Rx16 pharma wed_1115_1_ryle_2menkhaus_3mcginley

To Fill or Not to Fill,
That Is the Question
Presenters:
• Karen M. Ryle, RPh, MS, Associate Chief of Pharmacy for
Ambulatory Care, Massachusetts General Hospital
• Mike Menkhaus, RPh, EPRN Project Manager, Kroger
• Edward McGinley, MBA, RPh, DPh, President, National
Association of Boards of Pharmacy
Pharmacy Track
Moderator: Chad C. Corum, PharmD, Co-Owner and Pharmacist,
Corum Family Pharmacy, and Member, Operation UNITE Board of
Directors

Disclosures
Edward McGinley, MBA, RPh, DPh; Mike
Menkhaus, RPh; Karen M. Ryle, RPh, MS; and
Chad C. Corum, PharmD, have disclosed no
relevant, real, or apparent personal or
professional financial relationships with
proprietary entities that produce healthcare
goods and services.

Disclosures
• All planners/managers hereby state that they or their
spouse/life partner do not have any financial
relationships or relationships to products or devices
with any commercial interest related to the content of
this activity of any amount during the past 12 months.
• The following planners/managers have the following to
disclose:
– John J. Dreyzehner, MD, MPH, FACOEM – Ownership
interest: Starfish Health (spouse)
– Robert DuPont – Employment: Bensinger, DuPont &
Associates-Prescription Drug Research Center

Learning Objectives
1. Identify warning signs that a Rx will be
abused or diverted.
2. Explain a project that integrates PDMP data
into the workflow of a pharmacy system.
3. Compare in-workflow access to PDMP data
with traditional website access to PDMP
data.
4. Provide accurate and appropriate counsel as
part of the treatment team.

To Fill or Not to Fill: That is the
Question
Karen M Ryle, MS.,RPh

Disclosure
• Karen Ryle, MS, RPh has disclosed no relevant,
real or apparent personal or professional
financial relationships with propriety entities
that produce healthcare goods and services.

Pharmacist’s Corresponding
Responsibility
• CFR, Title 21 sec 1306.04,Purpose of Issue of
Prescription
• A prescription for a controlled substance to be
effective must be issues for a legitimate medical
purpose by an individual practitioner acting in the
usual course of his professional practice
• The responsibility for the proper prescribing and
dispensing of controlled substances shall be upon
the prescribing practitioner, but a corresponding
responsibility shall rest with the pharmacist who fills
the prescription

USA v Holiday CVS
• 2011-Pill Mill law prohibits Doctors from dispensing
Schedule II and III substances.
• More Oxycodone 30mg was distributed to Florida than
all states combined.
• 2 CVS pharmacies located in Sanford, Florida
• Purchased large amounts of controlled substances
without effective controls against diversion
• 1000Rx/day-mostly controlled substances
• Oxycodone 30mg Rx’s coming from 4 Doctors
• Rx’s coming from South Florida located 200 miles away
• Patients coming from Kentucky and Tennessee
• Many patients with the same diagnosis

USA v Holiday CVS
• Filling controlled substances for 6 months from one Doctor, whose
licensed expired.
• Filled a total of 55 prescriptions for Oxycodone 30mg from another
physician whose license expired.
• Customers started lining up at the pharmacy before it opened.
• Pharmacist put limits on the amount of Oxycodone given per day.
Prescriptions were filled on a first come first serve basis and would
often run out by 12 noon.
• Pharmacist tells the DEA: “We needed to save some for our legitimate
patients.”
• Pharmacy also put limits on “cocktail” prescriptions for Oxycodone,
Carisprodol and Alprazolam.
• Prescriptions were called and verified.
• Large amount of patients paying cash
• Multiple patients getting the same prescriptions
– Oxycodone 30mg and Oxycodone 15mg

USA vs. East Main Street Pharmacy
• When a pharmacist either knows or has a reason to
know that the prescription is not written for a
legitimate medical purpose.
• A pharmacist may not intentionally close his eyes and
thereby avoid knowledge of the real purpose of the
prescription.
• Red flags should have given the pharmacist “a reason
to know”.
• Dispensed cocktail prescriptions.
• No individualization of dosing.
• Multiple prescriptions for the strongest formulation
• Early refills..etc

