Changes in intravenous immunoglobulin prescribing patterns during a period of severe product shortages, 1995–2000

Pendergrast, Jacob; Sher, Graham D.; Callum, Jeannie

doi:10.1111/j.1423-0410.2005.00670.x

Cited by 29 publications

(43 citation statements)

References 16 publications

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“…This partly explains why IVIG was prescribed unnecessarily for many conditions. In comparison with other reports,11–15 the number of conditions for which IVIG was inappropriately used at our institution is unacceptably high, with only minimal response rate (26% in paediatric and 31% in adult patients). This is clearly reflected in the high cost of IVIG dispensed for those conditions.…”

Section: Discussioncontrasting

confidence: 68%

A utilisation review of intravenous immunoglobulin in a tertiary care hospital in United Arab Emirates

Dawoud¹,

Tatari²,

Gebran³

2012

Eur J Hosp Pharm

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Objectives To evaluate the utilisation of intravenous immunoglobulin (IVIG) at Tawam Hospital, a tertiary care teaching hospital, over a 1-year period. Methods Patients who received IVIG from March 2010 to April 2011 at Tawam Hospital were identified retrospectively using the hospital computer system. Their charts were subsequently reviewed and data were collected on patients' demographics, indication, dose regimen, adverse drug reactions and physician specialty. Indications were placed into three main categories: US Food and Drug Administration (FDA) labelled; off-label indications with evidence favouring IVIG efficacy; and off-label indications with lack of evidence for efficacy. Results A total of 134 patients (74 paediatric and 60 adult) were identified. In 39%of paediatric versus 46% of adult patients, IVIG was dispensed for appropriate indications (US FDA labelled and off-label with support for use). However, 61%of paediatric patients and 54% of adult patients received IVIG for inappropriate indications (off-label use without support). The estimated annual cost of IVIG is US$1.25 million, of which US$0.7 million was considered as inappropriate use. Conclusions A significant amount of IVIG was prescribed for inappropriate indications, resulting in a large financial burden on the institution.

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Section: Discussioncontrasting

confidence: 68%

A utilisation review of intravenous immunoglobulin in a tertiary care hospital in United Arab Emirates

Dawoud¹,

Tatari²,

Gebran³

2012

Eur J Hosp Pharm

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“…However, the infectious risk associated with pooled blood products such as IVIG cannot be dismissed, as a previous outbreak of hepatitis C associated with plasma-derived anti-D immunoglobulin has shown (28,29), and there is concern over emerging infectious agents such as prions, for which donors are not screened and which are resistant to heat treatment (30). IVIG therapy is expensive and its chronic worldwide shortage well documented (31,32). Therefore, a safe and effective recombinant alternative for antenatal treatment of FMAIT would be useful.…”

Section: Introductionmentioning

confidence: 99%

Developing recombinant HPA-1a–specific antibodies with abrogated Fcγ receptor binding for the treatment of fetomaternal alloimmune thrombocytopenia

Ghevaert

Wilcox²,

Fang³

et al. 2008

J. Clin. Invest.

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Fetomaternal alloimmune thrombocytopenia (FMAIT) is caused by maternal generation of antibodies specific for paternal platelet antigens and can lead to fetal intracranial hemorrhage. A SNP in the gene encoding integrin β3 causes a clinically important maternal-paternal antigenic difference; Leu33 generates the human platelet antigen 1a (HPA-1a), whereas Pro33 generates HPA-1b. As a potential treatment to prevent fetal intracranial hemorrhage in HPA-1a alloimmunized pregnancies, we generated an antibody that blocks the binding of maternal HPA-1a-specific antibodies to fetal HPA-1a1b platelets by combining a high-affinity human HPA-1a-specific scFv (B2) with an IgG1 constant region modified to minimize Fcγ receptor-dependent platelet destruction (G1Δnab). B2G1Δnab saturated HPA-1a + platelets and substantially inhibited binding of clinical HPA-1a-specific sera to HPA-1a + platelets. The response of monocytes to B2G1Δnab-sensitized platelets was substantially less than their response to unmodified B2G1, as measured by chemiluminescence. In addition, B2G1Δnab inhibited chemiluminescence induced by B2G1 and HPA-1a-specific sera. In a chimeric mouse model, B2G1 and polyclonal Ig preparations from clinical HPA-1a-specific sera reduced circulating HPA-1a + platelets, concomitant with transient thrombocytopenia. As the Δnab constant region is uninformative in mice, F(ab′) 2 B2G1 was used as a proof of principle blocking antibody and prevented the in vivo platelet destruction seen with B2G1 and polyclonal HPA-1a-specific antibodies. These results provide rationale for human clinical studies.

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“…During a drug shortage, if an allocation system like the one proposed here is used, physicians could become accustomed to prescribing using evidence-based medicine. Such was the case during the acute shortage of intravenous immunoglobulin several years ago (Pendergrast et al 2005). However, once restrictions were loosened as the shortage was alleviated, prescribing habits returned to their pre-shortage customs.…”

Section: Resultsmentioning

confidence: 96%

Unpredictable Drug Shortages: An Ethical Framework for Short-Term Rationing in Hospitals

Rosoff

2012

The American Journal of Bioethics

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Periodic and unexpected shortages of drugs, biologics, and even medical devices have become commonplace in the United States. When shortages occur, hospitals and clinics need to decide how to ration their available stock. When such situations arise, institutions can choose from several different allocation schemes, such as first-come, first-served, a lottery, or a more rational and calculated approach. While the first two approaches sound reasonable at first glance, there are a number of problems associated with them, including the inability to make fine, individual patient-centered decisions. They also do not discriminate between what kinds of patients and what types of uses may be more deserving or reasonable than others. In this article I outline an ethically acceptable procedure for rationing drugs during a shortage in which demand outstrips supply.

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Changes in intravenous immunoglobulin prescribing patterns during a period of severe product shortages, 1995–2000

Cited by 29 publications

References 16 publications

A utilisation review of intravenous immunoglobulin in a tertiary care hospital in United Arab Emirates

A utilisation review of intravenous immunoglobulin in a tertiary care hospital in United Arab Emirates

Developing recombinant HPA-1a–specific antibodies with abrogated Fcγ receptor binding for the treatment of fetomaternal alloimmune thrombocytopenia

Unpredictable Drug Shortages: An Ethical Framework for Short-Term Rationing in Hospitals

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