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Pharmacy Newsletter SEPTEMBER 2016 Q4 2016 Gold Coast Health Plan | Pharmacy Newsletter | September 2016 Q4 2016 2 Table of Contents SECTION 1: CMO Message .........................................................................................................................3 SECTION 2: Disease State Topic: Asthma ....................................................................................................4 SECTION 3: Formulary Changes.................................................................................................................7 SECTION 4. FDA Alerts: New FDA Drug Approvals, Drug Safety Labeling Changes, Drug Shortages, FDA Safety Alerts ..........................................................................................8 © 2016 Gold Coast Health Plan PN Q4 2016 The Pharmacy Newsletter is published quarterly for the provider community of Gold Coast Health Plan by the Communications Department. Information in the Pharmacy Newsletter comes from a wide range of medical experts. If you have any questions regarding its content, please contact GCHP’s Pharmacy Director Anne Freese, at [email protected] or 1-805-437-5652. Pharmacy Director: Anne Freese, Pharm. D. Chief Medical Officer: C. Albert Reeves, MD Editor-in-Chief: Steven Lalich Copy Editor: Susana Enriquez Pharmacy Relations | 888.531.0998 www.goldcoasthealthplan.org Gold Coast Health Plan | Pharmacy Newsletter | September 2016 Q4 2016 3 CMO Message Asthma is a significant chronic illness. At Gold Coast Health Plan (GCHP), approximately 12,000 members – mostly children – have been diagnosed with asthma. In addition to the preventive measures that a patient and his/her family can take, medication management is the primary means of treating this disease. For GCHP, anti-asthmatic medications are sixth among the prescriptions filled in all therapeutic classes. This is good, but we could do better. The results of our 2015 Healthcare Effectiveness Data and Information Set (HEDIS®), showed that just 32.12 percent of GCHP’s members were 75 percent compliant with the use of an asthma controller and 52.7 percent were 50 percent compliant. GCHP will soon be launching a new disease management program for asthma. We will be reaching out to members who have been diagnosed with asthma to offer them information on managing their asthma and to set them up to work one-onone with a nurse coach. The Plan’s highest utilizers will be offered an opportunity to participate in GCHP’s pilot program with Ventura County Public Health in which a nurse will do a home visit to help remove asthma triggers and review the asthma treatment plan with the members and their families. C. Albert Reeves, MD I encourage all of the Plan’s providers to implement asthma treatment plans for their patients who have asthma and to make sure that those who need a controller medication have it and use it consistently. As always, if you have any questions, please feel free to contact me or GCHP’s pharmacy director, Anne Freese. Regards, C. Albert Reeves, MD BACK TO THE TABLE OF CONTENTS Pharmacy Relations | 888.531.0998 www.goldcoasthealthplan.org Gold Coast Health Plan | Pharmacy Newsletter | September 2016 Q4 2016 4 Disease State Topic: Asthma The following is a summary of the guidelines for the treatment of asthma. The information has been developed from the Expert Panel Report 3 (EPR3): Guidelines for the Diagnosis and Management of Asthma as published by the National Heart, Lung, and Blood Institute. Click here to access the full report. The goals of therapy of asthma care are to reduce impairment and to reduce risk. Impairment is assessed by the presence of chronic and troublesome symptoms, use of short-acting beta agonists, pulmonary function, ability to maintain normal activity levels and the expectations/satisfaction of care. Risks include recurrent exacerbations, emergency department visits, hospitalizations, loss of lung function and potential adverse events of pharmacotherapy. There are four components of asthma care: 1. Assessing and monitoring asthma severity and control, 2. Education, 3. Control of environmental factors and comorbid conditions, and 4. Medications. This article focuses on medications and the availability of those medications on GCHP’s List of Covered Drugs. The Asthma Care Quick Reference: Diagnosing and Managing Asthma is a streamlined easy-to-use summary of the current recommendations from the EPR3. Click here to access the document. The table on page 5 is an excerpt from the reference that addresses the stepwise approach for managing asthma long term. BACK TO THE TABLE OF CONTENTS Pharmacy Relations | 888.531.0998 www.goldcoasthealthplan.org Gold Coast Health Plan | Pharmacy Newsletter | September 2016 Q4 2016 The drug classes noted in the table above are listed on page 6 with the specific agents that are available on