What Puts the “Special” in Specialty Pharmacy?
Author credit: Jordan Tait, PharmD Candidate 2022, Duquesne University
When asked to explain specialty medications during this rotation, I realized that I don’t have a specific definition in mind for them. My general idea was that specialty medications are “special” medications that are filled through a “special” pharmacy. In pharmacy school, the most we learned about specialty medications were that they exist and that most students would never come across them in their practice. I never thought more about exactly what specialty pharmacy is. Specialty pharmacy is a field that has been one of the largest growing over the years, and it is estimated that about half of all US drug expenditure on medications is spent on specialty, according to the ASHP Specialty Pharmacy Resource Guide.
So how is a medication classified as specialty? According to the National Association of Specialty Pharmacy (NASP), specialty pharmacy is defined as “a state-licensed pharmacy that solely or largely provides only medications for people with serious health conditions requiring complex therapies. These include conditions such as cancer, hepatitis C, rheumatoid arthritis, HIV/AIDS, multiple sclerosis, cystic fibrosis, organ transplantation, human growth hormone deficiencies, and hemophilia and other bleeding disorders”. ASHP defines specialty medications to include those “that require device training, high cost, special handling, storage, or delivery, are injectable, are used to treat rare diseases, and/or have severe side effects.” However, with further research into the topic, it seems that the definition of specialty seems to change between various organizations, which can be seen in the chart below.
I decided to dive a little deeper into a few specialty medications and non-specialty medications to consider ways in which they overlap. Looking at the charts below, I have included 3 specialty medications and 3 general medications. These general medications include high cost, injectable, and severe side effects/monitoring. Warfarin, clozapine, and insulin are medications that are found in nearly every pharmacy, and they require extensive monitoring that some “specialty” medications don’t even require. Warfarin requires maintaining an INR value within a specific range and monitoring twice weekly (or more), and if it falls out of this range the patient is at high risk of clotting or bleeding, and immediately needs re-dosed (there are anticoagulation pharmacists dedicated to dosing this medication). Clozapine has a REMS program that requires constant monitoring of ANC to ensure neutrophils do not drop, and this is either monitored weekly or monthly depending on the patient and ANC level. Insulin requires glucose monitoring multiple times a day by the patient, as too high of a dose can cause blood glucose levels to drop drastically, leading to severe hypoglycemia.
So, after looking at these charts that I have created, shouldn’t some of these general medications that are found in every pharmacy be considered specialty? Is there really a need for the term “specialty”? Can’t we just call it as it is: high cost medications, high monitoring medications, injectable medications, etc.? Let’s look at each of these questions I asked in more detail.
First, shouldn’t some of the general medications that are found and dispensed in every pharmacy be considered specialty medications? Let’s consider the fact that medications are classified as Rx-only/legend for a reason — they require some type of unique monitoring, counseling, or administration. Anything that is found behind the counter instead of over the counter is there because it cannot be available to the general public without a prescription for one reason or another.
Next, is there really a need for the term “specialty”? Looking at the arguments made so far, you can see that all specialty medications fall into categories of drugs that already exist. They fall into categories such as high cost medications, special storage medications, hazardous medications, unique monitoring medications, injectable medications, etc. We should be replacing the term “specialty” with terms that already exist and eliminate the need for an unnecessary category.
Finally, looking at these categories of medications I have highlighted, it doesn’t make sense for us to keep using the term “specialty” as an excuse for profit maximization (buying low and selling high). Instead, we should be charging prices that correspond to the category of medication that each drug falls into. For example, for injectable medications, charging based on the administration service provided, or for medications requiring special monitoring, charging based on the monitoring service required. It is time we quit hiding behind this label to justify higher profits.
Comment below what you believe the definition of specialty should be, I would love to hear what you think!
References:
https://naspnet.org/wp-content/uploads/2017/02/NASP-Defintions-final-2.16.pdf
Medication information found in Lexicomp (Lexi-Drugs)
