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What is pharmacology?
the study of the effects of chemicals on living organisms TERM 2
What is pharmacology for
PT's?
DEFINITION 2 study and evaluation of the use of drugs in humans, and some animals as it relates to functional activities TERM 3
What is a drug?
DEFINITION 3 any substance that alters the physiologic function in an organismused for the diagnosis, treatment or prevention of a disease TERM 4
Why is it important for a PT to understand
pharmacology?
DEFINITION 4 better understand a patients response to a drugknowledge of how certain rehab procedures may interact with medications is helpful in getting an optimal responseavoidance of adverse responses due to therapy and drug interactions TERM 5
How is pharmacology broadly
divided?
DEFINITION 5 PharmacotherapeuticsToxicology
Pharmacotherapeutics
refers to the use of specific drugs to prevent, treat or diagnose a disease TERM 7
Toxicology
DEFINITION 7 study of harmful effects of chemicals or drugs TERM 8
How is pharacotherapeutics subdivided?
DEFINITION 8 pharmacokineticspharmacodynamics TERM 9
pharmacokinetics
DEFINITION 9 study of how the body deals with drug absorption, distribution and elimination TERM 10
pharmacodynamics
DEFINITION 10 analysis of what the drug does to the body including mechanisms by which the drug exerts its effects
Generic drugs vs. Brand name
after expiration of the patent on the trade brand, other companies may produce the drug and market it by the drug's generic namegeneric drugs must contain the same active ingredient as the brand name but may contain different fillers, capsule types TERM 17
What is the purpose of the FDA?
DEFINITION 17 responsible for monitoring the use of existing drugs and developing and approving new drugs TERM 18
2 primary concerns of the FDA?
DEFINITION 18
- is the drugs effective in treating a certain condition?2. is the drug reasonably safe for human use? TERM 19
The development of a new drug involves what
steps?
DEFINITION 19 preclinical (animal) and clinical (human) studies TERM 20
Preclincal studies
DEFINITION 20 animal studies in one or more species to determine: basic pharmokinetics and pharmodynamic properties information on dosage and toxicity
How clinical studies begin?
if preclinical success, then pharma company files IND with FDAFDA approves application and human trials begins TERM 22
Phases of Clinical studies
DEFINITION 22 Phase 1: small numbers (20-80) healthy volunteers determine pharmacologic actions and toxic effectsPhase 2: small sample (200-300) with the specific disease or condition in question evaluate effectiveness, side effects and other risksPhase 3: expanded to hundreds/thousands with the disease or condition in question to obtain safety and effectiveness data TERM 23
What happens at the end of phase 3?
DEFINITION 23 the drug sponser applies for an NDAresults from clincal testing are reviewed by FDA and if favorable then approveddrug can be marketed and prescribed for use TERM 24
What is the 4th phase?
DEFINITION 24 post-market surveillance which is all methods used to continue monitoring drug safety and effectiveness after approval for public useconsists of reports from healthcare providers describing specific rare adverse side effects not discovered during clinical testing, information about how the drug is used in clinical practice and how the drug ocmpares to similar drugs on the market TERM 25
New drug development timeline
DEFINITION 25 7-9 years typically
What must OTC's demonstrate?
demonstrate adequate safety profile chances of toxic effects are small addictive/abuse potential is low TERM 32
Prescription only drugs
DEFINITION 32 aka Legend drugsto dispense: ordered by authorized practitioner with proper selection, measuring, compounding, labeling and packaging TERM 33
Controlled substance schedules?
DEFINITION 33 1- TERM 34
Schedule 1
DEFINITION 34 highest potential for abusenot used as acceptable medical treatment in the US EXCEPT THCex. heroin, LSD, marijuana TERM 35
Schedule 2
DEFINITION 35 approved for specific therapeutic purposes but still have high potential for abuse and addictionstates usually require strict control over prescribingex. morphine, methamphetamine
Schedule 3
lower abuse potential but still possible mild to moderate physical dependence, physiological dependence or bothex. codeine, anabolic steroids, barbiturates TERM 37
Schedule 4
DEFINITION 37 lower abuse potential than schedule 3limited possibility of physical or psychological dependenceex. anti-anxiety meds like diazepam, phenobarbital TERM 38
Schedule 5
DEFINITION 38 lowest relative abuse potentialex. low dose opioids used in cough meds and antidiarrheal meds TERM 39
How do drugs work on the cellular
level?
DEFINITION 39 changes the function of the cell wither by helping to restore normal physiologic function or to prevent a disease process from occurring. TERM 40
Dose
DEFINITION 40 the total amount (quantity) of a drug administered each timeex. 5 mgmust be large enough to obtain adequate concentrations to reach the target side so it may produce a beneficial effect but not too large as to produce excessive or toxic effects
Quantal dose-response curve
not the magnitude of the response but the % of the population who exhibit a specific response as the dosage is increasednot graded: either present or absent in each member of the population TERM 47
Median effective dose
DEFINITION 47 the dose at which 50% of the population respond to the drug in a specified manner TERM 48
median toxic dose
DEFINITION 48 dose at which 50% exhibit a particular adverse effect TERM 49
therapeutic index
DEFINITION 49 = the median toxic dose / median effective dosethe greater the TI, the safer the drug = it takes a much larger dose to evoke a toxic response than it does to cause a beneficial effectex. aspirin has TI = 30 but chemo drugs have TI = 1 or 2 TERM 50
Under what circumstances can a PT possess
and administer dangerous drugs?
DEFINITION 50 only if the drug is topical used:cooling and stretching external tissue during treatmentprescribed by a licensed physician for iontophoresis or the transmission of drugs thorough the skin using ultrasound
Nutraceuticals
supplements, herbs, vitamins and healing foods TERM 52
botanicals
DEFINITION 52 plant extracts usually classified withing the nutraceutical heading TERM 53
similar bioactive agents
DEFINITION 53 foxglove = digitalis = cardiac medication for a-fibginseng and red ginger = coumadin = anti-coagulation drug
