What Changed? A Quick Review of Guideline Updates

Transcription

1 What Changed? A Quick Review of Guideline Updates John A. Galdo, Pharm.D., BCPS, CGP (Jake) Assistant Professor and Community Prac3ce Residency Director Samford University Birmingham, AL Disclosure Dr. Galdo is a member of the Novo Nordisk Diabetes Speakers Bureau 1

2 Learning Objectives Describe where to find updated guidelines Discuss the major clinical changes in four major medical condieons Apply guideline revisions to your clinical pracece Implement a quality improvement plan based on advanced paeent care models Finding the Literature Academic Response Part of the Department of Health and Human Services - Agency for Healthcare Research and Quality (AHRQ) 2

3 6/14/16 So Well what about? Other Alternatives 3

4 Caveat!!! Always check how the guideline judges strength and level of evidence! Heart Attacks AMERICAN HEART ASSOCIATION AND AMERICAN COLLEGE OF CARDIOLOGY Early Hospital Care Recommendations COR LOE References Oxygen Administer supplemental oxygen only with oxygen saturation <90%, respiratory distress, or other highrisk features for hypoxemia Nitrates Administer sublingual NTG every 5 min 3 for continuing ischemic pain and then assess need for IV NTG Administer IV NTG for persistent ischemia, HF, or hypertension Nitrates are contraindicated with recent use of a phosphodiesterase inhibitor I C N/A I C ( ) I B ( ) III: Harm B ( ) 4

5 Early Hospital Care, Cont. Analgesic therapy IV morphine sulfate may be reasonable for continued ischemic chest pain despite maximally tolerated anti-ischemic medications NSAIDs (except aspirin) should not be initiated and should be discontinued during hospitalization for NSTE-ACS because of the increased risk of MACE associated with their use Beta-adrenergic blockers Initiate oral beta blockers within the first 24 h in the absence of HF, low- output state, risk for cardiogenic shock, or other contraindications to beta blockade Use of sustained-release metoprolol succinate, carvedilol, or bisoprolol is recommended for beta-blocker therapy with concomitant NSTE-ACS, stabilized HF, and reduced systolic function Re-evaluate to determine subsequent eligibility in patients with initial contraindications to beta blockers IIb B (232, 233) III: Harm B (234, 235) I A ( ) I C N/A I C N/A It is reasonable to continue beta-blocker therapy in patients with normal LV function with NSTE-ACS IIa C (241, 243) III: IV beta blockers are potentially harmful when risk factors for shock are present Harm B (244) CCBs Early Hospital Care, Cont. 2 Administer initial therapy with nondihydropyridine CCBs with recurrent ischemia and contraindications to beta blockers in the absence of LV dysfunction, increased risk for cardiogenic shock, PR interval >0.24 s, or second- or third-degree atrioventricular block without a cardiac pacemaker Administer oral nondihydropyridine calcium antagonists with recurrent ischemia after use of beta blocker and nitrates in the absence of contraindications CCBs are recommended for ischemic symptoms when beta blockers are not successful, are contraindicated, or cause unacceptable side effects* Long-acting CCBs and nitrates are recommended for patients with coronary artery spasm Immediate-release nifedipine is contraindicated in the absence of a beta blocker Cholesterol management Initiate or continue high-intensity statin therapy in patients with no ( I A contraindications 3) Obtain a fasting lipid profile, preferably within 24 h IIa C N/A I B ( ) I C N/A I C N/A I C N/A III: Harm B (251, 252) RAAS Inhibition! Recommendations COR LOE ACE inhibitors should be started and continued indefinitely in all patients with LVEF less than 0.40 and in those with hypertension, diabetes mellitus, or stable CKD (Section 7.6), unless contraindicated. ARBs are recommended in patients with HF or MI with LVEF less than 0.40 who are ACE inhibitor intolerant. Aldosterone blockade is recommended in patients post MI without significant renal dysfunction (creatinine >2.5 mg/dl in men or >2.0 mg/dl in women) or hyperkalemia (K >5.0 meq/l) who are receiving therapeutic doses of ACE inhibitor and beta blocker and have a LVEF 0.40 or less, diabetes mellitus, or HF. ARBs are reasonable in other patients with cardiac or other vascular disease who are ACE inhibitor intolerant. ACE inhibitors may be reasonable in all other patients with cardiac or other vascular disease. I I I IIa IIb A A A B B 5

