Pharmacology Update for Advanced Practice Nurses Trish Freeman, RPh, PhD Associate Professor, Pharmacy Practice and Science University of Kentucky College of Pharmacy University of Southern Indiana September 25, 2015 Learning Objectives At the conclusion of this program, the participant should be able to: - Identify select new molecular and biological entities, with the exception of diagnostic compounds, that entered the US market in 14-15 - Describe each agent's clinical use, mechanism of action, dosage, adverse reactions, contraindications, and drug interaction profile - Compare new medicines with other agents used for the same indications Learning Objectives At the conclusion of this program, the participant should be able to: - Review new guidelines for chronic diseases - Identify recent FDA safety issues with select drugs - Review the epidemiology of opioid addiction and use of naloxone for rescue in the context of SB 192 - Review use of KASPER when prescribing controlled prescription drugs - Describe results of the impact of KASPER on doctor-shopping and CS prescribing
Categories of NDAs ; New molecular entities (NMEs) - New drug products that contain a chemical substance as their active ingredient, marketed for the first time in the US New biologies - Vaccines or blood products New indications New dosage forms New generic forms Ivabradine (Corlanor ) New medication for chronic heart failure - Classified as a hyperpolarization-activated cyclic nucleotide-gated channel blocker Indication - Reduce risk of hospitalization for worsening heart failure in patients with stable, symptomatic chronic heart failure with ventricular ejection fraction <35% - Must be in sinus rhythm with resting heart rate >70 beats per minute on (or with CI to) beta blocker therapy
Ivabradine (Corlanor ) Mechanism of Action - Selectively inhibits If channel to reduce spontaneous pacemaker activity and decrease HR with no effects on contractility - e! w I Ivabradine (Corlanor ) Recommended dose: -5 mg BID - Adjust after 2 weeks of treatment based on heart rate - Maximum dose 7.5 mg BID - Initiate at 2.5 mg BID in patients with conduction defects or in whom bradycardia could lead to hemodynamic compromise ^' i, ^'V Dosage Adjustment... :.'.' Table 1. Dose Adjustment Heart Rate Dose Adjustment Increase dose by 2.5 nig {given twice daily) > 60 bpm up to a maximumdose of 7.5 me twice daily 50-60 bpm Maintain dose Decrease dose by 2.5 mg (given twice daily); < 50 bpm or signs and if current dose is 2.5 mg twice daily, symptoms of bradycardia discontinue therapy* *fsee Warnings andprecautions(5.3).]
Ivabradine (Corlanor) Contraindications: - Acute decompensated heart failure - Blood pressure less than 90/50 mmhg - Sick sinus syndrome, 3rddegree AV block unless pacemaker present - Resting HR <60 bpm at baseline - Severe hepatic impairment - Pacemaker dependence - Strong CYP3A4 inhibitors jj Ivabradine (Corlanor ) Wt Warnings: - Fetal toxicity - use contraception - A fib - monitor patients,, - Bradycardia - monitor HR - 2nd degree AV block \'~" Adverse Effects: - Bradycardia - Hypertension -A fib - Luminous phenomena ' v... v^. Ivabradine (Corlanor ) Drug interactions: - CYP3A4 inhibitors/ inducers - Negative chronotrooes llllh' I Iv 4Mfe
Sacubitril and valsartan (Entresto) New oral medicine for chronic heart failure Combination of a neprilysin inhibitor (sacubitril) and valsartan, an angiotensin II receptor blocker Indicated to reduce the risk of cardiovascular death and hospitalization in patients with chronic heart failure (NYHA Class ll-iv) and reduced ejection fraction [Sacubitril and valsartan (Entresto) AT. f.*c«j;tof *«*m S^:.iiril(A><U!?;i IKHS7 /j'.<, i4 *U«l f»i!,tl.l.. <: Sacubitril and valsartan (Entresto) Recommended dose: - Start with 49/51 mg BID: increase after 2 to 4 weeks to target dose of 97/103 mg Start with 24/26 BID in patients not currently receiving ACEI/ARB or in patients on low dose ACEI/ARB and patients with severe renal or moderate hepatic impairment Contraindications: - Patients with history of angioedema on ACEI/ARB - Concurrent ACEI therapy - Concurrent aliskiren therapy in patients with diabetes
Sacubitril and valsartan (Entresto) Warnings/precautions: - Angioedema - Hypotension - Hyperkalemia - Renal failure Adverse effects: - Hypotension - Cough - Dizziness - Renal failure - hyperkalemia Sacubitril and valsartan (Entresto) Drug Interactions: - Potassium sparring diuretics -ACEI/aliskiren/ARBs - Lithium -NSAIDs Omega 3 carboxylic acids (Epanova) New EPA and DHA (fish oil) indicated to lower triglycerides in patients with severe (>500 mg/dl) hypertriglyceridemia Dose: -2 to 4 grams daily Use with caution in patients with fish or shellfish allergies Nausea, diarrhea, abdominal discomfort and eructation May prolong bleeding time
The JAMA Network JAMA. 2014;311(5):507-520. doi:10.1001/jama.2013.2a4427 Table Title: Comparison of Current Recommendations W n JNC 7 Guido&nos The JAMA Network JAMA.2014;311(5):507-520. doi:10.1001/jama.2013.284427 Evidence-Based Dosing lor Antihypertensive Drugs I The JAMA Network From. 2014 Evidence-Based Guideline for the Management of High Blood Pressure in Adults: Report From the Panel Members Appointed to the Eighth Joint National Committee (JNC 8) JAMA. 2014;311(5):507-520. doi:10.1001ajama.2013.284427 Table Title; Strategies to Dose Antihypertensive Drugs'
I The JAMA Network isuro in Adults: Report From the ;3n(5):5G7-520.rtni:lu.l001/)ama.. Figure Legend: 2014 Hypertension Guideline Management Algorit angiotensin-converting enzyme: ARE. src:u!e-n!-.;n not be used in combination."ifblood prbssutb fails current individual therapeutic plan. ssure; OB3, dmstnlii: nb<i<1 press;-r*. t SI channel blocker.'acfj Is and ARSs si in-.1![_;() r.thrti when- ;i;: ;r;ir>ri:!lu hiibild New Endocrine Drugs ^ Empagliflozin and Lingagliptin i ;(Glyxambi ) Combination sodium-glucose cotransporter 2 (SGLT2) inhibitor and dipeptidyl peptidase-4 (DPP-4) inhibitor Indication: -Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes - Not for treatment of type 1 DM - Has not been studied in patients with hx of pancreatitis :id;