Naloxone for Opioid Overdose. PL CE LIVE January 2016 Forum. January 2016 PL CE LIVE. CE Information. Pharmacist Objectives

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1 January 2016 PL CE LIVE Rachel Maynard, PharmD Associate Editor Pharmacist s Letter/Pharmacy Technician s Letter CE Information Pharmacist's Letter / Therapeutic Research Center is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. PL CE LIVE editors disclose: No financial interests related to the content No commercial support and no advertising Supported entirely by subscriptions PL CE LIVE Drug Information Consultant discloses: Dr. O Mara reports that her spouse is employed by Celgene. Pharmacist Objectives Identify emerging trends in drug therapy and their place in patient care practices. Recommend appropriate use of naloxone for reversing opioid overdose. Describe two factors to consider when suggesting blood pressure goals. List three considerations regarding the use of hormonal contraception in women over age 35. Explain two similarities between insulin degludec and other long acting insulins. Pharmacy Technician Objectives Identify emerging trends in drug therapy and their place in pharmacy practice and operations. Compare and contrast naloxone formulations for reversing opioid overdose. Explain two factors to consider for older women using hormonal contraception. Describe three dispensing considerations with insulin degludec. List two advantages of dexamethasone to treat acute asthma exacerbations in children. Naloxone for Opioid Overdose NALOXONE The new Narcan nasal spray will lead to more emphasis on providing naloxone to patients at risk of opioid overdose. Over 40 Americans die from Rx opioid overdoses every day... and heroin overdose deaths have more than tripled since Having naloxone on hand can save a life in an opioid overdose. Recommend naloxone for opioid patients at risk. For example, look for patients taking high doses...switching opioids...combining opioids with benzos or alcohol...or with respiratory conditions (COPD, etc). Help sort through naloxone options. Explain that Narcan nasal spray does NOT need to be inhaled...and the Evzio auto-injector talks the user through the injection. Also consider preparing naloxone rescue kits. For IM use, include naloxone 0.4 mg/ml vials plus 2 syringes. For intranasal, use 2 mg/2 ml naloxone prefilled syringes plus 2 atomizers. A naloxone rescue kit may cost about $50...compared to $125 for Narcan nasal spray and $750 for Evzio. Most payers will cover some form of naloxone...but help with switches or prior auths if needed. Emphasize calling even if naloxone is given. Naloxone only lasts about 30 to 90 minutes...so symptoms can return after it wears off. Increase access to naloxone. Reach out to prescribers for an Rx... and know your state laws. You may hear naloxone doesn t need an Rx in some states. But a standing order or agreement with a prescriber is usually still required. For more ways you can reduce deaths due to opioid overdose, see our PL CE LIVE Archived Webinar: Overdose Prevention With Naloxone...our PL Detail-Document, Naloxone for Opioid Overdose: FAQs...and PL Toolbox, Appropriate Opioid Use

2 Opioid Epidemic Over 40 people in the U.S. die every day from Rx opioid overdose Morphine, fentanyl, oxycodone, etc Heroin overdose deaths have more than tripled since 2010 Prescription monitoring programs (PDMPs) Safe storage REMS for long acting opioids Avoiding risky combos Urine drug testing Overdose education Taking opioids as prescribed Abusedeterrent opioids Treatment agreements or pain contracts Naloxone Safe disposal Naloxone Opioid Opioid Receptor Naloxone takes effect in about 3 minutes Naloxone has stronger affinity for opioid receptors than most opioids Works at opioid receptor to displace opioid agonists Wears off in about 30 to 90 minutes Who is at Risk for Opioid Overdose? History of alcohol/ other substance abuse High daily doses of opioids Switching from one opioid to another Opioid + benzodiazepine, other sedative, or alcohol Opioid + respiratory condition (COPD, etc) Opioid + renal/liver disease 2

3 Naloxone Forms Nasal spray (Narcan) Auto injector (Evzio) Rescue kits Naloxone Nasal Spray (Narcan) Administered intranasally Does not need to be assembled before use One spray is delivered into one nostril Patient does not need to inhale Carton contains two, single use nasal sprays (naloxone 4 mg each) Costs ~$125 per pack Naloxone Auto-Injector (Evzio) Administered intramuscularly or subcutaneously Automated voice talks user through injection Package contains two autoinjectors (naloxone 0.4 mg each) + one trainer Costs ~$750 per pack Naloxone Rescue Kits Prepared by the pharmacy Intranasal kit: Naloxone prefilled syringes + mucosal atomizers Intramuscular kit: Naloxone vials + syringes Caregiver assembles device before use Costs ~$50 for 2 doses Intranasal (IN) Naloxone Kit At least 2 naloxone 2 mg/2 ml Luer Lock prefilled needleless syringes At least 2 mucosal atomization devices Fits into prefilled syringe Half the dose sprayed into each nostril Intramuscular (IM) Naloxone Kit Naloxone 0.4 mg/ml solution for injection At least 2 x 1 ml single dose vials OR 1 x 10 ml multi dose vial At least 2 retractable IM syringes Injected into shoulder or thigh muscle 0.4 mg / ml 2 mg / 2 ml 3

