Operating Plan for the Use of Restricted Veterinary Medicines According to
Specific Veterinary Operating Instructions (VOIs) at Massey University
1. Purpose
The Agricultural Compounds and Veterinary Medicine (ACVM) Act 1997 specifies how medicines
may be used in animals. Conditions of registration for restricted veterinary medicines require them
to be used either by a registered veterinarian or under the authority of and in compliance with a
valid authorisation issued by either a registered veterinarian or under and in accordance with an
approved operating plan. It is recognised that there is a need for registered veterinary and human
medicines to be used within research, testing and training organisations to prevent or reduce any
suffering of animals involved. For this reason, special provision has been made for these
institutions to allow non-veterinarians to legally use restricted medicines. This document outlines
how non-veterinarians at Massey University can become authorised to use specified restricted
medicines for research or teaching purposes (only).
This Operating Plan needs to be followed when restricted medicines are administered to an animal
by a non-veterinarian to manage that animal (most often to alleviate discomfort) and when an
animal will subsequently enter the food chain. It does not apply to experimental variables (e.g.
products being evaluated during a trial) unless the animals will enter the food chain. In addition,
non-veterinarians cannot be authorised to use restricted medicines for the health management of
an animal outside the scope of Animal Ethics Committee (AEC) approved protocols without
specific veterinary authorisation (which would be given independently from this Plan). Lastly, the
use of restricted veterinary medicines requiring administration only by a veterinarian and Class A
and B (Part 1 & 2) controlled drugs cannot be authorised under this Plan.
2. Responsibility
This Operating Plan must be followed by all non-veterinary personnel at Massey University who
intend to purchase, hold and use restricted medicines for the management of research, testing or
teaching animals in their care.
Massey University’s Animal Welfare Officer, Dr Juliet Cayzer, is responsible for administering this
Operating Plan.
3. References
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Relevant legislation (ACVM Act 1997, the Animal Welfare Act 1999, the Misuse of Drugs
Act 1995, the Medicines Act 1981 and the HSNO Act 1996).
The Massey University Code of Ethical Conduct for the Use of Live Animals for Research,
Testing and Teaching, Revised Edition 2008.
Massey University Animal Ethics Application for Approval of Proposed Research, Testing or
Teaching Procedures Using Live Animals.
NZFSA Veterinary Operating Instructions ACVM Guideline No 65, Dec 2009.
The Standard Operating Procedures that document the way in which specified medicines
and any surgical techniques are to be used.
4. Definitions
The following definitions and abbreviations are only for the purposes of this document.
Controlled Drug Register (CDR): The form used to log the purchase and use of each RVM in
order to account for medicine use.
Expected Treatment Outcome (ETO): The therapeutic or pharmacological response predicted
and intended to occur in an animal following treatment with a veterinary medicine.
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Human Medicines: Those medicines with the consent of the Minister of Health to be distributed in
New Zealand for use in human beings under the Medicines Act 1981 and in compliance with the
Misuse of Drugs Act 1975.
Issuing Veterinarian: A veterinarian who issues a VOI to support the veterinary authorisation he
or she has issued.
Manipulations:
1. ‘Manipulation’ (defined by the Animal Welfare Act 1999) in relation to any live animal means,
subject to subsections (2) and (3), interfering with the normal physiological, behavioural or
anatomical integrity of the animal by deliberately (a) Subjecting it to a procedure which is unusual or abnormal when compared with that to which
animals of that type would be subjected under normal management or practice and which involvesi. Exposing the animal to any parasite, micro-organism, drug, chemical, biological product,
radiation, electrical stimulation or environmental condition; or
ii. Enforced activity, restraint, nutrition or surgical intervention; or
(b) Depriving the animal of usual care; and "manipulating" has a corresponding meaning.
