Thomas Eingle, R.Ph. Inpatient Pharmacy Supervisor James A. Haley Veterans Hospital, Tampa, Fl.
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Transcript of Thomas Eingle, R.Ph. Inpatient Pharmacy Supervisor James A. Haley Veterans Hospital, Tampa, Fl.
Thomas Eingle, R.Ph.
Inpatient Pharmacy Supervisor
James A. Haley Veterans Hospital, Tampa, Fl
Disclosures
Thomas Eingle declares no conflicts of interest, real or apparent, and no financial interests in any company, product, or service mentioned in this program.
Objectives List drugs affected by national drug
shortage Breakdown and discuss cited reasons
for National Drug shortage Discuss FDA response Learn about resources to manage drug
shortages Discuss VAMC considerations in drug
procurement to solve drug shortages
Senate Finance Committee Hearing on “Drug Shortages: Why They Happen and What They Mean” December 7, 2011
“In the past five years, shortages have rapidly escalated, increasing from 70 in 2006 to 231 as of this November, and there appears to be no end in sight. “
Hot off the Press!
Sampling of Drug Shortages affecting Inpatient Hospital setting
Injectable Drug Injectable Drug
Amiodarone Furosemide
Atracurium Haloperidol
Atropine Heparin
Bumetanide Hydromorphone
Desmopressin inj Levofloxacin
Dexamethasone NaPO4 Lorazepam
Diazepam Magnesium sulfate
Digoxin Mannitol
Diltiazem Metoclopramide
Fentanyl Midazolam
Fluconazole Morphine
Fosphenytoin Pancuronium
Several ingredients for TPNs
Chemotherapy Chemotherapy
Bendamustine Leucovorin
Bleomycin Mannitol
Carboplatin Mesna
Cytarabine Methotrexate
Dacarbazine Methylene Blue
Daunorubicin Ondansetron
Dexrazoxane Paclitaxel
Doxorubicin Sodium Thiosulfate
Fludarabine Thiotepa
Fluorouracil Vinblastine
Sampling of Chemotherapy /Supportive Medication Shortages
http://www.ashp.org/DrugShortages/Current
Drugs on Shortage
List of current drugs on shortage available at http://www.ashp.org/DrugShortages/Current/ Lists Drugs on shortage with date revised If click on specific drug gives detailed information about:
○ Product affected○ Reason for shortage○ Available Products○ Estimated Resupply dates○ Related shortages
Drug Shortages by Primary Reason for Disruption in Production and Supply
[Food and Drug Administration, 10/31/11] Key: API = Actual Pharmaceutical Ingredient
Dosage Forms and Drug Source Affected
ismpinstitute.org
Cited Reasons for Drug Shortages Supply/Demand issues Production issues Aging Manufacturing Plants Shortage of Raw Materials Generic manufacturing not profitable Gray Market hoarding medications
A Matter of Simple Economics: Supply and Demand Increased demand for certain drugs can be
caused by:competing manufacturers that have discontinued
or withdrawn the product from the marketplaceshortage of raw materials
○ Foreign source○ Manufacturer not relinquishing exclusive raw
material contracts when the product is discontinued (usually because they are working on a “next generation” generic that will be soon marketed)
Supply/Demand Example
http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm
How manufacturing and supply chain issues can cause drug shortages.
www.FDA.gov
Production Problems
http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm
Contamination – i.e Dexamethasone from American Regent Limited Production of product Manufacturing Line Prioritization – i.e. Ketorlac Carpuject all strengths
Aging Production Plants
Shortage of methotrexate and doxorubicin was triggered by an FDA inspection of a generic manufacturing plant in Ohio. The Ben Venue Laboratories flunked because there was mold on the walls, rust from aging equipment falling into the medication and other violations of good manufacturing practice.
The Perfect Storm that Creates Drug Shortages for Generic Products Medicare restrictions on average sale prices (which
can only be updated every six months) for generic medicines
just-in-time inventory supply practices at hospitals reverse-auction contracts from large group
purchasing organizations for supplying generic drugs tougher FDA manufacturing and inspection
standards for domestic companies (which can raise costs)
increased global competition from low-cost suppliers in India and China
Gray Market
Gray Market They buy up drugs for everything from
cancer to infections, stockpile them, then sell them to hospitals at massive markups.
The average markup on drugs is 650% FDA is accepting cases of gray market
abuse that it would refer to the Department of Justice.
If you are experiencing issues with gray market suppliers, contact the FDA Drug Shortage Office.
FDA Response Work with manufacturers that report drug
shortage issues If necessary, ask alternative manufacturers
to increase production Expedite the review of data to support
approval of a new generic drug product Allow importation of product from other
countries until the shortage is resolved Assist manufacturer in instituting a drug
allocation program to limit distribution
FDA Response
Resources to Manage Drug Shortage
www.ashp.org/DrugShortages
http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm
Issues Specifically Related to VAMC VA can only order drug products that are
made in countries listed on the TAA Designated Country list.Turkey and India are not on this list
VAMC is not able to obtain emergency alternative medications as easily as other Non-VA hospitals.
Designated Countries
Conclusions Drug Shortages affect patient safety Resources are available to assist in
managing the drug shortage Best to research therapeutic alternatives
proactively Best to have an organizational agreement
on prioritizing patients and/or placing restrictions for use
Best to not hoard drugs that are on shortage or their alternatives
Questions?