Pharmacists serve a vital role as part of our health care teams. They typically advise patients and health care providers on the selection, dosages, interactions, and even the side effects of medications. This is why it should come as a surprise to patients that recently, pharmacists around the country have been saying they’re too busy to ensure patient safety.
In March 2010, a U.S. biosimilar pathway was signed into law as part of the Affordable Care Act (ACA). In February 2012, the Food and Drug Administration (FDA) issued three draft guidance documents on biosimilar product development to assist industry in developing such products in the United States. What, if any, additional guidance FDA may issue, and when, is uncertain.
Here’s the key: it’s currently up to state governments across the country to set policy on whether one biologic product may be substituted by dispensers when a different biologic product was prescribed. What you need to know is that FDA is responsible for determining what biologics and biosimilars get approved only after they are proven safe and effective. It’s up to individual state governments to decide how and when they can be substituted, much like generic drugs are substituted for name brands all the time.
What’s important to understand is that generic drugs and biosimilars are not the same thing. Generics are exact replicas of their name brand counter parts. Biosimilars are scientifically similar but not the same as their reference biologic counterparts. As a result, it’s critical that our state systems for substituting do not follow the structure of generic substitution. They are two entirely different situations.
Biologic manufacturers, patient advocacy organizations, and even biosimilar manufacturers agree there needs to be new guidelines to determine substitution for this new class of products. All of these stakeholders have been going from state to state testifying before state governments. In their testimony they are asking governments to include five basic principles in their state substitution laws of biosimilars:
a. Substitution should occur only when the FDA has designated a biologic product as interchangeable.
b. The prescribing physician should be able to prevent substitution.
c. The prescribing physician should be notified of any substitution.
d. The patient, or the patient’s authorized representative, should, at a minimum, be notified of any substitution.
e. The pharmacist and the physician should keep records of any substitution.
Patients and physicians across the country are agreeing with that the substitution principles are appropriate and needed. You might be asking, “so then what’s the hold up?” The biggest opponent testifying against these principles in every state has been the pharmacist (most recently the Delaware Board of Pharmacy). Specifically, pharmacists are opposed to principles “c”, “d”, and “e”. They are against all notification and record keeping requirements.
Why? Warning: their reasoning may offend you. Pharmacists are standing before state legislatures and saying that notifying a patient and their physician if a biologic or biosimilar is switched is “burdensome and onerous”. Or in other words, Pharmacists think notification and record keeping are too much added work.
Burdensome and onerous? Isn’t it the pharmacist’s job to ensure the safe and effective use of medication? These five principles establish transparency and communication between patients and their treatment teams. Physicians and their patients are in the best position to determine appropriate therapies. They have the full spectrum of their medical history. These principles protect the physician patient relationship. Yes, it may mean some added phone calls, paperwork, or data entry into electronic medical records. However, do you want to be in a health system that views added information to a patient’s medical record as burdensome or onerous? I know I don’t.