PHARMACIST'S LIABILITY IN THE 21ST CENTURY
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PHARMACIST’S LIABILITY IN THE 21ST CENTURY
SUNDAY/9:45-10:45AM
ACPE UAN: 0107-9999-17-266-L03-P 0.1 CEU/1.0 hr
0107-9999-17-266-L03-T 0.1 CEU/1.0 hr
Activity Type: Knowledge-Based
Learning Objectives for Pharmacists & Pharmacy Technicians:
Upon completion of this CPE activity participants should be able to:
1. Describe the potential legal liabilities, including malpractice exposure, associated with pharmacist
prescriptive authority, collaborative practice agreements, and medication therapy management.
2. Discuss recent case law regarding pharmacist prescriptive authority, collaborative practice agreements, the
provision of medication therapy management and other patient care services by pharmacists.
3. Identify best practices to minimize exposure to malpractice claims.
Speaker: Don McGuire, Jr., RPh, JD
Don McGuire is a pharmacist and an attorney. Don received his B.S. in Pharmacy (cum laude)
from Butler University College of Pharmacy in 1981. He practiced in community pharmacies
and was a manager in Richmond, Indiana and Greenwood, Indiana. In addition to community
practice, Don practiced hospital pharmacy, including four years as Director of Pharmacy for
Hendricks Community Hospital in Danville, Indiana. Don attended Indiana University School
of Law - Indianapolis, where he was a member of the Indiana Law Review. After graduating magna cum
laude in 1993, Don maintained a general practice of law in Danville and Indianapolis, Indiana. He practiced
law for five years before joining Pharmacists Mutual in 1998 as an attorney in the pharmacy professional
liability claims area. Don is currently General Counsel for Pharmacists Mutual and its subsidiaries. Don also
writes and lectures on pharmacy liability issues, patient safety, and pharmacy risk management.
Speaker Disclosure: Don McGuire, Jr. reports no actual or potential conflicts of interest in relation to this CPE
activity. Off-label use of medications will not be discussed during this presentation.
1/30/2018
Pharmacist's
Liability in the 21st
Century
Don R. McGuire Jr.
General Counsel & Sr. Vice President
Pharmacists Mutual Insurance Company
Disclosure
Don McGuire reports no actual or potential conflicts
of interest associated with this presentation.
1
1/30/2018
Learning Objectives
• Upon successful completion of this activity, participants
should be able to:
• Describe the potential legal liabilities, including malpractice
exposure, associated with pharmacist prescriptive authority,
collaborative practice agreements, and medication therapy
management.
• Discuss recent case law regarding pharmacist prescriptive
authority, collaborative practice agreements, the provision of
medication therapy management and other patient care
services by pharmacists.
• Identify best practices to minimize exposure to malpractice
claims.
1. Which is NOT a feature of Medication
Therapy Management?
A. Enhancing appropriate medication use
B. Increasing detection of adverse drug events
C. Written practice agreements
D. Improving outcomes
2
1/30/2018
2. A written collaborative pharmacy practice
agreement may include which of the
following?
A. The nature and scope of authorized drug therapy
management to be provided by a pharmacist
B. A description of specific disease states to be
managed
C. Protocol authorizing the ordering and interpretation
of laboratory tests
D. All of the above
3. Which practice involves the greatest risk of
legal liability for pharmacists?
A. Prescriptive authority
B. Collaborative practice
C. Medication therapy management
D. All of the above have the same level of risk
3
1/30/2018
4. True or False?
According to recent case law, Pharmacists engaged
in collaborative practice with Physicians are afforded
protection from lawsuits.
5. What should you do in order to minimize
your liability exposure?
A. Pharmacist must be experienced and maintain
training to recognize treatment issues
B. Critically examine the facts of each patient case
C. Assume that someone else will handle the
issue/problem
D. A & B
41/30/2018
Why Is This Topic Important?
The patient care duties of pharmacists have
evolved in the last 30 years and continue to
evolve
Some pharmacists view this evolution with
trepidation rather than seeing opportunity
Making well-informed decisions is the key to
evolving with minimal exposure
Stevens v. Rite Aid
• Pharmacist discharged because he refused
to administer immunizations
• Claimed trypanophobia (fear of needles)
• Jury awarded him over $2.5 million
• Verdict reversed on appeal – providing
immunizations was an essential function of
a pharmacist’s job duties at the chain
Stevens v. Rite Aid, 2017 U.S. App. LEXIS 4985 (2nd Cir. March 21, 2017)
51/30/2018
Jeffries v. United States
• Patient’s anticoagulation therapy was
managed by a pharmacist for 6 years
• Patient was scheduled for dental therapy, so
Coumadin was held and Lovenox introduced
• At subsequent appointment, patient’s INR was
low. Pharmacist recommended resumption of
Coumadin and return in 3 weeks
• Five days later, patient suffered a massive
stroke
Bridgette Jeffries, as Guardian for Melvin Eason v. United States of America, No. C08-1514RSL (W. D. Wash., Oct. 28, 2009)
Alrazzaq v. Walgreen
• Pharmacist prepared herpes zoster vaccine for
administration, but vaccine was contraindicated
for the patient
• Pharmacist offered vaccine to store manager
who was 31 and had no prescription
• Pharmacist terminated for breaching protocol
• Pharmacist admitted that she didn’t thoroughly
complete the training
• It’s basically the same as the flu vaccine training
Alrazzaq v. Walgreen Co., 2014 U.S. Dist. LEXIS 37192, (Mar 21, 2014)
61/30/2018
What Is Risk Management?
