12/9/2011
Objectives
Hot Topics in Pharmacy Law
Karen M Ryle, M.S., RPh
Associate Chief of Pharmacy
Ambulatory Care
Massachusetts General Hospital
Disclosure
• Describe the future online Prescription Monitoring Program
and how it will affect prescribing and dispensing of controlled
substances.
• Identify the types of medication errors that are required to be
reported to the Massachusetts Board of Pharmacy.
• Explain the new interim policy on changes permitted to
schedule II prescriptions.
• Discuss the mandatory education requirements for ALL
prescribers.
• Review the new policy on prescriptions for sex partners of
patients being treated for Chlamydia.
Continuing Pharmacy Education (CPE)
Monitor
• Although I am currently the Treasurer of
National Association of Boards of Pharmacy
and a member of the Massachusetts Board of
Registration in Pharmacy, I am giving this
presentation on behalf of myself and not as an
official representative of either organization.
• National collaboration between National
Association of Board of Pharmacy (NABP) and
Accreditation Council for Pharmacy Education
(ACPE)
• Create a CE profile at mycpemonitor.net
• Obtain an e-profile ID
• CPE providers will be sending continuing
education credits electronically to ACPE, then
to NABP to record in your e-profile
CPE monitor
Expedited Partner Therapy (EPT)
• In 2012, the service will make available the
CPE data to boards of pharmacy who request
information on licensee CPE as part of their
compliance activities.
• Your e-profile will store a comprehensive list
of all your CPE activities completed and will
allow you to verify your compliance with CPE
requirements in the state that you are
licensed in.
• Regulatory Changes: Effective September 2, 2011
• 105 CMR 700.00: Implementation of M.G.L. Chapter 94C (the
Controlled Substance Act)
• 105 CMR and 721.00: Standards for Prescription Format and
Security in Massachusetts
• Authorize a prescriber to provide treatment of chlamydia
infection by dispensing or prescribing a schedule VI controlled
substance for immediate treatment of the sex partner(s) of a
patient diagnosed with chlamydia infection.
• Chlamydia has become endemic in the Boston area with a
very high rate if re-infection.
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12/9/2011
Provisions of EPT
Pharmacist
The prescriber has the following options when
providing EPT:
1. The clinician provides a written prescription for a
named sex partner of the infected patient;
2. The clinician provides a written prescription using,
in place of the partner’s name and address,
“Expedited Partner Therapy”, “EPT”, which can be
filled at any Massachusetts pharmacy; or
3. The clinician dispensed the medication directly,
one dose to be take immediately by the patient,
and an additional dose to be delivered by the
patient to the sex partner (s) for each sex partner
• OK to dispense a prescription without a patient
name as long as “EPT” is written in place of the name
and address
• Partner Information Sheet must accompany the
prescription.
Error Reporting Requirements
Definitions
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• Duty to Report Certain Drug Dispensing Errors
to Board (Required 1/1/2010)
– Improper dispensing of a Rx resulting in serious
injury or death
– Within 15 business days after informed of error
– Retain records for 2 years from date filed with
board
– Continuous Quality Improvement (CQI) Program
What is a Medication Error?
• A preventable event that may cause inappropriate
medication use or patient harm.
Institute for Safe Medication Practices (ISMP)
• Errors of Commission
– An act of doing something wrong that leads to an undesirable outcome
• Dispense, Prescribe, Administer:
wrong drug, wrong strength, wrong directions, wrong route,
wrong patient, wrong dosage form etc
• Errors of Omission
• A failure to do the correct act that leads to an undesirable outcome.
– Action is not taken
• A failure to identify over utilization, therapeutic duplication, drug-drug interaction,
drug-disease interaction, drug allergy, clinical abuse/misuse, incorrect drug dosage
or duration of drug treatment
– This will be provided by Department of Public Health in an
easy-to-read language.
• The standard treatment for chlamydia infections is
one oral dose of 1g of the antibiotic Azithromycin
• Regulations do not state a particular antibiotic
• Massachusetts will be the 27th state to provide
regulations to help stop the spread of Chlamydia
• Improper dispensing
– Incorrect dispensing of a prescribed medication received
by a patient
• Serious injury
– Life threatening, results in serious disability or death or
required significant treatment measures
• Serious disability
– Injuries requiring major intervention and loss, or
substantial limitation, of bodily function lasting greater
then 7 days.
