Enhanced Recovery After Surgery: Where Do Pharmacists Come In?

Enhanced Recovery After Surgery: Where Do Pharmacists Come In? Melinda C. Joyce, Pharm.D., FAPhA, FACHE Vice President, Corporate Support Services Med Center Health Bowling Green, Kentucky Annual Meeting & Exposition Seattle, Washington March 22 25

Disclosures Melinda C. Joyce declare(s) no conflicts of interest, real or apparent, and no financial interests in any company, product, or service mentioned in this program, including grants, employment, gifts, stock holdings, and honoraria. 2

CPE Information Target Audience: Pharmacists ACPE#: 0202 0000 19 044 L04 P Activity Type: Knowledge based 3

Learning Objectives At the completion of this knowledge based activity, participants will be able to: Define enhanced recovery after surgery (ERAS) Identify approaches that will ensure ERAS. Discuss the role of the health system pharmacist in developing and implementing successful ERAS protocols. 4

Assessment Questions 1. Which of the following is NOT a goal of an enhanced recovery after surgery (ERAS) program? A. Reduction in complications B. Faster recovery C. Reduced length of stay D. No opiate use after surgery 5

Assessment Questions 2. Which of the following is one of the most important elements of a successful ERAS program? A. Pre admission counseling B. Restriction of food and liquids for at least 48 hours prior to surgery C. Use of nasogastric (NG) tubes after surgery D. Limited mobility for the first 24 hours after surgery 6

Assessment Questions 3. Which of the following has been found to be beneficial to decrease variability with ERAS? A. Availability of multiple order sets tailored to the individual surgeons. B. Restricted medications that may be prescribed only by providers that have been trained in ERAS. C. Standardized order sets that have been approved by the facility s Medical Executive Committee. D. Approved pre op antibiotic order sets only. 7

Assessment Questions 4. Pharmacists can assist with an ERAS protocol in which of the following ways? A. Refusing to fill opioid prescriptions at discharge for ERAS patients as the opioid is not needed. B. Assisting in the creation of ERAS order sets, especially with medication review. C. Not being available to be part of ERAS workgroups. D. Discontinuation of all oral medications prior to surgical procedures due to the risk of aspiration. 8

History Annual Meeting & Exposition Seattle, Washington March 22 25 9

Back to the Past The senior surgeon was in charge and what he/she said was followed no matter what Patients undergoing surgery had Prolonged fasting prior to the procedure Mechanical bowel preparation and nasogastric (NG) tubes were thought to be necessary Drains were thought to be essential Opioids were the pain management of choice Prolonged bed rest was recommended to facilitate abdominal wall healing The hospital stay was expected to be lengthy Patients were miserable 10

Henrik Kehlet, MD, PhD Dr. Kehlet was a colorectal surgeon and professor in Denmark Studied five essential elements of enhanced recovery for his patients in the 1990s Pre op education and preparation Epidural analgesia No NG tube Early feeding and ambulation Keep the patient normovolemic Why did Dr. Kehlet make these changes? 11

Surgical Stress Response The stress response of surgery is characterized by increased secretion of pituitary hormones and activation of the sympathetic nervous system Results of this stress response include Increased catabolism to mobilize substrates for energy Retention of salt and water to maintain fluid volume and cardiac homeostasis Increased sympathetic activity resulting in cardiovascular responses of tachycardia and hypertension Insulin release is diminished along with an increased release of glucagon, leading to hyperglycemia 12

Reduction in Surgical Stress Response Reduction of fasting times prior to the induction of anesthesia Avoidance of hypothermia Decrease of fluid overload Maintaining normoglycemia Reduction of post operative nausea and vomiting Pain control Early mobilization Resumption of diet as quickly as possible post operatively 13

Birth of ERAS Dr. Kehlet s approach to reduce surgical stress had significant results Reduced post operative hospital stay from 8 12 days to 2 3 days 1 Substantially decreased costs 1 After the initial demonstration, a collaboration was formed between five centers in Denmark, the Netherlands, Norway, Sweden, and England Developed, evaluated, and implemented standardized protocols Enhanced recovery after surgery (ERAS) was born by 2001 Although widely accepted in Europe, ERAS was slower to be implemented in the United States Many hospitals have now adopted ERAS protocols, especially for colorectal, gynecologic, and orthopedic surgeries 1 Kehlet H. Multimodal approach to control postoperative pathophysiology and rehabilitation. Br J Anaesth 1997; 78:606 17.

