Legislative Limbo

upcoming regulations and bill status

Upcoming regulations and bill status

OARRS:  New Gabapentin Requirement

Starting December 1, 2016 the Ohio Board of Pharmacy is now requiring pharmacies to submit gabapentin use to OARRS. Report if:

• Patient has a new prescription for a controlled medication (II-V) that was not previously on their profile history
• Patient has a prescription for a controlled substance and OARRS has not been checked for 12 months  
• Prescriber or patient is located outside usual pharmacy area  
• Whenever a pharmacist believes that a patient has received prescriptions from more than one prescriber in the previous 3 months, unless all prescribers work at the same practice
• Patient is exhibiting signs of potential abuse or diversion such as early refills or intoxication

Pharmacy groups hope to delay enforcement of USP <800>

The current implementation date of USP <800> is July 1, 2018. Ohio and five other pharmacy organizations wrote their state boards of pharmacy requesting a delay for implementation of <800> to 2021.  If implemented, this would require any pharmacy that compounds hazardous drugs, both sterile and non-sterile based on The National Institute for Occupational Safety and Health (NIOSH) list, to follow strict protocols such as but not limited to: 

• Compounding hoods will be required for both hazardous and nonhazardous compounding  
• Each hood is required to have at least one HEPA filter and must be contained in an area that is physically separated from other preparation areas  
• A negative pressure room is required

Why is this making headlines?

These updates would require any pharmacy compounding to be done under a hood, and place great restrictions on hazardous compounding that will cost pharmacies tens of thousands of dollars to remodel. For example, hormones such as estrogen and testosterone are on the NIOSH list, forcing pharmacies that compound hormone replacement therapy left with the decision if they would like to spend the money to remodel their practice.

'I'm just a bill' - Legislative Update

SB 332 (Formerly HB 421)
Status: voted out of the Senate on 9/28/16

Pharmacists would be allowed to administer (under a physician protocol) any of the following drugs to a patient with a valid prescription:

• Any long acting or extended release form of an opioid antagonist used to treat drug addiction  
• Any long acting or extended release antipsychotic  
• Hydroxyprogesterone caproate (hormone used to lower the risk of preterm birth)
• Medroxyprogesterone acetate  
• Cobalamin

The bill would also allow pharmacists to administer epinephrine or diphenhydramine, or both, to a patient in an emergency situation resulting from a possible adverse reaction to a drug.