GCHP’s List of Covered Drugs with any restrictions noted. Any agents not listed in the table will require an approved prior authorization in order to be covered and generally will require trial and failure of all agents listed on page 6. BACK TO THE TABLE OF CONTENTS Pharmacy Relations | 888.531.0998 www.goldcoasthealthplan.org 5 Gold Coast Health Plan | Pharmacy Newsletter | September 2016 Q4 2016 6 Note: Brand drugs are listed in all capital letters and generics are listed in lower case letters and italicized. Additions CLASS/MOA SHORT ACTING BETA AGONISTS INHALED CORTICOSTEROIDS COVERED AGENT RESTRICTIONS XOPENEX/XOPENEX HFA Requires prior trial and failure of albuterol. VENTOLIN HFA FLOVENT HFA ASMANEX PULMICORT FLEXHALER budesonide (solution for nebulizer) QVAR Limited to two inhalers per 31 days. Limited to two inhalers per 31 days for the 44 mcg product, and one inhaler per 31 days for the 110 mcg and the 220 mcg products. Requires prior trial and failure of Flovent. Limited to one inhaler per 31 days. Requires prior trial and failure of Flovent HFA or Pulmicort HFA. ARNUITY ELLIPTA LEUKOTRIENE RECEPTOR MODIFIER LONG ACTING BETA AGONIST AEROSPAN montelukast zafirlukast Requires a prior authorization stating that long term controller medications (inhaler corticosteroids and long-acting beta agonists) have been tried and failed. FORADIL Limited to one pack per 31 days. BROVANA Requires prior trial and failure of Foradil. SEREVENT COMBINATION PRODUCTS OTHER AGENTS Requires prior trial and failure of Foradil. PERFOROMIST ADVAIR HFA/ADVAIR Diskus Limited to one pack or one inhaler per 31 days BREO ELLIPTA Requires prior trial and failure of Symbicort or Advair. SYMBICORT AEROCHAMBER Limited to one inhaler per 31 days Limited to one per year. theophylline XOLAIR Requires a prior authorization stating the diagnosis, lab values of IgE, and prior trial and failure of an inhaled corticosteroid and a long-acting beta agonist. Quick Links CLICK EACH TOPIC FOR MORE INFORMATION GCHP Formulary BACK TO THE TABLE OF CONTENTS List of Participating Pharmacies Pharmacy Relations | 888.531.0998 Provider Resources www.goldcoasthealthplan.org Gold Coast Health Plan | Pharmacy Newsletter | September 2016 Q4 2016 7 Formulary Changes The following changes to the GCHP formulary will be effective October 1: Additions Drug Formulary Status/Change BRIVIACT (brivaracetam) Add with a PA with step therapy of Keppra. VENCLEXTA (venetoclax) Add with PA. CABOMETYX (cabozantinib s-malate) 20 mg, 40 mg, 60 mg tablet EPCLUSA (sofosbuvir; velpatasvir) clomipramine capsules Metformin, modified ER duloxetine capsules Add with a PA. Add with a PA to meet the DHCS Clinical Policy. Add with PA for documentation of failure of at least two other TCAs. Add with PA for documentation. Removed step therapy. Removals Drug Formulary Status/Change EDECRIN (ethacrynic acid) 25 mg tablets Brand removed; generic now available. CRESTOR (rosuvastatin) all strengths SPRYCEL (dasatinib) all strengths BANZEL (rufinamide) 200 mg, 400 mg VIMPAT (lacosamide) all strengths FLUMIST BACK TO THE TABLE OF CONTENTS Brand removed; generic now available. Brand removed; generic now available. Brand removed; generic now available. Brand removed; generic now available. No longer a Medi-Cal covered benefit; the CDC does not recommend its use during the 2016-2017 influenza season. Pharmacy Relations | 888.531.0998 www.goldcoasthealthplan.org Gold Coast Health Plan | Pharmacy Newsletter | September 2016 Q4 2016 8 FDA Alerts FDA New Drug Approvals This is a list of new drugs approved by the FDA. This is only a subset of all drugs that were approved and include all first-time approvals and any other significant drug approvals. Click here to access the FDA’s website. Brand Name Generic Name Dosage Form Summary of Indication and Mechanism of Action BYVALSON nebivolol hydrochloride; valsartan Tablet; Oral LANSOPRAZOLE lansoprazole GONITRO nitroglycerine POWDER; IV (INFUSION) BYVALSON is a beta adrenergic blocker and an angiotensin II receptor blocker (ARB) indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. RAYALDEE calcifediol NETSPOT gallium ga 68 dotatate Kit INJECTABLE; INJECTION INJECTABLE; INJECTION EPCLUSA sofosbuvir; velpatasvir SOLUTION; IV (INFUSION) KOVANAZE oxymetazoline hydrochloride; tetracaine hydrochloride TABLET; ORAL BACK TO THE TABLE OF CONTENTS NETSPOT, after radiolabeling with Ga 68, is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. GONITRO is a nitrate vasodilator indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease. RAYALDEE is a vitamin D3 analog indicated for the treatment of secondary hyperparathyroidism in adults with stage 3 or 4 chronic kidney disease and serum total 25-hydroxyvitamin D levels less than 30 ng/mL. Limitations of use: RAYALDEE is not indicated in patients with stage 5 chronic kidney disease or endstage renal disease on dialysis. EPCLUSA is a