DRUG SHORTAGES: REAL, IMAGINED, WHY?

A recent story on Boston's NPR station WBUR, stated that, to help first responders deal with drug shortages, Oregon has taken the unusual step of temporarily allowing ambulance services to carry and administer expired drugs.

And Oregon isn’t alone. The drug shortage crisis is hitting the whole country. Some blame a regulatory crackdown by the FDA. The FDA disputes that claim, and says the shortage is due to manufacturing and quality problems. And others say there’s little incentive to make generic drugs because of a low profit margin.

When did these shortages become so bad? And why?

The shortages go back to at least 2010. The majority of the drug shortage problems are with generic injectable products, which account for about 74% of the shortages; but the more critical issues to patient care are with injectable chemotherapy and anesthesia drugs. These products are more “medically necessary” than the non-sterile generic liquids that affect the drug repackaging world.

It has been noted that posting of drug shortages exacerbates the shortage, as a result of hoarding. (In early July 2012, President Obama signed “The Food and Drug Administration Safety and Innovation Act” to minimize the impact of drug shortages on patients. Hopefully this will help reduce the shortages of critical drugs.)

Other issues which contribute to the shortages include the JIT (just in time) mentality in the supply chain, and the existence of opportunists in the grey market, who acquire these critical products and make them available through alternate supply chains at a great mark-up in price.

For the most part, the product shortages that have had impact on the repackaging world are the generic liquids. They are relatively inexpensive. Also, they are not promoted in the grey market because they are relatively inexpensive and they are not considered “medically necessary”, as compared with chemotherapy and anesthesia drugs (often, these are not even prescription drugs.) The shortages we presently see are a result of manufacturers failing to supply these generic liquids in unit dose cups, and these products are still generally available in bulk packaging.

In my opinion, the newly passed legislation will have little or no impact on this class of drugs. As an FDA registered repackager, we look forward to filling this void in the marketplace with a high quality product, which allows our hospital customers to focus on their core competencies involving patient care, rather than repackaging liquid doses.

Have you experienced drug shortages in your facility? How do you feel the problem might be solved?

Here's to better solutions,  

             Dave Bystrom