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Combating the Drug Shortage Crisis. Moderator Ron Hartmann, PharmD , Senior Vice President, Pharmacy, MedAssets Panelists Valerie Jensen, RPh , Cpatain , USPHS, Associate Director, Drug Shortages Program, FDA

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Combating the drug shortage crisis

Combating the Drug Shortage Crisis


Ron Hartmann, PharmD, Senior Vice President, Pharmacy, MedAssets


Valerie Jensen, RPh, Cpatain, USPHS, Associate Director, Drug Shortages Program, FDA

Erin Fox, PharmD, FASHP, Director, Drug Information Service, University of Utah

Bona Benjamin, Director, Medication Use Quality Improvement, American Society of Health System Pharmacists

Mark Hendrickson, Director of Sciences and Regulatory Affairs, Generic Pharmaceutical Association (GPhA)

Combating the drug shortage crisis1

Combating the Drug Shortage Crisis

Erin R. Fox, PharmD

Director, Drug Information Service

University of Utah Hospitals and Clinics


This presentation represents my own opinions, not those of the University of Utah.

National drug shortages new shortages by year january 2001 to september 30 2013
National Drug Shortages New Shortages by YearJanuary 2001 to September 30, 2013

Note: Each column represents the # of new shortages identified during that year

National drug shortages active shortages by quarter
National Drug Shortages – Active Shortages by Quarter

Note: Each column represents the # of active shortages at the end of each quarter.

University of Utah Drug Information Service

Active shortages top 5 drug classes
Active Shortages Top 5 Drug Classes

University of Utah Drug Information Service

What do these numbers mean
What do these numbers mean?

Decreasing rate of new shortages

Ongoing shortages are not resolving

Continued daily impact for patients, clinicians, health systems, health care

Med watch trends reports related to safety medication quality and compounding quality
Med Watch Trends – Reports Related to Safety, Medication Quality, and Compounding Quality

*2013 are data through August

Fragile supply chain generic injectables
Fragile Supply Chain - Quality, and Compounding QualityGeneric Injectables

  • Concentrated market

    • Few products with > 3 suppliers

  • Manufacturing capacity

    • At capacity, no resiliency

    • Multiple products made on single line

  • Complex manufacturing process

    • No simple fixes for quality problems

    • Problems typically affect multiple products

    • ISPE survey identifies “Quality systems of manufacturing” as key cause of shortages

Economic drivers
Economic Drivers Quality, and Compounding Quality

ClinPharmacolTher. 2013;93:170-176

ClinPharmacolTher. 2013; 93:145-147

Example fragile supply chain electrolyte nutrition shortage
Example – Fragile Supply Chain Quality, and Compounding QualityElectrolyte / Nutrition Shortage

Key supplier

Warning letter 2011

Closed in 2012

Trace elements*

Zinc, Selenium*

Sodium phosphate

Potassium phosphate

Calcium gluconate

Calcium chloride

Sodium bicarbonate

Zinc shortage results in dermatitis at Children’s National

Where does fda fit

Where does Quality, and Compounding QualityFDA fit?

Fda s role
FDA’s Role Quality, and Compounding Quality

  • FDA CAN require:


    • FDASIA (Supply disruptions, discontinuations)

    • Manufacturing changes

    • No penalties

  • FDA CANNOT require manufacturers to:

    • Make a drug

    • Make more

    • Distribute in a particular way

  • FDA CANNOT fix a manufacturing problem

Patient care is top concern

FDA works to prevent and mitigate shortages

Fda s approach
FDA’s Approach Quality, and Compounding Quality

Prioritize based on medical necessity

Review risks / benefits of medication

Minimize risk to patients while maintaining availability

Work with manufacturers to address problems


  • Regulatory discretion

  • Request increased production

  • Expedite reviews

  • Temporary importation

Fda efforts
FDA Efforts Quality, and Compounding Quality

Prevention doesn’t work for every shortage

  • Unforeseen breakdowns, API shortage

  • Longstanding quality problems

    Fixes can take a long time

Summary Quality, and Compounding Quality

Drug shortages impact patients daily and are not resolving.

