Download Medication Errors

Medication Errors: How To
Prevent Them and What Can
Happen When They are Made
Angelo J. Cifaldi, R.Ph., Esq.
[email protected]
732-855-6096
Satish V. Poondi, R.Ph., Esq.
[email protected]
732-855-6154
Wilentz, Goldman, & Spitzer P.A.
90 Woodbridge Center Drive
Woodbridge, NJ 07095
© Angelo Cifaldi, 2011
What is a Medication Error
 "A medication error is any preventable event that
may cause or lead to inappropriate medication
use or patient harm while the medication is in the
control of the health care professional, patient, or
consumer. Such events may be related to professional
practice, health care products, procedures, and
systems, including prescribing; order communication;
product labeling, packaging, and nomenclature;
compounding; dispensing; distribution;
administration; education; monitoring; and use."
- National Coordinating Council for Medication Error
Reporting and Prevention
ISMP’s “ten key elements” of the
medication-use system
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Patient information: Failure to obtain the patient’s pertinent demographic (age,
weight) and clinical (allergies, lab results) information
Drug information: Failure to provide accurate and usable drug information
Communication of drug information: Miscommunication between MD, R.Ph.
and RN
Drug labeling, packaging and nomenclature: Drug names that look-alike or
sound-alike, as well as products that have confusing drug labeling and nondistinct drug packaging
Drug storage, stock, standardization, and distribution: Lack of Standard
drug administration times, drug concentrations
Drug device acquisition, use and monitoring: Lack of safety assessment of
drug delivery devices and/or a system of independent double-checks
Environmental factors: Environmental factors that often contribute to
medications errors include poor lighting, noise, interruptions and a significant
workload.
Staff competency and education: Staff education should focus on priority
topics, such as: new medications being used in the hospital, high- alert
medications, medication errors that have occurred both internally and externally,
protocols, policies and procedures related to medication use.
Patient education: Patients must receive ongoing education
Quality processes and risk management: The way to prevent errors is to
redesign the systems and processes that lead to errors rather than focus on
correcting the individuals who make errors.
Creating a System to Prevent
Medication Errors
 New and Existing Board of Pharmacy
regulations dealing with Medication
Errors
 Medication Errors probably cannot be
eliminated 100%, but utilizing best
practices can greatly reduce them.
Board of Pharmacy Regulations
Audit Trail Requirement
 N.J.A.C. 13:39-7.6: Audit Trail
 On or after April 5, 2011, a pharmacy
shall maintain an audit trail that records
and documents the unique and secure
user identifier(s) of the
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Pharmacist
Pharmacy Technician
Intern
Extern
Board of Pharmacy Regulations
Audit Trail Requirement
 Audit trail applies to each step pf
prescription handling
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Intake
Processing
Fulfillment
Dispensing
N.J.A.C. 13:39-4.19
Board of Pharmacy Regulations
Audit Trail Requirement
 All Entries to the audit trail made by a pharmacy
technician, intern, or extern shall be reviewed and
approved by the pharmacist;
 Audit trail documentation shall be generated at the
time each function is performed
 If more than one R.Ph. involved, the unique identifier
of R.Ph. responsible for the accuracy and
appropriateness of each function must be recorded
Board of Pharmacy Regulations
Audit Trail Requirement
 Audit trail documentation must be
maintained for at least a period of five
years.
