Unapproved Drugs

• FDA Approves Concentrated Morphine Sulfate Oral Solution for Relief of Acute and Chronic Pain
• Questions and Answers for Consumers about FDA's Action Involving Unapproved Narcotics Containing Morphine Sulfate, Hydromorphone, or Oxycodone
• Health-System Pharmacy News - FDA Tells Nine Drug Makers To Stop Selling Unapproved Narcotics
• Health-System Pharmacy News - FDA Targets Unapproved Drugs
• FDA Unapproved Drugs web site provides details on drugs that are marketed in the United States that do not have required FDA approval

News Articles on Drug Shortage

AJHP Articles

• Baumer AM, Clark AM, Witmer DR, et al. National survey of the impact of drug shortages in acute care hospitals. Am J Health-Syst Pharm. 2004; 61:2015-22.
• Fox ER and Tyler LS. Measuring the impact of drug shortages. Am J Health-Syst Pharm. 2004; 61:2009.
• Fox ER and Tyler LS. Managing drug shortages: 7 years experience at the University of Utah Hospitals and Clinics. Am J Health-Syst Pharm. 2003; 60:245-53.
• Fox ER and Tyler LS. One pharmacy's approach to managing drug shortages. Am J Health-Syst Pharm. 2003; 60:27-31.
• Jensen V, Kimzey L M, and Goldberger MJ. FDA's role in responding to drug shortages. Am J Health Syst Pharm. 2002; 59:1423-5
• Provisional observations on drug product shortages: Effects, causes, and potential solutions. Summary of a stakeholders' meeting on drug shortages convened by the American Medical Association and the American Society of Health-System Pharmacists, Washington, D.C., July 12, 2002.Am J Health-Syst Pharm. 2002; 59:2173-82.
• Wellman GS. National supply-chain survey of drug manufacturer back orders. Am J Health Syst Pharm. 2001; 58:1224-8

Other Journal Articles

• Nelson R E and Biberdorf R I. Nationwide Drug Shortages: It's Time to Take the Lead. Nutrition in Clinical Practice. 1998; 13:295-7.
• Schrand L M, Troester T S, Ballas Z K, Mutnick A H, and Ross M B. Preparing for drug shortages: One teaching hospital's approach to the IVIG shortage. Formulary. 2001; 36:52-9.
• Tyler LS, Fox ER, and Caravati EM. The Challenge of Drug Shortages for Emergency Medicine. Ann Emerg Med. 2002; 40:598-602

ASHP Policy Positions and Actions

• Drug Shortages - ASHP Policy Position 0002
  • Source: Council on Administrative Affairs
    To declare that pharmaceutical manufacturers, distributors, group purchasing organizations, and regulatory bodies, when making decisions that may create drug product shortages, should strive to prevent those decisions from compromising the quality and safety of patient care.
  • Approved by the ASHP House of Delegates, June 2000.
• Drug Product Shortages - ASHP Policy Position 0319
  • Source: Council on Legal and Public Affairs
  • To strongly encourage the Food and Drug Administration to consider, in its definition of “medically necessary” drug products, the impact of medication-use factors, taking into account that if an unfamiliar product is introduced in a clinical setting because the customary product is unavailable, there is increased risk to patient safety; further,
    
  • To support government-sponsored incentives for manufacturers to maintain an adequate supply of medically necessary pharmaceutical products; further,
    
  • To advocate laws and regulations that would (1) require pharmaceutical manufacturers to notify the appropriate government body at least 12 months in advance of voluntarily discontinuing a medically necessary product, (2) provide effective sanctions for manufacturers that do not comply with this mandate, and (3) require prompt public disclosure of a notification to voluntarily discontinue a medically necessary product; further,
    
  • To encourage the appropriate government body to seek the cooperation of manufacturers in maintaining the supply of a medically necessary product after being informed of a voluntary decision to discontinue that product.
  • Approved by the ASHP House of Delegates, June 2003. This policy position supersedes ASHP Policy Position 0221.
• ASHP Guidelines on Managing Drug Product Shortages [PDF]

Intravenous Immunoglobulin Guidelines & Resources

Administration & Monitoring Guidelines

Member Contributions

1. Pharmacy and Therapeutics IVIG Monitoring and Administration Guidelines: [PDF] chart format provides guidelines to those who routinely administer IVIG. Includes information on monitoring and management of IVIG adverse effects
2. IVIG Administration Guidelines: [DOC] provides information on ordering, administration, precautions and adverse events
3. IVIG 5% Administration Policy: [DOC] one page policy document providing purpose and procedural information for Physicians, Nursing and Pharmacy

Articles

1. Murphy E., et al. Developing Practice Guidelines for the Administration of Intravenous Globulin. J Infusion Nurs;28(4):265-272.
2. Shah S. Pharmacy considerations for the use of IVIG therapy. Am J Health-Syst Pharm. 2005;62:S5-S11.

