High Risk and
High Alert
Situations
William E. Fassett, PhD, RPh, FAPhA
Professor of Pharmacy Law & Ethics
Washington State University - Spokane
Objectives
• Identify high-alert situations that have led to
significant lawsuits in recent years
• Know situations where pharmacists have expanded
duties to patients beyond merely correct dispensing
• Understand strategies to deal with high-alert
situations
Disclaimers
• Unless cases are presented with citations to specific legal
opinions, be aware of the following:
o
o
o
The cases have been adapted and altered from actual cases, and are intended for
educational purposes only.
The patient names, prescriber names, and pharmacy names are fictitious. Any
similarity to any actual person or firm is coincidental.
The dates and locations have been changed.
• In general, cases have been abridged and not all relevant
factual elements have been included.
• The purpose of this discussion is intended to be educational,
and any advice I provide is that of a pharmacist interpreting
the clinical and operational issues involved from an
experienced pharmacist’s perspective.
• I am not an attorney and am not offering legal advice.
• Any legal applications of this discussion to your practice
should be discussed with your attorney.
Pharmacists’ Legal Duties
to Patients
• Dispense the prescription accurately and lawfully
• Generally, no “duty to warn” – 7 exceptions*
o Obvious error on the face of the Rx
o Pharmacist has specific knowledge of patient’s allergies, conflicting drug
use, or other propensity for harm
o When the prescription is contraindicated based on the package insert
o When the pharmacy has undertaken to provide a service like screening or
patient education
o When representations have been made to the public that promise
special services
o When a drug has been withdrawn from the market but the pharmacist
compounds the drug or otherwise continues to dispense it
o When a MedGuide is mandated for a drug and the pharmacist does not
provide it
• When you are the prescriber or modifier of an order,
you are responsible for all the duties of any prescriber
*Brushwood DB. Recent trends in pharmacy law and regulation. Pharm in Hist 2009; 51(3):98.
Today’s Cases
• Why we should still teach “Inorganic Medicinal
Products” in pharmacy school
• Don’t be afwaid of the your growing scope of
practice, but do be vewwy, vewwy, caweful.
• Nocturnal choices: Neil Young or Shakespeare?
o “They were flying Mother Nature’s silver seed to a new home in the sun”
o “Devoutly to be wish’d. To die, to sleep; to sleep: perchance to dream:
ay, there’s the rub.”
• Some recurrent identity crises
A basic
misunderstanding of
acidic nomenclature
Or, it’s time for the Glacial Age to come
to an end in medicine.
The stock order
• “Clinic Pharmacy”
• “Yes, this is Nurse Bedside. Do you have acetic acid
in stock?”
• “We have a pint in stock.”
• “OK. We’ll pick it up for use in the outpatient clinic.”
What did the clinic pick
up from the pharmacy?
What are the clinical uses
of acetic acid?
• Otitis externa – 2% solution (“Domeboro Otic”)
• Identify dysplasias of mucous membranes – 3-5%
solution (vinegar = 5%)
• Wound or bladder irrigation solution – 0.25% acetic
acid irrigation, USP
• Iontophoreses treatment of upper extremity soft
tissue injuries – 2% -10% solution
• Assess subclinical genital HPV – 3-5% solution
o The physician applied the product directly to the patient’s genital area to
assess possible HPV.
What is Glacial Acetic
Acid?
• Called “glacial” because
at the concentration of this
particular solution, when it
freezes, produces crystals
that look like glaciers.
• What is this freezing point?
o 17° C (62° F)
• What is this concentration?
o Anhydrous or nearly so ( 99.5%)
Repeat Safety Alert
(1st ISMP alert issued in 2005)
• National Alert Network – January 23, 2013
WARNING! Severe burns and permanent scarring
after glacial acetic acid (≥ 99.5%) mistakenly applied
topically
• Recent cases nationally:
o Severe burns and permanent scarring after GAA applied to skin instead of 5% solution
during surgery
o Nurse requested “acetic acid for irrigation” for a young woman with paraplegia,
osteomyelitis, and bilateral greater trochanter wounds. GAA used for 2 days instead of
diluted form
o Ambulatory surgery center requested 4% acetic acid for use during anoscopy. GAA
purchased by staff and patient suffered severe anal burns.
o GAA placed in bowl in OR; intended use to identify rectal condyloma. Patient required
extensive treatment and prolonged hospitalization.
• Our patient would be at least number 5!
