DRUG SHORTAGES: NAVIGATING THE CHALLENGE

DRUG SHORTAGES: NAVIGATING THE CHALLENGE

SUNDAY/9:45-10:45AM

ACPE UAN: 0107-9999-20-032-L03-P 0107-9999-20-032-L03-T

Activity Type: Knowledge-Based

0.1 CEU/1.0 hr 0.1 CEU/1.0 hr

Learning Objectives for Pharmacists & Pharmacy Technicians:

Upon completion of this CPE course participants should be able to:

1. Describe recent trends in the causes of drug shortages. 2. Discuss federal regulations related to manufacturing and how recent quality trends relate to drug shortages. 3. Evaluate potential solutions to the drug shortage problem.

Speaker: Erin Fox, PharmD, BCPS, FASHP Erin Fox completed a Drug Information Specialty Residency after graduating from the University of Utah College of Pharmacy in 1999. She serves as secretary of the P&T Committee and residency program director for the PGY2 Medication-Use Safety & Policy residency. Areas of interest include drug shortages, medication use policy, drug information, evidence based medicine, and drug costs. Erin frequently serves as a media resource regarding drug shortages and drug prices.

Speaker Disclosure: Erin Fox reports an affiliation with the University of Utah Drug Information Service, which has a contract to provide drug shortage information to Vizient. Off-label use of medications will not be discussed during this presentation.

Drug Shortages ? Navigating the Challenges

Erin R. Fox, PharmD, BCPS, FASHP Twitter: @foxerinr

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Disclosure

? This presentation represents my own opinions ? University of Utah Drug Information Service has a contract with

Vizient (a GPO) to provide drug shortage information. The total amount is < 5% of total budget. ? University of Utah Health is a Vizient member

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Learning Objectives

? Upon successful completion of this course, participants should be able to:

? Describe recent trends in the causes of drug shortages. ? Discuss federal regulations related to manufacturing and how

recent quality trends relate to drug shortages. ? Evaluate potential solutions to the drug shortage problem.

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University of Utah Drug Information and Drug Shortages

? Provide drug shortage content for ASHP ? Public website at shortages ? Partners since 2001 ? Voluntary reports are confirmed with manufacturers ? Collaborate with FDA's drug shortage team

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Current Trends

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National Drug Shortages - New Shortages by Year January 2001 to December 31, 2019

300 267

250 200 150 120

211 166 149 129

204

185

186

140

142 154 146

166

100

88 73 58 74 70

50

0 01 02 03 04 05 06 07 08 09 10 11 12 13 14 15 16 17 18 19

Note: Each column represents the number of new shortages identified during that year. University of Utah Drug Information Service Erin.Fox@hsc.utah.edu, @foxerinr

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National Drug Shortages - New Shortages by Year January 2001 to December 31, 2019, % Injectable

300 57%

250 200 150

73%

63%

55% 45% 61%

46%

45%

50%

45% 63% 58%

55% 39%

100

64% 52% 57% 64% 60%

50

0 01 02 03 04 05 06 07 08 09 10 11 12 13 14 15 16 17 18 19

Note: Each column represents the number of new shortages identified during that year. Green = injectable, yellow = non-injectable University of Utah Drug Information Service Erin.Fox@hsc.utah.edu, @foxerinr

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National Drug Shortages ? Active Shortages by Quarter

350

300

305 306 320 301

250 200

265 219

224

238

251

276

282 265

264

190 185 195 191 174 176 176 174 174 183 202

150

100

50

0

Note: Each point represents the number of active shortages at the end of each quarter. University of Utah Drug Information Service Erin.Fox@hsc.utah.edu, @foxerinr

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Active Shortages Top 5 Drug Classes

Active Shortages December 31, 2019

60

50

40

21

30

20

19

11

30

10 12

17

17

0

2

Antimicrobials

Chemotherapy

Cardiovascular

CNS

University of Utah Drug Information Service Erin.Fox@hsc.utah.edu, @foxerinr Green = injectable, yellow = non-injectable

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Injectable Non-injectable

2 19 Ophthalmic

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What do these numbers mean?

? The rate of new shortages is slowing, but long-term active and ongoing shortages are not resolving

? Trend this year is for more oral and topical products in short supply, especially cardiovascular (ARBs) and ophthalmic products

? Significantly more suppliers would not provide a reason for shortages (this is more common for non-injectable companies)

? FDA's Drug Shortage Task Force Report notes that more than 60% of shortages are due to quality issues at the manufacturer

?

? ?

Shortages-as-Matter-of-NatlSecurity.ashx?la=en&hash=FA494117C6255A5493F77B67EDE39DD28B790FAD

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What's making current numbers feel worse?

? Shortages of basic products impacting most patients ? High risk medications (opioids) ? EHR, automation, smart pumps

? All designed to require the use of the same product, all of the time

? Large amounts of product needed ? Uncertainty about compounding regulations ? Disruption in 503b market

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Quality

12

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