NAPLEX Complete Study Outline A Topic-Wise Approach DIABETES (2019)

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CopyrightJohanna Kristin Ellerup, PharmDContributing Editor: Olga Kalugina, PharmD2019Johanna Kristin Ellerup PharmDAll rights reserved.No part of this book may be reproduced, or stored in a retrieval system, or transmitted in any form orby any means, electronic, mechanical, photocopying, recording, or otherwise, nor in any languagewithout the express written permission of the author.Printed in the United States of America

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Table of ContentsDiabetesEpidemiology and Generalized Informaon:RecommendaonsPaent Counseling points:Cover termsClinical Pearls & Notes:Signs and symptoms of associated disease states:Pathophysiology:Treatment opons:Lifestyle Intervenons–DPP-4GLP-1Alpha-GlucosidaseMeglinidesSulfonylureasFirst GeneraonSecond GenerationSodium Glucose Transporter Protein2 – InhibitorsThiazolidinedionesBiguanidesAmylin AnalogInsulinAn-Hypoglycemic Agent/GlycogenolycClinical Guidelines:References:

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DiabetesEpidemiologyandGeneralizedInformation:Prevalence 1.25 million Americans. Incidence is 40,000 new diagnoseseach year.2013 – 33-49% of patients not meeting general targets for glucose33-49% of patients not meeting general targets for glucose, BP orcholesterol & only 14% met goal while not smoking.2012-17 – cost of diabetes (w/adjustments for inflation) increased 26%Social determinants of health are economics, environment, political &social conditions in which people live.14% of Americans suffer from food insecurity & increased risk of T2DM,suboptimal glycemic control, psychosocial conditions and low treatmentadherence 79.RecommendationsA—Clear evidence from well-conducted, generalizable randomizedcontrolled trials that are adequately poweredB—Supportive evidence from well-conducted cohort studiesC—Supportive evidence from poorly controlled or uncontrolled studiesE—Expert consensus or clinical experience-BMI - >=25Kg/m2 or >=23 Kg/m2 in Asian Americans. Considertesting [Level B recommendation]-Everyone gets tested at 45 years of age [B]-Repeat testing, if normal and conditions listed, roughly every 3years [C]-In patients w/pre-diabetes & T2DM – test & if needed treat forcardiovascular issues [B]-Pre-diabetes risk screening in children or adolescents who areoverweight (BMI >=85%) [B]

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-Patient centered, open-ended positive response, collaborative healthcare team approach. [B]-Multidisciplinary team with interactive communication [E] 79PatientCounselingpoints:1)Do not double doses. If close to the time of the next,subsequent dose, skip the dose you missed and continueregimen. Consider making a note (i.e., in diabetes diary) ofmissed dose to reconcile any blood glucose fluctuations.2)Swallow tablets/capsules whole. Do not crush or chew.3)Store all injectables out of direct sunlight. Refrigerate, do notfreeze, prior to use and maintain within acceptable roomtemperature once vial is punctured or pen is utilized.4)Do not shake injectables; instead hold between both palms andgently swirl.5)Use alcohol swabs to clean vials and skin prior to puncturingand rotate injection sites to reduce injection site reactions andlipodystrophy.6)Report any unusual or elevated reactions or side effects to yourdoctor immediately. If in doubt, call 911.7)Carry identification somewhere on your person at all timesindicating that you are diabetic for emergency purposes.8)Keep portable candies and long acting carbohydrates/proteinon hand and utilize mobile apps for guidance.9)Contact your provider during illness as physiologic needs maychange.10)Notify all providers of medical history, including history ofgallstones, ethanol, smoking, pancreatitis, hepatic/renaldisease, cholesterol level and current medications includingOver-the-Counter items, herbals and supplements.11)Check all vials and pens (where possible) for cloudiness,changes in color or particulate matter. Dispose of safely insharps containers.12)Unless otherwise stated in the package insert, cloudy insulins(glargine, isophane, etc.) should not be given intravenously.13)Vials follow ISMP (Institute for Safe ManufacturingPractices), US Pharmacopeia standards of 28 days stability

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after puncturing a multi-dose vial unless otherwise stated inthe package insert.14)Those with diabetes should check their feet routinely andprotect from cuts, corns, blisters and injuries that maycompromise skin integrity. Diabetic patients are more prone tofungal and bacterial infections of the extremities, especially ifthey suffer from diabetic neuropathy which can decreaseawareness. Suggest they make a habit of doing a quick, yetthorough, inspection while changing their socks, shoes. IF thepatient notices any changes to their feet or calves, advise themto notify their primary care physician, podiatrist and/ordermatologist immediately.