2. The term defined by subsection (1) does not include(a) Any therapy or prophylaxis necessary or desirable for the welfare of an animal; or
(b) The killing of an animal by the owner or person in charge as the end point of research, testing
or teaching if the animal is killed in such a manner that the animal does not suffer unreasonable or
unnecessary pain or distress; or
(c) The killing of an animal in order to undertake research, testing or teaching on the dead animal
or on prenatal or developmental tissue of the animal if the animal is killed in such a manner that the
animal does not suffer unreasonable or unnecessary pain or distress; or
(d) The hunting or killing of any animal in a wild state by a method that is not an experimental
method; or
(e) Any procedure that the Minister declares, under subsection (3), not to be a manipulation for the
purposes of this Act.
3. The Minister may from time to time, after consultation with the National Animal Welfare Advisory
Committee and the National Animal Ethics Advisory Committee, declare any procedure, by notice
in the Gazette, not to be a manipulation for the purposes of this Act.
Material Safety Data Sheet (MSDS)
Massey University Animal Ethics Committee (MUAEC)
Massey University’s Animal Welfare Officer (AWO)
Medicine Administration Record (MAR): The form used to record the administration of a RVM to
identified animals.
Research, Testing and Training Organisations (RTTO): Include all organisations or individuals
manipulating live animals for the purposes of research, testing, production of biological products or
teaching. These organisations and individuals will have a Code of Ethical Conduct approved by
the Director-General of the Ministry of Agriculture and Forestry and manipulations of animals will
be approved by an Animal Ethics Committee.
Restricted Veterinary Medicine (RVM): A restricted veterinary medicine is always a registered
trade name product with conditions of registration that restrict sale, purchase and use and require
an authorisation to purchase and use it.
Review Date: The date, nominated when the veterinary operating instruction (VOI) is issued, by
which the content of the VOI must be assessed and endorsed by the issuing veterinarian as
adequate for renewal.
Trade Name Product (TNP): An agricultural compound identified and packaged under a trade
name for a specified use or uses. All registered veterinary medicines are trade name products.
Unexpected Treatment Outcome (UTO): A therapeutic or pharmacological response at variance
with the predicted and intended response in an animal following treatment with a veterinary
medicine.
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Unrestricted Veterinary Medicine: A veterinary medicine product that has no access restrictions
on the sale/supply or use, allowing any person to hold it in stock, sell it or use it in a manner that is
consistent with any other conditions of registration on that veterinary medicine.
Use Period: A discrete duration of veterinary medicine use defined as commencing with the
removal of a veterinary medicine from secure storage and ending upon its return.
Veterinarian: A person who holds a current practising certificate issued by the Veterinary Council
of New Zealand (VCNZ).
Veterinary Authorisation: An instruction, in an appropriate documented form, from a veterinarian
authorising:
the purchase of an RVM by a person specified in the veterinary authorisation
the holding of an RVM by a person specified in the veterinary authorisation in anticipation of a
use according to the instructions of the authorising veterinarian
the use of an RVM by a person specified in the veterinary authorisation, in accordance with the
instructions of the authorising veterinarian.
Veterinary Operating Instruction (VOI): A set of instructions from an authorising veterinarian to a
non-veterinarian to hold and to use RVMs only in accordance with these instructions.
Withholding Time: The time period between the last administration of the medicine and entry of
the animal, its tissues or fibre into the food or other processing chain is defined as the withholding
period.
5. Procedures
a) Any proposed manipulation to animals for research, testing or teaching must have prior
approval from the Massey University Animal Ethics Committee (MUAEC). Personnel must
ensure that the suffering of animals under their care is minimised. If the use of restricted
medicines will reduce the discomfort of the animals caused by manipulations, then they must
be given appropriately.
b) A veterinarian who has experience with the species concerned should be consulted regarding
the most suitable use of RVMs if there is any doubt as to what is most appropriate for a given
situation. The plan for use of RVMs should then be documented in section 8(c) of the MUAEC
application form which seeks ethical approval for the research, testing or teaching project.
c) The AWO will indicate whether a detailed procedure needs to be written to document how the
RVM must be used in the proposed situation. The veterinarian consulted in 5 b) above may be
able to assist with this. If not, request assistance from the AWO.
d) If a surgical intervention is to be performed by a non-veterinarian, a detailed procedure
outlining how to perform this manipulation must also be written. This will require veterinary
consultation.
