THERE SEEMS TO BE A MISTAKE WITH MY
PRESCRIPTION
SATURDAY/4:30-5:30PM
ACPE UAN:
0107-9999-17-010-L05-P
0107-9999-17-010-L05-T
0.1 CEU/1.0 hr
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. Identify methodologies and techniques leading to more effective and efficient communication when
a pharmacy receives a report of a medication error from patients, staff or boards of pharmacy
2. Recall common mistakes to avoid when responding to a medication error
3. Plan appropriate responses to possible medication error scenarios using the established guidelines
Speaker: Donna Horn, BSPharm
Donna Horn is the Director of Patient Safety in community pharmacy at ISMP. She has more than 25
years of experience in the retail/chain community pharmacy practice setting, most recently serving
as the HIPAA Privacy Officer and Manager of Regulatory Affairs for Brooks/ Eckerd Pharmacy. Her
contributions include serving as President and Chairman of the National Association of Boards of
Pharmacy where her focus was in patient safety, primarily on reducing medication errors in
community pharmacy. She also served 11 years on the Massachusetts Board of Registration in
Pharmacy as both a member and as President. Most recently, Ms. Horn was elected as Board
Director and subsequently President of the American Society for Pharmacy Law, the first ever nonattorney to fulfill that role. She is a graduate of the Massachusetts College of Pharmacy and Allied
Health Sciences where she earned her bachelor’s degree in pharmacy. She is currently a Master’s
degree candidate at the University of Florida College of Pharmacy with a focus on Pharmaceutical
Outcomes and Policy as well as Patient Safety and Medication Risk.
Speaker Disclosure: Donna Horn 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.
2/4/17
There Seems to be a Mistake
with My Prescription
Donna Horn, RPh, DPh
Institute for Safe Medication Practices
Disclosure
Donna Horn reports no actual or potential conflicts of interest
associated with this presentation
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Learning Objectives
•
Upon successful completion of this activity, participants
should be able to:
1. Identify methodologies and techniques leading to more
effective and efficient communication when a pharmacy
receives a report of a medication error from patients, staff
or boards of pharmacy.
• 2. Recall common mistakes to avoid when responding to
a medication error.
• 3. Plan appropriate responses to possible medication
error scenarios using the established guidelines.
•
3
There Seems to be a Mistake with
My Prescription
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2/4/17
“This is not my medicine”
This type of error is among the most
common type of pharmacy errors
“I dropped off a prescription for antibiotics, an inhaler, and
albuterol for my son.
As I went to pick it up, they gave me the medication that
belonged to another patient with the same name.
My son did not take the wrong prescription, because we
noticed it was the wrong one.
I spoke to the pharmacist and they apologized, stating
they were too busy and it was ‘Chaos.’ ”
5
Case Report 1
Dispensed Amitriptyline 200 mg should be amitriptyline
20 mg
Assumed change in the way it
looked because it was generic
On medication for years for
migraine prevention
Took wrong dose and hallucinated
Not able to function and slept most
of the day
Called the pharmacy and told them
Pharmacist was not very apologetic
6
Did not tell patient what he gave
her
Told her to bring it in and he would
exchange it
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Case Report 2
Pharmacy leaving messages to pickup Rx
Curious, I called them back and got the name of the Dr's
office, which turned out to be a Woman's Health center
Someone using my identity?
Same name, date of birth, different middle name
Pharmacy had originally filled the prescription under
my name incorrectly
Nonchalant: as if this happens all the
time!
7
Case Report 3
• 51 yo woman was dispensed sertraline 100 mg
instead of synthroid 100 mcg
• Label stated synthroid and that it should be round
yellow tablet
it looked very similar to synthroid
• history of this pharmacy dispensing different generics to
her
•
• Became ill with various GI symptoms including
diarrhea after taking it for 4 days
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sertraline vs synthroid
9
Cover up?
• RPh told her that the NDC was the pill imprint
number and that “different manufacturers use the
same NDC and that this was just a different form
of synthroid she was reacting to”
• RPh said error was impossible because the pills
are filled by a machine
• RPh told her to take Tylenol
•
Has listed allergy to acetaminophen on profile
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Adequate Pharmacy Response?
• She called her doctor
• Pharmacy offered to refund her co-payment
and a $35 gift card
• Consumer is NOT interested in the money
and is more concerned with the ethical
implications of the original pharmacist
denying the error and not telling her truthful
information
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Pharmacy Response (cont.)
