PHAR100-0312: Pharmaceutical Regulatory Review 2012
(Accepted for Florida State Veterinary Board Pharmacy CE requirement)

INSTRUCTOR(S): Doug Kemp, Pharm.D, DICVP.
COURSE OPEN: March 26-April 12, 2012
REAL TIME SESSIONS (RTS): Monday, April 2; 9:00-11:00 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. Times and dates will be listed in your course confirmation email. Expect to spend up to 1 hour at one of the 2-4 practice sessions held prior to the first Real Time Session.

*The instructors for this course will be using audio which will require you to have a headset of 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 and veterinary technicians or veterinary support staff. This course has been submitted for RACE approval for veterinarians and veterinary technicians.

Course Description: Open to veterinarians and veterinary technicians or veterinary support staff. This course has been submitted for RACE approval for veterinarians and veterinary technicians.
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 extralabel use is allowed
• Compounding vs manufacturing issues

This course consists of one (1) 2-hour Real Time Sessions, 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.

* A portion of the lectures will be presented using audio. Please be prepared to listen.

Upon completion of this course, the participant should

• 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 textbooks: 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 2): Required Reading (prior to the April 2nd 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: http://sos.georgia.gov/plb/veterinary/minutes.asp

(Accepted for Florida State Veterinary Board Pharmacy CE requirement)

Tuition: Member $60 ($54 early bird special if enrolled by March 12, 2012).
Non-Member $124 ($112 early bird special if enrolled by March 12, 2012).

*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:

1. 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.
2. 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.
3. 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.
4. 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 Course Catalog at https://www.vin.com/CE/Catalog.htm

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

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