VCNZ Code of Professional Conduct

Veterinary Medicines

Veterinarians must exercise sound professional judgement when authorising, dispensing, recommending, selling and using veterinary medicines.

[Show All Explanatory Notes]

When using or selling any unrestricted veterinary medicine or dispensing a restricted veterinary medicine, veterinarians must:
1. Ensure effective product management (storage, reporting adverse reactions, maintaining the integrity of product, labelling, security, safety of handling); and
2. Practice in accordance with the Agricultural Compounds and Veterinary Medicines Act 1997, Animal Products Act 1999, Hazardous Substance and New Organisms Act 1996, Health and Safety in Employment Act 1992, Medicines Act 1981, Misuse of Drugs Act 1975 and associated subordinate legislation in relation to all these acts as well as other relevant legislation.
[Show Explanatory Notes - Section 1]
Understanding Section 1

Veterinarians are not obliged to maintain an inventory of veterinary medicines. Section 1 only applies to those veterinarians who purchase or stock veterinary medicines in order to use, sell or dispense them in the course of their practice.

Storage means holding supplies of veterinary medicines. The expectation is that storage will comply with product label requirements, the Hazardous Substances and New Organisms (HSNO) Act 1996, Misuse of Drugs Act 1995 and regulations, and the Health and Safety in Employment (HSE) Act 1992 and regulations.

While there is no legal requirement, there is an expectation that adverse events as a consequence of using a veterinary medicine will be reported to MAF and the manufacturer.

To maintain the integrity of a product means to store, transport, handle or supply it in a manner that does not compromise the confidence that the product still complies with the manufacturing specification (i.e. it is still as it was supplied by the registrant). A breach of the integrity of the product includes altering labels, opening sealed internal packaging, decanting, breaking down or supplying information in conflict with the label. All of these things can be done but, in doing so the veterinarian must accept responsibility for the action.

It is also expected that where any restricted veterinary medicine is dispensed that its labeling will comply with the NZVA guideline A Guide to Veterinary Pharmacy and Dispensing.

The labeling requirements for human medicines, off label use and compounded products are set out in the ACVM standard for prescription animal remedy veterinary medicines (search for full or partial document title on the MAF web page www.foodsafety.govt.nz/industry/acvm/about/index.htm)

Security refers specifically to the requirements for controlled drugs as specified in the Misuse of Drugs Act 1975 and regulations. There is an expectation that veterinarians must maintain sufficient security and control on all restricted veterinary medicines to ensure they are only used according to veterinary authorisation. From a MAF perspective, security also means ensuring lay staff do not sell restricted medicines without appropriate authorisation.

Safety of handling refers to the responsibilities that apply under the Health and Safety Act 1992.

For members of NZVA, guides to ACVM, HSNO, HSE and Misuse of Drugs legislation can be found on the NZVA website or information can be obtained from the NZVA office. Refer also to the legislative section and explanatory notes of this Code. The legislation can be found at www.legislation.govt.nz, and some guides can be found on the websites of the agencies who administer the legislation.

When using or recommending any unrestricted veterinary medicine or authorising any restricted veterinary medicine, veterinarians must:
1. Consider the implications of its use with regard to risks to public health, trade in primary produce, agricultural security, animal welfare, occupational health and safety and the environment, and act accordingly to avoid or mitigate significant risks;
2. Be satisfied that the choice of product is justified, and that use is appropriate to achieve the intended effect and ensure the welfare of the animal;
3. Provide appropriate advice on the management of residues and withholding periods in food producing animals;
4. Determine and provide the appropriate level of veterinary involvement (if any) required during and after administration in order to manage the risks;
  and
5. Determine and provide the appropriate level of advice and training (if any) to:
  1. Administer the veterinary medicine safely and appropriately; and
  2. Monitor the effects of treatment on the animals;
  3. Make provision for veterinary intervention in the case of adverse effects.
[Show Explanatory Notes - Section 2]
Understanding Section 2

Section 2 identifies the relevant expectations when a veterinarian is considering the treatment of an animal with a veterinary medicine with specific reference to product stewardship.

When the product is a restricted veterinary medicine these expectations apply to the veterinarian whether they personally use or administer the product, or whether they authorise another person to use or administer the product.

When the product is an unrestricted veterinary medicine (OTC) these expectations apply equally whether a veterinarian or one of the practice employees is using the product, or making recommendations about the product. Irrespective of the nature of the ownership of the practice veterinarians in the practice must take reasonable care to ensure that the staff are competent and that they perform to the standard expected in this Code. Where a veterinarian has reasonable cause to suspect that staff are not performing to the expected standards, this should be brought to the attention of the practice owners/principals. If the matter is not satisfactorily resolved the veterinarian should consider raising their concern with VCNZ.

A primary purpose of the Animal Compounds and Veterinary Medicines Act 1997 is to prevent or manage risks to public health, trade in primary produce, animal welfare and agricultural security associated with the use of agricultural compounds including veterinary medicines. Veterinarians must comply with the conditions of registration on all veterinary medicines they choose to use, sell or authorise. Inherent in this requirement is the expectation that veterinarians have read the conditions and have systems in place to warn them of any changes which might affect how the product is permitted to be used. The Health and Safety in Employment Act 1992, among other requirements, identifies an employer's responsibilities to identify hazards and to take steps to remove or manage them. As an extension of these legislative requirements, section 2(a) of this part of the Code sets out the expectation that veterinarians will identify and manage the risks (as identified) associated with using veterinary medicines. The underlying premise in this case is based on the longstanding medical principle 'First, do no harm'. A veterinarian's treatment should minimise the risk of unexpected harmful consequences to the patient, the owner, the veterinarian or their staff. Similarly a veterinarian's treatment should not cause a detrimental effect to agricultural trade or New Zealand agricultural security.

Veterinarians must be impartial and discerning in their sale or recommendation of products so that clients obtain and, equally importantly, know they can obtain an unbiased opinion on the safety, efficacy and worth of the products for particular conditions. The expectation is that commercial gain for the veterinarian will not influence the decision to use a veterinary medicine. Veterinarians must be satisfied that the use of a veterinary medicine is necessary to achieve a specific and required clinical effect.

Justified use means there is a valid reason to use the veterinary medicine based on accepted medical principles. Veterinarians are expected to make conscientious and judicious use of current best evidence and integrate this with their own clinical expertise and experience when making decisions about the treatment of their patients.

