Concentrated Insulin Confusion
Extreme caution should be used when administering U-500 insulin. This concentrated form is used for patients with marked insulin resistance who would otherwise need large volumes of U-100 insulin.
The clinical impact of these shortages cannot be underestimated. According to the EIN survey, the lack of specific antimicrobial agents led to an alteration of therapy by 82% of the respondents. The survey identified sepsis, streptococcal and enterococcal endocarditis, pneumococcal meningitis, group B streptococcal infections, and neurosyphilis as those indications most likely to require alterations of therapy. For some indications, the absence of specific antimicrobials removes the only adequately studied therapy. Penicillin G remains the drug of choice for the treatment of syphilis and is essential for the treatment of neurologic and congenital disease associated with that infection. The adequacy of alternative regimens remains to be validated.
The events of September 11, 2001 have focused unprecedented attention on the availability of antimicrobial agents and vaccines. The potential need for large amounts of specific antimicrobials was highlighted by the subsequent use of anthrax as an instrument of terror and the depletion of stocks of canadian ciprofloxacin HCI (Cipro drug, Bayer), the preferred agent for prophylaxis in patients exposed to anthrax. The increased demand for generic ciprofloxacin led to geographic shortages of this agent and a threat to patient care in general. Fortunately, that episode appears to have been limited in scope and duration. The effects, however, emphasize the vulnerabilities of the health care system to the finite supplies of specific antimicrobials. A more sustained absence of antimicrobials has been shown to adversely affect health care on a far wider scale.
The office of the inspector general (OIG) at the Department of Health and Human Services is expected to issue draft compliance guidelines for the pharmaceutical industry any day now. Once finalized, they will have a significant bearing on the relationship between drug companies, PBMs, drugstores, and physicians.
In a recent issue of P&T, the Institute for Safe Medication Practices (ISMP) described the wide scope of the shortage of fentanyl and the other challenges that health care organizations faced. The ISMP conducted a recent national survey regarding ongoing drug shortages and their threat to patient safety. Surprisingly, only 5% of the 344 respondents had established a formal process for managing drug shortages, but many offered advice for tackling the issue head on. The recommendations below include some of the survey findings and respondents’ suggestions that can be used to develop proactive guidelines to manage drug shortages. An ongoing task force, which networks with area hospitals and meets with clinicians from high-use areas where drugs are in short supply, might be helpful in carrying out these recommendations:
The drug approval process in this country is a rigorous one. There has long been interest in trying to help safe and effective drugs through this process efficiently, and in recent years, the Food and Drug Administration (FDA) has focused increased attention on the development phase, principally to assure that drug developers carry out appropriately designed studies of adequate size. According to Robert Temple, MD, director of one of the FDA’s five offices of Drug Evaluation, one of the most critical issues is the use of the control group in randomized clinical trials. In February, Temple visited the campus of Jefferson Medical College in Philadelphia, where he gave a lecture on active and placebo-controlled trials in clinical research.
Imagine that many of our readers remember HA1A, a.k.a. Centoxin. How tantaliz-ingly close we once came to a seemingly effective therapy for septic shock caused by gram-negative organisms and their deadly endotoxins. Indeed, our research team at Thomas Jefferson University Hospital (TJUH) in Philadelphia, in collaboration with our colleagues at the University Healthsystem Consortium (UHC) in Chicago, worked collab-oratively for a year prior to the anticipated release and approval of Centoxin.
© 2008 HIV/AIDS News & Information