Download Express Scripts Drug Information & Wellness Center Drug Information Updates

September 2011
Volume 3 Issue 7
Express Scripts Drug Information & Wellness Center
Drug Information Updates
Special points of interest:
In the New s:
 In the News
 New Formulations and Indications
Drug Shortages Bill Considered by Congress
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An amendment in the Food, Drug, and Cosmetic Act that will require manufacturers to notify the
FDA if they are discontinuing a drug product or if there is an interruption in the manufacturing
process.
FDA would get notified sooner and be able to work with other drug manufacturers who make the
drug. The goal is to increase production before a drug shortage.
Drug shortages have increased from 61 in 2005 to 178 in 2010. The FDA already tracks shortages to notify other manufacturers and have prevented 38 shortages in 2010 and 99 shortages in
2011.
START & STOPP Criteria
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New criteria designed to help improve drug use in the elderly
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Developed due to concerns about ease of use and applicability of the well known Beers Criteria
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START (Screening Tool to Alert doctors to the Right Treatment) : Identify areas where there
may be prescribing errors of omission in the elderly where they may be undertreated
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STOPP (Screening Tool of Older Persons’ potentially inappropriate Prescriptions) : Identify medications that are potentially inappropriate for the elderly so that they can be avoided
Primatene Mist to be Discontinued
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Primatene Mist, an epinephrine inhaler using chlorofluorocarbons (CFCs) as a propellant, is currently the only inhaler available without a prescription.
The US has been phasing out CFCs, which have been shown to deplete earth’s ozone layer, as
part of an international agreement.
Many inhalers use hydrofluoroalkane (HFA) as a propellant, and these require a prescription.
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After the year’s end, all inhalers will require a prescription, regardless of propellant.
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Primatene Mist will be removed from the market after December 31, 2011.
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New Intradermal Flu Vaccine
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The new Fluzone intradermal flu vaccine comes in a pre-filled syringe with an ultra-fine needle
that is only 1.5 mm long. The dose is 0.1 mL given preferably over the deltoid.
The main differences between Fluzone intradermal and the traditional Fluzone intramuscular are
increased injection site reactions such as erythema and swelling with the intradermal product.
Other side effects such as pain and headache were similar between the two formulations.
Fluzone intradermal has the same contraindications as Fluzone intramuscular, but is only recommended for use in 18 to 64 year olds.
Even though this years flu vaccine contains the same three strains of the virus as last year, the
CDC still recommends everyone older than 6 months receives the flu vaccine due to waning
immunity.
 New Generic Approvals
 Newly Approved Drugs
 Drug Information Question
 Cough and Cold Action Plans for Children Under the Age of 2 and Under the
Age of 4
 Apps of the Month
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Volume 3 Issue 7
Express Scripts Drug Information & Wellness Center
New Formulations and Indications:
Complera (emtricitabine / rilpivirine hcl / tenofovir disoproxil fumarate) by Gilead Sciences
Class: Combination Antiretroviral
Indication: HIV infection in treatment-naïve adults
MOA: HIV-1 reverse transcriptase inhibitor / HIV-1 non-nucleoside reverse transcriptase inhibitor / reverse transcriptase and HBV polymerase
inhibitor
New Formulation: emtricitabine 200 mg / rilpivirine 25 mg / tenofovir 300 mg tablet
Nucynta ER (tapentadol) by Janssen
Class: Opioid analgesic
Indication: Moderate to severe acute and chronic pain
MOA: Centrally-acting opioid that binds μ-opioid receptors and inhibits norepinephrine reuptake
New Formulation: extended release tablet: 50, 100, 150, 200, and 250 mg
Tamiflu (oseltamivir) by Genentech, Inc.
