Study Set Content:
An ethical breach is not necessarily a
legal breach.
An example of an ethical breach that could result in liability for the pharmacist would be a breach of
patient confidentiality, if that disclosure caused damages (e.g., loss of employment or the misuse of information gained in the course of employment).
Example of duty breached (legal duty):
You must show that you had a physician patient relationship with the doctor you are suing this means you hired the doctor and the doctor agreed to be hired. For example, you can't sue a doctor you overheard giving advice at a cocktail party. If a doctor began seeing you and treating you, it is easy to prove a physician patient relationship existed. Questions of whether or not the relationship exists most frequently arise where a consulting physician did not treat you directly.
In a study of DI requests, calls from consumers raised more ethical issues than
calls from health professionals
For example, should a pharmacist respond to a drug identification request for () medication? Is the situation different if the medication is a drug of abuse and the inquiry is from a parent, relative, teacher, or police officer?
someone else’s
provides little guidance for disclosure of DI for questionable purposes and pharmacists must exercise independent professional judgment and assume legal responsibility for that judgment when exercised.
Current law
clinician is negligent; the clinician is the
DIRECT CAUSE of harm
How can you say that the clinician is NEGLIGENT
o if he or she fails to use the level of skill, knowledge, and care that other reasonably careful practitioner would use in the same or similar circumstances
o This level of skill, knowledge, and care is sometimes referred to as “the standard of care” or “duty of
o Examples of malpractices include Failure to diagnose or misdiagnosis, Misreading or ignoring laboratory results, Unnecessary surgery, Surgical errors or wrong site surgery
How about negligence in the pharmacy practice?
o wrong dispensing
o incorrect directions on a label or fails to provide any instructions
o Not reviewing the drug with the patient
TORT LIABILITY TO THE PROVISION OF DRUG INFORMATION
a. Incomplete information
b. Inappropriate quality information
c. Outdated information
d. Inappropriate analysis
e. Dissemination of information
Is the pharmacist liable when the DI provided is incomplete? Should the pharmacist provide all the medication information via a DI sheet or patient package insert (PPI)?
INCOMPLETE INFORMATION
the court addressed the issue of whether the pharmacist’s failure to dispense the FDA mandated PPI for progesterone was the proximate cause of a congenital eye defect that occurred. Because congenital defects, but not eye deformities, were specified in the PPI, failure to provide the PPI could not be proven to be the proximate cause. Therefore, judgment was in favor of the pharmacy.
Parkas v. Saary
the pharmacist counseled the patient regarding drowsiness with Fiorinal ® (aspirin, butalbital, caffeine), but failed to provide a warning not to consume alcohol. The patient died presumably as a result of combining the drug with beer. Here, the DI provided was incomplete. The trial court did not find the pharmacist had a duty to warn in this instance. Although this case was decided before
Frye v. Medicare-Glaser Corporation
with its mandatory patient counseling provisions in effect, its outcome would not seem to have changed as a result.
• Other cases are finding pharmacists have a responsibility for patient counseling and drug therapy monitoring.
Omnibus Budget Reconciliation Act of 1990 (OBRA’90),
the pharmacy promised in its advertising that its computer system would detect drug interactions or warn patients about adverse drug reactions; the pharmacists were held liable when they failed to detect and warn the patient of a potential adverse reaction.
Sanderson v. Eckerd Corporation,
the court imposed a duty on a pharmacist to alert the prescriber when the dose prescribed is outside the therapeutic range.
Horner v. Spalitto
the pharmacy’s computer system was overridden, and the pharmacist failed to warn a patient allergic to aspirin and ibuprofen of the potential for cross allergenicity with ketorolac. The court found the pharmacist has a duty to warn when a contraindicated drug is prescribed
Happel v. Wal Mart Stores
where the plaintiffs alleged that the pharmacist’s failure to properly warn of the known dangers of desipramine was the proximate cause of the patient’s death, the court held that pharmacists have a duty beyond accurately filling a prescription “based on known contraindications, which would alert a reasonably prudent pharmacist to a potential problem.” 27 However, the court did not find for the plaintiff opining that pharmacist do not have knowledge that desipramine may cause hypereosinophilic syndrome.
Morgan v. Wal Mart Stores
the pharmacist dispensed an otic solution without warning of the risk of tympanic membrane rupture and the need to discontinue the drug if certain symptoms appeared. The plaintiff claimed that because of the lack of warning he suffered from severe and permanent injury including brain damage.
Heredia v. Johnson
“false information provided to another could result in harm to the recipient if the recipient acted relying on the false information”
INAPPROPRITATE QUALITY INFORMATION
