I hope that everyone is having a great holiday and enoying not even thinking about st*dying. I just wanted to wish eveyone a Merry Christmas and Happy Holidays! See you all, very soon!

-Delia

TAKE A BREAK

HEY YALL!!! WE ARE ALL STUDYING WAY TOO HARD! YOU DESERVE A BREAK. WATCH THIS, IT IS HILARIOUS!!!

UPDATE: Biochem Tomorrow!!!

Hey guys! I wanted to post some help, but I do not seem to have a recent file that is small enough. If you have anything helpful that is under 1 KB please send it to me or the google group.
I do know the breakdown:
40% Webster (1 20pt and 2 10 pt questions)
40% Mcbride (MULTIPLE CHOICE!)
20% Riggs (10 2pt multiple choice)

Hope it helps!!!!

breakdown of p&p test

Wilborn : Cell, transport, signal transduction, electrophysiology, muscle - 14

Sowell : NS and special senses - 9

Waldrop : NS and Dopamine - 6

Sowell : CV - 7

Luthin CV - 7

Waldrop : Blood - 3

Wilborn : Skin - 2

Wilborn : Bone - 2

Bumgardner : Immunology - 15

for casey!

here is an old dosage review, maybe it will help

also this: (thanks Michael)

Excipients:

Acidifying agents- Citric acid, HCl, H2SO4
Alkalinizing agents- NaOH, Sodium Bicarb
Adsorbent- activate charcoal
Antifungal- ___paraben, benzoic acid, sodium benzoate
Antimicrobial- Benzalkonium Chloride, benzyl alcohol (gasping baby syndrome...I think this what it caused), thimersol, pheylmercuric nitrate, phenol, cetypridinium chloride
Buffering agents- potassium phospate, sodium acetate, sodium citrate
Emulsifying Agents- acacia, cetyl alchohol, glycerol monostearate
Humectant- glycerin, propylene glycol
Levigating agents- mineral oil, glycerin, propylene glycol
Suspending/viscosity agents- agar, betonite, xantham gum, acacia, carrageen, micro crystalline cellulose, any cellulose, silicon dioxide, tragacanth, carbomer, bentonite, veegum
Emulsifying Agents- Water soluble polymers- celluloses, Natural polymers- acacia, agar, pectin, sodium alginate, xantham gum, gelatin Cellulose derivatives- stuff with cellulose in the name
"Flowability" of powder excipients- silicon dioxide
Glidants- Magnesium Stearate (see above as well)
Sugar, enteric, and film coatings
Drugs and things stressed about them:
Aspirin- ester hydrolysis
Amoxycilin- hydrolysis
Vancomyacin
Premarin
Penicillans- stability and basic structure
Sulfa drugs
Acetomenophen- basic structure
Phenylpropylnylamine (dimatab)-
Nasacort- triamcinolone acetonide, suspension
Maxidex- dexomethasone, suspension
Pred forte- this is a gimme, suspension usage
Cyclosproin- drug that is oil soluble used in emulsions
Tetracylcin- milk problems
Birth control and enteroepatic circulation
Prozac weekly- film coating protection, long half life
Duoneb- albuterol and imotropine bromide
Budesonide- corticosteroid
Triamcinlone acetonide- corticosteroid
Beclometasone- corticosteroid

physiology stuff

Here is a review of Dr. wilborns stuff from last years exam!

Also does anyone have a list of the medications and excipients from dosage that I could post!

Keep up the good work! I will post more stuff tonight, and anything that yall want up please email it to me!

better late than never

here is some last minute help

study questions

2004a

2004b

Amazing!!!

I just wanted everone to know, that while we were studying and resting this weekend, Emily Morris ran the St. Jude marathon in Memphis. I'm not sure but I think that is like 26 or so miles!!! So congratualtions Emily!!!!

Info Systems Review

(a little birdie sent me this...is not meant to be comprehensive, just something to get youstarted!)

You should be able to copy it and paste it into word!!!

Hope it helps!!!

Plagiarism

1. When an author presents as his or her ideas, language, data, graphs, or even scientific protocols created by someone else without giving proper credit.

2. There are 2 basic reasons to cite:

   • documentation (to support an idea)

   • acknowledgement (avoid plagiarism)

3. Rule of practice: place citation number closest to actual material you are referencing.

4. Personal communication is listed in running of text, not as works cited page. Use date of communication, oral or written, affiliation of person to est. relevance.

