Chapter 2 Drug Development and Ethical Considerations
"The process of drug discovery and manufacturing takes 10 to 12 years with a cost of more than $1 billion for each drug. Out of every 5,000 to 10,000 compounds that begin preclinical testing, only one makes it through the FDA approval process"
Core ethical principles
Respect for persons O treated as independent personas capable of making decisions in their own interests. Beneficence O is the duty to protect research subjects from harm. It involves ensuring the risks and possible benefits from participating in a research study are clearly defined, and ensuring the benefits are greater than the risks. Justice the selection of research subjects to be fair. Research must be conducted so that the
distribution of benefits and burdens is equitable
Phases of Pharmaceutic Research
Preclinical trials Human clinical experimentation 0 Phasel Phase II Phase III o Phase IV Clinical research study design Independent variable Dependent variable
American Nurses Association
Code of Ethics O "Was developed as a guide for carrying out nursing responsibilities in a manner consistent with quality in nursing care and the ethical obligations of the profession." Adopted in 1950 Revised in 2015 The Nurse's role in clinical research O Responsible for patient safety O Responsible for integrity of research protocol
Nursing Process: Clinical Research
Concept 0 Safety Assessment Up to 9 Identify patients who are eligible to participate in Phase II clinical research. Patient problems o Need for health teaching Planning Up to6 Plan participant care to ensure integrity and compliance with study protocol. Nursing Interventions Support the process of informed consent in a culturally competent manner. After reviewing the study protocol, administer study agent(s). Accurately and safely collect biospecimens.
10-15 years approz. $2.6 B
administration. Ensure safe care. Evaluation
Selected Drug Standards and Legislation
Selected drug standards and legislation Drug standards - United States Pharmacopeia and the National Formulary The International Pharmacopeia Federal legislation . 1912 . The Sherley Amendment 1938 . The Federal Food, Drug, and Cosmetic Act 1970 The Comprehensive Drug Abuse Prevention and Control Act 199ft Dietary Supplement Health and Education Act 1996 Health Insurance Portability and Accountability Act
2010 Patient Protection and Affordable Care Act 2012 Food and Drug Administration Safety and Innovation Act
Drug Development and Ethical Considerations
Nurse Practice Acts Canadian Drug Regulation o Health Products and Food Branch Review drugs for safety, efficacy, and quality prior to drug approval. 0 1996 . Controlled Drugs and Substances Act 2012 Safe Streets and Communities Act
Combat Drug Counterfeiting
Counterfeit drugs May contain incorrect ingredients May have insufficient amounts of active ingredients . May have no active ingredients May contain impurities and contaminants May be distributed in fake packaging
Role of nurse
Consumer education Drug Names Chemical names Generic names Brand/trade names Over-the-Counter Drugs OTC drugs Found to be safe and appropriate for use without direct supervision of health care provider o Available without a prescription
In 2002, FDA standardized