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CovertermsFasting Blood Glucose (FPG) – Macrovascular disease – Metformin,Insulin. Fasting – greater than 6 hours between meals – 70-100 (up to 130)Post-Prandial Glucose (PPG) and A1C – Microvascular disease – GLP-1,DPP4, Insulin & SGTP. Peak postprandial – (peak – 1-2 Hrs afterinitiationof meal) = <=180mg/dl.Preprandial – Similar to trough – just prior to eating 70-130HbA1C – Normal non-diabetic patients 4-6%. Very strict control is <7.Some patients may require <8 to prevent hypoglycemia.Primary failure – Inability to achieve disease remission/optimal effect withevidence based drug treatment and doses.Secondary effect – After initial success, the agent loses effectiveness whichmay be neutralization by pathogen enzyme secretion, alternate pathway orirreversible over-saturation of receptors (down regulation).75g oral glucose tolerance test (OGGT) – With either fasting plasmaglucose (FPG) or 2HR plasma glucose.The 2Hr plasma glucose diagnoses, overall, more patients than either theFPG or A1C.Diagnosis requires, at least, two elevated and separate test results (evenA1c) unless there’s obvious signs of hyperglycemia – 3P’s – polyuria(urine), polyphagia (eating) & polydypsia (drinking), etc. Repeat testing in3-6 months.8 This distinguishes transient hyperglycemia (temporaryalteration in diet, infection, drug treatment, etc.) from diabetes.Pre-diabetes – Not a clinical diagnosis, but rather a warning to increasemonitoring and non-pharmacologic pathways. 8Pediatric and geriatric patients display altered pharmacokinetic/dynamicsand therefore require different treatment, dosing or increased monitoring.Start low and go VERY slow. For example, pediatrics have different Vd andan immature GI tract/hormone secretions, so that a drug may have greatlyreduced serum levels or have a higher level excreted unchanged. Geriatrics

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may have greatly reduced renal or hepatic function not fully evident onlabs, so that the duration of action of a 6 hour tablet that undergoes secondpass effect may be increased to 24 plus hours in this patient population.The ‘Incretin Effect’ is defined as the insulin response difference in oralversus IV dosing of glucose. A possible explanation for this increasedeffect, in some cases a three-fold increase, is the digestive enzyme secretionin saliva. By the time food has entered the stomach via the loweresophageal sphincter, the pancreas has been actively stimulated inpreparation whereas an IV injection bypasses this mechanism.Under normal conditions, glucagon is secreted by the alpha cells of theIsle of Langerhans, which also secretes beta and delta cells, of the pancreasin response to fasting conditions and maintains glucose concentrationwithin the plasma. Insulin is secreted by the beta cells of the Pancreas, inresponse to meals and stimulates the uptake of glucose to peripheral tissueand out of the plasma circulation thereby reducing solutes in plasma.31ClinicalPearls&Notes:Categories of diabetes: Think - 3P’s – Poly-urea (urinating/micturating),Poly-dypsia (drinking), Poly-phagia (eating). Think – increased osmolarity(dissolved particles in solute) of blood for pathogenesis of primary andsecondary disease.All agents that induce the secretion of insulin can lead to pancreatitis.Genetic missense variants: Known pathogenicity in theGCK (highlyoverrepresented in DM),HNF1A,HNF4A,ABCC8, andINSgenes.11DNA amino acids: G (guanine), T (thymine), C (cytosine), A (arginine).SNP – Single Nucleotide Polymorphisms – change to one specificnucleotide in an open-reading frame that may alter thetranslation/transcription of that sequence.T1DM = Immune mediated or idiopathic – AKA Juvenile Diabetes.8T2DM = Insulin resistance peripherally w/relative insulin deficiency ormore commonly effect on insulin secretion with insulin resistance. AKAadult diabetes. In this class, hyperglycemia may follow metabolic

