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Critical Drug Shortages: A Major Public Health Problem That Affects Us All and How To Deal With It. Philip M. Rosoff, M.D., M.A. Professor of Pediatrics & Medicine Chair, Duke Hospital Ethics Committee Duke University Medical Center Durham, NC . Critical Drug Shortages.

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critical drug shortages a major public health problem that affects us all and how to deal with it

Critical Drug Shortages: A Major Public Health Problem That Affects Us All and How To Deal With It

Philip M. Rosoff, M.D., M.A.

Professor of Pediatrics & Medicine

Chair, Duke Hospital Ethics Committee

Duke University Medical Center

Durham, NC

critical drug shortages
Critical Drug Shortages
  • In the US (and Western Europe) we have been increasingly afflicted with unexpected and prolonged shortages of important drugs.
  • This can be due to a variety of reasons:
    • A business decision
    • A manufacturing problem
    • A base materials supply problem
fda current shortages as of 7 19 2011
FDA Current Shortages (as of 7/19/2011)

Levoleucovorin (Fusilev) 50 mg single use vials

Levorphanol 2mg Tablets

Lorazepam Injection

Magnesium Sulfate Injection

Methylphenidate HCl

Metoclopramide injection

Mexiletine Capsules (150mg, 200mg, and 250mg)

Mitomycin Powder for Injection

Mustargen (mechlorethamineHCl) injection

Multi-Vitamin Infusion (Adult and pediatric)

Nalbuphine Injection

NeoProfen (ibuprofen lysine) Injection

Neostigmine methylsulfateinjection

rotigotine transdermal system

Norepinephrine BitartrateInjection

Oxsoralen (methoxsalen) 1% topical lotion

Oxsoralen-Ultra (methoxsalen) 10 mg capsules

Phenylephrine HClInjection

Potassium Phosphate

Procainamide HCL Injection

Propofol Injection

Sodium Chloride 23.4%

Sodium Chloride 14.6% Injection

Sodium Phosphate Injection

Sulfamethoxazole 80mg/trimethoprim 16mg/ml injection

Tamiflu for Oral Suspension

Thiotepa for Injection

thyrotropinalfa

ThyrolarTablets

Vasopressin Injection

Vecuronium Injection

  • Acetylcysteine Inhalation Solution
  • Amikacin Injection
  • Amino Acid Injection
  • Ammonium Chloride Injection
  • Ammonium molybdate injection
  • Sodium phenylacetate and sodium benzoate Injection 10%/10%
  • Amphetamine Mixed Salts, ER Capsules
  • Aquasol A, 50,000 units/mL, 2 mL ampule
  • Arginine 10% injection (R-Gene 10)
  • Avalide (irbesartan and hydrochlorothiazide)Tablets
  • Bleomycin Injection
  • Calcitriol 1 mcg/mL Injection
  • Calcium Chloride Injection
  • Calcium Gluconate
  • Cisplatin injection 1 mg/mL solution
  • Cleviprex
  • Cyanocobalamin injection
  • Cytarabine Injection
  • Daunorubicin hydrochloride solution
  • Desmopressin Injection
  • Dexamethasone Injection
  • Digoxin Injection
  • Diltiazem Injection
  • Doxorubicin (adriamycin) lyophilized powder
  • Doxorubicin Liposomal (Doxil) Injection
  • Doxorubicin Solution for Injection
  • Ethiodol (ETHIODIZED OIL) ampules
  • Etoposide solution for injection
  • Fabrazyme (agalsidase beta)
  • Foscarnet Sodium Injection
  • Fosphenytoin Sodium Injection
  • Furosemide Injection
  • Haloperidol Decanoate Injection
  • Intravenous Fat Emulsion
  • Leucovorin Calcium Lyophilized Powder for Injection
  • Leuprolide Injection
partial drug shortage list from ashsp more comprehensive and up to date than fda
(Partial) Drug Shortage List from ASHSP*(more comprehensive and up-to-date than FDA)

*American Society of Health-System Pharmacists

tragic choices
Tragic Choices
  • In late December, 2010, we experienced a critical shortage of cytarabine, a chemotherapy drug that is integrally important in curative therapy for adult and childhood acute myelogenous leukemia (AML) and childhood acute lymphoblastic leukemia (ALL).
  • We came within 2 days of completely running out.
  • What to do if we have enough for one person and two people need it?
  • How do you choose?

Also see PM Rosoff (2011): AJOB (in press)

how should we decide
How Should We Decide?
  • What rules would you use?
  • Would you permit some forms of discrimination?
faced with a critical shortage how should we decide who gets the drug when not all can
Faced With A Critical Shortage, How Should We Decide Who Gets The Drug When Not All Can?
  • First come, first served?
  • A coin toss or lottery?
  • What should be the role of medical/scientific evidence?
  • Should there be “special” patients (i.e., VIPs)?
  • Should some people be a priori excluded?
    • For example, undocumented immigrants, prisoners, patients with a prior history of poor compliance?
unresolved questions
Unresolved Questions
  • Do we owe a greater “loyalty” to patients who live in NC than those referred from elsewhere?
  • What do we do with patients who hear that we may have the drug they need, but are not Duke patients (for example, they are UNC patients)?
  • Should we privilege the young over the old?
    • For instance children with AML have a 60% chance of cure, while adults have a 30% (of course, this is a population-derived statistic). Does that mean we should give the limited supply of cytarabine to children and not adults?
  • Do patients on therapy have a greater claim to drug than new patients who might have a better chance of cure?
  • Should we stop treatment of patients receiving a drug for unsupported (by evidence) reasons in order to conserve supplies?
  • Should “dying” patients have claim to any drugs other than “comfort” drugs during a shortage?