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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
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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
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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.
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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.
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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
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Provider Resources
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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
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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.
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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
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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.
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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
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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.
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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
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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.
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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.
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Q4 2016
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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
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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.
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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.
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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.
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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.
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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.
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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
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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.
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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.
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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.
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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.
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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)
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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.
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Gold Coast Health Plan | Pharmacy Newsletter | September 2016
Drug
Oral and injectable fluoroquinolone antibiotics
Opioid pain or cough medicines
with benzodiazepines
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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.
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Gold Coast Health Plan | Pharmacy Newsletter | September 2016
Q4 2016
23
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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