Transcript Prescription Medication and Illicit Drug Abuse - Alumni

Prescription Medication and
Illicit Drug Abuse and the
Role of the Pharmacist
S. Scott Collier
Diversion Program Manager - St Louis Division, Drug Enforcement Administration
Garth K. Reynolds, RPh
Executive Director, Illinois Pharmacists Association
St Louis College of Pharmacy
Alumni Association | Women in Pharmacy
Professional Workshop | 09 April 2016
Disclosures
 Scott Collier and Garth Reynolds declares no conflicts of
interest, real or apparent, and no financial interests in any
company, product or service mentioned in this program,
including grants, employment, gifts, stock holdings and
honoraria.
Pharmacist Objectives
 Discuss current trends in illicit drug abuse.
 Discuss impact of prescription medication abuse of
population and impact on pharmacy.
 Describe the expanding role of the pharmacist in providing
opioid antagonists and overdose management.
 Discuss current legislation and public policy concerning
pharmacists and opioid overdose management.
CPE Activity Information
 Target Audience: Pharmacists
 Activity Type: Knowledge
 Contact Hours: 1.0
 UAN: 0033-0000-16-007-L04-P
Question #1
Which drug is second only to marijuana in terms of the number
of illicit users?
a)
b)
c)
d)
Cocaine
Heroin
Rx Medications
Scooby Snacks
Question #2
What class of drugs is driving the rise in overdose fatalities in
the United States?
a)
b)
c)
d)
Heroin
Rx Opiates
Methamphetamine
Synthetic Cannabinoids
Question #3
Who is responsible for the proper prescribing and dispensing
of a controlled substance?
a)
b)
c)
d)
e)
Physician
Nurse
Patient
Pharmacist
A and D
Question #4
Illinois and Missouri (and other states) are increasing the
access to opioid antagonists by which of the following except:
a)
b)
c)
d)
Dispense via a Standing Order
Dispense via a Statewide Protocol
Written prescription from a prescriber
Selling over the counter without a prescription
Trends in Illicit Drug Abuse
Current Users
ANY ILLICIT DRUG:
27 million
(10.2 % of population)
MARIJUANA: 22.2 million
Rx Drugs: 6.5 million
COCAINE: 1.5 million
METHAMPHETAMINE: 569,000
HEROIN: 435,000
1SOURCE:
2014 National Survey on Drug Use and Health (NSDUH) published Sept 2015 by
the Dept of HHS / Substance Abuse and Mental Health Services Administration (SAMHSA)
Heroin Resurgent
 Suburban/Rural Teens
 Transitioning from Rx Narcotics such
as oxycodone/hydrocodone to heroin
 More Refined
 Smoke or snort
 Less stigma than needle
 Undercutting Rx Prices
 Pills up to $1/mg
 Heroin $10-$20
12
CDC: Overdose Deaths in US 2014
Total OD Deaths - 47,055
Heroin
RX Opiates
Other
15
16
Impact of Prescription Medication Abuse
Types Of Rx Medications Abused
2014
•
•
•
•
2013
Pain Relievers – 4.3 million
Tranquilizers – 1.9 million
Stimulants – 1.6 million
Sedatives – 330,000
 Pain Relievers – 4.5 million
 Tranquilizers – 1.7 million
 Stimulants – 1.4 million
 Sedatives – 251,000
2014/2013 National Survey on Drug Use and Health: Summary of National Findings (NSDUH),
Substance Abuse and Mental Health Services Administration, 2015/2014
Source Of Rx Medications
From a friend or relative for free - 53.0%
Bought from a friend or relative - 14.6%
Took from a friend or relative without
asking - 5.4%
Through one Doctor - 21.2%
Through more than one Doctor - 2.6%
Got pain relievers from dealer or stranger 4.3%
Bought on the Internet - 0.1%
Other - 4.3%
2013 National Survey on Drug Use and Health: Summary of National Findings (NSDUH), Substance Abuse
and Mental Health Services Administration, 2014
Current Teen Trends
 Teens tried prescription medication to get high - 17%
 10% - Pain Relievers
 Teens report abusing cough medicine - 12%
 Agree that Rx medicines are "much safer" to use than illegal
drugs - 40%
 Believe ADHD medications can be used as study aids – 31%
 Disapprove of their peers using prescription medications to
get high – 58%
http://www.dea.gov/pr/multimedia-library/publications/prescription_for_disaster_english.pdf
Economic Costs Of Prescription
Medication Abuse
