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Learning Objectives Celiac Disease: Implications for Pharmacotherapy and the Role of the Pharmacist Heather Walczyk, Pharm.D. PGY-2 Pharmacotherapy Resident Nova Southeastern University January 27, 2013
Discuss the pathophysiology, clinical presentation, and treatment of Celiac Disease Identify potential implications of Celiac Disease on the absorption and bioavailability of medications Recognize the role of the pharmacist and potential interventions for providing optimal pharmaceutical care to patients with Celiac Disease
Patient Case AW is a 18 y/o female figure skater who has a history of chronic nausea, diarrhea, and flatulence, particularly after consuming bagels, bread, and pasta. She made a self-diagnosis of lactose intolerance, and began to avoid dairy products. Five months later after no improvement, significant weight loss, and frequent dizziness, AW decided to seek medical attention.
Patient Case (cont.) (-) Lactose intolerance test (+) IgA and tTG antibodies (+) Celiac Disease biopsy during upper GI endoscopy Lifestyle modifications? Need for nutritional supplements? Need for symptomatic or pharmacologic treatment? Pharmacist counseling points
Celiac Disease Approx. 3 million (1%) Americans currently affected 97 % patients not diagnosed
Pathophysiology Chronic autoimmune disorder 1.
HLA-DQ2 and HLA-DQ8 proteins 2.
Higher incidence in women disease-related manifestations Green PHR, Jones R. Celiac disease: a hidden epidemic. New York: Harper Collins; 2006. National Institutes of Health. NIH Consensus Development Conference on Celiac Disease. 2004
Environmental factors Gliadins (wheat) Hordeins (barley) Secalins (rye)
“Hidden epidemic”
Men appear to have more severe
Genetic predisposition
3.
Immunologically-based inflammation Mucosa of the proximal small intestine Abnormal surface enterocytes and villi Green PHR, Cellier C. Celiac disease. N Engl J Med. 2007;357:1731-43. Green PHR, Jones R. Celiac disease: a hidden epidemic. New York: Harper Collins; 2006. Murray JA. The widening spectrum of celiac disease. Am J Clin Nutr. 1999;69:354-65.
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Malabsorptive Syndrome
Atypical Presentation
Pediatric Presentation
Diarrhea
Non-specific GI discomfort
Steatorrhea
Fatigue
Dental abnormalities ± malabsorptive problems Slowed intellectual development Iron deficiency anemia (IDA)
Weight loss
Depression
Failure to thrive
McAllister CS, Kagnoff MF. The immunopathogenesis of celiac disease reveals possible therapies beyond the gluten-free diet. Semin Immunopathol. 2012. 34:581-600
Nutritional Deficiencies
Bloating
Ailments from micronutrient deficiencies
Flatulence
Osteomalacia
Nutritional deficiencies
Arthralgia
Osteoporosis Epilepsy Stunted growth
Murray JA. The widening spectrum of celiac disease. Am J Clin Nutr. 1999;69:354-65. Drago S, DiPierro M, Catassi C, et al. Recent developments in the pathogenesis, diagnosis, and treatment of celiac disease. Expert Opin Ther Pat. 2002;12:45-51.
Dermatitis herpetiformis
Iron
Intestinal response to ingested gluten
Folate
IgA granules at the dermal-epidermal junction
Calcium Vitamin B12 Fat-soluble vitamins Potassium Magnesium See J, Murray JA. Gluten-free diet: the medical and nutrition management of celiac disease. Nutr Clin Pract. 2006;21:1-15.
Dermatitis herpetiformis
Occurs in 15 – 25 % patients Pruritic, bullous skin rash Elbows, knees, buttocks, and scalp Every individual with dermatitis herpetiformis has Celiac Disease Murray JA. The widening spectrum of celiac disease. Am J Clin Nutr. 1999;69:354-65. Korn D. Wheat-free, worry-free: the art of happy, healthy gluten-free living. Carlsbad, NY:Hay House;2002. Rodrigo L. Celiac disease. World J Gastroenterol. 2006;12:6585-93.
Diagnosis Recognition of symptoms Duodenal biopsy Intraepithelial lymphocytes Crypt hyperplasia Villous atrophy
Positive response to a gluten-free diet Positive serological testing Antigliadin antibodies Anti-tissue transglutaminase antibodies Endomysial IgA antibodies HLA-DQ2/HLA-DQ8 alleles Green PHR, Cellier C. Celiac disease. N Engl J Med. 2007;357:1731-43. Green PHR, Jones R. Celiac disease: a hidden epidemic. NY: Harper Collins; 2006. See J, Murray JA. Gluten-free diet: the medical and nutrition management of celiac disease. Nutr Clin Pract. 2006;21:1-15.
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Treatment Goals 1.
Relieving
Consultation with a dietitian
symptoms 2.
Education about disease Lifelong adherence to gluten – free diet Identifying and treating nutritional deficiencies
Reversing the consequences of malabsorption
Goal < 50 mg per day Amaranth
Millet
Sorghum
Buckwheat
Potato flour
Soybeans
Corn
Quinoa
Tapioca
Flax
Rice
Teff
Access to an advocacy group Continuous long-term followup by a multidisciplinary team
National Institutes of Health. NIH Consensus Development Conference on Celiac Disease. 2004. See J, Murray JA. Gluten-free diet: the medical and nutrition management of celiac disease. Nutr Clin Pract. 2006;21:1-15. Hallert C, Grant C, Grehn S, et al. Evience of poor vitamin status in celiac patients on a gluten-free diet for 10 years. Aliment Pharmacol Ther. 2002;16:1333-9.
Nutritional Supplementation Calcium 1g daily and Vitamin D 32,000 IU weekly Bone mineral density (BMD) remained low after 1yr
with GFD but
No additional benefit seen with supplements May require higher doses
Zinc Plasma levels
Strict, lifelong gluten-free diet (GFD)
Gluten-Free Grains/Flours
Healing the intestine
3.
Lifestyle Modifications
with GFD
No additional benefit with zinc supplement Rawal P, Thapa BR, Prasad R, et al. Zinc suppementation to patients with celiac disease—is it required? J Trop Ped. 2010;56(6):391-397. Aliment Pharmacol Ther. 2009;29:811-816.Mautalen C, Gonzalez D, Mazure R, et al. Effect of Treatment on Bone Mass, Mineral metabolism, and body composition in untreated celiac disease patients. Am J Gastro. 1997;92(2):313-318.