Documents of Interest

1. Access to IVIG by Safety Net Hospitals participating in the 340B Drug Discount Program. Public Hospital Pharmacy Coalition, September 2006
2. Update on IGIV Supply and Reimbursement. US Department of Health and Human Services & FFF Enterprises, May 2005
3. ASHP News Article: OIG Releases IVIG Report
4. Department of Health and Human Services Office of Inspector General Report: Intravenous Immune Globulin: Medicare Payment and Availability

Evidence For Use

Articles

1. Shah S. Pharmacy considerations for the use of IGIV therapy. Am J Health Syst Pharm 2005; 62: S5-S11.
2. Ballow M. Clinical and investigational considerations for the use of IGIV therapy. Am J Health Syst Pharm 2005; 62: S12-S18.
3. Orange J., et al. Use of intravenous immunoglobulin in human disease: A review of evidence by members of the Primary Immunodeficiency Committee of the American Academy of Allergy, Asthma and Immunology. J Allergy Clin Immunol;117(4):S525-53.
4. Dalakas M. The use of intravenous immunoglobulin in the treatment of autoimmune neuromuscular diseases: evidence based indications and safety profile. Pharmacol & Therapeutics 2004.102:177-193.
5. Sokos S., et al. Intravenous Immunoglobulin: Appropriate Indications and Uses in Hematopoietic Stem Cell Transplantation. BB&MT. 2002;8:117-130.
6. Ahmed R., et al. Consensus Statement on the Use of Intravenous Immunoglobulin Therapy in the Treatment of Autoimmune Mucocutaneous Blistering Disease. Arch Dermatol. 2003;139:1051-1059.
7. Kumas A., et al. Intravenous Immunoglobulin: Striving for Appropriate Use. Int Arch Allergy Immunol. 2006;140:185-198.

IVIG Tools

Member Contributions

1. IVIG Intravenous Order Template provides administration rate and special instructions.
2. IVIG Infusion Order Template is a detailed template providing rate, premeds, risk factors, ordering and monitoring instructions.
3. IVIG Shortage Update Message provides example of organization’s dissemination of information (situation, background, assessment, recommendation).
4. IVIG Side-by-Side Comparison multiple characteristics of available products including kinetics, adverse events, administration guidelines.
5. IVIG Worksheet is an internal pharmacy worksheet to evaluate, categorize, and track IVIG orders.
6. IVIG Pharmacy Procedures provides guidance for processing IVIG orders

Articles

Mahadevia P. The Pocketbook: Pharmacoeconomic Issues Related to Intravenous Immunoglobulin Therapy. Pharmacotherapy. 2005;25:94S-100S.

Treatment Guidelines/Protocols

Member Contributions

1. Pharmacy and Therapeutics IVIG Guidelines: chart format provides approved indications, criteria and recommended doses
2. IVIG Triage Plan: chart specifies levels of supply and prioritization of treatments. Includes strength of evidence for associated indications
3. IVIG HCA Pharmacy Protocol: includes information on preparation, dosing, adverse events and criteria for use

Articles

1. Pendergrast J.M., et al. Changes in intravenous immunoglobulin prescribing patterns during a period of severe product shortages,  1995-2000. Vox Sanguinis. 2005;89:150-160.
2. Darabi K., et al. Current usage of intravenous immune globulin and the rational behind it: the Massachusetts General Hospital data and a review of the literature. Transfusion. 2006;46:741-753.
3. Gurwitch M., et al. Intravenous Immune Globulin Shortage: Experience at a Large Children’s Hospital. Pediatrics. 1998;102:645-647.
4. Harvey R.D. The Patient: Emerging Clinical Applications of Intravenous Immunoglobulin.  Pharmacotherapy. 2005;25:85S-93S.
5. Siegel J. The Product: All Intravenous Immunoglobulins Are Not Equivalent. Pharmacotherapy. 2005;25:78S-84S

Useful Websites

• Clinical Immunology Society
• Immune Deficiency Foundation
• Reporting IVIG Shortages to HHS

Managing Drug Product Shortages Downloads

• Understanding and Managing Drug Product Shortages [PDF]
• ASHP Guidelines on Managing Drug Product Shortages [PDF]

Other Drug Shortage Websites

• FDA Drug Shortage Website
• CDC Vaccine Shortage Website