PHAR100-0416: Pharmaceutical Regulatory Review
The lectures for this course will be predominantly audio with some segments delivered in a text format.
Enrollment is closed.
Presenter: Doug Kemp, PharmD, DICVP
Course Open: April 27-May 21, 2016
Real Time Sessions (RTS): Wednesday May 4 and 11, 2016; 8:00-10:00 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 presenters 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 and
veterinary support staff actively interested in learning 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/technologists, support staff, and veterinary teams.
This course is approved by RACE for veterinarians and veterinary technicians/technologists. (RACE 22-25027)
Course Information:
The primary purpose of this course is to provide accurate and up to date information
regarding the security and accountability of controlled substances so that veterinary
practitioners can make best practice choices within their practice setting. The course
will include discussions of the impact of illicit use of controlled substances, the
incidence of illicit drug abuse in populations that might be hired into veterinary practices,
goals of creating a system of security and accountability, structure of the laws, regulations
and rules relating to controlled substances and how to access them, the
veterinarian/client/patient relationship, corresponding responsibilities of pharmacists,
scheduling of controlled substances, regulation of List 1 drugs (methamphetamine precursors),
DEA registrations, practitioners in charge, use of agents, appropriate screening and criminal
background checks for controlled substances access. storage requirements, record keeping,
ordering of controlled substances, receiving controlled substances, security/access within
practices, disposition records, automated dispensing devices, dispensing records, tamper
evident prescription pads, refills, multiple C-II prescriptions, packaging, labeling,
inventories, auditing requirements and procedures, relationship of the medical record to other
controlled substances records, electronic records, loss of theft reporting, disposal of
drugs including onsite destruction, inspections, transfers to other practices, filling
prescriptions, and penalties and fines.
Florida specific content includes definitions, requirements of a prescription, violations of
FL veterinary practice act, relationship of pharmacist filling prescriptions and practitioner,
use of agents for purposes of administration of controlled substances, prescription drug monitoring
program, distribution of controlled substances, labeling and packaging counterfeit resistant
prescription blanks, records, prohibited acts and penalties, List 1 drugs, prescription writing,
packaging and labeling of dispensed drugs.
The Food and Drug Administration portion of the course is intended familiarize course participants
with an understanding of the history and function of drug regulation. This section will include the
events that precipitated development of drug laws, the structure of drugs laws and regulations,
the function of Compliance Policy Guides, the importance of AMDUCA, and the legal status of compounding
and limitations of compounded products.
Week 1 (Real Time Session May 4, 2016):
Controlled Substances Regulation - Part 1
Presenter: Doug Kemp, PharmD, DICVP
Format: Text/Audio
Objectives: Upon completion of this session, the participant should be able to
- Demonstrate understanding of the impact of illicit drug use upon society
- Know the goals of creation and maintenance of a system
of security and accountability
- Locate relevant laws, regulations and rules via the Internet
- Demonstrate understanding of the corresponding good faith responsibilities of pharmacists
- Know that the DEA is monitoring veterinarians' activities
- Discuss the scheduling of controlled substances
- Demonstrate understanding of the laws created to control the methamphetamine problem
and the legal status of List 1 and List 2 substances
- Demonstrate understanding of DEA registration requirements and expectations and the use of agents
- Demonstrate understanding of the Veterinary Mobility Act
- Demonstrate understanding of expectations and issues associated with employee screening
and criminal background checks.