New suppliers are needed to manufacture generic drugs with both high quality and high reliability.

Hospitals need unit of use products – may be an opportunity for suppliers to enter the generic injectables market.

Questions? Quality, and Compounding Quality


Erin Fox

Drug shortages summit 2013

Drug Shortages Summit 2013 Quality, and Compounding Quality

Seeking long-range solutions for drug shortages

Presented to : Healthcare Supply Chain Expo 2013

By: Bona Benjamin, Director, Medication-Use Quality Improvement

American Society of Health-System Pharmacists

October 22, 2013

The difficult problem of shortages
The “difficult problem” of shortages Quality, and Compounding Quality

Apr 19, 2013 Drug Shortages 2.0: Long range solutions

Jul 12, 2002

Provisional Observations on Drug Product Shortages. Am J Health-Syst Pharm—Vol 59 Nov 15, 2002

Nov 5, 2010

Summit agenda
Summit Agenda Quality, and Compounding Quality

Update on FDASIA and FDA’s strategic plan

GPhA update on ARI

Analysis of economic factors

Group discussion of quality, economic, and contributory factors

* Woodcock, J, Wosinska, M. Economic and Technological Drivers of Generic Sterile Injectable Drug Shortages. Clinical Pharmacology and Therapeutics. 93-2: 170-176

Economic factors
Economic factors Quality, and Compounding Quality

Inverse relationship between tolerance for shortage risk and price of drug

Buyers in the dark

Price remains fixed – market fails to correct shortage

Discussion themes
Discussion themes Quality, and Compounding Quality

Ongoing shortages persistent

Traceability issues

  • Inequitable distribution

  • Hoarding/stockpiling

  • “Leaking” supply chain

  • Paper pedigree

    Low bid trumps guarantee of availability

Areas to explore legislative regulatory
Areas to explore Legislative/Regulatory Quality, and Compounding Quality

Accelerate/streamline DEA quota procedures

Continue to enhance FDA communication to providers


Areas to explore legislative regulatory1
Areas to explore Legislative/Regulatory Quality, and Compounding Quality

Consider the BARDA model

Give FDA sufficient resources to manage shortages

Require data that extends expiration dating, if needed.

Areas to explore economic incentives
Areas to explore Quality, and Compounding QualityEconomic incentives

Get payers involved

Offer multiple contract awards

Use FDA quality metrics in buying decisions

Explore corporate tax credits for firms that invest in quality

Areas to explore other
Areas to explore - Other Quality, and Compounding Quality

Better methods for demand forecasting

Unit of use presentations

Essential Drug List

Some good news
Some good news Quality, and Compounding Quality

Increased collaboration between industry and FDA DSP

“Workable pathway”

Increased interest from new firms

End users: “Guaranteed availability worth the price.”

Questions Quality, and Compounding Quality

Drug shortages industry prospective

Drug Quality, and Compounding QualityShortages: Industry Prospective

Mark Hendrickson

Director for Sciences and Regulatory Affairs

Generic Pharmaceutical Association

Introduction Quality, and Compounding Quality

The drug shortage problem has hit crisis proportions and is of extreme concern for patients, clinicians, the pharmaceutical industry and policymakers.

Drug shortages represent a complex, multi-faceted issue.

The generic pharmaceutical industry is devoted to working with all stakeholders to minimize current shortages and mitigate factors that could contribute to future shortages.

Why are shortages occurring
Why Are Shortages Occurring? Quality, and Compounding Quality

Causal factors of drug shortages are numerous and do not apply in every case. They include everything from:

  • An insufficient supply of available raw materials to meet demand.

  • Inadequate and delayed communications about shortages.

  • Unpredictable changes in product demand

  • Problems associated with the manufacturing and release of products.

    • Quality compliance

    • Limited number of production lines

    • Complexity of manufacturing sterile injectables

  • Most drugs are supplied by only one or two companies.*

    • Seven manufactures supply most of the market

  • Suppliers cite production-related issues and increased demand as top reasons for shortages.*

  • Hoarding of drugs in short supply can exacerbate shortage

*Source: “Drug Shortages: A Closer Look At Products, Suppliers And Volume Volatility” IMS Institute

For Healthcare Informatics, Nov. 2011

Drug shortage by the numbers
Drug Shortage by The Numbers Quality, and Compounding Quality

The drug shortage problem is highly concentrated.

