DPT 752
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| What is Pharmacology? | -the study of the effects of chemicals on living organisms-Clinical Pharmacology is the study and evaluation of the use of drugs in humans
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| What is a Drug? | - any substance that alters physiologic function in an organism- any substance used for the diagnosis, treatment or prevention of a disease
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| Pharmacotherapeutics | The area of pharmacology that refers to the use of specific drugs to prevent, treat, or diagnose a disease
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| Pharmacokinetics | The study of how the body dealswith a drug:AbsorptionDistributionElimination
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| Pharmacodynamics | The analysis of what the drug does to the body, including the mechanism by which the drug exerts its effects
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| Toxicology | The study of the harmful effects of chemicals
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| Pharmacy | The preparation and dispensingof medications
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| Pharmaceutical Care | “A patient-centered practice in which the which the practitioner assumes responsibility for a patient’s drug-related needs and is held accountable for this commitment”
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| Clinical Pharmacy | That area of Pharmacy concerned with the science and practice of rational medication useA health science discipline in which pharmacists provide patient care that optimizes medication therapy & promotes health, wellness & disease prevention
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| Pharmacist | A health professional trained in the art and science of the preparation, dispensing and rational use of drugsAn individual who has obtainedA degree in PharmacyLicense to practice Pharmacy by state’s Board of Pharmacy
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| Pharmacy Degree | Doctor of Pharmacy3-years pre-pharmacy courses3-or 4-years professional programMay also have completed1-year general residency and1-year specialty residency or2-year fellowship
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| Pharmacy Technician | Individuals who assist Pharmacists to prepare prescription medicationsMany states require licensing or certification with the state board of pharmacy
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| Chemical drug name | Refers to specific compounds structureUsually long & impossible to pronounce!
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| Generic drug name | Official or nonproprietary nameShorter & MAY be derived from chemical name
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| Trade name or brand name | Assigned to the drug by the pharmaceutical companyMay not resemble the generic or chemical name
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| Generic Drug Substitution | After the patent has expired on trade or brand name drug, any other pharmaceutical company may produce the drug and market it by the drug’s generic nameGeneric drugs must contain the same active ingredient as the brand-name drug
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| Drug Development & Approval | In the U.S. the Food & Drug Administration (FDA) is responsible for:monitoring the use of existing drugs and fordevelopment & approval of new drugs
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| U.S. Food & Drug AdministrationIn the development, approval and monitoring of drugs, the FDA has two primary concerns: | Is the drug effective in treating a certain condition?Is the drug reasonable safe for human use?
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| Drug Approval ProcessDevelopment of a new drug involves | Preclinical testingStudies in animalsClinical trialsStudies in humans
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| Animal (Preclinical) Studies | Drugs are typically tested in animals initially, sometimes in more than one speciesIf the results are favorable, the drug goes on to clinical trials in humans
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| Animal (Preclinical) StudiesInformation obtained includes: | Basic pharmacokinetic & pharmacodynamic propertiesDosage & toxicity
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| Human (Clinical) Studies | Drug sponsor files and investigational new drug application (IND) with the FDAOnce application is approved, may begin testing in humansPhase IPhase IIPhase II
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| Phase I Trials | Healthy volunteersDrug tested in small number of healthy volunteers (20-80 subjects)Obtain initial info about pharmacologic actions & possible toxic effects in humans
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| Phase II Trials | Test in small sample (200-300 people) who have a specific disease or conditionPrimary goals Evaluate effectiveness of the drug for a particular indicationAssess side effects & other risks
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| Phase III Trials | Evaluation expanded to include more patients (several hundred to several thousand) with the disease or condition the drug is being studied to treatAdditional information is obtained regarding safety & effectiveness
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| New Drug Application | Time course for completion of all testing mayb 7-9 years (except fast track)After Phase III trials the drug sponsor submits a new drug application (NDA) FDA review results of trials extensivelyIf found favorable, the NDA is approved by the FDA
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| Post-Marketing Surveillance | Should be instituted as soon as the NDA is approved
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| Post-Marketing SurveillanceReports from health care providers describing adverse effects that were not previously discovered | Obtain info about how a drug is used in clinical practice How that drug compares to similar drugs on the market
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| Categories of Drug Access in United States | Over-the-Counter Medications: May be sold without a prescriptionPrescription only Medications: Requires prescription from a health care practitionerControlled Substances: Includes legal & illegal drugsDrugs with potential for abuse
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| Over-the-Counter Drugs(OTC) | Used to treat relatively minor problemsEasier for consumers to obtainLess expensive?????Adequate safety profile???Chances of toxic effects relatively small WHEN USED IN RECOMMENDED AMOUNTS
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| Controlled Substances | Also referred to as “scheduled” drugsSchedule ISchedule IISchedule IIISchedule IVSchedule V
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| Scheduled I | Highest potential for abuseMost not typically used as acceptable medical treatment in U.S.Exceptions include marijuana, which may be used only in limited circumstances
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| Schedule II | Still have high potential for abuse & addictionApproved for specifid therapeutic purposesExamples: morphine, methamphetamineUsually states require stricter control over prescribing
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| Schedule III | Lower abuse potential, but still possibility of mild to moderate physical dependence, strong psychological dependence, or bothExamples: codeine, anabolic steroids
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| Schedule IV | Lower abuse potential than Schedule IIILimited possibility of physical and/or psychological dependenceExamples: diazepam, phenobarbital
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| Schedule V | Lowest relative abuse potential, but still someUsually opioids used in cough preparations and antidiarrheals
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| Drug Therapy Basic Concepts | DoseDosageDose-Response CurvesPotency
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| Drug Dose | Must be large enough to obtain adequate concentrations to reach target site, so that it may produce a beneficial, or therapeutic effectNot too large so that it may produce excessive or toxic effects
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| Dose-Response Curves used to: | Used to provide info about dosage range over which drug is effective & peak response that can be expected
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| Dose-Response Curves | Dose too low–no effectThreshold dose–response begins to occurContinues to increase in magnitude before reaching a plateauPlateau in response indicates no further increase in response with increased doseThis is the ceiling effect or max effect
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| Potency | Related to the dose that produces a given response in a specific amplitudethat more or less of a compound is required to produce a given responseCompare two similar drugs
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| Potency Example | Compare two similar drugsDrug A requires a 10mg dose for a response, while Drug B requires a 50mg dose to obtain the same response
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| Elements of Drug Safety | Quantal Dose-Response CurvesMedian Effective Dose (ED50)Median Toxic Dose (TD50)Therapeutic Index (TI)
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| Quantal Dose-Response Curves | Not the magnitude of the response, but the percentage of the population who exhibit a specific response as the dosage is increased
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| Median Effective Dose (ED50) | Dose at which 50% of the population respond to the drug in a specific manner
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| Median Toxic Dose (TD50) | Dose at which 50% exhibit a particular adverse effect
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| Therapeutic Index (TI) | The greater the TI, the safer the drugCalculated as ratio of TD50 to ED50
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NicoleB
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