ATTENTION: IMMUNIZATION TRAINING
Southwestern Oklahoma State University Rural Health is proud to offer you IMMUNIZATION TRAINING
on Saturday, October 24, 2015 from 8 am to 5 pm on the Weatherford Campus. This is a special offering
for the Rural Pharmacist brought to you by SWOSU Rural Health Network.
There will be 4 hours of home study material sent to you after registration with the 8 hour classroom
following. Class size is limited to 25 pharmacists.
This will qualify for 12 hours of CE by the Oklahoma State Board of Pharmacy. PLEASE REGISTER EARLY.
Class will be closed upon reaching 25 enrollees. The special training will cost $195.00.
(Please e-mail me randy.curry@swosu.edu or call 580-774-3760)
Rural Rocks
Recalls
 Combivent Defective Sprays Prompt Recall of 350,000+ Inhalers
 Methotrexatelnjection
 Cytarabine Injection 100 mg/5 ml
 0.9% Sodium Chloride injection
Shortages
 Numerous products
FDA Medwatch
 Drug Safety Labeling Changes
 Antibiotic Injectable Coming off
Patient Safety
 Compounded Drugs Stored in Becton-Dickinson (BD) 3 ml and 5 ml Syringes: FDA
Warning – Do Not Use
 Obesity Drug Labeling Updated with New Interaction, Side Effect
 Oxycontin Approved for Pediatric Patients
 (from Drug Topics:)
 Safeguarding the U.S. drug supply
 What you need to know to comply with the DSCSA
New Drug
 Corlanor
 Anti-Opioid Approved for New Indication
 FDA approves first treatment for sexual desire disorder
 FDA approves Boehringer Ingelheim’s StioltoTM Respimat as once-daily maintenance
treatment for COPD
 Information from Merck Regarding a Product Label Change
HIPAA
 Are You Confident About Passing a HIPAA Audit?
 Drug Pumps are Vulnerable to Hacking, FDA Warns
 Hack of UCLA Health may affect 4.5 million
 Medical Student Learns the hard way to not take selfies with your sick patient
HOSPITAL
 2015 Hospital
 National Patient Safety Goals
 To improve patient satisfaction, hospitals target sleep disruptions
INSURANCE
 2016 formulary exclusions in 9 key areas
 When an Overpayment Becomes a False Claims Act Issue: Explaining the First Judicial
Interpretation of the 60-Day Rule.
NEWS
 5 Articles listed below
RECALLS
 Defective Sprays Prompt Recall of 350,000+ Inhalers
o http://www.empr.com/safety-alerts-and-recalls/combivent-respimat-recall-defective-deliverysystem/article/433141/?DCMP=EMCMPR_DailyDose_cp&cpn=mylan_2014,strib_pharm,strib_mobile&hmSubId=&hmEmail=zc9AEZF4x4rPbtLJAxJhm
klDzcJVA8s10&NID=&dl=0&spMailingID=12156152&spUserID=NDgyNTEwMTE5NjYS1&spJobID=601226490&spR
eportId=NjAxMjI2NDkwS0
 Methotrexate Injection, USP 50 mg/2 mL (25 mg/mL), 2
mL Single-dose Vial, packaged in 5 x 2 mL vials per carton,
Rx only, labeled as a) Distributed by Pfizer Labs, Division of
Pfizer Inc., New York, NY 10017, NDC 0069-0146-01; and
b) Manufactured for: Mylan Institutional LLC, Rockford, IL
61103, NDC 67457-467-99.
 Cytarabine Injection 100 mg/5 mL (20 mg/mL), 5 mL
Single-Dose Vial (NDC 0069-0152-01), packaged in 10 x 5
mL Vials per carton (NDC 0069-0152-02), Rx only,
Distributed by Pfizer Labs, Division of Pfizer Inc., New
York, NY 10017.

 Lot #: a)
7801082, Exp.
07/15 and b)
7801421, Exp.
09/16
 Class I
 Presence of Particulate
Matter: observed during
testing of retained samples.
 Mylan
Institutional
LLC
 Lot #
7801050, Exp.
Date. 05/2015
 Class I
 Presence of Particulate
Matter: observed during
testing of retained samples.