fixed-dose combination of sofosbuvir, a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor, and velpatasvir, an HCV NS5A inhibitor, and is indicated for the treatment of adult patients with chronic HCV genotype 1, 2, 3, 4, 5 or 6 infection: • Without cirrhosis or with compensated cirrhosis. • With decompensated cirrhosis for use in combination with ribavirin. KOVANAZE contains tetracaine HCl, an ester local anesthetic, and oxymetazoline HCl, a vasoconstrictor. KOVANAZE is indicated for regional anesthesia when performing a restorative procedure on teeth 4-13 and A-J in adults and children who weigh 40 kg or more. Pharmacy Relations | 888.531.0998 www.goldcoasthealthplan.org Gold Coast Health Plan | Pharmacy Newsletter | September 2016 Q4 2016 9 Brand Name Generic Name Dosage Form Summary of Indication and Mechanism of Action XIIDRA lifitegrast SOLUTION/ DROPS; OPHTHALMIC SMOFLIPID 20% fish oil; medium chain triglycerides; olive oil; soybean oil Xiidra (lifitegrast ophthalmic solution) 5% is a lymphocyte function-associated antigen-1 (LFA-1) antagonist indicated for the treatment of the signs and symptoms of dry eye disease (DED). SYNDROS dronabinol SOLUTION; ORAL SYNDROS is a cannabinoid indicated in adults for the treatment of: • Anorexia associated with weight loss in patients with AIDS; and • Nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. EMULSION; INTRAVENOUS PHOTREXA riboflavin 5'phosphate sodium SOLUTION/ DROPS; OPHTHALMIC PHOTREXA VISCOUS IN DEXTRAN 20% riboflavin 5’phosphate sodium SOLUTION/ DROPS; OPHTHALMIC BACK TO THE TABLE OF CONTENTS Smoflipid is indicated in adults as a source of calories and essential fatty acids for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. Limitations of use: The omega-6: omega-3 fatty acid ratio and Medium Chain Triglycerides in Smoflipid have not been shown to improve clinical outcomes compared to other intravenous lipid emulsions. PHOTREXA VISCOUS and PHOTREXA are photoenhancers indicated for use with the KXL System in corneal collagen cross-linking for the treatment of progressive keratoconus and corneal ectasia following refractive surgery. PHOTREXA VISCOUS and PHOTREXA are photoenhancers indicated for use with the KXL System in corneal collagen cross-linking for the treatment of progressive keratoconus and corneal ectasia following refractive surgery. Pharmacy Relations | 888.531.0998 www.goldcoasthealthplan.org Gold Coast Health Plan | Pharmacy Newsletter | September 2016 Brand Name BELVIQ XR RELISTOR Generic Name lorcaserin hydrochloride methylnaltrexone bromide Dosage Form TABLET, EXTENDED RELEASE; ORAL TABLET; ORAL Q4 2016 10 Summary of Indication and Mechanism of Action BELVIQ XR is a serotonin 2C receptor agonist indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of: • 30 kg/m2 or greater (obese) or • 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes) Limitations of use: • The safety and efficacy of co-administration with other products for weight loss have not been established. • The effect of BELVIQ XR on cardiovascular morbidity and mortality has not been established. RELISTOR is an opioid antagonist. RELISTOR tablets and RELISTOR injection are indicated for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain. RELISTOR injection is indicated for the treatment of OIC in adults with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient. VIEKIRA XR dasabuvir sodium; ombitasvir; paritaprevir; ritonavir BACK TO THE TABLE OF CONTENTS TABLET, EXTENDED RELEASE; ORAL Limitations of use: Use beyond four months has not been studied in the advanced illness population. VIEKIRA XR includes dasabuvir, a hepatitis C virus non-nucleoside NS5B palm polymerase inhibitor, ombitasvir, a hepatitis C virus NS5A inhibitor, paritaprevir, a hepatitis C virus NS3/4A protease inhibitor, and ritonavir, a CYP3A inhibitor and is indicated for the treatment of adult patients with chronic hepatitis C virus (HCV): • Genotype 1b infection without cirrhosis or with compensated cirrhosis. • Genotype 1a infection without cirrhosis or with compensated cirrhosis for use in combination with ribavirin. Pharmacy Relations | 888.531.0998 www.goldcoasthealthplan.org Gold Coast Health Plan | Pharmacy Newsletter | September 2016 Brand Name ADLYXIN Generic Name lixisenatide QBRELIS lisinopril SUSTOL granisetron TROXYCA ER pimavanserin tartrate Dosage Form SOLUTION; SUBCUTANEOUS Q4 2016 11 Summary of Indication and Mechanism of Action ADLYXIN is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of use: • Has not been studied in patients with chronic pancreatitis or a history of unexplained pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis. • Not for treatment of type 1 diabetes or diabetic ketoacidosis. • Has not been studied in combination with short acting insulin. • Has not been studied in patients with gastroparesis and is not recommended in patients with gastroparesis. SOLUTION; ORAL