Pharmacy Newsletter - Gold Coast Health Plan · 2016. 9. 27. · ries and essential fatty acids for...

PharmacyNewsletterSEPTEMBER 2016

Q4 2016

Q4 2016Gold Coast Health Plan | Pharmacy Newsletter | September 2016 2

Pharmacy Relations | 888.531.0998 www.goldcoasthealthplan.org

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

Table of Contents

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

Q4 2016

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BACK TO THE TABLE OF CONTENTS Pharmacy Relations | 888.531.0998 www.goldcoasthealthplan.org

Asthma is a significant chronic illness. At Gold Coast Health Plan (GCHP), ap-proximately 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 therapeu-tic 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 control-ler 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-on-one 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.

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

CMO Message

C. Albert Reeves, MD



The following is a summary of the guidelines for the treat-ment of asthma. The information has been developed from the Expert Panel Report 3 (EPR3): Guidelines for the Diagno-sis 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 ac-tivity 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.

Disease State Topic: Asthma

The table on page 5 is an excerpt from the reference that addresses the stepwise approach for managing asthma long term.

http://www.nhlbi.nih.gov/guidelines/asthma/asthgdln.htm

http://www.nhlbi.nih.gov/guidelines/asthma/asthma_quickref.htm

http://www.nhlbi.nih.gov/guidelines/asthma/asthgdln.htm

http://www.nhlbi.nih.gov/guidelines/asthma/asthma_quickref.htm



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.



Note: Brand drugs are listed in all capital letters and generics are listed in lower case letters and italicized.

Additions

CLASS/MOA COVERED AGENT RESTRICTIONSSHORT ACTING BETA AGONISTS

VENTOLIN HFA Limited to two inhalers per 31 days.XOPENEX/XOPENEX HFA Requires prior trial and failure of albuterol.

INHALED CORTICOSTEROIDS

FLOVENT HFA 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.

ASMANEX Requires prior trial and failure of Flovent.PULMICORT FLEXHALER Limited to one inhaler per 31 days.budesonide (solution for nebuliz-er)

Requires prior trial and failure of Flovent HFA or Pulmicort HFA.

QVARARNUITY ELLIPTAAEROSPAN

LEUKOTRIENE RECEPTOR MODIFIER

montelukastzafirlukast Requires a prior authorization stating that long

term controller medications (inhaler corticoste-roids and long-acting beta agonists) have been tried and failed.

LONG ACTING BETA AGONIST

FORADIL Limited to one pack per 31 days.BROVANA Requires prior trial and failure of Foradil.SEREVENT Requires prior trial and failure of Foradil.PERFOROMIST

COMBINATION PRODUCTS ADVAIR HFA/ADVAIR Diskus Limited to one pack or one inhaler per 31 daysSYMBICORT Limited to one inhaler per 31 daysBREO ELLIPTA Requires prior trial and failure of Symbicort or

Advair.OTHER AGENTS AEROCHAMBER Limited to one per year.

theophyllineXOLAIR 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.

GCHP Formulary List of Participating Pharmacies Provider Resources

CLICK EACH TOPIC FOR MORE INFORMATIONQuick Links

http://64.232.102.10/download/GCHP_Covered_Drugs.pdf

http://64.232.102.10/download/GCHP_Pharmacies.pdf

http://goldcoasthealthplan.org/providers/resources.aspx



Formulary ChangesThe following changes to the GCHP formulary will be effective October 1:

Additions

Drug Formulary Status/ChangeCABOMETYX (cabozantinib s-malate) 20 mg, 40 mg, 60 mg tablet

Add with a PA.

BRIVIACT (brivaracetam) Add with a PA with step therapy of Keppra.EPCLUSA (sofosbuvir; velpatasvir) Add with a PA to meet the DHCS Clinical Policy.VENCLEXTA (venetoclax) Add with PA.clomipramine capsules Add with PA for documentation of failure of at least two

other TCAs.Metformin, modified ER Add with PA for documentation.duloxetine capsules Removed step therapy.

Removals

Drug Formulary Status/ChangeCRESTOR (rosuvastatin) all strengths Brand removed; generic now available.EDECRIN (ethacrynic acid) 25 mg tablets Brand removed; generic now available.SPRYCEL (dasatinib) all strengths Brand removed; generic now available.BANZEL (rufinamide) 200 mg, 400 mg Brand removed; generic now available.VIMPAT (lacosamide) all strengths Brand removed; generic now available.FLUMIST No longer a Medi-Cal covered benefit; the CDC does

not recommend its use during the 2016-2017 influenza season.



