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?