4 When Should Naloxone be Used? Advise using naloxone in cases of suspected opioid overdose Slow/shallow/abnormal breathing, excessive sleepiness, unresponsive, etc If in doubt, caregivers should give naloxone No pharmacological effect or harm in patients who have not taken opioids Naloxone Administration Emphasize calling 911, even if naloxone is given Possible additional naloxone doses Manage other possible overdoses Caution that naloxone can trigger withdrawal Sweating, agitation, increased heart rate/bp, etc Educate about rescue breathing and advise staying until help arrives Practice Pearls Most payers will cover some form of naloxone Help with switches or prior auths if needed Tell patient to practice, and to train others Consider having demo kits at the pharmacy Check expiration dates before dispensing Shelf life approximately 12 to 18 months Advise storing naloxone at room temperature Increase Naloxone Access Reach out to prescribers for an Rx if needed Know your state laws Some allow pharmacists to furnish naloxone under standing orders or collaborative practice agreements Some states allow naloxone Rxs for third parties Questions About Blood Pressure Goals 4

5 HYPERTENSION You ll hear controversy about whether it makes sense to aim for a LOWER systolic blood pressure in hypertensive patients. Recent guidelines recommend aiming for more relaxed BP goals, such as a systolic < 150 mmhg in patients 60 and older instead of < 140 mmhg...due to lack of evidence that lower is better. But the new SPRINT trial suggests that a lower systolic BP may be better for some patients...including those over age 75. For example, aiming for a systolic < 120 instead of < 140 prevents one more CV event for every 185 patients with CV risks treated/year. But this benefit may not apply to many of your patients. For example, it s too early to say if patients with diabetes, heart failure, or previous stroke benefit from a systolic < 120. Plus lower goals can be difficult to reach...and can lead to hypotension, electrolyte problems, and bumps in serum creatinine. Suggest individualizing BP goals based on med tolerability, adherence, cardiovascular risk, comorbidities, etc. In general, recommend sticking with current guidelines for BP goals. Suggest aiming for < 140/90 in most patients, including those with diabetes or kidney disease...or < 150/90 in those 60 and older. But be open to a systolic goal closer to 120 in some patients. For example, consider a lower systolic goal for patients with a previous heart attack or chronic kidney disease...if they can tolerate higher doses or adding meds to reach the goal. To hear our team discuss BP goals and measurement with a study author, go to our PL Detail-Document and listen to PL VOICES. Also see our PL Patient Education Handout, Blood Pressure Meds and You, for counseling tips...and our PL Algorithm, Stepwise Treatment of Hypertension, for help recommending BP meds Blood Pressure Goals JNC 8 Age < 60 Age 60 Diabetes or Kidney Disease The new SPRINT trial suggests that a lower systolic BP may be better for some patients. Less than 140/90 Less than 150/90 Less than 140/90 SPRINT Trial Over 9000 patients with a systolic blood pressure between mmhg At least 50 years old (average age 68) Increased cardiovascular risk No diabetes, heart failure, or history of stroke Assigned to systolic BP target of either: < 120 mmhg (intensive) < 140 mmhg (standard) Evaluated effect on CV outcomes or death SPRINT Trial Difference in primary composite outcome Intensive group: 1.65% per year Standard group: 2.19% per year Aiming for systolic BP < 120 versus < 140: Prevents one more CV event for every 185 patients with CV risks treated per year Findings seen in all groups, including patients over age 75 5

6 SPRINT Trial Keep in mind... Too soon to say if patients with diabetes, heart failure, or previous stroke benefit from a systolic < 120 mmhg Some estimate that about 20% of U.S. patients with hypertension would have qualified for SPRINT More BP lowering meds needed Intensive group used standard group used 1.8 Lower goals can be difficult to reach Average BP in intensive group was mmhg... standard group was mmhg Hypotension Fainting Electrolyte problems Bumps in serum creatinine What do you tell patients? Medication tolerability Blood Pressure Goals JNC 8 Shared decision making Individualize BP Goals Adherence Age < 60 Age 60 Diabetes or Kidney Disease Comorbidities CV risk Less than 140/90 Less than 150/90 Less than 140/90 6

