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Definition
| Any systematic error in a measurement process. One common effort to avoid bias in research studies involves the use of blinded study designs. |
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Definition
| A type of warning that appears in a drug's prescribing information, required by the U.S. Food and Drug Administration alerting prescribers of serious adverse events that have occurred with the given drug. |
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Term
Blinded investigational drug study |
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Definition
| A research design in which the subjects are puposely unaware of whether the substance they are administered is the drug under study or a placebo. This method serves to eliminate bias on the part of research subjects in reporting their body's responses to investigational drugs. |
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Definition
| Any drugs listed on one of the "schedules" of the Controlled Substance Act (also called scheduled drugs). |
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Double-blind investigational drug study |
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Definition
| A research design in which both the investigator(s) and the subjects are purposely unaware of whether the substance administered to a given subject is the drug inder study or a placebo. This method eliminates bias on the part of both the investigator and the subject. |
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Definition
| Variation in response to a drug because of a patient's age, gender, size, and/or body composition. |
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Definition
| Acceleration of the usual investigational new drug approval process by the U.S. Food and Drug Administration (FDA) and pharmaceutical companies, usually for drugs used to treat life-threatening diseases. |
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Health Insurance Portability and Accountability Act (HIPPA) |
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Definition
| An act that protects health insurance coverage for workers and their families when they change jobs. It also protects patient information. If confidentiality of a patient is breached, severe fines may be imposed. |
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Term
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Definition
| Written permission obtained from a patient consenting to the performance of a specific procedure (e.g., receiving an investigational drug), after the patient has been given information regarding the procedure deemed necessary for the patient to make a sound or "informed" decision. |
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Term
Investigational new drug (IND) |
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Definition
| A drug not approved for marketing by the FDA but available for use in experiments to determine its safety and efficacy; also, the actual name of the category of application that the drug manufacturer submits to the FDA to obtain permission for human (clinical) studies following successful completion of animal (preclinical) studies. |
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Investigational new drug application |
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Definition
| The type of application that a drug manufacturer submits to the FDA following successful completion of required human research studies. |
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Definition
| Another name for prescription drugs. |
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Definition
| A legal term established under the Harrison antinarcotic Act of 1914. It originally applied to drugs that produced insensibility or stupor, especially the opiods (e.g., morphine, heroin). The term is currently used in clinical settings to refer to any medically administered controlled substance and in legal settings to refer to any illicit or "street" drug. |
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Definition
| A special category of drugs that have been identified to help treat patients with rare diseases. |
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Definition
| Drugs available to consumers without a prescription. Also called nonprescription drugs. |
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Definition
| An inactive (inert) substance (e.g., saline, distilled water, starch, sugar), that is not a drug but is formulated to resemble a drug for research purposes. |
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Definition
| Provides an expanding body of knowledge for understanding the specific impact of cultural factors on patient drug response. |
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Definition
| An integrated system of beliefs, values, and customs that are associated with a particular group of people and are generally handed down from generation to generation. |
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Term
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Definition
| The ability to work with patients with proper consideration for the cultural context, which includes patients' belief systems and values regarding health, wellness, and illness. It also involves learning about different patients and their specific responses to treatment, including drug therapies. |
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Definition
| Ethnic affiliation based on shared culture or genetic heritage or both. |
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Term
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Definition
| The study of the effect of ethnicity on drug responses, specifically drug absorption, metabolism, distribution, and excretion (i.e., pharmacokinetics) as well as the study of genetic variations to drugs (i.e., pharmacogenetics) |
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Definition
| Often defined as a class of individuals with a common lineage in genetics, a race is considered to be a population having a somewhat different genetic composition or gene frequencies. Race is also used to refer geographical origins of ancestry. |
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Term
Phase I of investigational drug studies |
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Definition
- Usually involve small numbers of healthy subjects rather than those who have the disease or ailment that the new drug is intended to treat.