• She demanded an incident report be
completed and wanted a copy for her
records
• Store manager said “no”
• Corporate manager would call and “read” her
the report
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Patient’s View
• Her goal: to help implement quality
procedures at this pharmacy by bringing
attention to this mistake
• She verbalizes feeling extremely offended
by the pharmacist for not taking her or this
error and her symptoms seriously
13
Sound Familiar?
Certainly these are not unusual stories
• When a patient or caregiver thinks a mistake has been
made and brings it to your attention, what do you do?
• How do you respond?
• Does your organization have a policy for how to handle
these situations?
• All alleged errors or incidents should be handled by a
pharmacist, with professionalism, courtesy, and empathy
• The following recommendations will help the pharmacist
remain calm and reassured when dealing with a possible
incident
•
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How to Respond when a Medication
Error Occurs
• Have written procedures for handling medication
errors
• These procedures need to be seen, read and
understood by every member of the pharmacy team
Reviewed regularly for appropriateness to the specific
workplace
• Updated to reflect changes in workflow and additions of
technology
• Contain guidance about what to say and do and, what not to
say or do
•
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When an Error Occurs: Follow Policy
• Policy
principles
• Define staff roles in response to a
possible or actual medication error
• Description of how staff should respond to a
patient’s questions about what she may
assume is an error in dispensing
• Define how management should respond and
investigate the cause of an error
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Policy Guidelines (cont.)
Define when others (e.g., prescriber) should be notified
of an error
• Respond to the report immediately with concern. Assure
the patient reporting a potential or actual error that it is
important and a priority
• Whether the error is obvious or still a remote possibility,
respond to the discrepancy immediately
• Remedy the immediate situation with truth and honesty
•
• Be direct and open with the patient reporting the error
• Goal is to minimize any negative impact to the patient
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Policy Guidelines (cont.)
“Please let me explain what we believed happened
and how we plan to fix it” or “At this point I can’t
answer how this happened but I promise you I will look
into it and get back to you.”
• Document and report the event and response
Document the date, time, and specifics of the event
Report the event using the pharmacy’s internal reporting
system
• Notify supervisors, risk management, and the prescriber
when necessary
• Make a note in the patient’s profile so that staff is aware,
especially when the patient returns to the pharmacy
• Report the event confidentially to ISMP
•
•
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Policy Guidelines (cont.)
• Establish a Continuous Quality
Improvement (CQI) program to detect,
document, and assess prescription errors
in order to determine the cause, develop an
appropriate response, and prevent future
errors
• Follow up and alert staff to the situation
• Support staff involved in the incident
• Employee assistance programs
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Policy Guidelines (cont.)
• Practice and role play possible scenarios using
the established guidelines
A patient returns to the pharmacy counter, with a torn
bag and open vial, after just paying for his prescription,
and says, “This does not look like what I got last
month!”
• While counseling a patient on their warfarin dose
change, you discover that the strength on the label and
the tablets in the vial don’t match
•
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When an Error Occurs: Notify the
Patient
• IOM recommends that patients be notified when
an error occurs
• How and when this occurs, however, is important
for both patient care and risk management
• Ex: Soon after a patient leaves the pharmacy, it is
discovered that she received the wrong
medication. The patient must be contacted
immediately to have the wrong medication
returned to the pharmacy and have the error
corrected.
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Use Effective Communication
• Do:
• Stay calm
• Be polite and professional
• Be honest
• Be sincere
• Don’t:
• Panic
• Blame
• Provide information that
you are unsure of
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Try This:
“Mr. Brown, this is Donna from Family
Pharmacy. I am calling because it came to
our attention that you went home with
someone else’s medication. We would like
you to come to the pharmacy as soon as
possible so we can make sure you have the
correct medication. We are very sorry for the
mistake, and we are already looking into
ways to prevent this from happening again.”
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When an Error Occurs: When an
Error is Brought to Your Attention
• Have the conversation in a private area
• Thank the patient for bringing the error to your attention
• Acknowledge the patient’s efforts for taking part in
medication safety
• Listen attentively to the patient, without interrupting and
without distractions
• Show concern, and empathize with the patient’s
feelings
• Agree if appropriate, but don’t argue if you disagree
• Allow the patient the time they need to express their
feelings
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Common Mistakes to Avoid
Making
Excuses
• Do not say how busy you are
• Staffing problems or other factors
• Do not try to guess what happened
• Most errors have a number of contributing factors
Speculation
that need to be thoroughly investigated
Blaming
• Do not blame the prescriber or your staff members
• Do not blame circumstances
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Common Mistakes to Avoid
Blaming
the patient
Admitting
fault
Overagreeing
Making
false
promises
• Do not find a way to make the patient responsible for the error
• e.g., being in a hurry, not checking their medication
•When an error first comes to your attention, it is too soon to determine
all the factors involved in the error
•Explain that a complete investigation will be done
• Agreeing with everything the patient says, even if you disagree
• Say, “I am sorry you feel that way.”
