“You Don’t Have…What?” - Wild Apricot Spring Confer… · •MDI [s to Powder to…Elipta...

2/23/2016

1

“You Don’t Have…What?” Drug Shortage in the Hospital Setting

Rob Wills, Pharm.D., BCPS

Sr Clinical Manager of Pharmacy

St. Luke’s Boise & Meridian Medical Centers

March 2016

Disclosures

• Nothing to disclose

Objectives

• Identify at least two potential causes of drug shortages.

• Discuss at least two potential strategies to manage drug shortages in the hospital setting.

• Identify two resources that can notify them of current medication shortages.

Drug Shortages Forcing

Hard Decisions on

Rationing TreatmentsSuch shortages are the new normal in American medicine.

But the rationing that results has been largely hidden from

patients and the public.By SHERI FINKJAN. 29, 2016

“We essentially did military-style triage,”

• Dr. Fitzsimons restricts the limited supply to patients at the highest risk of bleeding complications.

• Dr. Brian Fitzsimons, an anesthesiologist at the Cleveland Clinic

• Credit T.J. Kirkpatrick for The New York Times

http://www.nytimes.com/2016/01/29/us/drug-shortages- www.gettyimages.com

http://topics.nytimes.com/top/reference/timestopics/people/f/sheri_fink/index.html

2/23/2016

2

Airforce.com

Emergency

• Time critical area

• Epinephrine

• Lorzepam

• Promethazine

• Ondansetron

• Multivites?

ER drug shortages for life-saving medications on the riseMonday, January 25, 2016 | By Zack Budryk

• Drug shortages in hospital emergency departments have worsened, increasing more than 400 percent since 2008, according to a study published in Academic Emergency Medicine.

• Nearly 1,800 drug shortages were reported between 2001 and 2014

• More than half of the shortages involved lifesaving drugs

• More than 1 in 3 involved drugs used in emergency rooms

• The drugs most at risk for a shortage

• infectious diseases

• Poisoning

• Severe pain

• Although shortages dropped between 2002 and 2007, they spiked 435 percent from 2008 to 2014.

Hawley, K., et al. Longitudinal Trends in U.S. Drug Shortages for Medications Used in Emergency Departments (2001–2014). Academic Emergency Medicine. 2016; 23(1):63-69.

Academic Emergency MedicineVolume 23, Issue 1, pages 63–69, January 2016

Academic Emergency MedicineVolume 23, Issue 1, pages 63–69, January 2016

http://go.questexweb.com/f00Ze7Q0HX00FQ1nMuF7s03

http://go.questexweb.com/I0F0ZMH0Q3s9ue1n0Z0QF07

http://onlinelibrary.wiley.com/doi/10.1111/acem.2016.23.issue-1/issuetoc


2/23/2016

3

Antibiotics

• Cefazolin

• Cefotetan

• Zosyn

• Meropenem

• Vancomycin

• Unasyn

Oncology• Drug Shortage Occurs

• First seek different formulation• Concerns over potential

errors in dosing and admin• Different concentrations• Different Packaging• Different storage

requirements, etc.

• Then seek alternative med• Possibly older line of therapy• Increase adverse events• Drug interactions• Decreased efficacy

• Worst case scenario• There are no alternatives• Result is to triage patients to

determine who gets meds

Goldsack J, et al. Impact of shortages of oncology injectable drugs on patient care. American Journal of Health-System Pharmacy April 1, 2014 vol. 71 no. 7 571-578

Young & Old

• “Two kids in front of you, you only have enough for one. How do you choose?”• DR. YORAM UNGURU

http://www.nytimes.com/2016/01/29/us/drug-shortages-

Large & Small

• Obese patients, who researchers found needed up to three times the amount of an antibiotic before surgery than average-size patients, were given only the standard dose at the Cleveland hospital until a shortage subsided.

http://www.nytimes.com/2016/01/29/us/drug-shortages-

familymedicinehelp.com

2/23/2016

4

Hospira.com Ehealthsource.biz hospira.com

Why are we talking about this?