6 Algorithm for Management of Patients With DeUinite or Likely NSTE- ACS NSTE- ACS: Definite or Likely Ischemia- Guided Strategy Early Invasive Strategy Initiate DAPT and Anticoagulant rapy 1. ASA (Class I; LOE: A) 2. P2Y12 inhibitor (in addition to ASA) (Class I; LOE: B) : Clopidogrel or Ticagrelor 3. Anticoagulant: UFH (Class I; LOE: B) or Enoxaparin (Class I; LOE: A) or Fondaparinux (Class I; LOE: B) Initiate DAPT and Anticoagulant rapy 1. ASA (Class I; LOE: A) 2. P2Y12 inhibitor (in addition to ASA) (Class I; LOE: B): Clopidogrel or Ticagrelor 3. Anticoagulant: UFH (Class I; LOE: B) or Enoxaparin (Class I; LOE: A) or Fondaparinux (Class I; LOE: B) or Bivalirudin (Class I; LOE: B) Can consider GPI in addition to ASA and P2Y12 inhibitor in high- risk (e.g., troponin positive) pts (Class IIb; LOE: B) Eptifibatide Tirofiban rapy Effective Medical therapy chosen based on cath findings rapy Ineffective rapy Effective rapy Ineffective PCI With Stenting Initiate/continue antiplatelet and anticoagulant therapy 1. ASA (Class I; LOE: B) 2. P2Y12 Inhibitor (in addition to ASA) : Clopidogrel (Class I; LOE: B) or Prasugrel (Class I; LOE: B) or Ticagrelor (Class I; LOE: B) 3. GPI (if not treated with bivalirudin at time of PCI) High- risk features, not adequately pretreated with clopidogrel (Class I; LOE: A) High- risk features adequately pretreated with clopidogrel (Class IIa; LOE: B) 4. Anticoagulant: Enoxaparin (Class I; LOE: A) or Bivalirudin (Class I; LOE: B) or Fondaparinux as the sole anticoagulant (Class III: Harm; LOE: B) or UFH (Class I; LOE: B) CABG Initiate/continue ASA therapy and discontinue P2Y12 and/or GPI therapy 1. ASA (Class I; LOE: B) 2. Discontinue clopidogrel/ticagrelor 5 d before, and prasugrel at least 7 d before elective CABG 3. Discontinue clopidogrel/ticagrelor up to 24 h before urgent CABG (Class I; LOE: B). May perform urgent CABG <5 d after clopidogrel/ticagrelor and <7 d after prasugrel discontinued 4. Discontinue eptifibatide/tirofiban at least 2-4 h before, and abciximab 12 h before CABG (Class I; LOE: B) Late Hospital/Posthospital Care 1. ASA indefinitely (Class I; LOE: A) 2. P2Y12 inhibitor (clopidogrel or ticagrelor), in addition to ASA, up to 12 mo if medically treated (Class I; LOE: B) 3. P2Y12 inhibitor (clopidogrel, prasugrel, or ticagrelor), in addition to ASA, at least 12 mo if treated with coronary stenting (Class I; LOE: B) In patients who have been treated with fondaparinux (as upfront therapy) who are undergoing PCI, an additional anticoagulant with anti-iia activity should be administered at the time of PCI because of the risk of catheter thrombosis. Section of rapy Immediate invasive (within 2 h) Ischemia- guided strategy Early invasive (within 24 h) Delayed invasive (within h) Refractory angina Signs or symptoms of HF or new or worsening mitral regurgitaeon Hemodynamic instability Recurrent angina or ischemia at rest or with low- level aceviees despite intensive medical therapy Sustained VT or VF Low- risk score (e.g., TIMI [0 or 1], GRACE [<109]) Low- risk Tn- negaeve female paeents PaEent or clinician preference in the absence of high- risk features None of the above, but GRACE risk score >140 Temporal change in Tn (SecEon 3.4) New or presumably new ST depression None of the above but diabetes mellitus Renal insufficiency (GFR <60 ml/min/1.73 m²) Reduced LV systolic funceon (EF <0.40) Early posenfarceon angina PCI within 6 mo Prior CABG GRACE risk score ; TIMI score 2 6