Why is ERAS Important Today? First, THE PATIENT! Second, Costs High, unsustainable, and variable rising costs of hospitalizations Government payment models for hospitals Value Based Purchasing Payment reduction programs Increasing demand Aging population Greater disease burden Results in a need to change what we are doing Improve patient experience Decrease length of stay Decrease post operative complications Decrease readmissions Increase revenue 15

What is ERAS? Annual Meeting & Exposition Seattle, Washington March 22 25 16

What is ERAS? A paradigm shift in surgery and surgical care of the patient More of a change in the philosophy of care Continuum of care from the initial need for surgery throughout the entire hospital stay and extending to the post discharge setting Multidisciplinary Patient centered 17

Elements of ERAS Intraoperative Postoperative ERAS Preoperative 18

Elements of ERAS Audit of Outcomes Preadmission Counseling Selective Bowel Prep Early Feeding Early Removal of Drains Carbohydrate Loading/ No Fasting Epidural/ Regional Anesthesia Stimulation of Gut Motility Multi Modal Analgesia Prevention of Nausea and Vomiting Early Mobilization ERAS Minimally Invasive No NG Tubes No Benodiazepine Pre Med Short Acting Anesthetic Agents Avoidance of Fluid Overload 19

Pre Surgery Traditional Pre Op Limited, fragmented education from healthcare providers No optimization of disease states or condition prior to surgery May or may not use pre admission testing (PAT) services offered by the hospital Mechanical bowel prep done routinely Clear liquids for at least 24 hours Nothing by mouth after midnight day of surgery ERAS Pre Op Extensive patient and family education Focused on certain milestones Pre admission testing necessary Management of pre existing conditions Minimal fasting, including clear liquids up to 4 hours prior to anesthesia Mechanical bowel prep only if indicated Oral antibiotic regimen to be completed prior to surgery High carbohydrate drink on the way to the hospital 20

Pre Op Counseling Extremely important for patient buy in and success!! Clear explanation of what will happen during the hospital stay and the role of the patient and family Explanation about the timing of the clear liquids and the carbohydrate drink Understanding what medications to take or which to hold Will be based on the type of procedure Oral prophylactic antibiotics, if indicated Understanding the importance of skin prep prior to surgery Reinforcement of the need to stop smoking and offer nicotine replacement Should not smoke on the day of surgery 21

Pre Op Counseling Expectations of the patient pre operatively Preventive care before the procedure, such as smoking cessation; better diabetes or hypertension control Expectations of the patient post operatively Early eating Fluid intake Ambulation Pain management Post op nausea/vomiting management Discharge planning 22

Importance of Pre Admission Testing Sub optimal or inadequate patient evaluation is often a major contributing factor to poor outcomes Pre operative screening and optimization of co morbidities prior to surgery Assessment of chronic medications Necessary to determine if any medications should be held prior to surgery and if so, for how long Appropriate screening tests Focus on those tests that may most impact the surgical procedure, such as the hemoglobin A1c May be necessary to delay elective procedures until the patient s diabetes is better controlled Will help to trigger insulin protocols that may be required during the stay Helps to facilitate communication between the surgeon/ anesthesiologist/ primary care provider 23

Why Carbohydrate Loading and Limited NPO? NPO is no guarantee of an empty stomach Reduces pre operative thirst, hunger, and anxiety Carbohydrate loading drink helps to attenuate insulin resistance induced by surgery and starvation Patient satisfier!! 24

Pre Op at the Hospital Traditional Pre Op Pre op sedative hypnotics, usually benzodiazepines given Pain medications not part of the usual routine DVT prophylaxis not considered Antibiotics given pre op if needed ERAS Pre Op Avoid routine pre op sedativehypnotics Use of oral pain medications: Acetaminophen 1000 mg Gabapentin 300 mg Celocoxib 200 mg Diclofenac 50 mg DVT prophylaxis Antibiotic regimen as indicated 25