DEA Response
• November 13, 2012 , DEA revoked their license
• Administrative Law Judge ruling
• Violated their corresponding responsibility by dispensing
prescriptions not for a “legitimate medical purpose”.
• Failure to maintain effective controls in place for ordering
large quantities of narcotics
• Filling prescriptions for controlled substances from physicians
whose license is expired is against the law.
• Simply calling a doctor’s office to verify that a he/she wrote a
prescription does not meet the requirement of legitimate.
• Failing to resolve red flags.
• Calling the prescriber will not resolve red flags because the
red flags indicate the prescriber is collaborating with the
patient.
• Revoked both DEA licenses

Red Flags for Pharmacist
1. Repeatedly dispensing “cocktailed”
prescriptions
2. No individualization of dosing by the
Prescriber
3. Filling multiple prescriptions for the strongest
formulations
4. Request for early refills
5. Doctors located 100 miles away from
pharmacy

Red Flags for Pharmacist
6. A large proportion (75%) of prescriptions filled
by the pharmacy were controlled substances
written by one particular physician
7. Pharmacist doesn’t reach out to other
Pharmacists to see why they aren’t filling the
particular doctor’s prescription
8. Patients travel in groups to the pharmacy
9. Filling a large percentage of cash prescriptions
10. “verification” of a prescription as “legitimate”
was not satisfied simply because the
practitioner said so.

NABP Red Flag Video
https://www.youtube.com/watch?v=WY9BDgcdxaM&feature=youtu.be

Opiate Naïve Patient
• Opioid tolerant patient is a patient that has been on
the equivalent of 60mg of oral Morphine daily, 30 mg
of oral Oxycodone daily, 8 mg of Hydromorphone daily
or equianalgesic dose of another opioid for over 1
week.
• 32 year old patient having back pain, prescribed
Tramadol 50mg q6 hours for pain, Methocarbamol
750mg, Carisoprodol 350mg and Alprazolam 2mg for a
few months.
• Pharmacy dispensed Fentanyl 75mcg patches to the
patient.
• Pharmacist received alert from 3rd party DUR asking to
confirm that the patient is opiate tolerant.
• Pharmacist thinks it is Ok because she was taking
Tramadol, a mild synthetic opioid.
• Patient expires within 48 hours.

Discussion
• Pharmacist overrides the DUR alert
• Patient does not meet the definition of opioid tolerant
• Pharmacist doesn’t know exactly what it means to be
opioid tolerant or naïve.
• She did not consult with the Doctor despite what she
indicated in the override. (consulted with prescriber-
filled as is)
• Can you convert someone from Tramadol to Fentanyl?
• What is the morphine equivalent dose?
• Did the pharmacist meet the standard of care?
• Fentanyl 75mcg=180mg Morphine
• Tramadol 200mg= 20mg Morphine

Morphine Equivalent Dose
• MED is a system to equate different opioids and
their varying potencies into a standard morphine
equivalent value.
• Conversion chart created by Centers of Disease
Control (CDC).
• Patients odds of overdosing or abuse increases
dramatically when a patient reaches a daily level
of 120 (CMS).
• Prescriber and/or pharmacist should “press
pause” to reevaluate the effectiveness and safety
of the patient’s pain management plan.
• MassHealth-prior approval for patients over 120
MED
• NYC MME calculator app on iphone

Methadone
• Nationally, Methadone accounts for 2% of opioid pain
prescriptions but 30% of opioid related overdoses.
• Very tricky to convert from other opioids
• Rule of thumb: Go LOW and SLOW
• Cross tolerance
• Full analgesic effect may not be obtained for 3-5 days
• Unique pharmacokinetic properties, analgesic action is
shorter than plasma elimination ½ life
• Methadone treatment for addiction is not reported to the
PMP
• Death of 22 year old-fell off horse, Methadone 10mg QID
• Counsel patient

Naloxone
• Naloxone reverses opioid related sedation and
respiratory depression= pure opioid antagonist.
• Fast acting, inexpensive and non-addictive with
minimal side effects.
• May be administered IM, IV, SC, IN
• Acts within 2-8 minutes.
• Lasts 30-90 minutes-overdose may return.
• Second dose may be necessary.

