PHAR100-0417: Pharmaceutical Regulatory Review 2017
The lectures for this course will be presented in an audio format.
Enrollment is closed.
Presenter: Heather Lindell, PharmD, BSPh, RPh, DICVP, FSVHP
Course Open: April 26-May 20, 2017
Real Time Sessions (RTS): Wednesdays, May 3 and 10, 2017; 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 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,
and other veterinary support staff.
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 3, 2017):
Controlled Substances Regulation - Part 1
Presenter: Heather Lindell, PharmD, BSPh, RPh, DICVP, FSVHP
Format: 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.
- recognize 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 10, 2017):
Controlled Substances Regulation - Part 2
Presenter: Heather Lindell, PharmD, BSPh, RPh, DICVP, FSVHP
Format: 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.
- recognize 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.
- demonstrate understanding of the limitations to drug distribution
from one practitioner to another.
- demonstrate understanding of the limitations to veterinarians
filling outside prescriptions.
- list some of the penalties and fines.
Week 3 (Message Board Discussions May 10-17, 2017):
Florida Specific Requirements
Presenter: Heather Lindell, PharmD, BSPh, RPh, DICVP, FSVHP
Format: Audio
Objectives (Florida): Upon completion of this session, the participant should be able to
- 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.
Objectives (FDA): Upon completion of this session, the participant should be able to
- 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:
Heather Lindell is a registered pharmacist in Georgia and Florida.
She is also a Diplomate of the International College of Veterinary Pharmacists (DICVP), 2002.
She earned a Bachelor of Science in Pharmacy (BSPh) in 1993 and a Doctorate of Pharmacy (PharmD) in 1994
from the University of Georgia, College of Pharmacy. She is currently the Assistant Pharmacy Manager
at the University of Georgia, Veterinary Teaching Hospital where she has been employed since 1994.
She teaches veterinary pharmacy to pharmacy students at the University of Georgia, College of Pharmacy
and Mercer University in Atlanta. She teaches pharmacology to veterinary students at the University
of Georgia, College of Veterinary Medicine. She is also a staff pharmacist at Northside Forsyth Hospital
where she has been employed since 1998. Heather is the current president-elect for the Society of
Veterinary Hospital Pharmacists and is a member of the RC Wilson Pharmacy Association, Atlanta Academy
of Institutional Pharmacists and Georgia Society of Health-Systems Pharmacists. Heather received the
Distinguished Alumna Award from the University of Georgia - College of Pharmacy for the 2016-2017 Academic year.
Total CE Credit: 5
Tuition: Member $115 ($103 early bird special if enrolled by April 12, 2017)
Non-Member $198 ($178 early bird special if enrolled by April 12, 2017)
Prices are listed in US dollars.
*To ensure participants are ready and prepared for classes,
enrollment will close on May 3, 2017 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 5 CE Credits, with a maximum of 5 CE Credits being available to any individual
veterinarian or veterinary technician/technologist.
This RACE approval is for the subject matter categories of:
Scientific and Non-Scientific-Practice Management/Professional Development
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.
|