ISMP Recommendations
• Do not stock glacial acetic acid in the pharmacy
o Stock 5% or vinegar or commercial 2% or 0.25% products
• Restrict purchasing of acetic acid to pharmacy
• Make glacial acetic acid “invisible” in purchasing
and ordering software
• Ensure correct strength is ordered
• Educate staff
• Order 5% acetic acid as “vinegar”
• Verify product – independent double-check of all
acetic acid solution orders before dispensing or
delivery
Collaborative
Drug Therapy
Agreements
Or, be sure to put the “management” in
collaborative drug therapy management
Must avoid SUBtherapeutic
drug therapy management
“Pharmacist to Dose”
•
Patient started on clindamycin + gentamicin presumptively secondary to
diagnosis of pelvic abscess
o
o
o
•
Treatment phase 1:
“Pharmacy to dose gentamicin”
• Initial dosing followed protocol :
o 2 mg/kg IV loading
o 1.5 mg/kg IV every 8 hours (4.5 mg/kg per day)
• Trough and peak levels ordered per protocol; WNL
• IV treatment continued x 48 hrs
• No c/s of abscess is performed
• Abscess not drained
Treatment phase 2:
Discharged to home on clindamycin orally 400 mg q.i.d. plus gentamicin 1.5 mg/kg IM daily
• Pharmacy accepts physician’s request to give IM dosing at 1.5 mg/kg/day and responsibility to
monitor therapy
• Pharmacy continues to monitor and orders peak and trough levels
• Patient continues on 1.5 mg/kg IM daily for 15 days
Treatment phase 3:
Readmitted – placed on daily IV gentamicin dosed per pharmacy
• Inpatient dosing is established by pharmacy at 5-7 mg/kg/day
• Dosing continued for 6 days, then discontinued
• At discharge, patient’s abscess is cleared, but her SCr has risen clinically significantly
7 days post-discharge, patient experiences signs of vestibular toxicity
Issues at Trial
•
Plaintiff alleged that the physician and the institutional
pharmacists were negligent; particular emphasis on treatment
phase 2:
o
o
o
o
•
Patient also alleged a separate cause of action:
o
o
o
•
•
Use of prolonged gentamicin without evidence of gentamicin-sensitive infection
Use of prolonged sub-therapeutic gentamicin
Management of gentamicin therapy by pharmacists not in accordance with the approved
protocol
• Defendants claimed that the low dose IM may have been used for synergism
• Clinda-gent not “synergistic” therapy
• Extended interval gentamicin therapy not to be used according to the protocol for synergism
with beta-lactam antibiotics
Lengthy unnecessary gentamicin therapy was proximate cause of vestibular toxicity
Neither physician nor pharmacists obtained informed consent before prescribing gentamicin
Neither physician nor pharmacists warned of risk of vestibular toxicity
Physician and pharmacy representative essentially claimed in deposition testimony that they were
unaware of the risk of vestibular toxicity from gentamicin
Defendants moved for summary judgment on issue of
pharmacists’ duty to obtain informed consent; motion denied
Case settled for undisclosed amount just before trial
When you Prescribe, YOU
must Follow Up
Pharmacist PCA dosing:
• Elderly patient admitted to hospital for pain management
• Pharmacists managed PCA therapy
• Final timeline: hydromorphone PCA as ordered by
pharmacists:
Time
PCA
dose
Lockout
Cont rate
1-hr lim
0730
4 mg
8 min
5 mg/hr
20 mg
2010
3 mg
8 min
3.5 mg/hr 18 mg
1015
3 mg
8 min
“D/C”*
18 mg
1200
2 mg
8 min
0 mg/hr
10 mg
• *- MD note: “pt can’t keep eyes open – D/C basal rate”
• At 1900 hours, patient suffered respiratory/cardiac arrest
RCA
• Cardiac arrest was secondary to respiratory arrest
• Respiratory arrest likely due to narcotics
• Question: what if the pharmacist’s orders at 1200
hours were never actually implemented?
Key CDTA Issues
• It is unwise for a pharmacist to take over management
of a drug that in not indicated or is ordered at the wrong
dose
• A pharmacist does not normally bear the burden of
obtaining informed consent, but does so if he or she is
the prescriber
o In a collaborative relationship, the pharmacist must at least determine if
informed consent has been obtained
o Obtaining informed consent is not a one-time event, but a process
o Patients may sue for failure to obtain informed consent as a separate cause of
action from negligence
• When the pharmacist initiates or modifies therapy, he or
she becomes the prescriber, and OWNS the outcome of
the therapy
o If it is to be, it is up to thee
Informed consent:
Elements to disclose to patient
• The nature and purpose of the proposed therapy
• The expected benefits of the proposed therapy
• The known likely material risks associated with the
proposed therapy
o Not necessary to disclose every risk
• Risks in the general population 1% probably should be disclosed
• Risks in the particular patient population of which the patient is a
member should be discussed (e.g., NSAIDs in the elderly)
• If applicable, disclose risks experienced in the particular prescriber’s
population or institution’s population
o “Material” means risks a reasonable patient would want to know in
deciding whether to undergo the proposed treatment
• Available alternatives to the proposed therapy
(including the possibility of doing nothing)
So, What is the
“Ambien”
Temperature?