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syndromes = obesity, HTN, hyperlipidemia and impaired fibrinolysis.(AHFS,3211)HbA1C – “…nonexzymatic glycosylation of other proteins throughout thebody as a result of recent (eg. previous 6-8 weeks) hyperglycemia.” (AHFS,3212)Microvascular complications include blindness, retinopathy, andnephropathy, co-morbid with dyslipidemia, blood pressure and vascularthrombosis. Most associated with PPG. AHFSAgents that have CYP 450, OAT/OCT, PgP interactions, etc – even when‘not clinically significant’ may play an important role to individual patientsdisplaying unexpected sides or reactions. Don’t dismiss them.Agents that are excreted in bile and/or unabsorbed from the GI tract iseliminated in feces. Consider this if agent affects GI transit time or binds tothe GI tract excessively.In general, the insulin or sulfonylurea dose is reduced preferentially overDPP-4, GLP-1 or SGTP.Beta blockers, hypothyroid agents, anxiolytics, catecholaminesagonists/antagonists may mask hypoglycemic signs and alter glucosemetabolism.Insulin is preferred in pregnancy and pediatrics due to increased Vd,decreased muscle and altered adipose tissue. In general, oral agents arereserved for 18+.Geriatric patients (70+) have reduced renal, hepatic and cardiac functionand therefore, in general, may use lower dosages or increased intervals withall agents to reduce hypoglycemia which can lead to falls, dizziness, alteredmental status, etc.Insulin is needed in ketonuria and glucosuria.Hypoglycemia treatment protocol – IV D50W 50mL Bolus with D10Wtitrated to glucose >100mg/dl. Glucocorticosteroids, such asdexamethasone, may be added.

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Signsandsymptomsofassociateddiseasestates:Hepatic Failure:ALT/AST >120 (3 times upper limit of normal [ULN]);elevated Alk Phos (indicative of liver, bone disease), yellowing of sclera,skin (jaundice), abdominal pain, nausea, vomiting, fatigue, anorexia, darkurine, ascites.Pancreatitis:Serum & urine amylases increased, amylase/CrCl ratio,electrolyte imbalance, sCa2+, glucose and lipase.Thyroid Tumors:Malignant or benign, lump on base of neck that (keycharacteristic) bobs up and down with swallow mechanism (followsthyroid), hoarseness, dysphagia, dyspnea). Prevalence ~ 6% female, 1-2%male. Up to 95% are benign, but must be evaluated. Consist of cysts, goiter(commonly in hypothyroid), adenomas and nodules. 57Lactic Acidosis:Fatigue, headache, mental instability, increased lactasedehydrogenase and liver function tests (LFT’s).Metabolic Acidosis:Tachypnea, anorexia, nausea, vomiting, lethargy,mental status changes and abdominal pain.Diabetic ketoacidosis:Blood glucose levels needn’t be >200, but anincreased anion gap, elevated blood and/or urine ketones, mental statuschanges may be present. Potential factors include hypovolemia, acute renalfailure, hypoxemia, reduced oral intake, ethanol ingestion, acute illness(infection) and reduced insulin dosage.Renal labs:Hgb/Hct, electrolytes, BUN/sCr, CBC. Signs: Increased waterretention (edema), HTN/hypotension, unconcentrated urine, skin turgor,appetite changes, digestion alterations, addition of NSAIDs, ACEI,diuretics, digoxin, etc.Fournier Gangrene: Necrotizing fasciitis, tenderness, swelling, redness ofgenitals, back to the rectum, 100.4+ fever, malaise, increased LDL-chypoglycemia.Alcohol consumption in Diabetes– Alcohol displays varying effectsdepending on fed/fasting state of patient and whether acute or chronicingestion. It can increase blood glucose in the fed state, due to a reduced

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inhibition (I.e., person may consume more carbohydrates calories), thesugar content of the drink itself, an alteration in fat metabolism, and anincrease in peripheral insulin resistance. Whereas in chronic or starvationstates the depletion of glycogen and alcohol preventing hepaticgluconeogenesis can cause blood glucose levels to plummet to dangerouslylow levels. This is compounded by the fact that hypoglycemia awareness isblunted during alcohol consumption and, due to the above listed events,there is an attenuated response to correction of hypoglycemia.80

