Pharmacology Cumulative Final EXAM PDF

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PHARMACOLOGY CUMULATIVE FINAL EXAM TEST 1 MATERIAL GENERAL PRINCIPLES PPT. •

What is pharmacology? - the study of drugs

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Pharmacology? - Is the study of drugs and their actions on living organisms

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Pharmacologist? - studies the physical responses and adaptations to drugs

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In relations to physical activity, pharmacological agents can? - enhance or inhibit sports performance - sedatives are very bad for sports performance because it will get you to stand still but you will likely pass out

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A brief history of pharmacology - pharmacology was originally developed as a tool by physiologists in the 19th century - physiologists still use exercise to test the drug all the time because it is an easy way to manipulate physiology

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1809 - Francois Magendie studied the action of nux vomica on dogs

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1838 - Oswald Schmiedeburg is considered the founder for modern pharmacology

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1847 - Claude Bernard discovered action of curare on neuromuscular junction

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1874 - Rudolf Buchheim was the first university chair of pharmacology

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1890 - John Abel was the first US pharmacology chair at the university of Michigan

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Before the FDA drugs were not controlled - dietary supplements are not controlled by the government - food is closely regulated more than drugs

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Drug development - can take 7-12 years

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United States Food and Drug Administration (FDA) - approves new drugs - monitors drugs for adverse or toxic effects - has the power to ban drugs

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Drug development: Pre-FDA status •

In vitro work - this needs to be done safely before you start to use animals

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lab animal studies - Give it to animals to see if it can be tolerated or effected - You are trying to build evidence and make sure it is good for humanity. - Might have teratogenic effect and will have to stop. - Has little safety margin and a lot of people have adverse effects.

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Drug development: Clinical testing of Investigational New Drug (IND) •

Phase 1 - 4-6-week trial with 10-20 “normal” patients to make sure that there aren’t any really bad adverse effects.

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Phase 2 - trials with humans who have the disease for which the drug is designed to help

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Phase 3 - 2-7 years - large sampling to provide feedback on adverse effects which may be infrequent - New Drug Application (NDA) if drug is found to be safe and effective after completion, generally takes 5-7 years to get to this point and another 2 years once application is made and it must be reviewed by the FDA, scientists, etc.

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Phase 4 - drugs approved for marketing by the FDA - continued evaluation of drug - post approval monitoring

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Special FDA programs •

Orphan Drug Act of 1983

- helps companies develop drugs when no reasonable expectation exist that the cost of developing and distributing the drug will ever be recovered by ale of the drugs because of the rare quality of the disease Examples include: - Thalidomide for leprosy (was banned by the FDA and reprimanded through the orphan drug act) - Triptorelin Pamoate for ovarian cancer •

Accelerated programs - offered by the FDA as “provisional approval” for life threatening disease if this drug is trying to improve something that needs to be helped - still need to go through all of phase 3 - shortens normal approval process of drugs that may save a patient’s life - ex: new AIDS drug research

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Compassionate access - allows access to unapproved drugs - allows patients to receive drugs (free) that have not yet been approved by FDA - requires institutional review board approval - the drugs may reduce the patients pain and suffering because they have a terminal illness

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Drug names - chemists makes the chemical structure of drugs •

Chemical name - scientific name that precisely describes its atomic and molecular structure

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Generic name - usually an abbreviation of the chemical name - it is a lot cheaper. - generic name must be the same as the official name - it must have the same active part

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Official name - listed in the US pharmacopeias and National Formulary - all drugs are in this book

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Trade or Brand name - selected by the drug company and protected by copyright - uses a catchy name and vibrant colors

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Drug names - Ex: - trade name= Claritin - generic name= loratadine - official name= loratadine

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Drug categories •

Prescription - legend drugs= is a pharmaceutical drug that legally requires a medical prescription to be dispensed by medical personnel - determined unsafe for OTC because of adverse effects

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Non-prescription drugs - available over the counter, can only buy so many at a time - no restrictions by the FDA - safe to use as directed

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Controlled substances - controlled because of danger of addiction

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5 schedules of controlled substances based on abuse •

Schedule 1 - high abusive potential - no accepted medical use in the USA - heroin, LSD, marijuana

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Schedule 2 - potential for abuse - severe physical and physiological dependencies - narcotics (morphine), oxycodone, amphetamines, barbiturates (sedatives)

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Schedule 3 - less abusive potential than schedule 2 drugs - moderate physical and physiological dependences

- non-barbiturates, non-amphetamines stimulants, limited amounts of narcotics (dose is low, risk of dependency is low)

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Schedule 4 - less abusive potential than schedule 3 - limited dependency potential - non-narcotics analgesics (tramadol), non-anxiety agents

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Schedule 5 - limited abuse potential - limited chance of dependence - codeine (cough syrup)

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Federal drug legislation and enforcement - controls the use of prescription and non-prescription drugs and controlled substances - includes the following acts: 1. pure food and drug act 2. Harrison narcotic act 3. pure food, drug, and cosmetic act 4. comprehensive drug abuse prevention and control act