Medications in the Pre Op Setting Avoid Benzodiazepine Pre Medications Increases cognitive dysfunction Especially in the elderly or frail patients Increases pharyngeal/ laryngeal dysfunction May increase the time to extubation Could lead to pulmonary aspiration, especially in elderly patients or patients with obstructive sleep apnea Focus should be on preventing anxiety through adequate pre surgery preparation Pain Medication Multi modal approach Minimizing the use of opioids helps with earlier return of bowel function Administering non opioid pain medication prior to the procedure helps to improve post operative pain and decrease opioid use Use non steroidal anti inflammatory agents (NSAIDs) when not contraindicated 26

Intra Op Traditional Intra Op Open incisions Liberal fluids IV analgesia, usually opioids Little attention to glucose ERAS Intra Op Minimally invasive techniques are preferred Laparoscopic Robotic Short acting anesthetic agents Regional anesthesia techniques Fluid management to keep patient normovolemic Multi modal pain management Maintenance of normothermia Insulin protocols 27

Multimodal Analgesia Under treatment of perioperative pain can lead to: Risk of thromboembolic complications Pulmonary complications Prolonged hospital stay Hospital readmissions for further pain management Decreased quality of life Potential for addiction or abuse Optimization of pain management is a key component to an ERAS protocol Multimodal analgesia is defined as the administration of two or more drugs that act by different mechanisms for providing analgesia 28

Non Opiate Pain Management Local and regional anesthesia Systemic lidocaine Acetaminophen NSAIDs Corticosteroids Ketamine Magnesium Alpha2 Adrenergic Agonists Gabapentinoids 29

Epidural and Regional Blocks Regional techniques, particularly epidural anesthesia are important Thoracic epidural analgesia (TEA) is considered to be the gold standard to control pain in patients undergoing open colorectal surgery as opposed to patient controlled analgesia or parenteral opioids Combinations of both local anesthetics and opioids are often employed in epidurals May be a challenge with coordinating time with DVT prophylaxis Must watch for urinary retention, unintentional hypotension, and motor blockade Depending on the type of surgery and extent of tissue damage, a thoracic epidural catheter is recommended to provide analgesia with a local anesthetic that does not include opioids 30

Epidural and Regional Blocks A transverse abdominis plane (TAP) block can be very beneficial but anesthesia must have the technical skill for this procedure Nausea and vomiting may be noted, but can usually be decreased through the pre emptive use of anti emetics A variant of the TAP block is the Quadratus Lumborum (QL) block, which can be tailored to different areas of the body, such as lower chest wall, upper abdomen, or lower abdomen 31

Acetaminophen Studies have shown that acetaminophen can reduce opioid consumption by about 30% The IV form can be used while the patient is NPO but once the patient is able to tolerate oral medications, it should be switched to the oral form No evidence that increased bioavailability of the IV form enhances efficacy outcomes Should be administered on a scheduled basis Still necessary to monitor daily acetaminophen dose but the scheduled regimen often negates this concern 32

NSAIDs Strong evidence that NSAIDS have benefit, especially when given on a scheduled basis Must be used carefully Risk/ benefits must be determined prior to surgery Cardiac history/ heart failure Renal function Surgical procedure and possible bleeding risk Risk of anastomotic leaks Various ERAS protocols have used both traditional NSAIDs, such as ketorolac or diclofenac and COX 2 inhibitors, such as celecoxib 33

Gabapentinoids Reduction in the release of excitatory neurotransmitters, such as glutamate, substance P, and calcitonin gene related peptide Best for neuropathic types of pain Analgesic effect comparable and synergistic with NSAIDs Useful adjuvant to epidural analgesia Decreased pain scores Increased patient satisfaction Help to improve functional recovery Gabapentin is more commonly used than pregabalin Some concern of abuse 34

Systemic Lidocaine Anti inflammatory analgesic Inhibition of N methyl D aspartate receptors Stimulates the secretion of the anti inflammatory cytokine interleukin 1 receptor antagonists Results in selective depression in pain transmission in the spinal cord and reduction in tonic neural discharge of active peripheral fibers Usually see decreased opioid requirements post operatively along with decreased post op nausea and vomiting Accelerate the return of bowel function No specific dose and duration of infusion has been determined 100 mg prior to incision and then 1 2 mg/kg/hour 35

Systemic Lidocaine Contraindications Unstable coronary disease or recent myocardial infarction Heart failure 1 st and 2 nd degree heart block Electrolyte disturbances Liver disease Seizure disorder Adverse Effects Numbness and tingling in fingers, toes, or inside the mouth Lightheadedness, dizziness, confusion Decreased hearing Severe adverse effects: Loss of consciousness; convulsions; cardiac arrhythmias 36

