Download January 2011 - Kaiser Permanente

Drug Therapy
Issue 1
January 2011
ADVISORY
Mometasone/Formoterol
(Dulera) Added to Formularies
(Brad Schaefer, PharmD Candidate, NEOUCOP, and Paul Bandfield, PharmD,
Formulary Management Services)
• Mometasone furoate/formoterol (Dulera) is a combination
Inhaled Corticosteroid (ICS) and Long-Acting Beta2-Agonist
(LABA) added to the Commercial and Medicare formularies
effective January 2011
• Dulera comes as an HFA inhalation aerosol in two strengths;
mometasone furoate/formoterol 100mcg/5mcg & 200mcg/5mcg
• Dulera received FDA approval for the treatment of asthma in
patients 12 years and older
o Dulera is not FDA approved for the treatment of COPD
o There is an ongoing trial looking at the safety and efficacy of
Dulera for persistent asthma in children ages 5-11
o Dulera is NOT to be used as a rescue medication
• Dulera is the preferred formulary medication for treatment of
moderate-to-severe asthma which cannot be controlled or is
unlikely to be controlled with inhaled corticosteroids alone in
members 12 and older
• Beclomethasone (QVAR) remains the preferred asthma
controller medication for members with mild-to-moderate
asthma
• Dulera presents a potential yearly cost savings of 20-50% over
fluticasone/salmeterol (Advair Diskus) depending on dose
Projected Cost Comparison
Generic (Brand) - Strength
Cost
Beclomethasone (QVAR) - 80 mcg (3 puffs BID)
$
Mometasone/formoterol (Dulera) - 100/5, 200/5
$$$
Fluticasone/salmeterol (Advair Diskus) - 100/50
Fluticasone/salmeterol (Advair Diskus) - 250/50
Fluticasone/salmeterol (Advair Diskus) - 500/50
$$$$
$$$$$
$$$$$$$
• A recent study showed similar safety between Dulera and Advair
metered dose inhaler (MDI)
• The study also evaluated efficacy and reported similar results
for Advair and Dulera
o However, the study had insufficient power to statistically
show non-inferiority
• As with Advair and all other combination products containing
ICS and LABA, it is recommended that Dulera is used for the
shortest duration possible to control asthma symptoms and then
stepped down to a single agent ICS
o All LABA containing products have a Black Box warning that
they may increase the risk of asthma-related death
Suggested Dosing:
Consider
Instead of
Generic (Brand) Strength
Mometasone/formoterol
(Dulera) 100/5 2 Puffs BID
Mometasone/formoterol
(Dulera) 200/5 2 Puffs BID
Generic (Brand) Strength
Fluticasone/salmeterol (Advair
Diskus) 250/50 1 Inh BID
Fluticasone/salmeterol (Advair
Diskus) 500/50 1 Inh BID
• Most common Dulera side effects are headache (up to 5%),
nasopharyngitis (5%), dysphonia (4-5%), sinusitis (2-3%), and
oral candidiasis (<1%)
Triad Alcohol Products Recall
(Andrea Nixon, PharmD, Formulary Management Services)
• Triad Group issued a voluntary nationwide recall of all lots of
OTC alcohol prep pads, alcohol swabs, and alcohol swabsticks
• Recall initiated due to concerns about potential contamination
of the alcohol products with the bacteria, Bacillus cereus
• One report of a non-life-threatening skin infection has been
received to date
• Affected alcohol products can be identified by either Triad
Group listed as the manufacturer or a third party manufacturer
using the following names in the packaging: Cardinal Health, PSS
Select, VersaPro, Boca/Ultilet, Moore Medical, Walgreens, CVS,
Conzellin
• This recall involves those products marked as STERILE as well
as non-sterile products
• Affected Triad Group alcohol products were distributed
nationwide to retail pharmacies, packaged in individual packets
and sold in retail pharmacies in a box of 100 packets
• The Triad Group alcohol prep pads are also co-packaged and
distributed in the following prescription injection medications:
o Betaseron
o Boniva Injection
o Copaxone
o Extavia
o Fuzeon