1. Drug product shortages can adversely affect drug therapy

2. Compromise or delay medical procedures

3. And can result in medication errors

4. Affects bottom line – budgeting med costs

5. And…can cause spontaneous yelling by pharmacists, pharmacy buyers, clinical managers

6. And...can cause hypertension and hair loss in managers

7. And...

Fox E, Birt A, James K, KoKKo H, Salverson S, and Soflin D. ASHP Expert Pannel on Drug Shortages. ASHP Guidelines on Managing Drug Product Shortages in Hospitals and Health Systems. Am J Health-Syst Pharm. 2009; 66:1399-406

Slowing Progress

A shortage of chemotherapy drugs such as doxorubicin is causing problems for clinical trials.COLIN CUTHBERT/SPL

http://www.nature.com/news/2011/111003/full/news.2011.570.html

Drug shortage slows clinical

trials

US researchers faced with

cancer-drug shortfall struggle

to keep trials on track.

2/23/2016

5

Who gets it?

• Some institutions prioritize based on age; others do not.

• Marc Earl, a Cleveland Clinic pharmacist, said children were not favored over adults during chemotherapy shortages

srxawordonhealth.comhttp://www.nytimes.com/2016/01/29/us/drug-shortages-

Playing the shortage game

• “We do play the pediatric card for sure,” said Alix Dabb, a pharmacy specialist in pediatric oncology at Johns Hopkins Hospital.

Cookschildrens.comhttp://www.nytimes.com/2016/01/29/us/drug-shortages-

Pharmacist Gatekeeper

Cookschildrens.comhttp://www.nytimes.com/2016/01/29/us/drug-shortages-

Chris Snyder, a pharmacist at the Cleveland Clinic, tracks a list of shortages that included more than 75 drugs the first week of January.

Learning Assessment Questions1. Which of the following are potential causes of drug

shortages?a) Voluntary recall

b) Change in guidelines that cause an unexpected increased demand

c) Raw & Bulk material unavailability

d) Industry consolidations

e) Both a and c are potential causes

f) All of the above are potential causes of drug shortages

Answer: F. All of the above

Academic Emergency MedicineVolume 23, Issue 1, pages 63–69, January 2016 http://betterbusinesshealth.mckesson.com/wp-content/uploads/2015/02/marketing-insights_vaccines_vaccine-factory-fc_full.jpg


2/23/2016

6

Contributing Factors

• Can be a result of one or multiple factors in a supply chain

• Supply Chain includes

• sources of raw materials

• manufacturers

• regulators

• wholesalers or distributors

• Natural disasters

• prime vendors

• group purchasing organizations

• And end- user health care systems


http://www.ncsl.org/portals/1/ImageLibrary/WebImages/Health/FDA_DrugShortage_Pie_Large.jpghttp://www.drugchannels.net/2011/11/whats-behind-drug-shortage-epidemic.html

Raw & Bulk Material Issues

• Unavailability of raw and bulk material • Suboptimal quality of raw materials • Raw material shortage can result from a number of factors

• including a sole source manufacturer that ceases operation,• suboptimal quality of the raw material• wars that disrupts importation

• In 2010, nearly half of drug shortages resulted from quality issues of raw materials• including impurities• microbial contamination• chemical instability

• 80% of the raw materials come from foreign markets• The market for Chinese active pharmaceutical ingredients (APIs) was reduced by

nearly 50% in 2010, • Heparin contamination in 2008

• Especially problematic when a major or sole-source supplier ceases production• Downstream effects of all the producers of finished product


http://z.umn.edu/INNOVATIONS 2011, Vol. 2, No. 4, Article 60

Manufacturing Difficulties and Regulatory Issues

Contributing factors may include:• Old or antiquated manufacturing

equipment• Shift of resources by the

manufacturer from maintenance of equipment and facilities to research and development

• Loss of experts or those experienced enough to maintain GMPs as a result of company mergers or retirements

• cGMP-related problems with subcontractors who supply products to multiple pharmaceutical manufacturers

• And limited FDA resources for timely inspections of manufacturing sites.