• Breathing, dressing, drinking, eating, eliminating waste, in/out of
bed, hearing, seeing, sitting, sleeping or walking
Three Behaviors We Can Expect
• Human error -inadvertent action;
inadvertently doing other that what should
have been done; slip, lapse, mistake.
• At-Risk behavior- behavioral choice that
increases risk where risk is not recognized or is
mistakenly believed to be justified.
• Reckless behavior – behavioral choice to
consciously disregard a substantial and
unjustifiable risk.
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12/9/2011
Human Error
At Risk Behavior
Reckless Behavior
Accountability for Our Behaviors
HUMAN ERROR
Inadvertent action: slip, lapse, mistake
Manage through changes in:
1. Processes
2. Procedures
3. Training
4. Design
Most medication errors are in this category
Action: Console
Accountability for Our Behaviors
AT-RISK BEHAVIOR
A choice: risk not recognized or believed
justified
Manage through:
1. Removing incentives for At-Risk Behavior
2. Treating incentives for healthy behaviors
3. Increasing situational awareness
Action:coach
Accountability for Our Behaviors
RECKLESS BEHAVIOR
Conscious disregard of unreasonable risk
Manage through:
1. Remedial action
2. Punitive action
Action: Punish
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12/9/2011
Board of Pharmacy
• Has jurisdiction over the licensee and is
charged with the duty to protect the public
• Discipline includes:
– Advisory letter (dismissal) with 2 CE’s
– Formal Reprimand
– Probation
– Suspension
– Revocation
• Other state boards may impose a fine
Report Submitted to the Board
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89 year old in SNF
Order for Nortriptyline 20mg
Nurse transcribed it as 200mg, MD signs
Pharmacist fills Rx for 200mg
Patient takes 4 X 50mg capsules for 10 days
Patient expires shortly after of pneumonia
Nortriptyline Report
Reported to the board under new regulation
Geriatric dose 30-50mg/day
Use with caution in the elderly
Pharmacist performed DUR override for high
dose alert
• High dose alert fatigue
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2nd Report
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92 year old
Received Glyburide 5mg TID
Drug prescribed: Ditropan 5mg TID for bladder
Patient blood glucose less than 10mg/dl
Patient hospitalized and transferred to SNF
Error reported under new regulation
Contributing Factors
• Both on the shelf under “D”
– Ditropan/Diabeta
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Tablets round/green, round/blue
No bar code scanning
In medicine on time blister packs
NDC not on the label to match
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12/9/2011
3rd Report
• 70 year old male with BPH (Benign Prostate
Hypertrophy
• Profile contains Doxazocin and Finasteride
• New Rx for Promethazine DM
– 2 tsp every 4-6 hours
• Pharmacist Reviews Drug Utilization Review (DUR)
• Contraindicated with patients with BPH
– Anticholinergic effects
• Pharmacist overrides Drug/Disease DUR
• Fills as Is
BPH patient
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Patient hospitalized
Caused catheterization
Sentinal event reported to the Board
Pharmacist indicates she was rushed
Alert fatigue?
4th Report
• 4 year old with Bipolar
• Rx written Risperidone 1mg/ml
– 2.5ml BID
• Normal Pediatric dose=0.25mg QD or
0.125mg BID
• Physician error
• Maximum dose 1mg QD
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Risperidone
• Pharmacy system did not indicate a high dose
alert.
• 3 rd party insurance did alert Pharmacist of
high dose
• Physician meant 0.25mg BID
• Patient got 10 times the dose
• Patient hospitalized
Fentanyl Case
• 52 Year old-day surgery for rhinoplasty for
snoring
• Prescribed Hydrocodone Liquid
– Nausea and vomiting
• Then prescribed Fentanyl 75mcg patch
• Daughter picks it up through the drive through
and tells the pharmacist it is for her father
that just had surgery
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12/9/2011
Fentanyl Case
• The daughter reads the patient information and
warnings to her father
– Not for short time pain
– Not for post-operative pain
– Not to use unless you have been on other narcotic
pain medicine regularly
• Applies the patch in the late afternoon
• Patient found dead the next morning
• Cause of death: Fentanyl overdose
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Board of Pharmacy New Policy
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Policy 2011-03: Permitted Schedule II prescriptions changes after
consultation with Practitioner.
