Keith Hautala

By

College: Medicine

UK Expert Advises FDA on Hydrocodone Policy

Published: Feb 18, 2013

LEXINGTON, Ky. (Feb. 18, 2013) — In January, an advisory panel of the Food and Drug Administration recommended tighter controls and greater scrutiny be placed on hydrocodone, one of the most widely abused pain medications in the United States, by reclassifying it from Schedule III to the more restrictive Schedule II.

 

Hydrocodone, an opioid painkiller (often combined with non-opioid analgesics and sold under various trade names, including Vicodin and Lortab) is the single most commonly prescribed medication in the United States, with more than 120 million prescriptions last year. It is also one of the most commonly diverted drugs.

 

Abuse of prescription pain pills, including those containing hydrocodone, has become a serious public health and law enforcement problem, particularly in rural, low-income areas — and notably in Eastern and Central Kentucky.

 

Sharon Walsh, director of the University of Kentucky's Center on Drug and Alcohol Research, gave expert testimony at the meeting that led to the up-scheduling recommendation.

 

Walsh, a professor in the UK College of Medicine with appointments in Behavioral Science, Psychiatry, and Pharmacology and Pharmaceutical Sciences, is a researcher specializing in substance dependence disorders, including opioid abuse. She has led pharmacological studies focused on developing new medications for the treatment of opioid use disorders, as well as improving the utility, safety and application of existing medications. She has also conducted studies evaluating opioids and related compounds for the potential to be abused.

 

"The FDA invited me as an outside expert to summarize the available human data on the pharmacological profile of hydrocodone," Walsh said. "We had conducted two of the critical studies here at UK that characterized hydrocodone when taken orally, and also when used intravenously, by comparing it to other common opioids with high abuse potential, such as oxycodone, morphine and hydromorphone." 

 

Those studies showed that hydrocodone was virtually indistinguishable from other opioids placed in Schedule II. These findings were in contrast to the information originally used in the 1970s when the decision was made to place hydrocodone combination products into Schedule III.

 

Walsh was initially appointed to the FDA as a special government employee in 2008. She has served as a consultant on various advisory committees. More recently, she has been invited by the FDA to speak as an outside expert to inform committee deliberations by presenting data on opioid pharmacology in humans.

 

The January meeting, of the FDA Advisory Committee on Drug Safety and Risk Management, was convened because the federal Drug Enforcement Administration had petitioned the FDA for a public hearing on up-scheduling hydrocodone combination products to Schedule II.

 

Drugs placed in Schedule II have more stringent requirements for prescriptions and controls over supply. One difference is that a Schedule II prescription must have a paper prescription written by the physician, which means a visit to the doctor’s office, and cannot be "called in" by phone, Walsh explained. 

 

Schedule II prescriptions are also usually written for only a maximum 30-day supply. Currently, hydrocodone prescriptions may be written with up to a six-month supply. This would mean more visits to the doctor would be required for those requiring long-term treatment.

 

By making the controls more restrictive, it is very likely that the absolute numbers of prescriptions will be reduced, Walsh says. 

"Just last month, we heard at a meeting in Frankfort that prescriptions for hydrocodone had already declined secondary to the introduction of House Bill 1, which enforces the use of the KASPER (Kentucky All Schedule Prescription Electronic Reporting) prescription monitoring program for hydrocodone combination products," she said. 

 

Epidemiological studies reveal that rates of abuse, drug dependence treatment admissions and overdose deaths increase proportionately with sales. It is likely, Walsh says, that decreasing availability will have a positive impact on rates of abuse of hydrocodone. However, there are also potential drawbacks to consider.

 

"The downside is that patients who have a legitimate need for these products for pain relief may have a more difficult time accessing them," Walsh said. "In some states, mid-level providers, such as physician assistants and nurse practitioners, may be licensed to prescribe Schedule III agents but not Schedule II.  Thus, if the change were enacted, some providers who could previously prescribe for their patients would be unable to do so."

 

MEDIA CONTACT: Keith Hautala, (859) 323-2396; keith.hautala@uky.edu

walsh.jpg
August
 
 
 
 
 