 Computer systems that automatically
generate the unique and secure user
identifier without requiring an entry by
the responsible party are prohibited
 Appropriate documentation identifying the
identifier must be maintained for at least
five years after the last date of
employment
Board of Pharmacy Regulations
Pharmacy Technicians
A pharmacy technician may:
 Retrieve prescription files, patient files and profiles, and other
pharmacy records
 Enter data
 Prepare labels
 Count, weigh, measure, pour and compound prescription
medications
 Fill automated systems
 Accept authorization for renewals and requests for refills
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N.J.A.C. 13:39-6.15
Provided that the prescription remains unchanged
The pharmacy technician or applicant shall identify him/herself as a
pharmacy technician when accepting authorization from a physician or
his/her agent
Board of Pharmacy Regulations
Pharmacy Technicians
A pharmacy technician may not:
 Receive new verbal prescriptions
 Interpret a prescription or medication order for therapeutic
acceptability and appropriateness
 Verify dosage and directions
 Engage in prospective drug review
 Provide patient counseling
 Monitor prescription usage
 Override computer alerts without first notifying pharmacist
 Transfer prescriptions from one pharmacy to another pharmacy
 Violate patient confidentiality
Board of Pharmacy Regulations
Pharmacy Technicians
Pharmacists shall not supervise more than 2
pharmacy technicians unless…
 Written job descriptions, task protocols, and policies
and procedures regarding technician duties to perform
 Each pharmacy technician passes the National
Pharmacy Technician Certification Examination (or a
board approved certification program) AND fulfills the
requirements to maintain this status
 OR completes a program that includes a testing component
that has been approved by the board
Board of Pharmacy Regulations
Maintaining Patient Profiles
 Greater number of Board of Pharmacy
inspections focusing on Patient
Profiles
 Recommend random self audits
 Verify Information
 Maintaining accurate and complete
profiles helps reduce medication
errors
Board of Pharmacy Regulations
Maintaining Patient Profiles
 The following information shall be recorded in the
profile system (N.J.A.C. 13:39-7.19):
 Family name and first name;
 Address and telephone number;
 DOB;
 Original or refill date the medication is dispensed;
 Prescription number;
 The practitioner’s name;
 Name, Strength, and Quantity of the drug dispensed;
 Pharmacist’s comments relevant to the patient’s drug
therapy; and
 Any allergies
 If no allergies, then that must be documented
Board of Pharmacy Regulations
Maintaining Patient Profiles
 “All prescription patients who
patronize a pharmacy shall have a
profile record . . . and the
pharmacist shall inquire as to
whether other prescription drugs
are being concomitantly utilized
in order to establish a current drug
history for the patient.”
Id.
New Prescription Labeling
Requirement
 P.L. 1977, c.240 (C.24:6E-9)
 Effective January 29th, 2010

If a nonbrand name drug product is dispensed, the pharmacist
shall include on the label of such drug product dispensed
pursuant to a prescription, the name of the brand name drug
and the name of the generic drug. The information required
pursuant to this section shall be in the following form, with the
generic name and brand name inserted as appropriate, “- - - - - - Generic for - - - - - - .”
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Example: Simvastatin Generic for Zocor
Manner of Issuance of Prescriptions
for Schedule II Substances
 Traditional New Jersey Rule: Physician
may prescribe a maximum of 30 days
or 120 dosage units, whichever is
less, unless an exception applies.
 Multiple Prescriptions now allowed
N.J.A.C. 8:65-7.5
Manner of Issuance of Prescriptions
for Schedule II Substances
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Physicians are permitted to issue multiple prescriptions
authorizing a patient to receive a total of up to a 90-day
supply of a Schedule II controlled dangerous substance
provided:
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Each separate prescription is issued for a legitimate medical
purpose by the physician acting in the usual course of
professional practice;
The physician provides written instructions on each
prescription, other than the first prescription if it is to be filled
immediately, indicating the earliest date on which a pharmacy
may fill each prescription
The physician determines that providing the patient with
multiple prescriptions in this manner does not create an undue
risk of diversion or abuse; and
The physician complies with all other applicable State and
Federal laws, rules and regulations.
Collaborative Practice
Proposed Regulations
 New rules authorizing pharmacists to
engage in collaborative practice with
licensed physicians have been
proposed.
 The proposed regulations are up for
public comment
 Collaborative practice will allow for
greater inter-disciplinary
communication
Preventing Medication Errors:
Use of Best Practices
 Importance of documenting actions
including phone calls to M.D.
 Inventory controls
 Routine checks for expired medication
 Purging the “Will Call Bin”
 Educate employees
 Not limited to those within the pharmacy
department
 Downstream activities (i.e. drivers) should be
included
 Written Policies and Procedures
Negligence
One must look at the following questions:
 Does defendant owe a duty to the plaintiff?
 What standard of care applies?
 Did the defendant breach the duty to
conform to the standard of care required by
law?
 Was the defendant’s conduct a cause in fact
of defendant’s harm?
Negligence
 Was the defendant’s conduct the
proximate cause of the plaintiff’s
harm?