Symptomatic Treatment Budesonide (Entocort®) GFD ± budesonide 6mg PO daily x4 wks Faster improvement of GI symptoms Higher overall well-being No side effects reported
Psyllium 2.5 – 30g daily in divided doses Beneficial for GFD-induced constipation Ciacci C, Maiuri L, Russo I, et al. Efficacy of budesonide therapy in the early phase of treatment of adult coeliac disease patients with malabsorption: an in vivo/in vitro pilot study. Clin Exp Pharm Phys. 2009;36:1170-1176.
“Gluten-free” foods contain less than 20 ppm of gluten See J, Murray JA. Gluten-free diet: the medical and nutrition management of celiac disease. Nutr Clin Pract. 2006;21:1-15. Rodrigo L. Celiac disease. World J Gastroenterol. 2006;12:6585-93. Drago S, DiPierro M, Catassi C, et al. Recent developments in the pathogenesis, diagnosis, and treatment of celiac disease. Expert Opin Ther Pat. 2002;12:45-51.
Nutritional Supplementation Folic acid 0.8mg, Vitamin B6 3mg, and Vitamin B12 0.5mg daily Improvement in well-being, anxiety, depression
Potassium, magnesium, iron, and other vitamins Should normalize upon initiation of GFD Additional supplementation only if indicated Hallert C, Svensson M, Tholstrup J, et al. Clinical trial: B vitamins improve health in patients with coeliac disease living on a gluten-free diet. Aliment Pharmacol Ther. 2009;29:811-816.
Causes of Treatment Failure Non-compliance with GFD Misdiagnoses Concurrent disorders Lactose intolerance Irritable bowel syndrome Bacterial overgrowth Pancreatic insufficiency Microscopic colitis
Refractory Celiac Disease Abdulkarim AS, Burgart LJ, See J, et al. Etiology of nonresponsive celiac disease: results of a systematic approach. Am J Gastroenterol. 2007;5:445.Ryan BM, Kelleher D. Refractory celiac disease. Gastroenterol. 2000;119:243. Carroccio A, Iacono G, Lerro P, et al. Role of pancreatic impairment in growth recovery during gluten-free diet in childhood celiac disease. Gastroenterology. 1997;112:1839.
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Refractory Celiac Disease Unknown cause No initial response to GFD (primary) Loss of response to GFD (secondary)
Occurs in approx. 5% patients Type 1 • Normal Tcells • 25% of cases
Type 2 • Aberrant Tcells • Poor prognosis
Al-toma A, Verbeek WHM, Mulder CJJ. Update on the management of refractory coeliac disease. J Gastrointest Liver Dis. 2007;16:57-63. Abdaliah H, Leffler D, Deenis M, et al. Refractory celiac disease. Curr Gastroenterol Rep. 2007;9:401-5.Gillett HR, Arnott DR, McIntrye M, et al. Successful infliximab treatment for steroid-refractory celiac disease: a case report. Gastroenterology. 2002;122:800-5.
Potential Complications Complication
Mechanism
Cancer
• • • • •
Ulcerative jejunitis
Prevention/Treatment
intestinal permeability of Strict adherence to GFD carcinogens Chronic inflammation and antigen stimulation Release of proinflammatory cytokines Immune surveillance problems Nutritional deficiencies
• Aberrant T-cells, consider • None, poor response to GFD if no response to refractory treatment • Resect ulcerated or • Poor prognosis strictured segment
Green PHR, Cellier C. Celiac disease. N Engl J Med. 2007;357:1731-43. Rodrigo L. Celiac disease. World J Gastroenterol. 2006;12:6585-93. Askling J, Linet M, Gridley G, et al. Cancer incidence in a population-based cohort of individuals hospitalized with celiac disease or dermatitis herpetiformis. Gastroenterology. 2002;123:1428-35.
Future Treatment Options
Refractory Celiac Disease Drug
Dose
Route
Frequency
Hydrocortisone (Solucortef®)
100 mg
IV
Q6H
Prednisolone (Orapred®)
40 – 60 mg then dec by 5 PO – 10 mg/d after a few wks
Daily
2mg/kg
PO
BID
4mg/kg
IV
Daily Daily
(Imuran®)
Azathioprine
Cyclosporine (Sandimmune®) Thioguanine
(Lanvis®)
0.3mg/kg
PO
Budesonide (Entocort®)
9 mg (6 – 12mg)
PO
Daily
Mesalamine (Asacol®)
800mg
PO
TID
Alemtuzumab (Campath®)
30mg
IV
Twice weekly
0.1mg/kg/day x5d
IV
1-3 courses q6 months
Cladribine
(Leustatin®)
Al-Toma A, Goerres MS, Meijer JW, et al. Cladribine therapy in refractory celiac disease with aberrant T cells. Clin Gastroenterol Hepatol. 2006;4:1322. Verbeek WH, Mulder CJ, Sweegman S. Aleztuzumab for refractory celiac disease. N Engl J Med. 2006;355:1396. Tack GJ, van Asseldonk DP, van Wanrooij RL, et al. Tioguanine in the treatment of refractory coeliac disease-a single centre experience. Am J Gastroenterol. 2002;97:2595. Vaidya A, et al. Azathioprine in refractory sprue. Am J Gastroenterol 1999;94:1967.
Extra-Intestinal Manifestations Manifestation
Treatment
GERD
• GFD
Iron-Deficiency Anemia
• GFD • Ferrous sulfate 200mg PO TID
Osteoporosis
• • • • •
Dermatitis herpetiformis
• GFD • Dapsone to relieve itching and rash • Avoid iodine and bromines
Peripheral Neuropathy
• GFD • None specified, no malabsorption of pregabalin
Infertility
None
GFD Calcium/Vitamin D supplementation Bisphosphonates, Calcitonin Estrogen replacement therapy Selective estrogen receptor modulators
Nachman F, Vazquez H, Gonzalez A, et al. Gastroesophageal reflux symptoms in patients with celiac disease and the effects of a glutenfree diet. Clin Gastroenterol Hepatol. 2011 Mar. 9(3):214-9. Barker JM, Liu E. Celiac Disease: Pathophysiology, Clinical Manifestation, and Associated Autoimmune conditions. Adv Pediatr. 2008;55:349-365. Mangione RA, Patel PN. Caring for patients with celiac disease: the role of the pharmacist. J Am Pharm Assoc. 2008;48:e125-e139. Hanu-Cernat DE, et al. Pregabalin assay in a patient with widespread neuropathic pain and late onset gluten intolerance. Pain Med. 2011 Aug;12(8):1262-6.