5. Place registered trademark with first use of word, then omit.

6. Sample citations:

Journal article

Smith J, Canton EM. Weight-based administration of dalteparin in obese patients. Am J Health-Syst Pharm. 2003;60:683-687.

Books with 2 or more authors

Aronoff GR, Berns JS, Brier ME, et al. Drug Prescribing in Renal Failure. 4^th ed. Philadelphia, PA: American College of Physicians;1999:39.

Chapter in a book

Wallace RJ Jr., Griffith DE. Antimycobacterial agents. In: Kasper DL, Fauci AS, Longo DL, Braunwald E, Hauser SL, Jameson JL, eds. Harrison’s Principles of Internal Medicine. 16^th ed. New York, NY: McGraw-Hill; 2005:951-952.

(authors of chapter, title of chapter only capitalize first word. In: author(s) of book OR EDITITORS, title of book italic or underlined. X ed. Place, State: Publisher; year: page number.

Package Insert

Lamasil [package insert]. East Hanover, NJ: Sandoz Pharmaceuticals Corp; 1993.

eBook

Rennie D, Guyatt G, eds. Users’ Guide to the Medical Literature: A Manual for Evidence-Based Clinical Practice [book online]. Chicago, IL:AMA Press; 2002. http: ……Accessed December 5, 2006.

Lexi programs

Lexi-Comp, name of book or data base (Lexi-Drugs, Comp + Specialties) [computer program]. Compiler of data base Skyscape; date and/or version/date of program

Tertiary Literature

Literature Hierarchy

3’ textbooks, review articles

2’indexing/abstracting sources

1’ original research

I. Tertiary Literature:

• established knowledge

• consists of package inserts; textbooks; review articles; full-text databases, PDA programs, and practice guidelines.

• Provides an “overview” of topics gathered from primary lit, condensed in organized format.

II. Advantages of 3’ Lit

1. convenient

2. concise

3. easy to use format

4. updated (some)

5. efficient

6. organized

III. Disadvantages of 3’ Lit

1. incomplete information

2. biased info

3. lag time

4. varied interpretations

MONOGRAPHS

Provides extensive overview of a medication

Examples of monograph references:

-package insert

-drug facts n comparisons

-AHFS

-USPDI vol 1

- Lexi-Drugs

-Clinical Pharmacology

-PDR (physicians desk reference)

PACKAGE INSERTS

-contain info from manufacturer

-info provided is FDA approved

-found in 1. Online and http://www.drugname.com/ 2. medication bottles 3. PDR

SECTIONS OF MONOGRAPH

1. Drug name- brand/generic

2. Description- chemical name, structure, dosage form info, inactive ingredients

3. Clinical Pharmacology- explains how rx works in body, differences in action based on gender, age, or ethnicity, and contains drug-drug interactions.

4. Indications/usage- lists uses that are FDA approved, conditions that have adequate date from clinical trials are included

5. Pregnancy/Lactation Category- rankings and lists if product is compatible in breast milk

6. Contraindications- lists situations rx should not be used, warns prescribers not to use rx in conditions in which more prone to adverse effect

7. Warnings/Precautions- discusses serious side effects that may occur in people, BLACK BOX WARNINGS- severe or life-threatening

Precautions- advises how to use rx safely and effectively, alerts prescribers to patients that need close observation, lab test info, pregnancy, geriatric and ped info in this section. Also lists DRUG INTERACTIONS

8. Adverse Reactions- lists all side effects that were reported in people who took rx wile it was tested. May be grouped by body systems. May include frequency of occurrence.

9. Overdosage- effects and treatment

10. Dosage/ administration- recommended doses, time and route,

11. How supplied- available forms of Rx, formulation description (color, shape, markings) Storage instructions, and number of units/package.

DRUG FACTS AND COMPARISONS

• -updated monthly

• -black box warnings

• Investigational drugs

• Manufacturer index

• Orphan drugs

• Normal lab values

• Drug ID database

• Rx, otc, and herbal info

• Extensive product listings

• Patient leaflets

AHFS

• American Society of Health-System Pharmacists

• Official source for unlabeled drug uses

• Incorporates evidence based medicine principles from nationally recognized organizations

• Most used by hospital pharmacists

USPDI VOL 1

• Official source of unlabeled drug uses

• Contains auxiliary information

• Does not have all drugs

• Monthly updates online

MICROMEDEX

• Online database

• Contains info related to ID of drug products

• Info of foreign drugs, drug interactions, and IV compatibility

• May contain info about FAQ related to drug therapy

• OFFICIAL COMPENDIUM for unlabeled drug uses

PDR (PHYSICIANS DESK REFERENCE)

• Contains selected package inserts for paid manufactures

• Medications organized by manufacture

• Contains photo of RX

• Updated annually

• Most used by Drs.