7 Discharge Recommendations COR LOE Medications required in the hospital to control ischemia should be continued after hospital discharge in patients with NSTE-ACS who do not undergo coronary revascularization, patients with incomplete or unsuccessful revascularization, and patients with recurrent symptoms after revascularization. Titration of the doses may be required. All patients who are post NSTE-ACS should be given sublingual or spray nitroglycerin with verbal and written instructions for its use. Before hospital discharge, patients with NSTE-ACS should be informed about symptoms of worsening myocardial ischemia and MI and should be given verbal and written instructions about how and when to seek emergency care for such symptoms. Before hospital discharge, patients who are post NSTE-ACS and/or designated responsible caregivers should be provided with easily understood and culturally sensitive verbal and written instructions about medication type, purpose, dose, frequency, side effects, and duration of use. For patients who are post NSTE-ACS and have initial angina lasting more than 1 minute, nitroglycerin (1 dose sublingual or spray) is recommended if angina does not subside within 3 to 5 minutes; call immediately to access emergency medical services. If the pattern or severity of angina changes, suggesting worsening myocardial ischemia (e.g., pain is more frequent or severe or is precipitated by less effort or occurs at rest), patients should contact their clinician without delay to assess the need for additional treatment or testing. Before discharge, patients should be educated about modification of cardiovascular risk factors. I I I I I C C C C C I C I C Diabetes AMERICAN DIABETES ASSOCIATIONS AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS 7

8 General Changes In alignment with the American Diabetes AssociaEon s (ADA s) posieon that diabetes does not define people, the word diabeec will no longer be used when referring to individuals with diabetes in the Standards of Medical Care in Diabetes. ADA will conenue to use the term diabeec as an adjeceve for complicaeons related to diabetes (e.g., diabeec reenopathy). Although levels of evidence for several recommendaeons have been updated, these changes are not included below as the clinical recommendaeons have remained the same. Changes in evidence level from, for example, C to E are not noted below. Standards of Medical Care in Diabetes 2016 contains, in addieon to many minor changes that clarify recommendaeons or reflect new evidence, the following more substaneve revisions. 8

9 Section 1: Strategies for Improving Care This seceon was revised to include recommendaeons on tailoring treatment to vulnerable populaeons with diabetes, including recommendaeons for those with food insecurity, cognieve dysfunceon and/or mental illness, and HIV, and a discussion on dispariees related to ethnicity, culture, sex, socioeconomic differences, and dispariees. More on Section 1 Food Insecurity/HIV Providers should evaluate hyperglycemia and hypoglycemia in the context of food insecurity and pro- pose solueons accordingly. A Providers should recognize that homelessness, poor literacy, and poor numeracy open occur with food insecurity, and appropriate resources should be made avail- able for paeents with diabetes. A PaEents with HIV should be screened for diabetes and prediabetes with a faseng glucose level before stareng aneretroviral therapy and 3 months aper stareng or changing it. If inieal screening results are normal, checking faseng glucose each year is ad- vised. If prediabetes is detected, conenue to measure levels every 3 6 months to monitor for progression to diabetes. E 9

10 Cognitive Dysfunction Section 2: ClassiUication and Diagnosis Comparison of diagnosec tests FasEng, 2- h post prandial, and A1c No one test is preferred Clarify age, BMI, and risk - > test all adults for diabetes at age 45, regardless of weight TesEng for asymptomaec adults of any age who are overweight or obese with one or more risk factors Section 3: Foundations of Care and Comprehensive Medical Evaluation CombinaEon of two seceons from 2015 guidelines Highlights importance of lifestyle and behavior NutriEon and vaccine guidelines streamlined 10