Implications for Pharmacotherapy Little data available Intestinal damage and chronic diarrhea may limit medication absorption propranolol absorption from proximal jejunum in 5 untreated patients absorption calcium, folic acid, Vitamin B12, etc. without treatment Improved absorption after intestinal healing with gluten-free diet
McAllister CS, Kagnoff MF. The immunopathogenesis of celiac disease reveals possible therapies beyond the gluten-free diet. Semin Immunopathol. 2012. 34:581-600
Mangione RA, Patel PN. Caring for patients with celiac disease: the role of the pharmacist. J Am Pharm Assoc. 2008;48(5):e125-e139. Sandle GI, Ward A, Rawlins MD, et al. Propranolol absorption in untreated coeliac disease. Clin Sci (Long). 1982 Jul;63(1):81-5.
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Gluten-free Prescriptions FDA does not require gluten content on labeling Resources for pharmacists www.glutenfreedrugs.com Product manufacturer Compounding pharmacy Sucrose
Agar
Alcohol
Dextrose
Gellan gum Guar gum Methylcellulose
Alginates
Glycerin
Reduction in time from symptom onset to diagnosis Recognition of signs and symptoms Awareness of common diseases misdiagnosed Referral for appropriate diagnostic evaluation
Gluten-Free Inactive Ingredients Acacia
Role of the Pharmacist
Honey Carrageenan
Fructose
Xanthan gum
Corn syrup
Sodium carboxymethylcellulose
Crospovidone
Propylene glycol
Polyvinylpyrrolidone
Croscarmellose sodium
Hydroxy-propylcellulose
Corn or potato-derived starches
Polyethylene glycol
Microcrystalline cellulose
Gluten-Free Drugs for Celiac Disease Patients. The Medical Letter on Drugs and Therapeutics. 2008. 50(1281):19-20.
Role of the Pharmacist
Irritable bowel syndrome
Allergies
Psychologic dysfunction
Ameba/parasitic infection
Inflammatory bowel disease
Gallbladder disease
GERD
Colitis
Ulcers
Cystic fibrosis
Viral gastroenteritis
Lactose intolerance
Chronic fatigue syndrome Mangione RA, Patel PN. Caring for patients with celiac disease: the role of the pharmacist. J Am Pharm Assoc. 2008;48(5):e125-e139.
Role of the Pharmacist
Helping patients avoid treatments with
Recommendations for vitamins and
inappropriate GI OTC remedies
nutritional supplements
Education relating to gluten-free diet
Recognize potential for decreased
and gluten-free drugs
absorption of other medications
Non-adherence to dietary restrictions is
Provide ongoing support, sensitivity
leading cause for treatment failure
to the impact that the diagnosis has
Pneumococcal vaccination
on patient and family members
Mangione RA, Patel PN. Caring for patients with celiac disease: the role of the pharmacist. J Am Pharm Assoc. 2008;48(5):e125-e139.
Assessment Questions 1.
Patients with untreated Celiac Disease may have difficulty absorbing calcium carbonate (Oscal®) supplements. a. True b. False
2.
Patients with Celiac Disease can present with symptoms of abdominal pain, diarrhea, and fatigue. a. True b. False
3.
The treatment of choice for Celiac Disease is a gluten-free diet for 6 months. a. True b. False
Patient Case AW is a 18 y/o female figure skater who has a history of chronic nausea, diarrhea, and flatulence, particularly after consuming bagels, bread, and pasta. She made a self-diagnosis of lactose intolerance, and began to avoid dairy products. Five months later after no improvement, significant weight loss, and frequent dizziness, AW decided to seek medical attention.
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Patient Case (cont.) (-) Lactose intolerance test (+) IgA and tTG antibodies (+) Celiac Disease biopsy during upper GI endoscopy Lifestyle modifications Need for nutritional supplements? Need for symptomatic treatment? Pharmacist counseling points
Initiate GFD Check BMD, labwork 3. Hold off on other treatment until fail GFD 4. Taking any other medications? 1. 2.
Take Home Points
Patient Case: Follow-Up GFD provided AW great improvement to overall well-being Symptoms slowly subsided and she gradually regained her strength Two years since her diagnosis, AW is still maintaining a gluten-free diet with no further complications or persistent symptoms
Helpful Resources
Chronic autoimmune disorder from gluten intolerance
Celiac Disease Foundation
Majority of patients are undiagnosed
The Essential Gluten-Free Restaurant Guide
Commonly confused with other disorders Treated with a lifelong gluten-free diet
www.celiac.org
www.triumphdining.com
Pharmacological agents for symptomatic relief
Celiac Disease Support Groups
Disease-modifying treatments currently being studied
Celiac News & Gluten Free Diet Resources
Pharmacists can play a valuable role in recognition and education of these patients
Gluten Intolerance Group
www.celiacgroups.com www.celiac-disease.com www.gluten.net
Thank you! Any Questions?
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Diverticulitis: Implications for Pharmacotherapy and the Role of the Pharmacist Veronica Sherman, Pharm.D. PGY-2 Critical Care Resident
Epidemiology
Objectives Discuss the epidemiology and risk factors of developing diverticulitis Understand the pathophysiology of diverticulitis Identify the symptoms associated with development and progression of diverticulitis Discuss the pharmacologic and non-pharmacologic treatment options for diverticulitis Address patient counseling points for those managing the symptoms and complications of diverticulitis Recognize the role of the pharmacist and potential interventions for providing optimal pharmaceutical care to patients with diverticulitis
Trend of Disease in the United States
More common in Western countries (developed nations) than in Africa and Asia 60% of Americans will develop diverticulitis Prevalence Increases with age More common in males at ages 50
National Digestive Diseases Information Clearinghouse (NDDIC). Diverticulitis. Accessed 12/11/2012
Pathophysiology Diverticulum: sac-like protrusion of the colonic wall Diverticulosis: presence of diverticula Diverticulitis: inflammation of diverticula National Digestive Diseases Information Clearinghouse (NDDIC). Diverticulitis. Accessed 12/11/2012
Masoomi, H., et al. Arch Surg. 2011;146(4):400-406.