e) Competency records documenting the degree of competency attained by personnel for a
particular manipulation must be maintained and signed by the trainer or assessor. The level of
competency at performing surgical procedures or administering restricted veterinary medicines
must be assessed and signed by a registered veterinarian. Personnel must be fully competent
at performing a required manipulation before they may perform it without supervision. Any
supervision must be provided by fully competent personnel.
f)
Non-veterinarians who wish to administer restricted medicines to animals must agree to comply
with this Operating Plan and with the specific Veterinary Operating Instructions issued for the
MUAEC approved protocol. A declaration must be signed in section 10 of the MUAEC
application form by all personnel administering RVMs to animals that they have read this
Operating Plan and agree to abide by it.
g) All veterinary or human medicines will be securely stored to allow authorised access only.
A secure drug store shall be lockable (key or combination) and preferably permanently
attached to a solid structural wall. It should be located in a building that is secure outside of
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work hours. Access to the secure drug store will be limited to trustworthy individuals who have
a good understanding of this Operating Plan and who are formally authorised by the
Organisation. The authorised persons shall receive and issue the medicines to and from the
secure drug store and maintain the Controlled Drug Register.
h) A material safety data sheet (MSDS) or packet insert must be present for each RVM used.
i)
Massey University’s AWO works alongside the MUAEC. After a relevant ethics application
(where there is a request for non-veterinary personnel to administer RVM’s) has been
approved by the committee, he/she will contact the chief applicant.
j)
When the requirements stated in 5c), 5d), 5e), 5f) and 5g) above have been fulfilled, the AWO
will issue authorisation for named personnel to administer RVM(s) for the purposes stated in
the approved MUAEC application.
This authorisation will be in the form of Veterinary
Operating Instructions (VOI). The AWO will also issue a Medicine Administration Record
(MAR) and a Controlled Drugs Register (CDR) (one Controlled Drug Register for each RVM).
An RVM purchase authorisation form will also be supplied unless the RVM(s) are obtained
from another veterinarian who oversees the health of the animals maintained by the research
or teaching group.
VOIs are valid for up to 12 months; this duration may be extended only after review by the
AWO. These reviews will usually be undertaken during a drug use audit. The VOI cannot be
extended beyond the expiratory date of the approved ethics application. It is the responsibility
of the user of the medicines to ensure that any VOI is current prior to its use.
j)
The purchase of RVMs into the drug store must be documented (for example, by a purchase
invoice) and this documentation signed by a veterinarian.
k) RVMs must be removed from the drug store only for use covered by a current VOI or for use by
or under the direction of a veterinarian.
l)
Each time a medicine is removed from the drug store, its use must be entered into the CDR.
The MAR must be completed every time an RVM is administered to animals. Each RVM will
be returned to the drug store promptly after use and the quantities used and returned will be
recorded on the CDR. If a veterinarian uses (or authorises the use of) an RVM that is used
under the authorisation of a VOI, that use will also be recorded on the CDR and the entry
signed by that veterinarian.
m) Records of stocks in storage, use of medicines and stock discarded or destroyed will be
reconciled with quantities purchased at least every six months and be available for audit.
n) Research, Testing and Training Organisations will retain records pertaining to the purchase
and use of veterinary and human medicines for five years.
o) Drug use audits will be performed by the AWO at least every 12 months. The scope of the
audit will include:
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Checking that each research group holds a copy of this Operating Plan, MSDSs or packet
inserts for each RVM held, all VOIs that have been active during the audit period, purchase
documentation for all RVMs purchased during the audit period.
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Determining whether all acquisitions of RVMs have been authorised by a veterinarian.
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Determining whether RVMs have been used by authorised personnel, as assessed by
signatures/initials on the CDR and MAR.
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Comparing entries on the MAR and CDR for an RVM, evaluating for congruence and
compliance with the VOI. The CDR and MAR will also be compared with the MUAEC
application. At least 50% of entries on the MAR and CDR will be reviewed. 100% of
entries will be reviewed for controlled drugs.
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RVMs in stock at the commencement of the audit period and amounts subsequently
purchased will be reconciled against RVMs used, discarded and remaining in stock.
