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Statutory and Regulatory Mandates for Prescribing and Dispensing
Controlled Substances in Kentucky
Roz Cordini
May 7, 2013
Louisville | Lexington | Memphis | Nashville | Jackson | New Albany | www.wyattfirm.com
House Bill 1
Initially presented in the Regular Legislative Session January 3 - April 12, 2012
Special Legislative Session – Approved 4/24/12 Effective Date: 7/20/12 Intent – Address the prescription drug abuse problem in Kentucky
The amount of prescription painkillers sold in states varies.
Source: CDC http://www.cdc.gov/homeandrecreationalsafety/rxbrief/index.html
PRESCRIPTIONS FOR CONTROLLED SUBSTANCES PER PERSON BY COUNTY 3RD QUARTER 2011
Controlled Substances Dispensed in Ky
0
50000000
100000000
150000000
200000000
250000000
Hydrocodone Oxycodone Alprazolam Diazepam Clonazepam Lorazepam
Drug Name
Dos
es D
ispe
nsed
2006 Doses 2011 Doses
Drug Overdose Rates by State, 2008
Drug Overdose Rates by State
Source: CDC http://www.cdc.gov/homeandrecreationalsafety/rxbrief/index.html
Source: CDC http://www.cdc.gov/homeandrecreationalsafety/rxbrief/index.html
100 people die from drug overdoses every day in the United States.
Source: CDC http://www.cdc.gov/homeandrecreationalsafety/rxbrief/index.html
Where the drugs come from
HB 1 – Scope Pain Management Facility Ownership/Oversight Use of KASPER Data
proactive use by Cabinet to identify illegal, improper, or inappropriate prescribing practices mandatory reporting to licensing boards
Linking KASPER data with the prescription drug monitoring programs of bordering states Establishment of a Prescription Monitoring Program Interstate Compact Mandatory drug testing in coroner’s cases Annual epidemiological reports to be published by the Office of Drug Control Policy Governor appointment of specialists to licensing boards Pharmacy reporting of thefts to the KSP Establishment of an implementation oversight committee Mandatory Prescribing, Dispensing and Reporting Standards Mandate to licensing boards to establish regulations pertaining to prescribing and dispensing of controlled substances
Primary Issues Related to HB 1
The term “prescription”
“Prior to” language in the prescribing requirements
“Initial” Prescription
Hospital/LTC facility querying of KASPER Hospital/LTC facility reporting dispensed doses into KASPER Cumbersome requirements for practitioners treating patients with controlled substances
HB 217 & Revised Regulations HB 1 “Clean-up” Bill
Effective 3/5/2013
Removed requirement that hospitals/LTC facilities report certain dispensed doses into KASPER
Removed the prescribing standards from the statute
Added opportunity for hospitals/LTC facilities to create “institutional accounts” Permitted an overall exception for hospitals/LTC facilities if a KASPER report is placed on the chart within 12 hours of admission KBML regulations revised
Treatment of pain Treatment of other conditions
Questions?
Roz Cordini rcordini@wyattfirm.com
(502) 562-7307
Wyatt, Tarrant & Combs, LLP 500 West Jefferson Street Suite 2800 Louisville KY 40202-2898
WTC 60222950.3
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