Pathophysiology 95% of patients have sigmoid diverticula Sigmoid colon has the smallest diameter and highest pressure Colon segmentation creates occlusions as muscles contract ↑ intraluminal pressure predisposing to mucosal herniation Stollman, N., et al. The Am J Gastroenterology 1999 Vol. 94, No. 11
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Pathophysiology Cont. Mycosis: thickening of the circular muscle layer, shortening of the taeniae, and luminal narrowing
Risk Factors Ingestion of NSAIDs, opiates, steroids
Low fiber diet Constipation
Diverticular Disease
Smoking
Consumption of caffeine, alcohol
Advancing age Physical inactivity
Increased elastin deposition in the taeniae Stollman, N., et al. The Am J Gastroenterology 1999 Vol. 94, No. 11
Stollman, N., et al. The Am J Gastroenterology 1999 Vol. 94, No. 11
Clinical Presentation Most Common • Left lower quadrant pain & abdominal tenderness • Nausea/vomiting • Constipation • Diarrhea • Urinary urgency, frequency, dysuria
Less Common • Mild fever & ↑ WBC • Amylase normal/ mildly elevated • Urinalysis sterile pyuria • Colonic flora on culture colovesical fistula
Janes, S., et al. BMJ 2006; 332: 271–5
Staging of Diverticular Disease (DD) Stage • Presence of diverticula I Stage • Asymptomatic DD II Stage III
• Symptomatic uncomplicated DD single episode, multiple discrete episodes, smoldering symptoms
Stage • Complicated DD IV Stollman, N., et al. The Am J Gastroenterology 1999 Vol. 94, No. 11
Obesity
Diagnosis Gold Standard: computer tomographic (CT) with contrast of the abdomen Abdominal and chest radiographs Water-soluble contrast enema if CT is not available Barium enema is absolutely contraindicated in the acute phase Janes, S., et al. BMJ 2006; 332: 271–5
Clinical Manifestations: Uncomplicated ~75% present as uncomplicated Occlusion of a diverticulum microperforation
inflammation and
Symptoms: Abdominal pain/distension Change in bowel habits N/v Urinary symptoms Fever and ↑ WBC is common Janes, S., et al. BMJ 2006; 332: 271–5
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Clinical Manifestations: Complicated Complications
Therapy: Uncomplicated Diverticulitis Inpatient vs outpatient care determined by:
Perforation • Free perforation
purulent or feculant peritonitis
Obstruction Fistula to bladder, vagina, small bowel, ureter, and skin Abscess (abdominal or pelvic) walled off or limited to mesentary or retroperitoneum
Nearly all patients require surgery Janes, S., et al. BMJ 2006; 332: 271–5
Severity of presentation Ability to tolerate PO medications Presence of comorbid disease(s) Support system
Patients should seek medical attention for: Fever Abdominal pain Unable to tolerate adequate liquids Stollman, N., et al. The Am J Gastroenterology 1999 Vol. 94, No. 11
Common Pathogens
Therapy: Uncomplicated Diverticulitis Antibiotic
Gram positive (G+) cocci:
Gram positive (G+) cocci:
Streptococci (α and γ hemolytic)
Metronidazole (Flagyl®)
Dose
Coverage
500 mg PO TID
Comments
Anaerobes
Take w/ food if upset stomach
Gram - & + • Pseudomonas aeruginosa
Cipro preferred for intraabdominal infections
Gram -, some +, anaerobes
Take w/ food if upset stomach
Anaerobes
If intolerant to Flagyl
Peptostreptococcus spp.
+
Gram positive (G+) bacilli:
Gram positive (G+) bacilli:
Corynebacterium spp.
Clostridium spp.
Gram negative (G-) bacilli:
Gram negative (G-) bacilli:
•Escherichia coli •Klebsiella pneumoniae
•Bacteroides (B. fragilis) •Fusobacterium spp.
Fluoroquinolone (PO) Ciprofloxacin (Cipro®) Levofloxacin (Levaquin®) Moxifloxacin (Avelox®)
• 500 mg BID • 750 mg daily • 400 mg daily OR
Amoxicillin/clavulanate (Augmentin®)
875/125 mg BID
Clindamycin (Cleocin®)
300 mg Q6 hrs
+
Stollman, N., et al. The Am J Gastroenterology 1999 Vol. 94, No. 11
Therapy: Complicated Diverticulitis
Treating Complications Peritonitis
Antibiotic (IV)
Dose & Frequency
Ampicillin/sulbactam (Unasyn®)OR Piperacillin/tazobactam (Zosyn®) OR Ticarcillin/clavulanate (Timentin®)
3 g q6 hrs 3.375 g q6 hrs 3.1 g q6 hrs
Ceftriaxone (Rocephin®)
1 g q24 hrs
Metronidazole (Flagyl®)
500 mg q8 hrs
Coverage
AE & Warnings
G -, G +, anaerobes
Renal function
G -, G +, anaerobes
Upset stomach
Anaerobes
Vomiting & diarrhea
Antibiotic (IV) Ampicillin
Dose and Frequency 2 g q6 hrs
OR
OR (if β-lactam intolerant)
Metronidazole (Flagyl®)
500 mg q8 hrs
Anaerobes
Vomiting & diarrhea
1.5-2 mg/kg q8hrs
500 mg q6 hrs 1 g q8 hrs 1 g QD
Ciprofloxacin (Cipro®) OR Levofloxacin (Levaquin®)
400 mg q12 hrs 500-750 mg QD
Vomiting & diarrhea
G-
Renal function
Metronidazole (Flagyl®) 500 mg q8 hrs
Anaerobes
Vomiting & diarrhea
G +, G -, anaerobes
Renal function, seizure risk
G +, G -, anaerobes
Renal function
OR G +, G -, anaerobes
Renal function, seizure risk with Primaxin,
Imipenem/cilastin (Primaxin®)
500 mg q6 hrs
Piperacillin/tazobactam (Zosyn®)
3.375 g q6 hrs
OR
OR
Stollman, N., et al. The Am J Gastroenterology 1999 Vol. 94, No. 11
G -, most G +, some anaerobes
+
+ Imipenem/cilastin (Primaxin®) OR Meropenem (Merrem®) OR Ertapenem (Invanz®)
AE & Warnings
+ Gentamicin
+
Coverage
Renal function, upset stomach, QT prolong.
