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65 Cards in this Set
- Front
- Back
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Why do PT's need Pharmacology? |
understand basic drug mechanisms to understand a patient's response to drugs
optimize therapy & drug treatment
avoid adverse interactions between therapy and drugs |
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Literature Hierarchy of Drug Information |
Primary literature is the most current - clinical journals
Secondary literature - reviews of previous reports
Textbooks - oldest and slowest information - drug development is a long process |
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What Info is Least Likely to Change About a Drug? |
the chemistry of a drug |
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The Physician's Desk Reference |
- limited listing of drugs - same info as in the package insert of drugs - little comparative information - companies pay to have their drug listed - updated quarterly |
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Drug Facts and Comparisons Book |
- lists nearly all marketed drug products - allows comparisons among similar classes of drugs - loose-leaf binder is updated monthly |
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AHFS Drug Information Book |
- publication of American Society of Hospital Pharmacists - includes much more detail about drug chemistry and structure - updated quarterly and new edition yearly - not very useful for us b/c it focuses on chemistry |
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Clinical Guides |
- important one - greater depth of info in a specific area - key prescribing info for use in clinical setting |
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Pharmacology Textbook |
- most authoritative textbook of pharmacology - not practical for PT's - provides well referenced details of the cellular and molecular mechanisms of drug actions |
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Internet Resources |
Pros - rich source of info - rapid, easy access - easily updated
Cons - no controls over truthfulness - often no distinction between fact, opinion and speculation - anyone w/ a website can claim expertise |
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Pharmacotherapeutics |
use of specific drugs to prevent, treat, or diagnose a disease - encompasses pharmacokinetics and pharmacodynamics |
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Pharmacokinetics |
study of how the body deals with the drug - absorption, distribution, elimination, administration and storage of a drug |
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Pharmacodynamics |
analysis of what the drug does to the body (including mechanism) - systemic and cellular effects |
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Toxicology |
a branch of pharmacology
study of adverse effects of drugs and what they do to the body |
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Pharmacy |
preparing & dispensary of medications
lots of responsibility
retail and clinical pharmacists |
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Drug Nomenclature |
Each drug has 3 names 1. chemical name - specific compound structure 2. generic name - official or nonproprietary name 3. trade name - "brand" or proprietary name
Use the generic name b/c it's easiest, effective and not brand specific |
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Look &/or Sound Alike Error |
- accounts for 25% of errors caused by name confusion - physicians use written or oral orders EX: Celebrex, Cerebryx & Celexa - analgesic, antiseizure & antidepressant |
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Are generic forms the same as the brand name? |
Yes, if bioequivalent |
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Tests to determine bioequivalence |
1. same type/amount of active ingredients 2. same administration route 3. same pharmokinetic profile - drug absorption, plasma levels, etc 4. same therapeutic effects |
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3 Parameters measures to Determine Bioequivalence |
1. area under the time/concentration curve 2. time to max concentration (tmax) 3. max concentration (Cmax) |
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How do they create Long Acting Medications? |
Oral meds - coated differently so that it takes longer for stomach acids to digest the coat |
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Generic Substitution |
- regulated under state laws, but is generally permitted for those products which are found to be chemically & biologically equivalent
- in most cases generic drugs DO NOT have to demonstrate therapeutic equivalence |
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Therapeutic Interchange |
substitution of one drug product, which may differ chemically from the prescribed product by provides the same therapeutic effect - different active ingredients, administration routes, etc. but they give the same effect |
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Bioavailability Study Subjects: FDA Guidelines |
* 18-24 healthy persons (usually male) * 21-35 years of age * within 10% of ideal body weight * fasting conditions * single dose, randomized, crossover design |
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Healthcare Dollar and Drugs |
Prescription drugs are less than 10% of healthcare money |
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Drug Expenditures Rising |
Annual percentage increase is 20% per year |
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Growth in U.S. Pharmaceutical Expenditures is Due to? |
- increase in price (not alone) - increase in volume - increase in innovation - increase in mix = what drugs are being used at a greater volume (often more expensive drugs)
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Why is there a push to use brand drugs over generic drugs in mix? |
to cover the cost of developing the drug |
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% of world's drugs that the U.S. consumes |
50% |
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% of drugs produced from the private sector |
90% |
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Is it better to be the 1st company to produce a drug or not? |
Yes, it's better
Want to be #1 b/c you will make the most money
There is a greater focus on making new drugs to treat something that was never before treated instead of re-vamping existing meds |
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Treatment Costs VS. Reduced Labor Costs |
It is more costly for people to be out of work than to pay for the medications |
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Which 7 Conditions has Volume as the Primary Driver for Increased Cost |
1. anti-depressants 2. anti-diabetics 3. anti-histamines 4. antihyperdislipidemics 5. asthma 6. gastro-intestinal 7. hormone replacement therapy |
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More Patients are Being Prescribed Drugs because…? |
- aging and chronic disease and comorbidities (longer survival) - recognition of gap between prevalence and appropriate treatment - improved detection (find it earlier so we can treat it earlier) - direct to consumer advertising * greater consumer awareness: 1992 pharm companies were allowed to advertise on TV |
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Direct-to-Consumer Advertising |