MOSBY’S DRUG CONSULT

• Contains Package inserts of all drugs

• Updated annually

• Contains photo of RX

CLINICAL PHARMACOLOGY

• Online database

• Contains info related to id, availability, choice for condition, interactions, alternative medicine

• Contains patient info in espanol

LEXI-COMP

• Online, print and PDA

• Contains drug interaction checker and drug ID

• Patient info in several languages

• Special population databases

• Retail prices

• Photos of RX

• International brand names available

• Compounding formulas

Free monograph references include

-RxList.com

-drugs.com

DRUG THERAPY REFERENCES

• Pharmacotherapy

• Applied therapeutics

UNLABELED USES

• AHFS

• USPDI vol 1 official compendia

• Micromedex

• Lexi-comp

• Facts n comparisons

GENERAL VS SPECIFIC

General offers overview

Specific have more comprehensive, focused info. Includes in-depth discussions of the topic and practice-related experiences to a greater extent than general

OTC/HERBAL

• Handbook of Nonprescription Drugs

• Natural Medicines Comprehensive Database

ADRs

• Meyler’s Side effects of Drugs

• Monograph references

COMPOUNDING

• Allen’s Compounding

• Pediatric Drug Formulations

DRUG INTERACTIONS

• Drug Interaction Analysis and Management (Hansten and Horn)

• Drug Interaction Facts

• Lexi- Interact

IV STABILITY/COMPATABILITY

• Handbook on Injectible Drugs

• King’s Guide to Parenteral Admixtures

PATIENT COUNSELING

• USPDI Vol 2

• MedFacts Patient Information (online or print)

• Lexi- Pals

COST

• Drug Topics Red Book

• Lexi-Comp (retail only)

• Clinical Pharmacology (retail only)

• Mosby’s Drug Consult (AWP)

PREGNANCY CATEGORY/ LACTATION

• Drugs in Pregnancy and Lactation (Briggs)

• Monographs (non-specialty)

DRUG INFORMATION CENTERS (Biomedical Lit Section of Notebook)

• Began in 1962, University of Kentucky

• “Source of selected, comprehensive drug information for staff physicians and dentists to evaluate and compare drugs”

• Questions generated by health care professionals

• Specialists usually trained in drug info practice

• Majority of questions concern therapeutic recommendations, ADRS, drug ID, and dosage

• Most (70%) DICS are in hospitals or medical centers; other areas include: colleges, libraries, and poison control centers

DIC DUTIES

• Answer questions

• Provide pharmacy and therapeutic support

• Develop policies and procedures

• Develop medication use programs

• Conduct research

• Train students/residents

POISON CONTROL CENTERS

• Accurate and timely info to enhance quality of care of patients calling

• Questions mostly generated by consumers

• More urgent responses required

• Specialists trained in clinical toxicology

• Some nationally certified

• Free service

ANSWERING DRUG INFORMATION QUESTIONS

Modified Approach (1986)

Step I: Secure demographics of requestor

1. requestor occupation

2. determine method of delivery

3. contact info

Step II: Obtain background information

1. essential for effectively using approach

2. used to help clarify question

3. determine if question is patient specific vs general

4. if patient specific acquire info concerning age, weight, allergies, organ function, ect.