Fox E, Birt A, James K, KoKKo H, Salverson S, and Soflin D. ASHP Expert Pannel on Drug Shortages. ASHP Guidelines on Managing Drug Product Shortages in Hospitals and Health Systems. Am J Health-Syst Pharm. 2009; 66:1399-406 rd.com

2/23/2016

7

Manufacturing Difficulties and Regulatory Issues• FDA and compliance with GMPs

• Lengthy process to get out of

• Some manufacturers decide just to close shop

• FDA wants to help the public…protect the public...so

• FDA actions are evaluated by FDA’s Center for Drug Evaluation and Research (CDER) drug shortage coordinator

• Want to determine if the action might create a drug shortage

• If corrective action involves a medically necessary product

• FDA will help the manufacturer get back up and running

• OR permit a foreign manufacturer to supply product


Recalls

• Generally occur due to a lapse or issue with manufacturing

• Usually affect specific lots but could be of significant scale

• Particularly significant for sole sourced products

• Or if this manufacturer's product really dominates the market

• Switching to alternatives can work but typically their production is not on the scale to fulfill the need

• Can cause ethical problem if the recalled product is all we have


Change in Product

• In formulation

• MDI’s to Powder to…Elipta and Respimat, oh my!

• Another is the transition from albuterol metered-dose inhalers (MDIs) containing chlorofluorocarbons to MDIs containing hydrouoroalkanes in 2006

• In Manufacturer

• Yes, Hospira/Pfizer we are looking at you!

• The great merger of Pfizer and Hospira has see product availability issues.

• Others?


Manufacturer’s Product Decisions and Economics• Decisions based on a variety of factors

• Availability of generic products

• Market size

• Patent expiration

• Drug-approval status

• Regulatory compliance requirements

• Anticipated clinical demand

• Management of new products

• Stopping or reducing production for new or other agents

• Manufacturer decides to stop permanently

• Hits hard for sole sourced items

• FDA application process


Industry Consolidations

• Mergers

• Yes, Hospira/Pfizer we are still watching

• Teva and Mylan Allergan

• Mylan (Merk & Abbot)

• Pharma companies believe that acquisitions are really the only way to see continued growth in revenues

• Cheaper than creating a blockbuster medication!

• Moving plant operations to another facility

• Waiting on a new facility to come online

Fox E, Birt A, James K, KoKKo H, Salverson S, and Soflin D. ASHP Expert Pannel on Drug Shortages. ASHP Guidelines on Managing Drug Product Shortages in Hospitals and Health Systems. Am J Health-Syst Pharm. 2009; 66:1399-406 http://fortune.com/2015/07/28/why-pharma-mergers-are-booming/

Distribution & Allocations

• Manufacturers bypass the typically wholesaler pathway and often allow for allocations

• Reduces hoarding by wholesalers and systems

• Problems arise when allocation is not available

• Promises, promises

• Specialty distribution

• Can cause delays

• Maybe not seen as often since this is usually with newer brand name meds that haven’t seen the shortages as of late like generic products


2/23/2016

8

Inventory Practices

• The Lean Journey OR ‘Just In Time’ inventory

• Next day delivery from wholesalers

• Allowed hospitals to keep inventory levels down

• Increases risk that if shortage occurs it can affect a Hospital or Health System very rapidly

