ANZCCART

Code of Practice for the Use of Veterinary and Human Medicines in Research, Testing and Teaching Organisations

Sponsor: The Royal Society of New Zealand 

For printing, here are the documents in pdf (requires Acrobat): Code | Appendix

Contents

Section 1: Introduction and Purpose

Section 2: Requirements and Approvals 

Part A.  Requirements of Research, Testing and Teaching Organisations and their Personnel

Part B.  Additional requirements relating to the use of Veterinary and Human Medicines in animals that may be used for products used by man or that may enter the food chain of other animals.

I.  Domesticated animals and animals held in captivity

II.  Animals released to the wild Part C.  Protection of Members of Animal Ethics Committees

Section 3:   Consequences of not complying with this Code of Practice 

Section 4:  Definitions

• Agricultural security
• Animal
• Human Medicines
• AECs
• Manipulations
• Off-label Use
• Prescription Animal Remedies
• Production Animals
• Registered Veterinary Medicines
• Research and Teaching Organisations
• Secure Drug Storage
• Use of Veterinary and Human Medicines
• Withholding Time
• Institutional Operational Plan (IOP)
• Institutional Drug Administration Order (IDAO)

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Section 1: Introduction and Purpose

Introduction

It is recognised that there is a need for registered veterinary and human medicines to be used within Research, Testing and Teaching Organisations to prevent and alleviate any suffering of animals involved in manipulations. Furthermore, many veterinary and human medicines will not be registered in New Zealand for use in all the animal species used by Research, Testing and Teaching Organisations. Use of these medicines in species for which they are not registered, is regarded as off-label use.

The Agricultural Compounds and Veterinary Medicines (ACVM) Act 1997 provides for the prevention or management of risks associated with the use of agricultural compounds and veterinary medicines in animals; specifically, risks to trade in primary produce, to animal welfare and to agricultural security.  It is also required that the use of agricultural compounds and veterinary medicines does not breach domestic food residue standards.

It is an offence under the ACVM Act to import, manufacture, sell or use a veterinary medicine, that is not encompassed under this legislation, by being specifically registered as a trade name product, or exempted as a defined group.

The ACVM Act also states, section 98 (2) (Subject to subsection (3)), “no prescription animal remedy may be administered to, or prescribed or dispensed in respect of, an animal except following a veterinary consultation in respect of that animal.”

In relation to animal welfare, the ACVM Act provides for the prevention or management of risks relating to animal welfare. Additionally,  Research, Testing and Teaching Organisations and their personnel are required by the Animal Welfare Act 1999 to minimise any suffering of animals in their care and undergoing manipulations. Codes of Ethical Conduct require that manipulations of animals carried out by Research, Testing and Teaching Organisations are approved by an Animal Ethics Committee (AEC) which has at least one member who is a registered veterinarian. Further, the AEC is required to monitor the standards of care of animals kept by the Organisation.

Purpose of this Code

The purpose of this Code is to facilitate the use of veterinary and human medicines  by Research, Testing and Teaching Organisations in a way that complies with  the relevant legislation and regulations in respect of the ACVM Act 1997, the Misuse of Drugs Act 1975, the Medicines Act 1981, and the HSNO Act  1996.

To enable Research, Testing and Teaching Organisations to use both veterinary and human medicines, approval is given for this use where the registered veterinary and human medicine is used by specified personnel for specific purposes and under veterinary supervision as detailed in an Institutional Operating Plan and in accordance with all other conditions of this approved Code.

The use of veterinary or human medicines in Research, Testing and Teaching Organisations must be by responsible, appropriately trained personnel, and must be able to be audited.  Storage of medicines must be secure and safe, and risks to trade in primary produce (including freedom of products from residues of medicines), to animal welfare and to agricultural security as specified in the ACVM Act must be controlled. This Code of Practice approved under section 28 of the ACVM Act by the Director General of the Ministry of Agriculture and Forestry defines the requirements that Research, Testing and Teaching Organisations and their personnel must meet when using veterinary or human medicines. 