Class: Neuraminidase inhibitor
Indication: Treatment and prevention of Influenza virus types A and B
MOA: Inhibits neuraminidase affecting influenza viral particle release
New Formulation: 6 mg/mL oral suspension, replacing 12 mg/mL suspension
New Generic Approvals:
Norethindrone / Ethinyl Estradiol / Ferrous fumarate
Estrostep
Enoxaparin
Lovenox
Eszopiclone
Lunesta
New ly Approved Drugs
Combination: Lamivudine / Tenofovir disoproxil fumarate / Nevirapine oral tablet by Matrix Labs (approved 9/8/11, tentative approval)
Class: combination antiretroviral agent
Indication: treatment of HIV-1 infection
MOA: inhibition of viral replication
Dosing: one tablet once daily (300 mg / 300 mg / 200 mg)
Combination: Lamivudine / Zidovudine oral tablet by Cipla Limited (approved 9/22/11, tentative approval)
Class: combination antiretroviral agent
Indication: treatment of HIV-1 infection
MOA: inhibition of viral replication
Dosing: one tablet once daily (30 mg / 60 mg)
New Molecular Entity: Firazyr (icatibant acetate) subcutaneous injection by Shire Orphan Therapies (approved 8/25/11)
Class: bradykinin B2 receptor antagonist
Indication: treatment of acute attacks of hereditary angioedema in adults 18 years of age and older
MOA: competitive antagonist selective for the bradykinin B2 receptor, with an affinity similar to bradykinin
Dosing: 30 mg injected subcutaneously in the abdominal area. If response is inadequate, an additional injection of 30 mg may be administered after at
least 6 hours have passed. Administer no more than 3 injections in 24 hours.
New Molecular Entity: Xalkori (crizotinib) oral tablet by Pfizer, Inc. (approved 8/26/11)
Class: receptor tyrosine kinase inhibitor
Indication: treatment of anaplastic lymphoma kinase-positive advanced non-small cell lung cancer
MOA: inhibits receptor tyrosine kinases including anaplastic lymphoma kinase, hepatocyte growth factor receptor, and recepteur d’origine nantais
Dosing: 250 mg twice daily; if dose reduction is necessary reduce to 200 mg twice daily, then again to 250 mg once daily if needed
Volume 3 Issue 7
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Drug Information Question
What is the appropriate treatment or plan of action for children under the age of two
and under the age of four with cough or cold symptoms?
The FDA has stated that there is no data to support the use of decongestants, expectorants, antihistamines, and antitussives in children under the age of two.1 Also, there is a high potential for serious adverse reactions with these medications in children such as death, convulsions, rapid heart rate, accidental overdose and decreased levels of consciousness. 1 Some manufacturers
have voluntarily changed product labeling to limit the use of these medications to those aged four years and older. 2 In addition,
the AAP has issued a policy statement that expresses there is no existing data that supports the use of dextromethorphan or codeine
as effective cough suppressants in children. Other ineffective treatments include guaifenesin, vitamin C, zinc, and Echinacea.3
For treating children less than 2 years of age with cough and cold symptoms, recommendations
are for non-pharmacologic therapy only. These are supported by the FDA and include:
 Applying saline nasal drops to keep nasal passages moist1,3,4
 Nasal suctioning with a bulb syringe to clear nasal passages1,3,4
 Using a cool mist humidifier to ease breathing by shrinking nasal passages (warm mist humidifiers can swell nasal passages and are not recommended) 1
 Drinking plenty of fluid to stay well-hydrated1
 Taking acetaminophen or ibuprofen to treat fever and/or pain3
For treating children 2 to 11 years of age with cough and cold symptoms, it is recommended to
first try the non-pharmacologic therapy listed above.2,3 If symptoms still persist, the potential benefits
should be weighed against the potential adverse effects. 3 If drug therapy is chosen, specific symptoms
should be targeted:
 Nasal obstruction: Topical or oral adrenergic agents, such as xylometazoline, oxymetazoline, or phenylephrine, can be
used for nasal obstruction. Prolonged use should be avoided as it may cause rebound congestion. Topical agents are typically more effective than oral agents, and oral agents are more often associated with CNS stimulation, hypertension, and
palpitations.3