 Mylan
Institutional
LLC
0.9 Percent Sodium Chloride Injection, USP (AUTO-C) by Baxter International: Recall Potential For Leaking Containers, Particulate Matter and Missing Port
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0.9 Percent Sodium Chloride Injection, USP, 50mL and 100mL by Baxter: Recall Particulate Matter
0.9 Percent Sodium Chloride Injection, USP, 250 mL by Hospira : Recall - Particulate
Matter
0.9 Percent Sodium Chloride Injection, USP, 250 mL VisIV Container by Hospira:
Recall - Particulate Matter
Adrucil (fluorouracil injection, USP) 5 g/100 mL (50 mg/mL) by Teva Parenteral
Medicines: Recall - Particulate Matter
SHORTAGES
August 18, 2015
 Piperacillin and Tazobactam (Zosyn) Injection (Currently in Shortage)
July 29, 2015
 Cefepime Injection (Currently in Shortage)
July 22, 2015
 Cefepime Injection (Currently in Shortage)
 Levetiracetam (Keppra) Injection (Currently in Shortage)
July 13, 2015
 Morphine Sulfate (Avinza) Extended Release Capsules (Discontinuation)
July 09, 2015
 Epinephrine 1mg/mL (Preservative Free) (Currently in Shortage)
 Sacrosidase (Sucraid) Oral Solution (Currently in Shortage)
Updated
August 20, 2015

Calcium Gluconate Injection (Currently in Shortage)
August 18, 2015
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Dexamethasone Sodium Phosphate Injection (Currently in Shortage)
Fomepizole Injection (Currently in Shortage)
Haloperidol Lactate Injection (Currently in Shortage)
August 17, 2015
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Cefazolin Injection (Currently in Shortage)
Cefepime Injection (Currently in Shortage)
Doxorubicin (Adriamycin) Injection (Currently in Shortage)
Haloperidol Lactate Injection (Currently in Shortage)
Leucovorin Calcium Lyophilized Powder for Injection (Currently in Shortage)
Levetiracetam (Keppra) Injection (Currently in Shortage)
Piperacillin and Tazobactam (Zosyn) Injection (Currently in Shortage)
Vancomycin Hydrochloride for Injection, USP (Currently in Shortage)
August 14, 2015
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Atropine Sulfate Injection (Currently in Shortage)
Calcium Chloride Injection, USP (Currently in Shortage)
Cefazolin Injection (Currently in Shortage)
Cefepime Injection (Currently in Shortage)
Dextrose 5% Injection Bags (Currently in Shortage)
Epinephrine 1mg/mL (Preservative Free) (Currently in Shortage)
Epinephrine Injection (Currently in Shortage)
Fentanyl Citrate (Sublimaze) Injection (Currently in Shortage)
Levetiracetam (Keppra) Injection (Currently in Shortage)
Lidocaine Hydrochloride (Xylocaine) Injection (Currently in Shortage)
Piperacillin and Tazobactam (Zosyn) Injection (Currently in Shortage)
Sodium Chloride 0.9% Injection Bags (Currently in Shortage)
August 12, 2015
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

Calcium Gluconate Injection (Currently in Shortage)
Cefazolin Injection (Currently in Shortage)
Cefotetan Disodium Injection (Currently in Shortage)
Dexamethasone Sodium Phosphate Injection (Currently in Shortage)
Haloperidol Lactate Injection (Currently in Shortage)
Imipenem and Cilastatin for Injection, USP (Currently in Shortage)
Leucovorin Calcium Lyophilized Powder for Injection (Currently in Shortage)
Lidocaine Hydrochloride (Xylocaine) Injection (Currently in Shortage)
Potassium Chloride Injection (Currently in Shortage)
Vancomycin Hydrochloride for Injection, USP (Currently in Shortage)
FDA Medwatch
 Drug Safety Labeling Changes
