On February 28, during the 2017 OPA Pharmacy Student Legislative Day, Representative Derek Merrin (R-Monclova Township) joined the 240+ student pharmacists, faculty members, and pharmacist volunteers to announce his introduction of new legislation that aims to tap pharmacists & pharmacy interns to ease access to epinephrine auto-injectors and to help facilitate better competition within the epinephrine auto-injector marketplace.
In summer 2016, local and national media pointed to Mylan's EpiPen as an example of drug pricing gone wrong. As 10TV reporter Kristyn Hartman demonstrated, a complicated drug pricing model that incentivizes higher drug prices points to the need for national movement on pricing transparency and pharmacy benefit manager (PBM) reforms. For more on that, click here, here, and here. The pricing controversy highlighted the need to facilitate easier patient access to epinephrine auto-injectors - both logistically and economically.
Aside from the problems associated with opaque pricing gimmicks, there are other factors that may be contributing to epinephrine auto-injector prices and accessibility, and Rep. Merrin's HB 101 will tackle two specific issues.
House Bill 101 allows pharmacists to substitute a prescribed, brand-name epinephrine auto-injector for a pharmaceutically equivalent epinephrine auto-injector. For example, if a physician prescribes EpiPen that retails at $600, a pharmacist could substitute a less expensive alternative, with the patient’s consent, that can cost hundreds of dollars less and still meet the patient's pharmaceutical needs. Epinephrine auto-injectors are not substitutable under current state law in most instances.
Here's why. According to Dr. Scott Gottlieb, former FDA deputy commissioner for policy, "One issue relates to the existing generic drug law, and FDA regulations that govern the generic approval process and the Abbreviated New Drug Application (ANDA) that a generic drug maker must file with FDA. Under the Agency’s interpretation of those rules, if a patient has to be re-trained to use a generic alternative to a branded product, then the alternative product cannot bear the same labeling as the drug it seeks to copy. As a result, it can’t meet the burden of the ANDA process and be approved as a generic equivalent. In other words, the generic drug can’t be considered the 'same' as the branded version that it seeks to copy, and serve as a fully substitutable alternative."
So essentially, because other epinephrine auto-injectors aren't substitutable under current law, if a physician issues a prescription for a branded epinephrine auto-injector, the pharmacist's hands are tied unless they work with the physician to get a new prescription for an alternative. This all unnecessarily wastes the time of the physician, pharmacist, and the patient. HB 101 would allow pharmacists to exercise their clinical judgment to make the necessary product switches, so long as the products are deemed pharmaceutically equivalent.
The second part of HB 101 enables pharmacists to dispense epinephrine auto-injectors to adults 18 years of age or older, under a physician’s protocol. The Ohio Board of Pharmacy, with consultation of the State Medical Board of Ohio, will establish protocol requirements that govern the conditions under which pharmacists can dispense epinephrine auto-injectors to adults without a prescription.
Currently, Ohio pharmacists & pharmacy interns can dispense/administer naloxone and all CDC-recommended vaccines without a prescription, as long as they are acting within a physician protocol. HB 101 would add epinephrine auto-injectors into the same category, thus eliminating the need to visit or contact the doctor for a new prescription every year.
Furthermore, as new laws took effect in 2016 to allow restaurants, swimming pools, colleges, and other public places to stock non-patient specific epinephrine for possible allergic reactions, this bill would eliminate the unnecessary step of these entities seeking out a doctor's prescription before obtaining the product to use in emergency situations, just like they use fire extinguishers today.
“This legislation is a free-market solution to the exorbitant cost of epinephrine auto-injectors. By easing access and government restrictions, consumers will have a better opportunity to obtain epinephrine auto-injectors at a lower cost,” said Representative Merrin.
For Ohioans at risk of anaphylactic shock, epinephrine delivered by an auto-injector is a medical necessity and often life-saving. However, the price and unnecessary logistical hassles have become a barrier to access and attainability. The good news is there are multiple epinephrine auto-injectors on the market and more in the pipeline. Under HB 101 consumers will have increased ability to work with pharmacists to secure the best epinephrine auto-injector at a competitive price.
“Representative Merrin’s bill checks all the boxes for what makes great legislation: eliminating barriers, easing access, reducing unnecessary hassles, and facilitating better competition," said Antonio Ciaccia, Director of Government & Public Affairs for the Ohio Pharmacists Association. "It could help save families hundreds of dollars per year and provide them with better access to a life-saving medication.”
Recently, the state of Idaho enacted a law to allow pharmacists to prescribe epinephrine auto-injectors, without any physician oversight or protocol arrangement. For more on that law and the impetus for its passage, click here.
Please contact your legislators, and ask them for their support of HB 101!