Approved by the Board of Pharmacy
Background:
– November 19, 2007, the Drug Enforcement Agency (DEA) published a
Final Rule in the Federal Register titles Issuance of Multiple
Prescriptions for Schedule II Controlled Substances. In the preamble
to the Rule, DEA stated that “the essential elements of a schedule II
prescriptions written by the practitioner (Such as the name of the
controlled substance, strength, dosage form and quantity
prescribed)….may not be modified orally”
– The DEA later acknowledged that these instructions conflict with DEA’s
previous policy permitting these changes to a schedule II prescription
that a pharmacist may make after consultation with the prescriber.
– On April 19,2010 DEA advised pharmacists to make changes in
accordance with the laws, regulations and policies of their particular
state.
Policy 2011-03
2. Schedule II prescription Information that MAY be changed or
added by a pharmacist following consultation with the
prescriber.
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Date written
Patient’s address
Drug form
Drug Strength
Quantity
Prescriber’s Address
Prescriber’s DEA No.
Directions for use
Substitution permitted
Refill information
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Policy 2011-03
The Board advise Massachusetts Pharmacists that,
until any new DEA rule is effective, schedule II
prescription changes should be made with the
following guidelines:
1. Methods of Changing Prescriptions/orders:
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1. A prescriber may provide a written change to the
prescription or order. This can be done by mail or
electronic transmission including e-mail and facsimile.
2. The change can be communicated orally. The Pharmacist
shall record the date, changes on the front or back of the
prescription after consultation with the prescriber.
Policy 2011-03
• Schedule II prescription information that may
NEVER be changed or added by a pharmacist
(regardless of whether consultation with the
prescriber occurred)
• Patient’s name
• Drug (controlled substance) name (except for
generic substitution permitted by state law)
• Prescriber’s name
• Prescriber’s signature
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12/9/2011
September 22, 2011
Mickey Mouse
100 Main Street
Disney World, FL
Hydromorphone 4 mg
#50
Sig: Take 1 tablet every 4 hours as
needed for pain.
Back order of Hydromorphone
4mg
RPh calls MD to change to 2mg
MD authorizes 2mg #100
With directions to take 2
Tablets every 4 hours as
needed for pain
September 22, 2011
Minney Mouse
100 Main Street
Disney World, Fl
Oxycodone/APAP 5mg/325mg
#100
Sig: Take 1-2 tablets every 4 hours
as needed for pain
No refills
No refills
Dr. Charles Feelgood
Dr. Charles Feelgood
1-800-111-2222
AF12345678
1-800-222-1111
Patient presents the
prescription to your
pharmacy and indicates
that she would like liquid
since she has difficulty
swallowing pills.
RPh calls the prescriber
and the prescriber and
he authorizes the
pharmacist to dispense
liquid Oxycodone/APAP
1-2 teaspoonfuls every 4
hours as needed for pain
Quantity 500cc
AF 12345678
Signature Charles Feelgood
Signature Charles Feelgood
Interchange is mandated unless the practitioner indicates “no
substitution”
Interchange is mandated unless the practitioner
indicates “no substitution”.
September 22, 2011
Chip Andale
100 Main Street
Disney World, FL
Oxycodone ER 10mg
#60
Take one tablet every 12 hours as
needed for cancer pain.
No refills
Patient present the prescription
to your pharmacy but is
uncomfortable taking
Oxycodone ER for fear of
recent robberies. He would like
you to call the doctor to change
it to something else
MD authorizes you to switch the
Medication to Morphine ER 10mg
#60 same directions.
Dr. Charles Feelgood
1-800-111-2222
Signature Charles Feelgood
Interchange is mandated unless the practitioner indicates
“no substitution”
September 22,2011
Donald Duck
100 Main Street
Disney World, FLA
Actiq 200mcg Lozenge
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Patient presents prescription
to your pharmacy. You do not
have Actiq in stock but you do
have Fentora Buccal tabs.
You call the prescriber to see
If you can switch to Fentora.