o http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm457920.htm?source=govd
elivery&utm_medium=email&utm_source=govdelivery
August 14, 2015
 Antibiotic Injectable Coming Off FDA Shortage List
o http://www.empr.com/news/cefazolin-injection-galaxycontainer/article/432764/?DCMP=EMCMPR_DailyDose_cp&cpn=mylan_2014,strib_pharm,strib_mobile&hmSubId=&hmEmai
l=zc9AEZF4x4rPbtLJAxJhmklDzcJVA8s10&NID=&dl=0&spMailingID=12141043&spUserI
D=NDgyNTEwMTE5NjYS1&spJobID=601021210&spReportId=NjAxMDIxMjEwS0
Patient Safety
 Compounded Drugs Stored in Becton-Dickinson (BD) 3 ml and 5 ml Syringes: FDA Warning - Do
Not Use
o http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedi



calProducts/ucm458955.htm
Da HeeHan, PharmD
August 17, 2015
Obesity Drug Labeling Updated with New Interaction, Side Effect
o http://www.empr.com/safety-alerts-and-recalls/xenical-labeling-updatedinteractions-adr/article/433134/?DCMP-EMC-MPR_DailyDose_cp&cpnmylan_2014,strib_pharm,strib_mobile&hmSubld-&hmEmailzc9AEZF4x4rPbtUAxJhmklDzclVA8s10&NID-&dl-0&spMailingID-1215615&spUserIDNDgyNTEwMTE5NjYS1&spJobID-601226490&spReportId-NjAxMjl2NDkwS0
This content is copyright protected. However, if you would like to share the information in this
article, you may use the headline, summary and link below:
Three Mylan plants in India hit with FDA warning letter by Zachary Brennan, 19-Aug-2015
As it tries to close its biggest deal ever – a $33 bn acquisition of Perrigo – Mylan is now also
dealing with an FDA warning letter citing cGMP violations tied to three of its manufacturing
facilities in India.
o http://www.in-pharmatechnologist.com/Product-Categories/APIs-activepharmaceutical-ingredients/Three-Mylan-plants-in-India-hit-with-FDA-warning-letter
o http://www.in-pharmatechnologist.com/Regulatory-Safety/Three-Mylan-plants-inIndia-hit-with-FDA-warning-letter
August 14, 2015
 OxyContin Approved for Pediatric Patients
o http://www.empr.com/news/oxycontin-approved-ages-11-andolder/article/432760/?DCMP=EMCMPR_DailyDose_cp&cpn=mylan_2014,strib_pharm,strib_mobile&hmSubId=&hmEmail=
zc9AEZF4x4rPbtLJAxJhmklDzcJVA8s10&NID=&dl=0&spMailingID=12139325&spUserID=
NDgyNTEwMTE5NjYS1&spJobID=601009363&spReportId=NjAxMDA5MzYzS0
From Drug Topics:
Safeguarding the U.S. drug supply
 What you need to know to comply with the DSCSA
o http://drugtopics.modernmedicine.com/drug-topics/news/safeguarding-us-drugsupply
New Drug or Treatment
 Corlanor® is indicated for1:
o http://www.corlanorhcp.com/?WT.z_co=A&WT.z_in=CHF&WT.z_ch=DSP&WT.z_ag=AG5
31&WT.tsrc=DSP&WT.mc_id=A_CHF_DSP_AG531
 Anti-Opioid Approved for New Indication
o http://www.pharmacytimes.com/product-news/fda-expands-indication-of-anti-opioiddrug?utm_source=Informz&utm_medium=Pharmacy+Times&utm_campaign=PT_Breaki
ng_News_8-12-15
 FDA approves first treatment for sexual desire disorder
o http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/UCM458734.htm?so
urce=govdelivery&utm_medium=email&utm_source=govdelivery
 FDA approves Boehringer Ingelheim’s Stiolto™* Respimat® as once-daily maintenance treatment
for COPD
o https://www.boehringeringelheim.com/news/news_releases/press_releases/2015/26_may_2015_copd.html
 Information From Merck Regarding a Product Label Change
o http://www.merck.com/product/usa/pi_circulars/p/pegintron/pegintron_pi.pdf?utm_so
urce=EMAIL&utm_medium=Email&utm_content=PG014&utm_campaign=US%2B%2BPEGINTRON%2B-%2BPHARMACIST%2BUPDATE%2BEMAIL%2B1%2BINFC-11526840003
HIPAA
 Are You Confident About Passing a HIPAA Audit?