Product Claim Ad - drug name, condition, risks & benefits (in a balanced fashion)
Reminder Ad - always comes after a product claim ad - assumes the audience is familiar w/ the drug - gets the drug name back out there in the mind of the consumer - blackbox label drugs are not
Help-Seeking Ad - disease/condition, but not a specific drug name - regulated by trade commission not the FDA |
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Rates of Undiagnosed, Untreated and Under-treated Illness |
Hypertension, Diabetes and Hyperlipidemia - half of people w/ these disease aren't even being treated (regardless of how much drug companies are spending) |
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FDA |
Monitors existing drugs and develops/approves new drugs |
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Primary Concerns w/ Drug Development and Approval |
Is the drug effective? Is the drug reasonably safe? |
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Phases of Testing |
Preclinical (animal) studies Clinical (human) studies - phase 1 - phase 2 - phase 3 - phase 4 |
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Preclinical Testing Phase |
Purpose: determine safety Subjects: lab animals Time length: 1-2yrs |
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Phase 1 |
Purpose: determine effects, safe dosage, pharmacokinetics Subjects: healthy human volunteers (20-80) Time Length: <1yr |
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Phase 2 |
Purpose: assess effectiveness in treating diseases Subjects: human volunteers w/ disorder (200-300) Time Length: 2 yrs |
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Phase 3 |
Subjects: assess safety & effectiveness in lg pop Subjects: human patients (1000-3000) Time length: 3yrs
* end of the line before they release the drug to the general public |
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Phase 4 |
Purpose: Monitor any problems that occur after NDA (New Drug Application) approval Subjects: general patient pop'n Time Length: indefinite |
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Success Rate of Drugs by Stages |
5,000-10,000 compounds screened 250 enter preclinical testing 5 enter clinical testing 1 is approved by FDA
*many veterinary meds come as a result of this process (find that it was helpful for animals but harmful to humans) |
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New Drugs Entering the Market |
- you want to be the first company to release the drug or you won't cover your expenses - only the top 2% of chemical entities that are created are profitable - some companies sell many drugs, but have one blockbuster drug that carries the company's profits |
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Consolidation Trends |
There are less drug companies now than 10 years ago - decreases competition - decreases options for the buyers to choose from |
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Over the Counter Drugs |
- lower dosage than the prescription - increased availability by increasing consumer access to them - cheaper for the health care system - increases consumer out of pocket expense |
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FDA Approval of OTC's |
- adequate safety profile - often a lower dosage |
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Concerns with OTC's |
Consumer self-care = decreased safety - assume ppl are smart enough to choose their own OTC's and know how to take them
Adverse reactions w/ prescription meds
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Controlled Substances Schedule |
- schedule 1-5 - the higher the schedule number, the lower the abuse/addiction risk |
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Schedule I |
Abuse/Addiction Risk: very high EX: heroin, LSD, marijuana (rarely used medicinally)
* ppl w/ cancer or other terminal illnesses will seek out these drugs b/c the symptoms of the disease are worse than the use of the substance |
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Schedule II |
Abuse/Addiction Risk: high EX: morphine, fentanyl, methamphetamine |
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Schedule III |
Abuse/Addiction Risk: low-moderate EX: codeine, anabolic steroids, certain barbiturates |
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Schedule IV |
Abuse/Addiction Risk: low EX: meprobamate, barbital, phenobarbital, stimulants/depressants |
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Schedule V |
Abuse/Addiction Risk: very low EX: low dose opioids (cough medicine) |
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Dose-Response Curves |
- For almost every drug, we see a graded response based on dose. Not an all or none phenomena. * EX: steroids
- Drugs can differ based on the dose required to generate a response (potency) * how much medication do you need to generate a response?
- Drugs can also differ on their maximal effect (efficacy) * what is the maximal effect (ceiling effect) of the response?
In all cases we need to compare the effects on the disease with the toxic effects produced |
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Ceiling Effect |
Happens when all of the receptors for that drug are taken up, therefore no more can bind to the receptors |
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Potency VS. Efficacy |
Some drugs are more potent than others - generate a response sooner w/ a smaller dosage - ppl having MI need this type of drug
Some drugs have more efficacy than others - generate a greater response - ppl w/ chronic, severe diseases will often have 2 drugs (one more potent and one w/ more efficacy) |
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Median Effective Dose (ED50) |
Dose required to produce 50% of the maximal effect |
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Median Toxic Dose (TD50) |
Dose required to produce adverse effects in 50% of the group tested |
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Median Lethal Dose (LD50) |
Dose required to cause death in 50% of the animals tested (animal studies only) |
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Therapeutic Index |
TI = TD50 (or LD50)/ED50
- indicator of drug's safety - the greater the TI, the safer the drug - a larger TI indicated a much larger dose is needed to cause a toxic response beyond the dose needed for a beneficial effect * EX: acetaminophen TI = 27; Vallium TI = 3 |
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Cancer Drugs and TI |
Some cancer drugs have a TI of almost 1 - meaning the drugs prescribed dosage is almost the same as the toxic dosage - the drug looks like it's killing them |
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Marketed Dose |
What drug companies determine to be the marketed dosage - if you market the drug too close to it's toxic effect ppl who take it will have many adverse effects - if you market the drug too far away from beneficial effect dose ppl who take it will have no response - companies tend to market the drug closer to the toxic effect b/c they want to prove that their drug works |
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Drug Development |
Developing drugs that work and finding doses that are non-toxic yet beneficial is quite complex and very costly
Drug companies work hard and spend money trying to get ppl to take their drug and physicians to prescribe it |