#100
Sig: Suck on one Lozenge every 4 hours
for breakthrough pain
No refills
Dr. Charles Feelgood
1-800-111-2222
AF12345678
Signature Charles Feelgood
Interchange is mandated unless the practitioner indicates “no
substitution”
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12/9/2011
Prescription Monitoring Program
(PMP)
• Changes to the PMP program went into effect on
January 1, 2011
• Requires pharmacies to report the dispensing of all
schedule II-V prescriptions
• Requires the pharmacy to collect a customer ID for
all new prescriptions in schedules II-V
• Requires reporting of out of state mail order
pharmacies
• Pharmacies are now required to report weekly
Benefits of having a PMP
1. Support access to legitimate medical use of
controlled substances
2. Identify and deter or prevent drug abuse and
diversion
3. Facilitate and encourage the identification,
intervention with and treatment of persons
addicted to prescription drugs
4. Inform public health initiatives through outlining of
use and abuse trends, and
5. Educate individuals PMPs and the use, abuse and
diversion of and addiction to prescription drugs
Massachusetts On Line PMP
On Line Prescription Monitoring
Program
• Secure Internet Portal
• Pharmacists and Prescribers enroll through
the virtual gateway
• Database contains 4 million Rx’s now of just
C2’s
• Will be updated monthly and include all
schedules
Prescription Monitoring Programs
• Currently 35 states have operational PMPs
• States differ in the types of controlled
substances that are reported
• States differ on the requirement of a proper
identification
• Each state controls who has access and for
what purpose
1. Instructions for Enrollment
Virtual Gateway Home Page
To logon to the Virtual Gateway (VG), go to www.mass.gov/vg and click on Logon to the Virtual Gateway.
• Can look up a single patient at a time
• You cannot look up prescription history of
anyone that is not your patient
• Detailed record of Controlled Rx’s
– Fill date
– Quantity
– Prescriber
– Pharmacy
– Includes both insurance and cash
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12/9/2011
Search Criteria
To search for an individual, complete the following required fields:
1. last name
2. first name
3. date of birth (ddmmyyyy, no slashes)
Click Search.
Record Overview
The record overview shows information about each prescription filled.
Click on the patient’s name to see a Person Summary. You also have the option to return to the
main screen if you want to search for another record. Or you can logout from this page.
Who can access the On line PMP
Information?
Emergency Room
• Licensed Health Care Professional authorized
to prescribe and dispense controlled
substances.
– Pharmacist
– Prescribers
• State and Federal Investigative agencies to
address drug diversion
– State Police
– DEA
– Licensing Boards
NABP Interconnect PMP
• Interstate PMP Data sharing through NABP PMP
Interconnect is now available
• It provides a way for States to report into ONE
database
• NABP is a system that Links PMPs across states to
facilitate data exchange
• Interconnected hub
• Used only to facilitate the communication process.
• NABP will not retain any prescription data
• The on line prescription monitoring program
will become particularly useful for emergency
room physicians that are being asked to
prescribe controlled substances
• Prevents the frequent flyers that bounce
around to different hospitals that are drug
seeking
• Provides access to controlled substance to
those patients who truly need it
Purpose if PMP InterConnect
• Reduce prescription drug abuse
• Reduce doctor shopping
• Early detection, intervention and prevention
of substance abuse and diversion of controlled
substances
• Ohio, Indiana and Virginia have begun
deploying PMP InterConnect
• NABP anticipates that 30 states will be
participating in 2012
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12/9/2011
Florida Case
• Dr. Barney Vanzant-License restricted in 2008, revoked in
2009.
• Accused of over prescribing controlled substances to at least 2
patients that both died, now up for 2 counts of manslaughter
• Daniel Joseph Lewis-31 yr old
– Prescribed 1070 Alprazolam, 1040 Methadone and 670
Lortab in 4 months
• Travis Bryan Walls- 25 yr old
– Prescribed 1938 methadone and 996 Alprazolam as well as
Lortab and Ultram
What is the Pharmacist Liability?
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3 month supply of Methadone
Visited 13 different pharmacies
Schedule of pharmacy visits
Paid cash, never early
Both died of multiple drug overdose
Does the pharmacist share responsibility?
What role could a PMP play in this case?
Florida Begins State PMP program
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• September 1, 2011 Pharmacist began
submitting data to the PMP program
• Controlled substances reported weekly
• Health care providers will have access to PMP
data beginning October 2011
• Tougher Florida laws to address “Pill Mills”.
• Recent shut down of 4 pain clinics resulted in
32 indictments for illegally distributing 20
million Oxycodone pills
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Sanchez v. Wal-Mart
Sanchez v. Wal-Mart
• Patricia Copening killed Gregory Sanchez Jr.
while driving under the influence of drugs
• Patricia Copening received 4500 Hydrocodone
tabs and 1300 Carisoprodol tabs from 13
different pharmacies over the course of 1 year
• Mr Sanchez was helping Robert Martinez
change a tire when he was struck and killed
• Police found prescription bottles and loose
tablets in the car and Patricia appeared
confused
• Prior to the accident, the Nevada Prescription
Controlled Substance Abuse Prevention Task
Force sent letters to 14 Las Vegas area
pharmacies informing them that Copening
may be abusing drugs.