Nasal Naloxone
• Standing order
• Collaborative Drug Therapy Agreement
• Pharmacist only dispensing
• Over-the-counter
• List states and different activity

Naloxone
• New Mexico allows the dispensing without a prescription.
• Idaho allows for Pharmacist prescribing.
• Rhode Island provided a waiver to pharmacies trained in
nasal naloxone to dispense under a collaborative drug
therapy agreement.
• Massachusetts can provide naloxone through a standing
order.
• 14 states now allow naloxone to be sold without a
prescription
• FDA already denied an OTC application
• States are looking at removing barriers for pharmacist
dispensing

Naloxone Kits
Includes 2 Naloxone syringes
Includes 2 atomizers
Instructions for use

How to Give Nasal Naloxone
1. Pop off two yellow
caps and one red cap.
2. Screw medicine
gently into delivery
device.
3. Hold spray device and
screw it onto the top of
the delivery device.
4. Spray half of the
medicine up one side
of the nose and half up
the other side.

Naloxone Rescue
• Over 2000 overdoses were reversed in
Massachusetts in 2013 due to naloxone initiative.
• Massachusetts leading the country in reversal of
overdoses.
• Quincy police Department takes the lead
• Good Samaritan law protects those that seek
help for someone overdosing from being charged
or prosecuted for drug possession or minor drug
crimes.
• Gloucester police department taking drug seizure
money to fund naloxone.

Drug Disposal
• Mail Back Programs
• Take Back Events
• Drug Disposal

To Fill or Not to Fill:
The Role of the Pharmacist
Mike Menkhaus, R.Ph.
Kroger Company
Edward G. McGinley, MBA, RPh, DPh
President, National Association of Boards of Pharmacy

Disclosure Statement
• Mike Menkhaus has disclosed no relevant, real,
or apparent personal or professional financial
relationship with proprietary entities that produce
health care goods and services.
• Edward G. McGinley has disclosed no relevant,
real, or apparent personal or professional
financial relationship with proprietary entities that
produce health care goods and services.

Learning Objectives
1. Identify warning signs that a Rx will be abused
or diverted.
2. Explain a project that integrates PDMP data
into the workflow of a pharmacy system.
3. Compare in-workflow access to PDMP data
with traditional website access to PDMP data.
4. Provide accurate and appropriate counsel as
part of the treatment team.

Notes:
• PMP and PDMP can be used
interchangeably.
• CS = controlled substances, as reportable
to PDMPs

Limited Use of PDMP Data
• Most states have developed excellent PDMP databases
over the past half decade – BUT, they have remained
significantly underutilized due to the difficulty of providing
efficient access
• A quick, efficient means to access the PDMP data is
crucial to provide clinical details the prescriber and
pharmacist need to ascertain if a true clinical need exists
for the CS therapy under consideration
• SAMHSA grants have been offered to states that are
willing to engage business partners to develop more user
friendly methods for access to the PDMP data

Kroger System
• Kroger participated in a pilot with the Ohio
PDMP (“OARRS”) to move PDMP access into
workflow
• Pilot was partially funded by a SAMHSA grant
• Partnership with Appriss, Inc., the host for
NABP’s PMP InterConnect program
• Provides access to PDMP Data from multiple
states in seconds
• Provides data analysis via NARxCHECK®

PDMP Data Access
• In Kroger’s system, at the DUR step in workflow,
CS Rxs have a PDMP button, labeled in Red
• Clicking that button will retrieve and display the
patient’s PDMP records from one or more states
• Sharing of PDMP data across state lines is still
hindered by privacy concerns, legislation and
technical details (mostly capacity)

Data Presentation
• The data is presented from most to least current
• It includes Rx attributes - the quantity dispensed, the days
supply and, for opioids, the Morphine MgEq dose/day
• The report also includes the prescribers & the dispensing
pharmacies

Data Analytics - example
• Initially, there is little reason for concern
–One concurrent prescriber
–Refills are on time with no/few
overlapping days
–Sometimes even a late refill
Screen prints from NARxCHECK®

Data Analytics (Cont. ….)
• No therapy gaps
• Appearance of early refills
• Prescriber change
– Was it clinically driven? (Specialist to general
practitioner)