Appropriate use means the particular product choice and the way it is administered is suitable for the situation.

Examples demonstrating justified and appropriate use include:

The use of an antibiotic may be justified in order to treat a bacterial infection. Whether the use is appropriate will depend on the choice of product for the situation, the dose rate used and the route of administration;

Non steroidal anti-inflammatory drugs may be a valid choice for pain relief, but an inappropriate analgesic in the haemodynamically unstable patient;

General anaesthesia may be able to be justified in order to carry out a surgical procedure, but may not be appropriate depending on the drugs used, the age and health status of the patient etc.

In all situations involving food producing animals the potential for residues must be addressed and clients provided with sufficient information to address any issues.

There is a professional responsibility, and under section 55 (3) of the Animal Compounds and Veterinary Medicines Act 1997, a legal requirement for veterinarians to provide information to prevent any residues in primary produce occurring from any animal treated with a veterinary medicine which contravene the requirements of the Food Act 1981 and the Animal Products Act 1999.

Veterinarians or their clients may be charged with an offence (under provisions of the Animal Products Act 1999, Food Act 1981 or both) for supplying primary produce that contravenes this legislation. The offence under section 55(3) of the Animal Compounds and Veterinary Medicines Act 1997 is specific to veterinarians and relates to whether or not they provided the client with information about not supplying the non compliant primary produce. Whether or not the veterinarian will be accountable depends on the information provided to the client.

Veterinarians must use (or give direction for use of) veterinary medicines in a way that is consistent with approved uses for the product and convey the label advice for withholding periods. If the label use is not approved then it cannot be presumed that the label information on withholding periods is relevant.

For an OTC product such as an anthelmintic, if a veterinarian determines it can be used in an off-label manner and advises an alternative withholding period, then a client may use the product legally in accordance with that advice. If as a result of the professional advice, non-compliances with the Animal Products Act 1999 thresholds are reported, then the veterinarian may be legally liable for actual losses by the client that are directly attributable to the professional advice.

Failure to provide appropriate advice to clients on residues in food producing animals or to keep a record of the advice given places the veterinarian at risk of prosecution.

The level of veterinary involvement required during and after the administration of a veterinary medicine will depend on the particular circumstances and the degree of risk that requires managing including, but not limited, to:

The type of veterinary medicine e.g. anaesthetic, antibiotic etc;

The regulatory requirements for that particular product;

The accepted standard of care upheld in the profession for that particular product or product type (ultimately if necessary this will be judged by a veterinarian's peers);

The route of administration e.g. IV, SC, PO;

The type of patient and existing condition;

The level of training and experience of the person who will be administering the product;

Whether the person administering can be appropriately trained to administer the product;

The level of monitoring required during and after administration;

The training and experience of the administrator to provide adequate monitoring; and

The potential risks (as identified in 2(b) above) involved with administration.

This clause relates to specific veterinary involvement. A client not able to administer a tablet to a dog or cat, or a client not able to administer an injection of antibiotic intramuscularly to a calf, does not necessarily mean veterinary involvement is required.

Where a veterinary medicine is deemed suitable to be administered by a lay person, the veterinarian has a responsibility to appropriately advise and train the administrator.

When using or authorising restricted veterinary medicines, veterinarians must comply with the requirements and expectations of MAF ACVM Group in relation to authorisation. This is set out in their published performance and technical standards: (foodsafety.govt.nz/elibrary/industry/Veterinarians_Recognised-Sets_Expectations.pdf)
Additionally veterinarians must:
1. Comply with all of the points in paragraph 2 above;
2. Obtain sufficient information to assist risk assessment and to support the choice of that veterinary medicine through either:
  1. Veterinary consultation as defined in the glossary, or
  2. Issuing Veterinary Operating Instructions as detailed in paragraph 4
3. Create and maintain appropriate records detailing the decision and the action taken; and
4. Honour requests for written authorisations in lieu of dispensing.
[Show Explanatory Notes - Section 3]
Understanding Section 3

The MAF document "Veterinarians Recognised (under s 62, Animal Compounds and Veterinary Medicines Act 1997) to Issue a Valid Authorisation for Purchase and Use of restricted Veterinary Medicines Requiring Veterinary Authorisation ACVM Performance and Technical Standards No 1" sets out MAF expectations under the Animal Compounds and Veterinary Medicines Act 1997 regarding the standards to be maintained by veterinarians recognised to authorise the purchase and use of restricted veterinary medicines (RVMs) that (under their conditions of registration) require veterinary authorisation. Veterinarians are expected to know and comply with the requirements detailed in this document. (search for the full or partial document title on the MAF web page www.foodsafety.govt.nz/industry/acvm/about/index.htm)

In addition to MAF's requirements this Code identifies further professional expectations that apply to veterinarians when authorising RVMs. There is a strong expectation that veterinarians will exercise sound professional judgement and adhere to both the legal and professional requirements that apply.

In order to authorise the use of a RVM the veterinarian must have gathered sufficient information to support that decision. The principal method of meeting that expectation is via consultation (see (d) below). An alternative option to consultation, which is only likely to be suitable in certain limited circumstances is through the use of Veterinary Operating Instructions (see Understanding Section 4). These two options define the only two processes by which veterinarians can authorise RVMs.

A veterinary consultation is a specific interaction between the veterinarian and client usually involving an animal(s) that the client is responsible for. There are several components to a consultation (see Code glossary for definition). For a more detailed breakdown of what is expected in terms of these components see - VCNZ Competency Standards and Performance Measures for Veterinarians - in relation to obtaining, recording and analysing information. The purpose of the consultation is to collect sufficient information about an issue of concern to the client (usually an animal health or production problem) in order to be able to decide on a course of action. Consultation will always involve collection of sufficient information through an interview with the client and will usually involve an examination of the animal(s) and/or their environment. The resulting course of action can involve any or all of but is not limited to: collection of further information through diagnostic testing; treatment with a veterinary medicine; treatment using a veterinary procedure; advice or recommendations; referral to another veterinarian; ongoing monitoring and follow-up.

The requirement for veterinary authorisation is removed where the use of a restricted veterinary medicine is allowed according to an operating plan approved under section 28 of the Animal Compounds and Veterinary Medicines Act 1997.

