The ASHP guideline focuses on patient safety considerations, factors that contribute to drug shortages, and how to appropriately plan for and communicate about the shortage. Drug shortages are a safety concern because a pharmacy must alter how a product is ordered, prepared, or dispensed, and clinicians must then prescribe unfamiliar alternatives. ASHP noted that several essential elements of infrastructure need to be in place before a shortage occurs, such as a drug shortage team, a resource allocation committee, and established processes for approving alternative therapies and addressing ethical considerations.
Fox discussed her experience with a recent shortage involving both lidocaine and bupivacaine.
“Both drugs are critically short right now and we had to change our practices in clinics and in some inpatient settings to allow flexibility for which strength to use. This change isn’t causing any clinical differences for our patients, but it did require significant changes to our electronic health record [i.e., about 20 hours of work] to allow our clinics to use either 0.5% or 1% lidocaine depending on what we have available at the time.”
FDA’s Drug Shortage website and database are updated daily with information from the manufacturers. Pharmacists and other health professionals can look up information on the website and FDA encourages manufacturers to provide as much information as possible about the shortage and the expected duration as well as which products remain available. The website can be accessed at www.accessdata.fda.gov/scripts/drugshortages/default.cfm, and any questions can be e-mailed to FDA at firstname.lastname@example.org