• Assure the patient that you will work toward making changes that will
reduce the risk of this happening again
• Do not promise compensation or any other action from your employer
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When an Error Occurs:
Communicating with Staff
• All staff must bring an error to the attention of the
pharmacist immediately, before engaging the
patient
• Each staff member involved in the error should be
made aware of the incident privately and in a
nonjudgmental manner
•
Ask staff about factors that may have contributed to the
error; ask for suggestions for practical ways to prevent
future errors
27
Communicating with Staff (cont.)
Immediate feedback
•
“Bill, Mr. John Brown was
given Mr. John Browne’s
prescription in error. Please
always ask and confirm the
patient’s date of birth before
ringing up the sale.”
Delayed, problem-solving
feedback
•
“Bill, I appreciate your efforts
to keep up with the high
prescription volume and
long pick up lines
but accuracy is of utmost
importance. Please give
some thought about what
we can do to make sure
prescriptions are dispensed
correctly. I will ask others to
do the same thing and I
want us to discuss some
possible strategies the next
time we have CQI meeting.”
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When an Error Occurs: Following Up
• Contacting prescribers
• Ex: Patient received the wrong medication for a
month before the error was discovered on a
refill
• Provide organized, concise and accurate
information to the prescriber using the SBAR
approach
29
•S
SITUATION What has happened? Be specific.
•B BACKGROUND Explain circumstances leading up to
this situation.
•A ASSESSMENT What do you think the problem is?
What is concerning you?
•R
RECOMMENDATION What do you need? What would
you do to correct the problem?
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SBAR
• Situation
• Identify the person to whom you are speaking
• Identify yourself, occupation and where you are calling from
• Identify the patient by name, age, sex, reason for call
• Identify what is going on with the patient (wrong medication, wrong strength,
etc.)
•
Background
• Give the patient's status
• Give the patient's relevant past medical history
• Brief summary of background
•
Assessment
• List if any vital signs that are outside of parameters; what is your clinical
impression
• Vital signs: heart rate, respiratory rate, blood pressure, glucose level, pain
scale, level of consciousness
• Severity of patient, additional concern
•
Recommendation
• Explanation of what you require, how urgent and when action needs to be
taken
31
• Make suggestions of what action is to be taken
• Clarify what action you expect to be taken
SBAR
• Situation: Dr. Jones this is Donna, RPh from
Family Pharmacy; John Brown, male, d.o.b.
8/21/59 self injected Lantus instead of Apidra
• Background: In error JB received 4 boxes of
Lantus, 3 were labeled as Apidra; self injected
Lantus 4 times per day
• Assessment: Patient feeling dizzy and weak with
profuse sweating; blood sugar 57 mg/dL
• Recommendation: Correct error; monitor blood
glucose levels; drink OJ
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When an Error Occurs: Investigating
an Error
• Error, no harm
• Investigation can be performed quickly and
informally. Interviewing the individual who made
the error may provide sufficient information to
identify how the error occurred and whether or
not any root causes can be identified.
• Error, harm
• Investigation becomes more challenging.
33
It’s the System…Not the People
“Incompetent people are, at most,
1% of the problem. The other
99% are good people trying to
do a good job who make very
simple mistakes and it’s the
processes that set them up to
make these mistakes.”
