On February 4, 2002, guidelines for the use of antiretroviral agents in HIV-infected adults and adolescents, developed by the Panel on Clinical Practices for Treatment of HIV Infection of the Department of Health and Human Services (DHHS), were revised. A panel subcommittee reviews and updates these guidelines each month (see the AIDS Web site).
Overview
Although the prevalence of acquired immunodeficiency syndrome (AIDS) in the U.S. continues to rise, there has been a concomitant decrease in AIDS-related morbidity and mortality as a result of advances in antiretroviral therapy. The efficient use of resources is necessary to ensure optimal patient care. To minimize the potential for developing resistance, initial antiretroviral regimens should maximally suppress viral replication.
The combined effect of several recent initiatives to control drug prices could move the Food and Drug Administration (FDA) beyond its traditional mandate to protect the public’s health and safety and into the role of an economic regulator. It is an unaccustomed mission and one that the FDA has little apparent interest in acquiring. So far, the change seems to lie largely beneath the public’s radar screen, but its implications could turn out to be dramatic.
Prescription drug counterfeiters have turned pharmacists, along with many other unsuspecting innocent people, into unwitting pawns. That conclusion, sad as it is, is unmistakable after reading the Counterfeit Drug Task Force interim report, issued by the Food and Drug Administration (FDA) in October 2003.
Problem: We received a report at ISMP that a three-month-old infant had been discharged from a hospital after surgery for a ventricular septal defect. At discharge, the child’s mother was handed a copy of instructions that called for the administration of 25 micrograms (25 mcg, or 0.5 ml) of digoxin (Generic Lanoxin Pediatric Elixir®, GlaxoSmithKline) (50 mcg/ml) twice a day. Because the mother had difficulty reading the form, she rewrote the instructions. Unfortunately, she incorrectly transcribed the dose as 2.5 ml instead of 0.5 ml. Consequently, the child received 150 mcg (0.15 mg) of digoxin for each dose, or 300 mcg (0.3 mg) daily.
Problem: The Institute for Safe Medication Practices (ISMP) has received numerous reports that syringes of medication have been mistaken for saline flush solutions, which are used in intravenous (IV) catheters. Such errors often result from look-alike labeling and packaging of multiple-dose vials or from unlabeled or mislabeled syringes. That’s exactly what happened recently in a pediatric emergency department (ED).
It is pretty scary when the senators who are writing an important piece of federal legislation don’t understand its provisions—but that is how complicated the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 is. This legislation will impose revolutionary changes on pharmacy players too. More on that in a moment.