Step III: Determine/ Categorize ultimate question

1. confirm request by restating question to requestor

2. aids in directing researcher to specific resource or type of resources

3. establish timeline for response

4. Classifications from practicum and website (adrs, bioequivalence, compounding, patient education, ect.)

Step IV: Develop search strategy and conduct search

a. choose references that complement question categorization

b. begin with established knowledge (3’ lit)

c. Secondary lit can be used

d. primary lit can be “consulted”

Step V: Perform evaluation, analysis, and synthesis

1. evaluate info located

2. answers may not be clearly stated

3. confirm answers in multiple references (> 2)

Step VI: Formulate and provide response

1. restate question with background info

2. include a brief review of search strategy and references used

3. include assessments of conflicting data

Step VII: Conduct follow-up and documentation

1. document question and response

2. conduct follow up

• protects against legal liability

• justification of professional value

• future reference

• quality control

• new info may become available

SECONDARY LITERATURE

Indexing and abstracting services of the primary and tertiary literature

PUB MED vs IPA

PubMed

• Scope is biomedical literature

• Contains information related to drugs and diseases

• Contains biomedical lit related to clinical practice

• Began in 1966 by national library of medicine

• Contains > 11 million references

• Indexes review articles, clinical trials, practice guidelines, editorials, letters, ect

• Updated daily

• Shortest lag time

• Freely accessible

• Contains full-text journal articles in addition to abstracts

• Contains links to articles that have fee

• Controlled vocabulary is Medical Subject Headings (MeSH)

IPA

• Pharmacy practice

• Clinical and technical drug info

• Pharmaceutical education

• Legal aspects of pharmacy

• Compounding formulations

• Medication protocol

• Produced by American society of health systems pharmacy

• Began in 1964

• Indexes > 750 journals, abstracts of papers presented at pharmacy meetings, US state journals, letters, editorials, and reviews

• Updated once monthly

• May have long lag time

• Contains journal articles in English, foreign languages, hum and non human subjects

• Only contains abstracts

• Controlled voc is SUGGEST

• Boolean operators and, or, not

ADVANTAGES/ DISADVANTAGES OF SECONDARY LITERATURE

Advantages

• Indexed by topic

• Uses controlled vocab

• Efficient method to search literature

• Organized format

• Different scopes per database

• Citations contain abstracts

• Full text journal articles may be available (PUBMED)

• Special search features (limits)

• Can store, email searches

Disadvantages

• Lag time for some databases (IPA)

• Limited scope

• Indexing methods

• Full text journals not available in some

• Equipment required

• Costs

PRIMARY LITERATURE

• Original publications published in biomedical journals; new information

• Most current resource of information

• Provides details of research methods and results

• Basis of secondary/tertiary lit

ADVANTAGES:

• current

• most subjected to peer review

• less lag time

• reader can critically evaluate to determine usefulness

• organized format

• provides specific details of study and results

DISADVANTAGES:

• flaws in study methods may exist

• all investigators do not follow format

• may not provide reader with enough info

• limited access

• results may be biased

• conclusions may be inflated

• interpretations may be varied

DESCRIPTIVE: CASE REPORT/SERIES

• records observations related to a drug or technology applied to a single patient or group of patients

• retrospective, observational

• does not involve multiple treatment periods

• useful in identifying drug toxicities

• results may or may not be compared to a control group

• hypothesis generating; results should be confirmed with a controlled, clinical trial

ADVANTAGE

• id treatments for rare disorders where large subject populations do not exist

• early recognition of drug toxicities

• hypothesis generating

DIS

• difficult to determine cause and effect

• interpretation can be difficult

• design and methods for conducting case report not well defined

• usually only applied when all treatment options have failed

EXAMPLE: 50 year old man presents to ER with a 36 yr history of painless decreased vision in his left eye after a visit to his family MD 3 days prior with complains of dizziness. The MD prescribed fosinopril 20mg/d and HCTZ 25 mg/d. The next morning the patient noted loss of vision in his left eye.

OBSERVATIONAL STUDIES

1. CASE CONTROL:

• useful for studying rare conditions

• short duration

• relatively small numbers of patients needed; inexpensive

• aid in generating hypothesis about causes of a new disease

• difficult to sort exposure and outcome

• only one outcome can be studied

• relies on self-report

• possible incomplete/inaccurate information on patients

• difficult to determine cause and effect

• risk factor may not be reason for group differences

2. COHORT

• describes incidence and investigates potential causes of a condition

• provides a view of “real life” since they reflect natural unfolding of a disease state or exposure to certain condition