11 More on Section 3 DSME In accordance with the naeonal standards for diabetes self- management educaeon (DSME) and support (DSMS), all people with diabetes should parecipate in DSME to facilitate the knowledge, skills, and ability necessary for diabetes self- care and in DSMS to assist with implemeneng and sustaining skills and behaviors needed for ongoing self- management, both at diagnosis and as needed thereaper. B EffecEve self- management, im- proved clinical outcomes, health status, and quality of life are key outcomes of DSME and DSMS and should be measured and monitored as part of care. C DSME and DSMS should be paeent centered, respecqul, and responsive to individual paeent preferences, needs, and values, which should guide clinical decisions. A DSME and DSMS programs should have the necessary elements in their curricula that are needed to prevent the onset of diabetes. DSME and DSMS programs should therefore tailor their content specifically when preveneon of diabetes is the desired goal. B Because DSME and DSMS can result in cost savings and improved outcomes B, DSME and DSMS should be adequately reimbursed by third- party payers. E Section 4: Prevention Recommend apps 11

12 Section 5: Glycemic Targets Recommend use of conenuous glucose monitoring and insulin pumps for adults age 65 years and older What are the glycemic targets again??? Section 6: Obesity Management Brand new seceon! Includes table of medicaeons for the treatment of obesity More on Section 6 Diet, physical acevity, and behavioral therapy designed to achieve 5% weight loss should be prescribed for overweight and obese paeents with type 2 diabetes ready to achieve weight loss. A Such interveneons should be high intensity ($16 sessions in 6 months) and focus on diet, physical acevity, and behavioral strategies to achieve a kcal/day energy deficit. A Diets that provide the same caloric restriceon but differ in protein, carbohydrate, and fat content are equally effeceve in achieving weight loss. A For paeents who achieve short- term weight loss goals, long- term ($1- year) comprehensive weight maintenance programs should be prescribed. Such programs should provide at least monthly contact and encourage ongoing monitoring of body weight (weekly or more frequently), conenued consumpeon of a reduced calorie diet, and parecipaeon in high levels of physical acevity ( min/ week). A To achieve weight loss of.5%, short- term (3- month) high- intensity lifestyle interveneons that use very low- calorie diets (#800 kcal/day) and total meal replacements may be prescribed for carefully selected paeents by trained praceeoners in medical care sewngs with close medical monitoring. To maintain weight loss, such programs must incorporate long- term comprehensive weight maintenance counseling. B 12

13 Medications in Obesity Section 7: Approaches to Glycemic Treatment Removed bariatric surgery and placed under seceon 6 More on Section 7 - Algorithms 13

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15 Section 8 AtheroscleroEc cardiovascular disease (ASCVD) has replaced cardiovascular disease (CVD) RecommendaEon for older adults WHAT Consider aspirin for women aged >50 years (was >60 years) Some paeents with diabetes may have benefit from ezeembe More on Section 8 EMPA- REG OUTCOME BI (Empagliflozin) Cardio- vascular Outcome Event Trial in Type 2 Diabetes Mellitus PaEents (EMPA- REG OUTCOME) Randomized, double- blind, placebo- controlled trial Cardiovascular outcomes (stroke, MI, amputaeon, or coronary, caroed, or peripheral artery obstruceon) in paeents with type 2 diabetes at high risk for cardiovascular disease. EMPA- REG OUTCOME showed that the therapy reduced the aggregate outcome of MI, stroke, and cardiovascular death by 14% (absolute rate 10.5% vs. 12.1% in the placebo group), due to a 38% reduceon in cardiovascular death (absolute rate 3.7% vs. 5.9%) 15