7 Be open to a systolic BP goal closer to 120 mmhg in some patients. Patients with previous heart attack or chronic kidney disease Consider whether the patient can tolerate higher doses or adding meds to reach goal Hormonal Contraception in Older Women CONTRACEPTION Women will ask you if they re too old to take hormonal contraceptives...and when they should stop. We know that combo OCs can prevent pregnancy in women over 40. And they may also help with vasomotor symptoms (hot flashes, etc). In many perimenopausal women, feel comfortable suggesting a combo OC...and lean toward one with 20 mcg of ethinyl estradiol. If needed, suggest extended- or continuous-cycle OCs to limit hormone-free days. But discourage using combo OCs, the patch, or ring in women over 35 with thrombosis risk factors...smoking, hypertension, etc. Instead, suggest an IUD (Mirena, etc) or implant (Nexplanon). These are safer in most high-risk women...and have the best efficacy. Dispel myths that hormonal contraceptives speed up or slow down menopause. But be aware some may cause withdrawal bleeding or amenorrhea...making it hard to know when menopause has occurred. In general, suggest stopping hormonal contraception by age most women have gone through menopause by then. Or advise women over 50 to switch to a NON-hormonal method...then stop a year after their last period, when menopause can be assumed. See our PL Chart, Comparison of Contraceptives, to sort through the options...and our PL CE, Choosing Wisely: Contraception years 51 years 60 years 7

8 Risk of maternal and fetal complications or mortality Risk of pregnancy Hormonal Contraceptives Combined hormonal contraceptives (estrogen + progestin) Combined oral contraceptives Patch Ring Progestin only contraceptives Progestin only pills: norethindrone (Camila, Errin, etc) Injectable: depot medroxyprogesterone (Depo Provera, etc) Implant: etonogestrel (Nexplanon) Intrauterine device (IUD): levonorgestrel (Mirena, etc) Considering Hormonal Contraception Possible Benefits Prevent pregnancy Considering Hormonal Contraception Possible Benefits Possible Risks Prevent pregnancy Risk of clots with age May help with vasomotor symptoms (hot flashes, etc) Regulate menses May help with vasomotor symptoms (hot flashes, etc) Regulate menses Conditions/comorbidities may affect clot risk Hormonal contraceptive type may impact risk Patient Considerations Age Risk factors or comorbidities Smoking, obesity, surgery, etc High blood pressure, diabetes, lupus, migraines, past history of a clot, etc Type of hormonal contraceptive Combined hormonal contraceptive Progestin only contraceptive In many perimenopausal women, feel comfortable suggesting a combined oral contraceptive. Suggest leaning toward one with 20 mcg of ethinyl estradiol If needed, suggest an extended or continuouscycle OC to limit hormone free days 8

9 Safe Use of Hormonal Contraception Discourage using combo OCs, the patch, or the ring in women over 35 with clot risk factors Smoking, hypertension, etc Suggest an IUD (Mirena, etc) or implant (Nexplanon) instead Safer in most high risk women Best efficacy Last at least 3 years Stopping Hormonal Contraception Hormonal contraceptives may make it difficult to know when menopause has occurred May cause withdrawal bleeding, amenorrhea, etc Stopping Hormonal Contraception In general, suggest stopping hormonal contraception by age 55 Most women have gone through menopause by then Or, advise women over age 50 to switch to a non hormonal method Then they can stop a year after their last period, when menopause can be assumed Insulin Degludec 9

10 DIABETES Tresiba (treh-see-bah, insulin degludec) is a new once-daily ULTRA long-acting insulin. It lasts about 42 hours...compared to about 24 hours for Lantus or Levemir and a little over 24 hours for Toujeo. You may hear that Tresiba s longer duration means it doesn t need to be used at the same time every day. But this isn t necessarily a benefit since it may impact adherence. Explain that Tresiba s long duration doesn t seem to lead to dose stacking or accumulation...including in patients with renal impairment. Tresiba lowers A1C about the same as Lantus...and has a similar overall risk of hypoglycemia. Tresiba 50 units/day costs about $450/month...compared to $400 or less for Lantus, Levemir, or Toujeo...or as little as $40 for NPH. Don t expect Tresiba to have much benefit over other longer-acting insulins...including NPH. Point out there ISN T a big difference in most outcomes between NPH and Lantus or Levemir in most type 2s. Suggest saving Tresiba if a true once-daily insulin is needed... such as patients who need over 80 units/injection of Lantus, Levemir, or Toujeo pen. The Tresiba 200 unit/ml pen delivers up to 160 units/dose. Advise patients to try to use Tresiba at the same time each day. Look for Basaglar, a new, potentially less costly version of insulin glargine, in about a year. It ll be similar to Lantus. Get our PL Charts, How to Switch Insulin Products and Comparison of Insulins, to help select insulin Insulin Effect Basal Insulins Morning Afternoon Evening Long-acting (Lantus, Levemir, etc) Time Night NPH Insulin Degludec ~42 hours Insulin degludec (Tresiba) A little over 24 hours Insulin glargine U 300 (Toujeo) ~24 hours Insulin glargine U 100 (Lantus) Insulin detemir (Levemir) Up to 24 hours NPH (Humulin N, Novolin N) Injected subcutaneously, once daily, any time of day Not necessarily a benefit could impact adherence Doesn t seem to lead to dose stacking, including in patients with renal impairment. Don t expect insulin degludec to have much benefit over other longeracting insulins... including NPH. 10

