Institutional Operating Plan

For the Use of Veterinary and Human Medicines

Institution:______

Group:______

1.Purpose

The Agricultural Compounds and Veterinary Medicine (ACVM) Act 1997 specifies how medicines may be used in animals. It does not allow for prescription medicines to be administered to any animal unless a veterinary consultation of that animal has been conducted. However, it also recognises that there is a need for registered veterinary and human medicines to be used within research, testing and teaching 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 registered medicines. A process is in place to approve the use of medicines by specific personnel for specific purposes. This Institutional Operating Plan outlines the process.

This plan needs to be followed when medicines are introduced to an animal to manage that animal (most often to alleviate discomfort) and when any product is given to an animal that will 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. The plan also does not apply when medicines are used for the normal health management of that animal outside the context of Animal Ethics Committee (AEC) approved protocols. Lastly, the use of PAR Class III animal remedies and Class A and B (Part 1 & 2) controlled drugs are not covered.

2.Responsibility

This plan must be followed by all non-veterinary personnel who intend to use prescription medicines for the management of research, testing or teaching animals in their care.

3.References

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 ANZCCART Code of Practice for the Use of Veterinary and Human Medicines in Research, Testing and Teaching Organisations (sponsored by the Royal Society of New Zealand).
The MasseyUniversity Code of Ethical Conduct for the Use of Live Animals for Teaching and Research, Revised Edition 2003
MasseyUniversity Animal Ethics Application for Approval of Proposed Experimental/Teaching Procedures Using Live Animals
The Standard Operating Procedures that document the way in which specified medicines and any surgical techniques are to be used.

4.Definitions

Agricultural Security

Agricultural security is defined under the ACVM Act as follows: “means the exclusion, eradication and effective management of:

I.Pests

a) includes any unwanted organisms, including micro-organisms, pest agents and any genetic structure that is capable of replicating itself (whether that structure comprises all or only part of an entity, and whether it comprises all or only part of the total genetic structure of an entity) that may affect plants, animals or raw primary produce; and

b) includes any entity declared to be a pest for the purposes of this Act by Order in Council made under sub-section (2);

c) does not include:

i. any human being or living organism that affects only human beings

ii. any living organism declared not to be a pest for the purposes of this Act by Order in Council made under sub-section (2).

II.Unwanted organisms under the Biosecurity Act 1993

Human Medicines

In this Code, Human Medicines are 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.

Manipulations

1. ‘Manipulation’ (defined by the Animal Welfare Act 1999), in relation to any live animal, means, subject to sub-sections (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 involves:

i. 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 sub-section (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 sub-section (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.

4. The Minister must, in deciding whether to publish a notice under sub-section (3) in relation to a procedure, have regard to the following matters:

(a) the nature of the procedure; and

(b) the effect that the performance of the procedure will or may have on an animal's welfare; and

(d) the extent (if any) to which the procedure is established in New Zealand in relation to the production of animals or commercial products; and

(e) the likelihood of managing the procedure adequately by the use of codes of welfare or other instruments under this Act or any other Act; and

(f) the consultation conducted under sub-section (3); and

(g) any other matter considered relevant by the Minister.

Prescription Animal Remedies

Prescription Animal Remedies are those veterinary medicines that are registered by the Director-General of the Ministry of Agriculture and Forestry in one of the following classes:

(a) Class I prescription animal remedy may be administered to an animal only:

(i) by a veterinary surgeon; or

(ii) under or in accordance with the authority or prescription of a veterinary surgeon.

(b) Class II prescription animal remedy may be administered to an animal only:

(i) by a veterinary surgeon; or

(ii) in the presence and under the direct control of a veterinary surgeon.

Production Animals

Production Animals include any animals used for the production of food, fibre or other products used by man or which enter the food chain of other animals. The animals most commonly fitting this description are sheep, goats, cattle, deer, pigs, chickens, horses, bees and fish.

Registered Veterinary Medicines

Registered Veterinary Medicines are those medicines registered for use in animals in New Zealand under Sections 21 or 27 of the ACVM Act 1997. Prescription Animal Remedies are Registered Veterinary Medicines that can be obtained only on the authority or prescription of a veterinary surgeon, or must be used under veterinary supervision or by veterinarians only (see specific definition in this section).

Research, Testing and Teaching Organisations

Research, Testing and Teaching Organisations 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.

Use of Veterinary and Human Medicines

Use in this Code includes the activities of acquiring (usually purchase), storage, administration and disposal of Veterinary and Human Medicines.

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.

Institutional Operational Plan (IOP)

A collection of documents (policy, best practice and standard operating procedures) that set out how the institution will manage the risks and meet the requirements indicated in the Code of Practice for the Use of Veterinary and Human Medicines in Research, Testing and Teaching Organisations.

Institutional Drug Administration Order (IDAO)

A document by which veterinary approval for the use of the medicine in the specified manipulation by specified non-veterinary personnel is issued.