“All in a dream …”
• West Virginia: woman, while sleeping following a
dose of zolpidem, got up, drove her car into ditch,
and suffered severe injuries.
o Sues pharmacy for, in part, failing to distribute required medication guide.
o Defendant pharmacy moves to dismiss under West Virginia law, citing the
Learned Intermediary Doctrine.
o Court denies motion, holding that plaintiff had stated a colorable cause
of action under the specific circumstances of the case. (Hartman v.
Caraco et al. 789 F.Supp. 2d 701, S.D. W.Va. 2011)
•
FDA discloses that it has received over 700 reports
of automobile accidents related to drivers who had
taken zolpidem
o A New Jersey man sentenced to 41 months in prison for causing a fatal
head-on collision while impaired by zolpidem (USA v. Smentkowski, No.
3:11-cr-00279-JAP, D. N.J., December 18, 2012)
Ambien doses too high
• Impaired ability to drive or operate machinery
associated with zolpidem blood levels of 50 ng/mL
or greater
• Results of pharmacokinetic trials, n = 250 men, 250 women, all
trials – blood levels 8 hours following the dose:
Dose
% women 
50 ng/mL
% men  50
ng/ml
Other
results
10-mg IR
15%
3%
3 women, 1
man 
90 ng/mL
12.5 mg CR
33%
25%
5% of pts 
100 ng/mL
6.25 mg CR
15%
5%
10% of
elderly 
50 ng mL
New doses and
recommendations
• FDA tells producers to change zolpidem labeling for
women:
o
o
o
o
Immediate-release: 5 mg/day
Extended-release: 6.25 mg/day
Recommend that prescribers consider same doses for men
FDA notes that it does not yet understand the mechanism that reduces
zolpidem clearance in women compared to men
• Particular caution should be given to patients who
need to drive in the morning following taking
zolpidem
• Dosage recommendations do not apply to
Intermezzo®
What to tell our patients
• Make sure every prescription container for zolpidem
products has a warning label concerning driving
• Counsel all patients receiving refills of or new
prescriptions for zolpidem about the new
recommendations
o Women on higher doses should consult their prescribers about reducing their
dose, especially if they need to drive the next morning
o Note that 15% of women will still be exposed to driving risk the next morning at
the lower dose
o Let patients know that being arrested while impaired by zolpidem will have the
same legal effect as being DUI for alcohol or pot
• Be sure to always dispense the FDA required Medication
Guide – whether on new or refill Rxs
• Confirm dosing on new Rxs for women that exceed the
new doses
“What you talkin’ about?
Ahm bein’ good!”
• From 2006 through mid-2010, patient receives long-term
zolpidem therapy for severe insomnia from 2 physicians
o
o
o
o
o
Through 2007 (Dr. A.), average consumption averaged 28 mg/day; instances existed
of multiple prescriptions filled at multiple pharmacies
Later (Dr. B.), consumption increased to around 100 mg/day
The patient also was prescribed, and consumed, a variety of opioids, as well as
diazepam and sertraline
Around 2008 “bad behavior” was reported to occur, culminating in criminal charges
for assault
A pharmacologist expert hired for his criminal case opines that his sexually aggressive
and assaultive behavior was caused by his becoming addicted to zolpidem
• The plaintiff subsequently sues the pharmacies that dispensed
the prescribed doses of zolpidem, which were as high as 10
tablets (100 mg total) per day on the face of the prescription
• However, at one point, when the pharmacist at one
pharmacy tried to refuse his prescriptions, he presented them
with a copy of his medical record to show that his use was
medically necessary
What the pharmacists at
one pharmacy did
• Faced with the long-term very high dosing, the
pharmacists in one pharmacy took several actions:
o Repeatedly consulted with the prescriber about the recommended doses and
duration of therapy
o Obtained new prescriptions for each dispensing
o Contacted the manufacturer of Ambien® to learn whether there was an
absolute upper limit to zolpidem dosing
• What they learned from the manufacturer
o No known upper or lethal dose of zolpidem
o Several studies in the literature demonstrate patient survival and long-term
recovery from doses exceeding 400 mg/day
o Detoxification from zolpidem is possible, according to literature reports
o Abrupt discontinuation will lead to withdrawal effects
• What they also did
o Eventually, they determined to discontinue providing services to the patient,
owing to his abusive behavior and a perception that he was a danger to
employees and other clients
“Here’s to you, Mrs.