• Reduces the cost of inventory on hand and optimizes cash flow

• Occurs not just with hospitals but with all points in the supply chain

• Distributors

• Manufacturers

• Stockpiling following rumors of shortages

• Rural hospitals

• Can’t borrow from neighbors

• More isolated from alternative supply


Inventory Practices

• Risk involved if all hospitals in an area use the same distributor

• Some shortages are wholesaler specific

• Contracts

• GPOs

• etc

Fox E, Birt A, James K, KoKKo H, Salverson S, and Soflin D. ASHP Expert Pannel on Drug Shortages. ASHP Guidelines on Managing Drug Product Shortages in Hospitals and Health Systems. Am J Health-SystPharm. 2009; 66:1399-406 nytimes.com

Demand & Practice Changes• Occurs when a new indication is approved for an existing drug

product

• When usage patterns change in response to new therapeutic guidelines

• When a substantial disease outbreak occurs

• Or when unpredictable factors influence demand

• Examples:

• When the CDC recommended annual influenza vaccination for children age 6–59 months in 2006

• Only one product had FDA-approved labeling for use in children 6–23 months old

• HD Flu Vaccine

• Shortages may be prolonged if there is significant lag time due to availability of raw materials


Natural Disasters

• Blocking Supply Routes• Salt Lake snowed in

• Ice

• Bad weather in other parts of country where product is located

• Damage to manufacturing facility• Tornados

• Hurricanes, etc

• 1998 – Hurricane George caused damage to manufacturing plants in Puerto Rico

• 2005 – Areas affected by Hurricanes Katrina and Rita found themselves in acute need of more medications without the ability to obtain them


Low Margin…for error

• Majority of drugs experiencing shortage from 2001 – 2014 were injectable drugs• Generic sterile injectable drugs

• WHY?• Low reimbursement rates from Medicare Part B

• Initiated in the Medicare Modernization Act of 2003• Commonly referred to as “ASP (average sales price) plus 6%,” • Caps Medicare reimbursement to hospital outpatient clinics and

individual physicians at 6% over the average sales price of the drug.

• Since generic sterile injectables are already priced very low, so the profit margin remains low

• Plus 6-month lag between manufacturers’ submission of ASP data and when changes in sales prices are reflected in reimbursement

• it is difficult for manufacturers to raise their prices more than 6% in any 6-month period. Even though this reimbursement policy

• Doesn’t directly apply to the inpatient setting but indirectly affects supply overall!


Lower Revenue Little Investment

• The constant drive to lower costs leaves little room for investment in manufacturing facilities

• Many manufacturers have dropped out of the market

• Number of manufacturers becoming very small

• Added Factor = Lack of “capacity”

• Another line or facility would not be available to manufacture the same product if active lines or facilities were deemed inoperable

• Shortages concentrated in drugs where the volume of sales and drug prices were declining in years preceding the shortage

• suggests that manufacturers may be diverting resources to more profitable product lines


2/23/2016

9

Drug Shortages & Increasing Labor Costs• To manage drug shortages

• All hands on deck significant use of resources• A survey conducted by the University of Michigan and the American

Society of Health-System Pharmacists (ASHP) indicated that drug shortages create cumulative estimated labor costs of approximately $216 million annually for hospitals nationwide

• Not just to identify alternatives• All steps needed to add/change to alternative product

• Adding to pharmacy database

• Ordering in new product

• Setting up smart pump library

• Cost info

• Safety processes

• Nurse education

• Pharmacy education

• Prescriber education

Goldsack J, et al. Impact of shortages of oncology injectable drugs on patient care. American Journal of Health-System Pharmacy April 1, 2014 vol. 71 no. 7 571-578

The Ripple Effects

• Compounding

• Gray Markets

• Labor Costs

• Patient Care

Theworldoftruth.org

Compounders

• Compounding pharmacies have also pursued the production of drugs that are in short supply

• Caution is warranted because preparations from these pharmacies may not meet applicable state or federal standards

• sources of raw materials used by compounding pharmacies have been questioned

• and apparent lapses in quality control have resulted in serious patient injury, including death