Concurrent prescribers! Suspicion should
rise significantly
Why concurrent prescribers (accidental or
intentional)
No gaps in therapy

Prescriber stopped prescribing
Suggestive of awareness of problem
Another new prescriber is added
Very significant therapy duplication
Need for intervention is very evident

• Poly-pharmacy & prescriber are clearly evident
• Prescriber out of pharmacy typical service area
• Concurrent patronage with Rx overlap & early
fills demonstrates abuse or diversionary intent
• Again, intervention need is obvious

What Now?
• Once evidence indicates that the patient is
inappropriately seeking CS Rxs, the clinician must ACT
• To date, the heavy emphasis on the benefits of PDMP
data review is to STOP the prescribing or dispensing of
CS Rxs
– Indeed, there is even a program call I-STOP
• With IMMEDIATE access to PDMP data, a new “I”
Program is possible – “I-DON’T START”!
– By use of the PDMP data and the knowledge of red
flags, prescribers can avoid prescribing and
pharmacies can decline to fill CS Rxs when no
legitimate need exists
• But this isn’t the end…..

Clinical Use of PDMP Data
• Once it’s determined a patient is attempting to procure a CS
Rx for reasons other than the clinical indications for the CS
drug, we can’t STOP there.
• We need yet another “I” program:
– “I START”
• I START identifying the underlying drug/alcohol problem
• I START engaging the patient in an intervention process
• I START identifying the path away from the downward
spiral of addiction to a drug and alcohol free life .… the
path to recovery
• And, when needed, I START engaging law enforcement

Advantages of In-workflow Access
• Web portal use typically requires multiple steps:
– Open web browser
– Log through internal firewall
– Navigate to state PDMP site & log in
– Enter patient criteria and search
– View/analyze PDMP data
– Repeat steps independently for additional states
• An in-workflow process
– Eliminates all login steps
– Can provide concatenated multi-state data
– Can perform analytics to facilitate review

Barriers
 Not Plug-N-Play
 Major impediments to complete access to patients’
PDMP history include:
Privacy laws and regulations
Technology problems
Development Prioritization
Incomplete National Network
Capacity concerns – many state PDMPs would not have the
band width to process PDMP report requests from all states
or even neighboring states
Legal requirements
Signing of MOUs for many states
Notarized registration (at least one state)

What To Do
In addition to supporting a national network of PDMPs:
E-D-U-C-A-T-E – particularly representatives and
regulators at the state and federal levels about SHARING
If a pharmacy dispenses a CS Rx to a patient,
unaware that the patient has already received a
sufficient supply in another state, and the patient
overdoses, it will be little consolation to tell loved ones
that we protected the patient’s privacy
Work through organizations, such as the National Council
for Prescription Drug Programs (NCPDP) and NABP
Engage your software vender or development team

What To Do (Cont. ….)
In addition to supporting a national network of
PDMP, continued:
Press for “in-workflow access to PDMP data”
based upon the utility of PDMP data as a clinical
decision making tool to help ensure patient safety
concerns
Contact your state representatives
PDMP access, in workflow, needs funding
A national network of PDMPs requires state
collaboration and sharing of data that may
require legislative changes

Rx Alternative Options
 There are alternative treatment modalities for most of the
indications for which CS Rxs are used
 For example:
Americans consume 80% of the global supply of
opioid pain killer while representing but 4.6% of the
world’s population
DO WE REALLY SUFFER 80% OF THE PAIN?
Other treatment options exist – we need to change
the current paradigm that looks first and foremost to
an CS solution

Additional Alternative Therapies
• Opioids are not the only over-consumed CS
– Sedatives
– Sleeping pills
– Muscle relaxants
– Stimulants (ADHD, weight loss, narcolepsy)
Common feature – CS drugs are the easiest option. But,
for each of these CS treatments, there are alternatives
treatments that can be used alone or in conjunction with
CS to eliminate or reduce CS need.