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Pure Food and Drug Act - passed in 1906 secondary to public pressure - created the FDA which was entrusted with the responsibility of testing all foods and drugs destined for human consumption - required prescription from licensed physicians before a patient could purchase certain drugs - required label warning on habit forming drugs

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Harrison Narcotic Act - passes in 1914 as reaction to increasing addiction to narcotics but was received poorly and illegal drug abuse increased - banned heroin in 1924 for any medical use - amended many times and replaced by the comprehensive drug abuse prevention and control act in 1970

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Pure Food and Drug and Cosmetic Act - 1938 law passed by congress to give FDA control over manufacture of drugs food and cosmetics - required substances to be safe for human use - required pharmaceutical companies to perform toxicology test before submission of a new drug - products need to be regulated

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Comprehensive Drug Abuse Prevention and Control Act - passed in 1970 to replace the Harrison narcotic act as well as 50 other pieces of drug legislation - regulates manufacture, distributing, and dispensing of drugs with a potential for abuse - established the 5 schedules that classify controlled substances as to: how dangerous they are, potential for abuse and addiction and whether they possess legitimate medicinal value - provides legal framework for DEA

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Drug Enforcement Administration (DEA) - DEA is a chief federal agency operating within the department of justice - responsible for enforcing the controlled substances act

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Drug use and pregnancy •

Category A - studies have not demonstrated risk to the fetus

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Category B - studies have not been done on humans but in animal studies there was no risk to the fetus

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Category C - studies have not been done on humans or animals or some studies done on animals have shown teratogenic effects

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Category D - studies have revealed adverse risk to the fetus so benefit-to-risk ratio must be established before use in pregnancy

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Category X - studies have revealed teratogenic effects in women and/or animals, fetal risk clearly outweighs benefit and drug is contraindicated in pregnancy

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Drug actions within the body - pharmaceutic phase - pharmacokinetic phase (absorption, distribution, metabolism, excretion) - pharmacodynamic phase

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Pharmaceutic phase - 1 of 3 phases for a drug taken by mouth - aka dissolution phase - the drug becomes a solution so that it can cross the biologic membrane - dissolution of the drug - must be in a solution to be absorbed - drugs in liquid form or injected do not go through this phase of needing to combine with body fluid •

Inhalation - inhaled gases get into circulation by gas exchange at the alveoli - burning the drug and inhaling the smoke or inhaling gasses - this route is even faster than IV injections - emphysema, asthma, and lung cancer are serious consequences

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Absorbed through skin or membrane - topical drugs= applied on top of skin or membrane - topical drugs include: lotions, ointments, sprays, solids, (suppositories) etc. - sniffing or snorting a drug crosses the mucous membranes of the nose - chewing or sucking on drugs gets the drug into circulation sublingually - diffusion across the skin from a transdermal patch

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Pharmacokinetic phase - 2 of 3 phases for a drug taken by mouth - aka what the body does to drugs - composed of 4 processes (absorption, distribution, metabolism, excretion) - movement of drugs across the body

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Absorption - passes into the circulating body fluids or tissues

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Distribution - transportation of the drug to the site of action

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Metabolism - drugs are converted into harmless substances

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Excretion - elimination of the drug from the body

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Pharmacodynamic phase - 3 of 3 phases for a drug taken by mouth - aka what a drug does to the body - the study of drug concentration and its effect on the body - biological or physiological response results - can produce primary of secondary physiologic effect or both - uses onset, peak, and duration to determine dosing - drugs actions and effect on the body - primary and secondary effects to target sites •

Alteration in cellular environment - osmotic pressure - lubrication - absorption

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Alteration in cellular function - can increase or decrease physiologic function

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Half life - measure of the rate at which the drug is removed from the body - a given drug will have an inherent half-life range in the body - to achieve a longer half-life various techniques may be adopted - it is possible to have coatings on capsules/particles within capsules where the inner ones dissolve later and therefore releases their drug more slowly

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Receptor-Mediated drug action •

Agonist - drug that binds with a receptor to produce results

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Antagonist

- drugs that bind with a receptor to block the results of an agonist to produce results •

Macromolecule Figure summary - poor receptor fit= no pharmacologic effect - some drug receptor fit= slight therapeutic response possible - Agonist= excellent receptor fit, therapeutic response

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Drug toxicity - the physical and physiological harm that a drug might present to the user in the short period after ingestion (acute toxicity) - uses the dose-response curve - dose response curve represents when a drug stops being helpful and starts being harmful - as you go up to 80% of the effective dose, 20% might be dying because of it - lines must be parallel to each other - the closer the lines are together= BAD - the further the lines are apart from one another= THE BETTER (the more you can increase the effective dose without having a dose that is killing more than it is helping) - close lines= BAD - far apart lines= GOOD

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Dose response curve •

Effective dose 50 (ED50) - drug dosage for effective response in 50% of sample

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Effective dose 99 (ED99) - drug dosage for effective response in 99% of sample

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Lethal dose 50 (LD50) - drug dosage for lethal response in 50% of sample

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Lethal dose 99 (LD99) - drug dosage for lethal response in 99% of sample

