NCM 106 Pharmacology: Drug Development Ethics
32 Questions
0 Views

Choose a study mode

Play Quiz
Study Flashcards
Spaced Repetition
Chat to lesson

Podcast

Play an AI-generated podcast conversation about this lesson

Questions and Answers

What are the three core ethical principles relevant to research involving human subjects?

Respect for persons, beneficence, and justice.

What does informed consent entail?

A mutual sharing of information, a process of communication, expressing respect for the person, and gaining the patient’s active involvement in their care.

Which phase of clinical experimentation tests a new drug for safety in a small group?

  • Phase I (correct)
  • Phase III
  • Phase IV
  • Phase II

    • Justice in research requires that the selection of research subjects be fair.

    <p>True</p> Signup and view all the answers

    What is the role of nurses in clinical research?

    <p>Nurses are responsible for the safety of the patient and the integrity of the research protocol.</p> Signup and view all the answers

    What does the acronym SAFER stand for regarding over-the-counter medications?

    <p>Speak up, Ask questions, Find the facts, Evaluate your choices, Read labels.</p> Signup and view all the answers

    Which of the following is NOT a responsibility of nurses regarding over-the-counter drugs?

    <p>Encourage higher dosages than recommended.</p> Signup and view all the answers

    How does the FDA ensure the safety and efficacy of over-the-counter drugs?

    <p>By requiring labels that list active ingredients, purposes, uses, warnings, dosage instructions, and inactive ingredients.</p> Signup and view all the answers

    What is the primary goal of Phase I in clinical trials?

    <p>To evaluate safety and determine a safe dosage range</p> Signup and view all the answers

    The American Nurses Association Code of Ethics serves to promote quality in nursing care.

    <p>True</p> Signup and view all the answers

    In which phase of clinical trials do researchers primarily assess the drug's effectiveness in a larger group?

    <p>Phase II</p> Signup and view all the answers

    The authoritative source of drug standards in the United States is the ______.

    <p>United States Pharmacopeia</p> Signup and view all the answers

    Match the phases of clinical trials with their primary objectives:

    <p>Phase I = Evaluate safety and dosage Phase II = Assess effectiveness in a larger group Phase III = Confirm effectiveness and monitor side effects Phase IV = Gather information on long-term effects</p> Signup and view all the answers

    Which of the following is NOT typically assessed during Phase III of clinical trials?

    <p>Gathering initial safety data</p> Signup and view all the answers

    Nurses play a minimal role in clinical research.

    <p>False</p> Signup and view all the answers

    What is the purpose of Phase IV clinical trials?

    <p>To gather information on long-term effects and side effects after the drug is marketed.</p> Signup and view all the answers

    What is a brand (trade) name for a drug?

    <p>A proprietary name chosen by the drug company</p> Signup and view all the answers

    The acronym SAFER stands for Speak, Ask, Find, Evaluate, Read.

    <p>True</p> Signup and view all the answers

    Name one example of an over-the-counter drug.

    <p>Pseudoephedrine or Emergency contraception</p> Signup and view all the answers

    OTC drugs must have labels that include the product's active ingredients, purpose, _____, warnings, dosage instructions, and inactive ingredients.

    <p>uses</p> Signup and view all the answers

    Which of the following is a recommended consideration for patients when using OTC drugs?

    <p>Consult a healthcare professional if symptoms persist</p> Signup and view all the answers

    Match the term with its definition:

    <p>Generic Name = The universally accepted name for a drug Brand Name = A proprietary name chosen by a company OTC Drug = Medication available without a prescription Inactive Ingredients = Substances in a drug that do not have medicinal properties</p> Signup and view all the answers

    Side effects from OTC drugs are common and should always be expected.

    <p>False</p> Signup and view all the answers

    What is the purpose of the SAFER acronym in relation to OTC drugs?

    <p>To help consumers make informed decisions before taking medication.</p> Signup and view all the answers

    What is a primary concern associated with counterfeit drugs?

    <p>They may contain insufficient amounts of active ingredients.</p> Signup and view all the answers

    Informed consent requires that participants be aware of the benefits of the research.

    <p>True</p> Signup and view all the answers

    What is the purpose of disclosing alternative procedures to subjects in research?

    <p>To allow subjects to know their options that may be advantageous.</p> Signup and view all the answers

    A _____ name describes a drug's chemical structure.

    <p>chemical</p> Signup and view all the answers

    Match the following terms with their descriptions:

    <p>Informed Consent = Agreement to participate after understanding risks and benefits Counterfeit Drugs = Medications with incorrect or insufficient ingredients Voluntary Participation = Right of subjects to refuse or withdraw without penalty Confidentiality = Protection of personal data of research subjects</p> Signup and view all the answers

    Which of the following is a reason for maintaining confidentiality in research?

    <p>To protect personal data from unauthorized access.</p> Signup and view all the answers

    Participants in research can be penalized for refusing to participate.

    <p>False</p> Signup and view all the answers

    What information should be provided if research involves more than minimal risk?

    <p>Details on compensation, medical treatments, and information sources.</p> Signup and view all the answers

    Study Notes

    Ethical Principles in Research

    • Three core ethical principles: respect for persons, beneficence, and justice.
    • Originated from the Belmont Report and outlined in the WMA Declaration of Helsinki.
    • Respect for persons entails treating patients as independent decision-makers and protecting those with diminished capacity.
    • Informed consent is a mutual information sharing process, emphasizing patient autonomy.
    • Healthcare providers explain studies, while nurses advocate for patients and ensure understanding of study protocols.
    • Essential for promoting participant safety and maintaining study integrity.

    Beneficence

    • Defined as the duty to protect research subjects from harm.
    • Mandates that benefits of a study must outweigh risks, ensuring clarity in risk-benefit discussions.