 Did the plaintiff suffer actual damage
compensable in negligence?
 Was the plaintiff’s negligence a
contributing factor?
Elements of a Negligence Case
A.
B.
C.
D.
E.
F.
G.
H.
Duty
Standard of Care
Breach
Cause in Fact
Proximate Cause
Damages
Vicarious Liability
Joint and Several Liability
Duty
 The law normally imposes a duty to
use due care on everyone.
 It is generally accepted that a
pharmacist owes a duty of care to a
patient and their dependents.
 This is based on the pharmacistpatient relationship.
Standard of Care
 After finding a duty, one next must
examine whether the defendant’s
conduct created an unreasonable risk
of harm to others.
 In the pharmaceutical setting that
question would be framed with regard
to a pharmacist.
Standard of Care (Differs
Depending on the Relationship)
1. Reasonable Person Standard
2. Professionals
a) Basic Standard
b) Expert Testimony
c) Special Considerations
Standard of Care
1. Reasonable Person Standard
 In a non-professional setting, the
reasonable person standard is utilized in
this analysis.
 It asks how would a reasonable person
have acted under similar circumstances.
Standard of Care
2. Professionals
 The standard of care utilized in a
professional setting is that which would
be exhibited by a professional under
similar circumstances.
 It is important to note that this standard
does not require at all times the
professional to act correctly.
Standard of Care
2a) Basic StandardProfessional conduct is measured
against the minimum common skill
of members in good standing in the
profession.
Standard of Care
2b) Expert Testimony - Is generally
required in determining how a
professional would have acted under
similar circumstances. In pharmacy
matters a pharmacist would give
testimony.
Standard of Care
2c)
Special Considerations
i) Locality Rule-Professionals will be held to the
standards of their locality. Thus, standards
may differ in a large city and a small town.
ii) Specialists-Held to the national standard.
iii) Civil and Criminal Statutes-If there is a
specific civil liability statute on point, the pharmacist
is subject to that penalty. Usually only a criminal
statute applies, and it is less clear.
Breach
 In performing a negligence analysis,
one must simply determine whether
defendant in fact breached the
applicable standard of care discussed
above.
 To make this determination, one need
look at the facts and determine if a
breach occurred.
Cause in Fact
After the plaintiff has proven the above
elements the next issue is whether
defendant’s conduct was a cause in fact
or factual cause of plaintiff’s harm.
Cause in Fact
1.
2.
3.
4.
“But For Test”
Substantial Factor Test
Action vs. Inaction
Summers vs. Tice
Cause in Fact
1. “But For Test”The but for test requires the injured
party prove that his injury would not
have occurred “but for” the negligent
actions of defendant.
Cause in Fact
2.
Substantial Factor Test Can be more stringent than the “but for”
test.
 Defendant’s negligent conduct must have
been a “substantial factor” in causing the
plaintiff’s injury.
Cause in Fact
3) Action vs. Inaction Defendants can be held
responsible for actions as well as
inactions.
 Action-Dispensing the wrong
medication.
 Inaction-Failure to warn of an
adverse reaction.
Cause in Fact
4) Summers vs. Tice
 Two hunters fired their shotguns in the
plaintiff’s direction.
 A shotgun pellet lodged in the plaintiff’s
eye.
 Since it was impossible for the plaintiff
to prove who shot the gun that caused
his injury the burden was placed on both
defendants and both were held
responsible.
Proximate Cause
 If all the above elements are
established, plaintiff must then
demonstrate proximate cause.
 This is sometimes referred to as legal
cause.
Proximate Cause
Definition:
Proximate cause is concerned with policy
considerations limiting the scope of liability.
For example: is it to society’s benefit to hold
the pharmacist liable for a certain type of
conduct?
Foreseeability:
The proximate cause issue centers on whether
the injury was reasonably foreseeable as
resulting from the conduct in question.
Palsgraph v. Long Island Railroad.
Damages
1.
2.
3.
4.
5.
6.
7.
8.
Mental Pain and Suffering
Physical Pain and Suffering
Medical Expenses
Lost Wages and Future Earnings (PA)
Child Care Costs
Loss of Consortium
Negligent Infliction of Emotional Distress
Punitive
Damages
1. Mental Pain and Suffering
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Mental anguish from an injury.