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Current VOIs will be reviewed and the expiratory date extended at the discretion of the
AWO.
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Findings will be reported to the MUAEC.
p) The consequences of not complying with the requirements of this document and the VOIs are
that the purchaser, holder or user of the restricted veterinary medicine (to which the VOI has
been issued) will be in breach of the condition of registration of the product. This is an offence
under section 55 of the ACVM Act if the breach was committed knowingly. Non-compliance
with this Operating Plan and VOIs may also result in the revoking of authorisation to administer
RVMs. The Pro Vice-Chancellor, College of Sciences, at Massey University has delegated to
MUAEC the role of monitoring compliance with the OP and VOIs. In the occurrence of noncompliance, the MUAEC will determine the appropriate course of action (for example, request
that the non-compliant personnel advise the Committee of how they will ensure future
compliance, increase the frequency of monitoring of use of RVMs, withdraw authorisation of
non-compliant personnel to administer RVMs). The AWO will notify the ACVM Group in the
event of any non-compliance that may affect the risks managed by the ACVM (risks to trade,
agricultural security, animal welfare and public health).
6. Additional requirements when using medicines in animals that may
become products used by man or that may enter the food chain
a) Personnel must ensure that animals that receive veterinary or human medicines are not used
for the production of food, fibre or other products used by people and do not enter the food
chain of other animals before withholding times have been observed. The animals must also
not be given, transferred or sold to another party who may fail to ensure this. The withholding
time for a particular medicine, along with any other relevant conditions of registration relating to
management of residues, will be documented on the VOI. Any other conditions stated in the
VOI must also be complied with.
b) If production animals will (or may) be provided for the production of food, fibre or other products
used by man or for food of other animals, the following requirements must be met:
(i) Animals must be individually and permanently identified.
(ii) A MAR must be completed in full for each animal (or group if appropriate), recording
all administrations of medicines to each animal.
(iii) A register of all MARs must be kept.
(iv) When disposing of animals, a person with authority within the Research, Testing
and Training Organisation shall obtain all MARs relating to those individual animals. If
the animals are to be sold, gifted or transferred to another party, the records will be
checked to ensure that withholding times have expired and any other conditions met.
The name and address of the party who received the animals and the date this
occurred will be recorded. If the animals are destroyed, the method of disposal of the
carcasses and the date of disposal will be recorded.
(v) All MARs will be kept for five years following the disposal of animals.
c) Production animals that are euthanased before withholding times or other conditions are
complied with must be securely stored until disposal by incineration or burial.
d) When an animal is treated with a medicine then released to the wild before the medicine’s
withholding period has expired, consideration must be given to the risk that the animal may be
captured or killed and used for products for use by human beings or for animal food.
When an appreciable risk is identified, consultation with the regulatory authorities responsible
should be undertaken to determine what controls must be applied to manage the risk.
Authorities likely to have a regulatory interest will include the Department of Conservation, the
Ministry of Agriculture and Forestry, and the Ministry of Fisheries, as necessary. Such controls
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may include, for example, permanent identification of the treated animals, notices advising the
public of the risks or notices warning the public about access to places affected.
7. Document control
The AWO is responsible for managing this Operating Plan. It must be reviewed annually to
ensure it remains current; the ACVM Group must be informed in writing of any amendment
made. The duration of ACVM approval of this Operating Plan is three years after the initial
approval date. Renewal of approval beyond this time will require re-submission of the
document to the ACVM Group.
Document version:
1
Date of release:
18 March 2011
Author/reviewer’s signature:
Duration of ACVM approval:
Annual Review due by:
18 March 2012
Date of review:
Reviewed by:
Owner of this Operating Plan: Massey University Animal Ethics Committee
Point of contact:
Juliet Cayzer BVSc DVCS
c/- Estendart Ltd
Massey University (internal mail: PN 851)
Private Bag 11-222
Palmerston North
Phone: 027 2462311
06 3500779
Email:
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j.cayzer@massey.ac.nz
Operating Plan Version 1, 07 February 11