Stollman, N., et al. The Am J Gastroenterology 1999 Vol. 94, No. 11
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Diet Recommendations If symptoms are severe (outpatient treatment) Clear liquids only Diet advanced after clinical improvement
Hospitalized patients Clear liquids or NPO with IV hydration
Resolution & Monitoring Resolution 1/3rd remain asymptomatic Risk Factors:
After acute phase of attack resolves High-fiber diet (≥25-35 g per day)
Family history, initial attack included complications, &/or attack involved >5 cm of the colon
1/3rd
have episodic cramps
1/3rd have 2nd attack Stollman, N., et al. The Am J Gastroenterology 1999 Vol. 94, No. 11
Stollman, N., et al. The Am J Gastroenterology 1999 Vol. 94, No. 11
Mesalamine Future Direction in the Treatment of Diverticulitis •Mesalamine •Rifaximin •Probiotics
5-aminosalicylic acid (5-ASA) Anti-inflammatory used to treat inflammatory bowel diseases Acts locally
GI tract
Side effects: GI symptoms (stomach cramps, n/v/d, gas) Counseling points Take with full glass of water Take Lialda (ER capsule) with a meal Do not break, crush, or chew tablets or capsules Mesalamine. [Package Insert]. Access 12/11/2012
Mesalamine Tursi, A., et al (2002) (conducted in Europe) (n=218) Design • Group A: 109 treated w/ rifaximin 400 mg BID + mesalazine 800 mg TID x 7 d, followed by rifaximin 400 mg BID + mesalazine 800 mg BID x 7 d/mo • Group B: 109 treated with rifaximin 400 mg BID x 7 d, followed by rifaximin 400 mg BID x 7 d/mo Results: symptom severity and bowel habits improved in group A vs group B w/i 3 mo. Symptomatic recurrence seen in 3 (A) vs 13 (B) patients in during follow-up Conclusion: rifaximin + mesalazine is more effective than rifaximin alone in symptom resolution and prevention of recurrence of diverticulitis. Ünlü, C., et al. Int J Colorectal Dis (2012) 27:1131–1136 Stollman N et al. Presented at: American College of Gastroenterology annual meeting; October 15-20, 2010; San Antonio, TX. Abstract.
Mesalamine DIVA Study (n=117) Evaluate safety and efficacy of Asacol® 2.4 g/d (400 mg mesalamine) in treating diverticulitis Primary endpoint: GSS at week #12 for diverticulitis symptoms Study arms • 1: placebo (mesalamine) days 1-14, then placebo (Align) + placebo (mesalamine) • 2: mesalamine days 1-14, then mesalamine + placebo (Align) • 3: mesalamine days 1-14, then mesalamine + Align Placebo % of responders *at week 12 *at week 52 % recurrent diverticulitis *at week 12 *at week 52
Mesalamine
Mesalamine + Align
41.4% (n=41) 50.0% (n=29)
62.5% (n=40) 66.7% (n=27)
48.1% (n=36) 29.2% (n=32)
20.0%(n=41) 31.0% (n=29)
12.5% (n=40) 28.1 % (n=32)
11.8%(n=36) 37.0% (n=27)
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Mesalamine PREVENT 1 Study (n=586) (Phase 3)
Rifaximin Papi, C., et al (1995) (conducted in Europe)
Randomized, prospective, double-blind study
Double-blind, placebo controlled (n=168)
Evaluate efficacy of mesalamine in reducing recurrence of diverticulitis
Evaluate efficacy of rifaximin in relieving symptoms in uncomplicated DD of the colon
Primary endpoint: % of subjects w/o recurrence of diverticulitis up to 104 wks after start of study
Arms evaluated q3 mo x 12 mo: • Fiber alone • Fiber + rifaximin 400 mg BID x7 d/mo
Arms • 1- 1.2 g/d; 2- 2.4 g/d; 3- 4.8 g/d; 4-placebo
Results: pending Stollman N et al. Presented at: American College of Gastroenterology annual meeting; October 15-20, 2010; San Antonio, TX. Abstract. Tursi, A World J Gastrointest Pharmacol Ther 2010 February 6; 1(1): 27-35
Results • 68.9% of patients in the rifaximin vs 39.5% in the placebo group were symptom-free or mildly symptomatic after 12 mo Papi C, et al. Aliment Pharmacol Ther. 1995 Feb;9(1):33-9.
Rifaximin Colecchia, A., et al (2007) (n=307) Evaluate long term (24 months) efficacy of rifaximin + fiber in reducing symptoms and/or complication frequency Conclusions: combination of cyclic rifaximin + fiber is more effective in reducing both symptom and complication frequency than fiber alone. • Long term administration of Rifaximin is safe and well tolerated
Probiotics Tursi, A., et al (2008) Prospective, dose-finding study (n=71) Assess 4 therapies with mesalazine ± probiotics in preventing recurrent diverticulitis Arms (probiotic = Lactobacillus casei DG 16 billion/d X10 d/mo) • M1: mesalazine 800 mg/d • M2: mesalazine 1.6 g X 10 d/mo • LM1: mesalazine 800 mg/d + probiotic • LM2: mesalazine 1.6 g + probiotic • L: probiotic
Conclusion: mesalazine ± L. casei maintain remission Tursi A., et al. 2008 May-Jun;55(84):916-20.
Colecchia, A., et al. World J Gastroenterol 2007 Jan 14;13(2):264-9.
Heczko, P.B,. Et al. J Phys and Pharmacology 2006. Vol 57, Suppl 9, 5.12.
Probiotics Available in the United States Brand Name
Contents
Align®
Bifidobacterium infantis
Culturelle®
Lactobacillus rhamnosus GG
DanActive®
Lactobacillus casei
Mutaflor®
Escherichia coli Nissle 1917
Florastor®
Saccharomyces boulardii
VSL#3®
Bifidobacterium breve, Bifidobacterium longum, Bifidobacterium infantis, Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus paracasei, Lactobacillus bulgaricus, Streptococcus thermophilus
Pharmacists’ Role: Counseling Points • High fiber diet • Physical activity • Limit alcohol and caffeine consumption • Smoking cessation
• NSAIDs • Opiates • Steroids
• Outpatient (PO) • *Fagyl • *Cipro • *Augmentin
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Questions (True or False) Your patients who are suffering from diverticulitis may experience symptom including, fever, constipation, and diarrhea The antibiotic option considered the most appropriate as outpatient therapy for patients with diverticulitis are Amoxicillin combined with Ciprofloxacin As a pharmacist, an appropriate recommendation for patients managing mild symptoms of diverticulitis include Metamucil, whole grains, and pain relief with Vicodin
Patient Case VS is a 62 y/o female with who comes to your pharmacy with a diagnosis of diverticulitis and a prescription for metronidazole and augmentin. She also explains that she is in constant pain. Q: What would be important counseling points for VS to help alleviate her symptoms, as well as any adverse effects she may experience?