An approved operating plan describes how a person (or an organisation) intends to meet a particular statutory obligation such as the conditions of registration of a restricted veterinary medicine. In the context of using restricted veterinary medicines, an approved plan describes the circumstances by which a specified veterinary medicine will be used by specified people who are not veterinarians in order to achieve identified treatment objectives. The operating plan provides the statutory basis for the authorisation of the restricted veterinary medicines, and removes the requirement for veterinary authorisation.

Operating plans approved under section 28 of the Animal Compounds and Veterinary Medicines Act 1997 are not the same as veterinary operating instructions. These are discussed under section 4 of these explanatory notes.

What VCNZ will consider as 'sufficient information', and whether the consultation process is adequate will depend on the particular circumstances. Ultimately in the event of a complaint investigation the test of reasonableness will be applied. That is taking into account the generally accepted standard of care that exists for this set of circumstances in practice, what actions or decisions would another veterinarian with the same training and experience reasonably make or take in the same circumstances?

VCNZ may from time to time publish statements setting out what is considered reasonable for specific circumstances. An example is the VCNZ Statement on the Information Requirements for Authorisation of Dry Cow Therapy. This sets out the minimum requirements for prescribing dry cow therapy.

When restricted veterinary medicines are being used to treat or control clinical or production problems that are being managed as a herd or flock problem, the expectation is that the requirements of consultation will be applied to the herd or flock rather than the individual animals within the herd or flock.

Veterinarians are required to obtain appropriate consent before proceeding with treatment. This is discussed in detail in the client relationships section of this Code, and related explanatory notes.

A specific requirement of any veterinary consultation is that the veterinarian must accept responsibility for the ongoing health and welfare of the animal in relation to the matters that have been consulted on. Following a consultation that leads to a particular course of action (see paragraph 3d above), the veterinarian must make provision for the appropriate ongoing management of the case in order to be able to reasonably achieve the agreed and identified outcome. This includes appropriate follow up treatment and monitoring, appropriate communication with the client, and making provision for emergency care in case of technical failure, adverse events or unexpected complications.

In 'making provision' the veterinarian may delegate the ongoing management to another veterinarian or person with the appropriate skills.

Accepting responsibility for the ongoing health and welfare does not mean the veterinarian is expected to accept the financial responsibility to achieve the agreed and identified clinical outcome. All anticipated costs associated with every stage of an agreed course of action should be communicated to the client and agreed upon as part of the consent process. In these circumstances, the responsibility for ongoing health and welfare is specific and limited to the animals and the clinical matters that have been consulted on. This responsibility does not extend to other animals owned by the client, or other unrelated clinical matters.

There are certain circumstances where it is considered acceptable for the veterinarian providing the authorisation not to have recently examined or seen the animals as part of a consultation, for example, the authorisation of a veterinary medicine for a client by a veterinarian who is employed in the same local practice (i.e. a co-worker in the practice) where the co-worker works in the same area of practice as the client's usual veterinarian, and where the usual veterinarian would have otherwise authorised the veterinary medicine because they have recently seen and therefore do have personal knowledge of the health condition / status of the animal(s).

Other than this there are few situations where not seeing or examining the animals would be acceptable.

Veterinarians should carefully consider the circumstances in which they use electronic means for authorising. Writing a veterinary authorisation based, for example, on an internet consultation is only likely to be considered acceptable by VCNZ in certain circumstances. Veterinarians authorising the use of veterinary medicines via electronic means are expected to provide their animal patients with the same standard of care and comply with the same expectations around consultation regardless of the communication method or service delivery mechanism used. Both of the following requirements apply when the authorisation of a restricted veterinary medicine follows an electronic consultation:

The veterinarian must have seen the animal(s) recently enough to have sufficient personal knowledge of the condition/health status of the animal(s) in order to be able to propose the particular course of treatment.

The veterinarian must be satisfied that a direct physical examination would not add critical information about the management of the case.

There are statutory requirements under the Animal Compounds and Veterinary Medicines Act 1997 and potentially the Misuse of Drugs Act 1975 for record keeping in relation to use of veterinary medicines and prescription medicines. There are particular expectations about records and the quality of records identified in the VCNZ Competence Standards and Performance Indicators. This Code also requires that records be kept and maintained in relation to treatment with veterinary medicines.

Where there has been a consultation and a veterinarian has proposed treatment with a veterinary medicine, the client is entitled to request from the veterinarian a written authorisation to take away and have the product dispensed by a different trader rather than have the consulting veterinarian dispense it. The consulting veterinarian is obliged to comply with that request. The expectation is that this would apply in every situation where the veterinarian would have otherwise dispensed product themselves.

There is no requirement for a veterinarian to provide a written authorisation to take away in a situation where the product would not normally be dispensed. For example where the product would normally be personally administered by the veterinarian for reasons of managing the risks associated with use), or where an adequate consultation has not occurred.

The expectation is that the written authorisation should be provided to the client within a reasonable timeframe and that except in exceptional circumstances this would be within 24 hours.

The veterinarian writing the authorisation (not the trader ultimately dispensing the product) is in every case responsible for meeting all of the requirements in sections 2 and 3 of this part of the Code.

Veterinarians are entitled to charge a reasonable fee for writing the authorisation. However, it would be unethical for a veterinarian to require that the client meet a different standard of consultation in order to be entitled to a written authorisation as compared to the standard of consultation that would normally be required if the veterinarian was dispensing the product. For example making the client undertake further diagnostic work because a written authorisation has been requested, when such work wasn't considered necessary for the veterinarian to originally dispense the product themselves.

When issuing Veterinary Operating Instructions (VOI), veterinarians must comply with the requirements and expectations of MAF ACVM Group in relation to VOI. These are set out in MAF's guidelines at
www.foodsafety.govt.nz/elibrary/industry/Veterinary_Operating-Guidelines_Issuing.pdf.

