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I thought it might be useful for the faculty types among the group to
share course syllabi. I would also like to know what people use to
help make the learning of PK easier for their students (of all
types). This might include videos, computer programs, visual tricks,
etc.
If anyone would like to discuss the course below (which also includes
pharmacokinetic debates - syllabus not provided) please feel free to
e-mail or call at (520) 626-5730 U.S. I will look forward to
comments and ideas.
I also have a nice handout on basic kinetics that I use to teach
current practitioners. It can be made available if anyone is
interested though I would appreciate acknowledgement (it has been
published).
ADVANCED CLINICAL PHARMACOKINETICS - PhPr 485
PHARMACOKINETICS DISCUSSION - PhPr 408b
COURSE SYLLABUS - 1996
Course Coordinator
John E. Murphy, Pharm.D., FCCP, FCP
Professor and Head, Department of Pharmacy Practice and Science
Room 313, Phone - 626-5730
Office hours by appointment. This allows me to prepare to devote time
to your questions. See or call Department Assistant or talk to Dr.
Murphy before or after class. I am happy for you to drop in without
an appointment but may not be available if attending to other
business. I trust you will understand.
Participating Faculty
Paul E. Nolan, Pharm.D., FCCP Suzanne Campbell, Pharm.D.
Brian Erstad, Pharm.D., FASHP Karen Ann Sauer, Pharm.D.
Victor A. Elsberry, Pharm.D., BCNS Michael Mayersohn, Ph.D.
Course Credit and Times
PhPr 485 - Three hours credit - combination of lectures/case
discussions Monday and Wednesday - 11:00 am to 12:15 pm (no break) -
Room 109
PhPr 408b - One hour credit - Therapeutic controversies
Friday - 10:00 am to 10:50 pm - Room 109 - lectures/case discussions
Rooms 109, 329 - debates (latter half of course)
Course Description
Advanced Clinical Pharmacokinetics - PhPr 485, is designed to provide
the skills necessary for employing pharmacokinetic principles in the
selection and evaluation of drug therapy. Emphasis is placed on
applying population average pharmacokinetic parameters and measured
drug concentrations to determination of dosage regimens for individual
patients. Factors which lead to variability in pharmacokinetic
parameters between and within individuals will also be stressed.
Students will evaluate the impact of variability on the development of
dosage regimens for example patient cases. Integration of literature
data on population averages to design of dosage regimens in example
patients is required. Precision is expected.
Pharmacokinetics Discussion - PhPr 408b, is designed to enhance the
student's ability to evaluate therapeutic controversies and to come up
with logical arguments for positions taken on issues. See additional
handout.
Prerequisites PhSc 407 and PhSc 408a
Required Textbook
Murphy, JE (ed). Clinical pharmacokinetics pocket reference.
Bethesda, MD: American Society of Health-System Pharmacists, 1993.
Note: Dr. Murphy=s proceeds from sale of the textbook to U of A
students are given to the student council. Suggested Textbooks
Rowland M, Tozer TN. Clinical pharmacokinetics: Concepts and
applications (3rd Ed). Philadelphia: Lea and Febiger, 1995.
Evans WE, Schentag JJ, Jusko WJ (eds). Applied Pharmacokinetics:
Principles of Therapeutic Drug Monitoring, 3rd Ed. Vancouver, WA:
Applied Therapeutics, Inc., 1992.
Other Useful Texts
Winter ME. Basic clinical pharmacokinetics, 3rd edition. Spokane, WA:
Applied Therapeutics, Inc., 1994.
Gibaldi M. Biopharmaceutics and clinical pharmacokinetics, 4th
edition. Philadelphia: Lea & Febiger, 1991.
Gibaldi M and Perrier D. Pharmacokinetics, 2nd edition. New York,
Marcel Dekker, Inc., 1982.
Taylor WJ, Caviness MHD. A textbook for the clinical application of
therapeutic drug monitoring. Irving, TX: Abbott Laboratories
Diagnostics Division, 1986.
Taylor WJ, Robinson JD. Simkin: Handbook of therapeutic drug
monitoring. Gainesville, FL: Simkin, Inc., 1991.
