DI Lecture 2 Quiz 1

• •Professional ethics: standards governing
• a profession (e.g. Pharmacist Code of Ethics)

• •Laws: standards governing society
• and the profession

•Ethical analysis: decision-making process

• –Rules: restricted scope (e.g. respect for
• patient-provider relationship)

• –Principles:  broad, all encompassing scope (e.g. respect
• for autonomy)

• –Ethical
• theory: the integration of rules and principles

•Procure background information

–Pertinent data

–Confirmation of involved parties

–Cultural perspective

• •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

• •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

• –Respect: individual right to make an un-coerced, informed decision regarding
• participation

–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

The Nazi Doctors in World War 2 experimenting on Jews and political prisoners

• •Standards for human experimentation
• (voluntary consent for participation, subjects informed of procedures and risk,
• beneficence)

•Milgram experiment

•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
• syphilis

• •OHRP (Office for Human Research
• Protections) and IRB Boards were established to protect humans subjects in
• studies

• •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

•Protocol review

–Study methodology

–Inclusion / exclusion criteria

–Recruitment methods

–Consent form

•Document development

•Content review

–Compensation

•Longitudinal monitoring

–Adherence with protocol

–Patient outcomes

•Research-related

–Protocol deviations

–Falsification of data

–Conflict of interest – investigator

•Publication-related

• –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

•Institutional review board (IRB)

•Positive qualities of journals

• Standards
• for document submission to a peer-reviewed journal

Risk in a pharmacy is the possibility of a loss, injury, disease, or death from the prescription.

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

• –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

• •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
• interpretation)

• •Liability*:
• 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

•Examples

• –Dispensing a medication for an non-FDA
• approved use

• –Provision of drug information that is
• incorrect

• •Vicarious liability: pharmacist liability extends to subordinates, whether student intern
• or technician (i.e. those instructed or supervised)

•Joint liability: inter-dependent relationships such as those encountered with interprofessional care

• •Strict liability: product defect, therefore no fault (e.g. text book publisher may not
• be held accountable for outdated information printed in a book)

• •Respondent superior: employer is
• responsible for employee

•Contractual agreements

• •Disclaimers that are truthful and
• realistic

• •Accurate and extensive documentation of
• activities

• •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)

•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

–Pill mills