    Risk-Benefit Ratio

    • Requires comprehensive analysis of potential consequences of clinical studies against inherent risks and expected benefits.

    Justice

    • Ensures fair and equitable selection of research subjects to prevent exploitation.

    Phases of Clinical Research

    • Good Clinical Practice (GCP) guidelines govern clinical trials involving human subjects.
    • Preclinical trials assess drug properties such as genotoxicity and pharmacokinetics.

    Human Clinical Experimentation

    • Historically biased towards Caucasian males; raises questions about generalizability for women and other ethnicities.
    • Four phases of human trials:
      • Phase I: Safety evaluation, dosage range, and identification of side effects.
      • Phase II: Effectiveness testing on a larger group while continuing safety assessments.
      • Phase III: Confirmation of effectiveness and comparison with standard treatments in extensive populations.
      • Phase IV: Post-marketing studies to monitor drug effects in diverse groups and long-term side effects.

    American Nurses Association Code of Ethics

    • Serves as a guide for nursing responsibilities, promoting ethical nursing practice and quality care delivery.

    Role of Nurses in Clinical Research

    • Nurses serve as frontline facilitators in clinical research, ensuring patient safety and adhering to research protocols.
    • Responsible for conducting patient education, informed consent, and vigilance during study participation.

    Drug Standards and Legislation

    • The United States Pharmacopeia (USP) establishes drug standards for safety, efficacy, and quality control.
    • Drugs that meet these standards display the “USP” designation.

    Drug Names

    • Chemical Name: Details the drug's chemical structure.
    • Generic Name: Universal, non-proprietary name not owned by any company.
    • Brand Name: Proprietary name chosen by the drug company, often trademarked.

    Over-the-Counter (OTC) Drugs

    • Considered safe for use without direct medical supervision.
    • FDA labeling requirements emphasize active ingredients, uses, warnings, dosage instructions, and inactive ingredients.

    Nursing Considerations for OTC Drugs

    • Patients should read labels, adhere to dosing instructions, and consult professionals if symptoms persist.
    • Awareness of potential side effects and interactions with other medications or health conditions is crucial.
    • Key elements include research purpose, duration of participation, procedures, risks, benefits, alternatives, confidentiality assurances, and voluntary nature of participation.

    Initiatives Against Drug Counterfeiting

    • Counterfeit drugs pose significant health risks, with estimates indicating over 10% of available drugs may be fake, containing incorrect or harmful ingredients.

    Special Considerations for Pediatric OTC Use

    • Parents must strictly follow dosage instructions based on age, avoid expired medications, and refrain from giving alcohol-containing drugs to children.

    Four Phases of Clinical Trials

    • Phase I: Initial testing of a new drug or treatment on a small group to assess safety, determine dosage, and identify side effects.
    • Phase II: Involves a larger participant group to evaluate effectiveness and further assess safety.
    • Phase III: Conducted on large groups to confirm effectiveness, monitor side effects, and compare with standard treatments.
    • Phase IV: Post-marketing studies to gather data on the drug's long-term effects and side effects across diverse populations.

    American Nurses Association Code of Ethics

    • Established as a guiding framework for nursing responsibilities, ensuring quality care and ethical practices within the profession.

    Nurse’s Role in Clinical Research

    • Nurses are crucial in clinical research settings, ensuring participant safety and adherence to research protocols.
    • They often encounter patients who may consider or are participating in clinical trials, emphasizing the importance of informed consent.

    Drug Standards and Drug Legislation

    • United States Pharmacopeia (USP): The official source for drug standards in the U.S., covering dosages, forms, drug substances, and compounded preparations.
    • Generic Name: The universally accepted name of a drug, not owned by any company.
    • Brand (Trade) Name: A proprietary name chosen by the drug company, often a registered trademark.

    Over-The-Counter Drugs (OTC)

    • OTC drugs are considered safe for use without healthcare provider supervision.
    • Common OTC examples include pseudoephedrine and emergency contraception.
    • Mandatory label information includes active ingredients, purpose, uses, warnings, dosage instructions, and inactive ingredients.

    FDA Recommendations (SAFER)

    • S: Speak up
    • A: Ask questions
    • F: Find the facts
    • E: Evaluate your choices
    • R: Read labels
    • Advise patients to read labels thoroughly and avoid exceeding recommended dosages.
    • Encourage consultation with healthcare professionals if symptoms persist.
    • Acknowledge variability in individual responses to medications.
    • Ensure patients are informed on potential side effects and risks associated with any drugs being taken.

    Clinical Research Participant Considerations

    • Provide detailed information on potential risks, benefits, and confidentiality regarding participation in research studies.
    • Explain voluntary nature of participation, non-penalizing refusal, and the right to withdraw at any time without penalty.

    Drug Counterfeiting Initiatives

    • Counterfeit drugs pose a global threat, with estimates indicating that over 10% of drugs may be counterfeit.
    • Risks of counterfeit drugs include incorrect or insufficient active ingredients, impurities, and misleading packaging.

    Drug Naming Conventions

    • Chemical Name: Specifies the drug’s chemical structure, providing insight into its makeup.

    Studying That Suits You

    Use AI to generate personalized quizzes and flashcards to suit your learning preferences.

    Quiz Team

    Related Documents

    NCM 106 Pharmacology In Nursing Module 1 PDF

    Description

    This quiz focuses on Module 1 of NCM 106 Pharmacology in Nursing, covering drug development and ethical considerations. Participants will explore the three core ethical principles that guide nursing practice in pharmacology. Test your knowledge and understanding of these essential topics.

    More Like This

    Use Quizgecko on...
    Browser
    Open
    Browser
    Browser