policies and laws_for_pharmacists_final_rev
DESCRIPTION
Pharmacy Track, National Rx Drug Abuse Summit, April 2-4, 2013. Policies and Laws for Pharmacists presentation by Dr. Lynn Rafferty and Joel ThornburyTRANSCRIPT
Policies and Laws for Pharmacists
Dr. Lynn Rafferty, Pharm. D, MBA, N.D., CNC, CNHP.
Assistant Professor at The College of Medicine, Nova Southeaster University
Joel Thornbury President, Kentucky Board of Pharmacy
Learning ObjecKves
1. Describe the relaKonship between federal law, state law and other regulatory requirements pertaining to diversion.
2. Outline the variables to consider when construcKng a strategy for diversion prevenKon, detecKon and remediaKon.
3. Formulate an effecKve plan of acKon when diversion is discovered or suspected.
Disclosure Statement
• Lynn Lafferty has no financial relaKonships with proprietary enKKes that produces health care goods and services.
• Joel Thornbury has no financial relaKonships with proprietary enKKes that produces health care goods and services.
Florida Law and the PracKce of Pharmacy
Lynn Lafferty, Pharm.D., N.D. Assistant Professor
College of Osteopathic Medicine Nova Southeastern University
*SPECIAL THANKS Dr. James Hall, Broward Task Force
Federal Laws
• Title 21 United States Code (21 U.S.C.) 801-‐971 and the DEA regulaKons, Title 21, Code of Federal RegulaKons (21 C.F.R.), Parts 1300 to End. – On line Pharmacists Manuel – Sec$on 1306.06 Persons en$tled to fill prescrip$ons
“A prescripKon for a controlled substance may only be filled by a pharmacist, acKng in the usual course of his professional pracKce and either registered individually or employed in a registered pharmacy, a registered central fill pharmacy, or registered insKtuKonal pracKKoner.”
–
Florida State Law
• Title XLVI, Chapter 893 • A pharmacist, in good faith and in the course of professional pracKce only, may dispense controlled substances upon a wriaen or oral prescripKon of a pracKKoner, under the following condiKons:
5,489 individuals died with one or more prescription drugs in their system. The drugs were at both lethal and non-lethal levels.
Prescription Drug-Related Deaths in Florida: 2011
Source: Florida Department of Law Enforcement: Florida Medical Examiners Commission Report 2011
Physician Dispensing
• Physicians ordering and dispensing prescripKon medicaKons – Used to be limited to emergency supply and samples
– Large problems with limited benefits to paKents.
Physician Dispensing Pros
• Improved paKent access to medicaKons • PaKent convenience • Generic and therapeuKc subsKtuKons due to the physician’s enhanced awareness of medicaKon costs
• Possible improved paKent adherence with medicaKon regimens
Physician Dispensing Cons
• Conflict of Interest – Large Problem with narcoKc dispensing
• Serious medicaKon safety concerns – loss of a crucial second check by a pharmacist and use of sofware to detect prescribing errors and ,
– lack of regulatory oversight • lax procedures for medicaKon labeling • record-‐keeping • storage • supervision of the dispenser
ARCOS
October2008 – March 2009
Top 25 Dispensing Practitioners of Oxycodone in the U.S.
(All in Florida)
Florida 9,201,731
Dose Units
5,233,785 Dose Units
Number of Oxycodone Reports Detected among Decedents in Broward County: 2007-‐2011
NUMBER of Oxycodone
OCCURRENCES Including
“Present” & “Cause of Death”
SOURCE: Florida Medical Examiners Commission Report 2011
119
171
225 236
174
0
50
100
150
200
250
2007 2008 2009 2010 2011
Broward
Number of Alprazolam Reports Detected among Decedents in Broward County: 2007-‐ 2011
NUMBER of Alprazolam
OCCURRENCES Including
“Present” & “Cause of Death”
SOURCE: Florida Medical Examiners Commission Report 2011
133
203
245 235
199
0
50
100
150
200
250
300
2007 2008 2009 2010 2011
Broward
Number of Emergency Departments Reports by Drug in Broward & Palm Beach Coun$es, FL: 2008,,2009
and 2010
5,560
4,479
4,081
2,351
2,913 3,299
2,274
2,900 3,110
2,000
2,500
3,000
3,500
4,000
4,500
5,000
5,500
6,000
2008 2009 2010
# o
f ED
Rep
ort
Esti
mat
es
SOURCE: US Dept. HHS-SAMHSA, CBHSQ: DAWN Emergency Dept. Estimates 2008-2009.
