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Drug Therapy ADVISORY FDA Alert: Injections Associated with Fungal Meningitis (Sean Krohn, PharmD Candidate 2013, NEOMED and Paul Bandfield, PharmD, Formulary Management Services) Methylprednisolone and triamcinolone acetonide injections compounded by a Massachusetts pharmacy, New England Compounding Center (NECC), have gained attention in the national media o Kaiser Permanente is NOT affiliated with the NECC and does NOT purchase products from this pharmacy o Kaiser Permanente has a rigorous process for approving compounding vendors and only contract with a select number of compounding pharmacies The Centers for Disease Control and Prevention (CDC) is working with the New England Compounding Center to contact patients who were potentially infected Federal health authorities said that prior to the recall, hundreds of vials were distributed to many medical facilities across the United States between May-September The steroid injections are injected into the lower back and travel to the brain via the cerebrospinal fluid Symptoms may not appear until 2-4 weeks after exposure and include fever, headache, neck pain, nausea, vomiting, confusion, and stroke-like symptoms If caught early, the disease can be treated with antifungal therapy Those infected are mainly the elderly with weakened immune systems, patients receiving chemotherapy, patients with asthma or cystic fibrosis or transplant patients Fungal meningitis is NOT contagious All products compounded at and distributed by the New England Compounding Center have been recalled More information can be found at: http://www.cdc.gov/hai/outbreaks/meningitis.html and http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAler tsforHumanMedicalProducts/ucm322849.htm Updates to the Beers Criteria (H. Paige Stewart, PharmD, Pharmacy Practice Resident) The Beers Criteria for Potentially Inappropriate Medication Use in Older Adults has been revised from the edition published in 2003 o The 2012 revision was released in August o The authors intend to update the list every 3 years “Older Adults” are defined as people age 65 or older The revision of the criteria consisted of: o Medication removal due to elimination from the market, lack of evidence, or evidence indicating the warning is not unique to the elderly population o Medication addition as a result of new drug approvals and increased evidence published o Additions and removals for drug-disease state interactions o Additional table column indicating strength of evidence supporting recommendation Issue 10 October 2012 Network Edition o Added “Use with caution” category Medications of note added to the criteria list: o All short-acting benzodiazepines regardless of dose Increases risk for cognitive impairment, delirium, falls, fractures, and motor vehicle accidents Avoid for treatment of insomnia, agitation, or delirium o Nonbenzodiazepine hypnotics (e.g. zolpidem, zaleplon) Increases risk for cognitive impairment, delirium, falls, fractures, and motor vehicle accidents o Sliding scale insulin Increased risk of hypoglycemia without improving hyperglycemia o Long acting sulfonylureas — chlorpropamide and glyburide Chlorpropamide — extended half-life in older adults; may potentiate hypoglycemia and causes syndrome of inappropriate antidiuretic hormone (SIADH) Glyburide — increased risk of hypoglycemia in older adults o Metoclopramide Increases risk of extrapyramidal side effects including tardive dyskinesia; risk further increased in frail older adults Avoid unless for gastroparesis Noted additions to drug-disease interactions o Rosiglitazone and pioglitazone with heart failure o Serotonin reuptake inhibitors in history of falls or fractures o Antipsychotics for behavioral problems of dementia o Anticholinergics to treat extrapyramidal side effects of antipsychotics or to treat Parkinson’s disease (benztropine and trihexyphenidyl) For complete list of The Beers Criteria with revisions, visit: http://americangeriatrics.org/health_care_professionals/clinical _practice/clinical_guidelines_recommendations/ Pantoprazole Added to Commercial Formulary (Alex Luli, PharmD Candidate 2013, NEOMED and Paul Bandfield, PharmD, Formulary Management Services) Pantoprazole 20mg and 40mg delayed-release tablets will be added to Commercial formulary, effective November 6, 2012 Studies have shown that pantoprazole 40mg is equally effective as omeprazole 20mg for various indications Pantoprazole inhibits CYP2C19 the least of all the Proton Pump Inhibitors (PPIs) o Omeprazole is the most potent inhibitor of CYP2C19 of all the PPIs o The concomitant use of clopidogrel and omeprazole may result in the diminished effect of clopidogrel o Pantoprazole is preferred over omeprazole in patient’s taking other drugs that are metabolized via