Pharmacology Unit 1 Week 1
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| What is a Drug? | any chemical that can affect living processes
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| What is Pharmacology? | the science that studies the effects of drugs within a living system
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| What is Clinical Pharmacology? | the study of drugs in humans
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| What is Pharmacotherapeutics? | use of drugs to diagnose, prevent or treat disease or to prevent pregnancy; the medical use of drugs
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| What are three sources of drugs? | Man Made, Plant, and animal
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| How are drugs used? | Symptomatic Treatment, To Diagnose, To prevent illness, Curative, To maintain health, Contraceptive use.
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| Ideal properties of a drug- the main properties | EFFECTIVENESS: the extent to which the drug elicits the response for which it is given
SAFETY: the extent to which it causes no harm
SELECTIVITY: the extent to which the drug elicits only the response for which it is given
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| What are other properties of an ideal drug? | Reversible action, predictability, easy administration, minimal interactions, low cost, chemical stability, simple generic names
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| What is the most important property a drug can have? | Effectiveness, or there is no justification for giving it.
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| This is no such thing as a safe drug | All drugs can cause harm.
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| There is no such thing as a selective drug. | All drugs can cause side effects.
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| What Does Therapeutic Objective mean? | Drug therapy should provide the maximal benefit with minimal harm.
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| Factors influencing drug responces | Administration, Pharmacokinetics, Pharmacodynamics
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| Factors influencing drug administration | Does, Route, timing
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| Factors influencing Pharmacokinetics | Absorption, distribution, metabolism, and excretion.
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| What is Pharmacodynamics? | The impact of a drug once it has reached its site of action. (Drug-receptor interactions)
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| Factors of individual variation | All patients are unique, do drug therapy must be tailored to fit each individual.
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| Examples of indivdual variations | Physiologic variables, pathological, genetic variables, drug interactions.
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| The steps of the nursing process | Assessment, Nursing diagnosis, planning, interventions, evaluation.
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| The nurse should know what essential drug knowledge? | Classification, use, mechanism of action, adverse effects, contraindications, interactions, implications.
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| Applying Pharmacology in pt care: Assessment | Collect baseline data, Identify high risk patients (pts at risk for adverse outcomes)
Assess self care capacity.
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| High Risk patient factors include | Disease processes, drug allergies, other drugs being used, diet, genetic heritage, pregnancy, and extreme youth or old age.
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| Capacity for self-care factors | Willingness and ability ro self administer medications.
Visual, manual dexterity, intellectual ability, mental illness, memory, finances, cultural attitudes.
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| Apply Pharmacology: Analysis and Nrse Diagnosis | Determine the appropriateness of the drug therapy.
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| Analysis of drug therapy | Desired Effects: Why is the drug being given?
Weight the risk and benefits: Contraindications and precautions. Potential side effects: acceptable? Interations?
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| What is a contraindication? | any pre-existing condition that precludes use of a particular drug under all but the most desperate circumstances.
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| What is a precaution? | pre-existing condition that significantly increases the risk of an adverse reaction, but not to a degree that is life threatening.
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| Parts to a Medication Order | Drug name (trade or generic), Dosage, Route, Frequency, Presriber signature
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| Evaluation: The patient is evaluated for | Therapeutic response
Adverse drug reactions/interactions
Compliance with drug therapy
Satisfaction with the drug regimen
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| Federal Pure food and drug act | 1906
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| Food drug and Cosmetic act | 1938 (required FDA approval before marketing
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| Kefauver Harris Amendments | 1962 Responce to thalidomide tragedy, Required proof of effectiveness of the drug before marketing and established rigorous criteria for testing new drugs
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| Controlled Substances Act | 1970 Set rules for manufacture and distribution of drugs with a potential for abuse
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| FDA modernization act | 1997- Created fast track for drugs to treat serious or life threatening conditions
Established a clinical trial database
Allows drug company to give health providers information regarding “off label” use
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| Randomized Control Trials | How clinical trials work
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| Use of controls | Some subjects are given a new drug, some given a standard, and some a placebo.
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| What is Randomization? | Subjects randomly assigned to either control group or the group receiving the new drug
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| What is single blinding? | Single blind: subjects do not know to which group they have been assigned.
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| What is double blinding? | Double blind: neither the subject nor the researcher know to which group the subject has been assigned.
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| The stages of drug development- Preclinical testing | Required before a new drug may be tested in humans. Evaluates for toxicities, Pharmacokinetic properties, potentially useful biologic effect - may take 1-5 years. Must apply to the FDA to begin testing in humans.
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| Clinical Trials: Stage 1 | Phase I
Healthy volunteers
For drugs likely to have severe side effects, trial done in volunteers who have the disease under consideration for the drug
Evaluation of drug metabolism
Determine effects on humans
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| Clinical Trials Stage 2 and 3 | Tested in patients with the disease under consideration
Determine therapeutic effects
Dosage ranges
Patient safety
Total number of subjects—500 to 5000
Duration of phases—3 to 6 months
After Phase III, application for conditional approval is made
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| Clinical Trials Stage 4 | Phase IV: Post-marketing Surveillance
With conditional approval from the FDA, Phase IV begins
Usage is for the general population
New side effects may be discovered
Voluntary reporting by health professions is essential
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| Limitations to testing procedures | Gender issues, Ethnic Issues, Age issues.
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| Gender issues in clinical testing | Until recently, few drugs were tested in women
1990s FDA issued guideline mandating participation of women in Phase II and III trials
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| Ethnic Issues in clinical testing | Until recently, most drugs were primarily tests in Caucasian males only
1990s FDA issued guideline mandating participation of minorities in Phase II and III trials
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| Age Issues in clinical testing | Children
FDA can now require drug companies to conduct clinical trials in children.
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| Factors influencing the failure to detect all adverse effects | Small number of patients in trials,
The careful selection of patients in the trials (they often do not have other conditions than the one for which the drug is being investigated)
Limited time frame (usually 3-6 months)
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| What is the role of the FDA? | To monitor and control the manufacture and marketing of all drugs.
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| Prescription drugs: | " means any drugs which are required by state law or regulation of the state board of pharmacy to be dispensed on prescription only or are restricted to use by practitioners only
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| Over the Counter: | You buy without prescription,
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| Chemical Drug name | Chemical description of the drug
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| Generic | Assigned by the US adopted names council
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| Trade | Proprietary or brand name.
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| Drugs are chemically equivalent if they contain the same amount of the identical chemical compound (drug) | Drugs are considered equal in bio-availability if they are absorbed at the same rate and extent.
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| Drugs can be chemcially equivalent yet differ in bioavailability. |
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| Criteria for Generic Drugs | Must contain same active ingredients as brand name. must have strength, doseage, and route that are identified with the brand. must be bio equivalent. Meet batch to batch requirements.
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| The law allows for a difference in bioavilability by as much as 20% but the average is | 3.5%
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| OTC labeling (2005 changes) | New labels are easy to understand words, bigger print, will look the same, be the same on every product. New "drug facts" label
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| What does new OTC labels contain? | Active ingredients, purposes, uses, warnings, directions for use, inactive ingredients.
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| Legal: | Nurse is legally responsible for for safe and accurate administration. Held libel for not giving a drug or for giving the wrong/too much drug. Nurse should question odd orders
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