o Nutropin A.Q. Pen
o Pegasys
o TNKase
• Patients and healthcare providers should not use the alcohol
prep pads packaged with these injection medicines and should
use an alternate alcohol prep pad not involved with the Triad
Group recall to disinfect prior to an injection
• A sterile gauze pad in conjunction with isopropyl alcohol may
be used alternatively to disinfect the injection site
• NOTE: The injection drugs are not contaminated and may
continue to be used in accordance with the package insert
• Kaiser Permanente Department of Pharmacy plans to notify
members who may have received affected Triad recalled alcohol
products in their prescription injection medication kits
• Specific customers distributing affected product and selling it at
the wholesale, hospital and retail pharmacy level have been
notified by certified mail with instructions on how to return
affected alcohol products
• Consumers with any of these affected alcohol products in their
possession, should not use the product and should return it to
the place of purchase for refund or call Triad Group Customer
Service at (262) 538-2900, 9:30 a.m. — 5:00 p.m. Mon — Fri
• http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAl
ertsforHumanMedicalProducts/ucm239319.htm
• http://www.triad-group.net/
(Continues on reverse side)
Issue 1
(Continued from reverse side)
Plavix / Proton Pump Inhibitor
(PPI) Interaction Update
(Alynn Anzevino, PharmD, Manager, Pharmacy Benefits and Formulary
Management)
• KP Ohio has approximately 200 patients on both clopidogrel
(Plavix) and a PPI
• Still appears to be an interaction between clopidogrel and PPIs
o Lack of clinical significance surrounding interaction
o Abundance of conflicting data in the primary literature
• Drug interaction flags still present in the KP Pharmacy PIMS
system and HealthConnect regarding Plavix and a PPI
• FDA still maintains this combination should be avoided
o Means the "major interaction" category cannot be deleted
from drug screening tools
• Studies currently exist where one can extrapolate that the Plavix /
PPI interaction may not be a problem
• However, it is still an evolving concern, even in light of the recent
COGENT Trial
• COGENT Trail Conclusion: “There was no apparent
cardiovascular interaction between clopidogrel and omeprazole,
but our results do not rule out a clinically meaningful difference in
cardiovascular events due to use of a PPI.”
• Approach on whether to continue treatment with the PPI should
be based on clinical judgment
• Medication therapy should be tailored to the individual patient's
situation
FDA Alert
New FDA Limits on Prescription Products
Containing Acetaminophen
(Brad Schaefer, PharmD Candidate, NEOUCOP, and Paul Bandfield, PharmD,
Formulary Management Services)
• FDA announced on January 13, 2011 that it will be requiring
manufacturers of prescription acetaminophen combination
products to limit products to 325mg of acetaminophen per dose
• This change does not take effect for 3 years, allowing for
companies to change their manufacturing and limit the
acetaminophen or discontinue production
• OTC acetaminophen products, such as Tylenol, will not be
affected by these new regulations
• This change is a result of the safety concern surrounding the
potential liver damage associated with taking too much
acetaminophen
o Patients should limit their daily acetaminophen intake to less
than 4g per day
o Elderly patients and those with liver disease should limit their
intake to even lower daily doses
• In addition to this change, the FDA will be requiring a new Boxed
Warning to be added to the label on all acetaminophen containing
prescription products
• KP has previously taken measures, such as HealthConnect
warnings, to suggest alternative medications when prescribing