Additionally veterinarians must:
1. Tightly define the specific treatment circumstances in which each restricted veterinary medicine is authorised to be used under VOI.
2. Authorise use of restricted veterinary medicines under VOI only in circumstances where there is no reasonable expectation that either veterinary judgement or a veterinary diagnosis would be needed to ensure that the use of the product in the specific case is appropriate and justified.
3. Not use VOI to authorise the use of any controlled drug as defined in the Misuse of Drugs Act 1975;
4. Be able to provide evidence that the process for developing and issuing VOI has been followed appropriately prior to implementation of the instructions;
5. Be able to provide evidence that they have identified:
  1. The specific competencies required of personnel authorised in the VOI;
  2. Appropriate detail on the training and assessment of the personnel in relation to those competencies
6. Make it a requirement of the VOI that specific records are kept in relation to every instance of use of the restricted veterinary medicines by VOI specified personnel. Records must document sufficient information to permit easy assessment of compliance with the terms of the VOI;
7. Be able to provide evidence of sufficient monitoring that allows the veterinarian to be confident that the terms of the VOI are being complied with;
8. Review the competency of the personnel at least annually by personally assessing the use of the restricted veterinary medicines by the user;
9. Withdraw the VOI immediately in situations of non compliance.
[Show Explanatory Notes - Section 4]
Understanding Section 4

Veterinary Operating Instructions (VOI) are a set of instructions from an authorising veterinarian to a non-veterinarian to hold a restricted veterinary medicine (RVM) in anticipation of use, for use only in accordance with the authorising veterinarian's instructions in circumstances in which the authorising veterinarian will not be carrying out a case-specific consultation, and where all matters requiring consideration by the veterinarian have been addressed in the instructions.

The two MAF documents "Veterinarians Recognised (under s 62, Animal Compounds and Veterinary Medicines Act 1997) to Issue a Valid Authorisation for Purchase and Use of restricted Veterinary Medicines Requiring Veterinary Authorisation ACVM Performance and Technical Standards No 1" and "Veterinary Operating Instructions ACVM Guidelines No 65" set out MAF's expectations in relation to VOI. (Search for the full or partial document titles on the MAF web page www.foodsafety.govt.nz/industry/acvm/about/index.htm). The first document also provides a template for developing VOI. MAF documents stipulate that compliance with the guidelines for VOI is not mandatory. However, in order to demonstrate compliance with the requirements of this Code, veterinarians must follow those guidelines and meet the minimum suggested requirements.

Additional to MAF’s requirements this Code identifies further expectations that apply to veterinarians when issuing VOI. These are set out below. Veterinarians must adhere to both the legal and professional requirements that apply. There is a strong expectation that veterinarians will exercise sound professional judgement when developing and issuing VOI.

The concept of VOI has evolved from the human medical use of Standing Orders. Doctors can write Standing Orders allowing designated persons with identified competencies to use specified prescription medicines to treat human patients without involving the doctor at the time. In the same way VOI are seen as a strategic tool allowing the optimal use of available skills in the workforce through the delegation of treatment roles that do not need to be specifically undertaken by a veterinarian to a less highly but still appropriately trained person.

VOI authorise that specified RVMs can be held by designated persons in anticipation of use. In all cases when people working under VOI use the RVMs, they are not prescribing or authorising them, but rather administering or supplying them and only pursuant to the documented instructions of the authorising veterinarian. In effect the authorised person is acting as an extension of the veterinarian.

VOI do not have to be linked to a case-specific veterinary consultation in relation to the animals being treated. Under the VOI, the specified person can only use the authorised RVM on the identified animals (or class of animals) in the defined circumstances. As long as the specified person complies fully with the conditions of the VOI, they are not limited to only using the RVMs on animals belonging to the veterinarian's clients. Neither are they limited to using the products following a consultation between the veterinarian and the owner of the animals. Consequently there is not necessarily a veterinarian-client relationship between the veterinarian issuing the VOI and the owner or the person in charge of the animals being treated under the authority of the VOI.

Veterinarians must anticipate the possibility of adverse events in relation to the use of the RVMs authorised under VOI and make provision for how those events will be managed. The VOI should identify these events as well as specifying how these will be managed. The person authorized under the VOI must be appropriately trained to manage those events which can be reasonably dealt with, without veterinary involvement. Veterinary intervention will be necessary in order to appropriately manage certain adverse events. In those situations, the VOI must define how that veterinary involvement will be provided. Unless provision for veterinary care in such events is readily available, it may not be appropriate to develop VOI. The authorising veterinarian will either need to provide that care themselves, or alternatively make prior arrangements with other veterinarians so that the service will be readily accessible if the need arises.

It is technically feasible for VOI to be written to be used on animals that are geographically remote from the authorising veterinarian. However, authorising veterinarians should bear in mind that it may be difficult to meet all of their VOI responsibilities (e.g. supervision of the VOI, managing adverse events etc.) in relation to VOI when the authorised person is acting remotely from them. Veterinarians are strongly advised to consider carefully and act with caution when considering VOI for situations where the animals to be treated do not belong to their clients.

Understanding Section 4(a) and (b):

VOI must be developed in such a way as to tightly define and ring-fence which animals can be treated, the precise types of treatment situations applicable and the decision making process expected of the user leading up to use. In every case when issuing VOI, the veterinarian must be satisfied that all of the clinical variables associated with the case have been sufficiently defined and managed so that the presence of a veterinarian is therefore not required in the particular identified circumstances in order for the user to decide whether or how the authorised products should be used.

VOI can only be considered an appropriate option in situations where there is no need for a veterinarian to make a clinical diagnosis in order to ensure the use authorised by the VOI is appropriate and justified and where there is no requirement for a veterinarian to exercise their professional judgement in relation to the decision to use the particular product.

For the purposes of illustrating how VOI might be used, it is likely that most animals treated under VOI will fit into one of three groups:

Prophylactic treatment of healthy animals for the purpose of preventing disease. Examples might include:
- Vaccinating a dairy herd for leptospirosis.
- Vaccination of animals admitted to a shelter organisation for the purposes of adoption.

Chemical restraint of healthy animals to facilitate the performance of a procedure or manipulation. Examples might include:
- Use of local anaesthetic/xylazine for disbudding calves
- Develvetting of deer
- Pre-medication of surgical patients

When authorising the purchase and use of restricted veterinary medicines to remove deer velvet veterinarians are strongly advised to comply with the MAF ACVM Performance and Technical Standard 1.1 Xylazine, Yohimbine and Lignocaine for the Purpose of Velvet Antler Removal. Veterinarians who comply with this standard can be assured that they will meet their legal and professional responsibilities under the Animal Welfare Act 1999, the Agricultural Compounds and Veterinary Medicines Act 1997 and the VCNZ Code of Professional Conduct.