General Course Objectives
The APhA published the results of its survey of competencies required
of practicing pharmacists. The list of competencies is entitled
"Standards of Practice for the Profession of Pharmacy", by S.H. Kalman
and J.F. Schlegel.
Included in these competencies are several responsibilities which
directly or indirectly involve the discipline of pharmacokinetics as
it applies to dosage regimen design. These are listed below:
The Pharmacist:
1. reviews and/or seeks additional drug-related information, e.g.,
cost, pharmacokinetic characteristics, bioavailability, common adverse
effects, to identify potential problems regarding drug therapy.
2. integrates drug-related and patient-related information in order to
determine appropriate course of action, e.g., timing of dosage
schedule, advising patients of possible adverse effects.
3. makes recommendations regarding drug therapy to the physician,
patient, or other persons involved with the patient's care.
4. continuously evaluates and monitors therapeutic response of patient
to prescribed medication.
5. evaluates the dose, route of administration, and frequency of
dosage administration, and consults with prescriber to provide
suggestions for alteration(s) of order.
The American Society of Health-System Pharmacists (ASHP) has published
practice standards which also address the use of pharmacokinetics in
patient care. In the "Statement on the Provision of Pharmaceutical
Services in Ambulatory Care Settings," the scope of activities
include, among other things, 1) assisting prescribers in the proper
selection and adjustment of drug therapy through application of
pharmacokinetic and other principles, and 2) detecting and reporting
adverse drug reactions, interactions, and non-compliant patient
behavior (all of which may be evaluated using pharmacokinetic
principles). In ASHP's "Statement on Clinical Functions in
Institutional Pharmacy Practice," the scope of practice includes
provision of written consultations in such areas as adverse drug
reactions, pharmacokinetics, nutritional support, and determination of
therapeutic endpoints. There is also an entire ASHP Statement on the
"Role of the Pharmacist in Clinical Pharmacokinetic Services" which
lists eight major activity areas.
A recent survey of pharmacokinetic services in the nation=s hospitals
(Murphy JE, Slack MK, Campbell - to be published in the Am J of
Health-Syst Pharm) found that provision of such services primarily
fell on staff pharmacists. As 64% of the hospitals returning the
survey indicated the provision of such services, it is likely that
many new pharmacy graduates will be required to evaluate the
pharmacokinetics of patients.
Finally, nearly all clinically related job opportunities stress the
need for expertise in pharmacokinetics. This course is designed to
provide the introduction to that expertise.
Course Learning Objectives
1. Given formal lecture/discussions and reading assignments, the
student will be able to use pertinent pharmacokinetic parameters for
each drug studied during the course to design dosing regimens or
predict concentrations from administered regimens.
2. Given
discussions and reading assignments, the student will be able to
discuss issues related to general variability of drug concentration
measurements caused by assay techniques, collection techniques, and
dose administration techniques.
3. Given discussions, reading
assignments, and homework problems, the student will be able to
discuss and evaluate the effects of variability, genetics, age,
weight, disease, and interacting drugs on the pharmacokinetics of
reviewed drugs.
4. Given formal presentations and discussions, the
student will be able to develop methods to evaluate the benefits of
therapeutic drug monitoring.
5. Given lectures, discussions, readings,
and homework, the student will be able to discuss the effect of
dialysis, volume of distribution, metabolite formation, and
pharmacological response on drug pharmacokinetics and patient
response.
6. Given cases presented by the instructor(s), the student
will be able to:
a. identify which patients present potential dosage
problems.
b. outline an approach for solving a patient's
dosage-regimen problem(s).
c. construct an appropriate pharmacokinetic
model to apply to the patient and drug.
d. develop a blood sampling
plan for each patient.
e. predict or determine a drug's clearance,
half-life, and volume of distribution in example patients.
f. identify
pertinent variables necessary to design a dosing regimen. These
include such things as the bioavailability (F) of the dosage form
chosen, the fraction of dose that is parent drug (i.e., the S), the
best patient weight to use in clearance or volume predictions (i.e.,
actual, ideal, or some adjusted weight).
g. use the literature and/or
a patient's data to design a pragmatic dosage regimen for the patient.
h. formulate the appropriate times for follow-up of the drug's blood
concentration and therapeutic response of the patient.