QBRELIS is an angiotensin converting enzyme (ACE) inhibitor indicated for: • Treatment of hypertension in adults and pediatric patients 6 years of age and older. • Adjunct therapy for heart failure. • Treatment of Acute Myocardial Infarction. INJECTABLE; INJECTION, EXTENDED RELEASE oxycodone hydrochloride; naltrexone hydrochloride SUSTOL is a serotonin-3 (5-HT3) receptor antagonist indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens. TROXYCA ER is a combination opioid agonist/opioid antagonist product indicated for the management of pain severe enough to require daily, around-theclock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of use: • Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve TROXYCA ER for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. • TROXYCA ER is not indicated as an as-needed (prn) analgesic. BACK TO THE TABLE OF CONTENTS Pharmacy Relations | 888.531.0998 www.goldcoasthealthplan.org Gold Coast Health Plan | Pharmacy Newsletter | September 2016 Q4 2016 12 Brand Name Generic Name Dosage Form Summary of Indication and Mechanism of Action ERELZI etanercept-szzs INJECTABLE; INJECTION ERELZI is a tumor necrosis factor (TNF) blocker indicated for the treatment of: • Rheumatoid Arthritis (RA). • Polyarticular Juvenile Idiopathic Arthritis (JIA) in patients ages 2 or older • Psoriatic Arthritis (PsA). • Ankylosing Spondylitis (AS). • Plaque Psoriasis (PsO). PALONOSETRON HYDROCHLORIDE palonosetron hydrochloride INJECTABLE; INJECTION Palonosetron Hydrochloride (HCl) Injection is a serotonin-3 (5-HT3) receptor antagonist indicated in adults for: • Moderately emetogenic cancer chemotherapy – prevention of acute and delayed nausea and vomiting associated with initial and repeat courses. • Highly emetogenic cancer chemotherapy – prevention of acute nausea and vomiting associated with initial and repeat courses. FDA Safety Labeling Changes This section includes all new safety labeling changes or updated boxed warnings or contraindications. Click here to access this information on the FDA’s website. Drug Elitek (rasburicase) Type of Change Boxed Warning BACK TO THE TABLE OF CONTENTS Change Change first section of Anaphylaxis to read: • Hypersensitivity Reactions: Elitek can cause serious and fatal hypersensitivity reactions including anaphylaxis. Immediately and permanently discontinue Elitek if a serious hypersensitivity reaction occurs. Pharmacy Relations | 888.531.0998 www.goldcoasthealthplan.org Gold Coast Health Plan | Pharmacy Newsletter | September 2016 Drug Sabril (vigabatrin) Tablets and Oral solution Xigduo XR (dapagliflozin and metformin HCl extended-release) Type of Change Boxed Warning Boxed Warning, Contraindications Q4 2016 13 Change Additional and updated bullets: • SABRIL can cause permanent bilateral concentric visual field constriction, including tunnel vision that can result in disability. In some cases, SABRIL also can damage the central retina and may decrease visual acuity. • Vision assessment is recommended at baseline (no later than four weeks after starting SABRIL), at least every three months during therapy, and about 3 to 6 months after the discontinuation of therapy. • Consider drug discontinuation, balancing benefit and risk, if vision loss is documented. • Risk of new or worsening vision loss continues as long as SABRIL is used. It is possible that vision loss can worsen despite discontinuation of SABRIL. • SABRIL should not be used in patients with, or at high risk of, other types of irreversible vision loss unless the benefits of treatment clearly outweigh the risks. • Use the lowest dosage and shortest exposure to SABRIL consistent with clinical objectives. Updated: Because of the risk of permanent vision loss, SABRIL is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the SABRIL REMS Program. WARNING: LACTIC ACIDOSIS • Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin-associated lactic acidosis was characterized by elevated blood lactate levels (>5 mmol/ Liter), anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate/pyruvate ratio; and metformin plasma levels generally >5 mcg/mL. • Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (e.g., cationic drugs such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (e.g., acute congestive heart failure), excessive alcohol intake, and hepatic impairment. • Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high risk groups are provided in the full prescribing information. • If metformin-associated lactic acidosis is suspected, immediately discontinue XIGDUO XR and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended. XIGDUO XR is contraindicated in patients with: • Moderate to severe renal impairment (eGFR below 60 mL/ min/1.73 m2), end stage renal disease or patients on dialysis. BACK TO THE TABLE OF CONTENTS Pharmacy Relations | 888.531.0998 www.goldcoasthealthplan.org Gold Coast Health Plan | Pharmacy Newsletter | September 2016 Q4 2016 Drug Type of Change Change Farxiga (dapagliflozin) tablets, 5 mg and 10 mg Contraindications Update phrase end-stage renal disease (ESRD) to (eGFR less than 30 mL/min/1.73 m2) end-stage renal disease (ESRD) Teriflunomide (Aubagio) Contraindications Hectorol (doxercalciferol) Contraindications Technivie (ombitasvir, paritaprevir, and ritonavir) Tablets Contraindications Tybost (cobicistat) Tablet Contraindications Nitromist (nitroglycerin) Contraindications 14 Addition: Patients with a history of a hypersensitivity reaction to teriflunomide, leflunomide, or to any of the inactive ingredients in AUBAGIO. Reactions have included anaphylaxis, angioedema, and serious skin reactions. Addition: Hectorol Injection is contraindicated in patients with previous hypersensitivity to doxercalciferol or any of its ingredients. PDE5 Inhibitor Use • Addition to the end of the paragraph: Do not use NitroMist in patients who are taking the soluble guanylate cyclase (sGC) stimulator riociguat. Concomitant use can cause hypotension. Table 2 (Drugs that are contraindicated with TECHNIVIE) Four drug classes added; please refer to label: • Anti-anginal (Ranolazine) • Antiarrhythmic(Dronedarone) • Antipsychotic (Lurasidone, and Pimozide) • GI Motility Agent (Cisapride) Table 2 Drugs that are contraindicated with concomitant use with Tybost and Atazanaivr or Darunavir Three drug classes added; please refer to label: • Antianginal (ranolazine) • Anti-gout (colcichine) • Antipsychotics (lurasidone and pimozide) Drug Shortages This section documents drug shortages that were updated in the past 30 days that affect the prescription benefit for GCHP. Click here to access this information on the ASHP Resource Center’s website. Drug Product Acetylcysteine Oral and Inhalation Solution Affected Manufacturers American Regent, Fresenius Kabi Summary American Regent has a consistent supply of acetylcysteine oral and inhalation solution. Fresenius Kabi states the reason for the shortage is increased demand. American Regent has acetylcysteine solution 100 mg/mL 10 mL vials on back order and the company cannot estimate a release date. Fresenius Kabi has acetylcysteine solution 100 mg/ mL 10 mL vials on back order and the company estimates a release date in mid-April 2016. BACK TO THE TABLE OF CONTENTS Pharmacy Relations | 888.531.0998 www.goldcoasthealthplan.org Gold Coast Health Plan | Pharmacy Newsletter | September 2016 Drug Product Affected Manufacturers Atropine Sulfate Ophthalmic Alcon Labs, Akorn, Sandoz Solution Q4 2016 15 Summary Alcon has discontinued Isopto Atropine. Akorn received FDA approval for atropine sulfate 1% ophthalmic solution in July 2014; this new product launched in January 2015. Sandoz could not provide a reason for the shortage. Cefpodoxime Aurobindo, Sandoz Akorn has atropine sulfate ophthalmic solution in 2 mL, 5 mL, and 15 mL bottles available in limited supply through April 2016. Aurobindo and Sandoz could not provide a reason for the shortage. Aurobindo has cefpodoxime oral suspension 50 mg/5 mL 50 mL bottles and 100 mg/5 mL 50 mL and 100 mL bottles on back order and the company cannot estimate a release date. Ciprofloxacin Oral Suspension Lupin Cyclopentolate Hydrochloride and Phenylephrine Hydrochloride Ophthalmic Solution Alcon Labs Dibucaine Ointment Fougera, Perrigo Sandoz has cefpodoxime 50 mg/5 mL oral suspension in 50 mL and 100 mL bottles on back order and the company cannot estimate a release date. Lupin did not provide a reason for the shortage. Lupin has ciprofloxacin oral suspension on longterm back order and the company cannot estimate a release date. Alcon has Cyclomydril ophthalmic solution on back order due to production delays. Alcon has Cyclomydril ophthalmic solution in 5 mL sizes on back order and the company estimates a release date in early-April 2016 for the 5 mL bottles. Perrigo and Fougera cannot provide a reason for the shortage. Perrigo has temporarily discontinued dibucaine ointment and the company cannot estimate a resupply date. Fougera has dibucaine ointment on long-term back order and the company cannot estimate a release date. BACK TO THE TABLE OF CONTENTS Pharmacy Relations | 888.531.0998 www.goldcoasthealthplan.org Gold Coast Health Plan | Pharmacy Newsletter | September 2016 Drug Product Diphtheria, Tetanus Toxoid, and Acellular Pertussis and Inactivated Poliovirus and Haemophilus B Conjugate Vaccine (DTaP - IPV/Hib) Diphtheria, Tetanus Toxoid, and Acellular Pertussis Vaccine (DTaP) Affected Manufacturers Sanofi Pasteur Q4 2016 16 Summary Sanofi Pasteur states the reason for the shortage is a manufacturing delay. Insufficient supplies for usual ordering. Sanofi Pasteur, GlaxoSmithKline Sanofi Pasteur has Pentacel vaccine on allocation. Sanofi Pasteur has Daptacel in short supply due to the shortage of other combination vaccines (e.g., Pentacel). GlaxoSmithKline has Infanrix