A Prescription for Negligence
Martin R. Dix, JD
Akerman LLP
Disclosures
Martin R. Dix “declare(s) no conflicts of interest,
real or apparent, and no financial interests in
any company, product, or service mentioned in
this program, including grants, employment,
gifts, stock holdings, and honoraria.”
The American College of Apothecaries, Inc. is accredited by the
Accreditation Council for Pharmacy Education as a provider of continuing
pharmacy education.
Learning Objectives
At the conclusion of this program, the participating
pharmacist or technician will be able to:
– Describe relationships between medical malpractice cases
and continuous quality improvement and peer review
processes.
– Identify areas of malpractice risk for pharmacies and
pharmacists.
– List common procedures related to malpractice cases.
– Explain the relationship of pharmacist disciplinary action to a
malpractice case.
Dispensing Errors1,2,3
• In 2011, community pharmacies dispensed almost 4 billion
prescriptions
– Pharmacists have direct responsibility for accurately dispensing
prescription orders - dispensing errors are a critical concern for
the practice of pharmacy
• Published studies regarding medication errors in community
pharmacies are limited:
– overall dispensing error rates range from 0.26% to 24%
– 0.1% to 4% of prescriptions dispensed had the potential to
contain clinically significant errors that could cause patient harm
or discomfort
• Using a conservative estimate of a 1% overall dispensing error rate,
this would translate to over 40 million dispensing errors in the US
each year
Known Factors that May Cause or
Contribute to Medication Errors
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Unavailable drug information
Miscommunication of drug orders
Handwriting
Confusion between drugs with
similar names
Misuse of zeroes and decimal
points
Confusion of metric and other
dosing units
Inappropriate abbreviations
Lack of appropriate labeling
Dose miscalculations
Knowledge Deficiencies
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Environmental factors such as
lighting, heat, noise
Interruptions
Complex or poorly designed
technology
Poor procedures or techniques
Job stress
General failure to act in
accordance with education and
training
Incorrect diagnosis
Patient misuse of medication due
to lack of patient information or
education
Other Common Causes of Pharmacy
Malpractice in a Retail Pharmacy
• Pharmacy technician fills bottle with the wrong drug and
pharmacist fails to correct the error
• Pharmacy technician fills bottle with the wrong dosage and
pharmacist fails to correct the error
• Pharmacy technician types instructions wrong and
pharmacist fails to correct the error
• Pharmacy technician types wrong drug or wrong dose into
the patient profile and pharmacist fails to correct the error
• Cashier places wrong prescription in patient’s bag
Continuous Quality
Improvement (CQI)
• Peer Review Process for review of pharmacy
“Quality Related Events”
• A planned process, to record, measure, assess
and improve the quality of patient care
• 18 states require CQI and another 4 recommend it
• Usually involves of the processes involved in why
the QRE occurred
Quality Related Events
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“Quality-Related Event” means the inappropriate dispensing or administration of a
prescribed medication including:
– A variation from the prescriber’s prescription order, including, but not limited to:
• Incorrect drug; strength or dosage form
• Incorrect patient; or
– Inadequate or incorrect packaging, labeling, or directions.
– Failure to identify and manage:
• Over-utilization or under-utilization
• Therapeutic duplication
• Drug-disease contraindications
• Drug-drug interactions
• Incorrect drug dosage or duration of drug treatment
• Drug-allergy interactions
• Clinical abuse/misuse
CQI and Peer Review
• Most states protect peer review organizations’
documents
• Protected documents include incident and risk
management reports, interviews, summaries, etc.
• Actual prescriptions and prescription records are
not protected
• Florida protects peer review and CQI reports, FL
Constitution allows discovery of certain documents
• Florida allows inspectors to see summaries
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Potential Legal Consequences
Associated with Prescription
Medication
Errors
Civil
– Malpractice/professional negligence action where injured patient sues
the pharmacy/pharmacist for harm caused by a medication error. If
successful, the patient will receive a monetary award.
Administrative
– Action taken by the state board of pharmacy against professional license.
Discipline could result in public reprimand, monetary fine, and/or license
probation, suspension, or revocation.
Criminal
– Involves criminal charges, such as manslaughter or reckless homicide,
against the pharmacist as a result of a medication error that caused
patient death. If convicted, penalties could involve probation or jail
sentence.
Pharmacist Malpractice and Discipline
(Administrative Action)4
• Pharmacists can be disciplined for malpractice
• Example: Florida disciplines pharmacists for :
• (g) Using in the compounding of a prescription, or
furnishing upon prescription, an ingredient or article
different in any manner from the ingredient or
article prescribed….