7. By
comparison and contrast, the student should be able to discuss the
potential effect of pharmacokinetic monitoring on the care of a
patient. Students should substantiate their evaluation with logical
data.
8. Students will understand the use of computer software to
analyze patient data and construct dosage regimens using Bayesian and
traditional predictions.
Course Format
All discussions will be based on required readings. Lectures will NOT
be the course norm. Student are expected to have read the assignment
and completed the homework assignments prior to attending class.
Tests will contain materials that were assigned but not necessarily
covered in class.
The instructor(s) will go over materials and present additional cases
for working both in and outside of class. Therefore, students should
come prepared to do calculations in class (i.e., BRING YOUR CALCULATOR
TO EVERY CLASS).
Students will be given case assignments related to use of computer
software.
Grading Scale and Allocation
PhPr 485 PhPr 408B
PhPr 485/408B
Quiz 10% Debate 35%
A 90.00 to 100
Mid-Term 1 25% Paper 35%
B 80.00 to 89.99
Mid-Term 2 25% Attendance 30%
C 70.00 to 79.99
Final (cumulative) 40%
D 60.00 to 69.99
F < 60.00
* A practice test will be provided prior to first quiz since this is
primarily review from PhPr 407 and it has been some time since the
course.
* There will be no make-up exams. Any student missing an exam
without a valid and documented excuse (e.g., in hospital, deathly ill)
will receive a grade of zero for the exam. Those with a valid and
approved (by Dr. Murphy) excuse will have the points for the missed
exam added to the final exam.
* Please carefully note the grading
scale. The .99 designation lets you know that rounding off will not
occur. There is always an arbitrary cut-off. This is mine. Make
sure to be above the value for a higher grade.
o Only non-programmed calculators may be used for
examinations. Use of a programmed calculator is considered
a violation of the student honor code.
Dr. Murphy's Philosophy of Grading
It is my belief that precision in the imperfect world remains
important for pharmacokinetics. Thus, I am trying to help guide your
learning of how to initiate therapy in patients in a more
sophisticated manner than just using the PDR. As an example, if you
forget to put in an S or F, transcribe a value incorrectly from a part
of your work sheet or the problem, or if you put in the wrong time,
even if off by only 15 minutes, no points will be awarded. It is
extremely important for you to understand this, whether you agree with
the philosophy or not or whether some other professor has a different
philosophy or not.
I award credit for a question which requires information from a
previous question when the first question is worked incorrectly.
Thus, if you work the first part incorrectly, there is no chance you
would get the second part right. As long as the second part is worked
correctly using the incorrect value from the first part, credit may be
given (though it may not be full credit).
PhPr 408b
The grading and course work of 408b will relate to seven debate
sessions. Each student will be part of a two person debate team which
will debate a pharmacokinetic or therapeutic controversy during a
scheduled session. Sixty points (out of 100) of the student's grade
will be based on this activity (35) and the subsequent paper (35).
The other 30 points of the grade will come from mandatory attendance
at the six other debate sessions (Equal points per session). There
will be no excuses for missing the debates. If an individual student
misses their own debate, they will automatically lose 25 points from
their grade - no excuses accepted. Their debate partner will be
required to present the entire debate for their side. Thus, each
student must be prepared to do their side=s entire debate. Papers
must be turned in on the day of the debate. In the terrible event
that a student does not present their own debate, their paper must be
turned in within two days after the scheduled debate day.
Some Notes on Academic Honesty
Only your work is acceptable. I work hard to enforce this policy and
am willing to go the punitive distance if someone attempts to use the
work of others. Debate papers are retained from previous years and
comparisons will be made if the topic is the same. Make sure your
work is original. There are multiple copies of each test so plan on
doing your own work for the ultimate satisfaction of knowing you
either did it right the first time or will have the opportunity to
learn from your mistakes. Use of a programmed calculator will be
considered academic dishonesty.