Treatment of an animal(s) identified to have a particular condition or state of health, where the presence of that condition or state is so obvious that a veterinarian is not needed to diagnose it under the particular circumstances in order to justify the authorised treatment. An example might be sedation of an agitated horse by a groom on an export flight.

There would be very few exceptions where veterinary diagnosis and judgement would not be considered a requirement in order to justify the appropriate use of antibiotics. Therefore, VOI are unlikely to be considered an appropriate way to authorise the use of these products.

Understanding section 4(c)
As the law is currently set out in the Medicines Act 1981, Misuse of Drugs Act 1975 and associated Regulations, it is ambiguous as to whether veterinarians are legally able to supply controlled drugs to animals not directly in their care, i.e. through veterinary operating instructions. Because of the concerns about the appropriate security and safety using these products and the potential serious legal ramifications for the authorising veterinarian, it is not acceptable to authorise controlled drugs using VOI. This does not limit the use and authorisation of controlled drugs following a veterinary consultation.

Understanding Section 4(d).
This section should be self explanatory. Veterinarians must always have developed the particular VOI before use of the RVMs.

Understanding Section 4(e)
The veterinarian must be satisfied that the person(s) identified in the VOI is adequately trained and experienced in the use of the specified veterinary medicine, and is able to safely, reliably and effectively carry out the instructions as documented. The issuing veterinarian must identify and document in the VOI:

the particular competencies required in relation to using the specified restricted veterinary medicines in accordance with the VOI; and

how the specified person is recognised as being in possession of those competencies (either by the specific training provided by the veterinarian, or relevant qualifications).

Understanding Section 4(f)
Veterinarians are required to keep accurate records detailing their own use of restricted veterinary medicines associated with consultations. It is expected that similar records must be kept by the person specified in the VOI which should document:

how, when, where and on whose animals RVMs were used and in what circumstances.

date of use; name and address of person in charge of the animals; identity of the animals (or herd or flock); the identity of the person using or providing the restricted veterinary medicine; volume or amount of product used; method of administration; reason for use; adverse reactions or events and sufficient details to allow immediate stock reconciliation.

Understanding Section 4(g)
VOI must define an end date or review date which must be no longer than 12 months from date of commencement.

Veterinarians must use their professional judgement to determine the level of monitoring/auditing that is required on a case by case basis in order to be confident that the conditions and terms of the VOI are complied with.

As part of this monitoring, the records of use must be examined in order that the veterinarian can be satisfied the treatment decisions of the specified person are valid and in compliance with the terms of the VOI. The frequency the records should be examined is reliant on the judgement of the veterinarian for the particular circumstances.

Reconciliation of all restricted veterinary medicine purchases and disposals, against the record/register must also be conducted frequently enough for the veterinarian to be confident that product use remains in compliance with the VOI. The veterinarian is expected to use their judgement when deciding how often these records should be checked in order to have confidence. However, it is expected that auditing will take place at least every 6 months, or at the conclusion of the term of the VOI if that is for a shorter period.

If the user specified in the VOI does not obtain the RVM direct from the veterinarian who has issued the VOI, then it would have to be purchased from an approved seller of RVMs using a veterinary authorisation issued for that purpose. The VOI is a standing direction governing use and should not be used as the authorisation to purchase. While it is conceivable that the VOI and veterinary authorisation to purchase an RVM could be one and the same, it would be a better form of supervision and control if the user specified in the VOI advised the veterinarian that stock of the RVM has been used (or is about to run out) and request the veterinarian to issue a veterinary authorisation to replenish the stock. That way the veterinarian has ongoing knowledge of the rate of use. It would be expected that the veterinarian issuing the VOI would address the replenishment of stock in a planned and proactive manner.

Understanding Section 4(h)
The MAF guidelines set out expectations regarding review of the VOI. Additionally this Code requires, (as part of the review process, and if the VOI is to be extended), that veterinarians review the competencies that are needed to carry out the instructions, and meet personally with the user in order to reconfirm their confidence that the user is working effectively and safely under the VOI. Ideally this would involve personally viewing the user administering the products.

Understanding 4(i)
VOI must be cancelled and withdrawn by veterinarians in any situation in which they are not confident that the instructions are being complied with. Non compliance by the specified person with the instructions of the authorising veterinarian puts the operator in breach of the conditions of registration of the product. If the veterinarian is aware of non compliance and takes no action to withdraw their authorisation, their status as a recognised person under the Animal Compounds and Veterinary Medicines Act 1997 may be put at risk.

Writing VOI does not exempt the veterinarian from ultimate responsibility for ensuring that the risks will be managed satisfactorily. Veterinarians who issue VOI must accept that they have obligations to ensure that the authorised person has had sufficient training, instructions and information to ensure that they will use the restricted veterinary medicine only in accordance with those instructions. If the specified person fails to comply with the operating instructions, or there is an unanticipated outcome from the use of the VOI, then questions may be raised. Questions that could be asked would include whether the authorised person had adequate training in the use of the restricted veterinary medicine and whether the veterinarian issued adequate instructions and used sound judgement in deciding that the specified person could and would comply before authorising the product(s). The veterinarian may not be responsible for the specified person’s behaviour if something went wrong, but could be held accountable for issuing inadequate instructions, or making a poor judgement about the capability and reliability of the client or continuing to authorise the supply in the face of doubt.

When using or authorising human medicines or the discretionary use of registered veterinary medicines " off label", veterinarians must:
1. Comply with all of the points in paragraphs 2 and 3 above;
2. Consider if there is a registered veterinary medicine that will adequately achieve the intended effect and ensure the welfare of the animal and, if appropriate, choose the registered veterinary medicine in preference; and
3. Not supply any Medsafe approved human medicine for use as a veterinary medicine, or any registered veterinary medicine off label unless the additional risks can be justified.
[Show Explanatory Notes - Section 5]
Understanding Section 5

The VCNZ statement The Discretionary Use of Human and Veterinary Medicines by Registered Veterinarians sets out VCNZ expectations in relation to using or authorising these types of products.

Off label use of a registered veterinary medicine occurs when the use does not comply with approved claims. Off-label use may involve the route of administration, dose rate, duration of treatment, target species or the condition being treated. Not all restricted veterinary medicines are permitted to be used off-label. Those where off-label use is prohibited have a condition of registration identifying this requirement. Where an OTC product is allowed to be used off-label it will carry a condition of registration stating that the user before such use must "seek advice from an appropriately qualified source and confirm that the intended use is not likely to cause unnecessary or unreasonable pain or distress in the animal treated."

