Drug shortages, whose to blame?

Medscape: “One cause of these shortages, pharmaceutical companies charge, is the amount of time it takes the DEA to approve controlled substance quotas. The DEA has created these quotas for each class of controlled substances and for each manufacturer of drugs containing these agents to prevent their diversion to illegal uses.”

The drug shortage problem is nothing new. It has become an everyday reality of pharmacy practice. ASHP has established a dedicated website for the problem, and the FDA has gone as far as to create a mobile app to help people track shortage information.

For most people the idea of a drug shortage seems silly, i.e. just make more. The problem is more complicated than that, however. The causes of drug shortages are multifaceted.

According to the ASHP Guidelines on Managing Drug Product Shortages in Hospitals and Health Systems, drug shortages are caused by the following factors: raw and bulk material unavailability, manufacturing difficulties and regulatory issues, voluntary recalls, change in product formulation or manufacturer, manufacturers’ production decisions and economics, industry consolidation, restricted drug product distribution and allocation, inventory practices (as it relates to distributors), unexpected increases in demand and shifts in clinical practice, nontraditional distributors, and natural disasters. That’s quite the list.

ASHP recommends several strategies for managing drug shortages, such as finding therapeutic alternatives, communicating with physicians, tightening control of available inventory, etc. In addition ASHP recommends against stockpiling. “Inventory management is a challenge during a shortage. Despite pressure to do otherwise, stockpiling (hoarding) in advance of a feared shortage can occur; this can exacerbate the shortage and divert unneeded supplies away from other health systems with patients in need“. Unfortunately hospitals are doing the exact opposite. Poor inventory practices have become commonplace in hospitals all over the country.

I’ve written about my thoughts on this before (Quick Hit: The unspoken contributor to drug shortages, strategic overstock). Recently I’ve interviewed several pharmacy directors, operations managers, buyers, etc. about how they’re handling drug shortages. As it turns out, the number one strategy remains stockpiling, i.e. hoarding.

Here are two examples:

1) Large acute care hospital (>500 beds). As part of their drug shortage strategy they purchased two years’ worth of propofol. Two years! What do you think the impact of that purchase is on the supply chain? How many hospitals weren’t able to get propofol because they were sitting on a two year stockpile? How many others did the same?

2) Small acute care hospital (<200 beds). As part of their drug shortage strategy they purchased a large quantity of 2mL magnesium sulfate vials. This particular facility only uses the vials in their crash carts, of which they fill “a couple a day”. From my estimation they had more than a years’ worth on the shelf. How many small hospitals could be using part of that supply to meet their crash cart needs?

Is this an acceptable practice? No, it’s clearly something that shouldn’t be allowed. The impact of such practices is felt across the entire healthcare industry. I find it interesting that regulatory agencies will fine hospitals for failure to document the use of a black box warning drug on a patient – a meaningless exercise that has virtually no patient care value – but they’re not willing to step in when something actually impacts patient care.

And what do hospitals think of the practice of hoarding? Don’t ask them about their crazy inventory practices because in their mind what they’re doing is completely justified. Many times I’ve heard “we do what’s best for our patients”. That’s actually a very shortsighted view of the global nature of the problem. The fact that other hospitals are “doing the same thing” means that the patients you’re trying to help may be harmed by perpetuating poor medication management strategies. Another hospital may be sitting on two years’ worth of a drug that you need. Think about it.

I have been in facilities with inventory stacked to the ceiling or sequestered in off-site storage areas. Such practices not only represent terrible inventory management, but creates an interesting dynamic where one hospital may have excess drug that is needed by another while being short on something that is being hoarded at another facility; and vice versa.

Drug shortages are a major problem, and have been for quite some time. And while there are many factors that contribute, I can’t help but wonder how much of the problem is self inflicted.