The ACVM Act, and hence this Code, applies to any product introduced into an animal for the purpose of the management of that animal (as opposed to products used as experimental variables, e.g. hypertensive agents used in a cardiovascular study or receptor agonists used in neurological studies) and to any product that is introduced into an animal that will enter the food chain. This Code does not cover the administration to animals of products (for example, medicines or biological agents) under development or for the purposes of registration trials,  and does not include the normal health management of experimental animals outside the context of research, testing and teaching protocols. The Code does not cover PAR Class III animal remedies nor Class A controlled drugs.

Research , Testing and Teaching Organisations should prepare an Institutional operational Plan (IOP) that indicates the policy and best practice ( including standard operating procedures SOP’s) that will be followed to facilitate the control and use of veterinary and Human medicines in accordance with this code.

Section 2: Requirements and Approvals

Part A:    Requirements of Research, Testing and Teaching Organisations and their Personnel

1  A copy of this Code as well as the Institutional Operating Plan must be held within each research group, which uses veterinary and human medicines in experimental animals.

2  The Research, Testing and Teaching Organisation must ensure that a registered veterinary practitioner, working on behalf of the organisation, has access to all necessary records, animal holding and use areas and all drug security/control areas. The veterinarian with this oversight responsibility for institutional drug control cannot also serve on the AEC in the capacity as the NZ Veterinary Association’s representative, because such persons must remain independent of the organisation. However, s/he may serve on the AEC in some other capacity, but such meeting service would be at the discretion of the institutional Code Holder.

3  Research, Testing and Teaching Organisations are required to develop an Institutional Operational Plan (IOP) which specifies how the following requirements will be met:

1.  A protocol issued by an authorised institutional official to cover all uses of veterinary and human medicines in animals used for research, testing or teaching. The protocol will assess the requirement for the use of the medicine to ensure the welfare of the animals to be manipulated and will document the means by which veterinary approval for the use of the medicine in the specified manipulation by the specified non-veterinary personnel are issued.

2.  The issuance of Institutional Drug Administration Orders (IDAO’s) approval by a registered veterinary practitioner, for the use of all veterinary and human medicines that addresses the points described below. ( see Appendix 1)

(a)  the medicine to be used, the dose rate, frequency of administration, and route  of administration;

(b)  the species, age, sex and condition of the animal to which the medicine will be administered;

(c)  the training and competence of named personnel who will use the medicine;

(d)  the possibility that animals may be used in the production of food, fibre or other products for use by man, or enter the food chain of animals (refer to Part B.);

(e)  the possibility of any threat to agricultural security; and ensure by contacting the ACVM Group, if there is any doubt, that there is no specific ban precluding a medicine under consideration from being used on the intended species or in the intended way;

(f)  other factors relevant to the use of the medicine, e.g. storage, use and disposal of needles and syringes,

(g)  potential adverse reactions where use is discretionary/off-label.

(h)  Applications for approval to manipulate animals that include the administration of a medicine shall include a declaration signed by the personnel undertaking the manipulation(s) that they have read this Code and will comply with the Code’s requirements. Veterinary or human medicines will only be administered to animals by staff specified in and for the purposes stated in AEC-approved applications or by or under the supervision of a registered veterinarian. When staff are using veterinary or human medicines in animals without supervision,  they must comply with the provisions of the Institutional Drug Administration Order.

4  Drug Storage All veterinary or human medicines will be stored in a manner that is secure to prevent any unauthorised removal other than for AEC-approved manipulations or by or under the direction of a registered veterinarian.

5  There must be written direction from a veterinarian for the purchase of PARs in bulk into the specified storage system of a research, testing or teaching organisation.

6  A record of all drug use as follows:

(a)  Records will be entered into a Controlled Drugs Register (CDR) each time that a veterinary or human medicine is removed from the secure store specifying the person responsible, the name of the medicine, the quantity removed, the AEC application approval number and the Institutional Drug Administration Order (IDAO) number authorising the use. The medicine will be returned to the secure store promptly after use and the quantities used and returned will be recorded. Use of medicines from the secure store by or under the direction of registered veterinarians for purposes other than AEC-approved manipulations will be similarly recorded.