Dr. Lucian Leape
Harvard School of Public Health
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DEVELOPING A CQI PROGRAM
The Importance of CQI in Ambulatory Practice
35
CQI - what it is NOT:
• Eliminate all errors
• Find incompetent people
• Focus on blame
• Result in punishment - disciplinary action
on license or job in jeopardy
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CQI - what it is:
• Reduces errors
• Improves systems
• Focuses on learning
• Requires a culture change
• Report for learning purposes
• Reward error reporting
• Does not punish or ridicule personnel
• Culture change towards safety and education
37
CQI - what it is:
• Leads to prevention
• Incorporates “safety” as part of the thinking
process during dispensing
• Aimed specifically at preventing well-known
and repetitive dispensing errors categories
• Detects, documents, assesses, and
eventually prevents future medication
errors
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50 states: 50 ways
• Required in: AZ, CA, CT, FL, IA, KS, KY,
MD, MA, NC, ND, OR, VA, WV
• MT some circumstances, SD mandates be
included in RX P&P manual
• IL, IN, OK hospital only
• ID, WY certain settings
• NY, TX encouraged/recommended
• NH promulgating regs
39
2016 NABP Survey of Pharmacy law
https://nabp.pharmacy/publications-reports/publications/
accessed 12/30/2016
CQI in NABP Model Practice Act
• Gives guidelines for states that want to add
regulations for mandating CQI programs
• Defines quality related event (QRE)
• Includes peer review and peer review committee
for whether patient safety standards are met
• Requires a quarterly self audit of quality
• Requires annual retraining
• Specifies time frame for documentation
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CQI in NABP Model Practice Act (cont.)
• May be considered by Board as a
mitigating factor during investigation of
QRE
• Reporting shall be to nationally recognized
error program designated by the Board
(with appropriate blinding)
• Recommends annual consumer surveys to
evaluate pharmacy performance
41
QRE Defined for Pharmacy
• Prescription processing error
• Incorrect drug, strength, dosage form, patient,
packaging/labeling/directions
• Failure to identify and manage
• Over/underutilization, therapeutic duplication,
disease/disease contraindication, drug/drug
interaction, incorrect duration or dosage, drugallergy interaction, clinical abuse/misuse
42
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Consumer Surveys
• At least once per year
• Phone, mail, electronically, or in person
• Pertinent questions
• Is the pharmacist accessible?
• Can you read your prescription label?
• Is your drug therapy helping you get
better?
• Use results to evaluate its own
performance
• Proof of completion
43
Develop a CQI Program that will…
• Identify and document QREs
• Minimize impact of QRE on patient
• Analyze data collected from the root cause
analysis (RCA) to assess causes and contributing
factors
• Use findings from analysis to formulate
appropriate responses
• Further develop systems and processes
• Provide education from CQI analysis to personnel
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CQI Program Template
1. Select a quality team leader
2. Define QRE
3. Describe your practice process
4. Develop a QRE reporting process
5. Train staff in CQI
6. Conduct CQI meeting
7. Implement changes and evaluate results
45
“I hope it wasn’t me who made the
mistake.”
46
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Investigation Techniques
• Start investigation as soon as possible
• People forget
• Hindsight bias sets in
• Devise a strategy
• Remain calm and focused
• Gather the facts before people forget and/or physical
evidence is lost
• Identify who you need to talk to and organize your
questions. You want to approach people only once.
• Review and store any physical evidence
• In our JB case, check stock placement in fridge, review labeled
boxes
47
When an Error Occurs: Interviewing
Those Involved
• Do not address the person involved in the error in a
public place. Avoid negative body language or
accusatory words
• Ask open-ended questions and take notes
•
•
•
Walk through what happened, as he remembers it
What was happening around him at the time?
Was the standard operating procedure followed or did
something happen to make him deviate from it?
• Prepare for the person to be emotional when
discussing the situation
• Remind the individual that everyone makes mistakes;
no one is perfect
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“I hope it wasn’t me who made the
mistake.”
“Not my
responsibility; I’m
only a fill in for the
sick pharmacist.”
49
Review Evidence
50
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2/4/17
Results of Interviewing Staff
• Quantity prescribed 720 mL
• Dispensed 480 mL stock bottle PLUS
240 mL “overflow” in brown rx bottle
• Valproic Acid stock bottle by Qualitest
incorrectly stocked behind open Lactulose
(also by Qualitest) stock bottle
• Bar code scanner only able to scan one
stock bottle
51
How to Document and Analyze Errors
• Utilize the Assess-ERR ™ Medication Error
Worksheet found in AROC document
• www.ismp.org/Tools/communitySafetyProgram.asp
• RCA for sentinel events
• www.ismp.org/tools/rca/
Pharmacy that has had no documented QREs in
three months time is not taking the program
seriously.
52
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When an Error is Brought to Your
Attention by the Board
Don’t panic
• Carefully review the facts supporting the allegation and
respond promptly to the Board
• Set the right tone:
•
• Never be nasty to the investigator
• Be friendly, cooperative and answer truthfully
Make copies of everything they request or take with them
• Put your best foot forward
• Know and follow your company’s policies for providing
records and notifying supervisors and other corporate
team members of the situation
•
53
Do’s (then Don’ts) in front of a Board
• Do be professional and dress accordingly.