16 Section 9: Microvascular Complications and Foot Care Nephropathy changed to diabeec kidney disease Guidance added for renal replacement therapy DiabeEc reenopathy: guidance was added on use of intravitreal ane- VEGF agents for macular edema Section 10: Older Adults scope of this seceon is more comprehensive Covers: NeurocogniEve funceon Hypoglycemia Treatment Goals Care in Skilled Nursing FaciliEes End of Life ConsideraEons Section 11: Children and Adolescents Nuanced like seceon 10 RecommendaEon for faseng lipid profile in children is now 10 years old (previously 2 years) 16

17 Section 12: Management of Diabetes in Pregnancy Importance of discussing family planning with paeents with preexisieng diabetes Change of target from <6% to <6-6.5% Glyburide was deemphasized due to inferiority compared to meqormin and/or insulin Section 13: Diabetes Care in the Hospital Revised to focus solely on diabetes care in the hospital sewng, including care standards, glycemic targets, and transieons from acute sewngs More on Section 13 17

18 Section 14: Diabetes Advocacy Go out and advocate! AACE 2016 Garber AJ et al. Endocr Pract. 2016; 22(1): AACE 2016 ADRs Garber AJ et al. Endocr Pract. 2016; 22(1):

19 AACE - Insulin Garber AJ et al. Endocr Pract. 2016; 22(1): Pharmacokinetic and Pharmacodynamic Parameters Effect of Insulin Logs ; Rapid AcEng Galdo JA, Thurston MM, Bourg CA. Clinical ConsideraEons for Insulin Pharmacotherapy in Ambulatory Care, Part One: IntroducEon and Review of Current Products and Guidelines. Clinical Diabetes. April Volume 32. Regular, R ; Short AcEng NPH, N ; Intermediate AcEng L ; Long AcEng Time; 24 hours Numerical Pharmaco- kinetics/dynamics Name Onset Peak Dura0on Rapid - Logs minutes minutes 3 5 hours Short - R 30 minutes minutes 8 hours Intermediate - NPH 1.8 hours 4 12 hours Up to 24 hours Long - L N/A* No Peak Up to 24 hours - D N/A No peak Up to 42 hours Galdo, J, Thurston, M, Bourg C. Clinical ConsideraEons for Insulin Pharmacotherapy in Ambulatory Care Part One: IntroducEon and Review of Current Products and Guidelines. AwaiEng PublicaEon

20 COPD GOLD JANUARY 2016 Changes look like Classify the Patient Patient A B C D Characteristic Low Risk Less Symptoms Low Risk More Symptoms High Risk Less Symptoms High Risk More Symptoms Spirometri c Classi cation Exacerbation s per year CAT GOLD < GOLD GOLD < GOLD mmrc 20

21 Pa0ent Group Recommended 1 st line Alterna0ve Other Possible Treatments A SA anecholinergic prn LA anecholinergic ophylline OR OR LA beta2- agonist SA beta2- agonist prn OR SA beta 2 - agonist + SA B LA anecholinergic OR LA beta2- agonist anecholinergic LA anecholinergic + LA beta2- agonist SA beta2- agonist and/ or SA anecholinergic C D ICS + LA beta 2 - agonist OR LA anecholinergic ICS + LA beta 2 - agonist AND/OR LA anecholinergic LA anecholinergic + LA beta2- agonist OR LA anecholinergic + PDE- 4 Inhibitor OR LA beta2- agonist + PDE- 4 Inhibitor ICS + LA beta2- agonist + LA anecholinergic OR ICS+ LA beta2- agonist + PDE- 4 Inhibitor OR LA anecholinergic + LA beta2- agonist OR LA anecholinergic + PDE- 4 Inhibitor ophylline SA beta2- agonist and/ or SA anecholinergic ophylline Carbocysteine N- acetylcysteine SA beta2- agonist and/ or SA anecholinergic FLAME Indacaterol- Glycopyrronium versus Salmeterol- FluEcasone for COPD (NEJM, June 9 th, 2016) LABA (indacaterol) + LAMA (glycopyrronium) OR LABA (Salmeterol) + ICS (fluecasone) Randomized, double- blind, double- dummy non- inferiority trial LABA+LAMA showed superiority Annual rate of exacerbaeon (3.59 vs 4.03, RR 0.89, 95% CI 0.83 to 0.96) Pst Brand name is UlEbro Breezhaler Drugs Steroids Beta Agonists CombinaEons Beclomethasone (QVAR) Formoterol (Foradil) Budesonide/Formoterol (Symbicort) Budesonide (Pulmicort) Salmeterol (Serevent) Mometasone/Formoterol (Dulera) FluEcasone (Flovent) Albuterol (ProAir, ProvenEl, Ventolin) FluEcasone/Salmeterol (Advair) Mometasone (Asmanex) Levalbuterol (Xopenex) 21