“The process of identification, analysis, and
either acceptance or mitigation of uncertainty
in a decision-making process.”
–Webster’s Dictionary
“The use of specific strategies in an effort to
minimize an organization’s exposure to liability
in the event a loss or injury occurs.”
Risk Management Strategies
4 Major Strategies to Manage Risk:
1. Avoid the risk
2. Accept the risk
3. Reduce the Probability
4. Transfer the risk
71/30/2018
Controlling the Environment (Reducing the
Probability)
The Risk Management Process
1. Identify the Risk
2. Select the Technique
3. Implement the Technique
4. Monitor and Make Necessary Changes
The Risk Management Process
Step 1: Identify the Risk
• Take a step back and observe
• Where could a mistake be made in
your pharmacy?
• Analyze each step of the Identify the
dispensing process; receiving an Risk
Rx, entering, filling, bagging, and Monitor and Select the
counseling Improve Technique
Implement
• Track and Trend the Technique
• Perform this analysis for each new
service contemplated
81/30/2018
The Risk Management Process
Step 2: Select the Technique (Best Practices)
• What types of changes would
reduce errors that are occurring?
• Where could those changes most Identify the
Risk
logically be made?
Monitor and Select the
Improve Technique
• Write down all ideas!
Implement
the Technique
• Select those that seem most
appropriate
The Risk Management Process
Step 3: Implement the Technique
• Incorporate the change into the
current process
Identify the
Risk
• Communicate with your staff
Monitor and Select the
Improve Technique
Implement
the Technique
91/30/2018
The Risk Management Process
Step 4: Monitor and Improve
• The changes probably won’t be
perfect on the first try
Identify the
• Be willing to try again, but be Risk
sure to allow enough time for a Monitor and Select the
true trial Improve Technique
Implement
• Encourage your staff to keep the Technique
an open mind about changing
the process
TRANSFER OF RISK
The easiest and most
popular way to do this is
to purchase insurance
101/30/2018
Negligence
• Elements
- Duty
- Breach of Duty
- Damages
- Proximate Cause
Duty
• The requirement to behave in a certain manner for
the benefit of another
• Does not mean warning about everything
• The actor must take reasonable steps to prevent
foreseeable harm
• Professionals have different duties than “ordinary”
people
111/30/2018
Breach of Duty
• Standard of Care – how you know when the duty
is performed
• Reasonable Person Standard – what would a
reasonable person do in the same or similar
circumstances?
• Legal Standard – law requires certain behavior
• Others – professional oaths, codes of ethics, etc.
Breach of Duty
• Failure to perform the duty
(nonfeasance)
• Duty performed
inadequately or incorrectly
(malfeasance)
• Breach is easy to spot when
an Rx is filled incorrectly
121/30/2018
Proximate Cause
• The breach of the duty must be
the direct cause of the injury
• Superseding or Interceding
Cause
Damages (Harm)
• Patient must have been
harmed in order to be
compensated
• Many states require
underlying physical
injury to make claim for
emotional injury
• Harm if not taken?
131/30/2018
Contributory Negligence
• Common law concept
• In order to recover, the plaintiff cannot be even 1%
at fault
• Defense merely needs to show some fault by
plaintiff to win
Comparative Fault
• Replaces Contributory Negligence
• Plaintiff has their percentage of fault subtracted
from the damages award
• 2 versions:
- Pure - plaintiff recovers damages, less their % of
fault
- Modified – If plaintiff is responsible for 50% or
more of fault, then no recovery
141/30/2018
Past Changes in Liability Exposure
Nichols v. Central Merchandise
16 Kan. App. 65 (1990)
• Rx for Gantanol
• Patient was pregnant
“…absent a contraindication or error on the face
of the prescription, the pharmacist has no duty
to warn…”
Kampe v. Howard Stark Professional Pharmacy
841 S.W.2d 233 (Mo.App. W.D., 1992)
• Rx’s were filled correctly,
but usage of the Rx’s was
not monitored
• Pharmacy’s duty is limited
to properly filling lawful
prescriptions
151/30/2018
Horner v. Spalitto
1 S.W.3d 519 (Mo. Ct App. Western Dist. 1999)
• Patient received Rx’s for
Placidyl 750mg q8h and
Diazepam 10mg q8h
Placidyl
• Rx’s were filled correctly
Horner v. Spalitto (cont.)