 Rhinorrhea: First generation antihistamines may be helpful in treating rhinorrhea, but second generation antihistamines
are not.3,4 The major adverse effect of first generation antihistamines is sedation, but evidence exists showing that sedation occurs less in children than adults. 3 Topical ipratropium bromide can also be used to treat rhinorrhea. It is associated
with less sedation than antihistamines, but can cause nasal irritation and bleeding. 3
 Sore throat: Mild analgesics can be used for sore throats. Aspirin should be avoided due to the potential for causing
Reye’s syndrome in children with concurrent influenza infections. 3
 Cough: If the cough is associated with postnasal drip, a first generation antihistamine may be effective. 3 Sugar or honey
containing cough drops are also an option for children who are old enough and for whom cough drops do not pose a
choking hazard risk. 3 A camphor/menthol/eucalyptus oils rub, such as Vicks Vaporub, may also be effective in treating
night time cough severity, cough frequency, nasal congestion, and increasing the ability to sleep. 3,5
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When drug therapy is chosen, the FDA recommends that these general rules should be reinforced with parents 2:
Check active ingredients to ensure child is not receiving the same medication from multiple drug therapies
Carefully read and follow the package directions to ensure child is receiving the correct amount of medications as most
adverse effects may be caused by overdose or misuse of the medication
Always use the measuring devices that are packaged with the medication and avoid using measuring devices from the
household, such as spoons or cups
Do not use products to make children sleepy
References:
FDA.gov [Internet]. Silver Spring: U.S. Food and Drug Administration; [updated 2011 Sep 10; cited 2011 Sep 12]. Special Features. Available from: http://www.fda.gov/Drugs/ResourcesForYou/SpecialFeatures/ucm263948.htm.
FDA.gov [Internet].Silver Spring: U.S. Food and Drug Administration; [updated 2011 Sep 10; cited 2011 Sep 12]. Consumer Updates. Available from: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm048515.htm.
Kliegman RM, Stanton BF, St. Geme JW 3rd, Schor NF, Behrman RE, editors. Nelson Textbook of Pediatrics. 19th ed.
Philadelphia: Saunders; 2011.
Long SS, Pickering LK, Prober CG, editors. Principles and practice of pediatric infectious diseases. 3rd ed. Philadelphia:
Churchill Livingstone; 2009.
Paul IM, Beiler JS, King TS, Clapp ER, Vallati J, Berlin CM Jr. Vapor rub, petrolatum, and no treatment for children
with nocturnal cough and cold symptoms. Pediatrics. 2010 Dec;126(6):1092-9.
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Express Scripts
Drug Information & Wellness Center
Southern Illinois University Edwardsville
Volume 3 Issue 7
Monday — Friday
8 a.m. — 4 p.m.
(618) 650-5142
Apps of the Month
The following applications for smartphones have been reviewed and critiqued by students and pharmacists:
LactMed
Cost: Free
Content: Database of drugs and other chemicals to which breastfeeding mothers may be exposed. Includes information on drug levels in breast milk and infant blood, as well as potential ADEs in the nursing infant. Therapeutic alternatives are provided.
This app is part of the National Library of Medicine’s Toxicology Data Network (TOXNET), and all data comes from scientific literature
and is fully referenced.
Rating (1-5):
AHRQ ePSS
Cost: Free
Content: Tool to determine appropriate preventive services for patients based on age, sex, pregnancy status, tobacco use, and sexual activity. Each service is given a graded recommendation. Also includes many screening tools.
This app is from the US Preventive Services Task Force under the Agency of Health Research and Quality.
Rating (1-5):
Noom Weight Loss
Cost: Free
Content: This app makes tracking exercise and food intake easy. Instead of requiring precise values about food intake, Noom uses a
calorie estimation technique and helps the user categorize food intake into 3 color-coded categories: “Great (green), Okay (yellow),
and Bad (red).” Noom displays a pie chart of food intake logged each day, displaying both the proportion of food the user actually ate
as well as what the pie chart would be for ideal dietary intake. This app is available in the Android Market only.
Rating (1-5):