The Oncology Drug Shortage A Crisis in Care Michael Link, MD - - PowerPoint PPT Presentation

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The Oncology Drug Shortage A Crisis in Care Michael Link, MD - - PowerPoint PPT Presentation

Dec 17, 2023 385 likes •586 views

The Oncology Drug Shortage A Crisis in Care Michael Link, MD Historical Drug Shortage Data 120 100 ASHP DS WRC launched 80 60 40 20 0 1996 1997 1998 1999 2000 2001 2002 Univ of Utah DIS National Annual New Drug Shortages

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SLIDE 1

The Oncology Drug Shortage

A Crisis in Care

Michael Link, MD

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SLIDE 2

Historical Drug Shortage Data

20 40 60 80 100 120

1996 1997 1998 1999 2000 2001 2002

Univ of Utah DIS National

ASHP DS WRC launched

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SLIDE 3

Annual New Drug Shortages

January 2001 to December 31, 2010

73 58 74 70 129 149 166 211 50 100 150 200 250 03 04 05 06 07 08 09 10

University of Utah Drug Information Service

Tripled since 2006

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SLIDE 4

National Drug Shortages

January 2001 to June 20, 2011

50 100 150 200 250 01 02 03 04 05 06 07 08 09 10 11 120 88 73 58 74 70 129 149 166 211 156 Shortages

Note: Each column represents the # of new shortages identified during that year Source: University of Utah Drug Information Service

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SLIDE 5

Shortages by Drug Class > 10 Shortages in 2010

5 10 15 20 25 30 19 20 13 14 28 17 13 11

Shortages

Shortages

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SLIDE 6

Shortages by Drug Class

23 23 15 15 34 23 13 14 8 11 8 6 16 3 2 7 10 20 30 40 50 60 2011 YTD 2010

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SLIDE 7

Comparing drug shortage trends Then and now…

  • 1996 - 2003

– Average # of drugs tracked: 60/year

  • 2003 – 2011

– Average # of drugs tracked: 150/year

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SLIDE 8

Crisis

  • Current pace is for >300 for 2011

– Q1 2010 = 49 shortages vs. Q1 2011= 89 – Jan 1, 2011 through June 20, 2011 = 156

  • Particularly concerning for oncology: 77% of 2010

shortages were of sterile injectables

  • Chemotherapy drug shortages

– 23 in 2010 and 11 so far in 2011 (Q1) – No alternatives to these drugs for most indications

  • Manufacturing issues are not resolving
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SLIDE 9

Causes of the Drug Shortage

  • Manufacturing difficulties/compliance issues
  • Corporate decisions/discontinuations
  • Market concentration/limited capacity
  • Raw materials/API shortage
  • Changes in clinical practice
  • Emergency situations
  • Hospital/pharmacy-based issues

*Source: FDA November 2010

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SLIDE 10

Causes of Drug Shortages 2010

No reason provided 47% Supply/ Demand 14% Regulatory 1% Raw Materials 3% Manufacturing 28% Discontinued 7%

Source: University of Utah DIS

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SLIDE 11

Shortages of Sterile Injectables: Marketing/Business Causes

For older sterile injectable products

– Fewer firms making these products – Not enough capacity – Complex manufacturing process – Generally not economically attractive; not enough financial return to justify corrective action when problem occurs – Resources directed to more profitable products

When one firm has problems or discontinues, a shortage almost always occurs.

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SLIDE 12

Oncology Drugs in Short Supply

DRUG APPLICATION

Bleomycin Lymphoma, testis Busulfan Bone marrow transplantation Cisplatin Testis, ovary, lung, sarcoma Cytarabine Leukemia, lymphoma Daunomycin Leukemia, lymphoma Doxorubicin Leukemia, lymphoma, breast, sarcoma Etoposide Leukemia, sarcoma, testis, lung Leucovorin Bowel, sarcoma. lymphoma Mechlorethamine Lymphoma Methotrexate Leukemia, lymphoma Taxol Breast, lung Thiotepa Bone marrow transplantation Vincristine Many cancers

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SLIDE 13

Consequences of Cancer Drug Shortage

  • Treatment delays—never a good idea
  • Substitution treatments

– Less effective therapies – Sometimes no effective work-around available

  • Increased patient anxiety
  • Time and expense of finding drug supply
  • Adverse effect on ongoing clinical trials
  • Price markup and increase costs of care
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SLIDE 14

Consequences of Cancer Drug Shortage

  • Unavailability of Potentially Curative Therapy

– Leukemia – Hodgkin disease – Non-Hodgkin lymphoma – Testis cancer – Sarcomas of bone and soft tissue – Multiple childhood cancers

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SLIDE 15

5 Yr Survival [%]

20 40 60 80 100

1960-63 1970-73 1974-76 1977-79 1980-82 1983-85 1986-88 1989-91 1992-97

Survival Trends in Common Pediatric Cancers

Hodgkin Lymphoma Wilms tumor ALL Non-Hodgkin lymphoma Brain tumors Neuroblastoma Bone tumors AML

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SLIDE 16

Improvement in Outcome Over Time: Results of COG Studies of ALL

20 40 60 80 100 2 4 6 8 10 12 14 16 18 1996-2000 (n=3421) 1989-1995 (n=5121) 1983-1988 (n=3711) 1978-1983 (n=2984) 1975-1977 (n=1313) 1972-1975 (n=936) 1970-1972 (n=499) 1968-1970 (n=402)

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SLIDE 17

Consequences of Cancer Drug Shortage—Childhood Leukemia

  • Acute Lymphoblastic Leukemia (ALL)

– Most common childhood cancer – 5000 cases annually in the USA – Currently ~ 85-90% are cured

  • Curative therapy for ALL

Vincristine* Mercaptopurine (pills) Prednisone (pills) Cyclophosphamide Asparaginase Cytarabine* Daunomycin* Methotrexate* + leucovorin* *In short supply

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SLIDE 18

Consequences of Cancer Drug Shortage—Bone Tumors

  • Osteosarcoma

– Most common bone tumor in children and adolescents – Currently 65% can be cured with surgery + chemotherapy – <10% cured with surgery but without chemotherapy

  • Curative therapy for osteosarcoma

Surgery Doxorubicin* Cisplatin* High dose methotrexate* + leucovorin* *In short supply