2. Physical Pain and Suffering
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Actual inflicted pain.
3. Medical Expenses
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Only those expenses not paid by insurance
4. Lost Wages and Future Earnings
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Plaintiff may be eligible for wage
reimbursement for lost work days and disability.
Damages
5. Child Care Costs
 Cost of raising a child or other relevant
damages.
6. Loss of Consortium
 Plaintiff may sue based on his or her
loss of the right of his/her spouse to the
company of, help of, affection of, and
sexual relations with his or her mate.
Damages
7. Negligent Infliction of Emotional Distress
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One has a legal duty to use reasonable care to
avoid causing emotional distress to another
individual.
An example is when a mother witnesses the
injury of her child.
8. Punitive
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A court can award damages in amounts that
exceed the economic losses and general
damages of an injured party. These are
intended solely to punish the defendant because
of reckless or malicious acts.
Vicarious Liability (Respondent Superior)
 An employer is liable for the
negligence of his employees.
 For example, the pharmacist could
be liable for the negligence of a
technician if he had a duty to check
his work.
Joint and Several Liability
Those who act together in committing
a wrong, or whose acts if independent
of each other, unite in causing a
single injury.
Thus, the defendants can be held
fully or partially responsible for the
entire injury.
Application negligence principles to
pharmacy negligence case: Case #1
Riff vs. Morgan Pharmacy,
William T. Stack, MD
Case: Riff vs. Morgan Pharmacy,
William T. Stack, MD.
Parties Involved
 Plaintiff: Patricia Riff & Joseph Riff
 Defendants:
William T. Stack, MD
Morgan Pharmacy
Case: Riff vs. Morgan Pharmacy,
William T. Stack, MD.
Facts
 On January 24, 1979, Patricia Riff was
complaining of a migraine headache
where her family physician, William T.
Stack prescribed her 12 Cafergot
suppositories.
 The instructions on the prescription
were to insert one in the rectum “every
four hours for headache”, with no
refills.
Case: Riff vs. Morgan Pharmacy,
William T. Stack, MD.
Facts
 The prescription was filled at Morgan
Pharmacy where no additional instructions
were given regarding the use and dangers of
the drug.
 On that evening, between Jan. 24th and the
morning of Jan. 25th, Mrs. Riff inserted 3-4
suppositories before obtaining relief.
 Mrs. Riff experienced a second migraine three
months later. She then used the remaining
suppositories from her first migraine attack
until her supply ran out.
Case: Riff vs. Morgan Pharmacy,
William T. Stack, MD.
Facts
 Mr. Riff requested a refill at Morgan Pharmacy which was
given with the same instructions. As a result, Mrs. Riff
used 15-17 suppositories by inserting one every 4 hours.
 On August 27, Mrs. Riff experienced a third migraine
headache. She discovered she only had one suppository
left so her husband requested another refill at Morgan
Pharmacy. Mrs. Riff used 5-6 suppositories.
 Cafergot suppositories come in a box that contains
instructions as to the maximum safe dosage. However,
it is undisputed that the only instructions the pharmacist
gave Mrs Riff was insert one Cafergot suppository every
4 hours for relief.
Case: Riff vs. Morgan Pharmacy,
William T. Stack, MD.
Facts
 On August 31, Mrs. Riff began experiencing
discomfort in her right foot. She went to the
hospital where they performed two
angiograms to rule out the possibility of a
blood clot. It was determined that there was
no blood clot and that the toxic effects of an
overdose of Cafergot was the cause.
 As a result, Mrs. Riff suffered permanent
damage from diminished blood circulation
and nerve damage to her foot.
Case: Riff vs. Morgan Pharmacy,
William T. Stack, MD.
Court Ruling (Trial Court - Jury)
 Found both defendants liable for the
damages caused by Cafergot
suppositories.
 Dr. Stack was found negligent for not informing
Mrs. Riff of the maximum dosage
 Morgan Pharmacy was found negligent for a breach
of duty on the basis that the pharmacist should
have either warned the patient of a maximum dose
(since no dose was given) or informed the physician
of the inadequacy of the directions on the
prescription.
Case: Riff vs. Morgan Pharmacy,
William T. Stack, MD.