available. Flurandrenolide Tape Sanofi Pasteur has Daptacel vaccine on allocation. Allergan Allergan states the shortage is due to manufacturing delays. Allergan is the sole supplier of flurandrenolide tape. Haemophilus B Conjugate Vaccine Sanofi Pasteur, GlaxoSmithKline, Merck Allergan has Cordran tape on back order and the company estimates a release date of late-September. GlaxoSmithKline relaunched Hiberix in August. Sanofi Pasteur has ActHIB in short supply due to the shortage of other combination vaccines (e.g., Pentacel). Merck has PedvaxHIB (Haemophilus b meningococcal protein conjugate vaccine) available. Hydroxyamphetamine Hydrobromide and Tropicamide Ophthalmic Solution BACK TO THE TABLE OF CONTENTS Akorn Sanofi Pasteur has ActHib vaccine on allocation. Akorn has Paremyd on shortage due to manufacturing delays. Akorn has Paremyd ophthalmic solution available in limited supply. Pharmacy Relations | 888.531.0998 www.goldcoasthealthplan.org Gold Coast Health Plan | Pharmacy Newsletter | September 2016 Drug Product Indomethacin Capsules Affected Manufacturers Glenmark, Heritage, Teva, Mylan Q4 2016 17 Summary Mylan, Glenmark, and Teva did not provide a reason for the shortage. Glenmark has all indomethacin presentations on intermittent back order and is releasing product as it becomes available. Heritage has indomethacin 50 mg capsules in 500 count on back order and the company cannot estimate a release date. Mylan Institutional has indomethacin 50 mg unitdose capsules in 300 count available with an expiration date of February 2017. The 25 mg unit-dose in 100 count are on back order and the company estimates a release date of mid-June 2016. The 50 mg unit-dose in 100 counts are on back order and the company estimates a release date of mid-June 2016. Leflunomide Tablets Liotrix Tablets Meningococcal Vaccines Teva has all indomethacin presentations temporarily unavailable and the company cannot estimate a release date. Heritage Heritage states the shortage is due to a delay in obtaining active ingredient. Heritage has leflunomide 10 mg and 20 mg tablets on tight allocation. The company estimates a return to full supply in March 2016. Actavis Thyrolar tablets from Actavis (formerly Forest) are on shortage due to manufacturing changes. Sanofi Pasteur, GlaxoSmithKline, Pfizer Actavis (formerly Forest) has all Thyrolar presentations on long-term back order and the company cannot estimate a release date. Sanofi Pasteur cannot provide a reason for the shortage. GlaxoSmithKline acquired Bexsero and Menveo from Novartis Vaccines and Diagnostics in 2015. Pfizer has Trumenba available. Methylphenidate Hydrochloride Chewable Tablets BACK TO THE TABLE OF CONTENTS Shionogi Pharma Sanofi Pasteur has Menomune-A/C/Y/W-135 on back order and the company cannot estimate a release date. Shionogi Pharma has Methylin chewable tablets on shortage due to manufacturing issues. Shionogi Pharma has all Methylin chewable tablets on long-term back order and the company cannot estimate a release date. Pharmacy Relations | 888.531.0998 www.goldcoasthealthplan.org Gold Coast Health Plan | Pharmacy Newsletter | September 2016 Drug Product Methylphenidate Transdermal Mupirocin Calcium 2% Cream Affected Manufacturers Noven GlaxoSmithKline, Prasco Q4 2016 18 Summary Noven has Daytrana patches on shortage due to shipping delays. Noven has all Daytrana presentations on back order and the company estimates a release date in late-April 2016. GlaxoSmithKline could not provide a reason for the shortage. Prasco discontinued mupirocin calcium 2% cream in February. Mupirocin Calcium 2% Nasal Ointment Ofloxacin Opthalmic Solution GlaxoSmithKline has Bactroban 2% cream in 30 gram sizes on back order and the company cannot estimate a release date. GlaxoSmithKline GlaxoSmithKline states the shortage is due to manufacturing issues. Akorn, Rising Pharmaceuticals, Valeant GlaxoSmithKline has Bactroban Nasal 2% Ointment in 1 gram tubes on back order and the company estimates a release date of 1st quarter 2017. Akorn, Rising and Valeant did not provide a reason for the shortage. Akorn has ofloxacin ophthalmic solution in 5 mL and 10 mL bottles on back order and the company cannot estimate a release date. Rising has ofloxacin ophthalmic solution in 5 mL and 10 mL bottles on back order and the company estimates a release date of mid-May 2016. Scopolamine Transdermal Patch Baxter, Sandoz Valeant has temporarily discontinued ofloxacin ophthalmic solution in 5 mL and 10 mL bottles and the company cannot estimate a release date. Baxter and Sandoz have Transderm Scop on shortage due to increased demand. There is insufficient supply for usual ordering. Baxter has Transderm Scop in 10 count on allocation. The 24 count presentation is on back order and the company estimates a release date of early-October 2016. Sandoz has Transderm Scop in 4 count on back order and the company estimates a release date of