Drug Shortages: Impact and Strategies
- Philip E. Johnson, MS, RPh, FASHP
Since this article has no abstract, we have provided an extract of the first 250 words of the full text.
The drug shortage problem is well established, rapidly growing, and a symptom of current economic conditions. In June 2011, the FDA Web site listed 71 drugs that were not available, representing more than 200 individual products, including the oncology drugs bleomycin, cisplatin, cytarabine, daunorubicin, doxorubicin, etoposide, leucovorin/levoleucovorin, mechlorethamine, thiotepa, and vincristine. Last year, 178 drugs were on the FDA list (Figure 1), and today drug availability is a daily concern that requires constant vigilance and keeps many oncology professionals “up at night.” Hopefully, the current crisis will be a catalyst for significant changes in the future.
What's Driving the Availability Problem?
“Fueling the problem are shortages of raw materials. Also, drugmakers are discontinuing older and off-patent drugs in favor of newer and more profitable ones, and issuing large recalls of drugs due to quality problems,” according to the FDA.1 Other reasons manufacturers state, listed on the FDA Web site, include increased market demand, manufacturing delays due to a change in manufacturing sites, a sub-contractor not meeting United States Pharmacopeia (USP) requirements, and issues associated with a new product launch. What is really behind these reasons and how they are interconnected?
Increased demand is the most frequently cited reason for shortages, often caused by competing manufacturers that have discontinued or withdrawn the product from the marketplace. Unavailability of raw materials is also frequently cited, not always because of a shortage from a foreign source. Unavailability can also occur because the manufacturer will not relinquish exclusive raw material contracts when the product is discontinued, thus driving the raw material supplier to contract with foreign drug manufacturers. The motive behind this strategy may be related to the original manufacturer having a “next generation” product that will capture greater market share if there is less competition from the “current generation” product.
There are also many acceptable reasons for …