Court Ruling (Appellate Court – As to
Pharmacy only)
 Morgan Pharmacy’s argument on appeal:

The function and duty of the pharmacy was only to
supply the medication and not to warn. Also, the
pharmacies conduct was not a substantial factor that
caused the harm to Mrs. Riff
 Appellate Court Ruling

The argument by Morgan Pharmacy is incorrect and
illustrated the disregard for the professional duty owed to
the plaintiffs. Sufficient credible evidence was established
to show that Morgan Pharmacy breached its duty by
failing to warn the patient or notify the physician of the
inadequacies of the prescription.
Case: Riff vs. Morgan Pharmacy, William
T. Stack, MD.
Judgement
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“The appellant would seem to argue that a pharmacy is no
more than a warehouse for drugs and that a pharmacist has no
more responsibility than a shipping clerk who must dutifully
and unquestioningly obey the written orders of omniscient
physicians. Such is not the case.”
“The practice of pharmacology is a regulated profession.
Pharmacists are required to hold a degree in pharmacology
from a school accredited by the American Council of
Pharmaceutical Education, to complete an internship, and to
pass a comprehensive examination administered by the State
Board of Pharmacy…the State Board of Pharmacy is
empowered and invested with the duty to regulate the practice
of pharmacy.”
Case: Riff vs. Morgan Pharmacy,
William T. Stack, MD.
 “In determining the degree of skill required of
a physician or other professional medical
personnel, the law does not demand
extraordinary skill, but, rather, that degree
which ordinarily characterizes the profession.”
 “A pharmacist is a professional. In the
performance of his professional duties he will
be held to a standard of care, skill, intelligence
which ordinarily characterizes the profession.”
Case: Riff vs. Morgan Pharmacy,
William T. Stack, MD.
 “In the instant case the pharmacy had a legal duty to
exercise due care and diligence in the performance of
its professional duties. Sufficient credible evidence
was presented to establish that Morgan Pharmacy
breached that duty by failing to warn the patient or
notify the prescribing physician of the obvious
inadequacies appearing on the face of the prescription
which created a substantial risk of serious harm to the
plaintiff. But for this negligence the error would have
been corrected and the injuries would not have
occurred. Causation was established.”
Application negligence principles to
pharmacy negligence case: Case# 2
Powers vs. Thobani, et al.
Case: Powers vs. Thobani, et al.
Parties Involved
 Plaintiff: Robert Powers representing the
Estate of late wife, Gail Powers
 Defendants: Shirin H. Thobani, M.D., Your
Druggist, Inc., and B.A.L. Pharmacy, Inc.,
D/B/A The Medicine Shoppe
Powers vs. Thobani, et al.
Facts
 The late Mrs. Powers had been receiving
approximately six months of treatment for neck and
back pain.
 Mr. Powers claims that Dr. Thobani prescribed and
the defendant pharmacies repeatedly filled, without
caution, prescriptions for OxyContin, Percocet,
Soma, Xanax, and diazepam repeatedly over six
months, in excessive amounts, and often within
days of filling previous such prescriptions in the
same pharmacy.
Powers vs. Thobani, et al.
Facts
 Filling continued in this manner until Mrs. Powers
collapsed in her home and died the next day at the
hospital without ever regaining consciousness.
 Autopsy revealed the cause of death was a “combined
drug overdose” with all drugs stated prescribed by
Thobani and filled by Your Druggist and The Medicine
Shoppe.
 Mr. Powers’ attorney accused the pharmacies of
negligence for failing to warn Mrs. Powers, her doctor, or
her husband that the amount and combinations of her
medications had the potential to be dangerous.
Powers vs. Thobani, et al.
Court Ruling (Trial Court)
 Trial court in Florida dismissed the lawsuit pointing out
that in Florida “there was no duty to warn by a
pharmacist as a matter of law based upon the facts
alleged in the case.”
 The dismissal was based upon similar rulings in two
cases filed in the Florida Court of appeals as well a
Supreme Court precedent.
Powers vs. Thobani, et al.