acetaminophen combination products (i.e., 5/325 instead of
5/500)
• http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAler
tsforHumanMedicalProducts/ucm239955.htm
January 2011
Other FDA Alerts
Multaq (dronedarone) - Drug Safety Communication: Risk of
Severe Liver Injury
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsf
orHumanMedicalProducts/ucm240110.htm
Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL):
Medication Use Error - Reports of Accidental Overdose
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsf
orHumanMedicalProducts/ucm239559.htm
Metronidazole Tablets, 250mg: Recall - Underweight Tablets
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsf
orHumanMedicalProducts/ucm239312.htm
Albuterol Sulfate Inhalation Solution 0.083%, 3 mL Unit Dose
Vials: Recall - Mislabeled Unit Dose Vials
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsf
orHumanMedicalProducts/ucm238624.htm
Acetadote (acetylcysteine) Injection: Recall - Particulate
Matter Found in a Small Number of Vials
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsf
orHumanMedicalProducts/ucm238494.htm
Sodium Bicarbonate Injection, USP, 7.5% and 8.4%, 50 mL
Single Dose Vials - Recall Due to Particulates in Some Vials
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsf
orHumanMedicalProducts/ucm238323.htm
Dexamethasone Sodium Phosphate Injection, 4 mg/mL, 30 mL
Multiple Dose Vial: Recall due to Particulates in Product
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsf
orHumanMedicalProducts/ucm238104.htm
Lipitor (atorvastatin) 40 mg: Recall Specific Bottles
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsf
orHumanMedicalProducts/ucm229006.htm
Recombinant Human Growth Hormone (somatropin): Ongoing
Safety Review - Possible Increased Risk of Death
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsf
orHumanMedicalProducts/ucm237969.htm
Anzemet (dolasetron mesylate): Drug Safety Communication Reports of Abnormal Heart Rhythms
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsf
orHumanMedicalProducts/ucm237341.htm
Avastin (bevacizumab): Process for Removal of Breast Cancer
Indication Begun
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsf
orHumanMedicalProducts/ucm237280.htm
Tessalon (benzonatate): Drug Safety Communication - Potential
for Accidental Ingestion by Children
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsf
orHumanMedicalProducts/ucm236928.htm
Rolaids Extra Strength Softchews, Rolaids Extra Strength plus
Gas Softchews, Rolaids Multi-Symptom plus Anti-Gas Softchews:
Recall - Foreign Materials in Products
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsf
orHumanMedicalProducts/ucm236907.htm
Reese Pharmaceutical Company OTC Products: Recall Mislabeled Guaifenesin Tablets
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsf
orHumanMedicalProducts/ucm236593.htm
(Continues on next page)
Issue 1
January 2011
(Continued from previous page)
Medicare Part D Deletions
Initiatives
Inter-Regional Clinical Pharmacy Services
Subcommittee (ICPSS) Initiatives
•
•
•
•
•
Dulera preferred to Advair for treatment of asthma
OxyContin discouraged compared to other long-acting opioids
Insulin NPH and 70/30 use preferred over Lantus and Levemir
Crestor half-tab initiative
Oral Sumatriptan preferred over other Triptan agents
Pharmacy Conversion Team Projects
• Methadone monitoring
• Crestor and Lipitor half-tab initiatives
Current Half-Tab Initiatives
Aricept
Brand Celexa
Crestor
Brand Imitrex
Brand Lamictal
Levitra
Lipitor
Brand Paxil
Provigil
Viagra
Brand Zocor
Brand Zoloft
Formulary Changes
The Ohio Regional Pharmacy & Therapeutics Committee approved
the following formulary changes
The KP Ohio Region Drug Formulary is available by accessing the
Lexi-Comp Online Formulary through the Ohio Intranet (Inside KP:
