Welcome to part four in the the saga of generic Concerta drug substitutions. The information in part three (part two and part one for those just joining us) raised several questions about pharmacy-level processes for generics that today’s column will start to answer. But first, a little housekeeping from last time.
Question from a reader
One reader asked for clarification on whether the Food and Drug Administration (FDA) requires brand name manufacturers to reveal proprietary information about a drug’s release technology as part of the process for determining therapeutic equivalency.
For some help on the subject, I posed the question to UW School of Pharmacy assistant professor Ryan Hansen, a comparative effectiveness research expert who was a practicing pharmacist in Washington for 14 years.
In Hansen’s experience, the FDA does not require that level of disclosure and the reason why is simple: The technology is a proprietary secret, and everything disclosed to the FDA becomes a matter of public record.
If a manufacturer wants to sell a generic version of a drug with a novel release mechanism like Concerta, he continued, they have to develop the technology on their own.
“They don’t give away trade secrets such that a generic company could just come along and copy what they’ve done,” Hansen said.
FDA approval requires only that the generic contain the same amount of the same active ingredient and that it meet the established bioequivalence standards for the brand name version.
Generics at the pharmacy
When I explained my story with Concerta generics to him in our phone interview, Hansen’s response summed up the experience succinctly.
“Concerta is a complicated drug,” Hansen said. “Fantastic technology innovation for patients with ADHD but very challenging to demonstrate bioequivalence.”
Given his familiarity with the Concerta “controversy,” I asked Hansen if he could think of a scenario that would explain how, in June 2017, a Concerta prescription could be filled with a generic substitution that had been downgraded to a BX (not bioequivalent) rating for almost three years.
But before he could answer that question, Hansen provided a little background on what happens when you drop off a prescription at your neighborhood pharmacy.
After receiving your order, the pharmacist checks the prescription form for two key details: whether the medication is identified specifically by brand name or by the active ingredient and which line — “Substitution permitted” or “Dispense as written” — your doctor has signed at the bottom. Then they look the drug up in their computerized pharmacy management system.
In the simplest cases, when the brand name drug is specifically mentioned and a doctor has signed above “Dispense as Written,” the pharmacist is just making sure they have enough name brand pills in stock to fill the order.
If, instead, that doctor signed above “Substitution permitted” line, the pharmacist will also check to see if there is a less expensive AB-rated (therapeutically bioequivalent) generic substitute available.
Though his exposure to the different pharmacy systems is not exhaustive, in Hansen’s experience, BX-rated options do not come up by default in these substitution searches.
Where they do show up is in searches for the active ingredient, which happens if the prescription does not specifically mention the name brand drug.
“Equivalence is all between brand and generic or generic and generic,” Hansen said. “If the label [on the BX-rated pills] from your pharmacy when you picked it up said ‘Methyphenidate ER substitute for Concerta,’ that would indicate to me that someone had … typed for Concerta” as opposed to the active ingredient when searching available products.
Hansen explained that he would need more situational information about an individual pharmacy’s processes, the status of its management system, and other factors to know why or how that specific Concerta search still led to filling the order with a BX-rated generic.
I kept my last bottle of Mallinckodt generics, so I checked the label when I got home. It read “Methyphenidate Hydrochloride ER”. No mention of Concerta anywhere, which makes bioequivalency kind of a red herring.
Remove the equivalency from the equation and more questions remain. Why did the pharmacy have BX-rated generics in stock in the first place? If there are multiple options, how does the pharmacists decide which to use? What does the state have to say about all of this? I’ll get back to you in a couple of weeks.