- The purpose is to determine the optimal dosage range and the pharmacokinetics of the drug (i.e., absorption, distribution, metabolism, and excretion) and to ascertain if further testing is needed. Blood tests, urinalyses, assessments of vital signs, and specific monitoring tests are also performed.
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Term
Phase II of investigational drug studies |
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Definition
- Involve small numbers of volunteers who have the disease or ailment that the drug is designed to diagnose or treat. Study participants are closely monitored to determine the drug's effectiveness and identify any adverse effects.
- Therapeutic dosage ranges are refined.
- If no serious adverse effects occur, the study can progress to phase III.
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Term
Phase III of investigational drug studies |
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Definition
- Involve large numbers of patients who are followed by medical research centers and ther types of health care facilities.
- Patients may be treated at the center itself or may be spread over a wider geographic area and be followed at a local inpatient or outpatient facility.
- The purpose of this larger sample size is to provide information about infrequent or rare adverse effects that may not yet have been observed during previous smaller studies.
- Information obtained helps identify any risks associated with the new drug.
- The three objectives of phase III studies are to establish the drug's clinical effectiveness, safety, and dosage range. After phase III is completed, the FDA receives a report from the manufacturer, at which the drug company submits a new drug application (NDA)
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Term
Phase IV of investigational drug studies |
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Definition
| Are postmarketing studies voluntarily conducted by pharmaceutical companies to obtain further proof of the therapeutic and adverse effects of the new drug. Data from such studies are usually gathered for at least 2 years after the drug's release. |
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Term
Three designated classes of drug recall based on FDA response to postmarketing data for a given drug |
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Definition
- Class I- The most serious type of recall -- use of the drug product carries a reasonable probability of serious adverse health effects of death.
- Class II- Less severe -- use of the drug product may result in temporary or medically reversible health effects, but the probability of lasting major adverse health effects is low.
- Class III- Least severe -- use of the drug product is not likely to result in any significant health problems.
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Term
Common practices of selected cultural groups |
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Definition
- African- Practice folk medicine; employ "root workers" as healers.
- Asian- Believe in traditional medicine; use physicians and herbalists in their health care.
- Hispanic- View health as a result of good luck and living right, and illness as a result of doing a bad deed; use heat and cold as remedies
- European- Hold traditional health beliefs; some still practice folk medicine
- Native American- Believe in harmony with nature; view ill spirits as causing disease.
- Western- Show increased participation in health care; demand more explanation about diseases and treatment, as well as the prevention of diseases.
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Term
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Definition
| Self-determination and the ability to act on one's own; related nursig actions include promoting a patient's decision making, supporting informed consent, and assissting in decisions or making a decision when a patient is posing harm to himself or herself. |
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Definition
| The ethical principle of doing or actively promoting good; related nursing actions include determining how the patient is best served. |
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Definition
| The duty to respect privileged information about a patient; related nursing actions include not talking about a patient in public or outside the context of the health care setting. |
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Definition
| The ethical principle of being fair or equal in one's actions; related nursing actions include ensuring fairness in distributing resources for the care of patients and determining when to treat. |
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Definition
| The duty to do no harm to a patient; related nursing actions include avoiding doing any deliberate harm while rendering nursing care. |
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Definition
| The duty to tell the truth; related nursing actions include telling the truth with regard to placebos, investigational new drugs, and informed consent. |
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Term
The international council of nurses (ICN) Code of Ethics for Nurses |
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Definition
- A guide for action based on social values and needs. The preamble identifies the four fundamental responsibilities of nurses--promoting health, preventing illness, restoring health, and alleviating suffering--and points out that the need for nursing is universal.
- The Code makes it clear that inherent in professional nursing practice is respect for human rights including the right to be treated with respect.
- The Code describes four principal elements that provide a framework for the standards of ethical conduct it defines: nurses and people, nurses and practice, nurses and the profession, and nurses and co-workers.
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