PHAR100-0413: Pharmaceutical Regulatory Review
(Accepted for Florida State Veterinary Board Pharmacy CE requirement)
Enrollment is closed.
INSTRUCTOR(S): Doug Kemp, Pharm.D., DICVP.
COURSE OPEN: April 14-May 1, 2013
REAL TIME SESSIONS (RTS): Sunday, April 21; 7:00-9:00 pm ET (USA)
Course RTS Times in Your Area:
World Clock Converter
Practice Sessions: In order to prepare you for a successful experience
in your CE course, we request you attend a Practice Session prior to the first
Real Time Session. Please arrive promptly at the start time; each Practice Session
is up to 1 hour in length.
For more information, please visit the
CE Practice Area.
*The instructors for this course will be using audio which will require you to have a headset or speakers to listen.
If you have any concerns regarding your computer's audio capabilities, please be sure to attend
one of the Practice Sessions.
Level and Prerequisites:
This
basic course will be open to veterinarians, veterinary technicians,
support staff, veterinary teams, etc. wishing to learn how to evaluate their practice
to reduce the risk of theft, diversion or prosecution for failure to maintain an
adequate system of security and accountability for controlled substances.
VIN CE Course: Open to veterinarians, veterinary technicians,
and veterinary support staff.
This course has been submitted for RACE approval for veterinarians and veterinary technicians.
Course Description:
Participants will learn the federal requirements that apply to the security
and accountability for controlled substances in veterinary practices, including:
- Why it is important to develop a good system for your practice
- Structure of applicable federal laws and how to find them
- Schedules of controlled substances
- Laws pertaining to ephedrine and other list 1 substances
- Registration requirements
- Use of agents
- Employee screening and criminal background checks
- Components of a distribution system
- Receiving and ordering records
- Storage requirements and disposal
- Disposition & dispensing records
- Audit requirements and recommendations
- Medical record documentation including computerized medical records
- Duty to report loss or theft
- Retention of records
- Inspections and inspectors
- Distribution to other practitioners and filling of prescriptions
written by other practitioners
- Penalties
The second portion of the course addresses Food and Drug issues relating to
veterinary practice, including:
- Structure of federal laws and regulations, and where to find them
- FDA friend or foe?
- Compliance policy guides
- How to respond to proposed regulations or compliance policy guides
- AMDUCA and when extra label use is allowed
- Compounding vs. manufacturing issues
This course consists of one (1) 2-hour Real Time Session, supplemental library materials,
interactive message board discussions, and a mandatory end-of-course test.
Successful completion (scoring 80% or better) on the end-of-course test is required
to earn a certificate of completion for the course.
Upon completion of this course, the participant should be able to
- Be able to evaluate their current practices, and if needed,
implement improvements that reduce the risk of theft, diversion or
prosecution for failure to maintain an adequate system of security
and accountability for controlled substances.
- Have a better understanding of the actions of FDA and will know how
to express their opinions to FDA.
- Know when they can use drugs in an extra-label manner and when they
are engaging in activities that are of enforcement priority by FDA.
- Know when he/she can use compounded drugs in veterinary practice.
Course Materials: Course materials will be available
in the course library prior to each Real Time Session.
Required Textbook(s): There is no required textbook for this course.
About the Instructors:
Douglas Kemp is board certified in Pharmacology/Toxicology from the
International College of Veterinary Pharmacists (ICVP), 2000. He earned a Doctor of
Pharmacy (Pharm. D) from Mercer University in 1975. He is currently working as the
Clinical Pharmacy Associate and Director of Pharmaceutical Services at the University
of Georgia college of Veterinary Medicine. Douglas is a member of the Veterinary Medicine
(Information Division) Expert Committee, USP and chairman of the Pharmaceutical
Administration Board, Department of Administrative Services, State of Georgia.
Course Outline:
Week 1 (Real Time Session April 21):
Required Reading (prior to April 21 Real Time Session):
Daily postings on the course message boards.
Content:
Controlled Substances
CE CREDITS: 3
** The Georgia State Board of Veterinary Medicine recently changed their requirement
on their required 2 CE hours on Georgia laws, rules and professionalism. This course
had been previously approved to meet this requirement, but according to the most
recent board meeting, one of the two CE hours must now be acquired in person.
Please read December 2, 2009 board meeting minutes for more information:
Tuition: Member $60 ($54 early bird special if enrolled by March 31, 2013)
Non-Member $124 ($112 early bird special if enrolled by March 31, 2013)
*To ensure participants are ready and prepared for classes, enrollment will close when
the maximum number of participants is reached or at 5pm ET the day of the first
Real Time Session unless otherwise noted. If the first Real Time Session is on a
weekend, course enrollment will close on the Friday before the first Real Time Session.
*For more information on how online CE works, see the
Participant Resource Center.
TO ENROLL:
- Enrollment qualifications: VIN CE courses are open to
VIN member and non-member veterinarians. Veterinarians enrolling in a VSPN CE course
must be a VIN member. Veterinary support staff must be a VSPN member to enroll in a
VSPN CE or a VIN CE course open to VSPN member enrollment.
- Each enrollee must be able to receive emails from @vspn.org
and @vin.com addresses. Email is our major form of communication with participants;
personal emails are highly recommended rather than clinic/hospital email addresses.
- Each person is individually responsible for his/her own registration.
To ensure that all information received is secure and correct, please do not enroll
for a course on behalf of another individual.
- For further assistance call 1-800-700-INFO (4636) or email (VIN CE)
CEonVIN@vin.com or (VSPN CE)
VSPNCE@vspn.org.
Please include the course title, your full name, and contact information in your correspondence.
*Note:
"This course is submitted for approval for 3 continuing education credits in jurisdictions
which recognize AAVSB RACE approval; however participants should be aware that some
boards have limitations on the number of hours accepted in certain categories and/or
restrictions on certain methods of delivery of continuing education."
Call VSPN/VIN CE at 1-800-700-4636 for further information.
(Attendees are encouraged to check with their licensing jurisdiction(s) for
information regarding recognition by their board).
Course withdrawal and refund policy: A complete refund of the paid course price will be
issued when your withdrawal request is received prior to the listed start date of the course.
If you wish to withdraw after the start date please contact the VIN/VSPN office 1-800-700-INFO (4636)
to discuss eligibility for a pro-rated refund.
* Note: To ensure rapid handling of your request for withdrawal, we recommend that you
call the VIN/VSPN office at 1-800-700-INFO (4636).
*For more information on VIN's upcoming CE courses, check the
VIN Course Catalog.
Katherine James, DVM, PhD, DACVIM (SAIM)
VIN Education Coordinator
VIN CE Services:
CEonVIN@vin.com
1-800-846-0028 or 1-530-756-4881 or direct line to VIN/VSPN from the United Kingdom: 01452226154
Andrea Pomposo (
Andrea@vin.com); ext 126
Debbie Friedler (
Debbie@vin.com); ext 756
Heather Schoffstall (
Heather@vin.com); ext 116
Jennifer Boyle (
JenniferB@vin.com); ext 169
Peggy Hall (
Peggy@vin.com); ext. 195
800.700.4636 | CEonVIN@vin.com | 530.756.4881 | Fax: 530.756.6035
777 West Covell Blvd, Davis, CA 95616
Copyright 2002, Veterinary Information Network, Inc.
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