FDA AlertsFDA New Drug ApprovalsThis 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 ActionNETSPOT gallium ga 68

dotatateKit 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.

BYVALSON nebivolol hydrochloride; valsartan

Tablet; Oral BYVALSON is a beta adrenergic blocker and an an-giotensin 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.

LANSOPRAZOLE lansoprazole POWDER; IV (INFUSION)

GONITRO nitroglycerine INJECTABLE; INJECTION

GONITRO is a nitrate vasodilator indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease.

RAYALDEE calcifediol INJECTABLE; INJECTION

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 end-stage renal disease on dialysis.

EPCLUSA sofosbuvir; velpa-tasvir

SOLUTION; IV (INFUSION)

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 combina-

tion with ribavirin.KOVANAZE oxymetazoline

hydrochloride; tetracaine hydrochloride

TABLET; ORAL KOVANAZE contains tetracaine HCl, an ester local anesthetic, and oxymetazoline HCl, a vasoconstric-tor. 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.

http://www.fda.gov/NewsEvents/ProductsApprovals/default.htm



Brand Name Generic Name Dosage Form Summary of Indication and Mechanism of ActionSYNDROS 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 che-

motherapy in patients who have failed to respond adequately to conventional antiemetic treatments.

XIIDRA lifitegrast SOLUTION/DROPS; OPHTHALMIC

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).

SMOFLIPID 20% fish oil; medium chain triglycerides; olive oil; soybean oil

EMULSION; INTRAVENOUS

Smoflipid is indicated in adults as a source of calo-ries and essential fatty acids for parenteral nutrition when oral or enteral nutrition is not possible, insuffi-cient, 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 riboflavin 5'- phosphate sodium

SOLUTION/DROPS; OPHTHALMIC

PHOTREXA VISCOUS and PHOTREXA are pho-toenhancers indicated for use with the KXL System in corneal collagen cross-linking for the treatment of progressive keratoconus and corneal ectasia follow-ing refractive surgery.

PHOTREXA VISCOUS IN DEXTRAN 20%

riboflavin 5’- phosphate sodium

SOLUTION/DROPS; OPHTHALMIC

PHOTREXA VISCOUS and PHOTREXA are pho-toenhancers indicated for use with the KXL System in corneal collagen cross-linking for the treatment of progressive keratoconus and corneal ectasia follow-ing refractive surgery.



Brand Name Generic Name Dosage Form Summary of Indication and Mechanism of ActionBELVIQ XR lorcaserin

hydrochlorideTABLET, EXTENDED RELEASE; ORAL

BELVIQ XR is a serotonin 2C receptor agonist indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight man-agement 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 es-tablished.

• The effect of BELVIQ XR on cardiovascular mor-bidity and mortality has not been established.

RELISTOR methylnaltrexone bromide

TABLET; ORAL 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 receiv-ing palliative care, when response to laxative therapy has not been sufficient.

Limitations of use: Use beyond four months has not been studied in the advanced illness population.

VIEKIRA XR dasabuvir sodium; ombitasvir; paritaprevir; ritonavir

TABLET, EXTENDED RELEASE; ORAL

VIEKIRA XR includes dasabuvir, a hepatitis C virus non-nucleoside NS5B palm polymerase inhibitor, ombitasvir, a hepatitis C virus NS5A inhibitor, parita-previr, 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.



Brand Name Generic Name Dosage Form Summary of Indication and Mechanism of ActionADLYXIN lixisenatide SOLUTION;

SUBCUTANEOUS 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 pan-

creatitis 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 gastropa-resis and is not recommended in patients with gastroparesis.

QBRELIS lisinopril 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.

SUSTOL granisetron INJECTABLE; INJECTION, EXTENDED RELEASE

SUSTOL is a serotonin-3 (5-HT3) receptor antago-nist indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and re-peat courses of moderately emetogenic chemother-apy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens.

TROXYCA ER pimavanserin tartrate

oxycodone hydrochloride; naltrexone hydrochloride

TROXYCA ER is a combination opioid agonist/opioid antagonist product indicated for the management of pain severe enough to require daily, around-the-clock, 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-opi-oid 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.



Brand Name Generic Name Dosage Form Summary of Indication and Mechanism of ActionPALONOSETRON HYDROCHLO-RIDE

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 vom-iting associated with initial and repeat courses.

• Highly emetogenic cancer chemotherapy – pre-vention of acute nausea and vomiting associated with initial and repeat courses.

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).

