Legislation introduced in Pa. to amend the Veterinary Practice Act:
The Food and Drug Administration has determined that select drugs can only
be used safely when patients and owners are provided with critical
information on the safe use of the drug. For humans, this information is
provided in the form of a Medication Guide. The veterinary equivalent is
known as the Client Information Sheet.
Owners of pets who have suffered adverse reactions to veterinary drugs have
reported to the FDA that they were not provided Client Information Sheets by
their veterinarians. For the past six years, owners have appealed to state
veterinary boards to mandate that vets provide this critical information to
owners to no avail. Similarly hundreds of complaints have been filed against
vets for not providing owners with Client Information Sheets and not one
case has said that this was required.
To remedy this situation in Pennsylvania, Senators Stack, Browne, Fontana,
Rafferty, Boscola, Costa and Ferlo have introduced legislation mandating
that veterinarians provide clients with Client Information Sheets for the
drugs that have them.
It is anticipated that similar legislation will be introduced in most other
states over the next few months.
Detailed background on this legislation is available at:
http://www.fda.gov/ohrms/dockets/dockets/04n0559/04N-0559_emc -000003-01.pdf
THE GENERAL ASSEMBLY OF PENNSYLVANIA
SENATE BILL
No. 1144 Session of 2006
INTRODUCED BY STACK, BROWNE, FONTANA, RAFFERTY, BOSCOLA, COSTA AND FERLO,
MARCH 20, 2006
REFERRED TO CONSUMER PROTECTION AND PROFESSIONAL LICENSURE, MARCH 20, 2006
AN ACT
Amending the act of December 27, 1974 (P.L.995, No.326), entitled "An act
regulating the practice of veterinary medicine and imposing penalties,"
further providing for definitions.
The General Assembly of the Commonwealth of Pennsylvania hereby enacts as
follows:
Section 1. Section 3(15) of the act of December 27, 1974 8 (P.L.995,
No.326), known as the Veterinary Medicine Practice 9 Act, amended December
9, 2002 (P.L.1370, No.167), is amended and 10 the section is amended by
adding a paragraph to read:
Section 3. Definitions.--As used in this act:
* * *
(15) "Veterinarian-client-patient relationship" means a relationship
satisfying all of the following conditions: (i) the veterinarian has assumed
the responsibility for making veterinary medical judgments regarding the
health of an animal and the need for veterinary medical treatment, and the
client, owner or caretaker of the animal has agreed to follow the
instructions of the veterinarian; (ii) the veterinarian has sufficient
knowledge of the animal to initiate at least a general, preliminary or
tentative diagnosis of the medical condition of the animal; (iii) the
veterinarian is acquainted with the keeping and care of the animal by virtue
of an examination of the animal or medically appropriate and timely visits
to the premises where the animal is kept; (iv) the veterinarian is available
for consultation in cases of adverse reactions to or failure of the regimen
of therapy; (v) the veterinarian maintains records on the animal examined in
accordance with regulations established by the board[.]; and
(vi) the veterinarian provides a client information sheet to the owner of
the animal in cases of dispensing prescription drugs that will be
administered by the owner in an outpatient setting.
(16) "Client information sheet" means a paper required by the Center for
Veterinary Medicine of the Food and Drug Administration for the purpose of
communicating important risk information to clients and that is given to a
veterinarian by a prescription drug manufacturer so that owners of an animal
are provided with vital product safety information including precautions,
contraindications, signs of a possible adverse reaction, and steps to take
in the event of an adverse reaction to the prescription drug.
Section 2. This act shall take effect in 60 days.
A6L63DMS/20060S1144B1612 - 2 -
View this legislation at:
http://www.legis.state.pa.us/WU01/LI/BI/BT/2005/0/SB1144P1612.HTM
Why Veterinary Drug Information?
http://www.veterinarydruginfo.com