• $55.7 billion in costs for prescription medication abuse in
2007
• $24.7 billion in direct healthcare costs
• Opioid abusers – 8.7 times higher direct healthcare costs
than non-abusers
• 32,449 opioid overdoses in Midwest (23.9%)
DEA Pharmacy Diversion Awareness Conference: Drug Trends Presentation, Schaumburg, Illinois – June 22, 2013
DEA Pharmacy Diversion Awareness Conference: Drug Trends Presentation, Schaumburg, Illinois – July 26, 2015
http://www.cdc.gov/vitalsigns/opioid-prescribing/index.html
http://www.cdc.gov/vitalsigns/opioid-prescribing/index.html
http://www.cdc.gov/drugoverdose/pdf/policyimpact-prescriptionpainkillerod-a.pdf
Number Of Pharmacy Thefts
 Nationwide (01/2009 – 07/2014)
 Employee Pilferage – 36,753
 Night Break-in – 5,315
 Armed Robbery – 4,033
 Dosage Units
 Employee Pilferage – 27.1 million units
 Night Break-in – 30.4 million units
 Armed Robbery – 7.3 million units
 Illinois ranks 25th in robberies
 Missouri ranks 28th in robberies
http://www.deadiversion.usdoj.gov/mtgs/pharm_awareness/conf_2014/august_2014/utah/gallagher.pdf
Types Of Diversion
• Prescription Forgeries
• Employee pilferage
• Illegal internet sites (pharmacies)
• Prescription rings
• Illegal prescribing
• Medication smuggling
• Pharmacy theft
NACDS/DEA Presentation on Drug Diversion, Saint Louis, MO, June 30, 2011
Techniques To Discourage Theft
• Improve physical security
• Increase awareness of security requirements
• Develop written security procedures
• Train employees
• Seek assistance from law enforcement
• Communicate with other pharmacies
DEA Pharmacy Diversion Awareness Conference: Drug Theft Prevention Presentation, Schaumburg, Illinois – June 22, 2013
Pharmacy Burglary Prevention
• Install an alarm system and test it often
• Install video cameras
• Communicate with local law enforcement
• Invite the local police to conduct a security assessment
• Ensure adequate outside lighting and leave some lights on
after closing
• Change locks, alarm codes, safe combinations when an
employee leaves
DEA Pharmacy Diversion Awareness Conference: Drug Theft Prevention Presentation, Schaumburg, Illinois – June 22, 2013
After a Pharmacy Burglary
• Call Law Enforcement, notify supervisor
• Do not touch anything – Protect crime scene
• Provide law enforcement with detailed list of what has been
stolen
• File a DEA Form 106 and BNDD Form
• Evaluate situation and improve security
DEA Pharmacy Diversion Awareness Conference: Drug Theft Prevention Presentation, Schaumburg, Illinois – June 22, 2013
Pharmacy Robbery Prevention
• Have at least two employees open and close the store
• Install hold-up/duress alarm systems
• Keep a minimum amount of controlled substances on-hand
• Stay alert to your surroundings; watch for suspicious people
and activity
• Train employees on scenarios
DEA Pharmacy Diversion Awareness Conference: Drug Theft Prevention Presentation, Schaumburg, Illinois – June 22, 2013
During a Pharmacy Robbery
• Do Not Resist! Cooperate and remain calm
• Avoid sudden movements
• Comply with robber’s demands; nothing more & nothing less
• Do not talk except to answer questions
• Do not stare directly at the robber
• Make mental notes of the robber’s description
• Clothing, hair length & color, size, build, tattoos, scars, and other
body features
DEA Pharmacy Diversion Awareness Conference: Drug Theft Prevention Presentation, Schaumburg, Illinois – June 22, 2013
After the Pharmacy Robbery
 Do not chase the robber
 Once the robber leaves, lock the door
 Get treatment for an injured
 Activate alarm system, as soon as possible
 Call Law Enforcement, then supervisor
 Do not touch anything – Protect crime scene
 Keep witnesses on site
 Quickly write down your mental notes
 File a DEA Form 106 and BNDD Form
DEA Pharmacy Diversion Awareness Conference: Drug Theft Prevention Presentation, Schaumburg, Illinois – June 22, 2013
National Take Back Initiative
• 11th National Take Back scheduled 04/30/2016
• 5.5 million pounds
• Many metro area local police departments and the regional
DEA office are conducting take back sites.