Answer: Increase fiber in her diet Increase physical activity Tylenol for pain relief (avoid aspirin) If she experiences an upset stomach with antibiotics, she can take them with a small meal
References Clinicaltrials.gov. Accessed 12/13/2012 National Digestive Diseases Information Clearinghouse (NDDIC). Diverticulitis. Accessed 12/11/2012 Masoomi, H., et al. Trends in Diverticulitis Management in the United States From 2002 to 2007. Arch Surg. 2011;146(4):400-406. Stollman, N., et al. Diagnosis and Management of Diverticular Disease of the Colon in Adults. The Am J Gastroenterology 1999 Vol. 94, No. 11 Janes, S., et al. Management of diverticulitis. BMJ 2006; 332: 271–5 Stollman N et al. Presented at: American College of Gastroenterology annual meeting; October 1520, 2010; San Antonio, TX. Abstract. Ünlü, C., et al. Systematic review of medical therapy to prevent recurrent diverticulitis. Int J Colorectal Dis (2012) 27:1131–1136 Adachi, J., et al. Rifaximin: A Novel Nonabsorbed Rifamycin for Gastrointestinal Disorder. Clin Infec Dis Vol 42, Issue 4; pp 541-547 Papi C, et al. Efficacy of rifaximin in the treatment of symptomatic diverticular disease of the colon. A multicentre double-blind placebo-controlled trial. Aliment Pharmacol Ther. 1995 Feb;9(1):33-9. Colecchia, A., et al. Efficacy of long term cyclic administration of the poorly absorbed antibiotic Rifaximin in symptomatic, uncomplicated colonic diverticular disease. World J Gastroenterol 2007 Jan 14;13(2):264-9. Tursi A., et al. Mesalazine and/or Lactobacillus casei in maintaining long-term remission of symptomatic uncomplicated diverticular disease of the colon. Hepatogastroenterology. 2008 MayJun;55(84):916-20. Tursi, A. Diverticular disease: A therapeutic overview. World J Gastrointest Pharmacol Ther 2010 February 6; 1(1): 27-35 Heczko, P.B,. Et al. Critical evaluation of probiotic activity of lactic acid bacteria and their effects. J Phys and Pharmacology 2006. Vol 57, Suppl 9, 5.12. Strate, L., et al. Use of Aspirin or Nonsteroidal Anti-inflammatory Drugs Increases Risk for Diverticulitis and Diverticular Bleeding. Gastroenterology. 2011 May ; 140(5): 1427–1433.
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Objectives Ulcerative Colitis and Crohn’s Disease: Implications for Pharmacotherapy and the Role of the Pharmacist Jessica Saiz de la Mora, Pharm.D. PGY-1 Pharmacy Practice Resident
Define inflammatory bowel disease (IBD). Describe differences between ulcerative colitis (UC) and Crohn’s disease (CD). Identify risk factors and proposed etiologies of UC and CD. Explain complications associated with UC and CD. Apply therapy and design a treatment plan based on the varying stages of UC and CD. Identify specific considerations for treatment plans including efficacy, adverse events, and monitoring parameters. Address patient counseling points for those managing the symptoms and complications of UC and CD. Recognize the role of the pharmacist and potential interventions for providing optimal pharmaceutical care in the management of IBD.
Clinical Presentation
Etiology Etiology unknown
UC 40-50% left colon 20% pancolitis
Inflammation 2̊ to antigen-driven response
Major contributing factors defects in intestinal epithelial barrier and immune system
• “Backwash ileitis”
Genetic
CD
https://ufandshands.org/crohns-disease
80-90% small intestine Areas of normal mucosa 20-40% fistulae
Disease Classification: UC Mild < 4 stools daily No systemic ∆ Normal ESR
Moderate > 4 stools daily Minimal systemic ∆
Severe > 6 stools daily with blood Fever, tachycardia, anemia, or ESR > 30 mm/h
Fulminant > 10 stools daily Continuous bleeding, toxicity, abdominal tenderness Need for transfusion Colonic dilation
• 1̊ relatives
Environmental
Pro-inflammatory cytokines
20-40 x higher risk
• NSAIDs, luminal bacteria, dietary • Smoking worsens CD, may improve UC
• IL-1, IL-6, TNF-α
Disease Classification: CD Remission Spontaneously OR After medical intervention
Mild to Moderate Tolerate PO diet 5mg/kg contraindicated in heart failure class III/IV
Treatment of UC Treatment disease location and severity UC distribution Distal disease distal to splenic flexure Extensive disease proximal to splenic flexure
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UC – Mild to Moderate Distal Disease First line
topical aminosalicylates
Oral mesalamine + topical mesalamine Refractory patients
prednisone
Maintenance Proctitis mesalamine suppository Distal disease extending to splenic flexure mesalamine enema Oral sulfasalazine, mesalamine, balsalazide NO topical steroids Nicotine replacement 15-20 mg/day transdermally
UC – Severe Disease
UC – Mild to Moderate Active Extensive Disease First line Oral sulfasalazine Equivalent mesalamine dose
Infliximab
moderate active disease
Refractory patients
prednisone
Refractory to steroids
Aminosalicylates preferred No chronic steroids Azathioprine or 6-MP steroid-sparing agents Infliximab
Treatment of CD
Severe symptoms refractory to oral/topical aminosalicylates or steroids
Mouth to anus Treatment disease location and severity Induction and maintenance
7-10 day course of IV steroids
Infliximab Metronidazole (Flagyl®) Refractory to IV steroids
IV cyclosporine
4 mg/kg/day Followed by PO therapy at 8 mg/kg/day
Refractory patients Toxic megacolon
azathioprine or 6-MP
Maintenance
colectomy https://ufandshands.org/sites/default/files/graphics/images/en/19293.jpg
Bowel decompression, broad-spectrum antibiotics, and colectomy
CD – Mild to Moderate Active Disease First line for ileal, ileocolonic, or colonic disease Oral aminosalicylates • Mesalamine • Sulfasalazine
Budesonide EC
No response Metronidazole • 10-20 mg/kg/day PO
Ciprofloxacin • 1 g/day PO
CD – Moderate to Severe Disease Steroids until resolution of symptoms Infliximab Alternate first-line
Certolizumab Adalimumab If antibodies to infliximab
Natalizumab No response to other therapy
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CD – Severe Fulminant Disease Administer IV steroids After 5-7 days, may need parenteral nutrition IV cyclosporine or tacrolimus if steroids fail Surgery
CD – Maintenance Therapy No long-term corticosteroids Azathioprine/6-MP After induction with steroids or infliximab
Infliximab Adalimumab Certolizumab Natalizumab No response to other therapy
Methotrexate Chronic active disease
Golimumab (Simponi®)
Future Directions New indications Golimumab (Simponi®) Ustekinumab (Stelara®)
TNFα antagonist FDA approved for ankylosing spondylitis, psoriatic arthritis, and moderate-severe rheumatoid arthritis PURSUIT Study
Adhesion molecule blockers Vedolizumab Etrolizumab
Chemokine antagonists
Study design
Multicenter, double-blind, placebo-controlled
Population
