PHAR100-0411: Pharmaceutical Regulatory Review 2011

INSTRUCTOR:
Doug Kemp, Pharm.D, DICVP.
COURSE OPEN: April 1 - April 20, 2011
REAL TIME SESSION: Sunday, April 10; 6:00 pm-8:00pm 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 RTS. Times and dates will be listed in the course confirmation email . Expect to spend 30-45 minutes at one of the 2 or 3 sessions prior to the first RTS.

Level and Prerequisites: This course is open to participants 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. This course has been submitted for RACE approval for veterinarians. VIN CE course open to all VIN and VSPN members.

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 extralabel use is allowed
• Compounding vs manufacturing issues

This course consists of one (1) 2 hour Real Time Sessions; library materials; interactive message board discussions; and a mandatory end of course quiz designed to enhance course effectiveness and material retention. Prior to the Real Time session on April 10, the instructor will post daily readings on the course message boards.

Upon completion of this course, the participant should be able to

Participants will 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. Participants will have a better understanding of the actions of FDA and will learn how to express their opinions to FDA. Participants will learn when they can use drugs in an extra-label manner and when they are engaging in activities that are of enforcement priority by FDA. They will also learn when they can use compounded drugs in veterinary practice.

Course Materials: Course materials will be available in the library prior to the Real Time Sessions.
Required textbook:
None
Recommended textbook:
None

Course Outline:
Week 1: (Real Time Session April 10):
Instructor: Doug Kemp, Pharm.D, DICVP.
Required reading: None
Content: Controlled substances

CE CREDITS: 3 (Accepted for Florida State Veterinary Board Pharmacy CE requirement)

**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

Tuition: $60 ($ 54 early bird special if enrolled by March 18, 2011).
** NOTE: 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 will close on the Friday before the first Real Time Session.

**For more on how online CE works see the VSPN Participant's Resource Center

Note: "This course has been 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: Withdrawal prior to the listed start date of a course entitles the registrant to a complete refund or a credit toward a future VIN CE course, whichever is preferred. Withdrawal within 1 week after the listed start date (i.e. including no more than one real-time session) entitles the registrant to a credit toward any future VIN CE course. (This policy does not apply to courses with only one real-time session.) After the first real-time session, a registrant may withdraw due to special circumstances and receive prorated credit towards a future VIN course. These requests will be handled on an individual basis. The amount of the prorated credit will be determined based on 65% of the time remaining in the course at the time of withdrawal. It is not possible to withdraw retroactively.
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 VSPN'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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