Specialty pharmacy: David does the necessary

David StanleyIt's one of the oldest lazy tricks for jump-starting a piece of writing, and honestly, I was a little embarrassed that I was going to stoop to it.

A deadline was looming, though, and while I wasn't in full-scale writer's block, I did need a little help to get the words flowing.  I wanted to write about specialty drugs, which seem to be the talk of the pharmacy world these days, and I figured the easiest way to get started would be to cut and paste the dictionary definition of “specialty drug.”

Webster's is the resource people usually turn to in situations like this. Funny thing happened, though, when I got into it.

Specialty drugs “will have a profound impact on the practice of pharmacy over the next 10 years,” as an article put it in this very magazine, yet Webster’s didn't seem to have a definition for the term. “They will affect all pharmacy practice settings and accelerate the importance of medication management to ensure the appropriate use of these important therapeutic agents,” the writer went on to say.

“This is huge,” I thought to myself. “I better make sure I get this definition right.” So I went to Chamber's, Oxford, and dictionary.com. Nothing.

I searched for a precise definition on the websites of FDA and of stakeholders that have a lot to say about the issue, and came up empty. (Oddly enough, two of the biggest voices in the debate over just who should be allowed to dispense “specialty drugs” both go by the acronym NCPA: The National Community Pharmacists Association and the National Center for Policy Analysis.)

It looked as if I wouldn't be using my lazy writer's trick after all.

Isn’t that special?

Some common terms did keep popping up. “Special storage and handling” was one of them. Maybe I could start there.

I checked out Sovaldi, the breakthrough hepatitis treatment that everyone seems to agree is a “specialty drug.” According to its package insert, it should be stored “at room temperature, below 86 degrees F.” Nothing special about that. It also says that the drug should be dispensed only in its original container - just like the non-specialty Pradaxa that sits on the shelf next to me as I type.

Another common characteristic of “specialty drugs” seems to be their expense, and at $1,000 a pill, Solvaldi certainly qualifies. Not every med that is given “specialty” status is that costly, however. Some run “only” a few thousand dollars for the most common unit-of-use containers. Like the Valcyte and Noxafil I order in and dispense every month, which don't seem to make the “specialty drug” cut.

I thought maybe I should get back to the “special storage and handling” angle. I remember when my employer started carrying the Zostavax shingles vaccine and a special thermometer was installed for the freezer. It was very important that the product not be stored at temperatures above 5 degrees F. To protect the company's investment, this thermometer had an alarm that would go off if it were exposed to something outside the specified temperature range. We also had to log twice a day that we checked the temperature of the freezer to ensure that it was working properly. Surely that made Zostavax one of those “specialty meds.”

Nope. (Or maybe it does, depending on whom you ask.)

My attempt to take a writing shortcut had turned into a lot more work than I expected.

Frustrated, I decided to take the bull by the horns and do the pharmacy world a favor.  I will now put forth what will be the only official definition of the term “specialty drug,”  which I propose shall be the  accepted standard until someone comes up with another.

New and only official definition

Specialty drug – (speh/shal/tee.druhg) n. Whatever a drug manufacturer or other pharmacy/medical association says it is. Subject to change at any time. Probably an expensive agent meant to treat disease that may or may not require special handling. Predicted to have a “game-changing” impact on the practice of pharmacy in the United States.

Any improvement on the above definition that we can come up with, before Whatever It Is changes our profession forever, will be very, very, welcome, and not just by lazy writers.