The product label includes all of the product proprietor information MAF has approved as being able to be supplied to the person the product is sold to, irrespective of the form of that information. Label information therefore includes:

The physical label attached to the product

Label information on product packaging

Additional loose material packed with the product

Medsafe (New Zealand Medicines and Medical Devices Safety Authority) is a business unit of the Ministry of Health and is the regulator responsible for administering the Medicines Act 1981. This Act establishes a pre-market evaluation and approval system for human medicines that is designed to ensure that new medicines meet the required standards. Medsafe does not assess human medicines in relation to their use in animals.

Where human medicines are used in animals, and when registered veterinary medicines are used off-label, there has been no regulatory assessment to determine the safety and efficacy of the product in these circumstances. Such use will likely involve additional risks over and above the use of a registered veterinary medicine which has been assessed for use for the particular purpose.

Where discretionary use (of either a human medicine or a registered veterinary medicine) is controversial or outside the mainstream standards of care, the veterinarian must obtain the informed consent of the client for this purpose.

The expectation is that if there is a registered veterinary medicine that can be used to achieve the same intended effect within the label and registration conditions, it should be chosen before the discretionary use of a human medicine or the off label use of a veterinary medicine. It is accepted that there may be circumstances where the discretionary use may be chosen in preference. This is acceptable as long as the decision can be justified and it is the exception rather than the rule.

When using or authorising a preparation that has been compounded, veterinarians must:
1. Comply with all of the points in paragraphs 2, 3 and 4 above;
2. In situations where there is no appropriate registered veterinary medicine consider if there is an appropriate Medsafe approved human medicine. If such a product is available and will adequately achieve the intended effect and ensure the welfare of the animal it must be chosen in preference to a compounded product;
3. Ensure that compounded products do not contain prohibited or restricted substances as defined by MAF ACVM Group;
4. In situations where the product is compounded personally, be competent in all aspects of formulation and manufacturing and take full responsibility for the product including its preparation, packaging and labelling;
5. Be satisfied that any third party contracted to do the compounding is competent, and issue the third party with a compounding order specifying the product, quantity, packaging and labelling;
6. Ensure that there is a documented system for compounding in place;
7. Retain full responsibility for the product even when it is compounded by a third party contractor;
8. Compound only enough product to manage short-term requirements and not store product in anticipation of future needs;
9. Not advertise or promote compounded products as veterinary medicine trade name products or display them for sale to the general public; and
10. Not import compounded veterinary medicines without approval from MAF ACVM Group.
[Show Explanatory Notes - Section 6]
Understanding Section 6

MAF and VCNZ recognise that veterinarians need to be able to compound preparations for the treatment of animals when the need arises. However, in accepting that the need exists, veterinarians should recognise that compounded preparations have avoided the usual regulatory assessment, and so expose the veterinarian, animals treated; people involved with treatment and the public interest to potential risks (see section 2(b)). Being able to compound veterinary medicines is a privilege granted to the veterinary profession that carries particular responsibilities. The expectations around compounding are identified in section 6 of the Veterinary Medicines section of the Code. For further information refer to the VCNZ Statement on Compounded Veterinary Medicines and MAF Guidelines on Developing a Documented System for Compounded Veterinary Preparations.

Veterinarians may compound product under one of the two exemptions from registration of veterinary medicines that are specified in the Animal Compounds and Veterinary Medicines regulations. A veterinarian, like anyone else, can also manufacture a trade name product that fits any of the defined product groups (based on scope of claims) specified in schedule 1 or 2 of the Agricultural Compounds and Veterinary Medicines (Exemption) Regulations 2011. Veterinarians who compound preparations become subject to ACVM requirements in Regulations 7, 10, 12 and 14 and it is important that they clearly understand those expectations. For further information refer to the VCNZ Statement Veterinarians and Manufacturing of Veterinary Medicines.

Compounding a veterinary medicine should be seen as a last resort and only undertaken because a product in the desired form or presentation is otherwise unavailable for animal treatment. The guiding principle should be that the compounded product improves the animal(s) welfare over and above anything else that is currently available and is therefore a more appropriate veterinary medicine to use.

The process of reaching a decision about product choice can be compared to a linear cascade. If there is a registered veterinary medicine that can be used in compliance with the label and registration conditions to achieve the intended clinical effect, it should be considered first. If there is no such suitable product, a registered veterinary medicine that can be used off-label should be considered next. Following that a human medicine, and following that a compounded medicine.

Veterinarians must take full responsibility for the product whether they do the compounding personally or contract someone else to do it.

Veterinarians should only compound sufficient material to satisfy their short-term requirements, and not in anticipation of future needs. Although product should really only be compounded for a particular case, it is recognised that there are situations where more than what is needed for one case has to be prepared at the same time. However, it is not acceptable for veterinarians to purposely set out to compound so much product that it has to be stored in anticipation of future use, or is distributed to other traders as this circumvents the normal regulatory requirements for registered veterinary medicines in routine use.

The expectation is that compounding should only happen in order to provide a product for a particular case. As such compounded veterinary medicines must not be advertised, promoted, or displayed for sale.

When decanting or breaking down a trade name product, veterinarians must ensure that:
1. The product is not altered in any material way, other than to change the original packaging and labelling;
2. No additional hazards are introduced through careless or inappropriate procedures during decanting or breaking down;
3. The choice of alternative packaging does not jeopardise the quality of the product; and
4. All the crucial information about the product is provided to the client, including the veterinarian's contact information and additional instructions.
[Show Explanatory Notes - Section 7]
Understanding Section 7

At times, a client may not be able to use all the product in the smallest pack size available. A veterinarian may, under the exemption from registration for compounding, decant off a portion of a liquid trade name product or break down a non-liquid/gas trade name product into smaller quantities. The veterinarian must ensure that:

The product is not altered in any material way other than to change from the original packaging and labelling;

No additional hazards are introduced through careless or inappropriate procedures during decanting or breaking down

The choice of alternative packaging does not jeopardise the quality of the product

All the crucial information about the product is provided to the client, including the veterinarian’s contact information and additional instructions.