Med Watch Trends –Reports Related to Safety, Medication Quality, and Compounding Quality

69

54 54

36

21

10

21 19

32

16

17

22

0

10

20

30

40

50

60

70

80

90

2009 2010 2011 2012 2013*

Compounding

Quality

Safety

http://www.fda.gov/Safety/MedWatch/default.htm*2013 are data through August

Hartmann R. et al. Combating the Drug Shortage Crisis. 2013 Healthcare supply Expo

Non-Traditional Distributors

• Open or Gray Market, alternative distributors

• Specialty, licensed distributors or brokers obtain products in short supply for the purpose of reselling them to end users who are unable to obtain them through their normal suppliers

• They aggressively market the availability of these products to hospitals, specialty health systems, home care agencies, and physician practices, generally at substantially higher prices

• PROBLEM

• Being able to ascertain the product’s pedigree or ensure the reliability of the product’s source

• Which could be outside the United States, and proper handling and storage throughout the chain of custody


http://democrats.oversight.house.gov/investigations/investigation-of-the-gray-market Pictureline.com

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

2/23/2016

10

http://www.drugchannels.net/2012/07/new-senate-report-ids-gray-market.html http://www.drugchannels.net/2012/07/new-senate-report-ids-gray-market.html

Gray Market Supply.gov• Most drugs enter the gray market

through pharmacies.• These pharmacies usually buy

drugs from legitimate Authorized Distributors of Record (ADR), including AmerisourceBergen, Cardinal Health, McKesson, and H.D. Smith.

• While some buyers are “fake pharmacies,” others appear to be legitimate purchasers, such as Walgreens Infusion Services and a Medicine Shoppe franchisee.

• Multiple secondary wholesalers handle gray market products, adding huge mark-ups along the supply chain.

democrats.oversight.house.gov/agenda/112th-congress-accomplishmentshttp:www.drugchannels.net/2011/10/congress-asks-where-gray-market-drugs.html

Learning Assessment Questions3. True or False: In 2012 the president signed an executive order requiring manufacturers to notify the FDA of of impending production disruptions in certain prescription medications.

a) True

b) False

Answer: True

FDAISIA• FDA Safety & Innovation Act

(July 2012)1. Manufacturers must give 6

month advance notice of temporary or permanent product discontinuations/shortages for all drugs and biologics

2. Approves user fees for generic drugs

3. Also gave FDA authority to expedite review of products and new drug applications

4. Requires the FDA to notify DEA of controlled substance shortages and request the DEA to increase quotas

5. Allows for the repackaging of drugs in short supply for use within the same health system without having to register as a manufacturer

Oertel M. Strategies for Managing Drug Shortages. UNC Grand Rounds 2012

Gov Steps In…

• The justification for FDASIA

• FDA’s bold moves to mitigate shortages

• Determine if other manufacturers are willing and able to increase production

• Expedite inspections and reviews of submissions

• Exercise temporary enforcement discretion for new

• sources of medically necessary drugs

• Work with the manufacturer to ensure adequate investigation into the root cause of the shortage

• Review possible risk mitigation measures for remaining inventory

http://www.fda.gov/downloads/NewsEvents/Newsroom/FactSheets/UCM373078.pdf

2/23/2016

11

Track & Trace Legislation• H.R. 3204, the Drug Quality and Security Act, was approved by a voice vote without amendments

following House passage in late September 2013.• H.R. 3204 will immediately go into effect in 2015.• The legislation sets a number of important deadlines for manufacturers.• By Jan. 1, 2015, all finished-dose forms of prescription drugs must include a lot-level transaction

history that documents each step a product takes from manufacturer to final sale. Manufacturers face the same deadline for establishing a system to quarantine, investigate and validate via the history record a product suspected of being counterfeit, adulterated or stolen.

• The bill also states that four years after enactment drugmakers must affix product identifiers to each package and case of a product that includes a numerical identifier, lot number and expiration date. When a manufacturer receives a returned product that it intends to redistribute, that manufacturer must verify the product identifier on each package beginning four years after enactment.