FDA Safety Labeling ChangesThis 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 Type of Change ChangeElitek (rasburicase) Boxed Warning 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.

http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm



Drug Type of Change ChangeSabril (vigabatrin) Tablets and Oral solution

Boxed Warning 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 discontinua-tion 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 SA-BRIL 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 con-sistent with clinical objectives.

Updated: Because of the risk of permanent vision loss, SABRIL is available only through a restricted program under a Risk Evalu-ation and Mitigation Strategy (REMS) called the SABRIL REMS Program.

Xigduo XR (dapagliflozin and metformin HCl extended-release)

Boxed Warning, Contraindications

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 symp-toms such as malaise, myalgias, respiratory distress, somno-lence, 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 re-nal 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, immedi-ately discontinue XIGDUO XR and institute general supportive measures in a hospital setting. Prompt hemodialysis is recom-mended.

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.



Drug Type of Change ChangeTeriflunomide (Aubagio)

Contraindications 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.

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)

Hectorol (doxercalciferol)

Contraindications Addition: Hectorol Injection is contraindicated in patients with pre-vious hypersensitivity to doxercalciferol or any of its ingredients.

Nitromist (nitroglycerin) Contraindications 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.

Technivie (ombitasvir, paritaprevir, and ritonavir) Tablets

Contraindications 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)

Tybost (cobicistat) Tablet

Contraindications 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 ShortagesThis 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 Affected Manufacturers SummaryAcetylcysteine Oral and Inhalation Solution

American Regent, Fresenius Kabi

American Regent has a consistent supply of acetyl-cysteine 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.

http://www.ashp.org/menu/DrugShortages/CurrentShortages



Drug Product Affected Manufacturers SummaryAtropine Sulfate Ophthalmic Solution

Alcon Labs, Akorn, Sandoz 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.

Akorn has atropine sulfate ophthalmic solution in 2 mL, 5 mL, and 15 mL bottles available in limited supply through April 2016.

Cefpodoxime Aurobindo, Sandoz 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.

Sandoz has cefpodoxime 50 mg/5 mL oral suspen-sion in 50 mL and 100 mL bottles on back order and the company cannot estimate a release date.

Ciprofloxacin Oral Suspension

Lupin Lupin did not provide a reason for the shortage.

Lupin has ciprofloxacin oral suspension on long-term back order and the company cannot estimate a release date.

Cyclopentolate Hydrochloride and Phenylephrine Hydrochloride Ophthalmic Solution

Alcon Labs 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.

Dibucaine Ointment Fougera, Perrigo Perrigo and Fougera cannot provide a reason for the shortage.

Perrigo has temporarily discontinued dibucaine ointment and the company cannot estimate a re-supply date.

Fougera has dibucaine ointment on long-term back order and the company cannot estimate a release date.



Drug Product Affected Manufacturers SummaryDiphtheria, Tetanus Toxoid, and Acellular Pertussis and Inactivated Poliovirus and Haemophilus B Conjugate Vaccine (DTaP - IPV/Hib)

Sanofi Pasteur Sanofi Pasteur states the reason for the shortage is a manufacturing delay.

Insufficient supplies for usual ordering.

Sanofi Pasteur has Pentacel vaccine on allocation.Diphtheria, Tetanus Toxoid, and Acellular Pertussis Vaccine (DTaP)

Sanofi Pasteur, GlaxoSmith-Kline

Sanofi Pasteur has Daptacel in short supply due to the shortage of other combination vaccines (e.g., Pentacel).

GlaxoSmithKline has Infanrix available.

Sanofi Pasteur has Daptacel vaccine on allocation.Flurandrenolide Tape Allergan Allergan states the shortage is due to manufactur-

ing delays.

Allergan is the sole supplier of flurandrenolide tape.

Allergan has Cordran tape on back order and the company estimates a release date of late-Septem-ber.

Haemophilus B Conjugate Vaccine

Sanofi Pasteur, GlaxoSmith-Kline, Merck

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 meningo-coccal protein conjugate vaccine) available.

Sanofi Pasteur has ActHib vaccine on allocation.Hydroxyamphetamine Hydrobromide and Tropicamide Ophthalmic Solution

Akorn Akorn has Paremyd on shortage due to manufac-turing delays.

Akorn has Paremyd ophthalmic solution available in limited supply.



Drug Product Affected Manufacturers SummaryIndomethacin Capsules Glenmark, Heritage, Teva,

MylanMylan, Glenmark, and Teva did not provide a rea-son 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 esti-mate a release date.

Mylan Institutional has indomethacin 50 mg unit-dose capsules in 300 count available with an expi-ration 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.