22 Drugs, Part 2 AnEcholinergic CombinaEon Ipratropium (Atrovent) Albuterol/Ipratropium (Combivent) Acidinium (Tudorza) Vilanterol/Umeclidium (Anoro Ellipta) Tiotropium (Spiriva) Vilanterol/FluEcasone (Breo) Umeclidinium (Incruse) Indacaterol/Glycopyrronium (UlEbro) Guideline for Prescribing Opioids for Chronic Pain CDC MARCH 2016 Quick Intro During , the percent change in death from opioids was 276% Next on the list was Alzheimer s at 68% Supply chain distribueon of opioids 96 mg of morphine per person in mg of morphine per person in 2007 WISQARS, 2000 and 2010; CDC/NCHS, Na3onal Vital Sta3s3cs System Centers for Disease Control and Preven3on. CDC grand rounds: Prescrip3on drug overdoses a U.S. epidemic. MMWR Morb Mortal Wkly Rep 2012; 61:

23 Effectiveness of Pain Medications Percent of people gewng 50% pain relief Two 5mg Percocet (~36%) Ibuprofen 200mg (~35%) Ibuprofen 400mg (~40%) Oxycodone 15mg (~21%) Ibuprofen Acetaminophen 500 (~62%) Gaskell H, Derry S, Moore R, McQuay H. Single dose oral oxycodone and oxycodone plus paracetamol ( acetaminophen ) for acute postoperaeve pain in adults. Cochrane Database Syst Rev. 2009; (3). doi: / cd pub2. Derry C, Derry S, Moore RA, McQuay HJ. Single dose oral ibuprofen for acute postoperaeve pain in adults. Cochrane Database Syst Rev. 2009;(3):CD doi: / CD pub2. Toms L, McQuay HJ, Derry S, Moore RA. Single dose oral paracetamol (acetaminophen) with codeine for postoperaeve pain in adults. Cochrane Database Syst Rev. 2008;(4):CD doi: / CD pub2. Derry C, Derry S, Moore R. Single dose oral ibuprofen plus paracetamol ( acetaminophen ) for acute postoperaeve pain ( Review ). Cochrane Database Syst Rev. 2013;(6). doi: / CD pub2. Level of Recommendations Category A: applies to all paeents; most paeents should receive recommended course of aceon Category B: individual decision making required; providers help paeents arrive at decision consistent with values/preferences and clinical situaeon Types of Recommendation Type 1: Randomized controlled trials (RCTs); overwhelming observaeonal studies Type 2: RCTs (limitaeons); strong observaeonal Type 3: RCTs (notable limitaeons); observaeonal Type 4: RCTs (major limitaeons); observaeonal (notable limitaeons) clinical experience 23

24 Quick Handout! Equivalent Table Project Purpose Primary Care Providers Family medicine, Internal medicine Physicians, nurse praceeoners, physician assistants TreaEng paeents >18 years with chronic pain Pain longer than 3 months or past Eme of normal Essue healing OutpaEent sewngs Does not include aceve cancer treatment, palliaeve care, and end- of- life care 24

