Intro to Medications Flashcards
Define a drug according to the FDA
A substance recognized by an official pharmacopoeia or formulary. A substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. A substance (other than food) intended to affect the structure or any function of the body
Pure Food and Drug Act of 1906
Required labels w/ active and dangerous ingredients. established purity levels.
Food, Drug, and Cosmetic Act of 1938
Required safety studies for new drugs;
was created after the sulfanilimide killed many kids
Durham-Humphrey Act of 1952
Gave the FDA the power to determine which products could be sold without prescription
Kefauver-Harris Amendments to the FDC Act 1962
Required proof of efficacy and safety; Process to report adverse events; FDA issued “Good Manufacturing Practice”
Drug Price Competition and Patent Restoration Act of 1984
Required bioequivalence for generic drugs
Dietary Supplement Health and Education Act of 1994
Required specific ingredient and nutritional information for dietary supplements;
Dietary supplement and nonprescription drug consumer protection act of 2006
Required manufacturers to report death, life-threatening experiences, inpatient hospitalizations, persistent or significant disability or incapacity, birth defects, or the need for medical intervention to prevent any such problem.
FDA amendment Act of 2007
Required postmarketing studies
Phase I of drug development
Small number of healthy volunteers; Open studies; Determine the pharmacokinetics of a drug (ADME); Is it safe?; Dose?
Phase II of drug development
Larger number of patients who have the disease; Proof of concept stage; Dose response curve determined; Adverse effects and Toxicities determined; Highest rate of drug failure is in this stage; 25% of drugs move to the next phase
Phase III of drug development
Large number of patients with the disease being tested; Test safety and efficacy; Studies usually double blinded or crossover in design; If drug meets expectations, New Drug Application(NDA) is submitted; FDA reviews NDA, if approved, the drug can be marketed
Phase IV of drug development
postmarketing studies; The FDA continues to monitor drugs after they are released on the market; The FDA may demand certain trials be conducted to assess or monitor for adverse events when the drug is used in the population at large.
Chemical name
describes the atomic or molecular structure of the drug (belongs to only one drug) ex: (2R,3R)-2-(2,4-difluorophenyl)-3-(4-methylenepiperidin-1-yl) butan-2-ol
generic name
official name—assigned by an official body, United States Adopted names (USAN) (belongs to only one drug) example: efinaconazole (Jublia™)
brand name
legal, proprietary name of the drug given by the company/manufacturer who markets the drug (belongs to only one drug)
Example: Jublia™ for toenail fungus
OTC (over-the-counter drugs)
“drugs” found to be safe and for use without supervision of a health care professional and can be purchased without prescription; Regulated by the FDA; After a drug has been on the market as a prescription item, it can be moved to over-the counter status
FDA Definition of Dietary supplements
a product intended for ingestion that contains a “dietary ingredient” intended to add further nutritional value to (supplement) the diet. It may be one or any combination, of the following substances: vitamin, mineral, herb or botanical.”
Identify the characteristics of a food and herbal supplements
fall under the category of food; New ingredients since 1994 must provide the FDA with evidence that it is safe before marketed.; Not required to test in clinical trials; The FDA can only stop a company from making a dietary supplement only after it proves that the product poses a significant risk to health.
Health literacy
degree to which individuals have the capacity to obtain, process, and understand basic health information and services needed to make health decisions.
Plain language
a strategy for making written and oral information easier to understand. one tool for improving health literacy; can understand the first time they read or hear it; a plain language document is one in which people can find what they need, understand what they find, and act appropriately on that understanding.
how health literacy effects the healthcare of patients
Navigate the healthcare system, including filling out complex forms and locating providers and services; Share personal information, such as health history, with providers; Engage in self-care and chronic-disease management; Understand mathematical concepts such as probability and risk
who is at risk for low health literacy
older adults, racial and ethnic minorities, people with less than a high school degree or GED certificate, people with low income levels, non-native speakers of English, and people with compromised health status
risk factors for poor medication adherence
AGE: <65 years of age less adherent than those 65 to 74
ETHNICITY
African Americans:
• lower adherence compared to Caucasians or Latinos:
• fill rate similar to Caucasians but discontinuation rate higher at 6 months
SKEPTICISM
DEPRESSION
# OF MEDICATIONS
FORGETFULLNESS
FINIANCIAL
Given a patient with poor medication adherence, select interventions to increase adherence rates
Develop a patient friendly environment so patients feel safe to tell you when they deviate from your prescribed treatment; Incorporate a medication adherence assessment tool into your practice; Have a high degree of awareness for non-adherence.
Define an adverse drug event
an unexpected harm arising from a justified action where the correct process was followed for the context in which the event occurred. Pt is harmed.
Identify the patients at most risk of a medication error. Patients
- On multiple medications
- multiple conditions
- cannot communicate well
- have multiple providers/ use multiple pharmacies
- do not take active role in their own care
- Infants and children (calculation errors)
Identify the 5 Rs with regard to medication safety
- Right patient
- Right drug
- Right route
- Right dose
- Right time