(b)  Records of usage of veterinary or human medicines, stocks in storage and stock discarded or destroyed will be reconciled with quantities purchased at 6-monthly intervals and available for audit.

(c)  Research, Testing and Teaching Organisations will retain records pertaining to veterinary and human medicines. Records for sale or use of medicines and controlled drugs should be kept for 5 years. The records retained will include purchasing records of all veterinary or human medicines showing quantity and date purchased and the Drugs Register.

7  Appendix 1 provides requirements for the drafting of Institutional Drug Administration Orders (IDAO) relating to the use of veterinary and human medicines in Research, Testing and Teaching Organisations.

Part B.    Additional requirements relating to the use of Medicines in Animals that may be used for products for use by man or that may enter the food chain of other animals.

I. Domesticated animals and animals held in captivity

1  Research, Testing and Teaching Organisations and their Personnel will ensure that animals administered with veterinary or human medicines are not used for the production of food, fibre or other products used by man, or do not enter the food chain of other animals before withholding times have been observed. The Institutional Operational Plan will specify procedures that ensure compliance with this requirement. Withholding periods for animals that will enter the human food chain are set by the ACVM Group. They are provided as:-

(a)  a condition of  the products registration and label.

(b)  veterinary discretionary or off-label use of a registered product applies when the compound is not the subject of experiment but used off-label as part of normal procedure, animal numbers are small and; substance, formulation and residue risks are well known and; the product is not controversial. In these instances the default withholding period for the class of animal should be applied (Ref the current ACVM Residue Standard.)

(c)   In all other circumstances covered by this Code, entry of an animal into the food chain is managed by a research approval. Applications for  research approvals are made to the ACVM Group.

2  Research, Testing and Teaching Organisations and their Personnel will ensure that veterinary or human medicines administered to animals do not pose a significant risk to agricultural security. Where an unregistered product containing animal or plant material is imported, approval from MAF Biosecurity must be obtained. A research approval  will not be issued for such a product by the ACVM Group unless a Biosecurity approval has been provided.

3  Research, Testing and Teaching Organisations must not supply  production animals administered with a veterinary or human medicine for:

(a)  The production of food, fibre or other products used by man or for food of other animals, or

(b)  Sale, as a gift or for transferral to another party who may use the animals for, or provide the animals for, the production of food, fibre or other products used by man or for food of other animals.

Unless the withholding time and any other conditions set in the approval process described in sections 1 and 2 above have been complied with.

To manage this requirement and provide accountability, where 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, Research Testing and Teaching Organisations must establish processes and documentation  in the Institutional Operational Plan  as follows.

(a)  Animals administered with veterinary or human medicines are individually and permanently identified

(b)  A Medicine Administration Record for each animal, or group if appropriate, is maintained to record all administrations of veterinary or human medicines to each animal.  This record shall include:

(i)  the individual identification of each animal

(ii)  the dates of each administration of the medicine(s;)

(iii)  the trade name and active ingredient(s) of the medicine(s);

(iv)  the dose rate, and  route  of administration;

(v)  the withholding time of the registered veterinary medicine or the withholding time for any “off-label” use of  veterinary or human medicines.

(vi)  identification of the individual personnel administering the medicine;

(vii)  the AEC Approval Number authorising the administration of the medicine or details of circumstances requiring the administration of the medicine

(viii)  the method of disposal of the animals by the Research, Testing  or Teaching Organisation. If animals are sold, gifted or transferred, the name and address of the party who received the animals

(c)  A register of all Medicine Administration Records is kept by the Organisation. This may be a central register, for smaller organisations, or for larger organisations, it may be a number of registers, each one maintained by a department, a section, or functional group

(d)  When disposing of animals, a person with authority 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 and any other conditions set have been 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 this occurred will be recorded.

(e)  All Medicine Administration Records will be kept for 5 years following the disposal of animals

 

4  Production animals that are euthanased before withholding times or other conditions set by the Institutional Operational Procedures, are complied with must be securely stored until disposed of by incineration or burial.