mid-September 2016. BACK TO THE TABLE OF CONTENTS Pharmacy Relations | 888.531.0998 www.goldcoasthealthplan.org Gold Coast Health Plan | Pharmacy Newsletter | September 2016 Drug Product Sumatriptan Nasal Spray Affected Manufacturers GlaxoSmithKline, Sandoz Q4 2016 19 Summary GlaxoSmithKline could not provide a reason for the shortage. Sandoz has sumatriptan nasal spray on shortage due to product constraints. GlaxoSmithKline has Imitrex 20 mg nasal spray on back order and the company estimates a release date in early-March 2016. Testosterone Cypionate Intramuscular Injection Tetracaine Hydrochloride Ophthalmic Drops Sandoz has sumatriptan 5 mg and 20 mg nasal spray on back order and the company estimates a release date of mid-to-late March 2016. Sun Pharma Sun Pharma did not provide a reason for the shortage. Ocusoft, Alcon Labs, Valeant Sun Pharma has all testosterone cypionate presentations on back order and the company cannot estimate a release date. Alcon, Valeant, and Ocusoft did not provide a reason for the shortage. Alcon has tetracaine 0.5% ophthalmic drops in 2 mL bottles on back order and the company cannot estimate a release date. Valeant has tetracaine 0.5% ophthalmic drops in 15 mL bottles on intermittent back order and the company is releasing supplies as they become available. Theophylline ExtendedRelease Tablets Major, Teva OCuSOFT has Tetravisc 0.5% 0.6 mL unit-dose in 12 count on back order and the company cannot estimate a release date. Major has theophylline extended-release tablets on shortage due to increased demand. Teva cannot provide a reason for the shortage. Major has theophylline extended-release tablets on back order and the company cannot estimate a release date. Teva has theophylline 300 mg extended-release tablets in 500 count on back order and the company estimates a release date of mid-April 2016. The 100 mg tablets in 100 count and 500 count, 200 mg tablets in 100 count, 500 count, and 1,000 count, and 300 mg tablets in 1,000 count are on back order and the company cannot estimate a release date. BACK TO THE TABLE OF CONTENTS Pharmacy Relations | 888.531.0998 www.goldcoasthealthplan.org Gold Coast Health Plan | Pharmacy Newsletter | September 2016 Drug Product Thrombin Topical Solution (Bovine) Affected Manufacturers Pfizer Q4 2016 20 Summary Pfizer states the reason for the shortage is manufacturing delay. Recombinant thrombin topical solution products (Recothrom) are available and not affected by this shortage. Vitamin E Aqueous Oral Solution Pfizer has Thrombin JMI 20,000 unit syringe spray kits on back order and the company estimates a release date of early-March 2016. Thrombin JMI 5,000-unit syringe spray kits and 20,000-unit pump spray kits are on back order and the company estimates a release date of late-April 2016. Hospira, Geritrex Hospira is changing manufacturing sites from a third-party manufacturer to in-house manufacturing. This has caused a delay in production. Geritrex could not provide a reason for the vitamin E drops shortage. Hospira has both Aquasol E Drop products on back order and the company cannot estimate a release date. Zolpidem Tartrate Immediate Release Tablets Aurobindo, Major, Mylan, Mylan institutional, Sandoz, Teva Geritrex has vitamin E drops on back order and the company cannot estimate a release date. Aurobindo, Major and Mylan could not provide a reason for the shortage. Aurobindo has zolpidem 5 mg and 10 mg tablets on back order and the company cannot estimate a release date. Major has zolpidem 5 mg and 10 mg tablets on back order and the company cannot estimate a release date. Mylan has all zolpidem 5 mg and 10 mg tablets on back order and the company cannot estimate a release date. Sandoz has zolpidem 5 mg and 10 mg tablets in 500 count on back order with an estimated release date of mid-April 2016 for the 5 mg tablets and lateMarch 2016 for the 10 mg tablets. Teva has zolpidem 10 mg tablets on back order and the company estimates a release date in early-April 2016. BACK TO THE TABLE OF CONTENTS Pharmacy Relations | 888.531.0998 www.goldcoasthealthplan.org Gold Coast Health Plan | Pharmacy Newsletter | September 2016 Q4 2016 21 FDA Drug Safety Communications This section includes drug alerts that were released in the last three months by the FDA that affect the prescription benefit for GCHP. Click here to access this information from the FDA’s website. Drug Communications Summary Over-the-counter antacid products containing aspirin The U.S. Food and Drug Administration (FDA) is warning consumers about the risk of serious bleeding when using nonprescription - also known as over-thecounter or OTC - aspirin-containing antacid products to treat heartburn, sour stomach, acid indigestion, or upset stomach. Many other products for these conditions are available that do not contain aspirin. Zecuity (sumatriptan) migraine patch The U.S. Food and Drug Administration (FDA) is