• Relegating a pharmacist to the role of order filler
fails to appreciate the role recognized in the PPA &
OBRA 90
• Holding as previous cases did would denigrate the
expertise which a pharmacist’s education provides
concerning drugs & their use
161/30/2018
Collaborative Practice Agreements
• Tremendous variation by state
• Technical and clinical exposures to consider
Collaborative Practice Agreements
Technical Exposures
• Must know what practices are allowed in your
state/practice setting
• Moving outside legal parameters could expose you
to Punitive Damages
• Make sure your patients know who you are and your
role
171/30/2018
Collaborative Practice Agreements
• Case - a Pharmacist was engaged in collaborative
practice with an internal medicine Physician. The
Physician was allegedly over-prescribing pain meds
and controlled substances. The Pharmacist was
sued along with Physician by three separate
patients. All of the patients alleged that the
Pharmacist represented himself as a Physician in
the practice.
Collaborative Practice Agreements
Clinical Issues
• Pharmacist must be trained and experienced to
recognize treatment issues
• Exposure will differ based on activity; initiating,
modifying or discontinuing therapy, ordering and/or
interpreting lab results
• Exposure will differ based on the patients being
treated
181/30/2018
Collaborative Practice Agreements
• Two cases involved monitoring of Gentamicin
dosing. In both cases, Pharmacist did not act
quickly enough when receiving lab results showing
high blood levels.
• Transition of care could impact these situations;
what in-patient care knew vs. what home-care
knows
• Another case – Patient received both Gentamicin
and Vancomycin. Vanco levels were ordered &
drawn, but Gent levels were not ordered. Patient
eventually suffered kidney damage and ototoxicity.
Medication Therapy Management
• Generally, exposure here would be less than
Collaborative Practice because therapy isn’t initiated
by pharmacists
• Pharmacists make recommendations regarding
therapy, but don’t order anything
• There is exposure for missed clinical interventions;
interactions, contraindications, overdosage,
underdosage, etc.
• Similar exposure as DUR/Counseling and LTC
Consulting
191/30/2018
Medication Therapy Management
• Pharmacist must be trained and experienced to
recognize treatment issues
• Must be able to communicate effectively with other
Health Care Professionals and patients
• Research and find answers to questions – don’t
guess
• Don’t assume that someone else will handle the
issue
Prescriptive Authority
• Again, variation by state
• Exposures will depend on type & extent of
prescriptive authority
• Would expect to see the highest potential exposures
here because of the initiation of therapy.
• Training is the key to minimizing these exposures
• Have no claims or court cases to present here
201/30/2018
Key Points
• All forms of Advanced Practice carry additional
levels of liability exposure
• Training and critical examination of the facts of each
case can lessen these exposures
• Never assume that someone else will handle the
issue/problem!
• Potential exposure alone is not a sufficient reason to
not advance
1. Which is NOT a feature of Medication
Therapy Management?
A. Enhancing appropriate medication use
B. Increasing detection of adverse drug events
C. Written practice agreement
D. Improving outcomes
211/30/2018
C. Written practice agreement
MTM doesn’t require any written agreement
2. A written collaborative pharmacy practice
agreement may include which of the following?
A. The nature and scope of authorized drug therapy
management to be provided by a pharmacist
B. A description of specific disease states to be
managed
C. Protocol authorizing the ordering and interpretation
of laboratory tests
D. All of the above
221/30/2018
D. All of the above
CPPA should cover all aspects of the collaboration so that each
party is aware of their responsibilities
3. Which practice involves the greatest risk of
legal liability for pharmacists?
A. Prescriptive authority
B. Collaborative practice
C. Medication therapy management
D. All of the above have the same level of risk
231/30/2018
A. Prescriptive authority
Initiation of therapy can entail significant risks, especially as
compared to MTM
4. True or False?
According to recent case law, Pharmacists engaged
in collaborative practice with Physicians are afforded
protection from lawsuits.
241/30/2018
False
There is no immunity provided by CPPA’s
5. What should you do in order to minimize
your liability exposure?
A. Pharmacist must be experienced and maintain
training to recognize treatment issues
B. Critically examine the facts of each patient case
C. Assume that someone else will handle the
issue/problem
D. A & B
251/30/2018
D. Both A & B are correct
Training and experience are crucial in limiting exposure in any
situation. Staying focused and critically examining the case in
front of you is also important.
Questions?
Don R. McGuire Jr., R.Ph., J.D.
General Counsel, Sr. Vice President Risk Management & Compliance
Pharmacists Mutual Insurance Company
PO Box 370
Algona, IA 50511
P. 800.247.5930 ext. 7312
E. don.mcguire@phmic.com
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