Pharmacist Malpractice and Discipline
(Administrative Action)
• Committing an error or omission during the performance of a
specific function of prescription drug processing, which
includes:
– Receiving, interpreting, or clarifying a prescription
– Entering prescription data into the pharmacy’s record
– Verifying or validating a prescription
– Performing pharmaceutical calculations
– Performing prospective drug review as defined by the board
Pharmacist Malpractice and Discipline
(Administrative Action)
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Obtaining refill and substitution authorizations
Interpreting or acting on clinical data
Performing therapeutic interventions
Providing drug information concerning a patient’s
prescription
• Providing patient counseling
Pharmacist Malpractice and Discipline
(Administrative Action)5
• Pennsylvania Pharmacy Act
– Section 5. Refusal to Grant, Revocation and Suspension.
• (a) The board shall have the power to refuse, revoke or suspend
the license of any pharmacist upon proof satisfactory to it that the
pharmacist:
– (12) Is guilty of incompetence, gross negligence or other
malpractice, or the departure from, or failure to conform to,
the standards of acceptable and prevailing pharmacy
practice, in which case actual injury need not be established.
Pharmacy Discipline
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Process is state specific
Usually starts with a complaint
Then an investigation by state investigators
Some states have a probable cause process
If no probable cause the case is dismissed
If probable cause there is a complaint
Usually offered a settlement agreement
Pharmacy Discipline
• Settlement Agreements Vs. Hearings
– Settlement Agreements
• “Respondent admits that the allegations, if proven,
would constitute violations of the Pharmacy Practice
Act.”
– Hearings
• Result in a Final Order
• “Respondent has violated Section 465.016, Florida
Statutes.”
Pharmacy Discipline
• Board of Pharmacy Response:
• Punishment
– Ranges from admonishment, to fines, to specific
conditions (i.e., remediation or programs), to suspension
for set time, to revocation
– Protect the public and encourage compliance
• Education
– Help prevent future errors
– Protect the public
Civil Liability
• Traditional “Causes of Action”
– Negligence Per Se
– Negligence
• Act or omission by pharmacy provider in which care
provided deviated from acceptable standards of practice
and caused injury to the patient
• Non-intentional, but it happened!
• Pretty cut and dry; we have a duty; causation is usually at
question!!!
Civil Liability
• 4 elements of professional negligence – Plaintiff must
prove ALL
– 1. Duty owed
– 2. Breach of duty
– 3. Causation
– 4. Damages
Civil Liability (Cont.)
• Typically a dispute between 2 citizens/legal entities
involving $$$$$$$
• Criminal and/or administrative action could also come
from same dispute
• Injured party = Plaintiff (P or )
• Person accused of causing injury = Defendant (D or )
Negligence Per Se
• Negligence Per Se involves a violation of a statute or
regulation especially designed to protect the public safety
– Recovery may be had for Negligence Per Se when:
• The harm resulting from the violation is the type that
the statute is designed to prevent,
• The plaintiff is a member of the class of persons
sought to be protected by the statute, and
• The violation is the proximate cause of the plaintiff's
injury
Reasons for using
Negligence Per Se
• Plaintiff does not have to prove negligence - just
prove violation of the law
• It makes the Defendant look worse
Negligence Per Se – Estate of
Johnson vs. Badger Acq.6
• Case against nursing home pharmacy (Omnicare) for:
– Failing to appropriately monitor the dispensing of medication
– Failing to appropriately monitor the proximity in which the
same medication was dispensed
– Failing to adequately monitor patient’s medication
administration
– Failing to appropriately monitor and address adverse effects
and drug interactions of medications
– Failing to conduct a thorough and adequate monthly drug
regimen review
Johnson v. Badger Acquisition
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Failing to adequately and timely account, and reconcile, the controlled drugs to
have been utilized
Failing to appropriately monitor and address the
undermedication/overmedication
Failing to adequately assess that the dosage of the medication administered
was inappropriate
Failing to timely report irregularities in medication reviews to appropriate
personnel
Failing to adequately develop the appropriate policies and procedures relating
to pharmacy services within the facility
Failing to provide adequate in-service education and training to nursing home
and pharmacy personnel
Failing to properly hire, retain, train, and supervise a licensed consultant
pharmacist to ensure that the residents received appropriate pharmacy
services
Johnson V. Badger Acq.