o http://hcsiinc.blogspot.com/2015/06/are-you-confident-about-passinghipaa.html?m=1
 Drug Pumps Are Vulnerable to Hacking, FDA Warns
o http://www.jdsupra.com/legalnews/drug-pumps-are-vulnerable-to-hacking72129/?utm_source=JD-Supra-eMail-Digests
 Hack of UCLA Health May Affect 4.5 Million
o http://hcsiinc.blogspot.com/2015/07/45-million-possibly-affected-in-ucla.html
 Medical Student Learns The Hard Way To Not Take Selfies With Your Sick Patient
o http://www.medicaldaily.com/medical-student-learns-hard-way-not-take-selfies-yoursick-patient-347870?rel=most_read2
HOSPITAL
 2015 Hospital
 National Patient Safety Goals
o http://www.jointcommission.org/assets/1/6/2015_HAP_NPSG_ER.pdf
 To improve patient satisfaction, hospitals target sleep disruptions
o http://www.fiercehealthcare.com/story/improve-patient-satisfaction-hospitals-targetsleep-disruptions/2015-08-17?utm_medium=rss&utm_source=rss&utm_campaign=rss
INSURANCE
 2016 formulary exclusions in 9 key areas
o http://drugtopics.modernmedicine.com/drug-topics/news/2016-formulary-exclusions-9key-areas?page=0,4
 When an Overpayment Becomes a False Claims Act Issue: Explaining the First Judicial
Interpretation of the 60-Day Rule
O http://www.jdsupra.com/legalnews/when-an-overpayment-becomes-a-false31874/?utm_source=JD-Supra-eMail-Digests
This content is copyright protected. However, if you would like to share the information in
this article, you may use the headline, summary and link below:
FDA approves first 3D-printed drug by Fiona Barry, 04-Aug-2105
A private Pennsylvania company says it has made the first 3D-printed drug to be approved by
the US FDA. http://www.in-pharmatechnologist.com/Product-Categories/Deliverformulations/FDA-approves-first-3D-printed-drug
http://www.in-pharmatechnologist.com/Drug-Delivery/FDA-approves-first-3D-printed-drug
This content is copyright protected. However, if you would like to share the information in
this article, you may use the headline summary and link below:
Echo’s cannabis API delivery formulation could aid low solubility drugs. By Dan Stanton, 30Jul-2015
A drug delivery platform which increased the bioavailability of a cannabis-based drug
candidate 30% could be used to boost solubility of other APIs, says Echo Pharmaceuticals.
http://www.in-pharmatechnologist.com/Product-Categories/Delivery-formulations/Echo-scannabinoid-delivery-tech-could-aid-low-solubility-drugs
This content is copyright protected. However, if you would like to share the information in
this article, you may use the headline, summary and link below:
Pfizer calls on Mylan to make generics for Japan. 28-Aug-2012
Mylan will manufacture Pfizer’s generic drugs for the Japanese market under a new
collaboration. http://www.in-pharmatechnologist.com/ingredients/Pfizer-calls-on-Mylan-tomake-generics-for-Japan
http://www.in-pharmatechnologist.com/Ingredients/Pfizer-calls-on-Mylan-to-makegenerics-for-Japan
NEWS
 Healthcare Internet On The Horizon
O http://www.healthitoutcomes.com/doc/healthcare-internet-on-the-horizon0001?sectionCode=Articles&templateCode=Single&user=3049723&source=nl:43661&utm_source=et_
6231164&utm_medium=email&utm_campaign=HCIT_2015-08-18&utm_term=ffdb479f-a19f-466babb0-55d4329c64fa&utm_content=Healthcare%2bInternet%2bOn%2bThe%2bHorizon
 Walmart gets serious about health care clinics
August 11, 2015 | By Michael Johnsen
o http://www.drugstorenews.com/article/walmart-gets-serious-about-health-careclinics?utm_term=DSN204761&utm_source=MagnetMail&utm_medium=subject&utm_term
=Weekend%20Update%3A%20DSN%27s%2010%20HOTTEST%20TRENDING%20stories%20thi
s%20week&utm_content=DSN-NLE-WeekendUpdate-08-15-15