Ohio Portal Æ Deliver Health Care Æ PHARMACY: Online
Formulary) or the Internet (online.lexi.com/login using login and
password: ohkprx). Formulary changes are updated in Lexi-Comp
on their respective effective dates.
Commercial Additions
Drug
Aztreonam (Cayston) 75mg/Vial Inhalation
Mometasone/Formeterol (Dulera) 100mcg/5mcg,
200mcg/5mcg Inh
Nitroglycerin (Nitrostat) 0.3mg, 0.4mg, 0.6mg SL
Tab
Pramipexole (generic Mirapex) 0.75mg Tab
Effective
Date
1.4.11
1.4.11
1.1.11
1.4.11
Medicare Part D Additions
Drug
Aztreonam (Cayston) 75mg/Vial Inhalation
Mometasone/Formeterol (Dulera) 100mcg/5mcg,
200mcg/5mcg Inh
Nitroglycerin (Nitrostat) 0.3mg, 0.4mg, 0.6mg SL
Tab
Pramipexole (generic Mirapex) 0.75mg Tab
Sildenafil (Revatio) 20mg Tab
Effective
Date
1.4.11
1.4.11
1.1.11
1.4.11
1.1.11
Commercial Deletions
Drug
Acetohydroxamic Acid (Lithostat) 250mg Tab
Carbachol (Ophth) (Carboptic) 3% Sol
Chlorpheniramine/Phenylephrine/Dextromethorphan (C-Phen DM) Drops
Chlorpheniramine/Phenylephrine/Dextromethorphan (C-Phen DM) Syrup
Chlorpheniramine/Phenylephrine (C-Phen) Drops
Chlorpheniramine/Phenylephrine (C-Phen) Syrup
Clozapine 12.5mg Tab
Cyclopentolate HCl (Cyclogyl) 0.5%, 2% Oph Sol
Leuprolide Acetate 1mg/0.2mL Inj
Nitroglycerin 2.5mg, 6.5mg, 9mg ER Cap
Potassium Citrate/Citric Acid Granules
Effective
Date
1.1.11
1.1.11
2.1.11
2.1.11
2.1.11
2.1.11
1.1.11
1.1.11
1.1.11
1.1.11
1.1.11
Drug
Acetohydroxamic Acid (Lithostat) 250mg Tab
Acyclovir Sodium 500mg/20mL Sol
Albuterol 90mcg Aero
Amino Acid Electrolyte Infusion (Travasol
2.75%/Dextrose 5%) 2.75% Inj
Amino Acid Electrolyte w/Calcium Infusion (Clinimix
E 5%/Dextrose 35%) 5%/D35W Inj
Amino Acid Infusion in D10W (Travasol
8.5%/Dextrose 10%) 8.5% Inj
Amino Acid Infusion in D20W (Travasol
5.5%/Dextrose 20%) 5.5% Inj
Amino Acid Infusion in D20W (Travasol
8.5%/Dextrose 20%) 8.5% Inj
Amino Acid Infusion in D50W (Travasol
8.5%/Dextrose 50%) 8.5% Inj
Amoxicillin/Potassium Clavulanate (Augmentin)
125mg Chew Tab
Amylase/Lipase/Protease [Pancrelipase] (Creon 20)
Cap
Antivenin Crotalidae Polyvalent Kit
Bivalirudin (Angiomax) 250mg Inj
Carbachol (Carboptic) 3% Oph Sol
Ceftizoxime in D5W (Cefizox) 1g, 2g Inj
Clozapine 12.5mg Tab
Cyclopentolate HCl (Cyclogyl) 0.5%, 2% Oph Sol
Cyclopentolate/Phenylephrine (Cyclomydril) Oph Sol
Dextrose in Lactated Ringers 2.5-1/2 Inj
Electrolyte-75 in Dextrose (Dextrose 5%/Electrolyte
#75) Vialfex #75 Inj
Immune Globulin [Human]IV (Carimune NF) 1g Inj
Immune Globulin [Human] (Flebogamma) 5% Inj
Interferon Alfa-n3 (Alferon N) 5MU/mL Inj
Leuprolide Acetate 1mg/0.2mL Inj
Measles/Rubella Vaccine (M-R-Vax II) Inj
Nandrolone Decanoate Oil 100mg/mL, 200mg/mL Inj
Pralatrexate (Folotyn) 20mg/2mL, 40mg/2mL Inj
Respiratory Syncytial Virus Immune Globulin
[Human] (Respigam) 50mg/mL Sol
RimabotulinumtoxinB (Myobloc) 2500U/0.5mL,
5000U/mL, 10,000U/2mL Inj
Sacrosidase (Sucraid) 8500U/mL Inj
Tamoxifen Citrate (Soltamox) 10mg/5mL Sol
Tetanus Toxoid Adsorbed (TE Anatoxal Berna) 10Lfu
Inj
Tiopronin (Thiola) 100mg Tab
Tretinoin (Retina-A) 0.05% Liq
Typhoid Vaccine (Vivotif Berna) EC Cap
Urea 40% Lot
Effective Date
1.1.11
1.1.11
1.1.11
1.1.11
1.1.11
1.1.11
1.1.11
1.1.11
1.1.11
1.1.11
1.1.11
1.1.11
1.1.11
1.1.11
1.1.11
1.1.11
1.1.11
1.1.11
1.1.11
1.1.11
1.1.11
1.1.11
1.1.11
1.1.11
1.1.11
1.1.11
1.1.11
1.1.11
1.1.11
1.1.11
1.1.11
1.1.11
1.1.11
1.1.11
1.1.11
Criteria Updates
Adalimumab (Humira)
Angiotensin II Receptors Blockers (ARB)
Entanercept (Enbrel)
Omega-3-Acid Ethyl Esters (Lozava)
Pentosan Polysulfate Sodium (Elmiron)
Revised 1.11
Revised 1.11
Revised 1.11
Revised 1.11
Revised 1.11
Inquiries
Ohio Regional Formulary Management/Drug Information Service
(8:30 a.m. — 5:00 p.m. Mon — Fri, excluding holidays)
E-mail: [email protected]
Pager for urgent inquiry: (216) 568-3133
References are available upon request.