• Court held:
– Omnicare had no legal duty to the patient
– Omnicare’s role with nursing home was administrative and
ministerial;
– Omnicare was responsible for recordkeeping and procedures
– Pharmacist has 4 duties:
• 1) He will compound the drug prescribed
• 2) He has used due and proper care in filling the prescriptions
• 3) The proper methods were used in the compounding
process • 4) The drug has not been infected with some adulterating
foreign substance
Civil Liability
• Professional Negligence / Malpractice
• Element 1: Duty of Care
– A pharmacist must use the degree of care that a
reasonable and prudent pharmacist would use under
similar circumstances
– “A pharmacist is bound simply to exercise the skill
generally possessed by well-educated pharmacists who
are considered competent in the profession of pharmacy”
– We have a duty to foreseeable people
– Human or honest error is no defense for a pharmacist
Civil Liability
• Element 2: Breach of Duty
– Generally, when a pharmacist fills a prescription in a
manner other than the way it was ordered he or she has
breached a duty of care owed to the patient
– To breach a duty, there must be a standard of professional
practice that exists and that the professional did not adhere
to the standard
– Expert witnesses can help prove if there was or was not a
standard of care to be followed (in instances other than
misfills)
– Can breach a duty by omitting or failing to do something
Civil Liability
• Element 3: Causation
– Even if a pharmacist owes a duty of care and that duty is
breached, the law still requires that the pharmacist’s
conduct CAUSED the alleged damages
– 2 Step Process
• P must show D’s conduct was a substantial factor in the
actual harm that occurred
– Actual cause usually proven by expert witness
• P must prove proximate causation to D
– Each link of chain must be foreseeable to the D (“but
for” test)
Civil Liability
• Element 4: Damages
– P must show Damages
– There is no recovery for negligence (or
malpractice) if no harm was done
• If a mistake is detected and rectified before
any physical harm can occur, there will
probably be no compensable damages
– Compensable damages can be actual or punitive
Civil Liability
• From past judicial opinions, the most common type of prescription
medication error leading to pharmacist liability for malpractice is
the straightforward misfilling of a prescription with a drug other
than what the prescriber intended.
– Previous legal cases have clearly established that pharmacists
have a legal duty to their patients to accurately fill
prescriptions
– Therefore, if there is a dispensing error and the patient, or
plaintiff, bringing the lawsuit proves that the error caused
harm, the patient or plaintiff will likely be successful in the
malpractice action
Civil Liability
• Numerous state courts have addressed cases considering
whether pharmacists can be civilly liable for allegations of
intellectual errors
– Although some state courts have declined to allow civil
liability, others have held that pharmacists can be liable
for such errors
• “Duty to Warn” theory - patients injured by prescription
drugs claim that the pharmacist had a duty to warn about
the potential adverse effects and other dangers associated
with prescription drugs
Civil Liability
• Expanded Responsibilities
– Pharmacists must still process orders accurately but also monitor
and affect drug therapy outcomes
– OBRA 90 (failure to counsel or failure to monitor or identify; including
potential problems such as addiction, excessive refills, side effects,
therapeutic duplication, drug-disease contraindications, allergies
– Duty to Warn cases (many fall under topics just mentioned under
OBRA 90 examples)
– Pharmaceutical Care (patient centered care) Model
• Medication therapy management/Drug therapy management
– Further expansions?
• PMP (prescription drug monitoring) Cases
• Dispensing of CS (controlled substances)
– Compounding
Civil Liability
• Failure to Warn Claims
– The General Rule: No generalized duty to warn of
adverse effects
– Learned Intermediary Doctrine
• Exceptions to the Rule:
– Obvious inadequacy on the face of the prescription
– Special knowledge of the pharmacist
– Voluntary undertaking
– Public expectations
• Limits on Expansion of the General Rule
Learned Intermediary Doctrine
• A majority of the states apply the learned intermediary
doctrine to relieve pharmacists of liability
• That between the doctor and the pharmacist, the doctor is in
the best position to warn the customer of a given
medication's generalized risks.
– Viewed more pragmatically, the doctrine prevents
pharmacists from constantly second-guessing a
prescribing doctor's judgment simply in order to avoid his
or her own liability to the customer
• Ignores patient counseling requirements
Klasch v. Walgreen (NV)7
Duty to Warn
• Patient with sulfa drug allergy was warned about using these drugs
by both the doctor and pharmacist.
– Patient used them anyway, had a severe allergic reaction went
into a coma and died
– Both sides sought summary judgment
• Walgreen defended on Learned Intermediary Doctrine.
• ”[W]e hold that a narrow duty to warn exists where, as in the instant
case, a pharmacy has patient-specific information about drug
allergies, and knows that the drug being prescribed is
contraindicated for the individual patient. In such instances, a
pharmacy has a duty to warn either the prescribing physician or the
patient of the potential danger.”
Kowalski v. Rose Drugs (AR)8
Learned Intermediary Doctrine
• Patient was taking: a mix of medications including: long and
short acting opiates, benzodiazepines, muscle relaxers, and
antidepressants.
• Then, Rose Drugs dispensed: a mix of medications
including: long and short acting opiates, benzodiazepines,
muscle relaxers, and antidepressants.
