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What are the three sources of ethical guidance when answering drug information requests?
- •Professional ethics: standards governing
- a profession (e.g. Pharmacist Code of Ethics)
- •Laws: standards governing society
- and the profession
•Ethical analysis: decision-making process
Ethical analysis encompasses three decision process guidance's, what are they?
- –Rules: restricted scope (e.g. respect for
- patient-provider relationship)
- –Principles: broad, all encompassing scope (e.g. respect
- for autonomy)
- theory: the integration of rules and principles
What are the five ethical analysis steps?
•Procure background information
–Confirmation of involved parties
- •Analyze background information in regard
- to ethical rules and principles, and develop ethical theories
•Prioritize ethical theories
- •Balance ethical theories with patient
- care outcomes
•Implement decision and monitor
Institutions have there own ethical analysis for support. What are examples of this?
- •Most practice institutions have policies
- and procedures to assist with ethical analysis
–Availability of guidance counselors
–Contractual agreements that delineate requestor and respondent responsibilities and describe legal and ethical rights
What are the three primary ethical principles associated with research initiatives?
- –Respect: individual right to make an un-coerced, informed decision regarding
–Beneficence: do no harm, promote good
–Justice: ensure adequate health care to all involved, and that benefits exceed risks
- •Research oversight via an Institutional
- Review Board
What is the famous historical unethical practice case that caused the development of the Nuremberg Code?
The Nazi Doctors in World War 2 experimenting on Jews and political prisoners
What is the Nuremberg Code?
- •Standards for human experimentation
- (voluntary consent for participation, subjects informed of procedures and risk,
What experiment tricked people into shocking people by using an authority figure to persuade them?
What case was conducted between 1932 to 1972 involving syphilis?
•Tuskegee Syphilis Study
- –1932 to 1972 – clinical study by the US Public Health Service that followed the
- progression of syphilis in 400 African American sharecroppers
- –Subjects were not informed they had syphilis and were not provided with treatment when
- penicillin became available in 1947
- –Resulted in deaths of subjects, infection of wives, and children born with congenital
These two boards were established due to the unethical practices occurring. What are they?
- •OHRP (Office for Human Research
- Protections) and IRB Boards were established to protect humans subjects in
What is the Institutional Review Board (IRB)?
- •Multidisciplinary committee that includes
- at least one lay person and another individual who is not affiliated with the
- institution (e.g. lawyer, clergy)
- •Oversight for review, implementation, and
- monitoring of research protocols within an institution
- •Primary responsibility is to protect the
- rights of participants and ensure confidentiality
What are the IRB responsibilities?
–Inclusion / exclusion criteria
–Adherence with protocol
What are the research related scientific misconduct?
–Falsification of data
–Conflict of interest – investigator
What are some examples of Publication related scientific misconduct?
- –Publication contains erroneous
- (false/fake) information
- –Publication contains selected information
- – incomplete disclosure
- –Duplicate publications – same report
- published in multiple journals
- –Conflict of interest – article reviewer
- or editorial staff
What are three ways to overcome scientific misconduct?
•Institutional review board (IRB)
•Positive qualities of journals
- for document submission to a peer-reviewed journal
Whats the definition of a risk in a pharmacy?
Risk in a pharmacy is the possibility of a loss, injury, disease, or death from the prescription.
What do pharmacists do to make sure the prescription given to the patient does not present a risk?
Pharmacists use a risk assessment. They asses the medication before prescribing. They also do risk management. They keep tabs on the patient after the medication has been prescribed
Whats Inherent risk and Non-inherent risk?
- –Inherent risk: drug-specific effects, not
- one a pharmacist could necessarily anticipate nor expect
- –Non-inherent risk: drug-specific effects that a pharmacist could
- anticipate or expect, whether common knowledge or identifiable through
- literature review
What is considered negligence in the pharmacy? What is information negligence?
- •Negligence*: failure to exercise care
- that would be expected of a pharmacist, resulting in an unintended injury
- •Information negligence
–Failure to confirm resources
- –Utilize appropriate resources but information provided is incorrect (e.g. inappropriate
What is liability? What is Reasonable care and Malpractice?
- state of being liable or obligated by law
- –Reasonable care: performance is status
- quo with professional standards
- –Malpractice: failure to perform according
- to professional standards
- –Dispensing a medication for an non-FDA
- approved use
- –Provision of drug information that is
What is Vicarious Liability?
- •Vicarious liability: pharmacist liability extends to subordinates, whether student intern
- or technician (i.e. those instructed or supervised)
What is Joint Liability?
•Joint liability: inter-dependent relationships such as those encountered with interprofessional care
What is Strict Liability?
- •Strict liability: product defect, therefore no fault (e.g. text book publisher may not
- be held accountable for outdated information printed in a book)
What is a Respondent Superior?
- •Respondent superior: employer is
- responsible for employee
What are some of the multiple ways you can reduce legal implications?
- •Disclaimers that are truthful and
- •Accurate and extensive documentation of
- •Development, implementation and
- evaluation of quality assurance standards
- •Maintain current records
- •Maintain professional competency through
- life long learning
- •Purchase individual professional
- liability insurance
–Separate from that provided by employer
- –Review, compare and contrast employer and personal policy (specifically limitations and
- exclusion clauses)
What are some cases of ethical legal case scenarios?
•Cases affecting the profession
- –Kentucky pharmacist who diluted chemotherapy agents, leading to the unnecessary death of
- several patients
- –Texas pharmacist who refused to fill a prescription for birth control because of
- religious/cultural beliefs
–Oregon of legalization of physician-assisted suicide
–Rationing of drugs secondary to shortages