SELECTED TIPS FOR THE 485 COURSE
* Use the book. It should be your first reference for population
values. Don't try to learn how to use the book on the test. Know
where the important information is for each drug (e.g., S and F for
each dosage form; CL, k, and V predictors; appropriate patient weight
to use for predictions, desired therapeutic ranges, drug and disease
interactions which affect predictors). Write whatever you need to in
the formula section of the book so that YOU understand which formulas
apply to which situations. Add any formulas that might be useful
(e.g., the Chiou equation). Don=t fill the book with excessive extra
writing, it will make finding important information more difficult on
a timed test.
* When asked to see a patient in consultation you will always be
predicting their concentration based on a dose. Thus, you must always
be able to estimate their clearance, k, and V (or just k and V).
Start practicing now.
* For drugs excreted significantly by the kidney, the following steps
are required:
Determine creatinine clearance (using appropriate weight).
Find the regression equation relating creatinine clearance to either
k or drug clearance. Solve it. Find the appropriate population
average volume of distribution. Relate it to the appropriate weight
(e.g., total weight for vancomycin, adjusted weight for
aminoglycosides and phenytoin, ideal weight for digoxin).
If you determined clearance above, divide that by volume to get k (watch
units).
Pick the appropriate equation which describes the dosing
situation and plug dose, k, V, or CL into it with the Ss and Fs. Find
the predicted concentration(s)
* For drugs not excreted by the kidney, use the population average
clearance provided in the book (which won't be related to CLcr).
* Always watch out for units - make them match the desired answer!
* Always remember that once a patient has measured concentrations,
these must be used to determine the patient's k, V, and/or CL. Do NOT
revert to population clearance to solve further questions, at least on
a test. In life, you will do the "internal Bayesian" approach of
comparing concentration results to population predictions - but not on
a test.
* Never, ever use the "average" dose or clearance when a more precise
prediction calculation can be made. For example, if you are asked to
solve for a dose to provide a certain concentration of lithium in a 29
year old patient and are provided with creatinine or creatinine
clearance, use of the age related clearances on page 169 of the text
or the initial dosage range on page 145 will result in no points
credit. Instead, you would use one of the clearance predictors on
page 168 and calculate the dose using the appropriate equation. If we
used the more imprecise averages, the variability will be increased.
These "averages" are appropriately used as a general check of your
predicted clearance or dose.
* The precise time after dose administration that the concentration
occurs is absolutely critical for a test. You will learn in practice
that some fudging can occur with limited error when drugs have a
long half-life. We will leave that learning to clerkships.
* Work extra problems (make them up or get them from where you work
outside - if you do) solving for dose, clearance, volume, k (and t2),
and Cssavg or C at any time after a dose - using population values or
measured concentrations for every drug. Use various patient weights
(undernourished, normal, and obese) and ages.
* Create a study group and teach each other. It is amazing how much
you learn if able to teach someone else. This is the most useful
suggestion of all.
* Precision is required. Though this may seem unnecessary in an
imperfect world, we must start somewhere and do our best. Multiplying
the imperfections through lack of attention to detail is not likely
improve the outcome.
* When concentrations are provided, choose the right equation (i.e.,
the one describing how the dose was actually give) to solve for k, V,
or CL.
* When a patient has been on a drug, loading doses are calculated to
seek the change in concentration desired. For example, if a patient
has a phenobarbital concentration of 20 mg/L and the desired new
concentration is 35 mg/L, the dose should be determined to change the
concentration 15 mg/L.
* Look at desired therapeutic range to determine dosage interval.
Using predicted or actual half-life determine how many half-lives are
necessary (for those drugs such as vancomycin and aminoglycosides).
Solve for dose after interval determined.
* When a question asks for peaks and troughs, you must have a k and V.
* When a question asks for average steady-state concentration, you
must have clearance (of course, k x V = CL).
* Be careful to find the appropriate S and F for each drug product or
dosage form and the appropriate pharmacokinetic parameter predictors
with appropriate patient weight. These can make or break your answer.
* Practice, practice, practice. The harder you practice, the luckier
you will get on the tests.
John E. Murphy, Pharm.D.