Having breached the integrity of the trade name product, the veterinarian must take full responsibility for any adverse consequences.

When providing a dispensing service for restricted veterinary medicines authorised by any veterinarian outside the practice, veterinarians must:
1. Have the appropriate MAF ACVM recognition to trade in restricted veterinary medicines;
2. Ensure that the veterinary medicine is supplied only to a person who has the appropriate authorisation;
3. Be satisfied that the authorisation is authentic and the person requesting the veterinary medicine is the one authorised to purchase it;
4. Give effect to the instructions of the authorising veterinarian if it is a veterinary authorisation; and
5. Keep a record of the transaction with a copy of the authorisation.
[Show Explanatory Notes - Section 8]
Understanding Section 8

Veterinarians providing a dispensing service for restricted veterinary medicines have some particular responsibilities.

MAF recognises all veterinarians with a current VCNZ practising certificate to authorise the purchase and use of restricted veterinary medicines requiring veterinary authorisation. Quite separate from recognition to authorise the purchase and use of restricted veterinary medicines requiring veterinary authorisation, veterinarians with current VCNZ practising certificates are recognised by MAF to sell such products as part of their own clinical veterinary services.

However, this recognition does not give the veterinarian the authority:

To dispense/sell any restricted veterinary medicine that requires authorisation only via an approved operating plan.

To fill veterinary authorisations issued by veterinarians that are not part of the same veterinary clinical practice.

Some veterinarians may wish to operate a restricted veterinary medicine dispensing service (ie a veterinary pharmacy) to fill authorisations from:

Other veterinarians; or

Other persons recognised by MAF to authorise the purchase and use of restricted veterinary medicines via approved operating plans.

In order to do this the veterinarian must have an operating plan approved by MAF governing the sale of restricted veterinary medicines. MAF should be contacted for guidance on the development of operating plans.

The accepted standard of practice for providing this dispensing service is detailed in the MAF Performance and Technical Standard - Veterinarians recognised (under s62 of the ACVM Act) to issue a valid authorisation for the purchase and use of RVMs requiring veterinary authorisation.

The specific expectations around providing a dispensing service are listed in the Code and are self explanatory.

For a generic chemical to be used as a veterinary medicine veterinarians must:
1. Recognise that there has been
  1. No regulatory assessment of the chemical for that purpose;
  2. No regulatory control of the quality and fitness for purpose for treatment of animals
2. Address the risk management in an adequate manner;
3. Make the client aware of the situation and provide adequate risk management advice.
[Show Explanatory Notes - Section 9]
Understanding Section 9

See the glossary definition for generic chemical. Examples include methylene blue, zinc oxide, potassium permanganate and magnesium sulphate, but does not include chemicals that are active ingredients that would prompt the requirement for registration e.g. zinc bacitracin, chloramphenicol etc

Any veterinary medicine with a specific condition of registration that it is only to be administered by a veterinarian, must not be authorised, dispensed or sold by a veterinarian.

[Show Explanatory Notes - Section 10]
Understanding Section 10

There are currently no restricted veterinary medicines that have a condition of registration requiring that they can only be administered by a veterinarian. These are usually products that have sufficient risk to the safety and or welfare of people or animals that they should only be managed by an approved trader who supplies veterinarians, or a veterinarian.

Products with this particular condition of registration must also be kept locked in a controlled drug cabinet with veterinary access only.

Veterinarians must not use, recommend or authorise the use of veterinary medicines, prescription medicines, pharmacy-only medicines or restricted medicines (as defined in the Medicines Act 1981) for use on humans.

[Show Explanatory Notes - Section 11]
Understanding Section 11

Recommending or authorising the use of veterinary medicines for use on humans is illegal and unethical and needs no further explanation. It must not be done.

The Medicines Act 1981 contains a specific exemption allowing veterinarians to authorise the sale, supply or administration of prescription medicines (as defined in the Medicines Act 1981) for the treatment of animals under the care of that veterinarian. The same legal restraint applies to pharmacy-only medicines and restricted medicines. It is illegal and unethical for veterinarians to authorise the use of these medicines for the treatment of humans.

Veterinarians must be satisfied that protocols exist and are followed by all staff to securely store and monitor the use of any controlled drugs used within their business. Those protocols must include as minimum requirements that:
1. The storage of all controlled drugs (including those classified C5 in the Misuse of Drugs Act 1975 under Schedule 3 Part 5) must comply with section 28 of the Misuse of Drugs Regulations 1977;
2. Every instance of sale or use of a controlled drug must be linked to a veterinary consultation. There must also be an accurate record which can be readily reported and reviewed. Veterinary businesses that do not use a computerised medical record system that is able to quickly and easily report on the sale or use of each controlled drug, must record each individual sale or use in a Controlled Drug Register. This register must take the form of a bound volume with consecutively numbered pages set out and used as described in Form 1 Schedule 1 of the Controlled Drugs Regulations 1977;
3. Every six months the stock of all controlled drugs held must be counted and recorded. At these times, for every strength of each controlled drug, there must be a reconciliation of the opening stock, closing stock, purchases and sales. This must be documented along with a proper explanation for any volume or amount which is not accounted for in the reconciliation. Records of reconciliations must be kept for four years; and
4. Extraordinary variances in the reconciliation that cannot be explained or are thought to be due to unauthorised use must be reported to VCNZ.
[Show Explanatory Notes - Section 12]
Understanding Section 12

Schedules 1 to 3 of the Misuse of Drugs Act 1975 identify those drugs which pose a risk of harm to individuals or to society through misuse and refers to these products as controlled drugs. Veterinarians are expected to know which controlled drugs (and which trade name products containing controlled drugs) are used in their practice and what the requirements are to manage them in compliance with the legislation and this Code.

Controlled drugs commonly found in veterinary practices include but are not limited to: morphine, fentanyl, pethidine, buprenorphine, codeine, ephedrine, pseudoephedrine, diazepam, midazolam, pentobarbital and ketamine.

Section 28 of the Misuse of Drugs Regulations 1977 sets out the legal requirements for the custody of controlled drugs. These apply to any person in possession of a controlled drug for the purposes of sale or for use in the course of their profession.

A number of drugs identified in Part 5 of Class C may be used occasionally by veterinarians. These drugs pose a potential risk to society through misuse and VCNZ considers that it is appropriate for veterinarians to take steps to store these products securely.