Note: Cocaine visits had sta$s$cally significant decreases from 2008 to 2009. Prescrip$on Opioid nonmedical use visits had sta$s$cally significant increases from 2008 to 2010. No sta$s$cally significant changes were noted for 2008 or 2009 compared with 2010 for Benzodiazepines.
Cocaine
NMU Benzodiazepines
Number of Emergency Departments Reports by Drug in Broward & Palm Beach Coun$es, FL: 2008,,2009
and 2010
5,560
4,479
4,081
2,928
2,870
3,249
2,351
2,913 3,299
2,000
2,500
3,000
3,500
4,000
4,500
5,000
5,500
6,000
2008 2009 2010
# o
f ED
Rep
ort
Esti
mat
es
SOURCE: US Dept. HHS-SAMHSA, CBHSQ: DAWN Emergency Dept. Estimates 2008-2009.
Note: Cocaine visits had sta$s$cally significant decreases from 2008 to 2009. Prescrip$on Opioid nonmedical use visits had sta$s$cally significant increases from 2008 to 2010. No sta$s$cally significant changes were noted for 2008 or 2009 compared with 2010 for Marijuana.
Cocaine
Marijuana
Number of Heroin-‐related Deaths in Florida: 2000 –2011
0 50
100 150 200 250 300 350 400 Florida
Miami-Dade Broward
SOURCE: Florida Medical Examiners Commission Reports 2000-2011
62
# Lethal Heroin Deaths
15 3
2012 ??
Sun SenKnel February 19, 2013
• “Heroin taking oxy's place for more addicts” – Heroin increasing – Lost opportunity to get people into treatment
Number of Primary Heroin Treatment Admissions Miami-‐Dade and Broward Coun$es, FL: 2009-‐2012
150 183
227
308
105
156 169
316
0
50
100
150
200
250
300
350
1 2 3 4 5 6 7 8
# of primary Treatm
ent A
dmission
s
SOURCE: Florida Department of Children and Families
2009 2010 2011 2012* 2009 2010 2011 2012*
Miami-‐Dade Broward
* 2012 Admissions based on 2 x‘s 1st Half 2012
FL House Bill 7095
EffecKve July 1, 2011 • PracKoners no longer authorized to dispense Schedule II or III
controlled substances. – Except: Emergency 72 hr. supply, correcKons, hospice, clinical trials, surgical
procedures, and methadone clinics
• Standards Made Clear – Complete medical history
– Wriaen individualized RX plan
– Wriaen controlled substance agreement – Reg. follow-‐up plan
• Must designate themselves as a controlled substance prescribing pracKKoner
• Counterfeit-‐proof Rx pad
Pharmacist
• Number one most respected professional • Most Accessible
– More paKent contacts than any other health care professional
• Has access to paKent, doctor and informaKon
• CriKcized not taking a strong role in addicKon medicine
Knowledge, Aktudes and PracKces of Pharmacists Concerning PrescripKon Drug Abuse, Lafferty, Hunter and Marsh
• 454 Pharmacists QuesKoned • 65% Retail, 16.5% Hospital, 9% Mail order
• 68% B.S., 25% Pharm.D.
• 65% Male and 35% Female
• 65% over 45 years old
Results
• Knowledge – Most did not answer the addicKon quesKons correctly • Only 28% knew the standard of care • Less than half said they knew about intervenKon and treatment
• EducaKon – Almost 30% had no substance abuse educaKon
– 67.5% had less than 2 hours
Treatment and IntervenKon
• Although most had not intervened, the more educaKon they had the more confident they were to do intervenKon
• They were also more likely to call the physician to speak about a problem.
EducaKon Needed
• Pharmacists can help by: – Calling doctors when they believe there is a problem
– Speaking to alternaKves to paKent – Checking and making sure they are not using mulKple pharmacies and doctors
– Intervening
Discussion
• Pharmacists Role – CerKficaKon program
– EducaKon needed to have a greater role – Pain pharmacy
• Society at Large – Oxycodone vs. Heroin
Abuse…a problem….Hello? Yes,
Kentucky Pharmacy is Here!!
April 2 – 4, 2013 Omni Orlando Resort
at ChampionsGate
Topics for Discussion
• 1. Describe what SS-‐HB1 has done to affect the Profession and help reduce diversion.
• 2. Provide an update on issues we faced and what Bill has just passed and signed to correct issues.
• 3. Formulate an effecKve plan of acKon when diversion is discovered or suspected.