investigating the risk of serious burns and potential permanent scarring with the use of Zecuity (sumatriptan iontophoretic transdermal system) patch for migraine headaches. The FDA is investigating the cause and extent of these serious side effects and will update the public with new information when the review is complete. These widely used products already contain warnings about this bleeding risk on their labels; however, the FDA is continuing to receive reports of this serious safety issue. As a result, the FDA will continue to evaluate this safety concern and plans to convene an advisory committee of external experts to provide input regarding whether additional FDA actions are needed. loperamide (Imodium) canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR) BACK TO THE TABLE OF CONTENTS OTC aspirin-antacid products are sold under various trade names, including Alka-Seltzer Original, Bromo Seltzer, Medique Medi Seltzer, Picot Plus Effervescent, Vida Mia Pain Relief, Winco Foods Effervescent Antacid and Pain Relief, and Zee-Seltzer Antacid and Pain Reliever. They are also available as generic products. The U.S. Food and Drug Administration (FDA) is warning that taking higher-than-recommended doses of the common over-the-counter (OTC) and prescription diarrhea medicine loperamide (Imodium), including through abuse or misuse of the product, can cause serious heart problems that can lead to death. The risk of these serious heart problems, including abnormal heart rhythms, may also be increased when high doses of loperamide are taken with several kinds of medicines that interact with loperamide. The majority of reported serious heart problems occurred in individuals who were intentionally misusing and abusing high doses of loperamide in attempts to self-treat opioid withdrawal symptoms or to achieve a feeling of euphoria. The FDS is continuing to evaluate this safety issue and will determine if additional FDA actions are needed. The U.S. Food and Drug Administration (FDA) has strengthened the existing warning about the risk of acute kidney injury for the type 2 diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR). Based on recent reports, the FDA has revised the warnings in the drug labels to include information about acute kidney injury and added recommendations to minimize this risk. Pharmacy Relations | 888.531.0998 www.goldcoasthealthplan.org Gold Coast Health Plan | Pharmacy Newsletter | September 2016 Drug Oral and injectable fluoroquinolone antibiotics Opioid pain or cough medicines with benzodiazepines BACK TO THE TABLE OF CONTENTS Q4 2016 22 Communications Summary The U.S. Food and Drug Administration (FDA) approved changes to the labels of fluoroquinolone antibacterial drugs for systemic use (i.e., taken by mouth or by injection). These medicines are associated with disabling and potentially permanent side effects of the tendons, muscles, joints, nerves, and central nervous system that can occur together in the same patient. As a result, the FDA revised the Boxed Warning, the agency’s strongest warning, to address these serious safety issues. The FDA also added a new warning and updated other parts of the drug label, including the patient Medication Guide. The FDA has determined that fluoroquinolones should be reserved for use in patients who have no other treatment options for acute bacterial sinusitis, (ABS), acute bacterial exacerbation of chronic bronchitis (ABECB), and uncomplicated urinary tract infections (UTI) because the risk of these serious side effects generally outweighs the benefits in these patients. For some serious bacterial infections the benefits of fluoroquinolones outweigh the risks, and it is appropriate for them to remain available as a therapeutic option. A U.S. Food and Drug Administration (FDA) review has found that the growing combined use of opioid medicines with benzodiazepines or other drugs that depress the central nervous system (CNS) has resulted in serious side effects, including slowed or difficult breathing and deaths. Opioids are used to treat pain and cough; benzodiazepines are used to treat anxiety, insomnia, and seizures. In an effort to decrease the use of opioids and benzodiazepines, or opioids and other CNS depressants, together, the FDA is adding Boxed Warnings, the agency’s strongest warnings, to the drug labeling of prescription opioid pain and prescription opioid cough medicines and benzodiazepines. Pharmacy Relations | 888.531.0998 www.goldcoasthealthplan.org Gold Coast Health Plan | Pharmacy Newsletter | September 2016 Q4 2016 23 Page left intentionally blank. BACK TO THE TABLE OF CONTENTS Pharmacy Relations | 888.531.0998 www.goldcoasthealthplan.org Q4 2016 Pharmacy Newsletter SEPTEMBER 2016 For additional information, contact Pharmacy Relations at 888.531.0998 Gold Coast Health Plan 711 East Daily Drive, Suite 106, Camarillo, CA 93010 www.goldcoasthealthplan.org