• Do be prepared.
• You may be sworn in and could be recorded.
• You will have to answer questions.
• Know your audience.
• Do accept responsibility, if warranted, and
express regret for any errors.
• Do show the Board what you have done to
prevent future mistakes.
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(Now the) Don’ts in front of a Board
• Don’t forget the Do’s
• Don’t forget the role of the Board
• Don’t be defensive or dismissive
• Don’t point the finger at someone else, like
a technician or company management
• Don’t talk too much
55
How to Avoid Discipline
• Put patient health and safety first
• Know your state’s pharmacy laws and rules
• Mistakes happen
• Issue is often “why” the law/policy was not followed
• Document, analyze, implement prevention plan
• Don’t screw up on the easy stuff:
• Know when your license is due for renewal
• Stay on top of your CE credits
• Don’t give your keys or passwords to others
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Group Case Study: Discussion
• Practice and role play possible scenarios using
the established guidelines
While entering the lot number of the vaccine into the
registry, RPh notices she administered Tdap instead of
DTaP to a 5-year-old patient. The patient is still in the
pharmacy.
• A patient brings his medication bottle to the pharmacy
for a refill. You realize Aripiprazole 20 mg was ordered
(label correct) but 5 mg was dispensed. His bottle is
empty.
• See pictures next slide.
•
57
So close….
Daptacel (DTaP) and Adacel (Tdap)
Similar brand names, generic designations,
and vaccine abbreviations (Tdap, DTaP)
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Oops
59
•S
SITUATION What has happened? Be specific.
•B BACKGROUND Explain circumstances leading up to
this situation.
•A ASSESSMENT What do you think the problem is?
What is concerning you?
•R
RECOMMENDATION What do you need? What would
you do to correct the problem?
60
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While entering the lot number of the vaccine into the
registry RPh notices she administered Tdap instead of
DTaP to a 5-year-old patient.
The patient is still in the pharmacy.
•S
•B
Person who woke up the
earliest this morning is the
reporter for the group
•A
•R
61
A patient brings his medication bottle to the pharmacy
for a refill. You realize Aripiprazole 20 mg was ordered
(label correct) but 5 mg was dispensed. His bottle is
empty.
•S
•B
Person who woke up the
latest this morning is the
reporter for the group
•A
•R
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Conclusions
• When communicating with a patient that
may have been involved with an incident:
• Give the situation your undivided attention
• Introduce yourself to the patent/caregiver
• Speak slowly and calmly
• Offer a sincere apology for the distress they are
experiencing in regard to the accuracy of their
prescription without admitting fault
63
Self Assessment #1
Which of the following statements are true when describing
a “continuous quality improvement (CQI)” program?
a. CQI can be defined as a system of standards and
procedures to identify and evaluate quality-related
events and improve patient care.
b. CQI can be defined as a system of standards and
procedures to identify pharmacists who make frequent
errors so their performance can be evaluated by a peerreview committee.
c. A CQI program is designed to detect, document,
assess, and prevent quality-related events.
d. a and c
e. b and c
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Self Assessment #2
A CQI Program should include all of the following EXCEPT:
a.
b.
c.
d.
e.
Steps to follow when a quality-related event (QRE)
occurs
How the analysis of a quality-related event should occur
How to use the program to evaluate individual staff
performance
Suggested error-prevention strategies
None of the above (all statements are true)
65
Self Assessment # 3
A QRE includes all dispensing errors as well as any failure
to identify and manage the therapeutic aspects of a
prescribed medication, such as drug-drug interactions or
drug-allergy interactions.
True
b. False
a.
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Self Assessment # 4
All of the state boards of pharmacies in the US require
community pharmacies to establish a CQI program
designed to detect, document, assess, and prevent QREs.
True
b. False
a.
67
Self Assessment #5
If a patient needs to be notified of an error
Focus on how to correct the error for the patient and
assure them that efforts will be made to reduce the risk
of a similar error occurring in the future.
b. Respond to the discrepancy immediately
c. Remedy the immediate situation with truth and honesty
d. All of the above
a.
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Closing Thoughts
“The attention and concern demonstrated to
the patient and family through the admission
of an error and afterward may actually
mitigate their response to the error.”
M.R. Cohen
69
“It is not uncommon for a patient who has
been the subject of a pharmacy error to say,
‘I know that mistakes happen. What upsets
me is not so much that the error occurred
but that the pharmacist didn’t seem to care
when I pointed out the error and asked for
help’.”
-D.B. Brushwood
70
35