Court Ruling (Court of Appeals)
 Mr. Powers argued that the distinct facts in this case
were too narrow in scope to compare with the other
rulings and the primary issue in this case was whether
pharmacists “owed a duty to provide for the health,
safety, and welfare of their customers who had their
prescriptions filled there commensurate with the
prevailing standard of care.”
 The case was appealed to the Fourth District Court of
Appeals whom disagreed with the trial court and ruled
that the “facts, as alleged and if proven at trial, could
give rise to a breach of a pharmacist’s duty to his or
her patients under the law” and quashed the dismissal
and sent the case back to trial.
Powers vs. Thobani, et al.
 The case was then appealed to the
Florida Supreme Court (not common
procedure as the case had not
proceeded to trial on merit).
 The Supreme Court agreed to review
based on perception there was a
conflict of opinion amongst lower
courts in pharmacist failure to warn
cases.
Powers vs. Thobani, et al.
Judgment
 “We hold that the trial court erred in
dismissing the negligence claims against
the pharmacies on a motion to dismiss.
While we cannot say whether Power’s
claims will necessarily survive a summary
judgment motion or prevail at trial, we are
unwilling to hold that under no set of
alleged or discoverable facts could Powers
sustain negligence claims against the
pharmacies’ motions to dismiss under
Florida law.”
Powers vs. Thobani, et al.
Judgment
 Court ruled it was not dealing with a case of
negligence but rather whether a cause of action for
negligence may arise if a pharmacist does not use due
proper care in filling a prescription.
 Florida appellate courts have recently begun to affirm
negligence actions against pharmacists.
 The Court acknowledged contradictions in prior cases
regarding duty to warn.
Powers vs. Thobani, et al.
Judgment
 “I can see no rational basis for distinguishing
between a pharmacy's liability for filling a
prescription incorrectly which causes serious injury
or death and a pharmacy’s liability for filling a
combination of prescriptions which the pharmacy
knows or should know that because of the adverse
interactions of the prescriptions there is a
substantial likelihood that they will cause serious
injury or death.”
Powers vs. Thobani, et al.
Judgment (continued)
 “In the first instance, the pharmacy is negligent in
compounding a prescription and in the second
instance the pharmacy is negligent in filling a
combination of prescriptions, which when taken
together will have the same result as compounding
the prescription improperly, or at a minimum is
negligent in failing to warn its customer of adverse
results of taking the prescriptions in combination with
each other. In each instance the pharmacy fails to
exercise reasonable care.”
Application of principles of negligence to a
pharmacy negligence case: Case# 3
Frye vs. Medicare-Glaser
Corporation et al.
Frye vs. Medicare-Glaser Co. et al.
Parties Involved
 Plaintiff: Corina Frye representing the
Estate of Stephen Frye, Deceased
 Defendants: Medicare-Glaser Corporation,
Dr. John Barrow, M.D., Evelyn
Nightengale, RPh.
Frye vs. Medicare-Glaser Co. et al.
Facts
 On August 28, 1986, Plaintiff’s decedent, Stephen
Frye, had arthroscopic knee surgery performed by Dr.
Barrow, who prescribed the drug Fiorinal postsurgery.
 The prescription was filled later that afternoon by Ms.
Nightengale and she labeled the container using the
label generated by the computer system of MedicareGlaser Co.
 There was no explicit instruction on the prescription
by Dr. Barrow to include a caution against alcohol
while taking the medication.
Frye vs. Medicare-Glaser Co. et al.
Facts
 In addition to the primary label, the program printed
three additional auxiliary labels warnings: “May cause
DROWSINESS”, “Caution: Federal Law prohibits
transfer of this drug to persons other than the patient
to whom it was prescribed”, and a label stating
“something to the effect that alcohol may intensify the
effect of this drug”.
 Ms. Nightengale applied the first two labels but left
out the alcohol warning because she believed people
might be offended to think the she believed they
drank.
Frye vs. Medicare-Glaser Co. et al.
Facts
 On September 3, 1986, Stephen Frye was found
dead in his trailer, and his date of death was
estimated to be the evening of September 1.
 Plaintiff claimed that Stephen Frye died as a result
of consuming Fiorinal and alcohol.
 Plaintiff filed a two count complaint against Dr. John
Barrow, M.D. for medical malpractice, claiming Dr.
Barrow failed to warn Stephen Frye of the
dangerous effects of taking alcohol and Fiorinal.