  • 58% of the drugs on the shortage list are produced by at least one facility undergoing remediation as a result of FDA action.*

  • Generic Injectables*

    • Make up over 80% of drugs in shortage.

    • Of the total generic injectable market, half are on the shortage list.

    • Oncology drugs make up the highest share of the shortages list at 16 %.

*Source: “Drug Shortages: A Closer Look At Products, Suppliers And Volume Volatility” IMS Institute

For Healthcare Informatics, Nov. 2011

Primary difficulties reported by patients and providers
Primary Difficulties Reported by Patients and Providers Quality, and Compounding Quality

No advanced warning and suggested alternatives

No information about cause of shortage

No information about duration of shortage

Difficulty obtaining suitable alternatives

Substantial resources necessary to educate practitioners on the use of alternatives

Possible loss of prior safety safeguards put in place

Combating the drug shortage crisis

Inspections Quality, and Compounding Quality& Drug Shortages: Is There a Correlation?

Inspections drug shortages is there a correlation
Inspections & Drug Shortages: Is There a Correlation? Quality, and Compounding Quality

In recent years, four trends have increased:

  • Registered manufacturing sites

  • Foreign inspections

  • Warning letters

  • Drugs in shortage

    Between 2000 and 2007, the number of warning letters issued to the generic injectable companies, who represent a significant portion of the generic injectable products currently listed on the FDA Drug Shortage website, was one (1)*

    Between 2008 and YTD 2013, the number of warning letters issued to these same generic injectable companies, was seven (7), a 7-fold increase*

    As a result of FDA actions, generic injectable companies have made the decision to take approximately 30% of the total capacity off-line for remediation efforts.

*Source: FDA Website –

Combating the drug shortage crisis

Accelerating Quality, and Compounding Qualitythe Recovery

Accelerated recovery initiative
Accelerated Recovery Initiative Quality, and Compounding Quality

An unprecedented multi-stakeholder initiative designed to provide FDA with additional scope of vision into manufacturing production planning schedules.

Represents private-public sector partnership.

Predicted on voluntary, confidential communication between manufacturers, an independent third party (IMS Health), and the FDA.

  • Information made available through ARI is designed to increase visibility and improve decisions related to manufacturing capabilities and production of priority products.

Accelerated recovery initiative1
Accelerated Recovery Initiative Quality, and Compounding Quality

The Premise:

  • ARI is designed to expand FDA’s “scope of vision”

    ARI uses real-time supply, distribution, and demand forecast information to determine current supply gaps compared to historical market requirements.

    This data could give the FDA a better understanding of current conditions internal to manufacturing company production planning and provide for real-time decisions. It could also provide the potential to expand the supply of critical medications, or avert future shortages.

Accelerated recovery initiative2
Accelerated Recovery Initiative Quality, and Compounding Quality

The Process

  • GPhA will identify a subset of products on the Drug Shortage List based on inclusion criteria, and provide this list of drugs to IMS

  • GPhA will contact all of the manufacturers of the products on the list in an effort to sign them up to participate in ARI

  • Participating manufacturers are expected to:

    • Provide IMS with their respective 90 day supply schedules/forecasts covering those products

    • Update monthly the supply schedules

    • Provide IMS with immediate notice of unanticipated changes to the existing supply schedule

  • IMS will prepare a “gap analysis” and send to the FDA

  • FDA could then utilize all available information to assist it’s remediation efforts

Accelerated recovery initiative3
Accelerated Recovery Initiative Quality, and Compounding Quality

The goal of the ARI is to:

  • Put in place industry practices that provide a more accurate, timely and comprehensive view of the current drug shortage situation.

  • Provide greater visibility to potential shortages solutions.

  • Establish processes that allow for potential, voluntary production adjustments to lessen or eliminate the impact of a current shortage.

Combating the drug shortage crisis

Thank Quality, and Compounding Qualityyou!