II.      Animals Released to the Wild

When native, feral or any animal is treated with a medicine with a withholding period imposed as a condition of registration under the ACVM Act 2001, and the animal is released to the wild within the withholding period, consideration must be given to the risk that the treated animal may be captured or killed in the wild and used for products for use by human beings or for animal food. 

When an appreciable risk is identified by the Organization or in the course of a study review by the AEC, consultation with the regulatory authorities responsible on a case by case basis should be undertaken to agree appropriate controls to 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 may include for example, permanent identification of the treated animals, or notices advising the public of the risks, or notices warning the public about access to places affected.

Part C.    Protection of Members of Animal Ethics Committees

No member of an AEC is to be personally liable for any act or omission done in good faith in the course of his or her duties as a member of that committee in meeting the requirements of this Code.

Section 3: Consequences of not complying with this Code of Practice

Failure to comply with this Code of Practice may result in prosecution under the ACVM Act 1997.

In the case of a natural person fines range from $5,000 to $30,000.  In the case of a corporation fines range from $75,000 to $150,000. Employers, and directors and officers of bodies corporate may also be liable.

Prosecutions may also be brought under the Animal Welfare Act 1999, the Dairy Industry Act 1952, the Meat Act 1981,  the Food Act 1981 or the Animal Products Act 1999.

Civil liability may also be incurred as a result of losses suffered by parties acquiring animals from Research, Testing and Teaching Organisations.

Section 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 subsection (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 subsection (2).

II.           Unwanted organisms under the Biosecurity Act 1993.”

Animal

An animal is defined in the Animal Welfare Act 1999 as any live member of the animal kingdom that

(a)  is (i) A mammal; or (ii) A bird; or (iii) A reptile; or (iv) An amphibian; or (v) A fish (bony or cartilaginous); or (vi) Any octopus, squid, crab, lobster, or crayfish (including freshwater crayfish); or (vii) Any other member of the animal kingdom which is declared from time to time by the Governor-General, by Order in Council, to be an animal for the purposes of this Act; and

(b)  includes any mammalian foetus, or any avian or reptilian pre-hatched young, that is in the last half of its period of gestation or development; and

(c)  Includes any marsupial pouch young; but

(d)  Does not include (i) A human being; or (ii) Except as provided in paragraph (b) or paragraph (c) of this definition, any animal in the pre-natal, pre-hatched, larval, or other such developmental stage:

For the purpose of this Code, the definition of animal is as above, but it includes foetuses of any age and any invertebrate species, that have the potential for contamination with drug residues and may enter the food chain.

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.

Animal Ethics Committee

Any organisation (or person) wishing to use animals in research, testing or teaching must submit a Code of Ethical Conduct to the Director-General of the Ministry of Agriculture and Forestry for approval.  Every code holder must establish and maintain an Animal Ethics Committee (AECs) or obtain approval to use the AEC of another organisation. The functions of the AEC include consideration and determination, on behalf of the code holder, of applications for the approval of projects, monitoring compliance with conditions of project approvals and monitoring animal management practices and facilities.

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 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 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.

4  The Minister must, in deciding whether to publish a notice under subsection (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

(c)  The purpose of the procedure; 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 subsection (3); and

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

Off-label Use

Off-label use is the administration to a species of animal of a medicine that is not registered under sections 21 or 27 of the ACVM Act 1997 for use in that species or for that use pattern in New Zealand

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:

(c) Class III prescription animal remedy may be administered to an animal only by 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.

Secure Drug Storage

A secure drug store shall be a lockable (key or combination) container preferably permanently affixed to a solid structural wall, located in sight of trustworthy personnel and in a building secured outside of work hours. Access to the secure drug store will be limited to trustworthy individuals knowledgeable of the requirements of this Code and formally authorised by the Organisation. The authorised persons shall administer the receiving and issuing of the Medicines from the secure drug store and maintain the Drug Register. Ideally, each Organisation would have a central Secure Drug Store for all Medicines covered by this code.  Large organisations may need more than one Secure Drug Store each of which may need to be administered separately and independently of others.

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) : Appendix 1

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

Appendix 1 in full.