Pharm Deck - Exam 1 Flashcards
Chapters 1-8, 33-39
What is “therapeutics”
(Pharm Ch 1. pg 4)
Therapeutics is concerned with the prevention of disease and treatment of suffering
What is “pharmacotherapy”?
(Pharm Ch 1. pg 4)
aka “pharmacotherapeutics” is the application of drugs for the purpose of treating diseases and alleviating human suffering.
What is a drug?
(Pharm Ch 1. pg 4)
a drug is a chemical agent capable of producing biologic responses with in the body.
The responses may be desirable (therapeutic) or undesirable (adverse).
What is a biologic?
(Pharm Ch 1. pg 4)
biologics are agents naturally produced in animal cells, by microorganisms, or by the body itself.
Biologics are large, complex molecules or mixtures of molecules that may be composed of living material e.g., hormones, monoclonal antibodies, antibodies, nat. blood products & components, interferons, and vaccines.
Biosimilar Drugs or Biosimilars
chemically synthesized drugs that are closely related to biologic medications having already received FDA approval. Maybe referred to as “reference products.”
Biosimilars are NOT required to undergo rigorous preclinical/clinical trials.
Complementary and alternative medicine (CAM) therapies.
Natural plant extracts, herbs, vitamins, minerals, dietary supplements. Might include body-based practices i.e., physical therapy, massage, acupuncture, hypnosis, and biofeedback
Therapeutic Classification
What is the drugs therapeutic USEFULNESS in treating a particular disease? e.g. Cardiac medicine: anticoagulant, antihyperlipidemic, antihyperintensive, etc. Also can be simply written as “drug used for stroke,” or “drug used for shock.” The key is to clearly state what a drug does clinically.
Pharmacologic Classification
Addresses a drug’s mechanism of action, or how a drug produces a PHYSIOLOGIC effect in the body e.g., a drug that lowers plasma volume is classified as a “diuretic,” a drug that blocks heart calcium channels is classified as a “calcium channel blocker.”
Chemical Name
Assigned using IUPAC nomenclature. A drug only has ONE chemical name, often COMPLICATED and DIFFICULT to remember or pronounce. Example: diazepam’s chemical name is 7-chloro-1
Generic Name
Assigned by UANC. Usually less complicated and easier to remember. THERE IS ONLY ONE generic name for each drug.
Example: ibuprofen is the GENERIC name for Advil (trade name).
Keep in mind: Biosimilars (hormones, etc.) are NOT exact copies of original medications so they should not be called generic medications, instead biosimilars use the generic name of the drug FOLLOWED by 4 lowercase letters. Example: infliximab-abda.
Trade Name
Short, EASY to remember and is assigned by the COMPANY that is MARKETING 💵 the drug. Also can be referred to as proprietary or brand name. Example: Advil, Benadryl , Excedrin.
Remember: A drug developer is given exclusive rights to name and market the drug for 17 years after a new drug application is submitted.
Differences between Generic & Trade Named Drugs
The answer is unclear and depends. Dosages may be identical, but drug FORMULATIONS are not always the same (I.e., different inactive or filler ingredients)
The key to comparing trade and generic may lie in measuring their bioavailability.
Bioavailability
the physiologic ability of the drug to reach its TARGET cells and produce its EFFECT.
Critical Thinking: what is a prototype drug, and how does it differ from other drugs in the same class?
Prototype drugs exhibit typical or essential features of the drugs within a specific class. By learning the characteristics of the prototype drugs, students may better anticipate the actions and adverse effects of other drugs in the same class.
Critical Thinking: what are biosimilar drugs? How do they differ from generic drugs?
Biosimilar drugs are drugs which are highly similar to biologic medications that have already received FDA approval. They are chemically synthesized and not required to undergo rigorous preclinical/clinical testing.
Because biosimilars are not exact duplicate copies of original medications (reference products) they should NOT be called generic medications.
What is a “pharmacopeia”
A comprehensive publication of drug standards; medical reference summarizing standards of drug purity, strength, and directions for synthesis.
What is the FDA (US Food and Drug Administration)?
Established in 1988, exercises control over whether prescription and OTC drugs may be used for therapy.
Mission:
1. facilitating the availability of safe, effective drugs, keeping unsafe products off the market.
2. Provide clear easy to understand drug labels
However… herbal and dietary suppliments can be marketed withOUT prior approval from the FDA.
What is a “black box warning”?
1997 FDA created to regulate drugs with “special problems.” A black box serves as a primary alert for identifying EXTREME adverse drug reactions i.e., death or serious injury.
Phases of Approval for Therapeutic and Biologic Drugs
- Preclinical Investigation
- Clinical Investigation (3 phases)
- Review of the New Drug Application
- Post marketing Surveillance
Preclinical Investigation
extensive laboratory research; testing on human and microbial cells cultured in the lab; Studies are performed in several species of animals; preclinical results are always considered inconclusive.
Clinical Investigation
Clinical Phases
1: Tests performed on volunteers to determine proper dosage, assess adverse effects
2: large groups of selected patients with the particular disease are then given the medication.
3: Is the drug effective? Did it make things worse? Does it safely interact with other meds?
New Drug Application
3rd phase of the drug approval process; drug’s trade name is finalized; FDA has 6 months to review drug
Postmarketing Surveillance
Final phase to survery for harmful drug effects in a larger population;
Prescriptive Authority for Nurses
ADVANCED practice nurses can prescribe drugs; regulated by state law