• Ten years after enactment, manufacturers must develop an electronic traceability system that identifies products down to the sales-unit level.

• The bill also directs HHS to seek public and industry input and issue guidance that:• Defines the circumstances in which a manufacturer can infer that drugs in a large container are what

they purport to be. HHS must hold a public meeting on the issue and then issue a guidance 18 months after that meeting;

• Explains how drugmakers and other supply chain stakeholder can get a waiver from any of the law’s requirements. The guidance is to be issued no later than two years from the date of enactment;

• Helps drugmakers establish mechanisms to identify a suspect product and what to do after it is identified as such. This guidance must be published no later than 180 days after enactment; and

http://www.fdanews.com/articles/160595-senate-passes-prescription-drug-track-and-trace-legislation

January 1st, 2015

• By January 1, 2015, dispensers (primarily pharmacies) must establish systems for verification and handling of suspect or illegitimate product

• The verification requirements include quarantine and investigation of suspect product to determine if it is illegitimate, and notification of FDA and immediate trading partners if illegitimate product is found.

• Also by January 1, 2015, dispensers must confirm that trading partners (manufacturers, repackagers, wholesale distributors, dispensers, and third-party logistics providers) are authorized, as defined by the Food, Drug & Cosmetic Act. FDA suggests checking with trading partners directly to confirm they are authorized, or checking the agency’s drug establishment registration database or the respective state authority to confirm licensure.

• By July 1, 2015, dispensers must be able to provide lot-level product tracing information—namely, transaction information, history, and statements—for 6 years. Such information may be requested by FDA or an appropriate state regulatory authority. (By January 1, 2015, manufacturers, repackagers, and wholesale distributors must provide lot-level product tracing information.) FDA published a related draft guidance in November 2014.

https://www.pharmacist.com/track-and-trace-law-2015-deadlines-new-requirements

Supply Chain

http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm277626.htm

Managing Shortages

Learning Assessment Questions2. Which of the following are potential strategies for managing drug shortages?

a) Auto substitution to equivalent or alternative agent

b) Partnering with outside health-systems to obtain critical supplies

c) Implementing conservations strategies for select patient groups in critical need of the medication

d) Developing strong communication pathways to connect with prescribers and other healthcare team members regarding the shortage and the alternatives

e) Both B & C are correct

f) All of the above

Answer: F. All of the above

Phased Approach


Drug Shortage Identified

Operational Assessment

Shortage Impact Analysis

Establish Final Plan

Communicate Implement

Therapeutic Assessment

http://www.fdanews.com/articles/160595-senate-passes-prescription-drug-track-and-trace-legislation

https://www.pharmacist.com/track-and-trace-law-2015-deadlines-new-requirements

2/23/2016

12

Phased Approach

• Drug Shortage Identification

• 9/10th of the battle

• Knowledge is key








WARNING “Drug Shortage Identified”

• WHAT’S YOUR SYSTEM?• Pharmacy buyers

• Wholesaler alert

• Backorders

• Drug Reps• Hospira, Baxter

• GPO• VHA, HealthTrust

• ASHP• University of Utah

• List serves• Lipids


• AKA Clinical Assessment

• Typically done by a pharmacist

• Identify primary patient population affected

• Identify therapeutic alternatives

• What’s the impact?• Critical med

• Are there alternatives?








Clinical Assessment

• Time to Panic?

• What if alternative is gone?

• In many cases the first 24 to 48 hours are crucial

• Caution – don’t become too trigger happy


• Validate details of shortage

• Determine stock on hand

• Determine supply from predetermined alternative sources

• Determine purchase history and/or current usage at sites

• Estimate time to impact on health system

• Determine supply of alternative drug products








Utilization & Where?

• Utilized in Key area

• Utilized by certain Group

• One physician?