Ketamine Inhibition of N methyl D aspartate receptors but also has activity at other site Low dose has been included in most ERAS protocols <1.2 mg/kg/hour as a continuous infusion and/or <1 mg/kg when given as a bolus Helps to decrease opioid consumption and lessen delirium Not associated with serious side effects May be best suited for the following types of cases: Procedures with high risk for developing chronic post surgical pain Opioid tolerant patients Patients with opioid induced hyperalgesia 37

Other Agents Magnesium Systemic administration of peri operative magnesium reduces post operative pain and opioid consumption Corticosteroids, such as dexamethasone Single dose IV dexamethasone at doses over 0.1 mg/kg is an effective adjunct to reduce post operative pain and opioid consumption 38

Post Op Traditional Post Op Foley out on Post Op Day (POD) 2 3 NG tube NPO or clear liquids for 1 2 days IV opioids per patient controlled analgesia (PCA) pumps Up in chair for 1 2 hours on POD 1 IV fluids ERAS Post Op Early removal of Foley (often on POD 1) No NG tube Regular diet on POD 1 Multi modal pain management Walking on day of surgery Up as much as possible beginning on POD 1 Gum chewing 39

Early Mobilization and Feeding Mobilization Prolonged bed rest leads to an increased risk of thromboembolism and a decrease in muscle strength, pulmonary function, and tissue oxygenation With early removal of catheters and IVs, much easier for the patient to be up and moving Very important that patients understand that they will be expected to be out of bed on the day of surgery Early Oral Intake Facilitates early return of bowel function No IV helps to avoid fluid overload Chewing sugar free gum for > 10 minutes 3 to 4 times a day is a proposed mechanism for sham feeding and helps gastric stimulation 40

What About Opioids? For many types of surgeries, the multi modal approach without opioids will be sufficient for pain management Opioids are often viewed as rescue analgesia when non opioid agents have not provided adequate relief Using an opioid in combination with the non opioid agents may help to enhance the effect of the opioid and decrease overall opioid consumption Limiting opioids helps to reduce the adverse effects, such as sedation, postop nausea and vomiting, urinary retention, ileus, and respiratory depression Limiting opioids may help to decrease length of stay 41

Discharge Traditional Discharge Little plan for discharge Hospitalization would often last for 8 to 12 days Patient often weak and more debilitated due to NPO status and little mobility Patient still dependent upon opioids for pain management ERAS Discharge Begins prior to the surgical procedure Evaluation of support systems once patient is discharged Expectations set for what to do after discharge Including pain management Wound care Follow up appointments set before procedure occurs 42

Development of an ERAS Program Annual Meeting & Exposition Seattle, Washington March 22 25 43

Multidisciplinary Team Approach Identify key members of the multidisciplinary team Must include pharmacists Assemble ERAS workgroup Education Roles and responsibilities Construct ERAS protocols/ order sets Pre Op Intra Op Post Op Educational materials 44

Multidisciplinary Team Approach Develop checklists Pre admission testing Prep/Hold area Anesthesia Nursing Post Acute Care Unit (PACU) Med/ Surg Nursing Units Data Collection and Evaluation What worked and what did not 45

ERAS Pathway Approach Step 1: Determine interest level Step 2: Assemble ERAS workgroup with physician champions Step 3: Gather literature; Educate the workgroup; Collect baseline data Step 4: Collect protocols for each phase of the continuum Step 5: Review current practices for ERAS incorporation 46

ERAS Pathway Approach Step 6: Develop protocols and order sets Step 7: Trial protocols and evaluate effectiveness Step 8: Collect and analyze data in light of the new pathway Step 9: Finalize pathways; Share data with all involved Step 10: Celebrate! 47

Barriers The Ostrich Approach: But we have always done it this way and I see no reason to change Requires working together as a multidisciplinary team Communication between disciplines and communication with the patient are paramount Requires patient involvement Requires lots of patient education at all phases of the continuum Requires attention to detail must follow the pathway/ protocol Audit for non compliance and address early 48

Pharmacists Are Critical Team Members Pharmacists were invaluable in helping develop the ERAS order sets Selection of medications Antibiotics Deep vein thrombosis (DVT) prophylaxis Appropriate doses of the medications Appropriate timing of the medications Standardization of medications Education about the medications Automating the order sets into the electronic health record In the ambulatory setting, the pharmacist is instrumental in reinforcing the use of the pre op oral antibiotic regimen and the use of the skin cleanser 49