25 Developed 12 Recommendations Think JNC- 8 Answering queseons Determining when to inieate or conenue opioids for chronic pain Opioid seleceon, dosage, duraeon, follow- up, and disconenuaeon Assessing risk and addressing harms of opioid use Recommendation 1 Non- pharmacologic therapy and non- opioid pharmacologic therapy are preferred for chronic pain. Clinicians should consider opioid therapy only if expected benefits for both pain and funceon are anecipated to outweigh risks to the paeent. If opioids are used, they should be combined with non- pharmacologic therapy and non- opioid pharmacologic therapy, as appropriate. (RecommendaEon category A: Evidence type: 3) Recommendation 2 Before stareng opioid therapy for chronic pain, clinicians should establish treatment goals with all paeents, including realisec goals for pain and funceon, and should consider how therapy will be disconenued if benefits do not outweigh risks. Clinicians should conenue opioid therapy only if there is clinically meaningful improvement in pain and funceon that outweighs risks to paeent safety. (RecommendaEon category A: Evidence type: 4) 25

26 Recommendation 3 Before stareng and periodically during opioid therapy, clinicians should discuss with paeents known risks and realisec benefits of opioid therapy and paeent and clinician responsibiliees for managing therapy. (RecommendaEon category A: Evidence type: 3) Recommendation 4 When stareng opioid therapy for chronic pain, clinicians should prescribe immediate- release opioids instead of extended- release/long- aceng (ER/LA) opioids. (RecommendaEon category A: Evidence type: 4) Recommendation 5 When opioids are started, clinicians should prescribe the lowest effeceve dosage. Clinicians should use caueon when prescribing opioids at any dosage, should carefully reassess evidence of individual benefits and risks when increasing dosage to 50 morphine milligram equivalents (MME)/day, and should avoid increasing dosage to 90 MME/day or carefully jusefy a decision to Etrate dosage to >90 MME/day. (RecommendaEon category A: Evidence type: 3) 26

27 Recommendation 6 Long- term opioid use open begins with treatment of acute pain. When opioids are used for acute pain, clinicians should prescribe the lowest effeceve dose of immediate- release opioids and should prescribe no greater quanety than needed for the expected duraeon of pain severe enough to require opioids. 3 days or less will open be sufficient; more than 7 days will rarely be needed. (RecommendaEon category A: Evidence type: 4) Recommendation 7 Clinicians should evaluate benefits and harms with paeents within 1 to 4 weeks of stareng opioid therapy for chronic pain or of dose escalaeon. Clinicians should evaluate benefits and harms of conenued therapy with paeents every 3 months or more frequently. If benefits do not outweigh harms of conenued opioid therapy, clinicians should opemize other therapies and work with paeents to taper opioids to lower dosages or to taper and disconenue opioids. (RecommendaEon category A: Evidence type: 4) Recommendation 8 Before stareng and periodically during conenuaeon of opioid therapy, clinicians should evaluate risk factors for opioid- related harms. Clinicians should incorporate into the management plan strategies to miegate risk, including considering offering naloxone when factors that increase risk for opioid overdose, such as history of overdose, history of substance use disorder, higher opioid dosages (>50 MME/day), or concurrent benzodiazepine use, are present. (RecommendaEon category A: Evidence type: 4) 27

28 Recommendation 9 Clinicians should review the paeent s history of controlled substance prescripeons using state PDMP data to determine whether the paeent is receiving opioid dosages or dangerous combinaeons that put him/her at high risk for overdose Clinicians should review PDMP data when stareng opioid therapy for chronic pain and periodically during opioid therapy for chronic pain, ranging from every prescripeon to every 3 months. (RecommendaEon category A: Evidence type: 4) Recommendation 10 When prescribing opioids for chronic pain, clinicians should use urine drug teseng before stareng opioid therapy and consider urine drug teseng at least annually to assess for prescribed medicaeons as well as other controlled prescripeon drugs and illicit drugs. (RecommendaEon category B: Evidence type: 4) Recommendation 11 Clinicians should avoid prescribing opioid pain medicaeon and benzodiazepines concurrently whenever possible. (RecommendaEon category A: Evidence type: 3) **This is a drap quality measure with PQA** 28