• Procedural?

2/23/2016

13

Shortage Impact

• Estimate Impact on Patient Care• Therapeutic differences• Prescribing processes

• Procedural• Day/time• Codes/sepsis

• Distribution processes• Controlled Med• Procedural area• Clinic site

• Administration processes

• Financial Ramifications








http://www.pharmaceuticalcommerce.com/index.php?pg=manufacturing_and_packaging&articleid=27506&keyword=drug%20shortages-prevention-management-Parenteral%20Drug%20Association


• Hit the go button

• Implement

• Communicate








Implement

• Pull the trigger

• IT system changes• CPOE

• Pharmacy systems

• Smart pumps

• Automated Dispensing Cabinets

• Technological changes• Barcode scanning

• Inventory system

• New procedures








Communicate

• System wide email

• Team huddles

• Newsletter

• Staff

• Physicians

• Rounding








Critical drug shortage: Olanzapine injectionNovember 21, 2014SituationOlanzapine injection 20 mg/mL is on national backorder with an estimated release date in early December 2014.BackgroundOlanzapine injection is an intramuscular atypical antipsychotic that is indicated to treat acute psychomotor agitation in patients with schizophrenia or bipolar mania. It is also often utilized in the inpatient setting for acute agitation.AssessmentOlanzapine injection may be intermittently available prior to the release date. There are currently two alternative short-actingintramuscular atypical antipsychotics available for use in patients with acute agitation: aripiprazole and ziprasidone.Thorazine injection is a short-acting typical antipschotic but is not recommended for the treatment of acute agitation due to its severe adverse effect profile. Additionally, haloperidol injection is a typical antipsychotic available for the treatment ofacute agitation and psychosis. The table below provides dosing information and additional considerations.RecommendationsHaloperidol may be used for the management of agitation related or unrelated to schizophrenia and bipolar disorder in the inpatient setting via the IV or IM route, as appropriate.The intramuscular atypical antipsychotics (olanzapine, aripiprazole and ziprasidone) should all be reserved for use in patients with acute agitation in patients with schizophrenia and bipolar disorder.During the shortage period, if a short-acting intramuscular atypical antipsychotic is warranted, prescribers should select an alternative agent (i.e. aripiprazole or ziprasidone). Risk vs. benefit should be weighed for each patient prior to therapyInitiation.

Example: Seton Health

http://doctors.seton.net/stories/story-detail/critical-drug-shortage-olanzapine-injection

http://doctors.seton.net/stories/story-detail/critical-drug-shortage-olanzapine-injection

2/23/2016

14

http://pharmacyservices.utah.edu/rxweblinks/08.html

Pharmacy Buyers - St. Luke’s Treasure Valley

Drug Code

NDCDescription Next Release

MAX Mont

hly Usage / Each

BIP Total Qty

MIP Total Qty

BIP Total Days

MIP Total Days

Total Days On

Hand

Expected Run Out

DateNotes

503700264-

3105-11CEFAZOL DUPLEX INJ 2GM BRAU x 24

MFR Allocating -No ETA

2400 1000 1272 13 16 28 3/10/2016

Order from Pharmedium when needed, on Allocation to McK but McK has to supply Bbraun with a PO in order for them to

