Transcript Drug Shortages by Primary Reason for Disruption in Production and

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
Sampling of Chemotherapy /Supportive
Medication Shortages
Chemotherapy
Chemotherapy
Bendamustine
Leucovorin
Bleomycin
Mannitol
Carboplatin
Mesna
Cytarabine
Methotrexate
Dacarbazine
Methylene Blue
Daunorubicin
Ondansetron
Dexrazoxane
Paclitaxel
Doxorubicin
Sodium Thiosulfate
Fludarabine
Thiotepa
Fluorouracil
Vinblastine
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 marketplace
 shortage 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
 Contamination – i.e Dexamethasone from American Regent
 Limited Production of product
 Manufacturing Line Prioritization – i.e. Ketorlac Carpuject all strengths
http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm
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




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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



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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/Dr
ugShortages/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 NonVA 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?