5.Procedures

a)Any proposed manipulations on animals for teaching or research must have prior approval from the Animal Ethics Committee (AEC). Personnel must ensure that suffering of animals in their care is minimised. If the use of prescription medicines will reduce discomfort of the animals caused by manipulations, then they must be given appropriately. A veterinarian who has experience with the species concerned should be consulted if there is any doubt as to what is most appropriate in a given situation. Note that the AEC is legally required to monitor the standards of care of animals kept by research or teaching groups.

Who will you consult? This person/one of these people must be consulted if there is no current medication protocol for the planned manipulation and the manipulationwill cause the animals to suffer more than a Grade O (without any intervention).

b)Ensure that a detailed procedure is written that clearly outlines how the prescription medicine must be used in the proposed situation. The consulting veterinarian above may be able to assist with this. If not, contact MasseyUniversity’s Research Support Veterinarian (RSV) who will provide assistance or facilitate finding a veterinarian who can help.

c)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. Who will you consult?

d)Training records documenting the degree of competency attained by personnel for a particular manipulation must be maintained and signed by the trainer. The level of competency at performing surgical procedures or administering prescription 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. Fully competent personnel must provide any supervision.

e)Non-veterinarians who wish to administer prescription medicines to animals must read and agree to comply with the ‘ANZCCART Code of Practice for the Use of Veterinary and Human Medicines in Research, Testing and Teaching Organisations’. It can be found at: Each research or teaching group must hold a copy of this Code (a copy is held where/by whom?). This document should be read and understood prior to submitting an ethics application. In section 10 of the Massey University Animal Ethics Committee’s application form is a declaration that the Code has been read and will be complied with. All personnel who are not registered veterinarians and who wish to administer prescription medicines to animals for the purposes of the particular ethics application must sign this.

f)All veterinary or human medicines will be securely stored to prevent any unauthorised removal other than for AEC-approved manipulations, or by or under the direction of a registered veterinarian.

A secure drug store shall be lockable (key or combination) and preferably permanently attached to a solid structural wall. It should be located in sight of trustworthy personnel and in a building that is secure outside of work hours. Access to the secure drug store will be limited to trustworthy individuals who are knowledgeable of the requirements of the ANZCCART Code and formally authorised by the organisation. The authorised persons shall receive and issue the medicines from the secure drug store and maintain the Drug Register. Who is responsible for receiving and issuing medicines?

A material safety data sheet (MSDS) must be present for each medicine used and be readily accessible if an accident with the drug occurs. These sheets may be obtained from the MasseyUniversity website ( then enter the name of the medicine into the database); from the World Wide Web (search for “MSDS” and the name of the medicine); or from the supplier or manufacturer of the medicine.

g)The RSV works alongside the Massey University Animal Ethics Committee. After a relevant ethics application (where there is a request for non-veterinary personnel to administer prescription medicines) has been approved, the RSV will contact the chief applicant.

h)The RSV may request to see the following:

written procedures detailing how the relevant prescription medicines will be used and any surgical procedures performed.

training records (including Health and Safety training) of personnel who want to administer the medicine/s.

a suitable drug store and MSDSs obtained.

proof that personnel have read the Code of Practice for the Use of Veterinary and Human Medicines in Research, Testing and Teaching Organisations and have signed the declaration on the animal ethics application form agreeing that they will abide by it.

i)When the above requirements have been fulfilled, the RSV will issue permission to administer registered medicines for the purposes stated in the ethics approved application. An Institutional Drug Administration Order (IDAO), which is a detailed prescription, will give permission for named personnel to administer the specified prescription medicines to animals in the research or teaching protocol. The instructions on the IDAO must be complied with. The RSV will also issue a Medicine Administration Record and a Controlled Drugs Register (one drug register for each prescription medicine).

Non-veterinary personnel cannot use prescription medicines without written authorisation in the form of an IDAO. The only exception to this is the administration of Class l PARs following a veterinary consultation of the animal/s concerned.

j)The purchase of prescription medicines into the drug store must be documented. There must be written directions from a veterinarian for drugs purchased. (How will your system comply with this requirement?)

k)Each time a medicine is removed from the secure store, its use must be entered into the Controlled Drugs Register (CDR). The Medicine Administration Record must be completed every time the medicine is administered to animals. The medicine will be returned to the secure store promptly after use and the quantities used and returned will be recorded on the CDR. All use of medicines from the secure store by or under the direction of registered veterinarians for purposes other than AEC-approved manipulations will also be recorded.

Records of usage of medicines, stocks in storage and stock discarded or destroyed will be reconciled with quantities purchased at six-monthly intervals and available for audit.

Research, testing and teaching organisations will retain records pertaining to the purchase and use of veterinary and human medicines for five years.

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. They must also not be given, transferred or sold to another party who may fail to ensure this. The withholding time for a particular medicine will be documented on the IDAO. Any other conditions stated in the IDAO must also be complied with.

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 medicine administration record (available from the RSV) 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 medicine administration records must be kept. By whom and where is it kept?

(iv)When disposing of animals, a person (who?) with authority (from whom?) within the research, testing and teaching organisation shall obtain all medicine administration records relating to the 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 medicine administration records will be kept (where or by whom?) for five years following the disposal of animals.

b)Production animals that are euthanased before withholding times or other conditions are complied with must be securely stored until disposed of by incineration or burial. Where? Procedure to be followed?