Moderate to severe UC Failed treatment with 6-MP, azathioprine, steroids +/5-ASA or steroid dependent TNF-inhibitor naïve
Intervention
774 patients Placebo 200 and 100 mg at weeks 0 and 2 400 and 200 mg at weeks 0 and 2
Results
Clinical response at 6 weeks 55% in the high-dose group and 51.8% in the lowdose group vs. 29.7% of placebo (P 200 ng/mL AND TSAT > 20% Peritoneal (PD)/non- dialysis (ND): Target: ferritin > 100 ng/mL AND TSAT > 20% KDIGO Guidelines (2012) Ferritin < 500 ng/mL AND TSAT < 30 % Routine use of IV iron to maintain ferritin > 500 ng/mL and TSAT >30% is NOT recommended CKD-HD: Strong recommendation for IV route CKD-PD or ND: Insufficient evidence to recommend IV over oral 1) 2)
KDOQI .Am J Kidney Dis Vol 47, No 5, Suppl 3, 2006 KDIGO Clinical Practice Guideline for Anemia in Chronic Kidney Disease. Kidney inter., Suppl. 2012; 2: 279–335
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IDA in cancer patients NCCN guidelines1: Functional IDA (ferritin < 800 ng/mL & TSAT 15 years: Hgb, M: 12.0 g/dl or Hb increase > 2g/dl from baseline
Lexicomp. "Drug Information Handbook.” 21th edition. 2012. Foote EF. Nephrology. ACCP Updates in Therapeutics; 2012,503-533
Adjust dose based on Hgb response (25% intervals) If Hgb >1 g/dL/2-wk period: dose by ≥25% If Hgb does not by >1 g/dL after 4 wks: dose by 25% Monitor: Hgb (weekly until stable, then every 2-4 weeks), BP, iron stores (ferritin, TSAT) Potential risks: death, MI*, stroke, pure red cell aplasia, tumor progression or recurrence in certain cancers, thrombosis 1) 2)
Lexicomp. "Drug Information Handbook.” 21th edition. 2012. Foote EF. Nephrology. ACCP Updates in Therapeutics; 2012,503-533
*Myocardial Infaction
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Latest FDA recommendations
Clinical trials CHOIR1 (n=
Study
1432 )
TREAT
2 (n=4038)
Population Stage 3-4 CKD 1º: Composite death, MI, hospitalization for CHF & stroke
Stage 3-4 CKD w/ DM 2 1º: Composite outcomes of death or a CV event & of death or ESRD
ESA
Epoetin alfa
Darbepoetin alfa or placebo
Target Hgb
Low Hgb 11.3 g/dL (n= 717)
13.0 g/dL in darbe group (n=2012) Placebo group (darbepoetin as rescue if Hb 10 g/dL; reduce or d/c ESA AND individualize therapy based on goal
Note: ESA are now under FDA’s risk Evaluation and Mitigation Strategy program (REMS) Obtained from http://www.fda.gov/Drugs/DrugSafety/ucm259639.htm#table
ESA therapy-REMS ESA indications anemic cancer patients: Non-myeloid malignancies (anemia is due to chemotherapy) At least 2 additional months of planned chemotherapy Not indicated if: Current hormonal, biologic or radiation therapy (unless also on chemotherapy) Patient on chemo but expected outcome is cure Substitute for RBC transfusions ESA-APPRISE Program, available at https://www.esa-apprise.com/ESAAppriseUI/ESAAppriseUI/default.jsp
ESA APPRISE Oncology Program Goals: Support informed decisions Reduce risk associated with ESA therapy Requirements: Educate & Review Enroll (& renew every 3 years) Obtain informed consent • Provide Medication Guide and conduct risk/benefit discussion • Sign an acknowledgment form
Failure to comply will result in suspension of ESA access Visit www.esa-apprise.com or call 1-866-284-8089 Obtained from ESA-APPRISE Program, available at https://www.esa-apprise.com/ESAAppriseUI/ESAAppriseUI/default.jsp
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Patient Case JD is a 61 year-old, 89.7 kg, male with end-stage renal disease (ESRD) requiring chronic HD.
Patient Case Which of the following is the best approach to manage JD’s anemia?
PMH: Hypertension, ESRD, type 2 diabetes Medications: Epoetin (Procrit) 9,000 units subQ 3xweek, insulin glargine (Lantus) 10 units subQ HS, losartan (Cozaar) 25 mg PO daily, nephrocaps PO daily Labs: Hgb 10.3 g/dL, Na 139 mEq/L, K 4.5 mEq/L, Mg 2.1 mg/dL, Scr 6.2 mg/dL, calcium 9.5 mg/dL, ferritin 22 ng/mL, TSAT 11%., white blood cell count & mean corpuscular volume (within normal limits)
Increase dose of ESA Add oral iron C. Add IV iron D. Continue current regimen, patient is at goal A. B.
Causes of Vitamin B12 Deficiency Malabsorption syndromes Inadequate intake
Common causes
At risk population
Gastric abnormalities Pernicious anemia, gastritis, autoimmune atrophic gastritis
Inadequate utilization
Bowel disease Malabsorption syndrome, Crohn’s, ileal resection
Inherited transcobalamin II deficiency 1) Herrmann et al.Dtsch Arztebl int. 2008;105(40): 680-5 2) www.uptodate.com
Vitamin B12 Anemia Presentation Non-specific Mania & psychosis, fatigue, irritability, depression
Neurologic Bilateral parasthesia, ataxia, dementia-like symptoms
Hematologic Macroovalocytic anemia 1) Herrmann et al. Dtsch Arztebl int. 20082 105(40); 680-5. 2) www.uptodate.com
Laboratory findings Macrocytosis (MCV > 100 fl) + hypersegmented polymorphonuclear leukocytes B12 level < 200 pg/mL, iron, indirect bilirubin homocysteine levels (5-15 mcm/L) Decreased Hgb
Vegetarians, vegan Elderly Neurodegenerative and neuropsychiatric disorders Chronic alcoholics Medications (PPI*, H2b**, Metformin)
•*Proton pump inhibitors •**Histamine 2 receptor blockers
Treatment with Vitamin B12 Goals Reversal of hematologic manifestations, reinstate body stores, prevention or resolution of neurologic symptoms B12 formulations: IM, SubQ, Oral, SL, Nasal Response Reticulocytosis within 2–5 days Hct normalization within weeks Clinical controversy
IM v.s. Oral
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Pernicious anemia
Oral v.s. IM B12 for vitamin B12 anemia Study
Kuzminski et al. 1998; (n=38)
Bolaman et al. 2003; (n=70)
Design
Prospective, randomized, open label Prospective, randomized
Criteria
-Cobalamin level < 160 pg/ml - methylmalonic acid, total homocysteine or both (>3SD )
Intervention PO: 2 mg daily x 120 days B12 therapy IM:1mg on days 1,3,7,10,14,21,30,60 & 90 Outcomes
Andres et al. 2005 (n=10) Objective: Assess efficacy and tolerability of oral crystalline cyanocobalamin 1000 mcg/day in patients with pernicious anemia
-Cobalamin level < 160 pg/ml -Megaloblastic anemia -MCV > 94 fl PO: 1mg daily for 10 d, wkly x 4 wks, monthly indefinitely IM: Same as above
Methods: Patient >18 years with documented pernicious anemia received 1000 mcg PO daily for 3 months. Monitored:cobalamin, iron, folate, homocysteine and CBC
•B12 levels: Oral (643 + 328 pg/mL) • mean B12 levels in both groups at 90 days (P< 0.001) v.s IM (306 +118 pg/mL) at 2m (P0.05) +165 pg/mL) at 4m; P< 0.0005) •Sub-optimal homocysteine for •Reticulocytosis was observed in both groups both groups ( Hb, MCV, • in methylmalonic acid at 4 WBC, Platelets) months (P< 0.05) •Neurologic improvement in both 1) Kuzminski et al.Blood 1998; 92:4 (1191-1198) groups at 4 months 2) Bolaman Z et al.. Clinical Therapeutics 2003; 25:12 (3124-3134).
