarbamol and tramadol, the following pharmacokinetic information can be utilized in pain management development:
  • Elimination Half Life: The time required for the body to eliminate half of an administered dose of any substance by regular physiological processes.4 
     Tramadol: 4
  1. tramadol hydrochloride, immediate-release: adults, 5.6 to 6.7 hours
  2. tramadol hydrochloride, immediate-release: geriatric (aged 75 years and older), 7 hours
  3. tramadol hydrochloride, immediate-release: hepatic impairment, 13 hours
  4. tramadol hydrochloride, IV: renal impairment (CrCl less than 30 mL/min), 10.6 hours to 11 hours
            Methocarbamol: 4
  1. Normal Patient: 1.1 h +/- 0.27 h (mean)
  2. Elderly: 1.5 h +/- 0.4 h (mean)
  3. Renal impairment: 1.2 h +/- 0.6 h (mean)
  4. Cirrhosis: 3.38 h +/- 1.62 h (mean)
 
            When developing multimodal pain management plans, health care professionals should take the long-term effects of chosen medications into consideration. Tramadol is a synthetic opiate (narcotic) analgesic used to treat moderate to severe pain. 5 Like numerous opioids, tramadol's mechanism of action involves binding of the opiate receptors in the central nervous system (CNS). Because of the way that it works in the CNS, tramadol can be addictive even though it is considered to be one of the least potent opioids. It is designed to treat acute pain over a short period; however, over time its abuse can lead to addiction. According to a report released by the World Health Organization, approximately 95% of tramadol abuse cases in one study involved a prior history of other substance abuse. 5 However, even those without a history of substance abuse are not excluded from the development of dependence. Once dependence develops, it is more likely that an individual may begin abusing the drug by using it in ways other than what has been prescribed. 5 Methocarbamol is a centrally acting muscle relaxant that can be used to treat skeletal muscle spasms and pain. Methocarbamol has documented, reduced potential for abuse, especially in comparison to tramadol. Studies comparing it to lorazepam (benzodiazepine) and diphenhydramine (antihistamine), along with a placebo, find that methocarbamol produces increased "liking" responses and some sedative-like effects. 6 To note, at increased doses of methocarbamol dysphoria is reported and is considered to have an abuse profile likened to, but weaker than, lorazepam. 6
 
References:
Note: Acceptable references and AMA format required
 
  1. Manworren RC. Multimodal pain management and the future of a personalized medicine approach to pain. AORN J. 2015;101(3):308-14.
  2. Montgomery R, McNamara SA. Featured article: Multimodal Pain Management for Enhanced Recovery: Reinforcing the Shift From Traditional Pathways Through Nurse-Led Interventions. AORN Journal. 2016;104(Supplement):S9-S16. doi:10.1016/j.aorn.2016.10.012.
  3. Polomano RC. Concepts in Acute Pain Management: A Nurse's Guide to Multimodal Approaches to Drug Therapy: INROADS into Pain Management Initiative. www.inroadsforpain.com/#. Available at: http://www.aspmn.org/documents/2009ConferenceHandouts/INROADSNationalSyllabusFINAL. Accessed September 19, 2018.
  4. IBM Micromedex® Drug Interaction Checking (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. Available at: https://www-micromedexsolutions-com.proxy-s.mercer.edu/. Accessed: September 19, 2018.
  5. Available at: https://lagunatreatment.com/tramadol-effects/. Accessed September 19, 2018.
  6. Preston KL, Wolf B, Guarino JJ, Griffiths RR. Subjective and behavioral effects of diphenhydramine, lorazepam and methocarbamol: evaluation of abuse liability. J Pharmacol Exp Ther. 1992;262(2):707-20.

 
Clinical Writing Opportunities 
Writing a clinical article for the GSHP newsletter is a great way for students to get publication experience. Topics can be anything related to hospital-system pharmacy. Examples include (but are not limited to): new drug updates, national policy updates for hospital pharmacy, guideline updates, therapeutics reviews, and clinical controversies. Articles are generally 1-3 pages in length, and can include tables and figures. Interested members and students should email Steve Glass (sglass@gshp.org) for more details.

Did you know that if you missed one of our monthly webinars, you can view them on the GSHP website?

Go to:  https://www.gshp.org/development_webinars.aspx 
     


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