Count II was filed against Medicare-Glaser Co. and
Evelyn Nightengale for “negligent undertaking”,
claiming defendant undertook a duty to warn and
failed to do so, causing the death of Stephen Frye.
Frye vs. Medicare-Glaser Co. et al.
Court Ruling (Trial Court)
 Trial court in Illinois granted a summary judgment
motion in favor of the defendants, as they believed
the complaint filed failed to show a cause of action.
Court Ruling (Court of Appeals)
 Trial courts decision was reversed and remanded as
the court stated the defendants had no initial duty to
warn but assumed a duty to warn by placing a
warning on the drug. Thus, the defendants, were
liable for providing a complete warning of the dangers
of the drug combination, which they failed to provide
in a negligent course of action.
Frye vs. Medicare-Glaser Co. et al.
Judgment
 The appellate court ruling was reversed by the Illinois
Supreme Court and the trial courts award of summary
judgment was reinstated. Thus, the pharmacy was
dismissed.
 “First, if we were to hold that by choosing to place the
“drowsy eye” label on the Frye’s contained defendants
were assuming duty to warn Frye of all of Fiorinal’s
side effects, we believe that pharmacists would refrain
from placing any warning labels on containers. Thus,
consumers would be deprived of any warnings which
might be beneficial.”
Frye vs. Medicare-Glaser Co. et al.
Judgment
 “Moreover, requiring Nightengale to warn Frye
of all potential side effects of Fiorinal because
she chose to warn him of the drug’s propensity
to cause drowsiness would be difficult from a
practical standpoint.”
 In essence, the Supreme Court isolated the
warnings Nightengale gave and indicated these
were proper, thus, the pharmacist was not
negligent since what he warned on was proper.
Case #4: Dooley vs. Everett
Parties Involved
 Plaintiff: Randy Dooley, Brenda
Dooley on behalf of Brandon Dooley
 Defendants:
Leon E. Everett, MD
Revco Discount Drug Center
Revco D.S.
Dooley vs. Everett
Facts
 Dr Leon Everett, a family physician, began treating
Brandon Dooley (minor plaintiff) when he was three years
old. In June of 1985, he was hospitalized for pneumonia
and given Theophylline. In January of 1986, Dr. Everett
diagnosed Brandon with asthma and again prescribed
Theophylline.
 Theophylline is a prescription medication for asthma that
has a recommended therapeutic range of 10-20
micrograms per milliliter. Serum levels less than then 10
have no therapeutic value while those greater than 20
have potential toxicity. Revco filled the Theophylline
various times between 9/14/1987-12/17/1987. Dr.
Everett had also increased the dose form 150 mg twice a
day to 200 mg three times a day.
Dooley vs. Everett
Facts
 On 12/17/1987, Dr Everett prescribed Erythromycin 400
mg four times a day for 10 days concomitantly with the
Theophylline 200 mg three times a day for Brandon.
 On 12/23/1987, Brandon suffered cerebral seizures as
the result of toxic levels of Theophylline in his blood.
 At the time of the prescription, the package insert for
Erythromycin stated that patients receiving Theophylline
and Erythromycin together may be at risk for elevated
Theophylline levels and toxicity, and that the dose of
Theophylline may be needed to be reduced.
Dooley vs. Everett
Facts
 At the time Revco filled the prescription, they did
not alert the plaintiff about the potential interaction
nor did they contact Dr. Everett.
 Dr. Everett was familiar with potential side effects
resulting from the toxic serum levels of Theophylline
in the blood. He knew these included nausea,
vomiting, and seizures.
 The pharmacist on duty at the time Brandon’s
prescription was delivered did not know that
Erythromycin could interact with Theophylline, and
that this combination posed a risk of serious injury
to Brandon.
Dooley vs. Everett
Ruling
 The trial court held there was no duty to detect the
interaction and thus, granted defendants’ Revco Discount
Drug Centers, Inc. and Revco D.S., Inc.’s motion for
summary judgment and dismissed plaintiffs’ complaint.
 The issue on appeal was whether the facts in the record
there is a genuine issue of material fact regarding
whether a pharmacist has a duty to warn a customer
and/or the customer’s physician of the potential
interaction between two different prescription drugs
written by the same physician on two different days and
which are filled as written by the same pharmacist on
different days.