CYP2C19 (clopidogrel and citalopram) who require PPI therapy o At approved doses, pantoprazole does not significantly alter active clopidogrel levels and no dosage adjustment is necessary per the pantoprazole prescribing information (Continued on reverse side) Issue 10 — Network Edition (Continued from reverse side) Avoid NSAIDS in Patients with Chronic Kidney Disease (Carina Haught, PharmD Candidate 2013, Ohio Northern University and Paul Bandfield, PharmD, Formulary Management Services) Chronic kidney disease (CKD) is defined as the irreversible loss of renal function as a result of reduced glomerular filtration rate (GFR) and metabolic waste buildup in the blood CKD is classified in 5 stages o Stage 1: GFR of > 90 o Stage 2: Mild; GFR of 60 to 89 o Stage 3: Moderate; GFR of 30 to 59 o Stage 4: Severe; GFR of 15 to 29 o Stage 5: Kidney failure; GFR <15 Non-steroidal anti-inflammatory drugs (NSAIDs) generally should be avoided in patients with CKD o Especially avoid in patients with Stage 3, 4 or 5 CKD o Except low dose aspirin for cardiovascular indications NSAIDs inhibit prostaglandin synthesis causing additional reduction in renal blood flow o Can also cause sodium retention, edema, HTN and hyperkalemia NSAIDs can also reduce the effectiveness of ACE inhibitors, angiotensin receptor blockers and loop diuretics Patients may not be aware that over-the-counter (OTC) NSAIDs can also exacerbate kidney damage Researchers for the CDC found that 5% of people with moderate to severe kidney disease used OTC NSAIDs regularly o 11% of patients with moderate to severe kidney disease had prescriptions for NSAIDs Alternatives to NSAIDs o Acetaminophen (Tylenol) o Opioids o Low dose prednisone Other FDA Alerts Hospira Lactated Ringer's And 5% Dextrose Injection, 1000 Ml, Flexible Containers: Recall - Mold Contamination http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAler tsforHumanMedicalProducts/ucm322966.htm Initiatives Inter-Regional Clinical Pharmacy Services Subcommittee (ICPSS) Initiatives OxyContin use discouraged over other long-acting opioids Generic statin agents preferred over brand statin agents (i.e., Atorvastatin preferred over Vytorin and Crestor) Regular Insulin preferred over Analog/Combo Insulin agents Generic atypical antipsychotic agents preferred over brand Boceprevir (Victrelis) preferred over Telaprevir (Incivek) Skeletal muscle relaxant use discouraged in elderly Hydroxyzine use discouraged in elderly Pharmacy Conversion Team Projects Half-Tab Initiatives Bupropion immediate release to Bupropion extended release October 2012 Current Half-Tab Initiatives Abilify Crestor Levitra Nuvigil Viagra Aricept Imitrex Lexapro* Paxil Zocor Celexa Lamictal Lipitor Provigil* Zoloft *Both brand and generic tablet products are half-tab initiatives Formulary Changes The Ohio Regional Pharmacy & Therapeutics Committee approved the following formulary changes. The KP Ohio Region Drug Formulary is available by accessing the Lexicomp Online Formulary: The KP Ohio Region Drug Formulary is available by accessing the Lexicomp Online Formulary through the Internet (http://online.lexi.com/login) using login and password: ohkprx Formulary changes are updated in Lexicomp on their respective effective dates Commercial Additions Drug Pantoprazole (generic Protonix) 20mg, 40mg Cap Raltegravir (Isentress) 25mg, 100mg Chw Tab Effective Date 11.6.12 10.2.12 Commercial Deletions Drug Triamcinolone Acetonide (Kenalog) Aerosol Spray Effective Date 11.6.12 Medicare Part D Additions Drug Aclidinium Bromide (Tudorza Pressair) 400mcg/actuation Inh Amylase/Lipase/Protease [Pancrelipase] (Viokace) 39,150U, 78,300U Tab Bosutinib (Bosulif) 100mg, 500mg Tab Enzalutamide (Xtandi) 40mg Cap Mirabegron (Myrbetriq) 25mg, 50mg ER Tab Prednisone (Rayos) 1mg, 2mg, 5mg Delayed Release Tab Raltegravir (Isentress) 25mg, 100mg Chw Tab Rotigotine (Neupro) 1mg/24hr, 2mg/24hr, 3mg/24hr, 4mg/24hr, 6mg/24hr, 8mg/24hr Transdermal Patch Sumatriptan (Sumavel Dosepro) 12 mg/mL Prefilled Syr Teriflunomide (Aubagio) 7mg, 14mg Tab Effective DateNew Tier 10.2.12 - Tier 4 10.2.12 - Tier 4 10.2.12 - Tier 5 10.2.12 - Tier 5 10.2.12 - Tier 4 10.2.12 - Tier 4 10.2.12 - Tier 5 10.2.12 - Tier 4 10.2.12 - Tier 4 10.2.12 - Tier 5 Criteria Updates Aprepitant (Emend) Budesonide Enteric Coated Capsule (Entocort EC) Itraconazole (Sporanox) and Ciclopirox Olamine (Penlac) Milnacipran (Savella) Oral Proton Pump Inhibitors Serotonin 5HT-3 Receptor Antagonists Triptans Varenicline (Chantix) Revised 10.12 Revised 10.12 Revised 10.12 Revised 10.12 Revised 10.12 Revised 10.12 Revised 10.12 Revised 10.12 Inquiries Ohio Regional Formulary Management/Drug Information Service (8:30 a.m. — 5:00 p.m. Mon — Fri, excluding holidays) E-mail: [email protected] Pager for urgent inquiry: (216) 568-3133 References are available upon request