Teva has all indomethacin presentations temporar-ily unavailable and the company cannot estimate a release date.

Leflunomide Tablets 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.

Liotrix Tablets Actavis Thyrolar tablets from Actavis (formerly Forest) are on shortage due to manufacturing changes.

Actavis (formerly Forest) has all Thyrolar presen-tations on long-term back order and the company cannot estimate a release date.

Meningococcal Vaccines Sanofi Pasteur, GlaxoSmith-Kline, Pfizer

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.

Sanofi Pasteur has Menomune-A/C/Y/W-135 on back order and the company cannot estimate a release date.

Methylphenidate Hydrochloride Chewable Tablets

Shionogi Pharma 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.



Drug Product Affected Manufacturers SummaryMethylphenidate Transdermal

Noven 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.

Mupirocin Calcium 2% Cream

GlaxoSmithKline, Prasco GlaxoSmithKline could not provide a reason for the shortage.

Prasco discontinued mupirocin calcium 2% cream in February.

GlaxoSmithKline has Bactroban 2% cream in 30 gram sizes on back order and the company cannot estimate a release date.

Mupirocin Calcium 2% Nasal Ointment

GlaxoSmithKline GlaxoSmithKline states the shortage is due to manufacturing issues.

GlaxoSmithKline has Bactroban Nasal 2% Oint-ment in 1 gram tubes on back order and the com-pany estimates a release date of 1st quarter 2017.

Ofloxacin Opthalmic Solution

Akorn, Rising Pharmaceuticals, Valeant

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.

Valeant has temporarily discontinued ofloxacin oph-thalmic solution in 5 mL and 10 mL bottles and the company cannot estimate a release date.

Scopolamine Transdermal Patch

Baxter, Sandoz 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 alloca-tion. The 24 count presentation is on back order and the company estimates a release date of ear-ly-October 2016. Sandoz has Transderm Scop in 4 count on back order and the company estimates a release date of mid-September 2016.



Drug Product Affected Manufacturers SummarySumatriptan Nasal Spray GlaxoSmithKline, Sandoz 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.

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.

Testosterone Cypionate Intramuscular Injection

Sun Pharma Sun Pharma did not provide a reason for the shortage.

Sun Pharma has all testosterone cypionate pre-sentations on back order and the company cannot estimate a release date.

Tetracaine Hydrochloride Ophthalmic Drops

Ocusoft, Alcon Labs, Valeant 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.

OCuSOFT has Tetravisc 0.5% 0.6 mL unit-dose in 12 count on back order and the company cannot estimate a release date.

Theophylline Extended- Release Tablets

Major, Teva 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 compa-ny 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.



Drug Product Affected Manufacturers SummaryThrombin Topical Solution (Bovine)

Pfizer Pfizer states the reason for the shortage is manu-facturing delay.

Recombinant thrombin topical solution products (Recothrom) are available and not affected by this shortage.

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 esti-mates a release date of late-April 2016.

Vitamin E Aqueous Oral Solution

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.

Geritrex has vitamin E drops on back order and the company cannot estimate a release date.

Zolpidem Tartrate Immediate Release Tablets

Aurobindo, Major, Mylan, Mylan institutional, Sandoz, Teva

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 late-March 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.



FDA Drug Safety CommunicationsThis 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 SummaryZecuity (sumatriptan) migraine patch

The U.S. Food and Drug Administration (FDA) is investigating the risk of seri-ous burns and potential permanent scarring with the use of Zecuity (sumatrip-tan 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.

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-the-counter 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.

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.

OTC aspirin-antacid products are sold under various trade names, including Alka-Seltzer Original, Bromo Seltzer, Medique Medi Seltzer, Picot Plus Effer-vescent, 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.

loperamide (Imodium) The U.S. Food and Drug Administration (FDA) is warning that taking high-er-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 addi-tional FDA actions are needed.

canagliflozin (Invokana, Invoka-met) and dapagliflozin (Farxiga, Xigduo XR)

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.

http://www.fda.gov/Drugs/DrugSafety/ucm199082.htm



Drug Communications SummaryOral and injectable fluoroquino-lone antibiotics

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 ner-vous 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 un-complicated 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.

Opioid pain or cough medicines with benzodiazepines

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 sei-zures. In an effort to decrease the use of opioids and benzodiazepines, or opi-oids 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.



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Pharmacy NewsletterSEPTEMBER 2016

For additional information, contact Pharmacy Relations at 888.531.0998Gold Coast Health Plan 711 East Daily Drive, Suite 106, Camarillo, CA 93010www.goldcoasthealthplan.org

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