Professor and Head
Department of Pharmacy Practice and Science
(520) 626-5730 (P), (520) 626-7355 (FAX)
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Thank you for the teaching material. I have printed it and will look at
it in more detail later.
I would be very interested in this type of sharing especially clinical
cases/examination questions/ the tricks you allude to/teaching strategies
etc etc.
I am the course co-ordinator for a Coursework Masters degree in Clinical
Pharmacology which has one Module called "Therapeutic Drug Monitoring &
Toxicology". We are constantly on the lookout for ways of improving and
for new material.
Looking forward to future interactions.
Regards
Colin Pillai
Senior Lecturer & Acting Head of Department
Department of Pharmacology
University of Durban-Westville
Private bag X54001
Durban 4000
South Africa
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Dr. Murphy,
Thank you for your effort and time in sharing the pharmacokinetic
syllabus. I teach a basic Biopharmaceutics and Pharmacokinetics course
for B.S. pharmacy students. I follow "Applied Biopharmaceutics and
Pharmacokinetics" by Shargel and Yu. The book has many errors and very
theoretical. I am thinking of changing the text book and adopt "Clinical
Pharmacokinetics" by Rowland and Tozer as the text book. Since our School
is going to offer Pharm. D. from this year, I am writing a syllabus for
Clinical Pharmacokinetics to be taken later on in the program. Your e-mail
information is certainly helpful in this regard. If you have any more
suggestion please let me know. I will greatly appreciate looking into the
course contents for PhPr 485.
Also, I am going to Ross University School of Medicine, Dominica
to give some lectures on Pharmacokinetics to the Medical Students. I would
like to look at your published handout on basic kinetics.
Best regard,
M. Delwar Hussain, Ph.D.
Assistant Professor
School of Pharmacy
University of wyoming
Laramie, WY 82071-3375
Tel: (307) 766 6129
Fax: (307) 766 2953
E-mail: delwar.-a-.uwyo.edu
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In response to John Murphy's request for information and sharing of ideas
for teaching pharmacokinetics, I have attached an abstract of a program that
I have provided as freeware on the internet. See the following Web page:
http://www.netvoyage.net/~labsoft
This program is described in more detail in the following reference:
Michael B. Bolger, Amer. J. of Pharmaceutical Education (59), Winter 1995.
Please reply by E-mail if you would like a reprint.
The Cyber Patient: A Multimedia Pharmacokinetic Simulation Program for Case
Study Generation in a Problem-Solving Curriculum.
Michael B. Bolger, USC School of Pharmacy, 1985 Zonal Ave. PSC 700, Los
Angeles, CA 90033
Cyber Patient is a multimedia pharmacokinetic (PK) simulation
program that
can be used for development and presentation of problem-solving case
studies. This simulation program is appropriate for use in pharmacy or
medical schools to assist the instructor in development of PK drug models.
The PK drug models are used by students to generate their own data for use
in a problem-solving curriculum. In addition, Cyber Patient can be used in
the pharmaceutical industry for pharmacokinetic drug simulations.
The Cyber Patient simulation is an MS-Windows program based on a
numerical
method for solution of the differential equations that describe one and two
compartment models. The simulation places the user in the role of a health
care professional that has primary care responsibility for a patient who is
taking medication. The user can load a PK model from the disk or create a
model by entering the appropriate PK parameters into text boxes on the main
screen. A patient view menu can be programmed by the instructor to contain
a sound (.WAV) or video (.AVI) files that describes the patient's condition.
When blood levels are too low the user observes a "sick" patient and when
therapeutic blood levels are achieved, the user observes a "treated"
patient. However, if blood levels get too high the patient can be
programmed to have a "toxic" reaction.
Each time the simulation is run, the user must select five time
points for
collection of drug level data from the central compartment. Following the
simulation, blood level data is displayed in graphical format as well as
being placed in the Windows clipboard (with random error) for convenient
pasting into another application or spreadsheet for determination of the
best fit parameters.
In addition to the simulation of pharmacokinetics, Cyber Patient
contains
an extensive help system that is a "hypertext" introduction to basic
pharmacokinetics. The Help system allows the user to search for information
about pharmacokinetic terms and to follow "hypertext" links from one topic
to the next.
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