Peer-reviewed study correlates adverse drug events (ADEs) with form of drug administration; can pharma manufacturers help?
A first-of-its-kind study, according to its sponsors, of preventable medication errors due to use of injected drugs, finds a billion-dollar problem in US healthcare. And while many of these errors (such as sepsis) result from poor treatment compliance, some can be attributed to the conventions of injection administration: opening a vial, filling a syringe and administering the drug. Automatic dispensing systems, barcoded medication administration (which is supposed to be a standard of practice already) and other techniques—some of which can be influenced by the choices made by pharma manufacturers in their production and packaging—could address this issue.
The report, “National Burden of Preventable Adverse Drug Events Associated with Inpatient Injectable Medications: Healthcare and Medical Professional Liability Costs,” was published in American Health and Drug Benefits (www.ahdbonline.com) in mid-December, and was funded by Becton Dickinson (Franklin Lakes, NJ) in partnership with Milliman Inc. (Seattle, WA). (Becton Dickinson is a leading supplier of injectable drug components and systems; Milliman performs analysis of health costs and medical claims.) The authors used medication-error data from databases such as MedMarx; drug-administration data from Premier, payer claims from MarketScan, as well as federal and American Hospital Assn. data.
In healthcare, an “adverse drug event” (ADE) is roughly equivalent to an “adverse event” as collected by FDA’s MarketWatch (see p. 1); but preventable ADEs bring in other factors besides the physiology of the drug. To perform the analysis, the study authors also made use of another convention in healthcare—grouping treatments by Disease Reference Group (DRG).
Major findings include:
• Preventable ADEs associated with injectable medications impact more than 1 million hospitalizations each year.
• Preventable ADEs due to injectable medications cause $2.7 billion to $5.1 billion in annual costs to U.S. healthcare payers. Those costs average $600,000 per hospital each year.
• The medical professional liability (MPL) cost for inpatient ADEs from injectable medication reaches an industry-wide $300 million to $610 million annually. The MPL costs an average of $72,000 per hospital each year.
• To arrive at the cost of these ADEs, the authors compared hospitalization cases, by DRG, where ADEs occurred with those that did not.
The likelihood of an ADE by type of drug administered was found to be insulin (with a 1.16% probability of an ADE); the mean for all injectables is 0.25%. And the leading DRGs where ADEs occur is septicemia and, generally, respiratory system interventions with or without mechanical ventilation. (It's worth noting, too, that a single DRG case can involve multiple injections.)
The authors conclude that “a large proportion of medication errors (56%-62%) occur during the administration step of the medication use process,” and therefore not involving drug preparation. However, there are actions to take: “Some interventions developed through systematic approaches to error prevention that dramatically reduce the frequency of medication errors and that also impact injectable medications include computerized physician order entry with decision support, automated medication dispensing systems, and bar-coded medication administration.”
Companies involved with designing and manufacturing injectable drug components, labels and safety features such as prevention of accidental sticks pitch their products to pharma manufacturers with the claim that the better designs are cost-justified by reducing accidents and ADEs; but hospital purchasers looking only at the price of the delivered medication are not factoring the ADE costs into their evaluations. Another area of interest is the drug container: while most injectables are packaged as vials (and some of those as “multidose” vials that have been used to treat more than one patient at a time); the alternative, generally regarded as safer but more expensive, is the prefilled syringe. With the current push for higher levels of performance by hospital systems, the hope is that that a total-cost evaluation will resonate with hospital administrators.