• On 09/09/2014, DEA released new regulations that will allow
pharmacies to participate and collect medication as an
ongoing service.
http://www.dea.gov/divisions/hq/2015/hq100115.shtml
Role of the Pharmacist
NABP AWARxE “Red Flags” Campaign
 In 2014, NABP produced a video to educate pharmacists on
common “red flags” for prescription forgeries/fraud.
 www.youtube.com/watch?v=WY9BDgcdxaM
Our Responsibilities
• Legal responsibility to acquaint yourself with the state and federal
requirements for dispensing controlled substances.
• Have a legal and ethical responsibility to uphold these laws and to
help protect society from drug abuse.
http://www.deadiversion.usdoj.gov/pubs/brochures/pharmguide.htm
Our Responsibilities
• Personal responsibility to protect your practice from becoming an
easy target for drug diversion.
• Be aware of the potential situations where drug diversion can occur
and safeguards that can be enacted to prevent this diversion.
http://www.deadiversion.usdoj.gov/pubs/brochures/pharmguide.htm
Our Responsibilities
• The dispensing pharmacist must maintain constant vigilance
against forged or altered prescriptions.
• The law holds the pharmacist responsible for knowingly dispensing
a prescription that was not issued in the usual course of
professional treatment.
http://www.deadiversion.usdoj.gov/pubs/brochures/pharmguide.htm
Characteristics Of Prescription Forgeries
• Rx looks “too good”; the prescriber's handwriting is too
legible
• Quantities, directions, or dosages differ from usual medical
usage
• Rx does not comply with the acceptable standard
abbreviations or appear to be textbook prescriptions
http://www.deadiversion.usdoj.gov/pubs/brochures/pharmguide.htm
Characteristics Of Prescription Forgeries
• Rx appears to be photocopied (or computer generated)
• Directions written in full with no abbreviations
• Rx written in different color inks or written in different
handwriting
http://www.deadiversion.usdoj.gov/pubs/brochures/pharmguide.htm
Prevention Techniques
• Know the prescriber and the prescriber’s handwriting and
signature
• Know the patient
• Check the date on the Rx. Has the order been presented in a
reasonable time
• Verify questionable Rx orders with prescriber or prescriber’s
office
• Request proper identification
http://www.deadiversion.usdoj.gov/pubs/brochures/pharmguide.htm
Prevention Techniques
• Follow your companies policies and procedures concerning Rx
forgeries
• If you have a possible forgery; call and verify with the prescriber.
