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- Administering (nurses)
- Monitoring (nurses)
what are SALAD drugs
sound alike look alike drugs
what to report when a medication error is made
- Medication administered
- Actual dose
- Observed changes in patient condition
- Prescriber notified/follow-up orders
External reporting of medication errors
- USPMERP (United States Pharmacopeia Medication Errors Reporting Program)
- MedWatch, sponsored by FDA
- Institute for Safe Medication Practices (ISMP)
- The Joint Commission
- Continuous assessment and updating of patient medication information
- Joint Commission requirement
- This should be done at each stage of health care delivery:
- Admission, status change, patient transfer within or between facilities/provider teams and discharge
Controlled substances schedule
New drug development
- Investigational new drug (IND) application
- -informed consent
US FDA drug approval process
- -Preclinical testing
- -Informed consent
- -Clinical studies
- -Investigational drug studies
- -Expedited drug approval
Clinical phases of investigational drug studies
- Phase I: small sample of healthy people
- Phase II: small sample of people that have the condition that would benefit from medication
- Phase III: large sample of people who would benefit
- Phase IV: Post marketing
Ethical Nursing Practice
- American Nurses Association (ANA) Code of Ethics for Nursing
- International Council of Nurses (ICN) Code of Ethics for Nursing
- •Assess the influence of a patient’s
- cultural beliefs, values, and customs
•Compliance level with therapy
•Varying responses to specific drugs
•Changing national demographics
•Influence of ethnicity and genetics
•Rapid and slow acetylators (metabolize drugs more quickly or slowly)
•Examples of various ethnic groups found in the U.S.
•Health beliefs and practices
•Past uses of medicine
•Over-the-counter drugs and treatment
Any systematic error in a measurement process. One common effort to avoid bias in research studies involves the use of blinded study designs
black warning box
A type of warning that appears in a drug's prescribing information and is required by the U.S. Food and Drug Administration (FDA) to alert prescribers of serious adverse events that have occurred with the given drug.
Blinded investigational drug study
A research design in which the subjects are purposely unaware of whether the substance they are administered is the drug under study or a placebo. This method serves to minimize bias on the part of research subjects in reporting their body's responses to investigational drugs
Any drugs listed on one of the “schedules” of the Controlled Substance Act (also called scheduled drugs).
The customary beliefs, social forms, and material traits of a racial, religious, or social group.
double-blind investigational drug study
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 under study or a placebo. This method minimizes bias on the part of both the investigator and the subject.
Variation in response to a drug because of a patient's age, gender, size, and/or body composition.
The rules of conduct recognized in respect to a particular class of human actions or a particular group.
Relating to or characteristics of a human group having racial, religious, language, and other traits in common.
The study of the effect of ethnicity on drug responses, specifically drug absorption, metabolism, distribution, and excretion (i.e., pharmacokinetics; see Chapter 2) as well as the study of genetic variations to drugs (i.e., pharmacogenetics).
expedited drug approval
Acceleration of the usual investigational new drug approval process by the FDA and pharmaceutical companies, usually for drugs used to treat life-threatening diseases.
Health Insurance Portability and Accountability Act (HIPAA)
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.
Written permission obtained from a patient consenting to a specific procedure (e.g., receiving an investigational drug), after the patient has been given information regarding the procedure deemed necessary for him or her to make a sound or “informed” decision.
Investigational new drug (IND)
A drug not yet approved for marketing by the FDA but available for use in experiments to determine its safety and efficacy.
Investigational new drug application
An application that must be submitted to the FDA before a drug can be studied in humans.
another name for prescription drugs
A special type of negligence or the failure of a professional and/or individual with specialized education and training to act in a reasonable and prudent way.
A legal term established under the Harrison Narcotic Act of 1914. It originally applied to drugs that produced insensibility or stupor, especially the opioids (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.
The failure to act in a reasonable and prudent manner or failure of the nurse to give the care that a reasonably prudent (cautious) nurse would render or use under similar circumstances.
A special category of drugs that have been identified to help treat patients with rare diseases.
Drugs available to consumers without a prescription. Also called nonprescription drugs.
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.
Descendants of a common ancestor; a tribe, family, or people believed to belong to the same lineage.
The most intangible domain of the learning process. It involves affective behavior, which is conduct that expresses feelings, needs, beliefs, values, and opinions; the feeling domain.
The domain involved in the learning and storage of basic knowledge. It is the thinking portion of the learning process and incorporates a person's previous experiences and perceptions; the learning/thinking domain.
The degree to which individuals have the capacity to obtain and then process and understand basic health information as well as basic health information and services needed to make appropriate health decisions
The domain involved in the learning of a new procedure or skill; often called the doing domain.
A system of directed and deliberate actions intended to induce learning.
Herbal medicine, chiropractic, acupuncture, massage, reflexology, and any other therapies traditionally not emphasized in Western medical schools but popular with many patients.
Alternative medicine when used simultaneously with, rather than instead of, standard Western medicine.
The practice of medicine as taught in Western medical schools.
A product that contains an ingredient intended to supplement the diet, including vitamins, minerals, herbs, or other botanicals.
the practice of using herbs to heal
Plant components including bark, roots, leaves, seeds, flowers, fruit of trees, and extracts of these plants that are valued for their savory, aromatic, or medicinal qualities.
Unintentional adverse effects that are caused by the actions of a prescriber, other health care professional, or by a specific treatment.
Simultaneous use of both traditional and alternative medicine.
Medications that are not legally available without a prescription from a prescriber (e.g., physician, nurse practitioner, physician assistant; also called prescription drugs).
over-the-counter drugs (OTC)
Medications that are legally available without a prescription.
The pharmacologically active ingredients in herbal remedies.