The FDA’s current drug shortage list (here) contains 93 entries with 10 of those entries being for drug shortages that are resolved. This means that the FDA currently lists 83 drugs that are actually in shortage. The American Society of Health-Systems Pharmacists (ASHP) listing (here) currently reports 222 drug shortages. Why is there such a large discrepancy? Good question, eh?
It appears that the ASHP list is a bit more granular than the FDA listing as it reports shortages from companies and shortages on specific dosage forms, product strengths, and different fill volumes for injectables. However, the ASHP list does not appear to make a distinction between how some of the specific company issues impact demand on a national level or the general availability of the drug itself, nationally. The FDA’s listing criteria represent a more critical evaluation of the overall national drug supply and demand. As the Agency states on its website:
“When a medication is not available, it can be helpful to make FDA’s Drug Shortages staff aware. Usually when a drug is not in stock, it’s a temporary, localized issue and more product is on the way. Occasionally local supply issues can be a signal of a future drug shortage.
When FDA receives reports of new local shortages, we contact the manufacturers to confirm if their available supply will meet the national demand for the drug. If a drug is at risk of going into shortage, sometimes this advanced notice helps FDA take early action to prevent or shorten the duration of a shortage.”
Therefore, it appears that the FDA listing and the actions that the FDA may take tend to drill down more on the overall availability of drug manufacturers to meet current national demand even though some regional shortages may be occurring or reported.
While shortages continue to occur due to manufacturers’ discontinuation of products, “GMP issues, increase in product demand, recalls, supply interruptions, or other events,” as noted above, the FDA does work with other manufacturers to assess the impact on national demand in an effort to understand the disruption and what actions to take to mitigate the product shortage, if necessary. For instance, a manufacturer that currently holds 5% of the drug-product market share and discontinues its product is less likely to have a great impact on national demand; however, a firm that holds 30-40% of the market share will have a more significant and immediate impact on a potential national drug shortage.
While this distinction may explain some of the differences between the FDA and ASHP listing, it does not help the patient if they cannot get their medication at their local pharmacy due to regional supply issues.