Then if needed call the police
• If you believe there is a pattern developing: contact the Board,
BNDD (MO), ILPMP (IL), or DEA
http://www.deadiversion.usdoj.gov/pubs/brochures/pharmguide.htm
Prescription Monitoring Programs
http://www.cdc.gov/drugoverdose/pdmp/
Prescription Monitoring Programs
http://www.nabp.net/system/rich/rich_files/rich_files/000/001/270/original/pmpmap-2-16-16.pdf
http://www.cdc.gov/media/modules/dpk/2016/dpk-pod/rr6501e1er-ebook.pdf
Pharmacist Role with Opioid Antagonist
 Pharmacist as Educator:
 Motivating people to be obtain an opioid antagonist;
 Pharmacist as Facilitator:
 Working with other healthcare providers and community
organizations to increase access to opioid antagonists;
 Pharmacist as Practitioner:
 Protecting vulnerable people, consistent with state law.
http://prescribetoprevent.org/wp2015/wp-content/uploads/naloxone-access.pdf
Naloxone Kit Dispensing Options
Intramuscular Naloxone
Kits contain the
following, at a minimum:
• Two (2) single-use 1 ml
vials Naloxone
Hydrochloride
(0.4mg/ml)
• Two (2) intramuscular
needle syringes
• Overdose prevention
information pamphlet
with step by step
instructions for use.
Intranasal Naloxone
Kits containing, at a
minimum:
• Two 2 ml Luer-Jet
Luer-lock syringes
prefilled with
Naloxone
Hydrochloride
(2mg/2ml)
• Two mucosal
atomization devices
• Overdose prevention
information pamphlet
with step by step
instructions for use.
Auto-injector Kits
Containing the
following:
• Naloxone HCL 0.4
mg/ml pre-packaged
kits (Evzio, NDC
60842-030-01)
•
Containing 2 autoinjectors with audio
instructions and 1
training device and
step by step
instructions for
administration of
Naloxone by autoinjector.
Patient Education and Counseling
 Indications/Usage
 Contraindications
 Precautions
 Adverse Reactions
 Follow-Up Requirements
Current Legislation and Public Policy
Standing Order
 26 States have regulations that state that a pharmacist may
dispense naloxone (opioid antagonist) via a Standing Order
between a pharmacist and physician.
 14 States have regulations for a Statewide Protocol.
Illinois (PA 99-0480 aka HB1)
 Sponsor: Rep. Lou Lang (D-Skokie)
 Medication Take Back program to be established by 06/01/2016. Pharmacy participation
will be voluntary. All Pharmacies will display a sign of local state-approved drop-off
sites.
 Pharmacies need to have in place and post a policy regarding the type of identification,
if any, necessary to receive a prescription.
 Requires for sequential C-II prescriptions that prescribers must document reason of
medical necessity for the (2) additional 30-Day supply in patient’s medical record.
 Additional data element of Days Supply required to be transmitted to the Prescription
Monitoring Program (PMP).
 Reporting to the Prescription Monitoring Program (PMP) changes from within 7 days to
the end of the next business day.
 Statewide standing order, developed by the Department with Dept of Public Health and
Dept of Human Services, for pharmacists to dispense opioid antagonist (naloxone);
pharmacists will need to complete a training program.
 Exemption of civil liability for dispensing or administering an opioid antagonist without
fee or compensation.
Missouri (HB1568)
 Sponsor: Rep. Steve Lynch (R-Waynesville)
 Establishs that a pharmacist or pharmacy technician may sell or
dispense an opioid antagonist under physician protocol.
 Liability provisions for the pharmacist and pharmacy technician for
dispensing.
 Expands that any person may carry an opioid antagonist.
