She easiest way to get more generic versions of biotechnology (bio-generic) drugs onto the U.S. market would be to pass a law allowing the Food and Drug Administration (FDA) to approve them. The hardest part would then be the need for the FDA to figure out how to structure a sensible approval process.
INTRODUCTION
A color-coding system for the pharmacological class of ophthalmic medications, along with similar corporate logos, fonts, and package sizes, has led to numerous errors with these products. Anti-infective agents are tan, steroids are pink, mydriatic and cycloplegic agents are red, beta blockers are yellow, and so on. However, individual products and dosage strengths within each drug class are not color-coded, and mix-ups have been widely reported within each class.
Occasionally, I receive unsolicited e-mail reports from various international consulting companies and other health care-related organizations. Recently, a report from PriceWater-houseCoopers (PWC) and its Health Research Institute caught my attention.
Case 1 (An Endogenous Error)
An endogenous error arises solely from within an individual, from a random and unpredictable cognitive event such as miscalculating a dose or prescribing a drug at a dose appropriate for the next medication being contemplated.
Case 1
A physician ordered a heparin infusion with directions to follow a weight-based nomogram for laboratory monitoring and dose adjustments. Later that evening, the nomogram indicated that an intravenous (IV) bolus dose of heparin 1,700 units should be administered based on the patient’s activated partial thromboplastin time (aPTT) level.
I ike it or not, part of our national lexicon includes the phrase “How you doin’,” often attributed to denizens of our beloved city of the founding fathers, namely, Philadelphia. I thought about how we’re doin’ when I had an opportunity to review the annual report of the Agency for Healthcare Research and Quality (AHRQ) on the state of health care quality in our nation.
A new Medicaid rule has retail pharmacies worried that lower reimbursements for popular generic drugs might cause their profits—and their business—to disappear. But the pharmacies had better not hold their breath as they wait for Congress to come to their rescue.
Published on July 6, 2007, the new rule essentially implements a congressional law in 2006 that requires Medicaid to adjust how the average manufacturer’s price (AMP) is calculated; the AMP, in turn, determines a state’s reimbursement to pharmacies. This ruling affects only generic drugs, not brand-name products. The federal government reimburses the states for patients’ drug expenditures according to an impossibly confusing formula built around a concept called “federal upper limits.” The formula, consequently, depends on the AMP.