11 Insulin Degludec vs. Insulin Glargine Glycemic Control Lowers A1C about the same Considerations With Insulin Degludec Consider cost differences 50 units/day Insulin degludec $450/month Insulin glargine or detemir $400/month or less NPH $40/month Hypoglycemia Similar overall risk Considerations With Insulin Degludec Available only in FlexTouch pen 100 units/ml, 5 pens per box Delivers up to 80 units per injection 200 units/ml, 3 pens per box Delivers up to 160 units per injection When Should Insulin Degludec Be Used? Suggest saving it for when a true once daily insulin is needed Patients who use insulin glargine or another basal insulin twice a day Patients who need over 80 units per injection of insulin glargine or detemir pens Find out what s preferred by insurance Practice Pearls: Insulin Degludec NPH Insulin detemir Insulin glargine Insulin degludec Convert unit per unit, give degludec once daily Consider 20% dose reduction if switching from twicedaily schedule Recommend not increasing dose more often than every 3 to 4 days Practice Pearls: Insulin Degludec Advise patients to try to use at the same time each day Tell patients to dial up to the prescribed dose Leave needle in skin for 6 seconds Once in use, tell patients to keep pen at room temp for up to 56 days Watch for mix ups with U 100 versus U

12 Dexamethasone for Asthma Exacerbations ASTHMA More children will get just ONE or TWO doses of dexamethasone for asthma exacerbations. We re seeing a shift away from the typical 3- to 5-day course of prednisone or prednisolone to a 1- to 2-day course of dexamethasone. Dexamethasone is longer acting...and may cause less vomiting. Plus new evidence suggests that a SINGLE dose of dexamethasone seems to improve acute asthma symptoms and prevent hospitalization as well as a 3-day course of prednisolone. In kids with mild to moderate exacerbations, consider suggesting dexamethasone...especially if adherence or tolerability is a concern. Be prepared for these Rxs by having dexamethasone on hand. Recommend 0.3 or 0.6 mg/kg orally once daily for 1 or 2 days, up to a max of 16 mg/dose...or as one IM dose. For kids who can t swallow tabs, recommend crushing and mixing them with chocolate pudding or applesauce to help mask the bitter taste. Or suggest dexamethasone 1 mg/ml concentrated solution. Discourage the 0.5 mg/5 ml liquid...due to the large volume day course of prednisone or prednisolone 1 2 day course of dexamethasone Advantages of Dexamethasone Shorter course Dexamethasone is longer acting and more potent Better tolerability Dexamethasone may cause less vomiting Effective One dexamethasone dose seems to improve acute asthma symptoms and prevent hospitalization as well as a 3 day prednisolone course In kids with mild to moderate asthma exacerbations, consider suggesting dexamethasone... especially if adherence or tolerability is a concern. 12

13 Dexamethasone for Asthma Exacerbations Recommend appropriate dexamethasone doses: 0.3 or 0.6 mg/kg orally once daily for 1 or 2 days Up to a max of 16 mg/dose 0.3 or 0.6 mg/kg IM single dose Dexamethasone Availability Dexamethasone tablets: Recommend crushing and mixing with chocolate pudding or applesauce to help mask bitter taste if needed Dexamethasone liquid: 1 mg/ml concentrated solution (Intensol) 30% alcohol 0.5 mg/5 ml elixir or solution discourage due to volume Dexamethasone injectable: mg/ml oral suspension (alcohol free) can be compounded with Ora Sweet + Ora Plus or Ora Blend For IM injection Practice Pearls Encourage follow up with prescribers as needed Emphasize proper use and adherence to maintenance meds Review and reinforce asthma action plan Polls/Questions 13