Week 2 (Real Time Session May 11, 2016):
Controlled Substances Regulation - Part 2
Presenter: Doug Kemp, PharmD, DICVP
Format: Text/Audio
Objectives: Upon completion of this session, the participant should be able to
- Discuss records of a controlled substance security and accountability system
- Demonstrate understanding of controlled substances ordering, including paper 222 forms and CSOS systems
- Know that unusual orders might trigger a call or visit from DEA
- Demonstrate understanding of how to store controlled substances receiving reports in a retrievable manner
- Discuss secure storage of controlled substance
- Discuss disposition records
- Demonstrate understanding of the potential applications of computer driven dispensing devices in veterinary medicine
- Demonstrate understanding of the requirements for dispensing/prescription records for controlled substances
- Demonstrate understanding of the use of tamper resistant prescription blanks for controlled substances prescribing
- Demonstrate understanding of limitations on refills for controlled substances
- Demonstrate understanding of appropriate packaging and labeling for dispensed drugs
- Demonstrate understanding of the importance of inventory and use audits and record keeping
- Demonstrate understanding of the necessity of medical records supporting uses of controlled drugs
- Demonstrate understanding of current requirements for disposal of controlled drugs
- Demonstrate understanding of how to respond to a visit by enforcement
- Know the limitations to drug distribution from one practitioner to another
- Know the limitations to veterinarians filling outside prescriptions
- Know some of the penalties and fines
Week 3 (No Real Time Session, Message Board Discussions May 12-18, 2016):
Florida Specific Requirements & FDA
Format: Message Board Discussions
Objectives: Upon completion of this session, the participant should be able to
Florida Specific Requirements:
- Demonstrate understanding of the definitions in Ch 893
- Demonstrate understanding of the requirement for prescribing controlled
drugs separately from other drugs
- Demonstrate understanding of required components of a prescription
- Demonstrate understanding of prescription violations of the FL Veterinary Practice Act
- Know the corresponding responsibilities of pharmacists
- Know the supervisory responsibilities of veterinarians working with staff
- Know that veterinarians are not required to participate in the drug monitoring program
- Demonstrate understanding of the packaging and labeling requirements for dispensed drugs
- Discuss the requirement for the use of counterfeit resistant prescription
blanks for controlled substances prescribing
- Know the FL requirements for record keeping
- Recognize acts prohibited by FL laws, penalties
Food and Drug Administration:
- Discuss the history and function of drug regulation in the United States
- Discuss the function and importance of Compliance Policy Guides
- Discuss the implications of AMDUCA
- Discuss the legal status of compounded drugs and their limitations
Successful completion (scoring 80% or better) on the end-of-course test is required
to earn a certificate of completion for the course.
To learn more about the requirements for earning a CE certificate, please refer to
Receiving Your CE Credit and Course Completion Certificate.
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 Presenter:
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. Recently retired, Douglas Kemp's previous positions held: Staff
Pharmacist Athens Regional Medical center from 2007-2014. From 1979 to 2004 and 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.
Total CE Credit: 4
Tuition: Member $84 ($76 early bird special if enrolled by April 13, 2016)
Non-Member $157 ($141 early bird special if enrolled by April 13, 2016)
*To ensure participants are ready and prepared for classes,
enrollment will close on May 4, 2016 at 5 pm ET (USA)
or when the maximum number of participants is reached.
*For more information on how online CE works, see the
Participant Resource Center.
To Enroll:
Enrollment is closed.
- 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 800-846-0028 ext. 797 or email
CEonVIN@vin.com.
Please include the course title, your full name, and contact information in your correspondence.
"This program (22-25027) is approved by the AAVSB RACE to offer a
total of 4 CE Credits, with a maximum of 4 CE Credits being available to any individual
veterinarian or veterinary technician/technologist.
This RACE approval is for the subject matter categories of:
Scientific,
using the delivery method of Interactive-Distance: (Web-based, Teleconference or Audio-Conference).
This approval is valid in jurisdictions which recognize AAVSB RACE; however, participants are
responsible for ascertaining each board's CE requirements."
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 office 800-846-0028 ext. 797
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 office at 800-846-0028 ext. 797.
*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
800-846-0028 or 530-756-4881; ext. 797
or direct line to VIN/VSPN from the United Kingdom: 01 45 222 6154
or direct line to VIN/VSPN from Australia: 02 6145 2357
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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