Ch. 5 & 6 Flashcards
When do drug manufacturers issue recalls?
when a drug they make has been shown to be harmful to the public or if evidence is found that prescribing the medication will cause harm
What are the classifications of drug recalls and what are they based on?
based on the severity of harm, class I, II and III
Explain the three classes of drug recalls
class I: the product is dangerous or defective and can potentially cause serious injury or death, class II: the product could potentially cause adverse effects or temporary illness or injury, class III: products are unlikely to cause adverse health effects but they violated FDA manufacturing or labeling laws
What are the three types of liabilities?
breach of contract, intentional torts, and nonintentional torts
What is negligence?
the delivery of care that is below the expected standard
What is the most common liability seen in healthcare?
negligence
What is the standard of care?
the level of care that a reasonably healthcare professional would provide in the same or similar circumstances
What is malfeasance?
the performance of a totally wrongful and unlawful act
What is misfeasance?
the performance of a lawful act in an illegal or improper manner
What is nonfeasance?
the failure to act when one should
What are the four elements that need to be established in order to prove negligence?
whether the healthcare professional owed a duty of care to the accuser, the healthcare professional breached the duty of care, the breach of care was a direct cause of the patient’s injury, and if there is a legally recognizable injury to the patient
What is malpractice?
a higher level of negligence that results in injury, damage, loss, or death
What three types of damages can be rewarded to a patient who wins a malpractice case?
nominal, actual, and punitive
What is vicarious liability?
when a healthcare organization is held responsible for a negligent act by one of its employees
What are intentional torts?
they are acts committed willfully and knowingly against another person
What is invasion of privacy?
the dissemination of information about anoterh person’s private personal matters
What is the performance of a totally wrongful and unlawful act?
malfeasance
What do we call negligence performed by a professional?
malpractice
To limit manufacture of this medication, sales are limited to 3.6 grams per person per day and no more than 9 grams per person per month
methamphetamine
The Omnibus Budget Reconciliation Act of 1990 requires pharmacists to counsel Medicaid patients on their medications, providing the following information to patients…
the name and description of the medication; dosage, route, and duration of therapy; any special directions or precautions the patient must follow; common severe side effects or interactions that may occur; self monitoring techniques; proper storage; refill information; what to do if the patient misses a dose
