Veracity, Autonomy, Fidelity/Confidentiality, HIPAA, Avoidance of Killing, Formularies/Drug Distribution Systems
Veracity
legal principle that states that a health professional should be honest and give full disclosure to the patient, abstain from misrepresentation or deceit, and report known lapses of standards of care to the proper agencies
habitual observance of truth in speech or statement; truthfulness
When is it okay to lie?
Hippocratic Oath allows a lie to a patient if it spares the patient agony. Why?
It judges the immoral act of lying against the beneficial consequences of the lie
Lying as whole is immoral, but ‘beneficial consequences’ to lying makes it moral via Hippocratic Oath
When is it okay to lie?
APhA has conflict → Second Principle
Looks at consequences (‘case-by-case’ evaluation)
When is it okay to lie?
APhA has conflict → Third Principle
Ignores consequences, looks to principles; respect patients ability to make their own decision based off information pharmacist gives (‘alternative rules’ analysis)
Situations that challenge veracity
Condition of doubt
Are all patient facts known?
Is drug information fact or opinion?
Lying in order to benefit the patient
Use of placebos
Protect the welfare of others
When complete disclosure is unwanted
Patient doesn’t want to be told
Family doesn’t want patient to be told
Autonomy
The doctrine that the individual human will, is, or ought to be governed only by its own principles and laws
The capacity of a rational individual to make an informed, un-coerced decision
What is the central premise of ‘informed consent’ and ‘shared decision making’?
Autonomy
Age of majority
Age at which one can make informed decisions for themselves
18 years old
14 or 16 years old in some jurisdictions (mainly females)
Internal constraint issues
Conscious vs. Unconscious
When capacity is in question
Emergency - consent is assumed
Non-emergency - who is surrogate?
Competency
Court determination
Court will appoint surrogate (i.e. power of attorney)
External constraints
In a “total” institution (i.e. prisons, boarding schools, military)
Irresistibly attractive offers
Imprisoned - improved conditions, release/early parole
Terminal illness - longer life, cure
Does/can another ethical principle conflict and override the patient’s autonomy?
Beneficence, preserving life (i.e. avoidance of killing)
Fidelity
Faithfulness to a person, cause, or belief, demonstrated by continuing loyalty and support
Strict observance of promises, duties, etc
Adherence to truth; accuracy in reporting detail
In provider-patient relationship, what is the covenant or contract between the two, consisting of mutual promises?
Fidelity
What does promise-keeping demonstrate?
Loyalty
Types of possible promises that may be in conflict when determining when it is okay to break a promise
Promises to patient
Promises to self
Promises to family
Promises to other providers
Promises to profession
Implicit
Not written down / Not spoken
Explicit
Spoken / Written
When might it be okay to break a promise?
Possibly when the promise was given to a colleague/patient who is:
Incompetent
Impaired
Planning violence
Dishonest/Engaged in criminal activity
Dead
In what situations can the promise of confidentiality possibly be broken?
When it benefits the patient
When it benefits others
Terminal infectious diseases
Patient is planning violence on another
When the patient dies
What does HIPAA stand for?
Health Insurance Portability and Accountability Act
Provisions of HIPAA 1996
Protects the privacy of patient information
Provides for the electronic and physical security of patient health information
Requires the “minimum necessary” use and disclosure of private health information
Specifies patients’ rights regarding the approval of access and use of their health information
Updated HIPAA → HITECH Act 2009 Provisions
Notification requirements when a privacy breach occurs
Fine and penalty increases for privacy violations by covered entities and business associates
Patients’ right to request copies of their electronic health care record in electronic format
Holding business associates civilly and criminally liable directly for privacy and security violations
HIPAA training helps one understand…
Who has to follow HIPAA?
When does one have to do so?
How does HIPAA affect you?
Why is HIPAA important?
Where can you get more information regarding HIPAA?
Who has to follow HIPAA?
Any “covered entity” or “business associate”, other than the involved patient, who controls or comes in contact with a patient’s protected health information
What is protected health information (PHI)?
Information related to a patient’s past, present or future physical and/or mental health or condition; includes at least one of the 18 personal identifiers in association with health information
Most common PHI identifiers
Name
Postal Address
Telephone Number
Social Security Number
etc.
Notice of privacy practices
A statement given to each patient describing how the practice will use and disclose health information and outlining the patient’s rights under HIPAA
Acknowledgement
Written documentation that the notice was provided to a patient, and either signed by the patient, their personal representative, or completed by a staff member explaining why the patient did not sign it
Authorization is required for any PHI uses and disclosures other than
Treatment
Payment
Health care operations
Legal mandates
For what reason can you use PHI?
Only to do your job!
How does HIPAA apply to you?
Assure that every patient or representative, at the first contact with the organization, receives the organization’s notice of privacy practices and acknowledges receipt of it
Use and disclose only the minimum PHI necessary for treatment, payment or other allowed health care operations
Patient must provide an authorization before his/her PHI may be used (i.e. Psychotherapy notes, Research)
Responsibility for the security of all PHI - Do not share/give anyone any passwords; Log-off computers when finished and secure any paper records containing PHI; Destroy, shred or put in designated areas all paper that could contain PHI
“Killing”
An act of causing death, especially deliberately
Cause to die; put to death, usually intentionally or knowingly
To deprive of live
“Avoidance”
The act of keeping away from or preventing from happening
Is killing always immoral?
Some believe killing of any kind is never morally justified —
Nonviolence is supreme
Can a killing ever be justified?
Self-defense (defense of life)
Police actions (defense of others’ lives)
War (defense of country)
Protection of property
State executions
Euthanasia (mercy killing) - assisted vs suicide
What used to happen if you attempted suicide?
Imprisonment, because you attempted to destroy “government property” (your body)
Distinctions in killing
Motive
merciful or not
Distinctions in killing
Actor in killing
Self (suicide), Other (homicide)
Distinctions in killing
Consent to killing
Voluntary (one’s free will)
Involuntary (against victim’s wishes)
Non-voluntary (without approval or disapproval)
Distinctions in killing
Types of euthanasia
Homicide on request (provider kills on patient’s request)
Assisted suicide (supply information/materials)
Consequentialists
Beneficence and nonmaleficence (do good and avoid harm)
Rigorists (Nonconsequentialists)
Pure application of a principle (e.g., justice, autonomy, veracity, fidelity)
Rule-utilitarians (Rule-consequentialists)
Application of the ethical principle that produces the best consequences
Formulary
A listing of drugs intended to include a large enough range of meds and sufficient info about them to enable health practitioners to prescribe treatment
A list of preferred pharmaceuticals to be used by a managed care plan’s network physicians, chosen based on drugs’ efficacy, safety, and cost-effectiveness
What ethical principles might apply?
Ethical principles possibly applicable to formulary decisions:
Justice - Distribution of scarce “insurance” resources, as well as drug resources
Beneficence and nonmaleficence - Do what’s best and avoid harm
Veracity - Always provide the best for the patient
Fidelity - Promise to give the best to the patient
Autonomy - Allow the patient to decide
Avoid killing - Abortifacients, Euthanasia
Problems with Formulary Systems
Increasing complexity of drugs challenges abilities of P&T Committees. How or why?
Many stakeholders are questioning the validity of the use of formulary systems. Why?
Which is more important: drug cost or drug benefits?
Beneficiaries of insurance plans want what was prescribed - not what the insurance plan (i.e. PBMs) wants them to have.
Who is making the health care decisions: Insurance companies (PBMs) or health care personnel?