Don’t Get Caught Short with

Medication Shortages

Tammy Cohen BS, PharmD, MS, FACHE, FASHP, FTSHP

Vice President, Pharmacy Services

Baylor Scott & White Health

1. Discuss impacts of drug shortages

2. Review common causes of drug shortages

3. Outline shortage impact mitigation strategies

Objectives

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Drug Shortages – What is it?

The FDA defines a drug shortage as:

“A period of time when the demand or projected demand for the drug within the U.S.

exceeds its supply.“

FDA Drug Shortages Infographic

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https://www.fda.gov/drugs/drug-shortages/drug-shortages-infographic

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National Drug Shortages: Annual New Shortages

by Year January 2001 to June 30, 2019

Note: Each column represents the number of new shortages identified during that year. University of

Utah Drug Information Service

https://www.ashp.org/Drug-Shortages/Shortage-Resources/Drug-Shortages-Statistics

Increased spend:

• Time/staffing to implement mitigation strategies and manage shortages

• Inability to meet requirements for 340B programs

• Higher cost of second choice and simple supply and demand – generic inversion

Results of Drug Shortages

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Patient care impacted

• Lack of medication for the patient, resulting in changed dosage, or second choice

medication, and potentially higher cost

Results of Drug Shortages cont.

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9

340B Impacts

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• In response to shortage drugs are purchased from multiple manufacturers

with available product

• Using this method, it is often not possible to achieve a full “bucket” to

purchase on a 340B account

• 340B savings are not realized

340BMfg A

10%

Requirement

met

Mfg B

5%

Requirement

met

Mfg C

13%

Requirement

met

Mfg D

2%

Requirement

met

In June 2018, a group of 31 U.S. Senators and 104 members of the House of

Representatives wrote to Scott Gottlieb, MD, then Commissioner of the FDA, to ask

for assistance in addressing the nations drug shortage crisis.

• In response, the FDA convened an inter-agency Drug Shortages Task Force.

• A team of FDA economists and other scientists to analyze drugs that went into shortage

between 2013-2017 to find the underlying cause of the shortages.

o They analyzed 163 drugs and found that:

▪ 63% were sterile injectables

▪ 67% were drugs that have a generic version on market

o They were older drugs, with a median time since first approval of almost 35 years.

Response from Congress

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Why do Drug Shortages Occur?

https://www.pharmacytimes.com/publications/issue/2019/may2019/what-factors-are-contributing-to-drug-shortages

Causes of Drug Shortages

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Manufacturing Standard Non-

Compliance

Raw Material Shortages

Manufacturing Capacity Issues

Restricted Distribution/

Product Allocation

Poor Ordering Practices

Device Issues

Causes of Drug Shortages

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Manufacturing Standard Non-

Compliance

Raw Material Shortages

Manufacturing Capacity Issues

Restricted Distribution/

Product Allocation

Poor Ordering Practices

Device Issues

Manufacturer standards are not transparent across the industry which prevents

purchasers from favoring manufacturers with higher standards/rates of compliance

• ceftolozane / tazobactam injection: Merck has Zerbaxa on shortage due manufacturing issues related

to sterility. They are the sole suppliers of ceftolozane and tazobactam injection. There is a global recall of

Zerbaxa.

Manufacturing standard non-compliance:

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Causes of Drug Shortages

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Manufacturing Standard Non-

Compliance

Raw Material Shortages

Manufacturing Capacity Issues

Restricted Distribution/

Product Allocation

Poor Ordering Practices

Device Issues

Hinges on the number of suppliers for materials – if a natural disaster hits or political

disruption effects the only country where raw materials are produced, supply will drop

leading to final product shortages.

Raw Material Disruption:

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China manufactures the raw material for

penicillin

Italy manufactures the raw material for

Succinylcholine

Causes of Drug Shortages

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Manufacturing Standard Non-

Compliance

Raw Material Shortages

Manufacturing Capacity Issues

Restricted Distribution/

Product Allocation

Poor Ordering Practices

Device Issues

Typically a result of quality issues delaying manufacture from a single manufacture →

generic products are typically manufactured on the same line as many other products and

there is no redundancy built in when something goes wrong; a small number of

manufacturers are responsible for production of the majority of injectable drug products

• Atropine Syringe and Epinephrine Syringe: Amphastar (IMS) and Pfizer are the only manufacturers. Pfizer’s

syringes are on manufacturer backorder with no estimated release date. Amphastar is releasing products periodically

but unable to keep up with demand.

• Protamine Injection: Fresenius Kabi is the sole manufacturer, and their shortage is due to manufacturing delays. The

estimated release is TBD. There are short-dated 25ml vials available.