• Pharmacy was aware that Copening was filling
Hydrocodone from 12 other pharmacies but
went ahead and filled the prescription
anyway.
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12/9/2011
Sanchez v. Wal-Mart
• Does the Pharmacy owe a duty of care to Mr.
Sanchez?
Sanchez v. Wal-Mart
• Nevada Supreme Court dismissed 7 chain
pharmacies and 1 independent pharmacy
• Under the circumstances of this case,
pharmacies do not owe a duty of care to a
third party (Mr. Sanchez)
• There is no pharmacist/patient relationship
with Mr. Sanchez
• However, there is a duty of care to Mrs.
Copeland.
Policy on the Management of Pain
Policy on the Management of Pain
• Revised August 16, 2011 to reflect addition of
education requirements
• Purpose: To Insure Patient Access to
Appropriate and Effective Pain Management
• Inappropriate management of pain includes
non-treatment, under-treatment, over
treatment and the continued use of
ineffective treatment
• The Board encourages pharmacists to view
pain management as part of pharmacy
practice for all patients in pain, whether acute
or chronic.
• Pharmacist should provide access to pain
medication to patients with legitimate needs
in accordance with accepted standards of
pharmacy practice.
Mandatory Educational Requirements
for Prescribers
Education Requirements
• January 1, 2011, pursuant to MGL c. 94C section 18
(e)
• All prescribers including pharmacists engaged in
collaborative drug therapy management (CDTM) who
are authorized to prescribe controlled substances
pursuant to a CDTM agreement (247 CMR 16.00),
upon initial application for MA Controlled Substance
Registration and subsequently during each
pharmacist licensure renewal period (2 yr), must
complete education requirements.
• Must include:
– Effective pain management;
– Identification of patients at high risk for substance
abuse; and
– Counseling patients about side effects, addictive
nature and proper storage and disposal of
prescription medications.
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12/9/2011
Corresponding Responsibility
Violation of CFR, 21,1306.04
• 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
• A prescription purporting to be a prescription
issued NOT in the usual course of professional
treatment and the person knowingly filling
such a purported prescription, as well as the
person issuing it, shall be subject to the
penalties provided for violation of the
provisions of law relating to controlled
substances
Case Study #1
Discussion
• Doctor shopper-2 pharmacies-5 MD’s
• Multiple Rx’s for controlled substances for many years
• Pharmacy A fills
– Hydrocodone/APAP
– Oxycodone/APAP
– Oxycodone ER
• Pharmacy B fills
– Hydrocodone/APAP
– Fentanyl
– Rx for Fentanyl 75mcg written by a friend of the family
• Patient expires within 24 hours of Fentanyl Rx
• Cause of death-Multiple drug poisoning
Multiple Physicians treating patient
Rx’s not filled early
Pharmacy A-Insurance
Pharmacy B- Cash
Should the Pharmacist question the Fentanyl
Rx from out of state?
• Is there a Patient/Doctor relationship?
• Should Pharmacy question therapy of
Hydrocodone to Fentanyl switch?
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Case #2
• Pharmacy receives prescription from patient
for Fentanyl 75 mcg patch for back pain (not
indicated on Rx)
• New to pharmacy
• Rx written from Ophthalmologist
• Pharmacy fills Rx
• Patient expires within 48 hours from overdose
of Fentanyl
Discussion
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Patient works in the MD office
Patient/Physician relationship
Scope of Practice
Diagnosis
Counseling
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12/9/2011
Case # 3
• Pharmacy repeatedly fills “cocktail” prescriptions for
multiple patients from the same physician.
• Cocktail known as “home run” includes:
Stop and Think Question
• Is the pharmacist violating “Corresponding
Responsibility” by filling these prescriptions?
– Hydrocodone 10mg
– Carisprodol 350mg
– Alprazolam 2mg
• No individualization of dosing by the
prescribing physician
• Prescribing and dispensing the strongest
formulations
DEA’s Ten Red Flags
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
DEA’S Ten Red Flags
• 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.
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