Dooley vs. Everett
Ruling


“The question is whether the scope of the duty owed by the
pharmacist to the customer includes a duty to warn. The fact
that the pharmacy owes it customer a duty in dispensing
prescription drugs is without question. Revco simply argues
that the duty to warn of potential drug interactions is not a
part of its duty. The plaintiffs have introduced expert proof
against this assertion. Therefore, whether the duty to warn of
potential drug interactions is included within the pharmacist’s
duty to his customer is a disputed issue of fact preventing the
granting of summary judgment.”
“We therefore reverse the judgment of the trial court and
remand for a trial on the merits.”
Case #5: Huggins vs. Longs Drug
Stores California, INC.
Parties Involved
 Plaintiff: Barbie Huggins
 Defendants: Longs Drug Stores
Huggins vs. Longs Drug Stores California, INC.
Facts
 Barbie and Robert Huggins are the parents of a child,
Kodee, who received an overdose of an antibiotic
(Ceclor) at two months of age due to the pharmacy’s
negligence in providing instructions for dosage.
 Kodee’s pediatrician prescribed Ceclor for an ear
infection on 10/09/1989. His mother first gave the
drug between 7 and 8 p.m that evening and
repeated the dose the next morning. When she
returned from work around 4 p.m., Kodee was “out
of it” and thought it was due to medication. Kodee
was unresponsive and appeared to be in a very deep
sleep.
Huggins vs. Longs Drug Stores California, INC.
Facts
 Thereafter, on October 10, Barbie received a call from her
mother who told her that Kodee had received an overdose.
She instructed Barbie not to give the baby any more
medicine. Barbie than called her husband, Robert, letting
him know of the mistake and than took Kodee to the
pediatrician.
 The parents sued defendant pharmacy for damages for
negligent infliction of emotional distress. In the complaint,
the parents alleged that the pharmacy owed them a duty
due to their relationship with the pharmacy. The parent’s
also alleged that they resided with the child, obtained
medical treatment, and cared for him.
Huggins vs. Longs Drug Stores California, INC.
Facts



At her deposition, Barbie answered affirmatively when asked if
her emotional distress started after her own mother had called
her and advised her that there had been an overdose. However,
in opposition to the motion, she submitted a declaration dated
February 21, 1991, in which she stated that she observed her
child’s lethargy prior to knowing its cause, and she suspected that
the medication caused it. His lethargy worried her but “not a lot.”
Robert’s declaration showed that his distress occurred after he
learned that his son was receiving an overdose of Ceclor.
As to administration of the drug, Barbie stated she personally
gave the drug October 9 and 10 but she was not sure who gave it
on the morning of the 10th. She said the pharmacist’s mistake
caused her to make her own son ill which shocked and grieved
her. She still worries about future effects of the over dose.
Huggins vs. Longs Drug Stores California, INC.
Facts
 Although Robert saw his wife administer the drug in a
dose of two and one- half teaspoons, he could not say if
he gave the drug to Kodee himself; he did not recall
ever doing so.
 Ron Spolar, a pharmacist, stated at deposition that the
dosage should have been half a teaspoon or two and
one- half cc’s rather than the two and one- half
teaspoons on the prescription label. He stated that a
pharmacist always has the duty to verify the quantity of
a drug in filling a prescription.
Huggins vs. Longs Drug Stores California, INC.
Ruling





In this matter, the court reversed the summary judgment and indicated
their was a question of fact.
The court believed the law could support a breach of the duty to the
caregiver (mother) to her child whom she dispensed medication too.
The court in suggesting a duty indicated the relationship of parties must
not be overlooked. The question should be was there a special
relationship between the pharmacist who labels a prescription for
administration to an infant and the caregivers who purchase the
prescription and rely on its directions?
The court also believed that to sustain the negligent infliction of
emotional distress claim, the plaintiff must show they are the parents or
close relatives since these people will suffer a greater degree of
distress. Extending the duty to non-related people would extend
liability too far in the chain.
Also, the court ruled that there must be a contemporous observation of
the injury. One cannot only see the result of the injury.