give an ETA

420400264-

3175-11CEFOTETAN DEXT INJ 2GM BRAU x 24

MFR Allocation 96 0 0 0 0 0 2/11/2016 No Sub Avail

79876329-

3316-01EPINEPH 1MG/10ML SYR IMS X 10 MFR Allocation 115 40 85 10 22 33 3/14/2016

Sub on MFR Allocation, Hospira Sub 2720621 ETA June - ON QH,

1mg 1ml Amp 2783603 avail #54 MFR Allocation 2-11-16, 30ml 1763093 avail >100 in

stock 2-11-16

72000264-

1940-20POT CHLOR 15% (2MEQ/ML) 250ML BULK BOTTLE B Braun

MFR Allocation, No ETA

41 14 0 10 0 10 2/21/2016No RED avail 2-11-16, Sub 1200575 No ETA 02-08-16

na00409-

6653-05POTASSIUM CL 2 MEQ/ML VIAL 20 ml

Late Feb 300 100 150 10 15 25 3/7/201620ml Sub 1156249 shipping 1-

27-16

153963323-

0187-30SODIUM CHLORIDE 4 MEQ/ML 30ML Vial x 25

Late Feb 308 125 22 12 2 14 2/25/2016No Drop Ship or Emergency

stock avail 12-17, 100ml avail Direct 12-17-15

219, 9072

00009-0047-22

SOLU-MEDROL A-O-V 125MG 2ML 25


675 100 75 4 3 8 2/18/2016No Sub or Red avail 1-28-16,

Drop ships avail #6 per week 2-09-16

21800009-

0039-28SOLU-MEDROL A-O-V 40MG 1ML x 25


238 140 150 18 19 37 3/18/2016No Sub or Red avail 1-26-16,

Drop ships avail #6 per week 2-09-16

249200409-

3379-04ZOSYN (PIPER/TAZ) INJ ADV 4.5G HW 10

Late Feb 1,940 500 200 8 3 11 2/21/2016 HW - Direct avail 1-22-16

248400206-

8855-16ZOSYN (PIPERACIL-TAZOBACT) VL 4.5GM x 10

FFF - No ETA 640 1630 390 76 18 95 5/15/2016

No Direct or Drop Ship Avail From Below MFR's

APP - ETA Early AprilAPOTEX - Early March Sandoz - LTBO No ETA

AUR - ETA Early FebFrozen bags on allocations list no long term contract needed

not avail as DS through McK 10-20-15

Hospira Sub ETA June, SagentEarly March MFR Allocation

2/23/2016

15

http://infusionnurse.files.wordpress.com/2010/09/drugcartoon.jpg

ASHP Guidance for Purchasing Drug Products in Short Supply 1. Each health system must determine its philosophy on

purchasing drugs from

• the gray market

• compounding pharmacies and on compounding agents in-house

2. These decisions should be made before the pressure and emotion of a specific shortage occur.

3. Each option and its potential effect on patient risk should be evaluated.

4. Nontraditional drug product sources (e.g., secondary wholesalers) have extremely limited supplies, and the quality of these products may be questionable, as the provenance of the medication may be unknown.

http://www.ashp.org/DocLibrary/Policy/DrugShortages/Purchasing-Drug-Products-in-Short-Supply.aspx

ASHP Guidance for Purchasing Drug Products in Short Supply • In the event that the drug product is available only from non-

contracted manufacturers or through nontraditional distributors

• the increased costs of using these sources should be estimated. Using alternative therapies may also increase costs.

• The financial implications should be presented through budget channels, with a request and justification for contingency funds.

• Additional expenditures caused by drug product shortages (e.g., overtime spent in locating product, extra or priority deliveries, in-house compounding or packaging) must be documented to explain budget variances and to support future budget proposals.


ASHP Guidance for Purchasing Drug Products in Short Supply • A consequence of some drug shortages is that product

becomes available from secondary sources at sometimes drastically different price levels.

• ASHP recommends that health systems verify that a wholesaler is licensed to distribute products in their state prior to purchasing drug products from noncontractedwholesalers.

• Information about each state licensing entity is available from

• FDA at http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/ucm281446.htm

• Health systems should also consider requesting pedigree or other tracking information before purchasing products in short supply


http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/ucm281446.htm

2/23/2016

16

“You Don’t Have…What?” - Wild Apricot Spring Confer… · •MDI [s to Powder to…Elipta...

Documents

Transcript of “You Don’t Have…What?” - Wild Apricot Spring Confer… · •MDI [s to Powder to…Elipta...