All controlled drugs not required for immediate use must be locked up in a controlled drugs cupboard according to strict specifications set out in section 28. Immediate use means the amount of controlled drug which can be reasonably expected to be used in the course of the particular working day. At the end of the working day, those controlled drugs which have been available for immediate use must be locked up securely in the controlled drugs cupboard.

Veterinarians who carry controlled drugs in their vehicles for use in the course of their work must also comply with these requirements. Those controlled drugs not required for immediate use must be stored in a locked metal compartment securely fixed to the vehicle. If the vehicle is left unattended the veterinarian must take all reasonable steps to secure the vehicle against unlawful entry.

Section 41 of the Misuse of Drugs Regulations 1977 provides an exemption for practitioners (veterinarians, dentists and medical practitioners) removing the need for them to keep a Controlled Drug Register unless specifically required to by the Director General of Health. However, because of the potential for abuse, VCNZ considers that there is an overriding professional obligation for veterinarians to oversee and manage the use of controlled drugs to a higher standard than the obligations imposed by law.

All controlled drugs are either registered as prescription medicines (under the Medicines Act 1981) or as restricted veterinary medicines (under the Animal Compounds and Veterinary Medicines Act 1997). To authorise the use of controlled drugs for the treatment of animals, veterinarians must comply with sections 2, 3 and 5 of the Veterinary Medicines section of this Code. Veterinarians must have met the requirements for consultation, and have created and maintained appropriate records detailing the treatment decision.

Additionally, veterinarians must be able to quickly and easily produce a summary report detailing the use of controlled drugs within their practice for examination and review. It will be sufficient in those practices using proprietary computerised medical record software where the software programme can produce a report(s) summarising all sales and use of each dose size of each controlled drug for them to be able to generate such a report(s) on request. In situations where there is no computerised medical record programme, or the software programme cannot generate the required report a Controlled Drug Register must be kept.

The computer generated report referred to in i) above must include the following fields: authorisation date; name and address of client; name of patient; name and strength of controlled drug product; volume or amount used; and authorising veterinarian.

A Controlled Drug Register is a hard cover bound volume with consecutively numbered pages set out as described in Form 1 Schedule 1 of the Controlled Drugs Regulations 1977. Each page of this register must only be used for one kind and one strength of controlled drug. Controlled Drug Registers can be purchased.

Section 43 of the Misuse of Drugs Regulations 1977 sets out the legal expectations around stocktaking requirements for controlled drugs. These apply only to those people required under the regulations to keep a Controlled Drugs Register. Because of the exemption under section 41, veterinarians are not subject to this legal requirement. However, this Code requires, as part of responsible oversight of the use of controlled drugs in their practice, that veterinarians regularly reconcile the physical stock of these products against sales and purchases. An important component of this process is the need to account for variances. Where this reconciliation identifies stock of controlled drugs which cannot be accounted for the veterinarian must provide a reasonable and justifiable explanation must be provided.

The minimum frequency for regular stocktaking and reconciling controlled drugs is six monthly. All practices already undertake a stocktaking of their full inventory at least annually as part of their accounting procedures. This annual stocktaking and one other specific controlled drugs stocktaking six months later would allow practices to meet the requirements of this part of the Code.

Following stocktaking, the purchases and sales for each strength of every controlled drug used must be reconciled with the movement in the count of physical stock for those products. This reconciliation only needs to take account of the total volume of sales and purchases in the first instance. Only when the reconciliation for any particular controlled drug does not balance is there a need to investigate the circumstances and determine whether there is a reasonable explanation for the variance. This may involve the examination of individual sales and purchase transactions and the administrative process by which sales and purchases are recorded.

In situations where the reconciliation does not balance veterinarians are expected to explain the variance and take corrective action to ensure that the reconciliation balances next time. In situations where the variance is considered extraordinary and unable to be explained, or possibly associated with unauthorised use, veterinarians must notify VCNZ. Where corrective action is taken to improve the accuracy of future reconciliations but there continues to be extraordinary variances, this must be reported to VCNZ.

Documented records of the stocktaking and reconciliation process must be made and maintained for four years to allow review if needed.

There are a variety of strategies which can ease the burden of compliance with the above requirements:

Develop good systems to ensure that all purchases and use are accurately tracked.

Maintaining a logbook that tracks the purchase and use of full packs of controlled drugs is simple and will make reconciliation much easier.

Stocktake and reconcile use of controlled drugs more frequently. It may be easier in some practices to undertake this more often (monthly or quarterly) and not have to spend time reconciling large discrepancies every six months.

Consider reducing the number of controlled drugs used in the practice
- e.g. treatment options for urinary incontinence in dogs which are not controlled drugs.

Veterinarians must not advertise or display restricted veterinary medicines where such action has the potential to influence the end user's expectation about the necessity to use a specific product.

[Show Explanatory Notes - Section 13]
Understanding Section 13

The MAF document "Advertising guidelines for products registered under the Animal Compounds and Veterinary Medicines Act 1997" (www.foodsafety.govt.nz/elibrary/industry/advertising-guidelines-acvm.pdf) sets out MAF expectations under the Animal Compounds and Veterinary Medicines Act 1997 regarding the standards to be maintained by veterinarians when advertising and promoting veterinary medicines. Veterinarians are expected to know and comply with the requirements detailed in this document.

Veterinarians may advertise or promote (including offering purchasing incentives) restricted veterinary medicines to end users provided there is no specific condition of registration prohibiting this. However, they must explicitly state that the product is only available under veterinary authorisation. Veterinarians should not advertise restricted veterinary medicines if it is likely to jeopardise the risk management role of the prescribing veterinarian. In all cases, the veterinarian should emphasise that end users should discuss treatment options with their veterinarian. The over-riding principle is that advertising must not be used to affect the decision to authorise the use of the product.

Particular veterinary medicines will have a specific condition of registration that prohibits advertising to end users. For such products there is no discretionary judgement to be made. The products must not be advertised or promoted, and no purchase incentives may be offered.

Restricted veterinary medicines should not be displayed in public view such that the products themselves or their labels might influence the purchasing decision.

For further information refer to the Professional Integrity Code Section 9 and explanatory notes

Flowchart of Veterinary Medicine Supply

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Veterinary Medicines

Glossary