Results: 9/10 (90%) patients had increase cobalamin level( mean 117.4 (30.8) pg/ml, p 30 or > 25 with at least 1 co-morbidity factor Or, measurable body fat content of > 25% males > 30% females Prescriptions must be in writing and signed by the prescriber Faxed, phoned, or electronic prescriptions are not valid
Revised on May 27, 2010 to require that Medication Errors courses must be Board approved. As of, March 21, 2012- All Medication Errors courses must be Florida Board of Pharmacy approved. We can no longer use Medication Errors courses that are only ACPE approved to fulfill our CE requirement. Only valid if completed before March 21, 2012.
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64B16 28.1081 40 hour rule The prescription department manager may petition the Board in writing to operate the prescription department for less than forty (40) hours per week, but no less than twenty (20) hours per week. Prior to approving reduced hours, the Board may require the prescription department manager to appear before the Board to explain in detail the services that will be performed.
Any pharmacy open less than 40 hours shall have a policy and procedure that provides a mechanism for access to a pharmacist during the time the pharmacy is not open for the remainder of the forty hour week Any pharmacy that is not open 40 hours a week, must post the days and hours that the pharmacy is open and the information for afterhours access
Technician Training Programs (Requiring Approval) Technician Training Program (Deemed approved) ASHP Programs licensed or approved before 1/1/2011 SACS Programs licensed or approved before 1/1/2011 FDOE Programs licensed or approved before 1/1/2011 Programs issuing certificates of completion provided by federal armed services Programs accredited, approved or licensed by COE before 1/1/2011
Over 46K have registered-almost 6K Null/Void As of 12/31/12- More than 17K have not yet renewed their registration and are delinquentPDM is responsible to make sure that Techs are registered by the BOP- Delinquent fee is $25.00 As of 1-1-2011, the only option to register, is the successful completion of a Board approved program Student pharmacy technicians attending a training program are allowed to work in a pharmacy. Must wear identification as a student
Employer based Sponsored by a Florida permitted pharmacy or affiliated group of pharmacies under common ownership Minimum of 160 hours Training must not exceed 6 months Provided solely to employees Requires submission of application to the Florida Board of Pharmacy
Pharmacy Technician Responsibilities May assist pharmacists May initiate communication with prescribers office to confirm information on Rx May initiate communication with prescriber or their agent to clarify key information. May initiate or accept authorization for an existing Rx renewal Rule defines what technicians cannot do
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Rx is cheaper if you buy it in bulk Pharmacy Technician Responsibilities Must wear a clearly visible badge that identifies the employee by name and status as a “Registered Pharmacy Technician” Must state their name and verbally identify themselves as a registered pharmacy technician during phone calls and other forms of communications. Must complete 20 hours of CE before 12/31/2014 4 hrs live and 2 hrs Medication Errors, No HIV/AIDS
FEDERAL ISSUES - DEA ELECTRONIC SIGNATURES ON CONTROLLED SUBSTANCES PRESCRIPTIONS ARE THEY VALID? WHAT DOES THE DEA SAY ON THIS ISSUE
E-Prescribing systems must undergo review and be certified by a federally approved certification authority The pharmacy system must also be certified If prescriber states that their software is certified by the DEA, then ask for written proof As of this date, no software vendor has been approved by the DEA for controlled substances E-Prescribed prescriptions
Federal Issues- Medicare Part D Refill requests for controlled substances can not have pre-populated fields DEA says that we are acting as an agent of the prescriber if we send a request with the information pre filled for the prescribers signature Most computer programs have been updated to let the prescriber fill in the information They only send the name of the drug, quantity and last fill date
As of, May 1, 2012, pharmacist are required to dispense a written notice with a Medicare Part D coverage denial CMS Notice of Appeal Rights- Standardized Pharmacy Notice Form : Number CMS 10147 Available on the CMS web page under “MEDICARE” “CMS FORMS” “CMS FORMS LIST” Web site: www.cms.gov
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Federal Issues- FDA Risk Evaluation and Mitigation Strategies (REMS) Congress authorizes FDA to require manufacturers to develop and comply with REMS when FDA determines a program is needed to ensure the benefits of a drug continue to outweigh its risks REMS programs generally require various restricted distribution elements to prescribe and or dispense
Elements to assure safe use- ETASU Certification and specialized training of prescribers, pharmacies, pharmacists and other dispensors- Actiq and Fentora Restricted distribution of a drug to limited settings Patient monitoring and or patient registryIPledge program Dispensing to a patient based on evidence or other documentation of a safe use conditions, such as lab results- Clozaril Prescriber and or pharmacist registry
QUESTIONS?
Federal Issues- REMS includes: Medication Guide Patient package insert Communication plans for health care providers Implementation system Total REMS approved- #177 Med Guide only #123 More than a Med Guide #54 Of the 54, those with communication plans #37 Of the 54, those with ETASU #17
True or False Questions Prescriptions with electronic signatures are valid if given to the patient? A prescription order for a controlled substance can be written together with other medicinal drugs from a different schedule on the same blank? A prescription order for a controlled substance with an electronic signature is a valid prescription?
Florida Pharmacy Association 850-222-2400 Pharmview.com
123rd FPA Annual Meeting and Convention July 10 – 14, 2013
JW Marriott Grande Lakes Orlando, Florida
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