 Status: Passed House and Public Health Hearing held in Senate.
http://www.house.mo.gov/billsummary.aspx?bill=HB1568&year=2016&code=R
Question #1
Which drug is second only to marijuana in terms of the number
of illicit users?
a)
b)
c)
d)
Cocaine
Heroin
Rx Medications
Scooby Snacks
Question #1
Which drug is second only to marijuana in terms of the number
of illicit users?
a)
b)
c)
d)
Cocaine
Heroin
Rx Medications
Scooby Snacks
Question #2
What class of drugs is driving the rise in overdose fatalities in
the United States?
a)
b)
c)
d)
Heroin
Rx Opiates
Methamphetamine
Synthetic Cannabinoids
Question #2
What class of drugs is driving the rise in overdose fatalities in
the United States?
a)
b)
c)
d)
Heroin
Rx Opiates
Methamphetamine
Synthetic Cannabinoids
Question #3
Who is responsible for the proper prescribing and dispensing
of a controlled substance?
a)
b)
c)
d)
e)
Physician
Nurse
Patient
Pharmacist
A and D
Question #3
Who is responsible for the proper prescribing and dispensing
of a controlled substance?
a)
b)
c)
d)
e)
Physician
Nurse
Patient
Pharmacist
A and D
Question #4
Illinois and Missouri (and other states) are increasing the
access to opioid antagonists by which of the following except:
a)
b)
c)
d)
Dispense via a Standing Order
Dispense via a Statewide Protocol
Selling over the counter without a prescription
Written prescription from a prescriber
Question #4
Illinois and Missouri (and other states) are increasing the
access to opioid antagonists by which of the following except:
a)
b)
c)
d)
Dispense via a Standing Order
Dispense via a Statewide Protocol
Selling over the counter without a prescription
Written prescription from a prescriber
References
 Drug Enforcement Administration
 www.DEADiversion.usdoj.gov
 Office of National Drug Control Policy
 www.whitehouse.gov/ondcp
 CDC: Guideline for Prescribing Opioids for Chronic Pain
 www.cdc.gov/media/modules/dpk/2016/dpk-pod/rr6501e1erebook.pdf
 FDA: Medicines Recommended for Disposal by Flushing
 www.fda.gov/downloads/Drugs/ResourcesForYou/Consumers/Bu
yingUsingMedicineSafely/EnsuringSafeUseofMedicine/SafeDispo
salofMedicines/UCM337803.pdf
References
 Illinois: Controlled Substances Act – 720 ILCS 570
 www.ilga/gov/legislation/ilcs/ilcs5/asp?ActID=1940
 Illinois: Administrative Rules for Controlled Substance Act – 77 IAC 3100
 ilga.gov/commission/jcar/admincode/077/07703100sections.html
 Illinois: Administrative Rules for Electronic Prescription Monitoring Program –
77 IAC 2080
 ilga.gov/commission/jcar/admincode/077/07702080sections.html
 Illinois: Administrative Rules for Electronic Prescription Monitoring Program –
77 IAC 2081
 ilga.gov/commission/jcar/admincode/077/07702081sections.html
 Missouri: Controlled Substance Statutes
 http://www.moga.mo.gov/mostatutes/ChaptersIndex/chaptIndex195.html
 Missouri: Administrative Rules for Controlled Substances – 19 CSR 30
 s1.sos.mo.gov/cmsimages/adrules/csr/current/19csr/19c30-1.pdf
References
 Prescribe to Prevent
 prescribetoprevent.org
 APhA: Pain Relief in Brief – OTC Oral Analgesic Selection
and Patient Education
 pharmacist.com/sites/default/files/files/15183_PainReliefBrief_FINAL%20with%20SME%20statement%20
070215.pdf
 ACPA: Opioid Induced Constipation Conversation Guide
 theacpa.org/uploads/ACPA-Opioid_Constipation_Chart-V4.pdf
 CPNP: A Practical Guideline for Pharmacists
 cpnp.org/_docs/guideline/naloxone/naloxone-access.pdf
Questions
S. Scott Collier
Garth K. Reynolds, RPh
Diversion Program Manager
St Louis Division
Drug Enforcement Administration
[email protected]
Executive Director
Illinois Pharmacists Association
[email protected]
P: 314/538-4712 | F: 314/538-4767
Illinois Pharmacists Association – IPhA
204 West Cook Street
Springfield, Illinois 62704
P: 217/522-7300 | F: 217/522-7349
www.ipha.org
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