Robinson … or is it
Robertson?”
What the labels said
Life Balance Pharmacy
200 W 1st St. – Blue Hills, CA – 416-255-2555
Lennette Taylor
DOB 4/8/63
What the patient said
“I want to pick up the prescriptions for Lieutenant Taylor.”
• The patient’s first name was “Lieutenant” – it was not a rank
• The patient had diabetes and hypertension
• The patient was functionally illiterate
• He consumed his own meds and those intended for Lennette
Taylor
• He later sued, alleging that the prescriptions dispensed to him
for Lennette Taylor were the cause of his subsequent kidney
failure
• The pharmacy argued that he signed for the prescriptions and
was counseled on them
• Because a medical expert at trial testified that the error was
not the proximate cause of the kidney failure, the jury found
for the defendant pharmacy
Taylor v. Thrifty Payless, Inc., B232635, Cal. App. Dist. 2 Div. 3, Unpublished, October 30, 2012
What are the odds?
•
•
•
Two women not related to each other:
o
o
Yolanda Vessell, DOB Oct 1955 (Yolanda Vessell 1)
Yolanda Vessell, DOB not Oct 1955 (Yolanda Vessell 2)
o
o
o
Yolanda Vessell 1 was a patient of Dr. Beier, a dentist
Yolanda Vessell 2 was a patient of Dr. Fallin, a dentist
Dr. Fallin purchases Dr. Beier’s practice. Yolanda Vessell 1’s records become merged with Yolanda
Vessell 2’s records – what could possibly go wrong?
Both Yolanda’s saw local dentists
November 2005 – Dr. Fallin telephones an Rx for amoxicillin for
Yolanda Vessell 2 to Walmart Pharmacy
o
o
•
By coincidence, Yolanda Vessell 1’s husband picks up her Rxs,
including the clindamycin Rx
o
•
The pharmacist notes a PCN allergy, and calls dentist, who changes Rx to clindamycin. When
confirming the change, the dental office tells Walmart that the patient’s DOB is October 1955
The pharmacy assigns the order to Yolanda Vessell 1, on the basis of the DOB
In spite of never being a patient of Dr. Fallin, whose name is on the label, Yolanda Vessell
consumes the clindamycin, is injured, and sues Walmart
The Court granted Walmart’s motion for summary judgment,
holding that the pharmacy properly filled the prescription, relying
on the patient name and birthdate provided by the dentist.
Vessell et al. v. Fallin Family Dentistry et al., No. 2011 CA 1702, La. App. 1st Cir., (unpublished
opinion), May 3, 2012
Across the pond …
“Blind man dies in Boots blunder with wrong
prescription after he is unable to tell the
difference” – London Mail Online, 2012 Sep 8
• 83-yr old Douglas Lamond received someone
else’s medications from a Boots pharmacy in the
UK. He was unable to recognize the error owing
to his visual deficiencies.
• “Boots, which has sent a message of condolence
to his family, has refused to reveal which branch
mixed up the prescriptions or which drugs were
involved. Extra safeguards have been put in
place at the pharmacist’s branches to ensure the
mistake is not repeated.”
Problems with dispensing
to wrong patient
• Possible liability for harm to patient receiving the
wrong drug
• Loss of the cost of the medications when wrongly
dispensed
o If Medicaid or Medicare Part D, certainly cannot re-bill for the misdispensed drug
• HIPAA violations – disclosing to the wrong patient
information concerning the other patient’s
medications
• DEA violations – if the “missing drug” is a controlled
substance, must file a statement of loss with DEA
So, What to Do about ID?
• Always seek multiple
ways to identify the
patient
o
o
o
o
o
o
Full name
Date of Birth
Medical ID number
Address
Gender
Photo
• Don’t forget the lesson
of the railroad crossing:
National Patient
Safety Goal:
2 forms of ID
• Counseling will overcome
o If the patient doesn’t know the
purpose of the drug you are
dispensing, why not?
o If the patient is seeking
something for cough, why should
the prescription contain
estrogen?
Any Questions?