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Therapeutic index - determines the ratio of lethal dose to effective dose - it suggests the drugs toxicity - therapeutic index= LD50/EF50

- the amount found to incur a 50% chance of dying relative to the amount that would be effective for half the population - therapeutic index is a measure of the relative safety of a drug •

Margin of safety - LD1/ED99 - the amount that would be effective for 99% of population in order to incur a 1% chance of toxicity - these ratios are easier to calculate for prescription drugs than street drugs

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Drug reactions •

Adverse or allergic reactions - adverse reactions are also called side effects when they are mild - allergic reaction= can be caused by hypersensitivity reactions and may prompt body to produce antibodies against what it perceives as an antigen - anaphylactic shock is an extremely serious allergic reaction and can be life threatening if not recognized and treated immediately

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Drug idiosyncrasy - any abnormal or unusual reaction to a drug - if the reaction is the opposite of the intended response, than it is a paradoxical reaction - if the reaction is excessive compared to the intended response than the patient is said to be hypersensitive to the drug - unknown cause and no predictability - possibly associated with genetic background

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Drug tolerance - gradual decrease in responsiveness to the drug if the drug is taken repeatedly - might have to increase dose to make it effective vs making it lethal - what a chronic user takes to what a non-user takes can have very different effects - the length of time a person regularly takes the drug impacts tolerance - Behavioral tolerance= the environment the user is in can impact tolerance - Metabolic tolerance= over time the liver can increase breakdown of drug if taken regularly

- Cellular tolerance= receptors will up regulate or down regulate if too much or too little of drug is taken over time •

Drug dependence - physical dependence= person develops physical symptoms during withdrawal form a drug - drug has become normal part of physiological environment - withdrawal symptoms are typically opposite of the drug’s effects - psychological dependence= person attempts to avoid the withdrawal difficulties and feeds the craving/desire for drug - substance dependence= person with significant signs of dependent relationship with drug - substance abuse= person who continues to take a drug even when the drug is creating specific problems for the user

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Cumulative drug effect - additive effects of the drug with each dose - normally associated with liver or renal disease patients - altered half life - the state at which repeated administration of a drug may produce effects that are more pronounced than those produced by the first dose

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Toxic reactions - poisoning of the system secondary to overdose of chemicals in the blood concentration - differences in half-life between patients

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Pharmacogenetic reactions - genetically caused abnormal response to a drug - ex: hemolysis - one of the many uses of the mapped human genome

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Drug interactions - drug/drug •

Additive drug reactions - combined effect of 2 drugs is equal to the sum of each drug - 1+1=2 - ex: heparin and alcohol

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Synergistic drug reaction - drugs interact with each other and cause an effect that is greater than the sum of the individual effects - 1+1=4 - ex: hypnotic drugs

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Antagonistic drug reaction - one drug renders the other inactive - one drug may have a greater affinity for the receptor

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Polypharmacy - taking of multiple drugs - potential for interactions - often practiced by the elderly who have more than one condition to be medicated - people aged 65 and older make up 13% of the population, but account for around 30% of prescribed drugs - increases possibility of adverse reactions (included OTC products as well)

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Dietary supplement health and education act - passed in 1994 to define substances for mineral, vitamins, amino acids, herbs, etc. - permits general health claims such as “improve health” or “promotes regularity” as long as the label has a disclaimer that the FDA has not approved it to diagnose, treat, cure, or prevent any disease - FDA has power to enforce this law

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Center for complementary and alternative health - national institute of health established the office of alternative medicine in 1992, changed name in 1998 - established because of the increased interest in alternative therapy in the US - patients need further education in this regard as much misinformation has been made public since patients often view herbs as harmless

THE ADMINISTRATION OF DRUGS PPT. •

6 rights of drug administration 1. Right patient 2. Right time

3. Right dose 4. Right route of administration 5. Right drug 6. Right documentation •

The right drug - getting the wrong drug could be dangerous if the patient are given a drug that is toxic to them - also if they patient doesn’t get the drug they need •

Examples of easily confused drugs ▪

Captopril and Capitrol - Captopril= ACE inhibitor to reduce BP - Capitrol= antibacterial shampoo

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Fosamax and Flomax - Fosamax= slows bone density loss, induces a calcium uptake. May have to supplement with calcium supplements - Flomax= increased urinary flow in men with enlarged prostate

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Consideration in drug administration - drug errors - the medication order - once a week drugs (ex: Fosamax) - as needed or circumstances arise (ex: pain control) - stat order which means immediate administration (ex: epinephrine for someone who is in shock)

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Drug errors - occurs when one of the 6 rights of drug administration goes wrong - you may counter the effects they need - need to give the right drug - need to make sure that there are no adverse effects from the wrong drug to be given the right drug (could be synergistic) - people may make mistakes - drug errors must always be reported

- drug errors may occur during: transcription, dispensing, and/or administering •

Drug errors severity scale - A= no error, no harm - B= error occurred but it didn’t reach patient - C= error reached patient but no harm occurred - D= error resulted in need for increased monitoring but no harm occurred - E= error resulted in need for additional treatment, intervention, and caused temporary harm - F= error resulted...