29 Recommendation 12 Clinicians should offer or arrange evidence- based treatment (usually medicaeon- assisted treatment with buprenorphine or methadone in combinaeon with behavioral therapies) for paeents with opioid use disorder. (RecommendaEon category A: Evidence type: 2) Tools and Materials Provider and pa0ent materials Checklist for prescribing opioids for chronic pain Fact sheets Posters Web banners and badges Social media web bu ons and infographics CDC Opioid Overdose Website Guidelines in Practice KNOWING IS HALF THE BATTLE 29

30 Staying up to date So Many Options IndicaEons Missing or too much? Efficacy Monitor and assess Safety ADRs Assess Drug Allergies Vaccines Time with paeents Adherence NSTE- ACS What's something you learned today? Now... Develop into an interveneon 30

31 Diabetes What's something you learned today? Now... Develop into an interveneon COPD What's something you learned today? Now... Develop into an interveneon Opioids What's something you learned today? Now... Develop into an interveneon 31

32 Quality Improvement MAKE YOUR SYSTEM BETTER! Project Management A project is Unique inieaeve (aka NOT rouene) Specified deliverables Defined beginning and end A temporary endeavor undertaken to create a unique product, service, or result (PMI, 2013) Steps in Project Management Define the problem Execute the Plan Monitor & Control Process Develop SoluEon OpEons Plan the Project Close the Project 32

33 PMBOK Process Descrip0on IniEaEng Planning ExecuEng Monitoring/ Controlling Closing Purpose Authorize a project Planning & scheduling the work in the project Performing the project as planned and scheduled in the planning process Keep track as the project progresses & idenefy variance from the plan Formally closes the project Scope Cost Time Requirements BudgeEng Scheduling Lean Lean Management or Lean Thinking Japanese manufacturing, parecularly Toyota ProducEon System Succinctly: Using Less to Do More Key Concepts Leadership MUST come from the top Culture enere company must be behind the ship D Andreama eo A, et al. Lean in healthcare: A comprehensive review. Health Policy (2015), h p://dx.doi.org/ /j.healthpol Going Lean in Health Care. InnovaEon Series White Paper InsEtute for Healthcare Improvement. Lean Culture Comparison Tradi0onal Culture FuncEon Silos Managers direct Benchmark to jusefy not improving: just as good Blame people Rewards: individual Supplier is enemy Guard informaeon Volume lowers costs Internal focus Expert driven Lean Culture Interdisciplinary Teams Managers teach/enable Seek the ulemate performance, the absence of waste Root cause analysis Rewards: group sharing Supplier is ally Share informaeon Removing waste lowers cost Customer focus Process driven Going Lean in Health Care. InnovaEon Series White Paper InsEtute for Healthcare Improvement. Adapted from AP Byrne and OJ Fiume 33

34 Eliminate Waste Waste is anything that does not add value from the customer point of view Storage, inspeceon, delay, waieng in queues, and defeceve products do not add value and are 100% waste MeeEngs! Ohno s Seven Wastes: Operationally Taiichi Ohno Student of W. Edwards Deming DefecEve products OverproducEon Queues Overprocessing TransportaEon MoEon Inventory 5 System Sort/segregate When in doubt, throw it out Simplify/straighten Methods analysis tools Shine/sweep Clean daily Standardize Remove variaeons from processes Sustain/self- discipline Review work and recognize progress 34

35 5 System - Expanded Safety Build in good praceces Support/ maintenance Reduce variability and unplanned downeme Institute of Safe Medicines Practice (ISMP) ISMP Self- Assessment Updated version will be released later this year 35

36 Results from ISMP! Domain I: Pa0ent Informa0on A (1) B (2) C (3) D (4) E (5) # (%) # (%) # (%) # (%) # (%) Assessment Plan Talk with Your Neighbor Define some areas of improvement As a team, let s try to find a method to improve What was the Intervention? Let s design a paeent- centered interveneon now John A. Galdo, Pharm.D., BCPS, CGP (Jake) jgaldo@samford.edu Visit GPhAconven0on.com/grow to download materials from this and other presentaeons. 36