• Patient mixed with alcohol and died.
• Prescriptions written by Dr. Mann were filled at Rose Drugs.
Kowalski v. Rose Drugs (AR)
Learned Intermediary Doctrine
• Court found:
– Controlled substances act does not create a duty
to warn
– OBRA 90 imposes responsibilities on
pharmacist, but does not create a duty to warn or
a private cause of action against pharmacists
– Arkansas pharmacy laws and regulations do not
create a duty to warn
Kowalski v. Rose Drugs (AR)
Learned Intermediary Doctrine
• Maj. Opinion: ( Leaned Intermediary Doctrine): “the patient must
look to the physician, for it is only the physician who can relate
the propensities of the drug to the physical idiosyncracies of the
patient. “It is the physician who is in the best position to decide
when to use and how and when to inform his patient regarding
risks and benefits pertaining to drug therapy:
– 2 Judge Dissent: “The majority opinion fails to recognize that,
far from being a robot, the pharmacist is a critical link in the
prescription chain who owes a duty of due care to customers.”
– Exception to Learned Intermediary Doctrine where drugs are
contraindicated
BUSTETTER V. ARMOR COR.
HEALTH SERV., INC. 9
• Patient (prisoner) sues doctor, nurse, jail, and pharmacy for
dispensing rosiglitazone (for Type II diabetes) when all
involved allegedly knew he had Type I
• No duty to warn unless there is something wrong on the
face of the prescription
• Case reviews Florida cases:
– McCleod - No duty to warn- duty to take proper care in
dispensing prescription(1965)
– Pysz - No duty to warn of dangers of Quaaludes (1982)
BUSTETTER V. ARMOR
• Court concluded: Facts of this case more like
Badger Acquisition and Estate of Sharpe (both C.
PH’s at nursing homes)-pharmacist never saw
patient- not like Dee, Thobani and Arrington
• No duty to warn of a drug’s ineffectiveness
• No duty to second guess the prescription if not
obviously flawed or does not impose a risk of death
Duty to Not Dispense?
• After warning, Is there a duty to not dispense when
drug is contraindicated?
• Can a pharmacist refuse to dispense when he or
she does not know diagnosis?
• What happens if you refuse to dispense and person
is injured?
Is the Learned Intermediary
Doctrine Eroding?
• OBRA 90 and state patient counseling
requirements
• Pharmacists hold themselves out as the “drug
experts”
• More drugs
• More pharmacies and pharmacists
• More injuries
Civil Cases
• May start with either a claim or file a “Complaint” in court
• If a complaint, the pharmacist and pharmacy have to be
“served”
• Once served, you have a set time to find a lawyer and
“Answer” (usually 20 days)
• Discovery – Interrogatories
– Depositions
– Expert Witnesses
– Subpoenas and Request for Documents (HIPAA)
Civil Cases
• Motions
• Motion for Summary Judgment
• No facts in dispute and on any reading of the facts
there is or there is not liability
Civil Cases
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Possible Scenarios:
Dismissal
Settlement
Mediation
Jury trial
Civil Cases
• Defenses to Negligence
– Contributory Negligence
– Comparative Negligence
• Failure to mitigate
– Assumption of the Risk
– Statute of Limitations
QUESTIONS?
References
1. The Use of Medicines in the United States: Review of 2011. Report by the IMS Institute
for Healthcare Informatics. Available at:
http://www.imshealth.com/ims/Global/Content/Insights/IMS%20Institute%20for%20Healt
hcare%20Informatics/IHII_Medicines_in_U.S_Report_2011.pdf
2. Flynn EA, Barker KN, Carnahan BJ. National observational study of prescription
dispensing accuracy and safety in 50 pharmacies. J Am Pharm Assoc. 2003;43:191200.
3. Kuiper SA, McCreadie SR, et al. Medication error in inpatient pharmacy operations and
technologies for improvement. Am J Health-System Pharm. 2007;64(9):955-959.
4. Section 465.016, Florida Statutes.
5. Pennsylvania Pharmacy Act, Section 5.
6. Estate of Johnson v. Badger Acquisition, 983 So. 2d 1175 (Fla. 2d DCA 2008)
7. Klasch v. Walgreen Co., 264 P.3d 1155-2011.
8. Kowalski v Rose Drugs 2011 Ark. 44, 378 S.W.3d 109 (AR S. Ct. 2011).
9. Bustetter v. Armor Cor. Health Serv., Inc. Case No. 8:12-cv-1236-T-24 TGW (M.D. FL
2013)
Need More Information?
Martin R. Dix, JD
Akerman LLP
106 E. College Ave., Suite 1200
Tallahassee, FL 32301
(850) 224-9634
[email protected]