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OPA releases sample protocol for pharmacists to dispense epinephrine autoinjectors without a prescription

Representative Derek Merrin speaks at OPA Legislative DayIn 2019, Ohio delivered a big win to patients who suffer from life-threatening allergies when Governor John Kasich signed HB 101, the Epinephrine Accessibility Act, into law.

In the face of EpiPen shortages and affordability issues, HB 101, sponsored by Representative Derek Merrin (R-Monclova Township), tapped pharmacists & pharmacy interns to ease access to epinephrine auto-injectors and to help facilitate better competition within the epinephrine auto-injector marketplace.

The Ohio Pharmacists Association (OPA) worked extensively with Representative Merrin and stakeholders to develop and refine the language in HB 101 that will reduce patient barriers to affordable epinephrine autoinjectors.

The Epinephrine Accessibility Act 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 can retail for more than $600, a pharmacist could substitute a less expensive brand alternative, with the patient’s consent, that can cost hundreds of dollars less and still meet the patient's pharmaceutical needs. Epinephrine auto-injectors were not substitutable from brand to brand under the old state law in most instances.

The second part of the law enables pharmacists to dispense epinephrine auto-injectors to adults 18 years of age or older without a prescription (under a physician’s protocol) once the pharmacist establishes that the patient has already received an initial prescription for epinephrine. So essentially, once a patient gets an initial prescription for epinephrine, as an adult, they would not need to go back to the doctor each year for a new prescription; they could simply get it at the pharmacy without the new physician order.

The law called for the Ohio Board of Pharmacy, with consultation of the State Medical Board of Ohio, to establish protocol requirements that govern the conditions under which pharmacists can dispense epinephrine auto-injectors to adults without a prescription.

We are pleased to report that those rules and requirements are now finalized, and OPA has created a sample protocol for pharmacists to utilize to begin implementing the new law and scope of practice.

Protocol for Dispensing Epinephrine Autoinjectors without a Prescription

Section 4729.47 of the Ohio Revised Code authorizes a pharmacist or pharmacy intern to dispense epinephrine autoinjectors without a prescription pursuant to a physician protocol. To implement this section of law, the State of Ohio Board of Pharmacy has adopted the following rules:

4729:1-3-06 - Dispensing of epinephrine autoinjectors by pharmacists

4729:2-3-06 - Dispensing of epinephrine autoinjectors by pharmacy interns

OPA has created a protocol as a member benefit for OPA members to use in their practices.

This protocol meets the board requirements for a physician-established protocol for dispensing epinephrine autoinjectors without a prescription to individuals at least 18 years of age who meet the criteria specified in Ohio Revised Code and Administrative Code.

Protocol for Dispensing Epinephrine Autoinjectors without a Prescription

To assist pharmacists in understanding the new epinephrine laws, the board of pharmacy has developed a frequently asked questions document, available at:  http://www.pharmacy.ohio.gov/EpiLaws

Thank you for helping to reduce patient hassles and costs in order to obtain these life-saving medications.


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