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Pathophysiology:1)Type1Diabetes– Polygenic form. Attributed to several genes,includingHLA-DQA1,HLA-DQB1, and HLA-DRB1 genescontribute 5% toT1DM population. HLA is human leukocyte(white blood cell) antigen (a pathogenic cell). Considered auto-immune – where immune cells are attacking Isle of Langerhans-Pancreatic Beta Cells that secretes insulin. Pancreatic alpha-cellssecrete glucagon.16Signs – 3P’s, unexplained weight loss, excessive fatigue.Signs of DKA – “Sweet fruity breath” – Hallmark feature, dry orflushed skin (also thyroid or CHF), stomach pain (variety, includingliver, bowel obstruction, etc), disoriented, SOB.Number 1 treatment is insulin replacement.Several agents- DPP4, GLP-1, Sulfonylureas, Meglitinides- are notcompatible with T1DM because they stimulate the secretion of insulinfrom the pancreas which is the key feature separating Type 1 fromType 2. Hence, the side effect of pancreatitis for these agents.132)Type2Diabetes– Polygenic form. Think – overuse/over-stimulation disease.IGF2BP2-SNP rs4402960 (Insulin-likegrowth factor 2 mRNA-binding protein 2; single NucleotidePolymorphism) G/T, TERT rs2735940 T/C, TERT rs2736098G/A.15 T2DM is also associated with Metabolic Syndrome(hypercholesterolemia, hyperglycemia, hypothyroidism,hypertension), which doesn’t rule out an inflammatory disorder.Evidence shows that the DASH and Mediterranean diets may havepositive outcomes.-This is the only type of diabetes that is amenable to diet and exercisealone.Signs – 3P’s, increased fungal infections, sores that don’t heal (mayalso indicate cancer, psoriasis, etc).3)DiabetesInsipidous– Polygenic form. “Sweet Urine.” Insipidus– (think – insipid) light and odorless. Normally, adults passapproximately 1-2 quarts (1/2 gallon, app 1890ml) of urine daily.DI patients can pass up to 20 quarts (app 5 gallons) ofunconcentrated urine, due to an abnormality in renal tubular

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filtering. Important difference - Normal blood glucose levels(normoglycemic).FourmajortypesofDI:a.Centrallymediated– Hypothalamus or pituitary.Vasopressin, a vasoconstricting agent that increases plasmasodium leading to increased water retention and increasedblood pressure, does not concentrate the urine. Causesinclude central trauma, infection, meningeal inflammation,etc.b.Nephrogenic–Adrenally mediated. Vasopressin does notconcentrate urine. BUN/sCr can be utilized to discernwhether there is pre-renal implications (blockage), lithiumand other exogenous xenotropic causes, altered electrolytestatus.c.Dipsogenic–Excess fluid intake, especially water. Analtered mental or physiologic status that causes more fluidintake than the body can normally process, therebyunfiltered excretion of the excess. Causes include all thosepreviously listed.18d.Gestational– Transient. May be caused by prostaglandinor oxytocinase/vasopressinase that inactivates vasopressin.Treatment of choice is DDAVP (desmopressin) thatmimics the effects of vasopressin without inactivating orattenuating oxytocin (Pitressin – used to reduce pre-termlabor).194)GestationalDiabetes– Treatment is insulin, as transport of oralagents across the placenta, risk of hypoglycemia and their variedside effects on the developing fetus is controversial at best. Co-morbid diseases include pre-eclampsia (very elevated bloodpressure that is dangerous to both the mother and fetus), enlargedbaby (possible developmental and/or physiological disorders),20At-risk mothers - age >35, previous gestational diabetes or primaryfamily member, previous high birth weight delivery, pre-pregnancyobesity, hormonal disorders (ie., Polycystic Ovarian Syndrome).May be managed with non-pharmacologic factors and insulin. If

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uncontrolled, infants have a higher predisposition of developmentaldisorders (learning disabilities), heart disease, hyperlipidemia anddiabetes later in life.5)MonogenicDiabetesSyndromes– A form of non-autoimmune,early-onset diabetes that arises from a variant in one gene. Itaccounts for 1-4% of all DM cases in the US. May or may not begermline or a spontaneous mutation.11,12a. Neonatal – May be transient, occurring only as the neonatebegins to mature, or may be lifelong. Occurs in ~1 out of400,000 US infants. Key determinant is that T1DM israrely seen before 6 months of age, but NDM exists atbirth. May also appear slightly later, ie toddler onward.b. Maturity Onset Diabetes of the Young (MODY) – Amonogenetic disease that is heritable. Historically, thesepatients have chronically elevated blood glucose, but notnecessarily peripheral or end-organ disease or overweight.Diagnosed via genetic testing. Medications are notnecessarily preferred in this patient class.6)SecondaryDiabetes: Exocrine Pancreas (cystic fibrosis,pancreatitis, etc), Drug/Chemical induced, neonatal diabetes (non-NDM form), etc.

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