1
Employee Educational Assistance Award
Landscape/Mindscape: Selections from the Wells Fargo Collection
Fri
2
Employee Educational Assistance Award
Landscape/Mindscape: Selections from the Wells Fargo Collection
Sat
3
Employee Educational Assistance Award
Landscape/Mindscape: Selections from the Wells Fargo Collection
Artful Sunday: Wrapped Art
Sun
4
Employee Educational Assistance Award
Mon
5
Employee Educational Assistance Award
Landscape/Mindscape: Selections from the Wells Fargo Collection
Tue
6
Employee Educational Assistance Award
Landscape/Mindscape: Selections from the Wells Fargo Collection
Get Moving - A Walking Group for Caregivers
Wed
7
Employee Educational Assistance Award
Landscape/Mindscape: Selections from the Wells Fargo Collection
Thu
8
Employee Educational Assistance Award
Landscape/Mindscape: Selections from the Wells Fargo Collection
Fri
9
Employee Educational Assistance Award
Landscape/Mindscape: Selections from the Wells Fargo Collection
Sat
10
Employee Educational Assistance Award
Landscape/Mindscape: Selections from the Wells Fargo Collection
Sun
11
Employee Educational Assistance Award
Mon
12
Employee Educational Assistance Award
Landscape/Mindscape: Selections from the Wells Fargo Collection
UK Working Moms Connection
Tue
13
Employee Educational Assistance Award
Landscape/Mindscape: Selections from the Wells Fargo Collection
Wed
14
Employee Educational Assistance Award
Landscape/Mindscape: Selections from the Wells Fargo Collection
Thu
15
Employee Educational Assistance Award
Landscape/Mindscape: Selections from the Wells Fargo Collection
Fri
16
Employee Educational Assistance Award
Landscape/Mindscape: Selections from the Wells Fargo Collection
Sat
17
Employee Educational Assistance Award
Landscape/Mindscape: Selections from the Wells Fargo Collection
Sun
18
Employee Educational Assistance Award
Mon
19
Employee Educational Assistance Award
Tue
20
Employee Educational Assistance Award
Chronic Disease Self-Management Program
Wed
21
Employee Educational Assistance Award
Thu
22
Employee Educational Assistance Award
Midnight Dodgeball Tournament
CARES First Year Focus Parent Meetings
CARES First Year Focus Parent Meetings
Parent and Families Reception
Residence Hall Floor Meeting
Off-campus Freshmen Check-in
K Team Meeting: K Week Kick-off
Death By Chocolate
Fri
23
Employee Educational Assistance Award
A Parent's Guide to Life after August 23
Campus Safety Information Session
Donut Avoid The Study
Common Cents: Money Management for College Students Session 1
See Blue...See Community
Succeeding in A Large Lecture Classroom
Horses, Bluegrass, Basketball, and More: Welcome to Kentucky
Success at Any Age: College Tips for Adult Learners
Write Right: Tips for Writing Well in College
Common Cents: Money Management for College Students Session 2
How to Graduate in Four Years
Parental Involvement in Fraternity and Sorority Life
Parents Watch for Warning Signs: Suicide Prevention for College Students
Preparing to be a Pre-Professional
Presentation U!: Where YOU are the Ultimate Presentation
Religious Life at UK
Successful Off-Campus Living
The Transfer Student Cruise: Navigating your way through UK
UK Parking & Transportation 101
You Heard It Here First: Tips From A Faculty Member
New Student Induction Ceremony
Minority Student Welcome
Transfer Student Cookout
K Team Meeting: K Week Overview
Men's Soccer vs. Georgia State
Big Blue U
Campus Ruckus
Campus Ruckus
Sat
24
Employee Educational Assistance Award
LNFS Presents: Jackass 3
LNFS Presents: Godzilla
Pedalpalooza
K Team Meeting: Lunch and Campus Tour
Center for Community Outreach: Do Good, Start Here.
UK Lex-Mart
Alternative Service Breaks: See the World, Change the World
From the Real World to the Amazing Race, Don't Wipeout: Your Advisor, Advising, and You
Blackboard Basics
Student Government Association Information Session
EMPOWER: Women’s Leadership Retreat Interest Session
Student Center Spectacular
Student Center Spectacular
Sun
25
Employee Educational Assistance Award
UK FUSION
UK Parking & Transportation 101
University of Kentucky Association for Transfer Students Interest Session
Candy, Condoms, Coffee
Cleaner, Healthier, Cheaper, Faster: Why Bicycling is the Best Way to Get Around Campus (and how to do it safely)
Working on Campus
K Team Meeting: Dinner with your K Team
Meijer Mania
Mon
26
Employee Educational Assistance Award
Last Day to Drop a Course with 100% Refund
Chem at UK Cafe-N-OJ with the Student American Chemical Society
Coffee (or Coke), Cookies, & Communication!: Come see blue. at Presentation U!
Don't Blow Yourself Up: Surviving Chemistry
Fraternity Recruitment Info Session
OMG! Did I Just E-Mail That to My Professor???
Surviving Your First Year and Beyond: Strategies To Do Well in Your Classes
Sustainable UK: Exploring Environmental Programs in the College of Agriculture, Food, and Environment (CAFE)
A User Guide for Your Mathematics Class
Discover the UK Art Museum
K Team Meeting: Common Reading Experience Discussion
Common Reading Introduction for International Students
Transfer Student Meet and Greet
We Are UK
Rec 'N Roll 2014
Big Blue Bingo Night
Mic Check
Tue
27
Employee Educational Assistance Award
Fraternity Recruitment Info Session
LNFS Presents: Jurassic Park
First Day of Classes
Open House - Special Collections Research Center
King Cookout
Campus Outreach
Opening Act: The Amazing Spider-Man 2
Wed
28
Employee Educational Assistance Award
Internship Info Session
LNFS Presents: Her
LNFS Presents: Captain America: The Winter Soldier
Student Involvement Fair
OrgSync Info session
LGBTQ* Welcome Back
Dive Into Diversity!
CATalyst's Dive Into Diversity Session
Residence Hall Floor Meetings
Thu
29
Employee Educational Assistance Award
Sea of Blue
One Last Beach Bash: RSA Block Party
LNFS Presents: Team America: World Police
Pills and Pizza
K Week Event: Pills and Pizza
Kentucky Volleyball vs. Wichita State
Kentucky Women's Soccer vs. Francis Marion
Fri
30
Employee Educational Assistance Award
LNFS Presents: Neighbors
The Tailgate "Kick-Off"
Kentucky Volleyball vs. Butler
Kentucky Football vs. UT-Martin
Kentucky Volleyball vs. Virginia Tech
Sat
31
Employee Educational Assistance Award
Kentucky Women's Soccer vs. Ohio
Men's Soccer vs. Belmont
Sun
 
 
 
 
 
 

Wed, 08/27/2014

Thu, 08/28/2014

Reset Page