A portion of the Med Center Health ERAS order set 50

Med Center Health Results Annual Meeting & Exposition Seattle, Washington March 22 25 51

Med Center Health Med Center Health is a not for profit health system located in south central Kentucky The flagship hospital is The Medical Center, located in Bowling Green, Kentucky and there is another acute care hospital and three critical access hospitals that are part of the system There are over 30 entities that are part of the system The Medical Center is a 325 bed hospital with robust surgical services Located on the campus of The Medical Center is the University of Kentucky College of Medicine, Bowling Green campus and the Western Kentucky University College of Nursing 52

Med Center Health Approach Chief of Anesthesia brought the idea of ERAS forward to Administration Enrolled in the Improving Surgical Care and Recovery program through the Agency for Healthcare Research and Quality Colorectal surgery was addressed first Are adding gynecologic surgery and orthopedic surgery Developed an ERAS workgroup Education of the workgroup members about ERAS Divided the work among sub committees Development of order sets Education for staff Patient education Data collection/ outcomes measurement 53

Med Center Health Approach Workgroup met regularly with reports from the sub committees Work progressed for several months before any potential patients were evaluated Order set development was the most involved and took the most time followed by the patient education materials First colorectal surgery cases were scheduled for the first week of September Workgroup continued to meet to refine processes and to review data 54

ERAS Results First ERAS colorectal surgeries began on September 4, 2018 Through November 20, 2018, 33 patients have participated in the ERAS pathway, with six different surgeons Age range: 28 89 years Average age: 62.3 years Male: 18 Female: 15 55

ERAS Results Results are promising but a bit skewed due to small denominator 5/33 (15.2%) had complications The complications were not related to the ERAS protocols 2/33 (13.3%) expired Both patients did have complications 5/33(15.2%) have been readmitted within 30 days CY 2017 readmission rate was 5.4% Nausea Sepsis from wound infection Cholecystitis Abdominal abscess 56

ERAS Results ALOS for all ERAS patients: 6.12 days ALOS for 28 patients that did not have complications: 4.89 days CY 2017 ALOS: 9.34 days 10/33 (30.3%) received no opioids as an inpatient 11/33 (33.3%) received no prescription for an opioid at discharge Increases noted on HCAHPS scores for the main Med/Surg unit that cares for the ERAS patients HCAHPS Domain August, 2018 November, 2018 Communication w/ Nurses 70.4% 93.3% Communication about Pain 53.6% 85.7% Care Transitions 57.4% 81.5% Would Recommend Hospital 55.6% 77.8% 57

Lessons Learned Have a committed champion! Involve key individuals from the very beginning Education and discussion often occurred in the Operating Room Must have all disciplines involved from the beginning to get their buy in Start slowly and then expand Look to others for examples of protocols and then tailor to your particular facility Clinical Informatics was hugely beneficial in helping to develop order sets/ protocols 58

Lessons Learned Never underestimate the importance of pre admission testing and counseling Helps to determine those patients that may not be candidates for ERAS Collect and review data and use that data to help facilitate change Widely disseminate the data Dedicated ERAS Coordinator/ data collector can be beneficial 59

Conclusions ERAS has been found to be effective in: Reduction of complications Reduction in length of stay Reduction in expenses Faster recovery for the patient Increase in patient satisfaction ERAS is continuing to gain popularity and is expanding into many types of surgeries Pharmacists are key members of the multidisciplinary team and should take the lead on appropriate medication use 60

References ARHQ Safety Program for Improving Surgical Care and Recovery https://qi.facs.org/iscr/ American College of Surgeons: Improving Surgical Care and Recovery https://www.facs.org/quality programs/iscr ERAS Society http://www.erassociety.org/ Johns Hopkins Medicine: Armstrong Institute for Patient Safety and Quality; ARHQ Safety Program for Improving Surgical Care and Recovery https://www.hopkinsmedicine.org/armstrong_institute/improvement_projects/i nfections_complications/improving_surgical_care_and_recovery.html 61

Enhanced Recovery After Surgery: Where Do Pharmacists Come In? Questions?? Annual Meeting & Exposition Seattle, Washington March 22 25