• difficult to determine cause and effect

• expensive

• inefficient way to study rare outcomes

3. CROSS SECTIONAL

• do not have to wait for outcome to occur

• inexpensive

• short duration

• difficult to establish cause and effect

• not useful for rare diseases

• subject to transient effects that may occur during study

4. CLINICAL TRIALS

-gold standard

- can determine cause and effect

- can quantify differences between groups

-provides evidence for/against clinical practice use

-costly

-time consuming

- may not be able to apply results into clinical practice

-publication of results may be delayed

EDITORIALS

• commentaries about current controversies

• commentaries from experts in the field related to a study

• may be biased

LETTERS TO EDITORS

• brief reports

• preliminary observations

• may ask authors of a recent study questions

STRUCTURE OF CLINICAL STUDY REPORT

1. Abstract- article summary

2. Introduction- rational of study/ background info/ objective or purpose

3. Methods- study design/ patient inclusion/exclusion info/ explanation of what was measured/description of intervention and control/statistical analysis

4. Results- patient demographics/ measurements for endpoint(s)/ medication side effects reported

5. Discussion- interpretation of study results

6. References/ Bibliograph

7. Fine Print- acknowledgements/ funding/ peer review dates

BIOMEDICAL EXTRAS- LECTURE BY DR. LAUDERDALE 10/26/06

1. Peer review process

GOALS

1. to raise quality of end product (journal)

2. provide mechanism for fair and objective decision making

ADVANTAGES

1. incorrect work filtered out

2. increased accuracy and clarity of end product

DISADVANTAGES

1. decreased timeliness and increased time to publication

Upon peer-review have options of:

Accept manuscript

Accept manuscript with minor revisions

Accept manuscript with major revisions

Reject manuscript

Journal supplements

Not a regular issue of journal

Usually a theme-disease or drug

Differences exist between supplement and parent journal

May not be peer reviewed

Can be sponsored by pharmaceutical company which is way to push their drug

Pure Food and Drug Act of 1906

• prohibit adulteration and misbranding of food and drugs

• only prevent false statements for strength, quality, purity, but not false or misleading claims of cure or efficacy

Food, Drug and Cosmetic Act of 1938

• sulfanilamide elixir

• had to prove drug was safe

• required testing with results

• directions for use and habit forming properties

• exempted all pre-1938 drugs

Durham- Humphrey Amend. 1951

• federal law prohibits dispensing without a prescription

• started OTC vs prescription drugs

Kefauver-Harris Amend 1962

• Thalidomide

• Required drug not only to be safe, but effective

• Retroactive to 1938

Orphan Drug Act 1983

• provided tax incentives exclusitivity and grants to companies developing drugs for diseases that affect small number of people

Drug Price Competition and Patent Term Restoration Act 1984

• streamline generic approval (ANDA) but still aid and encourage research with patents

Dietary Supplement Health and Education Act 1994

• defined dietary supplement- permitted some claims on drug

• no regulation of strength, FDA must prove Unsafe before removal from market

Food and Drug Administration Modernization Act 1997

• expedite availability of drugs

• fast track designation for key drugs

• ensured continuation of pharmacy compounding

FDA APPROVAL PROCESS

Phase I

• determine the safety and toxicity of a drug

• pharmacokinetics

• pharmacology

• dose range

• last 6 months to 1 year

• patient population of 20-80 HEALTHY volunteers

Phase II

• determine efficacy of drug in targeted disease state

• duration- 2 years

• patient base 100-200 with disease state

Phase III

• further build on safety and efficacy established

• duration 3 years

• patients 600-1000

NDA

PHASE IV

• post marketing trials

• additional information on drug’s risks and benefits

• evaluates different doses

• safety in extended patient population

1

getting ready for finals

Hey everyone! This afternoon I filed all of our extra handouts. So if you have missed a class or lost your handout you can probably find a copy of it in the filing cabinet in the back of the room. They are organized by class and instructor. Hope it helps!!!

Physiology

Yea!!! The physiology test is over!!!! The Learn Team is planning on meeting with Dr. Wilborn the coming Monday, and we want your feedback. The test key is posted so go look at it and give us your feedback. You can put your comments and questions in the folder located in the back of the room or email them to me (deliacharest@bellsouth.net).

Also Dr. Bumgarner is going to have extended office hours before the final. Here is the schedule!!!

this sunday dec 3 2pm - 6pm

next week:

monday - thursday 5pm - 9 pm
saturday 10am - 2 pm
sunday 2pm - 9 pm * this is the day before our final*

his office phone is 726 - 2981
he prefers you coming in person, and second he would like you to call him
email is his third choice b/c "immunology is hard to explain over the email"

good luck with studying!!!! Have a good weekend!

ps if you have anything that you would like for me to post, please just email it to me!