Alternative Pain Therapies
Examples of pain treatment options with proven
efficacy include:
 Alternative medications
 NSAIDS
 Glucosamine with Chondroitin
 Herbal remedies
 Physical Treatments, including
 Physical Therapy
 Acupuncture
 Yoga
 Hypnosis
 Massage
 Diet

Alternative Pain Therapies, Continued
• Advantages of alternative pain treatments:
– Alternative pain treatments can be used in
conjunction with each other
– Concurrent use may reduce the dose of medications,
particularly opioids
– Most alternative pain treatments have very limited
and far less dangerous side effects
– There are no addiction concerns
– In many cases, they provide complete or partial
resolution of the underlying cause of pain
– Diet and some physical therapy may require no
additional expense

Summary
We have a long way to go. Take-aways:
– Money spent at the front end (preventing addiction) is
far more effective than spent at the back end
– In workflow design can include tools to facilitate the
data analysis
– Increased PDMP access = fewer CS Rxs, more timely
interventions for recovery, less potential for abuse
– Minimizing CS usage = fewer addictions, less abuse
– Change the treatment paradigm!
• Consider alternative treatments FIRST
• Intervene when appropriate

Thank you.
There will be an opportunity for questions at the end
of Ed’s portion of this presentation.

NABP Mission Statement
NABP is the independent, international,
and impartial Association that assists its
member boards and jurisdictions for the
purpose of protecting the public health.
50 United States, four US jurisdictions,
and 12 international associate members

Shortcomings of Prescription
Monitoring Programs (PMPs)
• Patients cross state borders
• Low utilization by health care
• Separate website
• Registration and login
• Data entry – patient demographics

Background on NABP Involvement
With PMPs
• NABP’s mission is to support state boards of pharmacy
and assist other regulators to protect the public health.
• In fall 2010, NABP was approached by several members.
• They requested a low-cost, easy-to-implement, highly
enhanced solution for interstate data sharing.

• NABP PMP InterConnect® creates interoperability for
individual state PMPs via a hub system.
• Physicians and pharmacists log into their own state PMP
and select other participating states from which they
want data.
• PMP InterConnect routes the requests to the various
states and the information back to the home PMP for
delivery to the physician or pharmacist in one collated
report. Patient data is encrypted.

Next Steps to Increase Utilization
of PMP Data
• Automate requests for PMP data into workflow via
– Health care systems or electronic health record
vendors
– Pharmacy software systems
– Health information exchanges
• Increase efficiency by providing access to
analytical tools, eg, NARXCHECK®

Automated Requesting
• No registration
• No usernames/passwords
• No data entry
• No added steps
• No delay

What it means to be a pharmacist…
• Professional and social responsibility to be
proactive participants in your practice,
community, and profession.
• To lead and to inform.
• To provide information and service to our
patients.

Can each person make a difference?
• NABP Efforts:
– Presidential initiative: Provide pharmacists with the
tools and resources to make a difference
– www.awarerx.pharmacy enhanced to provide more
pharmacist resources
– Pharmacist Pledge: Personal commitment and
reminder of their professional obligation, with handy
access to the AWARXE® Prescription Drug Safety
Program tools
Each person can make a difference.

After You Take the Pledge –
Ten Things You Can Do
1. Share the pledge with colleagues and encourage them
to sign it.
2. Learn more about prescription drug abuse and misuse.
3. Check PMPs regularly when filling prescriptions.
4. Learn your pharmacy’s protocol for assisting a patient
who may be abusing prescription drugs, so that you can
take action if needed.
5. Educate patients on medication safety issues, such as
safe use, handling, and storage of medication.

6. Promote proper medication disposal:
a. Set up a disposal box on site at your pharmacy; or
b. Have a disposal site that you can recommend to patients.
7. Remind patients to securely store their medications.
8. Download and print AWARXE flyers for patients who
would like detailed information about:
a. proper disposal;
b. secure medication storage;
c. buying medicine safely online; and
d. statistics about the abuse and misuse of prescription
drugs.

9. Hang AWARXE posters (available to download and print)
in your pharmacy, office, or other practice settings.
a. The striking images can alert patients and colleagues
to prescription drug abuse at a glance.
b. A proper medication disposal poster is also available.
10. Give presentations using AWARXE’s PowerPoint slides,
which include presenter notes.

Take the Pledge.
Remember your Pledge.
Make a difference!
Thank You!

Rx16 pharma wed_1115_1_ryle_2menkhaus_3mcginley

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