• Sincalide Injection: Bracco Diagnostics is the sole manufacturer. The shortage is due to manufacturing delays, and

they do not have an estimated release date

• IV fluid Production: In 2017 Hurricane Maria disrupted Baxter International’s IV fluid production facilities in Puerto

Rico and B. Braun announced they were slowing production. o Although Hurricane Maria affected Baxter’s facilities in Puerto Rico, there have been limited supplies of IV fluids since 2014. Since

that time, the approved manufacturers Pfizer/Hospira and now ICU Medical, Baxter and B. Braun, have worked with FDA to meet

steadily increasing demand for IV fluids.

Manufacturing Capacity Issues:

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Generic Inversion Example

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Year over year growth in generic drug spend (cost per unit)

“Officials Question the Rising

Cost of Generic Drugs”

New York Times – Oct 2014

Generic Drug Jan.

2013

Jan. 2014 Jan. 2015

Nitroprusside $43.67 $206.34 $206.28

Vasopressin $27.61 $90.05 $283.00

Hydralazine $2.00 $2.32 $79.86

Isuprel $443.75 $2,096.72 $2,096.07

Point of price inversion for generics

Causes of Drug Shortages

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Manufacturing Standard Non-

Compliance

Raw Material Shortages

Manufacturing Capacity Issues

Restricted Distribution/

Product Allocation

Poor Ordering Practices

Device Issues

Bypassing normal supply chain, mandatory order direct from manufacturer,

allocations, etc.

• Betamethasone Acetate/Betamethasone Sodium Phosphate Susp Injection: Manufacturers have not

provided a reason for the shortage. American Regent has a limited supply that they are allocating weekly.

Restricted distribution/product allocation:

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Supplier

Hospital

One

Hospital

Two

Hospital

Three

Hospital

Four

A L L O C A T I O N

Causes of Drug Shortages

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Manufacturing Standard Non-

Compliance

Raw Material Shortages

Manufacturing Capacity Issues

Restricted Distribution/

Product Allocation

Poor Ordering Practices

Device Issues

Poor ordering practices, stockpiling before announced price increases, hoarding

caused by rumors of an impending shortage, and unexpected delivery delays

Poor Ordering Practices:

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Causes of Drug Shortages

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Manufacturing Standard Non-

Compliance

Raw Material Shortages

Manufacturing Capacity Issues

Restricted Distribution/

Product Allocation

Poor Ordering Practices

Device Issues

Shortage of epi due to injectors The FDA declared an EpiPen shortage across much

of country in April 2018. The supermarket chain Wegmans first reported shortages of the

medication injector in its pharmacies in late April 2018. In late 2018 in an effort to reduce the

shortage the FDA extended the expiration dates of certain batches of EpiPen’s

Device Issues:

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Emergency Syringes

• Sodium Bicarbonate Injection

• Atropine Injection

Other Device Issues

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Long-term shortages of the syringes could become a problem as suppliersscramble to meet demand that will rise into the hundreds of millions. TheDepartment of Health and Human Services said last month that it hadadvised the FDA about the potential of a long-term shortage of the specialinjectors.BD, the largest syringe manufacturer in the world, said last month thatestablishing new production lines to make more of the special equipmentwill not be a rapid process. Under a U.S. government contract, BD isexpanding production of standard syringes at a plant in Nebraska, aprocess that began last year and is expected to be complete by the summer.B. Braun and Smiths Medical, two other large manufacturers, declined tocomment in detail on demand created by Pfizer. B. Braun said it does notmake the low-dead-zone syringes in the United States and that its foreignaffiliates lack capacity.

How can you manage it?

Compound it Use a different

productGo without

Get ahead - watch FDA site/ twitter/

vendor relationships / ASHP/ FDA

Delay elective care Use of meds for off

label use

Shortage Management Process

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Receive potential shortage

notification

ConfirmCollect

Data and Information

Inform and discuss

Develop an action plan

Implement action plan

M

O

N

I

T

O

R

Example of Management Process

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On the Pharmacy & Therapeutics council agenda

A budget line item

Cost of software to track shortages

Communication Plans

A new job created to track and manage shortages

Cost of labor increasing to track shortages

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• Partnership to reduce impact of drug shortages and associated

price increases− Portfolio of generic drug for which volumes are guaranteed to health system

partners

− Health systems order generic products included in a portfolio through the

partnership as opposed to the standard supply chain thereby ensuring product

availability at an expected cost

Drug Shortage Risk Reduction Strategy

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Questions

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