Around the house, I like to say my wife does biology; I do physics. I’ll thus have to ask her about Senate Bill 75, a new bill in the hopper this morning seeking to “establish certain provisions regarding the dispensing of biological products.”
SB 75 adds “biological products” to the items pharmacists may legally dispense. The bill slips “Biological product,” as defined in 42 U.S.C. 262(i), as of January 1, 2018″ into our Pharmacies and Pharmacists chapter. Here’s that federal definition:
(i) “Biological product” defined In this section:
- The term “biological product” means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein (except any chemically synthesized polypeptide), or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings.
- The term “biosimilar” or “biosimilarity”, in reference to a biological product that is the subject of an application under subsection (k), means—
- that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components; and
- there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product.
- The term “interchangeable” or “interchangeability”, in reference to a biological product that is shown to meet the standards described in subsection (k)(4), means that the biological product may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product.
- The term “reference product” means the single biological product licensed under subsection (a) against which a biological product is evaluated in an application submitted under subsection (k) [42 U.S. Code § 262, subsection (i), downloaded from Cornell Law School Legal Information Institute, 2018.01.16].
I’ll check with smarter observers like my wife on the biomedical impact of Senate Bill 75. But as I check for political physics in play, I notice that SB 75 appears to authorize pharmacists to dispense “biosimilar” or “interchangeable” biological products, which enjoy an “abbreviated licensure pathway” made possible by the Affordable Care Act. Thus, hard-core Republican House co-sponsors Les Heinemann, Chip Campbell, Michael Clark, and Lynne DiSanto appear to be joining prime Senate sponsor Deb Soholt in promoting health care activity made possible by ObamaCare.
If Heinemann, Campbell, Clark, and DiSanto can support this practical part of the ACA, can Medicaid expansion be far behind?
“FDA Approves the First Gene Therapy to Treat an Inherited Disease ”
https://www.lexology.com/library/detail.aspx?g=26d8ed82-ef24-41ca-8236-1a99126f4103
“The PHSA does not explicitly list gene therapy as a biologic product. It defines “biological product” as any “virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein (except any chemically synthesized polypeptide), or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings.” 42 U.S.C. § 262(i)(1). “
Speaking of toxins and serums, etc. a 6 year old Texas boy just died of rabies gotten from a bat.
When a pharmacist receives a prescription for a brand name drug which is not listed by generic name in the nonequivalent drug product formulary prepared by the board, the pharmacist shall select a lower-priced therapeutically equivalent drug which the pharmacist has in stock, unless otherwise instructed by the patient at the point of purchase or by the patient’s practitioner
The bad part of the bill also includes no liability on pharmacist if they don’t give you the brand name or generic version. A pharmacist who selects an equivalent drug product or interchangeable biological product pursuant to this chapter assumes no greater liability for selecting the dispensed drug or biological product than would be incurred in filling a prescription for a drug or biological product prescribed by its established or, generic, or proper name
Wow Debbie, that is not good. Most people are really clueless about what is prescribed to them and this makes it even more so. Wonder who the lobbyist is for the pharmacy’s in South Dakota? Must have made a buck or ten on this deal.
Amazon is looking for someone to run what may be a huge pharmaceutical operation.
“In July, CNBC reported the e-commerce giant had a secret healthcare team — dubbed 1492 — that is exploring new technology opportunities in healthcare, including both hardware and software projects. However, Amazon has yet to publicly address the health team.
Now, Amazon is seeking an “experienced HIPAA professional who will own and operate the security and compliance elements of a new initiative.” The HIPAA Compliance Lead will work with Amazon’s product managers, software developers, bizdev and legal teams to ensure its services comply with the privacy law. This suggests Amazon may be looking to work with outside partners that manage personal health information, according to CNBC.
Though there have been speculations about Amazon’s entry into healthcare — whether that be through pharmacy or technology — the company may be looking for a healthcare privacy expert to equip its Alexa voice assistant for the industry, CNBC reports.”
So there you go, just get on your broadband and that scrip could be delivered to your front door in the time it takes to crank up the cold old jalopy out front and drive to Walmart. All of this with little effort and the correct order as ordered.
There are other states that have this bill , however in other states it requires the Pharmacist to notify the doctor if neither the brand name or the generic is used……… That is common sense so at least the dr can raise red flags if you are taken other medications or have a reaction , then at least the dr knows what the possible cause is . SD doesn’t have that safety valve- Time to jump the state line and start going to the next state for medicines.